Ward Dean And James South

You are taking comments out of context here.

I don't think so. Mchael's remark is a simple, declarative statement. If the rest of the post that you quoted followed that remark with several documented reasons to support his opinion of South, then I would apologize for my hasty inferences, but that is exactly the material that I would like to see. I doubt that Michael did so, in this case, at least.

I don't believe in this magic just like I don't see any evidence that the individual you referenced has ever prescribed Piracetam to any of his patients. In fact, wouldn't that technically be impossible considering Piracetam isn't in the USP?

It depends upon how you define prescription. Dr. Fulton prescribes Piracetam as part of a cognitive enhancement mix for my father (a healthy, but aging, individual) through Kronos's compounding pharmacy. I am afraid that you shall simply have to take my word for that, though.

Yeah, I guess it sorta sounds "cool" to be "anti establishment" if ya know what I mean.  However, I won't be fooled by silly magic tricks.

Lol. I am the last to be anti-establishment in this area merely for the sake of it. I despise unqualified and unethical health hucksters as much as you do. So, I look for scientific evidence, as well. However, I also will not be fooled by the blinkered stupidity of those who feel that, unless the Gods behind the AMA and the FDA wholeheartedly approve of something, then it must be quackery. From what I have seen, QuackWatch at times falls into that category, which is unfortunate, since I feel that it potentially provides a very valuable service. At any rate, I try to achieve a healthy balance between scientific rigor and an open-minded acknowledgment of the fact that the contemporary American medical establishment is not omniscient.

Take care, as well.

[quote name='aldebaran']I don't think so. Mchael's remark is a simple, declarative statement. If the rest of the post that you quoted followed that remark with several documented reasons to support his opinion of South, then I would apologize for my hasty inferences, but that is exactly the material that I would like to see. I doubt that Michael did so, in this case, at least.[/quote]

Okay, I suppose if you are using the number two (#2) definition of criticism below...first, let's define criticism:

[quote name='http://www.m-w.com/cgi-bin/dictionary?book=Dictionary&va=criticism']Main Entry: crit·i·cism
Pronunciation: 'kri-t&-"si-z&m
Function: noun
1 a : the act of criticizing usually unfavorably b : a critical observation or remark c : CRITIQUE
2 : the art of evaluating or analyzing works of art or literature; also : writings expressing such evaluation or analysis
3 : the scientific investigation of literary documents (as the Bible) in regard to such matters as origin, text, composition, or history[/quote]

Now, let me place Michael's comments into context:

[quote name='Michael']There really is a lot of bunk in the supplement and 'smart drug' world, and he's right to demand evidence, and not the all-too-typical and frankly embarrassing citation of anecdotes and popular articles written by salespeople as documentation."

...

In (1), "Nootropyl (Piracetam) ... was tested for its effect on man by administering it to normal volunteers. The subjects were given 3x4 capsules at 400 mg per day, in a double blind study. Each subject learned series of words presented as stimuli upon a memory drum. No effects were observed after 7 days but after 14 days verbal learning had significantly increased."

(2) was "A double-blind, intra-individual cross-over comparison of the mental performance of 18 aging, non-deteriorated individuals ... with reduced mental performance possibly related to disturbed alertness" "during two 4-week periods of piracetam (1-acetamide-2-pyrrolidone) and placebo administration performed using conventional and computerized perceptual-motor tasks. In a majority of these tasks the subjects did
significantly better when on piracetam than on placebo, a finding consistent with ratings completed by two independent observers." How close to normal aging, and how relevant to the youthful and healthy, is open to some question. A review (11) adds the following, not stated in the abstract: " Moderate but statistically significant improvements (up to 12% vs placebo; p < 0.05) in a range of assessments of cognition were obtained in 18 healthy individuals aged 50 years or more who received piracetam as part of an 8-week, doubleblind crossover study. However, individuals' own ratings of their mental and psychological condition did not reveal any significant differences between piracetam and placebo. "

I DO have copies of the full texts of these trials (1,2) hidden away in my files somewhere, but I'll not be able to look into them to get more details for a month or two; anyone with easy access, please do report.

(6) summarizes (4) VERY briefly thus: "Five double-blind controlled studies in normal adults have used tests of verbal learning and memory; in all the published studies piracetam was superior to placebo in verbal function {citing my (1,2,4,5,9) -MR}." (11), likewise, includes it with (1,2) as being among "A small number of placebo-controlled studies {that} have shown that piracetam improves aspects of mental performance in healthy volunteers." Unfortunately, (4) is in German and unavailable to me.

Further details are alleged to be provided by this article on piracetam by James South: "Giurgea and Salama {my (3) below -MR} report the confirmation of Dimond/Brouwer's work by Wedl and Suchenwirth in 1977 {my (4) below -MR}. Wedl found significant improvement in mental performance in a group of 17 healthy young volunteers given 3.2 grams per day Piracetam for five days." Unfortunatel again, (3) is not even a MEDLINE-indexed item; moreover, Giurgea does seem to be a somewhat 'tainted' source, as the inventor of piracetam and long-term UCB employee. Further, James South is, in my opinion, a very unreliable source of information on drugs and supplements.[/quote]

I believe Michael might be trying to point out some obvious conflict of interest issues as I also tried to above. Also; in my view, Michael isn't going to be happy with extrapolations from animals to humans; nor do I believe he would accept evidence from aged and demented individuals and extrapolate that onto a healthy population; and it seems South might be perhaps a bit more liberal with his extrapolations than some might prefer.

[quote name='aldebaran']It depends upon how you define prescription. Dr. Fulton prescribes Piracetam as part of a cognitive enhancement mix for my father (a healthy, but aging, individual) through Kronos's compounding pharmacy. I am afraid that you shall simply have to take my word for that, though.[/quote]

Piracetam is not a prescription drug in the USA and therefore cannot be legally be administered in a traditional clinical setting. The reason no US Medical Doctor openly advocates the use of Piracetam might be because Doctors prefer to avoid expensive malpractice lawsuits.

[quote name='http://www.legal-explanations.com/definitions/malpractice.htm']Malpractice
(n) Malpractice is engaging in some activities or involving in some procedure which are not normally expected from them as a prudent and professionally accepted method. The person doing malpractice is liable for damages. Eg. the attorney pass on the secrete information to the opposite advocate amounts to a malpractice[/quote]

If there is a substantial body of peer reviewed evidence that might suggest that Piracetam (or any other drug or supplement for that matter) could measurably improve cognitive performance in healthy individuals, that still wouldn't automatically make it legal to prescribe in a clinical setting. At this time, the FDA does not recognize cognition enhancement for healthy individuals as a therapeutic option; therefore, even if there was a body of peer reviewed evidence that might suggest that a particular drug or supplement could improve cognitive performance in healthy individuals, that still wouldn't necessarily automatically make it legal for a physician to recommend for his or her patients.

At this time, the only real evidence of a true cognitive performance enhancing drug comes from research on Provigil (modafinil). So, if we wish to prove that Piracetam is an effective cognitive enhancer for healthy individuals, we should conduct the proper research before coming to any premature conclusions of efficacy.

[quote name='aldebaran']Lol. I am the last to be anti-establishment in this area merely for the sake of it. I despise unqualified and unethical health hucksters as much as you do. So, I look for scientific evidence, as well. However, I also will not be fooled by the blinkered stupidity of those who feel that, unless the Gods behind the AMA and the FDA wholeheartedly approve of something, then it must be quackery. From what I have seen, QuackWatch at times falls into that category, which is unfortunate, since I feel that it potentially provides a very valuable service. At any rate, I try to achieve a healthy balance between scientific rigor and an open-minded acknowledgment of the fact that the contemporary American medical establishment is not omniscient.[/quote]

Good; because I know several people who are.

I also think it's a little bit presumptuous to blame the AMA and the FDA for everything; also, who says you need Quackwatch? I've heard that Quackwatch is pretty much for medical industry "newbs" who don't know how to find their state medical board to run the history on their doctor. I mean, if you can find out yourself that your Doctor has been convicted of multiple counts of malpractice and medical insurance fraud all on your own, who needs Quackwatch?

[quote name='aldebaran']Take care, as well.[/quote]

Thank you again for your consideration. I do enjoy debating with you because you stick to the data and don't degenerate into ad hominems.

Click HERE to rent this advertising spot for BRAIN HEALTH to support LongeCity (this will replace the google ad above).

it seems South might be perhaps a bit more liberal with his extrapolations than some might prefer.

Because South has always endeavored meticulously to document his articles using independent scientific references, the potential "conflict of interests" aspect of his work does not bother me so much. I think that you have a point regarding the extrapolations, though.

Piracetam is not a prescription drug in the USA and therefore cannot be legally be administered in a traditional clinical setting. The reason no US Medical Doctor openly advocates the use of Piracetam might be because Doctors prefer to avoid expensive malpractice lawsuits.

Here, I am a little puzzled. I thought that Piracetam was classified as a dietary supplement in the U.S. If that is the case, then wouldn't it be legal to prescribe it, just as it would be legal to prescribe B vitamins or folic acid for a vitamin deficiency? Also, don't American physicians have great leeway to prescribe most medications "off list" (I believe that that is the term)?

At any rate, perhaps the best way to clear the potential confusion here is for me simply to ask the doctor I mentioned for what purpose he prescribes Piracetam, exactly. I should have an appointment with him during the next month or so, and I shall try to report his answers here when I do, if there is interest.

So, if we wish to prove that Piracetam is an effective cognitive enhancer for healthy individuals, we should conduct the proper research before coming to any premature conclusions of efficacy.

As I stated before, I agree that more rigorous and modern studies are necessary in this area.

I also think it's a little bit presumptuous to blame the AMA and the FDA for everything; also, who says you need Quackwatch?

I agree, regarding the AMA and the FDA, and such blame is not my purpose. I do think that they tend to be often over-conservative and narrow-minded, though, and my criticism was aimed at that aspect of what are otherwise very worthwhile organizations.

As for QuackWatch, you are quite right; who needs them, indeed? I have seen them referenced here a few times, though, so a comment seemed in order. My practice before seeing a new doctor is always to contact the state medical board to obtain a list of malpractice claims, complaints, and the like.

Thank you again for your consideration. I do enjoy debating with you because you stick to the data and don't degenerate into ad hominems.

Not a problem. Like most others, I've lost my temper in these sorts of fora before, but I really do try to watch that. As the cliche goes, a good debate should generate more light than heat. The aim should not be to try to score points, but to provide alternative views of a given subject, so that the participants and whoever is following the debate can all benefit from the various perspectives and evidence, if any, on offer, and make up their own minds.

Because South has always endeavored meticulously to document his articles using independent scientific references, the potential "conflict of interests" aspect of his work does not bother me so much. I think that you have a point regarding the extrapolations, though.

As Michael noted, it appears there might be a case in which there is a reference to a non Pubmed indexed publication:

Further details are alleged to be provided by this article on piracetam by James South: "Giurgea and Salama {my (3) below -MR} report the confirmation of Dimond/Brouwer's work by Wedl and Suchenwirth in 1977 {my (4) below -MR}. Wedl found significant improvement in mental performance in a group of 17 healthy young volunteers given 3.2 grams per day Piracetam for five days." Unfortunately again, (3) is not even a MEDLINE-indexed item; moreover, Giurgea does seem to be a somewhat 'tainted' source, as the inventor of piracetam and long-term UCB employee. Further, James South is, in my opinion, a very unreliable source of information on drugs and supplements.

3. C. Giurgea, M. Salama (1977) "Nootropic drugs" Prog. Neuro-Pharmac. 1.235-47. [Cited by James South article].

...and also, as Michael seems to have pointed out -- this is a reference from a publication that was conducted by the original patent holder and inventor (is inventor the right word? Or is it discoverer?) of Piracetam; so the combination of a reference that is not publicly available at Medline and the fact that the study in question was conducted by the patent holder and inventor of the respective compound...brings up the issue again of bias, conflict of interest -- that might make the reference in question appear to have serious credibility issues.

Here, I am a little puzzled. I thought that Piracetam was classified as a dietary supplement in the U.S. If that is the case, then wouldn't it be legal to prescribe it, just as it would be legal to prescribe B vitamins or folic acid for a vitamin deficiency? Also, don't American physicians have great leeway to prescribe most medications "off list" (I believe that that is the term)?

It seems to be true that Piracetam is classified as a "dietary supplement." However, it is probably a good idea to also note that this "dietary supplement" classification is a default for a lot of substances that have little to no scientific support and might in fact be dangerous. Here are some important facts to note about the supplement market:

Consumer Reports (May 2004) and the “Dirty Dozen” unsafe herbs still readily available

· “CONSUMER REPORTS has identified a dozen (supplements) that … are too dangerous to be on the market. Yet they are.” Introductory paragraph in red ink.

· Factors contributing to unsafe supplements on the market.

· “ ‘The standards for demonstrating a supplement is hazardous are so high that it can take the FDA years to build a case,’ said Bruce Silverglade, legal director of the Center for Science in the Public Interest, a Washington D.C., consumer advocacy group”(pg. 12).

· “The FDA’s supplement division is understaffed and underfunded, with about 60 people and a budget of only 10 million “dollars)…” (pp. 12-13).

· “…Overwhelming opposition from Congress and industry forced it to back down” when the FDA first tried to regulate ephedra in 1997 (pg. 13).

· The public assumes a greater degree of government regulation than exists – in a 2002 Harris Poll of 1010 adults, 59% of respondents believed that supplements must be approved by a government agency before they can be sold to the public, 68% thought the government requires warning labels on supplements with regard to potential dangers, and 55% thought that supplement manufacturers could not make safety claims without solid scientific support.

Also note:

DEFINITION OF DIETARY SUPPLEMENT

FDA traditionally considered dietary supplements to be composed only of essential nutrients, such as vitamins, minerals, and proteins. The Nutrition Labeling and Education Act of 1990 added "herbs, or similar nutritional substances," to the term "dietary supplement." Through the DSHEA, Congress expanded the meaning of the term "dietary supplements" beyond essential nutrients to include such substances as ginseng, garlic, fish oils, psyllium, enzymes, glandulars, and mixtures of these.

The DSHEA established a formal definition of "dietary supplement" using several criteria. A dietary supplement:

1) is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.

2) is intended for ingestion in pill, capsule, tablet, or liquid form.

3) is not represented for use as a conventional food or as the sole item of a meal or diet.

4) is labeled as a "dietary supplement."

5) includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

A medical doctor is just like a normal person in most cases. However, there is a little something called a doctor/patient relationship...

Medicine

Until the early decades of the twentieth century, methods of treating disease were rooted in local customs and beliefs, not in a professional or scientific consensus. The medicine practiced in one area or by one group was often quite different from medicine elsewhere.

