To: boschneeman@ucdavis.edu
Subject: Dr.Schneeman- What Pharmaceutical Research Grants Have You Been Funded By During Your Career?
To: Barbara Olds Schneeman, Ph.D.
Chair- NAS Committee to Create a Framework to Evaluate the Safety of Dietary Supplements
Dr.Schneeman:
I have read your CV at
http://outreach.ucdavis.edu/boschneeman.cfm
I've read and also listened to the web archive of the meeting at which you discussed the completion of NAS' paper "Dietary Supplements: A Framework for Evaluating Safety" (Your opening statement, as Chair of the Committee which produced this report is shown below.)
I have read this report and as a person who recovered from a life threatening illness (schizophrenia) via a suppressed alternative treatment mode (orthomolecular medicine) in the late 1970s after prescription pharmaceutical drugs almost killed me, I am distrustful of this report and also of what the FDA might attempt to use it for given the revolving door between the FDA and the pharmaceutical industry.
Given that the National Academy of Sciences is not subject to the Freedom of Information Act because its not part of the government, and given that I assume you would like to dispel any concerns I and the 1800 + vitamin consumers on my email distribution list, and untold number of visitors to the IAHF website have on this issue, I would like you to volunteer a complete list of all pharmaceutical research grants involved in the funding of nutritional research you've been involved with over the years.
While the titles of the papers you were involved in writing for various scientific journals are listed in your CV, nothing is mentioned as to your sources of funding- and I would like complete details regarding all pharmaceutical research grants you've worked under during the course of your career immediately, along with the same sort of information for all of the other authors of this biased, unscientific report.
In your report to the FDA you recommend that Congress revisit DSHEA to amend it vis a vis Adverse Event Reporting requirements claiming that unless the law is revisited, the FDA won't have the proper tools to adequately protect consumers. In your report you recommend changing DSHEA to require the toll free number of FDA's "Medwatch" program be required to be added to the labels of dietary supplements. (These recommendations show obvious support for Senator Durbin's bill S.722, The Dietary Supplement Safety Act of 2003 but its not moving, nor is it GOING to move. It has NOT moved since your public meeting to announce completion of your report, nor is it GOING to move- but its obvious what NAS and FDA are trying to do- you're trying to create false definitions of supplement safety to set us up to lose in a future WTO trade dispute via which our domestic vitamin laws can be forcibly harmonized to a genocidal international Codex standard. ) S.722 is worded such that if a person uses both a dietary supplement and a prescription drug concurrently, and a Medwatch Report is generated, no determination is actually made as to causality, yet the dietary supplement would automatically be blamed.
How is it that you consider annonymous case reports from MEDWATCH to be in any way "scientific"?
Couldn't any opponent of a given dietary supplement who wants a product to be banned phone in false reports to the FDA, and wouldn't the Agency add this false data to their database for PR purposes? (Yes- I know someone who tested the system and FDA DID do JUST THAT.
The late Brian Leibovitz, PhD tested Medwatch this way. Leibovitz was the editor of the Journal of Applied Nutrition, and later of the Journal of Optimal Nutrition. He worked directly with the late Dr.Linus Pauling. He discusses this in an interview which can be heard at http://www.citizensvoice.org/index2.html)
News reports from Reuters, AP, UPI published in the aftermath of your public meeting re this report all say that you're saying that the FDA can start banning products based on animal data, lab data, tests of similar substances, and Medwatch reports, even if these reports don't PROVE a product is in fact DANGEROUS. You do say this in your report below where you say that the FDA can ban a product if they consider it to pose a significant or unreasonable risk based on any of these factors.
I regard your report to be BIASED and MISLEADING. You are an ACADEMIC, not an orthomolecular doctor, a naturopath or an herbalist with actual clinical experience in treating patients using nutrients or herbs. You don't even have the level of knowledge or awareness of a simple clerk in a health food store who has seen the benefits dietary supplements can cause. Your knowledge is THEORETICAL, so explain to me why I or any OTHER vitamin consumer, health food store, alternative medical practitioner or vitamin manufacturer on earth should trust this NAS report?
Given the extreme health hazards documented by JAMA caused by pharmaceutical prescription drugs,
I am OFFENDED that the FDA has paid the National Academy of Sciences to generate this wholly UNECESSARY report. How much was NAS paid by the FDA to produce this garbage?
I would also have you know that the American people voted with their FEET against a TYRANNICAL FDA when DSHEA was passed by Congress in 1994, it was our way of telling our illustrious Congress that we REFUSE to live in a NANNY STATE in which the government attempts to tell us what we can and cannot INGEST into _OUR BODIES_ which belong to US and _NOT_ to the government.
I would also have you know that two lawsuits have been filed against the FDA's final rule on Ephedra, and its going to be overturned in court.