In rural America, laypeople combined local folk custom with information gleaned from medical dictionaries and popular texts to treat injuries and illnesses. Similarly, doctors, not yet an elite professional group, were usually trained through a combination of schooling and apprenticeship. A large number of medical schools were business institutions organized for the profit of local practitioners. Students, often from lower-middle- or working-class backgrounds, paid to attend lectures of dubious worth. Formal medical education, largely unregulated, could vary in length, content, and structure, and after 1847, when the American Medical Association (ama) was formed, its lack of standardization was much criticized.

Few during the nineteenth century agreed on what constituted appropriate practice. Furthermore, most doctors and educated people were skeptical of those who sought to unify medicine under any one therapeutic umbrella. Calls for uniformity were perceived as little more than a political ploy to gain a measure of legitimacy for a particular medical interest group. Throughout much of the century, the disparate demands of different groups created a diverse body of therapeutic knowledge and practice. Accordingly, training differed for rural doctors, urban doctors, homeopaths, allopaths, eclectics, Thomsonians, and a host of others. Those treating different classes and ethnic groups were forced by the realities of the medical marketplace to adjust their practice.

Each group of practitioners identified with a particular "school" or "sect" of medicine. Rural doctors depended mostly on herbal treatments. Thomsonians and later the eclectics were among the botanical schools that developed throughout rural New England, the South, and the Midwest; these groups incorporated local folk customs into their therapeutics. In cities regular practitioners, homeopaths, and many others competed with one another for patients. Thus, unlike today, when patients have little control over the types of therapies used, patients in nineteenth-century America could choose among a wide variety of therapies.

Doctors, by and large, were "family" or "community" practitioners engaged in general medicine; only a small number specialized in surgery, ophthalmology, or other areas. Family doctors, the bulk of the profession, lived in the communities where they practiced, making house calls or treating patients in offices located in their homes. Often they and their patients were members of the same church or club. The family doctor would preside at the significant events in people's lives, tending to births as well as deaths. He saw it as his role to comfort the family, and it was not unusual for him to move into a patient's house for the duration of an illness.

This relationship between doctors and patients was not necessarily a product of a deep-seated belief in democracy or in the importance of trust and understanding in the therapeutic process. Rather, it was an outgrowth of the professional environment. These doctors were working in an era of great uncertainty concerning medical procedures and outcomes, and they were in severe competition with one another for clients. A large number of medical schools combined with loose licensure requirements produced an oversupply of practitioners. Without the options of research positions in universities, hospitals, or institutes, and without specialized forms of practice, doctors depended on the goodwill of their patients for their economic survival. Competition for patients was fierce by the end of the century, and familiarity, a pleasant demeanor, courteousness, and understanding were essential qualities for the successful doctor.

Because medical knowledge was sketchy and doctors depended on their patients for a living, they tended to practice in familiar ways that were accepted by their patients. This does not mean that they did not believe in their treatments, but that in many ways their knowledge was not much more sophisticated than that of their patients. Most doctors employed bleeding, cupping, purging, and other seemingly draconian measures to treat their patients. Because illness was often equated with moral failings, what we see as cruelty was viewed then as an appropriate consequence of transgressions.

Those who rejected regular therapeutics could turn to other, milder forms of practice. Appealing to merchants and other urban groups, homeopathy provided milder therapies and perhaps more elegant rationales. What might have been lacking in scientific rigor was made up for by the intimacy of practice itself. The authority of the practitioner rested as much on his social relationship to his patient as it did upon scientific fact.

Around the turn of the century a significant movement arose devoted to reforming medical education. By standardizing the training of physicians and controlling entry into the profession through licensure, reformers hoped to make medical practice itself more uniform. The movement culminated in the now-classic Carnegie Bulletin Number Four, or the "Flexner Report," which called for the reorganization of medical school curricula.

The report, named for its author, Abraham Flexner, illustrates some of the divisions within the medical community during these years and the centrality of arguments regarding standardization to those who sought to influence the health system. First, it called for the establishment of a common medical education built around laboratory science and two years of clinical experience as well as lectures. Second, it asserted that the guiding principles of professional behavior should be determined by the "science" of medical practice rather than the "art" of individual attention. Like the busy machine shops and industrial factories that were proving so successful in turning the country into an industrial power, medicine would be turned into a technically exact scientific enterprise. Finally, it called for the exclusion of women, blacks, and the poor from practice.

The Flexner Report, the product of a long, rancorous struggle among educators on the ama's Council on Medical Education, achieved only some of its aims. Medical practice would remain a field filled with uncertainties and nonstandardized procedures, but the standardization of the social background of doctors would be realized. By the end of the nineteenth century, the eclectic nature of medical practice and the unregulated environment in which it had developed had created a large, diverse set of educational institutions that catered to women, black, and poorer students. In fact, there were sixteen women's medical schools by 1900 and ten black medical colleges, primarily in the southern states, by the same year. Also, the majority of students attending the various medical colleges were lower or lower middle class. But, by 1916, only two female women's colleges and two black schools remained in existence, and many of the proprietary institutions that had catered to part-time and working students had closed.

Reformers saw little need to protect these poorly endowed institutions in part because they believed that the future of scientific medicine would make social diversity within its ranks unimportant. If the physician of the future was to be a scientist treating patients regardless of social class or race, then there was little need to protect certain groups in medicine; doctors were to treat organs rather than people. In Flexner's model, white upper-middle-class male physicians would add to the social status of the profession without sacrificing the quality of care. Flexner's discussion of the future of the "Poor Boy," "Women," and "Negros" in medicine showed a simplistic, naive belief in the ability of medical science to resolve the issues of equity and equality that became the central concerns of health planners in the 1960s and 1970s.

Although the effect of the reform movement had profound implications for the social characteristics of American physicians, it had less of an impact on their practices. By and large, doctors were still tied to their private offices and were very defensive about "interference" from those seeking to standardize or evaluate their treatments. With no central organization capable of oversight, doctors adopted the mantle of science and the aura of scientists while maintaining their autonomy over treatment and procedure.

In recent years, however, the medical profession has faced a series of crises that have undermined its autonomy and undercut its authority. The staggering increase in the costs of basic health services and the growing skepticism of Americans with regard to professional dominance have produced a variety of movements to find alternatives to traditional forms of care. The 1960s saw a critique of medicine that emphasized the maldistribution of physicians, their extraordinary incomes, and the elitist, conservative nature of the ama. Further, the dearth of hospital and physicians' services for the nation's poor added an obvious political dimension to the arguments over the medical profession.

These critiques spurred broad efforts to reform the health system. First, the long-standing struggle to enact a national health insurance plan culminated in the 1965 passage of Medicaid for the poor and disabled and Medicare for the elderly. Second, the argument that there were too few physicians provided a rationale for rapidly expanding the number of medical schools. Third, the argument that existing services were badly distributed and unable to address the pressing needs of the nation's poor led the Office of Economic Opportunity (oeo) within the Department of Health, Education, and Welfare to organize innovative programs to provide services to the urban poor. The oeo, for example, funded such efforts as the Urban Corps, which awarded scholarships to medical students in return for a commitment to serve poor communities and neighborhood health centers.

Another criticism during the 1960s and 1970s grew out of the women's movement. Critics attacked the male dominance of the profession and pressed for greater participation of women. As a result, the numbers of women entering the medical profession increased dramatically.

All these complaints reflected a growing sense that medicine had become far too removed from the population it served and that the sensitivity of medical practice to patient needs had been sacrificed on the altar of science and technology. By the late 1960s, some had begun to question the efficacy of medicine itself; critics contended that despite its increased costliness, it had done little or nothing to improve the overall health of the nation. Some even argued that medicine could be harmful--that it could cause iatrogenic (physician-caused) diseases. By the 1980s, the negative perceptions of medicine and its practitioners had had a strong impact: malpractice lawsuits skyrocketed in number and more restrictions were placed on educational subsidies for specialist training and undergraduate medical education.

Moreover, in the 1980s, lawyers, courts, ethicists, and philosophers began to explore questions that had previously been the preserve of the medical community alone. When should medical procedures be used to terminate pregnancies? Should physicians be allowed to use technology indefinitely to prolong life? Who should provide care and what type of care should be provided for the terminally ill? Only twenty years before, the general critique of medicine had argued that there were too few physicians and that more services were needed. The assumption was that medicine was a universal good that should be readily available to everyone. But the deep questioning of the efficacy of medicine and of the system had led to profound ethical and political debates that are still being argued.

Bibliography:

Charles Rosenberg, The Care of Strangers (1987); David Rosner, A Once Charitable Enterprise: Hospitals and Health Care in Brooklyn and New York (1981); Rosemary Stevens, In Sickness and in Wealth (1988).


Author:

David Rosner

A Medical Doctor can prescribe or advise his or her patient to take any substance...however, if it is a recommendation from a real (board certified, licensed, relatively and respectively clean criminal and medical record) doctor -- there is, of course, the issue of malpractice that could threaten his or her practice. The only way Piracetam could be prescribed legally in a clinical setting is for the FDA to recognize it as an effective drug and place it into US Pharmacopeia . Until then, the Doctor is risking a malpractice suit -- if he or she prescribes it to his or her patient to treat a condition that otherwise could be addressed through more conventionally (or "well established") accepted methods.

Medical malpractice is an act or omission by a health care provider which deviates from accepted standards of practice in the medical community and which causes injury to the patient. In the United States and other countries, a specific medical malpractice law has developed. In English law, the issue of liability is a subset of professional negligence where, under the Bolam Test, a doctor will be liable unless shown to have acted in accordance with a reasonable body of medical opinion. In Australia, this test has been replaced but the principles are comparable. In recent years doctors have blamed these types of lawsuits for large rate increases in medical malpractice insurance, resulting in calls from some groups for tort reform.

The medical malpractice claim

The parties
The plaintiff is the patient, a legally designated party acting on behalf of the patient, or by the executor or administrator of a deceased patient's estate (in the case of a wrongful death suit).

The defendant is the health care provider. Although a 'health care provider' usually refers to a physician, the term includes any medical care provider, including dentists, nurses, and therapists. Relying on vicarious liability or direct corporate negligence, claims may also be brought against hospitals, clinics, managed care organizations or medical corporations for the mistakes of their employees.

Elements of the case
A plaintiff must establish all four of the following elements, for a successful medical malpractice claim.[1]

A duty was owed - a legal duty exists whenever a hospital or health care provider undertakes care or treatment of a patient.
A duty was breached -- the provider failed to conform to the relevant standard of care. The standard of care is proved by expert testimony or by obvious errors (the doctrine of res ipsa loquitor or 'the thing speaks for itself').
The breach caused an injury -- The breach of duty was a proximate cause of the injury.
Damages -- Without damages (losses which may be pecuniary or emotional), there is no basis for a claim, regardless of whether the medical provider was negligent.

The trial
Like all other tort cases, the plaintiff (or the plaintiff's attorney) files a lawsuit in a court with appropriate jurisdiction. Between the filing of suit and the trial, the parties (or their attorneys) are required to 'share information' through a process known as discovery. Such information includes interrogatories, requests for documents, and depositions. If both parties agree, the case may be settled early on negotiated terms. If the parties cannot agree, the case will proceed to trial.

The plaintiff has the burden of proof to prove all the elements by a preponderance (51%) of evidence. At trial, both parties will usually present experts to testify as to the standard of care required, and other technical issues during trial. The fact-finder (judge or jury) must then weigh all the evidence and determine which is the most credible.

The factfinder will render a verdict for the prevailing party, and asseses the compensatory and punitive damages, within the parameters of the judge's instructions. The verdict is then reduced to the judgment of the court. The losing party may move for a new trial. In a few jurisdictions, a plaintiff who is dissatisfied by a small judgment may move for additur. In most jurisdictions, a defendant who is dissatisfied with a large judgment may move for remittitur. Either side may take an appeal from the judgment.

Expert testimony
Expert witnesses must be qualified by the Court, based on the prospective experts qualifications and the standards set from legal precedent. To be qualified as an expert in a medical malpractice case, a person must have a sufficient knowledge, education, training, or experience regarding the specific issue before the court to qualify the expert to give a reliable opinion on a relevant issue. The qualifications of the expert are not the deciding factors as to whether the individual will be qualified, although they are certainly important considerations. Expert testimony is not qualified "just because somebody with a diploma says it is so" (United States v. Ingham, 42 M.J. 218, 226 [A.C.M.R. 1995]). In addition to appropriate qualifications of the expert, the proposed testimony must meet certain criteria for reliabilty. In the United States, two models for evaluating the proposed testimony are used:

The more common (and some believe more reliable) approach used by all federal courts and most state courts is the 'gatekeeper' model, which is a test formulated from the US Supreme Court cases Daubert v. Merrell Dow Pharmaceuticals (509 U.S. 579 [1993]), General Electric Co. v. Joiner (522 U.S. 136 [1997]), and Kumho Tire Co. v. Carmichael (526 U.S. 137 [1999]. Before the trial, a Daubert hearing[2]will take place before the judge (without the jury). The trial court judge must consider evidence presented to determine whether an expert's "testimony rests on a reliable foundation and is relevant to the task at hand." (Daubert, 509 U.S. at 597). The Daubert hearing considers 4 questions about the testimony the prospective expert proposes:

Whether a "theory or technique . . . can be (and has been) tested"
Whether it "has been subjected to peer review and publication".
Whether, in respect to a particular technique, there is a high "known or potential rate of error"
Whether there are "standards controlling the technique's operation".
Some state courts still use the Frye test that relies on scientific consensus to assess the admissibility of novel scientific evidence. Daubert expressly rejected the earlier federal rule's incorporation of the Frye test. (Daubert, 509 U.S. at 593-594) Expert testimony that would have passed the Frye test is now excluded under the more stringent requirements of Federal Rules of Evidence as construed by Daubert.

In view of Daubert and Kuhmo, the pre trial preparation of expert witnesses is critical. [3]


Damages
The plaintiff's damages may include compensatory and punitive damages. Compensatory damages are both economic and non-economic. Economic damages include financial losses such as lost wages (sometimes called lost earning capacity), medical expenses and life care expenses. These damages may be assessed for past and future losses. Non-economic damages are assessed for the injury itself: physical and psychological harm, such as loss of vision, loss of a limb or organ, the reduced enjoyment of life due to a disability or loss of a loved one, severe pain and emotional distress. Punitive damages are only awarded in the event of wanton and reckless conduct.

Statistics on malpractice and preventable medical error
Main article: Medical error
Medical malpractice claims can help identify areas where primary health care in the United States needs improvement, according to the American Academy of Family Physicians. The Academy refers to a study entitled "Learning from Malpractice Claims about Negligent, Adverse Events in Primary Care in the United States", in suggesting that the medical community can learn from tort claims. In that study, researchers looked at primary care malpractice claims settled between 1985 and 2000 in the United States. The study focused on a subset of 5,921 claims that were clear errors. The researchers found:

68 percent of the errors were in outpatient settings and resulted in more than 1,200 deaths.
Negligence was more likely to have severe outcomes when they occurred in hospitals, but the total number of high severity outcomes and death was larger in the outpatient setting.
Of the 10 most prevalent medical conditions with error-related claims, no single condition accounted for more than five percent of all negligent claims.
Diagnostic error accounted for more than one-third of the claims.[4]
A recent study by Heathgrades found that an average of 195,000 hospital deaths in each of the years 2000, 2001 and 2002 in the U.S. were due to potentially preventable medical errors. Researchers examined 37 million patient records and applied the mortality and economic impact models developed by Dr. Chunliu Zhan and Dr. Marlene R. Miller in a study published in the Journal of the American Medical Association (JAMA) in October of 2003. The Zhan and Miller study supported the Institute of Medicine’s (IOM) 1999 report conclusion, which found that medical errors caused up to 98,000 deaths annually and should be considered a national epidemic. [5]

A 2006 follow-up to the 1999 Institute of Medicine of the National Academies study found that medication errors are among the most common medical mistakes, harming at least 1.5 million people every year. According to the study, 400,000 preventable drug-related injuries occur each year in hospitals, 800,000 in long-term care settings, and roughly 530,000 among Medicare recipients in outpatient clinics. The report stated that these are likely to be conservative estimates. In 2000 alone, the extra medical costs incurred by preventable drug related injuries approximated $887 million -- and the study looked only at injuries sustained by Medicare recipients, a subset of clinic visitors. None of these figures take into account lost wages and productivity or other costs.[6]

Criticism of Medical Malpractice Lawsuits
Some doctors' groups and insurance companies have criticized medical malpractice litigation, claiming the process is expensive, adversarial, unpredictable, and inefficient. They claim that the cost of medical malpractice litigation in the United States has steadily increased at almost 12% percent annually since 1975.[7], and an estimated 60% of malpractice lawsuit expenses are now consumed by administrative, or transaction, costs (eg, lawyer fees, expert witness charges, court costs), as compared with 25% to 30% for systems such as workers' compensation. Jury Verdict Research, a database of plaintiff and defense verdicts, says awards in medical liability cases increased 43 percent in 1999, from $700,000 to $1,000,000.

These critics assert that these rate increases are causing doctors to go out of business or move to states with more favorable tort systems.[8] Not everyone agrees, though, that medical malpractice lawsuits are solely causing these rate increases. A 2003 report from the General Accounting Office found multiple reasons for these rate increases, only one of which was medical malpractice lawsuits.[9]

Tort reform advocate Common Good has proposed creating specialized medical courts (similar to existing administrative tax or workmen's comp court proceedings) where medically-trained judges would evaluate cases and subsequently render precedent-setting decisions. Proponents believe that giving up jury trials and scheduling noneconomic damages such as pain and suffering would lead to more people being compensated, and to their receiving their money sooner. While this proposal has been criticised as depriving Americans of their right to a trial by jury, a number of groups have supported this proposal, including doctors' lobbying groups such as the AMA[citations needed], Forbes[citations needed] magazine, USA Today and Wall Street Journal editorial pages.[10] Other tort reform proposals, some of which have been enacted in various states, include placing limits on noneconomic damages and collecting lawsuit claim data from malpractice insurance companies and courts in order to assess any connection between malpractice settlements and premium rates.[11]

In contrast, trial lawyers have asserted that the medical malpractice crisis is a myth. In May 2006, the study "Claims, Errors, and Compensation Payments in Medical Malpractice Litigation" was released by the Harvard School of Public Health. This study supported a trial lawyer position that in most cases the claimants were entitled to compensation. According to the study, "the vast majority of expenditures go toward litigation over errors and payment of them."

Medical malpractice cases seem to be a real money maker for the legal industry...

At any rate, perhaps the best way to clear the potential confusion here is for me simply to ask the doctor I mentioned for what purpose he prescribes Piracetam, exactly. I should have an appointment with him during the next month or so, and I shall try to report his answers here when I do, if there is interest.

If I were you, I might consider refraining from asking your Doctor to comment on Piracetam with application to "you" -- his or her legal "patient." Maybe try to make up a hypothetical "friend" who was thinking of taking Piracetam -- that way the Doctor might be able to tell you what he or she thinks without having him or her worry so much about a lawsuit. Also it might be a wise idea to bring in some peer reviewed papers so the respective individual can take a look at what the rest of the medical community might think on the matter.

As I stated before, I agree that more rigorous and modern studies are necessary in this area.

I believe the necessary studies can be conducted to investigate whether or not Piracetam is an effective cognition enhancer. However, considering Piracetam is no longer patented -- the incentive of conducting such research is small -- therefore it might gain little or no financial support when more potentially profitable compounds can be investigated at greater returns. I am still optimistic that soon such research will be conducted; however. I'm working on a possible solution.

I agree, regarding the AMA and the FDA, and such blame is not my purpose. I do think that they tend to be often over-conservative and narrow-minded, though, and my criticism was aimed at that aspect of what are otherwise very worthwhile organizations.

The FDA and AMA are heavily influenced by public opinion; politicians write the policies that dictate the FDA regulations and enforcement...the AMA is supposed to be scientific, so strong evidence is required. Peer reviewed journals with highest impact factors are obviously "the" place to have your research published should we wish to bring cognition enhancement into the limelight. Dr. Danielle Turner et. al's publication on cognitive enhancement in healthy subjects (using modafinil) is -- thus far -- the only publication that holds water in this respect.

As for QuackWatch, you are quite right; who needs them, indeed? I have seen them referenced here a few times, though, so a comment seemed in order. My practice before seeing a new doctor is always to contact the state medical board to obtain a list of malpractice claims, complaints, and the like.

For me -- if it quacks, it's a duck. I don't need to visit Quackwatch. These days you can even run criminal histories on your ex girl friends (for a small fee, of course!) thanks to http://www.intelius.com/. You don't even need the state board anymore except often to see if a physician is licensed or not...

Not a problem. Like most others, I've lost my temper in these sorts of fora before, but I really do try to watch that. As the cliche goes, a good debate should generate more light than heat. The aim should not be to try to score points, but to provide alternative views of a given subject, so that the participants and whoever is following the debate can all benefit from the various perspectives and evidence, if any, on offer, and make up their own minds.

I like that..."good debate should generate more light than heat."

Take care, see you around.

Edited by nootropikamil, 13 December 2006 - 06:56 PM.

Michael seems to have pointed out -- this is a reference from a publication that was conducted by the original patent holder and inventor (is inventor the right word? Or is it discoverer?) of Piracetam; so the combination of a reference that is not publicly available at Medline and the fact that the study in question was conducted by the patent holder and inventor of the respective compound...brings up the issue again of bias, conflict of interest [...]

I agree that the concerns Michael indicates are potentially valid ones, and that they are worth considering. It is, however, the "further" that caught my eye in his statement regarding South''s lack of reliability. In other words, it seems that Michael is adducing South's alleged lack of reliability as more evidence of his critique, and is not merely limiting it to the issue at hand in his post.

Also, while I agree that it is problematic for an inventor of a substance and an employee of the company that produces it to publish studies favorable to his drug, it seems also problematic to chase such a person from the field and forbid him from doing so. I thought that the solution to such a dilemma was to publish in peer-reviewed journals. I do not know how damning it is to be published in a non Medline-indexed source, but it would be damning, indeed, to publish such research in a non peer-reviewed journal.

Further, do you or anyone else know for what journal this citation form, " Prog. Neuro-Pharmac.", stands? I ran a Google search using this abbreviation, and could find only the references to it in South's article and in this forum. That fact suggests to me the possibility that the citation form in South's article could be incorrect. Until we know the journal name, and search for it again in Medline, I would be hesitant to accept as a matter of fact that it is a non Medline-indexed journal.

In any case, I do not have copies of his articles handy, but I am reasonably certain that South's citations are all not so potentially tainted as this one. I could be mistaken, of course.

it is probably a good idea to also note that this "dietary supplement" classification is a default for a lot of substances that have little to no scientific support and might in fact be dangerous.

Agreed, but this is a difficulty we all face. That is why I assume you advocate independent testing and freely available, meaningful COAs. What I dislike intensely is our friend the FDA's using this fact to try to take from us the choice of whether to assume this risk.

the Doctor is risking a malpractice suit -- if he or she prescribes it to his or her patient to treat a condition that otherwise could be addressed through more conventionally (or "well established") accepted methods.

True enough, but I do not think that this would apply to prescribing a substance such as Piracetam, though. Malpractice would would have to result in demonstrable harm in order to be actionable, and it is difficult to imagine a plausible set of facts resulting from Piracetam usage that would lead to such harm. In addition, the verdict would be very fact-specific, and would turn on the specific disease in question, the specific preferred treatments in question, what exactly the accused physician did and did not do, and the like.

If I were you, I might consider refraining from asking your Doctor to comment on Piracetam with application to "you" -- his or her legal "patient."

I had planned simply to ask him for what purposes he prescribes it, in general.

However, considering Piracetam is no longer patented -- the incentive of conducting such research is small [...]

Exactly. This remains the problem with determining the efficacy of so many natural (read, "non-patentable and unprofitable") substances. It is quite frustrating. I am very glad to read that there may be possible solutions forthcoming, though.

You don't even need the state board anymore except often to see if a physician is licensed or not...

Very true, but the state boards are a quick and free way to check the record of a physician that one is considering. I imagine, though, that the levels of information and usefulness vary from state to state.


Regards. I hope that examinations are done, or nearly so.

I agree that the concerns Michael indicates are potentially valid ones, and that they are worth considering.

Hm....I wonder what reputable scientists might think about the credibility of references used to make health claims to support the use of Piracetam that supposedly come from research published by the patent holder of Piracetam -- if they do not seem to exist? I wonder. [glasses] A lot of people seem to like that House MD dude; but I don't have a TV (on purpose, I might change one day and decide to get one, who knows?), so I don't really know for sure what criteria he would use to support the use of any drug or supplement -- but I am confident the script writers would not be so negligent to cast an MD who is unaware of the convention of peer review...

These days almost everyone already knows of the necessity for a little convention called peer review. I guess we should assume there are some "newbs" here...so for their sake (hey, I was a newb once too!):


A reviewer at the National Institutes of Health evaluates a grant proposal.

Peer review (known as refereeing in some academic fields) is a process of subjecting an author's scholarly work or ideas to the scrutiny of others who are experts in the field.

It is used primarily by editors to select and to screen submitted manuscripts, and by funding agencies, to decide the awarding of monies for research.

The peer review process is aimed at getting authors to meet the standards of their discipline and of science generally. Publications and awards that have not undergone peer review are likely to be regarded with suspicion by scholars and professionals in many fields. Even refereed journals, however, have been shown to contain error, fraud and other flaws that undermine their formality.

In the case of manuscripts, the editor will pass manuscripts that are accepted for publication to a publisher who will be responsible for organizing redactory services, printing and distribution of the publication. In specialist academic (scholarly) journals, the editor (or increasingly group of editors) is normally a well-respected academic in the field, and edits the journal on behalf of a learned society or a commercial publisher. Some journals have professional editors employed by the publisher (e.g. Nature) or the charity (eg Science) owning the journal. Most academic publishers have commissioning editors who solicit books from appropriate authors. An editor is ultimately responsible for the quality and selection of manuscripts chosen to be published, usually basing their decision on peer review, although the authors are always responsible for the content of each manuscript. The editor does not revise and correct spelling and grammar - that process is carried out by a 'Copy Editor' (again, the editor controls the quality of this process).

Reasons for peer review
A rationale for peer review is that it is rare for an individual author or research team to spot every mistake or flaw in a complicated piece of work. This is not because deficiencies represent needles in a haystack, but because in a new and perhaps eclectic intellectual product, an opportunity for improvement may stand out only to someone with special expertise or experience. For both grant-funding and publication in a scholarly journal, it is also normally a requirement that the work in both novel and substantial. Therefore showing work to others increases the probability that weaknesses will be identified, and with advice and encouragement, fixed. The anonymity and independence of reviewers is intended to foster unvarnished criticism and discourage cronyism in funding and publication decisions. However, as discussed below under the next section, US government guidelines governing peer review for federal regulatory agencies require that reviewer identity be disclosed under some circumstances.

In addition, since the reviewers are normally selected from experts in the fields discussed in the article, the process of peer review is considered critical to establishing a reliable body of research and knowledge. Scholars reading the published articles can only be expert in a limited area; they rely to some degree on the peer-review process to provide reliable and credible research which they can build upon for subsequent or related research. As a result, significant scandal ensues when an author is found to have falsified the research included in an article, as many other scholars, and the field of study itself, has relied upon that research. (See below peer review and fraud.)

It is, however, the "further" that caught my eye in his statement regarding South''s lack of reliability. In other words, it seems that Michael is adducing South's alleged lack of reliability as more evidence of his critique, and is not merely limiting it to the issue at hand in his post.

Well, the truth of the matter is -- once again -- there is no evidence strong enough to pass a peer review that might suggest Piracetam is an effective cognition enhancer for healthy individuals. So, the real issue we should be focused upon is ensuring such research is conducted as soon as possible so we can move forward to other (from my perspective), more promising compounds.

Also, while I agree that it is problematic for an inventor of a substance and an employee of the company that produces it to publish studies favorable to his drug, it seems also problematic to chase such a person from the field and forbid him from doing so. I thought that the solution to such a dilemma was to publish in peer-reviewed journals. I do not know how damning it is to be published in a non Medline-indexed source, but it would be damning, indeed, to publish such research in a non peer-reviewed journal.

Further, do you or anyone else know for what journal this citation form, " Prog. Neuro-Pharmac.", stands? I ran a Google search using this abbreviation, and could find only the references to it in South's article and in this forum. That fact suggests to me the possibility that the citation form in South's article could be incorrect. Until we know the journal name, and search for it again in Medline, I would be hesitant to accept as a matter of fact that it is a non Medline-indexed journal.

The abbreviation might mean something...however, that does not change the fact that the study in question was supposedly published by the patent holder...it can be proven that more than 50% of published research is faulty...

Why Most Published Research Findings Are False
John P. A. Ioannidis

Summary
There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true.  Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research.

John P. A. Ioannidis is in the Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece, and Institute for Clinical Research and Health Policy Studies, Department of Medicine, Tufts-New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts, United States of America. E-mail: jioannid@cc.uoi.gr

Competing Interests: The author has declared that no competing interests exist.

Published: August 30, 2005

DOI: 10.1371/journal.pmed.0020124

Also good to check out: http://en.wikipedia....ict_of_interest

In any case, I do not have copies of his articles handy, but I am reasonably certain that South's citations are all not so potentially tainted as this one. I could be mistaken, of course.