See the legal opinion of Hyman- Phelps- McNamara PC on the ILLEGALITY of the FDA's ban on ephedra at http://www.nha2004.com
Explain to me how you justify the banning of dietary supplements which I and countless millions of other people world wide have used in complete SAFETY on a basis of ANIMAL TESTING given the extreme DIFFERENCES in human and animal metabolism? Also explain to me how you justify doing testing on animals in the first place when it comes to dietary supplements given their extreme SAFETY?
Send me a complete detailed list of all pharmaceutical research grants you have worked under during the course of your career.
You are a public figure, and I am posting this email on my website and am sending it to my email distribution list.
If you should fail to respond properly to my questioning, this will be very publicly noticed by vitamin consumers world wide who will then REDOUBLE their efforts to protest the MADNESS of this outrageously BIASED, grossly UNSCIENTIFIC so called "report."
In Total Disgust,
John C. Hammell, President
International Advocates for Health Freedom
http://www.nationalacademies.org/webcastarchive.html April 1
re : http://books.nap.edu/books/0309091101/html/
http://www4.nationalacademies.org/news.nsf/isbn/s0309091101?OpenDocument
Dietary Supplements: A Framework for Evaluating Safety
Institute of Medicine and National Research Council
Public Briefing
April 1, 2004
Opening Statement
by
Barbara O. Schneeman
Associate Vice Provost for University Outreach, and Professor of Nutrition and Food Science
University of California, Davis
and
Chair, Committee on the Framework for Evaluating the Safety of Dietary Supplements
Good morning. On behalf of the entire committee, I would like to welcome you to this public briefing on a report that we hope will help the Food and Drug Administration enhance its ability to protect the health and well-being of the American public. I'd like to begin with some general comments and then open the briefing to questions and discussion.
The FDA approached the Institute of Medicine of the National Academies with a request to devise a science-based approach to evaluating the safety of supplement ingredients under the authority of current statutes. Over several decades, the agency tried several approaches to regulating supplements, sometimes meeting resistance from industry and the public. In 1994 Congress passed the Dietary Supplements Health and Education Act, known as DSHEA, in order to define FDA's authority to regulate dietary supplements.
In short, DSHEA states that supplements are to "supplement the diet" and are thus to be regulated like foods, meaning that they are assumed to be safe. Therefore, like food processors, supplement manufacturers are not required to conduct specific and defined safety tests on their ingredients or provide to the FDA documentation on the safety of their products. Many of the supplements on the market are probably safe. However, to identify and take action on the occasional problem product, the FDA must rely on available evidence and information to evaluate whether the ingredient in question poses an unreasonable risk.
Through this report, we offer the FDA a science-based approach by which the agency can use different kinds of available data to better identify supplements of concern, and then evaluate the safety of these ingredients. This approach works within the parameters of the current law governing how dietary supplements are regulated.
A key point of this report is that the FDA does not have to find direct evidence of actual harm from use of a supplement ingredient to determine that the product poses an unreasonable risk to consumers' health. According to DSHEA, the agency can act to protect the public's health when an ingredient poses a significant or unreasonable risk. Determining whether an ingredient carries unreasonable risks does not require the same level of definitive proof that would be needed to document actual harm.
The report describes the different kinds of data the agency can use in its safety evaluations. Often, useful information on an ingredient's effects in people is lacking because the supplement manufacturers are not required to conduct pre-market testing or report evidence of adverse experiences. Moreover, historical use of an ingredient often is not sufficient to demonstrate that an ingredient does not cause harm. We discuss the significance of other kinds of information, such as data from animal studies, tests done in laboratories, or toxicity of similar or related substances. Some of these types of data may be sufficient by themselves for the FDA to determine that a supplement ingredient poses an unreasonable risk.
With the approach devised by the committee, it is possible for the FDA to conduct effective safety evaluations within the current regulatory framework established by DSHEA. However, in the process of devising this approach and reviewing the science, the committee noted that constraints imposed by aspects of DSHEA limit the agency's ability to conduct these evaluations as effectively and efficiently as possible. We have recommended some changes that could mitigate these constraints and make the law more effective in meeting the goal of protecting public health.
For example, reports of adverse events associated with the use of a product can be an important way by which the FDA becomes aware of potential health risks. Currently, supplement manufacturers and distributors are not required to notify the agency about health problems that they discover related to the use of their products. The law should be modified to require such reporting. But other parties also bear responsibility for ensuring that health problems related to use are brought to the FDA's attention. Health professionals should be educated about ways to report health concerns and encouraged to use them. Likewise, the toll-free number for the FDA's MedWatch should be printed on all supplements' packaging so that consumers have a clear way to relay any health concerns.
While the committee was not formed to do a cost analysis of implementing this framework, implementing any framework to systematically evaluate the safety of dietary supplement ingredients will require additional resources. We recommend that Congress provide the FDA additional funding so that it can more effectively protect the public's health.
This concludes my opening remarks. My colleagues and I will now take your questions. Those of you listening to our webcast can send in questions by e-mail, using a link on the National Academies home page. Those of you in the room should step to one of the microphones in the aisles. And we ask everyone to identify yourself and your organization before asking your question. We'll begin with a question in the room. 