Once again, I'd like to repeat that the quest for the strongest evidence is part of thinking scientifically and has nothing at all to do with James South, MA.

Agreed, but this is a difficulty we all face. That is why I assume you advocate independent testing and freely available, meaningful COAs. What I dislike intensely is our friend the FDA's using this fact to try to take from us the choice of whether to  assume this risk.

I advocate independent testing because it can mean the difference between life and death. I don't trust that many people and for good cause. It comes down, over and over again, to one critical point -- evidence.

Let's suppose I purchase product "x" from supplier "y." Supplier "y" tells me that product "x" is "z" pure. Because supplier "y" has a conflict of interest implicated by the fact he or she can profit from the sale, it is therefore highly probable that supplier "y" could claim product "x" is "z" pure when it in fact is only "z - k" pure. Similarly, a man can claim to a woman (or vice versa) that he's never engaged in sexual activity, therefore he carries no STD...however, because a man might experience more sense pleasure from engaging in an unprotected sexual act, there can exist s a conflict of interest in the claiming -- all the reason for independent testing of potential mates as unregulated drugs and/or supplements that are highly likely to end up inside your body and can cause as much or more damage than your average STD. So, yeah, I'm in favor of results of independent testing of anything my body comes in contact with. While it may be true that the body is temporary, I still think we should cherish it as it is seems to be the vehicle for the soul.

True enough, but I do not think that this would apply to prescribing a substance such as Piracetam, though. Malpractice would would have to result in demonstrable harm in order to be actionable, and it is difficult to imagine a plausible set of facts resulting from Piracetam usage that would lead to such harm. In addition, the verdict would be very fact-specific, and would turn on the specific disease in question, the specific preferred treatments in question, what exactly the accused physician did and did not do, and the like.

Malpractice is technically a term used to define the implementation of a therapy that can be construed in a court of law as not the accepted method. Hypothetically, if it can be demonstrated that a physician administers a therapy to his or her patient when there is a more generally accepted method -- a lawsuit can be filed and damages can be awarded to the plaintiff. So, if a physician is administering a therapy to his or her patient to treat a supposed condition that has a more well accepted (by the medical community) treatment, he or she could be forced into a long (and expensive!) court proceeding. Most doctors I've met try to minimize the possiblity that they end up having to litigate expensive lawsuits -- therefore, the doctors I've met and work with tend to stick to the evidence and drugs that are legal to prescribe.

I had planned simply to ask him for what purposes he prescribes it, in general.

I've studied particular compounds more than a doctor or two I've worked with. However, at the end of the day, I can't write myself a prescription. In addition to holding a licence to practice medicine, a Doctor of Medicine also needs to be registered with the DEA, so having a clean criminal and medical record are just prerequisites (for me at least).

Exactly. This remains the problem with determining the efficacy of so many natural (read, "non-patentable and unprofitable") substances. It is quite frustrating. I am very glad to read that there may be possible solutions forthcoming, though.

Very true, but the state boards are a quick and free way to check the record of a physician that one is considering. I imagine, though, that the levels of information and usefulness vary from state to state.

Yes, the state boards can give you some very helpful information. I just put the joke about checking out ex girlfriends criminal records as a joke because I hope mine are checking mine out; because mine is as clean as can be.

Regards. I hope that examinations are done, or nearly so.

It is now vacation time. I am probably going to stay down in SD as long as my school's gym is open.

A lot of strong, peer reviewed evidence has recently been published in the media that suggests that having a vigorous physical fitness program as part of a healthy diet (this includes the right supplements and such) is "the" way to go when it comes to living a long and healthy life. Being physically fit also might increase the chances of my genetic profile being passed sooner and in a more fertile mate than otherwise possible.

Also see this topic, if you have a chance: Best Anti-aging value, Which supps are the best? .

It's a lot of fun debating with you. ceya 'round.

I have been a long time friend and colleague of both these gentlemen that this thread is about, (Ward Dean and James South). In the case of James I should say "was" because in February 2006 at the age of 56 he died of a basal carcinoma that had only become apparent a few months previously. You may also like to know that I am the VP of International Antiaging Systems so let he shed some real light on their "interests" as well, because much of what has been said here of a negative nature is frankly crap.
Firstly neither of these guys owned any stock in IAS or VRP, but they were paid to research and write articles about all sorts of products and protocols. Why? Because they were not only damn good at it with the right credentials, (medical doctor and biochemist respectively) but as true mavericks, supporters and followers of the field you couldn't find anyone better, e.g. understanding the actions, effects and issues and in many cases using many of the products themselves. Plus you need to have known these guys to understand their intense and private sides to appreciate how unbelievably honest they are. For example they simply would not have written about something they did not believe in- you couldn't get them to do it for love nor money, and believe me these two have never been motivated by money- so forget thinking that they only wrote stuff because they were being paid for it. In fact James was such a private man that he spent most of his life on the borders of poverty, living in a log cabin in the Oregon Mountains and driving a clunker of a car, if he had enough he was content. He hunted deer and his wife grew fruit and vegetables in the garden, a generator provided electric and water was obtained from a nearby stream- for real this is how it was for him.
As for Ward he has been so passionate about so many things in his life and such an American hero that one of these days someone will write a book about him; (Korean War vet & numerous other invasions serving as Surgeon Commander in the elite Delta Force). His patriotism has taken him to the point whereby he believes strongly that paying US Federal taxes is wrong and that because it was never ratified it is illegal. If you know your constitution well enough you will understand this viewpoint. It wasn't that he didn't pay taxes (he paid all local and State), it wasn't that he couldn't afford to pay the Federal taxes; it was that his beliefs were so strong that he was prepared to go to jail to denounce them, and that is how he finds himself in the Montgomery prison today.
Both these brilliant men are a huge loss to the alternative medicine, nutritional, preventative, whatever you want to call it field. Anyone who knew them, and in particular James, (who I often refered to as a walking encyclopedia) would understand how dedicated they were to the subjects that mattered to them. As individuals you couldn't have wished to have better people on your side in a crisis because they would stand by you through thick and thin. Believe me I wish there were a thousand more like these guys, things would be very different. I've lost two friends, that's all I have to say on the matter. Phil

Nootropikamil:

I think that we have covered the issue pretty well, by now, so the following are more or less summary observations highlighting what I gather to be the final areas of agreement and disagreement.

These days almost everyone already knows of the necessity for a little convention called peer review.

Indeed. I'd just like to reiterate, though, that it is not an established fact, to me, at least, that the journal that South cited is not peer reviewed or Medline indexed. We appear to agree that it is wise to do everything in one's power to avoid even the appearance of a conflict of interests. We do not necessarily agree as to the particular case of South.

[W]e should be focused upon [...] ensuring such research is conducted as soon as possible so we can move forward to other (from my perspective), more promising compounds.

Agreed, although, in the truly scientific spirit, we must also be open to the possibility of surprising results from whatever studies may come.

(With regard to Modafinil, I would add as an aside that, leaving to the side for a moment its properties and efficacy, so long as it remains trapped within the straitjacket of FDA-scheduled substances, it is, as a practical matter, essentially useless for healthy individuals who wish to enhance cognition).

it can be proven that more than 50% of published research is faulty...

Exactly. This fact, however, means that we have to be careful of accepting study citations from any source.

Once again, I'd like to repeat that the quest for the strongest evidence is part of thinking scientifically and has nothing at all to do with James South, MA.

Agreed, but let me repeat as well that the questions regarding credibility of South's (and Dean's) work are what led me to begin this thread. It is fine to go beyond that narrow scope, of course, but I do not want to lose all sight of the original topic, either.

Hypothetically, if it can be demonstrated that a physician administers a therapy to his or her patient when there is a more generally accepted method -- a lawsuit can be filed and damages can be awarded to the plaintiff.

Damages can be awarded only if there is resultant harm to the plaintiff. Otherwise, the suit will be dismissed before it ever reaches trial. While there is a legal concept known as "damnum absque injuria", I have never heard of its being applied to a medical malpractice case.

I've studied particular compounds more than a doctor or two I've worked with. However, at the end of the day, I can't write myself a prescription. In addition to holding a licence to practice medicine, a Doctor of Medicine also needs to be registered with the DEA, so having a clean criminal and medical record are just prerequisites (for me at least).

I have no reason to question my doctor's competence in any of those respects, but I do not expect you or anyone else to take my word for his competence, either.

This has been an interesting exchange for me, as well. Thanks you for explaining your views. Unless there is anything new to discuss, I suppose that that is all, from me, on this one.

Phil Micans:

Thank you for your contribution. It is clear, I hope, that my purpose in beginning this thread was merely to see what the individuals in this forum think of the work of Dean and South, and to request evidence from those whose comments I have seen here have been critical of their work on some level.

Indeed. I'd just like to reiterate, though, that it is not an established fact, to me, at least, that the journal that South cited is not peer reviewed or Medline indexed. We appear to agree that it is wise to do everything in one's power to avoid even the appearance of a conflict of interests. We do not necessarily agree as to the particular case of South.

From my perspective, if there is no evidence that the study ever occurred, why bother? I guess you are free to do whatever you please with your time...

Agreed, although, in the truly scientific spirit, we must also be open to the possibility of surprising results from whatever studies may come.

Not really -- it depends on the audience you are addressing. Well trained and credible individuals in the field of science or medicine have to worry about their reputation and don't go around promoting the use of Piracetam because the evidence is too weak to establish its efficacy. That's why you still have been unable to cite a single credible medical professional in the USA that openly advocates the use of any so called "smart" drug -- except for maybe Provigil (modafinil).

(With regard to Modafinil, I would add as an aside that, leaving to the side for a moment its properties and efficacy, so long as it remains trapped within the straitjacket of FDA-scheduled substances, it is, as a practical matter, essentially useless for healthy individuals who wish to enhance cognition).

Once again, not really...

Provigil (modafinil) can still be prescribed off label for any indication a physician desires...as long as there is evidence -- however, I think the only logic "trapped" in this discussion is your argument that Piracetam can be legally prescribed by a Medical Doctor in the US -- please find evidence to refute the fact that not a single credible health care professional prescribes Piracetam to his or her patients in the USA. Please let me remind you that's simply not possible because Piracetam cannot be prescribed -- because it is not in the USP.

Exactly. This fact, however, means that we have to be careful of accepting study citations from any source.

Yes, and I am really not sure how this comment fits in with the rest...

Agreed, but let me repeat as well that the questions regarding credibility of South's (and Dean's) work are what led me to begin this thread. It is fine to go beyond that narrow scope, of course, but I do not want to lose all sight of the original topic, either.

We are now limited by the scope of evidence. Please support your arguments with evidence.

Damages can be awarded only if there is resultant harm to the plaintiff. Otherwise, the suit will be dismissed before it ever reaches trial. While there is a legal concept known as "damnum absque injuria", I have never heard of its being applied to a medical malpractice case.

I think you need to go speak with an attorney that specializes in tort law...again, please support your arguments with evidence (or a specific example is even better!) rather than provide us with anecdotes and "I heard" (that's called hearsay).

I have no reason to question my doctor's competence in any of those respects, but I do not expect you or anyone else to take my word for his competence, either.

This has been an interesting exchange for me, as well. Thanks you for explaining your views. Unless there is anything new to discuss, I suppose that that is all, from me, on this one.

It's fun for me too...take care.
[tung]

Well, I was ready to move on, but, since you've asked a few specific questions, I shall answer them as best I can.

From my perspective, if there is no evidence that the study ever occurred, why bother?

I think it far more likely that the citation was incorrect than that the study was invented, but I have better things to do than to try anything further to verify that, as well. Unless, however, Michael chimes in with the name of the journal that he is supposed to have checked, so that I can verify the matter for myself, I am not accepting as established fact that the study in question is not in a Medline-indexed or peer-reviewed journal.

[Aldebaran] Agreed, although, in the truly scientific spirit, we must also be open to the possibility of surprising results from whatever studies may come.

[Nootropikamil] Not really -- it depends on the audience you are addressing. Well trained and credible individuals in the field of science or medicine have to worry about their reputation and don't go around promoting the use of Piracetam because the evidence is too weak to establish its efficacy.

I am really not certain what you mean here. My point was simply in response to your comment that new studies are necessary to put the nootropics question to rest, so that we may move on to consideration of, from your perspective, more promising substances. I was simply stating my general agreement, but that we must also be open to the possibility that such studies might demonstrate the nootropics' efficacy, after all. Otherwise, what is the point of doing further studies, if you have already decided that they won't yield results, other than the negative ones that you seem to have made up your mind to expect?

That's why you still have been unable to cite a single credible medical professional in the USA that openly advocates the use of any so called "smart" drug -- except for maybe Provigil (modafinil).

I have not extensively researched the question, so I cannot say how many such physicians there are in the U.S. Have you? I think it suffices, however, that I have already given the name of one licensed U.S. physician who advocates the use of Piracetam, although I admit that I do not yet know exactly for what purpose (neuro-protection or cognitive enhancement).

please find evidence to refute the fact that not a single credible health care professional prescribes Piracetam to his or her patients in the USA. Please let me remind you that's simply not possible because Piracetam cannot be prescribed -- because it is not in the USP.

First, what, exactly, is your definition of the word prescribe? I suspect that it is too narrow. Here is mine, from the Oxford English Dictionary:

"3. Med. a. trans. To advise or order the use of (a medicine, remedy or treatment), with directions for the manner of applying it. Const. as in 2".

Is the OED too general for you? Then how about this definition, from Medline Plus's Online Medical Dictionary:

"Main Entry: pre·scribe
Pronunciation: pri-primarystressskrimacrb
Function: verb
Inflected Form(s): pre·scribed; pre·scrib·ing
intransitive verb : to write or give medical prescriptions
transitive verb : to designate or order the use of as a remedy "

Nowhere in either definition does it state that a substance must be in the USP in order for a physician to prescribe it. A physician may prescribe any remedy, be it folic acid, Piracetam, or Vicodin, regardless of whether the remedy requires a written prescription on a leaf from a prescription pad in order to obtain the remedy from a pharmacy. It is true that substances listed in the USP are available only by prescription, but it is not true that a physician may prescribe only substances listed in the USP.

As I mentioned, previously, Dr. William Fulton of the Kronos Group prescribes, according to the definitions that I have quoted, above, Piracetam to my father. Further, a search of the Arizona Medical Board's Web site reveals that Dr. Fulton is a Board-certified physician, that he is licensed and in good standing to practice medicine in the state of Arizona, and that he has no criminal convictions and no malpractice claims against him.

Therefore, based upon the above, you are in error to assert that there is not a single credible health care professional in the United States who prescribes Piracetam to his patients, and that I have been unable to cite such an individual.

QUOTE (aldebaran)

Exactly. This fact, however, means that we have to be careful of accepting study citations from any source.


[nootropikamil] Yes, and I am really not sure how this comment fits in with the rest...

It fits in that it is a reminder that the studies you or anyone cites may be part of that fifty percent of studies containing faulty research that you mention. That is one reason why, as I have stated in another thread, I am reluctant to engage in "the battle of the studies" when debating these sorts of questions--although, sad to say, it is often the only way to do so.

QUOTE (aldebaran)

Agreed, but let me repeat as well that the questions regarding credibility of South's (and Dean's) work are what led me to begin this thread. It is fine to go beyond that narrow scope, of course, but I do not want to lose all sight of the original topic, either.


[nootropikamil] We are now limited by the scope of evidence. Please support your arguments with evidence.

Again, I am really not sure what you mean. My comment requires no support, because it is merely a rejoinder to the following statement:

I'd like to repeat that the quest for the strongest evidence is part of thinking scientifically and has nothing at all to do with James South, MA.

In other words, I was merely reminding you that, although I agree with your general statement, the origin of the thread is about James South (and Ward Dean). Hence, although, as I mentioned, I do not mind expanding the discussion a bit, I also do not want to lose sight of the original topic.

As for the case of South, himself, we have discussed that as thoroughly as we are able, I feel, and I have outlined in my previous post the areas where we appear to agree and to disagree regarding his particular case. So far as I am concerned, the burden of proof is upon the person (Michael, in this instance) who made the general assertion that South is not a reliable guide to supplements. It is not my duty to prove that South is a reliable authority on the subject. Attempting to shift the burden of proof, of course, is a neat rhetorical tactic--that is, when it works. It's not going to work with me, however. Sorry!

You, on the other hand, have raised legitimate questions about aspects of South's work regarding nootropics, which I respect, and which I have acknowledged. You have not, however, conclusively proven--and yes, the burden is upon you to do so, if that is what you aim to do--that his work is inherently flawed, or that he is incorrect in any of his claims, even those regarding nootropics. Again, you have merely raised questions--which is fine, and quite valuable. This thread, however, is not a referendum or a proving ground for arguments regarding nootropics. It is to discuss the reasons for criticisms of Dean's and South's work.

So, those are the facts, and I don't think that there is really anything more to be said on that particular subject.

[aldebaran] Damages can be awarded only if there is resultant harm to the plaintiff. Otherwise, the suit will be dismissed before it ever reaches trial. While there is a legal concept known as "damnum absque injuria", I have never heard of its being applied to a medical malpractice case.


[nootropikamil] I think you need to go speak with an attorney that specializes in tort law...again, please support your arguments with evidence (or a specific example is even better!) rather than provide us with anecdotes and "I heard" (that's called hearsay).

*Chuckles* I am an attorney, although my specialty is not "tort law" (there really is no such specialty in the legal profession, as a matter of fact, although some attorneys may use the term in their advertisements). Also, although I keep my license current, I no longer practice law. I have, however, studied torts, of course.

At any rate, the explanation of medical malpractice that you cite in your previous post mentions the need for harm, as well, so I am puzzled that you are demanding a further example from me. That, however, is easy enough to provide. Since I am licensed to practice in New York, I shall offer a New York example, although I would very surprised if other state laws were to differ.

"The requisite elements of proof in a medical malpractice action are deviation or departure from the accepted practice, and evidence that such departure was the proximate cause of injury or damage". Holbrook v. United Hosp. Medical Center, 248 A.D. 2d 358, 669 N.Y.S. 2d 631 (2d Dep't 1998).

So, without harm, there is no cause of action for medical malpractice in the state of New York. Again, I would be very surprised if that were not the case in all the states, as well, but I haven't the time to do a fifty-state survey, unless you want to pay me; sorry!


So, I have answered your questions to the best of my ability. Because my original questions regarding Dean and South have also received answers--at least, the best answers that I am going to get, here--and because we have covered the matter thoroughly, and seem to be running in circles, a bit, I am moving on from this thread, unless anyone else has anything new to add to it. Thank you again for an interesting exchange of views.

Edited by aldebaran, 19 December 2006 - 06:33 PM.

I will do my best to answer your questions here to the best of my ability; however, it is holiday time...

[quote name='aldebaran']I think it far more likely that the citation was incorrect than that the study was invented, but I have better things to do than to try anything further to verify that, as well. Unless, however, Michael chimes in with the name of the journal that he is supposed to have checked, so that I can verify the matter for myself, I am not accepting as established fact that the study in question is not in a Medline-indexed or peer-reviewed journal.[/quote]

Next time, I might suggest checking your references for their strength before using them for support.

[quote name='aldebaran']I am really not certain what you mean here. My point was simply in response to your comment that new studies are necessary to put the nootropics question to rest, so that we may move on to consideration of, from your perspective, more promising substances. I was simply stating my general agreement, but that we must also be open to the possibility that such studies might demonstrate the nootropics' efficacy, after all. Otherwise, what is the point of doing further studies, if you have already decided that they won't yield results, other than the negative ones that you seem to have made up your mind to expect?[/quote]

I already tried to emphasize the importance of peer review -- and I guess I will repeat again that there is no peer reviewed literature available that might suggest suggest Piracetam is an effective cognition enhancer in healthy individuals and the evidence elsewhere is quite sketchy too. Please provide us with evidence to support your claims.

Please take the time to carefully review the posts on the previous page.

[quote name='aldebaran']I have not extensively researched the question, so I cannot say how many such physicians there are in the U.S. Have you? I think it suffices, however, that I have already given the name of one licensed U.S. physician who advocates the use of Piracetam, although I admit that I do not yet know exactly for what purpose (neuro-protection or cognitive enhancement).[/quote]

I have not seen any evidence to suggest that a licensed medical practitioner has ever prescribed Piracetam to any patient in the USA. Once again, I will reiterate that is not possible.

I challenge you to please provide us with some evidence to support your claim.

[quote name='aldebaran']First, what, exactly, is your definition of the word prescribe? I suspect that it is too narrow. Here is mine, from the Oxford English Dictionary:

"3. Med. a. trans. To advise or order the use of (a medicine, remedy or treatment), with directions for the manner of applying it. Const. as in 2".

Is the OED too general for you? Then how about this definition, from Medline Plus's Online Medical Dictionary:

"Main Entry: pre·scribe
Pronunciation: pri-primarystressskrimacrb
Function: verb
Inflected Form(s): pre·scribed; pre·scrib·ing
intransitive verb : to write or give medical prescriptions
transitive verb : to designate or order the use of as a remedy "[/quote]

Licensed Medical Doctors in the USA must be registered with the DEA to be able to write a legal prescription. Nowhere in the USP is Piracetam -- however, there are many other dietary supplements (as defined by DSHEA) that are listed in the USP.

Let me please inform you about USP using publicly available evidence:

Here is what the USP label looks like:



[quote name='http://www.usp.org/USPVerified/dietarySupplements/']USP Verified Dietary Supplements

What the USP Verified Mark Means on a Supplement Label
The distinctive USP Verified Mark represents that USP has rigorously tested and verified the supplement, to assure the following:

What's on the label is in fact in the bottle—all the listed ingredients in the declared amount.
The supplement does not contain harmful levels of contaminants.
The supplement will break down and release ingredients in the body
The supplement has been made under good manufacturing practices.
USP is an independent, not-for-profit organization. No other organization in the U.S. that tests supplements is recognized in federal law as the nation's official standard-setting body for medicines and supplements. USP standards are enforceable by the FDA.

Why it's Important to Know What USP Verified Assures
Integrity Tests based on USP standards have shown that contents of many supplements sold in retail stores don't match the label and that some supplements contain significantly less or more than the claimed amount of key ingredients. There may be a serious health risk when supplements taken to prevent a specific health problem do not contain ingredients in appropriate quantities. You must be sure of the identity and amount of ingredients in your supplements if you want to be sure you're getting value for your money.
Purity Some supplements may contain lead, mercury, other heavy metals, pesticides, bacteria, molds, toxins, or other potentially harmful contaminants. You must be sure these contaminants are not present at levels that can cause health problems.
Dissolution If a supplement does not break down properly to allow its ingredients to dissolve in the body, it means you won't get the full benefit of its contents. It's important for you to know that the supplement has been tested against recognized standards, as the USP Verified Mark indicates.
Safe manufacturing Assurance of safe, sanitary, well-controlled, and well-documented manufacturing and monitoring processes is proof that the supplement manufacturer is quality-conscious and concerned for your well-being.

Learn about USP's rigorous process to verify supplements.

Find out about USP's professional education program on dietary supplements.


Nowhere in either definition does it state that a substance must be in the USP in order for a physician to prescribe it. A physician may prescribe any remedy, be it folic acid, Piracetam, or Vicodin, regardless of whether the remedy requires a written prescription on a leaf from a prescription pad in order to obtain the remedy from a pharmacy. It is true that substances listed in the USP are available only by prescription, but it is not true that a physician may prescribe only substances listed in the USP.

As I mentioned, previously, Dr. William Fulton of the Kronos Group prescribes, according to the definitions that I have quoted, above, Piracetam to my father. Further, a search of the Arizona Medical Board's Web site reveals that Dr. Fulton is a Board-certified physician, that he is licensed and in good standing to practice medicine in the state of Arizona, and that he has no criminal convictions and no malpractice claims against him.

Therefore, based upon the above, you are in error to assert that there is not a single credible health care professional in the United States who prescribes Piracetam to his patients, and that I have been unable to cite such an individual.[/quote]

Once again, it is impossible for a physician to prescribe a substance (ie write a prescription) that is not in the USP. That's just a fact, Jack. Your physician may suggest that you ingest a non USP verified dietary supplement at the risk of a malpractice suit. In fact, physicians are at risk of a malpractice suit even for supplements and drugs that are listed in the USP. It is not that hard to file a lawsuit. It just takes some initiative by a plaintiff. A case may be thrown out of court; however, that does not make lawyers work for physicians for free, dude.

[quote name='aldebaran']It fits in that it is a reminder that the studies you or anyone cites may be part of that fifty percent of studies containing faulty research that you mention. That is one reason why, as I have stated in another thread, I am reluctant to engage in "the battle of the studies" when debating these sorts of questions--although, sad to say, it is often the only way to do so.[/quote]

You are taking comments out of context here. Please place your comments into context and support them with evidence.

[quote name='aldebaran']Again, I am really not sure what you mean. My comment requires no support, because it is merely a rejoinder to the following statement:[/quote]

Needs no support for whom? Okay maybe for you -- however, I don't believe much without strong evidence.

[quote name='aldebaran']In other words, I was merely reminding you that, although I agree with your general statement, the origin of the thread is about James South (and Ward Dean). Hence, although, as I mentioned, I do not mind expanding the discussion a bit, I also do not want to lose sight of the original topic.

As for the case of South, himself, we have discussed that as thoroughly as we are able, I feel, and I have outlined in my previous post the areas where we appear to agree and to disagree regarding his particular case. So far as I am concerned, the burden of proof is upon the person (Michael, in this instance) who made the general assertion that South is not a reliable guide to supplements. It is not my duty to prove that South is a reliable authority on the subject. Attempting to shift the burden of proof, of course, is a neat rhetorical tactic--that is, when it works. It's not going to work with me, however. Sorry!

You, on the other hand, have raised legitimate questions about aspects of South's work regarding nootropics, which I respect, and which I have acknowledged. You have not, however, conclusively proven--and yes, the burden is upon you to do so, if that is what you aim to do--that his work is inherently flawed, or that he is incorrect in any of his claims, even those regarding nootropics. Again, you have merely raised questions--which is fine, and quite valuable. This thread, however, is not a referendum or a proving ground for arguments regarding nootropics. It is to discuss the reasons for criticisms of Dean's and South's work.

So, those are the facts, and I don't think that there is really anything more to be said on that particular subject.[/quote]

That's all you have to say on the subject. I'm cool with that. However, once you decide to support your arguments with evidence, I'm happy to play quid pro quo.

I feel I have addressed most of these issues already on the previous page; and I am getting tired of repeating myself...please find some evidence to support your claims.

[quote name='aldebaran']*Chuckles* I am an attorney, although my specialty is not "tort law" (there really is no such specialty in the legal profession, as a matter of fact, although some attorneys may use the term in their advertisements). Also, although I keep my license current, I no longer practice law. I have, however, studied torts, of course.

At any rate, the explanation of medical malpractice that you cite in your previous post mentions the need for harm, as well, so I am puzzled that you are demanding a further example from me. That, however, is easy enough to provide. Since I am licensed to practice in New York, I shall offer a New York example, although I would very surprised if other state laws were to differ.

"The requisite elements of proof in a medical malpractice action are deviation or departure from the accepted practice, and evidence that such departure was the proximate cause of injury or damage". Holbrook v. United Hosp. Medical Center, 248 A.D. 2d 358, 669 N.Y.S. 2d 631 (2d Dep't 1998).

So, without harm, there is no cause of action for medical malpractice in the state of New York. Again, I would be very surprised if that were not the case in all the states, as well, but I haven't the time to do a fifty-state survey, unless you want to pay me; sorry![/quote]

Yeah, and this topic is getting expensive for me too. However, it's interesting that you claim to be an attorney. Maybe you should have mentioned this in the beginning of the topic?

[quote name='aldebaran']So, I have answered your questions to the best of my ability. Because my original questions regarding Dean and South have also received answers--at least, the best answers that I am going to get, here--and because we have covered the matter thoroughly, and seem to be running in circles, a bit, I am moving on from this thread, unless anyone else has anything new to add to it. Thank you again for an interesting exchange of views.[/quote]

Dean and South might be the hippest G's on the planet. But that alone doesn't make their views hold water in the field of science.

Take care.

Edited by nootropikamil, 23 December 2006 - 06:23 AM.

whoops, double post, please remove. I guess I pressed reply once too many too quick.

This article that I found at the US Pharmacist website might be helpful; so I thought I might copy it here. I would edit my previous post; however, the forum software has glitches...

The source page is: http://www.uspharmac...page=8_1500.htm



The USP Dietary Supplement Verification Program: Helping Pharmacists and Consumers Select Dietary Supplements

John Atwater, PhD
Jennifer Montgomery-Salguero, BS
David B. Roll, PhD
United States Pharmacopeia
Rockville, Maryland

US Pharm.2005;6:61-64.

In the fall of 1994, the U.S. Congress passed the Dietary Supplement Health and Education Act (DSHEA). This law treats dietary supplements as foods and defines them as "vitamins, minerals, amino acids, botanicals, and 'other' dietary ingredients." The law contains a number of unusual provisions, not the least of which is that the Food and Drug Administration was given the burden of proving a supplement is harmful rather than requiring that the manufacturer prove that it is safe.

At the time of passage of DSHEA, the FDA estimated that there were about 4,000 dietary supplement products on the market. Since this controversial law was passed, the number of products has increased to more than 29,000, with more than 1,000 products being added each year. The plethora of products makes it extremely difficult for pharmacists, other health care professionals, and consumers to make informed decisions about which brands and products to select. The selection process becomes even more confusing due to widespread reports of adulterated, subpotent or superpotent, and even dangerous dietary supplements. It is apparent that those using and recommending dietary supplements need guidance in the selection process.

In October 2001, the United States Pharmacopeial Convention, Inc. (USP) launched a verification program for dietary supplements designed to provide assurance to consumers that the products they purchase contain the ingredients listed on the label at the stated level(s). In addition, the program evaluates and verifies supplements according to stringent standards for product purity, accuracy of ingredient labeling, and proper manufacturing practices.

Why USP?
USP, founded in 1820, is a nongovernmental, nonprofit organization whose mission is to promote public health. Scientific experts from pharmacy and numerous other fields, including the dietary supplement industry, volunteer their efforts to support USP's work.

Federal law recognizes USP as the official body that sets standards for prescription drugs and dietary supplements. USP has set FDA-recognized standards for more than 4,000 prescription and over-the-counter drugs that pharmaceutical manufacturers are required by federal regulation to meet or exceed. USP has brought that experience to the dietary supplement industry and has developed standards for hundreds of dietary supplement ingredients and products. These standards are compiled in a separate dietary supplements section in the United States Pharmacopeia (USP28). Although supplement manufacturers are not required to comply with USP monographs, according to DSHEA, a dietary supplement represented as meeting USP­NF standards is deemed misbranded if it fails to conform to those standards.

Thus, verification of dietary supplements is a natural progression of USP's long-established history of standards setting and promotion of public health.

A Compelling Need
It is estimated that in 2002, Americans spent nearly $19 billion on dietary supplements; nearly half of this was spent on vitamins and minerals, and about one fourth on herbal products. There are numerous reports in the literature of supplements that were found to be inferior in one or more aspects. Clearly, not all supplements are created equal, as is illustrated in FIGURE 1. The calcium supplements taken by this individual over a three-day period are obvious in the x-ray image. It is readily apparent that the tablets have not dissolved and thus are not having their intended effect.



ConsumerLab.com has analyzed 27 multivitamin/mineral supplements for labeled content, disintegration, and lead content. In this study they found that nine of the products failed one or more of the USP requirements. The most common problems related to vitamin A. For example, one children's product contained more than 150% of the labeled content, exceeding the established upper limit for an adult. One of the multiproducts failed the USP disintegration test. Another, a prenatal product, contained only 75% of the amount of folic acid claimed on the label, while one of the multiproducts had only 50% of the claimed amount of this important vitamin. Given what we know about the importance of folic acid in prevention of spina bifida and other neural tube defects, these inferior products should concern all health care professionals.

In a separate study of 32 coenzyme Q10 (CoQ10) supplements tested by ConsumerLab.com, the content ranged from no detectable quantity in one product to 175% of the claimed amount in another. Thus, simply by changing brands, a consumer could go from 0% to 175% of the labeled amount of CoQ10.

Similarly, it is easy to find reports of botanical products that do not meet label specifications. In a recent study published in the Canadian Journal of Clinical Pharmacology, 54 commercial St. John's wort products were tested for the marker compound hypericin. Only two products tested within 10% of the stated label amount, and on average, most products contained only half of the labeled amount of hypericin.

In addition to concerns about the quality of botanical products, a daunting task facing pharmacists and consumers is choosing a product from among the vast number of brands in the marketplace. A recent paper describes a survey of 20 retail stores in a large metropolitan area for products containing the herbs Echinacea, St. John's wort, Ginkgo biloba, garlic, saw palmetto, ginseng, goldenseal, aloe, "Siberian ginseng" (eleuthero), and valerian. For these 10 herbs, consumers had a choice of 880 products and could select from 241 different brands. For example, there were 143 garlic products (33 brands), 138 Ginkgo biloba products (34 brands), and 130 St. John's wort products (34 brands). This survey did not analyze the products for labeled amount but did find that a substantial number of products were not labeled properly and showed a wide variation in label information in regard to plant part ingredients and recommended serving size. In some cases, experienced pharmacists on the survey team were not able to discern ingredient information from the labels. The authors posed the rhetorical question, "If pharmacists trained to interpret pharmaceutical product descriptions are unable to understand the labels for some of these products, how can a layperson make sense of them, much less compare products with a benchmark or with one another or convey this information to their physician?"

The USP verification program for dietary supplements is an attempt to help pharmacists and consumers answer this and other questions regarding dietary supplement quality.

How the Verification Program Works
USP will not accept a product into its verification program if the product contains an ingredient with known safety concerns. However, USP does not comprehensively address the issue of safety. No single program or organization could be expected to completely address this issue because it has broad implications, including drug­nutrient interactions, contraindications, and side effects. To thoroughly tackle these issues would require the combined resources of government, industry, and educational institutions. Despite these obstacles, USP has developed a process by which its Dietary Supplement Information Expert Committee evaluates the safety of ingredients so as to prevent those with known safety concerns from entering the verification program. Examples of dietary supplements that have been excluded from the verification program include ephedra, kava, comfrey, chaparral, and the Chinese herb aristolochia.

In the complex, technical world of dietary supplement manufacturing, finished product testing is not enough to ensure the overall quality of dietary supplements. The verification program's principal distinguishing element is the premise that good manufacturing practices (GMPs) are the most essential elements needed to produce a quality product. The program verifies that GMPs are being used by thoroughly examining the manufacturer's quality systems, conducting an on-site audit of compliance with USP's General Chapter <2750> Manufacturing Practices for Dietary Supplements, reviewing quality control and manufacturing product documentation, and performing extensive laboratory testing of products prior to verification.

Once the dietary supplement is granted use of the USP verification mark, USP periodically conducts random off-the-shelf tests on verified products to ensure that they continue to meet the strict program standards, and the organization performs periodic manufacturing site audits to ensure continued compliance with .

Impact of the Verification Program
The verification program has had a significant impact on the quality systems and manufacturing practices of participating companies. Examples include:
• Additional testing for undesirable contaminants.
• Reformulation of products that fail to dissolve.
• Reformulation to ensure the formulation provides 100% of label claim throughout the shelf life of the product.
• Characterization and quantification of botanical marker compounds.
• Implementation of stability study protocols to establish appropriate expiration dating.
• Labeling changes to ensure an accurate list and appropriate quantitative claims for ingredients.

Significance of the USP Verification Mark
The USP verification mark can be used only by manufacturers that are participating in the program, whose manufacturing and quality control facilities have been audited and checked, whose manufacturing documentation has been reviewed, and whose products have been tested by USP for conformance to USP­NF standards.

If a product submitted to USP for verification meets the standards of the program, it will be awarded the USP verification mark. FIGURE 2 shows the trademark symbol used to indicate that a product has been verified by USP. The USP mark helps assure consumers, health care professionals, and supplement retailers that the product:
• Has labeling that is accurate.
• Contains the ingredients stated on the label, in the designated amount or strength.
• Meets stringent standards for product purity and passes federal requirements for limits on contaminants, such as heavy metals, pesticides, and microbes.
• Has been manufactured properly and complies with USP and proposed FDA standards for good manufacturing practices, by using safe, sanitary, well-controlled procedures.



Products bearing the USP Verified mark have been available since the beginning of 2003 and can be found in most major drug, food, and discount retailer stores and selected health food stores. It is estimated that by the end of 2004, 20% to 25% of the mass-marketed vitamin and mineral supplements displayed the USP Verified mark.

More information about the program, including participating companies and verified products, can be found at www.uspverified.org.

USP also has a continuing education program which can be presented to pharmacy state associations and other organizations whose members would benefit from learning more about the USP verification process as well as how USP standards can be used to select dietary supplements. More information about this program can be found at the Web site above.

References to cited research can be obtained by contacting the authors at jxs@usp.org.

To comment on this article, contact editor@uspharmacist.com.

Vol. No: 30:06 Posted: 6/15/2005


December 2006

e-CONNECT Newsletter

View e-CONNECT Newsletter
Pharmacists
About USPharmacist
Article Archive
Author Guidelines
Classifieds/Career Center
Contact Us
Conventions Calendar
Links
Patient Teaching Aids
Subscribe

Latest CE Lessons

Pharmacotherapy for Weight Loss
Payment is required for the exam to be graded.

Facts or Fiction 2006: Influenza in America and Global Influences
This Continuing Education article is supported by an educational grant from Roche Laboratories, Inc.

Emergency Contraception: A Guide to Over-the-Counter Availability
This Continuing Education article is supported by an educational grant from Duramed Pharmaceuticals, Inc.

Performing Background Checks on Pharmacy Employees
Payment is required for the exam to be graded.

Advanced Topics in Medicare Part D
This Continuing Education article is supported by an educational grant from UnitedHealthcare.

Using Insulin Analogs and Premixed Analogs in Patients with Type 2 Diabetes: A Practical Guide for Pharmacists
This CE program is supported by an educational grant from Novo Nordisk Inc.

Review of Select NMEs
Payment is required for the exam to be graded.

New Drug Review
Payment is required for the exam to be graded.

More ...


Featured Articles

An Overview of Orthostatic Hypotension
Drug-Induced Osteoporosis
Subclinical Hypothyroidism
Pharmacoeconomic Advantages of Insulin Analogs
Immunosuppressants Used in Solid Organ Transplantation

More...

Here's an update on the conflict of interest case for those interested in following up...from here: http://sciencenow.sc...ull/2006/1208/1


Mea culpa. Trey Sunderland testifies at a Senate hearing earlier this year.
Credit: Christine McCarty/The Committee on Energy and Commerce

NIH Researcher Pleads Guilty to Conflict of Interest
By Constance Holden
ScienceNOW Daily News
8 December 2006

National Institute of Mental Health scientist Trey Sunderland pled guilty today to violating conflict-of-interest rules when he accepted nearly $300,000 for drug company consulting services--without getting required approval from his superiors or disclosing the income to the National Institutes of Health (NIH) (ScienceNOW, 5 December)

According to a plea agreement with the U.S. District Court in Baltimore, Sunderland will be put on probation for 2 years and assigned 400 hours of community service at his formal sentencing on 22 December. He also has to forfeit the $300,000, plus a fine not to exceed $100,000. He was spared the 1-year prison sentence allowed by law.

Sunderland, who specializes in finding biomarkers for predicting Alzheimer's disease, was among a number of NIH scientists who were investigated following reports that they had undisclosed corporate relationships. He was the only one to be charged with a felony.

This report in today's news seems to be related.

LAtimes.com: News Source



FDA to tighten conflict-of-interest rules

The agency will bar experts from advisory panel votes on products made by companies they have financial interests in.

By Ricardo Alonso-Zaldivar
Times Staff Writer

March 22, 2007

WASHINGTON — The Food and Drug Administration said Wednesday that it would bar outside medical experts with a financial interest in a manufacturer from voting on advisory panels assessing whether drugs or other products made by that company are safe and effective.

The proposed restrictions — which would also apply to experts with ties to competing firms — would significantly strengthen the FDA's conflict-of-interest policy. One recent study suggests that more than one-fourth of FDA advisors may be prohibited from voting.

Industry supporters reacted cautiously to the announcement, saying it may limit the pool of qualified advisors the FDA can draw on. Consumer groups welcomed the move, although some said the proposed policy came with a considerable loophole.

That's because the FDA would still permit experts with as much as $50,000 in financial ties to manufacturers to participate on panels as nonvoting advisors, giving them an opening to sway those voting.

FDA officials said the agency was tightening its rules as part of a broader effort to regain the public's trust.

The withdrawal of the painkiller Vioxx and revelations about the suicide risks of antidepressants, along with other safety problems, have tarnished the FDA's image. A September report from the Institute of Medicine of the National Academies called on the FDA to adopt stronger policies to minimize conflicts of interest among advisory panel members.

Critics have accused the agency of becoming too cozy with industry, and Congress is working on legislation to strengthen the FDA's safety program.

Dozens of advisory committees guide much of the FDA's decision-making on drugs and other products. Panel members — usually prominent physicians and academic researchers — vote on issues such as whether risky medications should be taken off the market, or what information should be provided to patients and doctors.

The FDA generally follows the recommendations of the panels, which also may include nonvoting members representing consumers and industry.

The financial ties to be examined under the guidelines include individual research grants, contracts and consulting fees, and investments in company stock, the FDA said. The agency will look at conflicts in the year before an advisory panel meets.

"The major achievement here is that you cannot vote on an advisory panel if you have a conflict of interest," said Rep. Maurice D. Hinchey (D-N.Y.), who has been a sharp critic of the agency. "It's not perfect, it's not the end of the road — but it is a step in the right direction."

But Diana Zuckerman, president of the National Research Center for Women & Families, said a $50,000 exemption was too generous.

"Think of all the members of Congress who have gotten into trouble for much less," she said. "People do crazy things for a lot less than $50,000 — including people who earn a lot of money."

The new restrictions will take effect after a 60-day period for public comment.

Current FDA rules automatically bar outside experts from taking part in an advisory panel meeting if their investments in a company likely to be affected by the decision exceed $100,000 or account for at least 15% of their net worth. Those with smaller investments may take part, but must file a disclosure form. Such conflicts are routinely noted in an FDA statement at the start of each meeting.

The current policy allows many experts with consulting contracts or other financial ties to manufacturers to fully participate in advisory committee meetings that involve products made by the specific firms.

A study published last year in the Journal of the American Medical Assn. found that 28% of committee members disclosed financial conflicts, but only 1% recused themselves from voting under current rules.

FDA officials said they could not reliably estimate how many current advisors would be disqualified under the new policy.

"One of the difficulties in trying to come up with that exact number is that it's meeting-specific," said Jill Hartzler Warner, an FDA lawyer. "You have to know [in advance] the meeting topic." But officials said the agency would step up its efforts to recruit panel members without any conflicts.

The JAMA study found only a weak link between the participation of members with conflicts and the outcome of meetings. In a majority of cases, excluding the advisors with conflicts would have reduced the margin of approval for the drug that was being considered, but it would not have changed the final outcome.

"We think we have already done a good job" keeping FDA decisions free of any conflict, said Randall Lutter, acting deputy commissioner for policy. But he acknowledged that current conflict-of-interest rules had been unevenly applied across different advisory panels.

"We are committed to making the process even stronger and better-understood," Lutter said. The new policy will increase "consistency, predictability and transparency," he added.

But FDA officials would not say exactly how they arrived at the $50,000 figure as the threshold for financial conflicts.

Lutter said the threshold struck "an appropriate balance" between allowing the FDA to tap the expertise of academic scientists involved in industry-funded research and the need to reassure the public that the agency's decision-making process was sound.

Independent experts close to the pharmaceutical industry said the new policy appeared to mark a change in direction for the agency.

"I am surprised the FDA is doing this," said economist John E. Calfee of the American Enterprise Institute. "It's a more activist FDA than I would have expected."

Hinchey, the New York congressman, said newly confirmed FDA Commissioner Andrew C. von Eschenbach was making a concerted effort to respond to problems that critics had identified.

But Dr. Peter Lurie, author of last year's JAMA study that revealed the extent of FDA conflicts, said financial interests were not the only source of potential bias. Doctors treating patients in clinical practice, he said, are often more likely to approve a drug than are medical researchers, who focus on statistics.

"Conflict-of-interest guidelines are important, but they don't solve all the ills," said Lurie, deputy director of Public Citizen's Health Research Group, a consumer advocacy organization. "There's an inordinate focus on clinicians and an insufficient focus on statisticians and epidemiologists, who tend to look at the data in a more dispassionate way. The clinicians always want more toys."


*
--------------------------------------------------------------------------------
ricardo.alonso-zaldivar@latimes.com

Copyright 2007 Los Angeles Times

Here is another take that goes into more detail and is more specific than the article posted above about what exactly the FDA is considering changing in the rules:

Portable Planet: News Source

FDA Cracking Down On Conflicts Of Interest
Published by Staff March 24th, 2007 in Health, World.



The U.S. Food and Drug Administration (FDA) today announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest for its advisory committee members and for recommending eligibility for meeting participation. FDA is accepting public comments on the proposal for the next 60 days.

“FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Randall Lutter, Ph.D., FDA’s acting deputy commissioner for policy. “Today’s draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process.”

FDA currently screens all prospective advisory committee participants before each meeting to determine whether the potential for a financial conflict of interest exists. Under law, FDA may grant a waiver when certain criteria are met, such as when the need for an individual’s expertise outweighs the potential for a conflict of interest.

The draft guidance document would replace guidance issued in 2000 on FDA Waiver Criteria ( http://www.fda.gov/o...rest/intro.html ). The 2000 guidance attempted to address the complex set of variables that can be applied in reaching a decision about an individual advisory committee participant. However, because of its complexity, FDA officials found it difficult to achieve consistent results that the public could readily understand.

This new guidance ( http://www.fda.gov/o...oiguidedft.html ) would reduce the likelihood that the process for recommending waivers would vary from meeting to meeting. In addition to a more streamlined approach for considering who may participate in meetings, FDA would tighten its policy for considering eligibility for participation. If an individual has disqualifying financial interests whose combined value exceeds $50,000, after applying certain exemptions, the person would generally not be considered for participation in the meeting, regardless of the need for his or her expertise. If the financial interests are $50,000 or less, after applying certain exemptions, the individual might be recommended to participate as a non-voting member. Only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members.

Financial interest means the potential for gain or loss to a person (or their family and outside affiliations) as a result of the government’s action on a particular topic. Financial interests screened include, but are not limited to, stock ownership, related research and consulting arrangements.

A notice will appear in the Federal Register soon. To submit electronic comments on the draft guidance, visit http://www.regulations.gov/ or http://www.fda.gov/dockets/ecomments . Written comments may be sent to: Division of Dockets Management (HFA-305), U.S. Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. Comments must include the docket number 2007D-0101.

Today’s announcement is part of the agency’s overall effort to improve its advisory committee process. As announced in January, FDA will be establishing a new advisory committee on how to improve FDA’s communication policies and practices consistent with the best available and evolving evidence. In addition, the agency launched a Web page dedicated to improving recruitment of advisory committee members and enhancing public participation in the process. For more information, go to: http://www.fda.gov/oc/advisory/.

Advisory committees provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, biological products, medical devices, and food. In general, advisory committees include a chair, several members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be consulted as needed. Although the committees provide advice to the agency, their recommendations are not binding and FDA makes final decisions.

Source: FDA

I just put the joke about checking out ex girlfriends criminal records as a joke because I hope mine are checking mine out; because mine is as clean as can be.

It seems soon I might have a somewhat "unclean" record...oh well, it's for weed and a pipe, so I'm not so concerned about it.

I'd post the charges here to show I'm not kidding or anything, but since the county where I was ticketed publishes dockets so soon after the summons, I'll probably wait until the information is public domain to make any type of formal statement...

Legal use of medical use of marijuana seems commonsense to almost everyone these days -- especially considering how dangerous alcohol appears to be -- and which seems to be a major causative factors in dangerous an early death -- see this report to understand how...and alcohol is perfectly legal for anyone over 21 in the US.

See this topic to evaluate some of the evidence to support medicinal use of marijuana.

And although medical marijuana may be legal in California and many other states, a prescription for marijuana in California might not be valid in other states -- even those that do allow medical marijuana...so before you consider traveling to another state, consider that you might get ticketed for possession...

Take care.

Edited by nootropikamil, 24 April 2007 - 09:19 AM.

How does weed affect your memory?

It sucks you may have a record now. I, myself, have one, and it has ruined my life! And, it is only a drug offense----ONLY ONE. It was a possession of coke charge from 2003. I will be getting the "felon" expunged here within a year.

You should be able to get your misdemeanor offense expunged as well. The time frame differs from state to state though.

How does weed affect your memory?

It sucks you may have a record now.  I, myself, have one, and it has ruined my life!  And, it is only a drug offense----ONLY ONE.  It was a possession of coke charge from 2003.  I will be getting the "felon" expunged here within a year. 

You should be able to get your misdemeanor offense expunged as well.  The time frame differs from state to state though.

I'm not sure exactly how marijuana (cannabis) affects memory...and I'm not sure I'd want to work anywhere that would deny an applicant a job based on a pot conviction. One thing that's great about the State of California is the fact that marijuana is only a civil offense -- so you just get a fine and that's it.

THE QUESTION of whether or not the penalties for possession of small amounts of marijuana (legally defined as any part of the plant cannabis sitiva) should be reduced is not only a legal one, but also involves social, economic, law enforcement and administration of justice problems.

Eight states — Ohio, Mississippi, Minnesota, Oregon, California, Alaska, Colorado and Maine — have already reduced their penalties to the point where the penalty for possession of small quantities of cannabis is a fine only, rather than imprisonment.

The issue has come to a point for several reasons:

• Widespread use — 53 per cent of adults under age 25 have tried marijuana.
• New medical data — marijuana has been shown to be less harmful than alcohol or tobacco.

Back to the topic of conflict of interest:

Reuters: News Source



Posing as pals, drug reps sway doctors' choices
Mon Apr 23, 2007 8:11PM EDT
By Julie Steenhuysen

CHICAGO (Reuters) - As much as doctors would like to deny it, subtle attention from friendly drug sales representatives can have a big impact on what drugs they prescribe, according to two U.S. studies published on Monday.

"Physicians underestimate their own vulnerability. They think they are smarter ... but they are not trained in recognizing this kind of manipulation," said Adriane Fugh-Berman, a Georgetown University Medical Center researcher and co-author of one of the studies.

Fugh-Berman teamed with Shahram Ahari, a former drug representative for Eli Lilly and Co., who now works at the University of California, San Francisco's school of pharmacy.

Their study, which appears in the Public Library of Science journal PLoS Medicine, details the elaborate methods used by drug company sales representatives to make friends and influence drug sales.

"Reps scour a doctor's office for objects -- a tennis racquet, Russian novels, '70s rock music, fashion magazines, travel mementos or cultural or religious symbols -- that can be used to establish a personal connection with the doctor," Fugh-Berman and Ahari wrote.

"A friendly physician makes the rep's job easy because the rep can use the 'friendship' to request favors, in the form of prescriptions.

"Physicians who view the relationship as a straightforward goods-for-prescriptions exchange are dealt with in a businesslike manner. Skeptical doctors who favor evidence over charm are approached respectfully, supplied with reprints from the medical literature and wooed as teachers," they wrote.

Sales representatives also ingratiate themselves by lining up paid speaking engagements for doctors and arranging educational grants to those who frequently prescribe their drugs.

The study comes as drugmakers are smarting over the public revelation this month from an AstraZeneca drug sales representative, who said in a unauthorized newsletter to staff: "There is a big bucket of money sitting in every office. Every time you go in, you reach your hand in the bucket and grab a handful."

An AstraZeneca spokeswoman said the manager was fired and the company was looking into the incident, which she said violates a core value of serving patients.

QUICK VISIT, LASTING EFFECTS

Another study found that even a brief visit by a drug sales rep could have a powerful impact.

The study analyzed surveys done by a market research firm that chronicled a doctor's intention to prescribe the epilepsy drug gabapentin during the period of 1995 to 1999, when it was sold by Warner-Lambert under the brand name Neurontin.

Pfizer Inc., which acquired that unit in 2000, paid a $240 million fine four years later for illegal promotion of the drug for unapproved uses such as migraines or pain.

The surveys involved 116 visits to 97 doctors.

They found that after 46 percent of the visits, the doctors said they intended either to prescribe gabapentin more often or to recommend it to colleagues more often.
[b]
"The remarkable thing is how effective a very brief visit by a drug representative -- most often less than five minutes -- can be in influencing physicians' choices to use a drug for an unapproved indication," Dr. Michael Steinman of the San Francisco Veterans Affairs Medical Center said in a statement.

Besides free drug samples, salespeople often bring gifts, lunch for the doctor or office staff, new pens and coffee mugs. "The doctor feels subtly, even subconsciously, indebted to the representative," Steinman said.

© Reuters 2006. All rights reserved. Republication or redistribution of Reuters content, including by caching, framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

Reuters journalists are subject to the Reuters Editorial Handbook which requires fair presentation and disclosure of relevant interests.

Peace.

I just put the joke about checking out ex girlfriends criminal records as a joke because I hope mine are checking mine out; because mine is as clean as can be.

It seems soon I might have a somewhat "unclean" record...oh well, it's for weed and a pipe, so I'm not so concerned about it.

I'd post the charges here to show I'm not kidding or anything, but since the county where I was ticketed publishes dockets so soon after the summons, I'll probably wait until the information is public domain to make any type of formal statement...

Legal use of medical use of marijuana seems commonsense to almost everyone these days -- especially considering how dangerous alcohol appears to be -- and which seems to be a major causative factors in dangerous an early death -- see this report to understand how...and alcohol is perfectly legal for anyone over 21 in the US.

See this topic to evaluate some of the evidence to support medicinal use of marijuana.

And although medical marijuana may be legal in California and many other states, a prescription for marijuana in California might not be valid in other states -- even those that do allow medical marijuana...so before you consider traveling to another state, consider that you might get ticketed for possession...

Take care.

First off, a major reason I am providing this evidence in public is I am mildly concerned that I will have a possession of drug paraphernalia (a marijuana pipe) on my record and I want it to be known that the pipe was a weed pipe, not a crack or a meth pipe. I am certainly not just trying to be all "crazy" here and draw unnecessary attention to myself, trust me.

To provide corresponding evidence for my claims, I will now present some files from my recent encounter with the Arizona Justice of the Peace. I have edited out some information so not every person on the web can find out what county, attorney, judge &c. was involved in charging me with a marijuana pipe and a bag of weed considering how much more dangerous alcohol and tobacco seem to be are and these are perfectly legal.

However, my defense attorney from Arizona advised I entered into a plea agreement and was only charged with possession of the paraphernalia (a marijuana pipe).

I have to pay a fine, do eight hours of a drug diversion program, and am on unsupervised probation. The evidence can be found below...I need a prescription...it looks like I'll need to stay off weed for a while.

Take care. If the Navigation team would rather have me simply link off site to my private forum where these files require registration to view, please let me know and I can update accordingly.

File 1: Click here to view

File 2: Click here to view

File 3: Click here to view

I would happily provide more evidence if it is desired. I feel this is enough evidence to substantiate my claim.

Peace.

Edited by adam_kamil, 01 June 2007 - 05:12 AM.

Click HERE to rent this advertising spot for BRAIN HEALTH to support LongeCity (this will replace the google ad above).

[quote]
[quote]
I agree that the concerns Michael indicates are potentially valid ones, and that they are worth considering.
[/quote]

Hm....I wonder what reputable scientists might think about the credibility of references used to make health claims to support the use of Piracetam that supposedly come from research published by the patent holder of Piracetam -- if they do not seem to exist? I wonder. [glasses] A lot of people seem to like that House MD dude; but I don't have a TV (on purpose, I might change one day and decide to get one, who knows?), so I don't really know for sure what criteria he would use to support the use of any drug or supplement -- but I am confident the script writers would not be so negligent to cast an MD who is unaware of the convention of peer review...

These days almost everyone already knows of the necessity for a little convention called peer review. I guess we should assume there are some "newbs" here...so for their sake (hey, I was a newb once too!):


A reviewer at the National Institutes of Health evaluates a grant proposal.

[quote]
Peer review (known as refereeing in some academic fields) is a process of subjecting an author's scholarly work or ideas to the scrutiny of others who are experts in the field.

It is used primarily by editors to select and to screen submitted manuscripts, and by funding agencies, to decide the awarding of monies for research.

The peer review process is aimed at getting authors to meet the standards of their discipline and of science generally. Publications and awards that have not undergone peer review are likely to be regarded with suspicion by scholars and professionals in many fields. Even refereed journals, however, have been shown to contain error, fraud and other flaws that undermine their formality.

In the case of manuscripts, the editor will pass manuscripts that are accepted for publication to a publisher who will be responsible for organizing redactory services, printing and distribution of the publication. In specialist academic (scholarly) journals, the editor (or increasingly group of editors) is normally a well-respected academic in the field, and edits the journal on behalf of a learned society or a commercial publisher. Some journals have professional editors employed by the publisher (e.g. Nature) or the charity (eg Science) owning the journal. Most academic publishers have commissioning editors who solicit books from appropriate authors. An editor is ultimately responsible for the quality and selection of manuscripts chosen to be published, usually basing their decision on peer review, although the authors are always responsible for the content of each manuscript. The editor does not revise and correct spelling and grammar - that process is carried out by a 'Copy Editor' (again, the editor controls the quality of this process).

Reasons for peer review
A rationale for peer review is that it is rare for an individual author or research team to spot every mistake or flaw in a complicated piece of work. This is not because deficiencies represent needles in a haystack, but because in a new and perhaps eclectic intellectual product, an opportunity for improvement may stand out only to someone with special expertise or experience. For both grant-funding and publication in a scholarly journal, it is also normally a requirement that the work in both novel and substantial. Therefore showing work to others increases the probability that weaknesses will be identified, and with advice and encouragement, fixed. The anonymity and independence of reviewers is intended to foster unvarnished criticism and discourage cronyism in funding and publication decisions. However, as discussed below under the next section, US government guidelines governing peer review for federal regulatory agencies require that reviewer identity be disclosed under some circumstances.

In addition, since the reviewers are normally selected from experts in the fields discussed in the article, the process of peer review is considered critical to establishing a reliable body of research and knowledge. Scholars reading the published articles can only be expert in a limited area; they rely to some degree on the peer-review process to provide reliable and credible research which they can build upon for subsequent or related research. As a result, significant scandal ensues when an author is found to have falsified the research included in an article, as many other scholars, and the field of study itself, has relied upon that research. (See below peer review and fraud.)
[/quote]

[quote]
It is, however, the "further" that caught my eye in his statement regarding South''s lack of reliability. In other words, it seems that Michael is adducing South's alleged lack of reliability as more evidence of his critique, and is not merely limiting it to the issue at hand in his post.
[/quote]

Well, the truth of the matter is -- once again -- there is no evidence strong enough to pass a peer review that might suggest Piracetam is an effective cognition enhancer for healthy individuals. So, the real issue we should be focused upon is ensuring such research is conducted as soon as possible so we can move forward to other (from my perspective), more promising compounds.

[quote]
Also, while I agree that it is problematic for an inventor of a substance and an employee of the company that produces it to publish studies favorable to his drug, it seems also problematic to chase such a person from the field and forbid him from doing so. I thought that the solution to such a dilemma was to publish in peer-reviewed journals. I do not know how damning it is to be published in a non Medline-indexed source, but it would be damning, indeed, to publish such research in a non peer-reviewed journal.

Further, do you or anyone else know for what journal this citation form, " Prog. Neuro-Pharmac.", stands? I ran a Google search using this abbreviation, and could find only the references to it in South's article and in this forum. That fact suggests to me the possibility that the citation form in South's article could be incorrect. Until we know the journal name, and search for it again in Medline, I would be hesitant to accept as a matter of fact that it is a non Medline-indexed journal.
[/quote]

The abbreviation might mean something...however, that does not change the fact that the study in question was supposedly published by the patent holder...it can be proven that more than 50% of published research is faulty...

[quote]
Why Most Published Research Findings Are False
John P. A. Ioannidis

Summary
There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true.  Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research.

John P. A. Ioannidis is in the Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece, and Institute for Clinical Research and Health Policy Studies, Department of Medicine, Tufts-New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts, United States of America. E-mail: jioannid@cc.uoi.gr

Competing Interests: The author has declared that no competing interests exist.

Published: August 30, 2005

DOI: 10.1371/journal.pmed.0020124

[/quote]

Also good to check out: http://en.wikipedia....ict_of_interest

[quote]
In any case, I do not have copies of his articles handy, but I am reasonably certain that South's citations are all not so potentially tainted as this one. I could be mistaken, of course.
[/quote]

Once again, I'd like to repeat that the quest for the strongest evidence is part of thinking scientifically and has nothing at all to do with James South, MA.

[quote]
Agreed, but this is a difficulty we all face. That is why I assume you advocate independent testing and freely available, meaningful COAs. What I dislike intensely is our friend the FDA's using this fact to try to take from us the choice of whether to  assume this risk.
[/quote]

I advocate independent testing because it can mean the difference between life and death. I don't trust that many people and for good cause. It comes down, over and over again, to one critical point -- evidence.

Let's suppose I purchase product "x" from supplier "y." Supplier "y" tells me that product "x" is "z" pure. Because supplier "y" has a conflict of interest implicated by the fact he or she can profit from the sale, it is therefore highly probable that supplier "y" could claim product "x" is "z" pure when it in fact is only "z - k" pure. Similarly, a man can claim to a woman (or vice versa) that he's never engaged in sexual activity, therefore he carries no STD...however, because a man might experience more sense pleasure from engaging in an unprotected sexual act, there can exist s a conflict of interest in the claiming -- all the reason for independent testing of potential mates as unregulated drugs and/or supplements that are highly likely to end up inside your body and can cause as much or more damage than your average STD. So, yeah, I'm in favor of results of independent testing of anything my body comes in contact with. While it may be true that the body is temporary, I still think we should cherish it as it is seems to be the vehicle for the soul.

[quote]
True enough, but I do not think that this would apply to prescribing a substance such as Piracetam, though. Malpractice would would have to result in demonstrable harm in order to be actionable, and it is difficult to imagine a plausible set of facts resulting from Piracetam usage that would lead to such harm. In addition, the verdict would be very fact-specific, and would turn on the specific disease in question, the specific preferred treatments in question, what exactly the accused physician did and did not do, and the like.
[/quote]

Malpractice is technically a term used to define the implementation of a therapy that can be construed in a court of law as not the accepted method. Hypothetically, if it can be demonstrated that a physician administers a therapy to his or her patient when there is a more generally accepted method -- a lawsuit can be filed and damages can be awarded to the plaintiff. So, if a physician is administering a therapy to his or her patient to treat a supposed condition that has a more well accepted (by the medical community) treatment, he or she could be forced into a long (and expensive!) court proceeding. Most doctors I've met try to minimize the possiblity that they end up having to litigate expensive lawsuits -- therefore, the doctors I've met and work with tend to stick to the evidence and drugs that are legal to prescribe.

[quote]
I had planned simply to ask him for what purposes he prescribes it, in general.
[/quote]

I've studied particular compounds more than a doctor or two I've worked with. However, at the end of the day, I can't write myself a prescription. In addition to holding a licence to practice medicine, a Doctor of Medicine also needs to be registered with the DEA, so having a clean criminal and medical record are just prerequisites (for me at least).

[quote]
Exactly. This remains the problem with determining the efficacy of so many natural (read, "non-patentable and unprofitable") substances. It is quite frustrating. I am very glad to read that there may be possible solutions forthcoming, though.

Very true, but the state boards are a quick and free way to check the record of a physician that one is considering. I imagine, though, that the levels of information and usefulness vary from state to state.
[/quote]

Yes, the state boards can give you some very helpful information. I just put the joke about checking out ex girlfriends criminal records as a joke because I hope mine are checking mine out; because mine is as clean as can be.

[quote]
Regards. I hope that examinations are done, or nearly so.
[/quote]

It is now vacation time. I am probably going to stay down in SD as long as my school's gym is open.

A lot of strong, peer reviewed evidence has recently been published in the media that suggests that having a vigorous physical fitness program as part of a healthy diet (this includes the right supplements and such) is "the" way to go when it comes to living a long and healthy life. Being physically fit also might increase the chances of my genetic profile being passed sooner and in a more fertile mate than otherwise possible.

Also see this topic, if you have a chance: Best Anti-aging value, Which supps are the best? .

It's a lot of fun debating with you. ceya 'round.
[/quote]

I am quoting myself above for posterity's sake because I included what I consider to be an accurate representation of the term "peer review," and I think the WSJ article quoted below fits here the best.

I think maybe we should first try to determine if we can find a significant difference between the definition of "peer review" on approximately December 15, 2006 (quoted above) and today -- June 17, 2007:

[quote]
Peer review (known as refereeing in some academic fields) is a process of subjecting an author's scholarly work or ideas to the scrutiny of others who are experts in the field. It is used primarily by editors to select and to screen submitted manuscripts, and by funding agencies, to decide the awarding of grants. The peer review process aims to make authors meet the standards of their discipline, and of science in general. Publications and awards that have not undergone peer review are likely to be regarded with suspicion by scholars and professionals in many fields. Even refereed journals, however, can contain errors.

In the case of manuscripts, the editor will pass manuscripts that are accepted for publication to a publisher who will be responsible for organizing redactory services, printing and distribution of the publication. In specialist academic (scholarly) journals, the editor (or increasingly group of editors) is normally a well-respected academic in the field, and edits the journal on behalf of a learned society or a commercial publisher. Some journals have professional editors employed by the owner of the journal. An editor is ultimately responsible for the quality and selection of manuscripts chosen to be published, usually basing their decision on peer review, although the authors are always responsible for the content of each manuscript. The editor does not revise and correct spelling, grammar and formatting - that process is carried out by a copy editor, although the editor controls the quality of the process.

Reasons for peer review
A rationale for peer review is that it is rare for an individual author or research team to spot every mistake or flaw in a complicated piece of work. This is not because deficiencies represent needles in a haystack, but because in a new and perhaps eclectic intellectual product, an opportunity for improvement may stand out only to someone with special expertise or experience. For both grant-funding and publication in a scholarly journal, it is also normally a requirement that the work is both novel and substantial. Therefore showing work to others increases the probability that weaknesses will be identified, and with advice and encouragement, fixed. The anonymity and independence of reviewers is intended to foster unvarnished criticism and discourage cronyism in funding and publication decisions. However, as discussed below under the next section, US government guidelines governing peer review for federal regulatory agencies require that reviewer identity be disclosed under some circumstances.

In addition, since the reviewers are normally selected from experts in the fields discussed in the article, the process of peer review is considered critical to establishing a reliable body of research and knowledge. Scholars reading the published articles can only be expert in a limited area; they rely to some degree on the peer-review process to provide reliable and credible research that they can build upon for subsequent or related research. As a result, significant scandal ensues when an author is found to have falsified the research included in an article, as many other scholars, and the field of study itself, may have relied upon that research (see Peer review and fraud below).
[/quote]

These definitions look very similar...however, I think it might be important to note what ImmInst advisor Dr. Brian Wowk wrote on Oct 31 2006:

[quote]
There is a reason why many institutions (not just in science) require correspondence in writing, not emails or Internet posts. It's too easy to put forth half-formed ideas and out-of-context information in brief Internet posts. Forums, blogs, and wikis are intrinsically undisciplined media. The barriers between having a thought and publishing the thought are way too low. Even worse, if a Wiki with broad access politically positions itself as an authority on some subject, scientists who really are authorities will have to spend inordinate amounts of time on edit wars rather than getting real work done. This is not how science gets done.
[/quote]

The bottom line I guess is Wikipedia itself is not peer reviewed! Any random person can log in and write whatever they choose, so I generally cross check whatever data I may find at a Wikipedia page with a stronger source of evidence (usually a primary source).

Here's the article that I think fits here the best. Note this is an article published in The Wall Street Journal -- the one Newspaper that holds more captive eyes of the US financial market than any other News publication in the world (ask your stock trader). One usually does not encounter as many scientific-focused publications on WSJ as one might find as other newspapers may, but WSJ sure covers the markets! ...however, this is an excellent article that's probably worth your attention. I won't really comment here because this is over my head -- however, I have indeed highlighted some of the more controversial segments... [sfty]

Enjoy:

[quote]The Wall Street Journal: News Source



Political Peer Review
June 18, 2007; Page A16

Does this sound familiar? A questionable survey finds that an FDA-approved pharmaceutical may carry some risks. A respectable but increasingly politicized medical journal publishes the research and attaches an alarmist commentary. A media panic ensues. Democrats ride the story to kick up support for what they wanted to do all along, which is increase regulation over "Big Pharma." Meanwhile, the complex science is trampled in the commotion.

Well, it's not Vioxx -- at least not yet. The latest drug panic concerns Avandia, a medicine used to treat diabetes. The facts aren't all in, but that didn't impede Representative Henry Waxman from calling the controversy "a case study of the need for reform of the nation's drug safety laws." Since the next flashpoint will inevitably come with the meeting of an FDA advisory panel on July 30, let's review what we know.

* * *
Avandia, or rosiglitazone, is a sophisticated drug that works at the gene level to lower blood sugar in diabetics; manufactured by GlaxoSmithKline, it was approved by the Food and Drug Administration in 1999. The accusation is that Avandia increases risks for cardiovascular problems, including heart attacks, according to a study published in May in the New England Journal of Medicine (NEJM). It was accompanied by an editorial encouraging physicians to stop prescribing Avandia and condemning the FDA's "desultory approach" and "regulatory failure." That all but guaranteed a round of press hysterics.

Sure enough, first-time Avandia prescriptions are down 40%, and down overall by 20%. Endocrinologists and their patients were bound to be wary, but the NEJM study was problematic. Steven Nissen of the Cleveland Clinic employed a statistical technique called meta-analysis, which pools data from smaller clinical trials to suggest overall trends. Meta-analysis can be a useful contribution to medical knowledge, but it is in no way conclusive.

Several aspects of the Nissen study are particularly troubling. The assertion that Avandia raises the absolute risk for heart attacks by 43% relied on a methodology that excluded data in which there were no reported adverse events, skewing the results. The NEJM editorial itself acknowledged that "A few events either way might have changed the findings" and that "the possibility that the findings were due to chance cannot be excluded." Even the Lancet, the British medical journal with its own politicization issues, clucked about the NEJM's "alarmist headlines."

FDA critics say the agency's failure was to insufficiently warn Avandia patients of these risks, whatever they were; and that this is particularly egregious because diabetics are already prone to heart disease. But the reverse is also true: The high cholesterol and blood pressure, obesity and other conditions associated with diabetes might account for any problems, not Avandia. Correlation is not causation.

Besides, the data Dr. Nissen analyzed did not control for cardiac events, so things like indigestion and heartburn may have counted. GlaxoSmithKline is conducting its own clinical trials, which are more rigorous, to be concluded next year. The interim results showed that Avandia patients had a 7% decrease in heart attacks, and a 17% decline in deaths from cardiac events, though these aren't yet definitive either.

The larger political context here is the evidence of collusion to gin up one more drug-company "scandal." Dr. Nissen has a reputation as an adversary of the pharmaceutical industry, and was involved in the controversy that led Merck to withdraw Vioxx from the market in late 2004. He admitted that he consulted with several Congressional committees, including Mr. Waxman's, before the NEJM published his Avandia paper. At a Waxman hearing, Dr. Nissen said he shared his "preliminary analysis" and "discussed some pending legislation." Ostensibly serious medical research isn't supposed to be peer reviewed by the Democratic majority.

The pending legislation is Mr. Waxman's counterpart to the Senate's Enzi-Kennedy drug safety bill, which, if passed, will bolster the FDA's authority to require postmarket testing. But it's hard to tell why Avandia is the "case study" for this agenda: GlaxoSmithKline was already engaged in extensive postmarket trials before this scandal broke -- beyond those that would be required by Enzi-Kennedy. And Glaxo makes the data from its completed trials transparent on the Internet, where Dr. Nissen acquired it in the first place. So much for Mr. Waxman's repeated claims that Big Pharma is suppressing negative results.

Avandia will now be getting a "black box" warning from the FDA, the most stringent possible regulation short of a ban. Though the controversy will no doubt escalate with the July 30 FDA review, Avandia will probably remain available to patients and their doctors for some time. For now, that's better than the Merck situation, with Vioxx off the market and the company mired in litigation.

At bottom, the Avandia fuss is political, not medical, and it turns on risk itself: how to strike the best balance between patient safety and lifesaving therapies. The FDA already does too much onerous bottlenecking of new drugs. Those who think otherwise ought to make an honest case -- not rely on political sensationalism.[/quote]

Peace and love.

Edited by adam_kamil, 18 June 2007 - 05:44 AM.