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FDA "Talk Paper" on Dangers of RenewTrient Appears to be Without Foundation
June 1999 GHB Report
by Ward Dean, M.D.
On January 16, 1999, The FDA issued a "Talk Paper" (T99-5, Figure
1), titled "FDA warns about products containing gamma butyrolactone
or GBL and asks companies to issue a recall." This Talk Paper claimed
that "GBL related products have been associated with reports of at
least 55 adverse health effects, including one death." Establishment
newspapers and television stations across the country accepted the FDA’s
claims at face value without further investigation. This resulted in a
flurry of news features by some of the nation’s top reporters and
journalists (i.e., writers for the NY Times, San Francisco Chronicle,
CNN, etc), blaring the dangers of this latest "date-rape" menace.
Furthermore, it was largely on the basis of this FDA Talk Paper that the
Florida Attorney General initiated legal action against manufacturers
of GBL-containing dietary supplements.
Although professionally I am not an investigative reporter, I think I have already investigated this matter in more depth than our mainstream, orthodox press.
From previous experience, I am all too familiar with FDA Talk Papers. Shortly after our book, Smart Drugs & Nutrients (1990) was published, the FDA issued a Talk Paper on Smart Drugs, which included a wealth of misinformation and deception about a number of cognitive enhancing substances. Fortunately, I was able to respond to each of the FDA’s allegations in a chapter in a subsequent book, Stop the FDA (Morgenthaler and Fowkes, 1992). Stop the FDA also included chapters by Dr. Linus Pauling,
Senator Orrin Hatch, Durk Pearson and Sandy Shaw, and many others concerned by the FDA’s propensity to warp the facts to meet its altered view of reality. In my chapter I addressed each and every issue raised by the FDA, and, backed up by meticulous documentation, showed point-by-point how they had either twisted the truth or simply lied outright.
Now the FDA has been caught in the act again. Based on my previous experience with Talk Papers, I contacted the author of the most recent fabrication, Ruth Welch of the FDA Press Office. I asked whether she could provide me with any documentation to substantiate and analyze these "adverse events." Ms. Welch responded that the only information "available to the public" was on the FDA’s web site (www.fda.gov/foods/dietarysupplements/specialdietarysupplements/). However, when I went to the web site, I found reference to only 10 alleged "adverse events," including one death, which involved the co-ingestion of other substances.
I was aware of the overwhelming safety of GHB and its precursor, butyrolactone (GBL) — the active ingredient in RenewTrient and similar products (see "Blue Nitro, an Explosive Media Campaign" in this supplement). Consequently, I submitted a Freedom of Information Act (FOIA) request to the FDA (Fig. 2) to obtain further information about these alleged adverse events. In response, the Department of Health and Human Services FOIA office informed me that "we have no data in our adverse event file pertaining to your request (Fig 3)." No data?
Now, either (1) the folks in the FDA’s FOIA office don’t know what is going on or are not being truthful and are not releasing information they are obligated to divulge; or (2) the folks who produce Talk Papers for the FDA are up to their old tricks. In either case, the "press-release regurgitators" of the mainstream media were certainly not living up to journalistic standards which obliges them to confirm the veracity of their stories, and to check multiple sources.
References:
Dean, Ward. Does the FDA Need Smart Drugs, in: Stop the FDA: Save Your Health Freedom, by Morgenthaler and Fowkes (eds), Health Freedom Publications, Menlo Park, 1992, pp. 147-153.
Dean, Ward, and Morgenthaler, John. Smart Drugs & Nutrients, Smart Publications, Petaluma, 1990.
Morgenthaler, John, and Steven Wm. Fowkes. Stop the FDA: Save Your Health Freedom, Health Freedom Publications, Menlo Park, 1992.
Ruth Welch’s phone number and email address are: 202-205-4144, rwelch@bangate.fda.gov
Contact your State Representative to block GHB and related legislation in your state.
Contact your U.S. Representative to investigate the deceptive press releases of the FDA.
FDA
TALK PAPER
Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
FDA WARNS ABOUT PRODUCTS CONTAINING GAMMA BUTYROLACTONE OR GBL AND ASKS COMPANIES TO ISSUE A RECALL
The Food and Drug Administration is alerting consumers not to purchase or consume products, some of which are labeled as dietary supplements, that contain gamma butyrolactone (abbreviated as GBL). FDA has also asked the companies that manufacture these products to voluntarily recall them. The agency has received reports of serious health problems -- some that are potentially life-threatening -- associated with the use of these products.
Although labeled as dietary supplements, these products are illegally marketed unapproved new drugs. Products containing GBL are marketed under various brand names including Renewtrient, Revivarant or Revivarant or Revivarant G, Blue Nitro or Blue Nitro Vitality, GH Revitalizer, Gamma G, and Remforce. They are promoted with claims to build muscles, improve physical performance, enhance sex, reduce stress and induce sleep.
GBL is also known by the chemical names 2(3H)-furanone dihydro; butyrolactone; gamma butyrolactone; 4-butyrolactone; dihydro-2(3H)-furanone; 4-butanolide; 2(3H)-furanone, dihydro; tetrahydro-2-furanone; and butyrolactone gamma.
GBL related products have been associated with reports of at least 55 adverse health effects, including one death. In 19 of those cases, the consumers became unconscious or comatose and several required incubation for assisted breathing. Other reported effects included seizures, vomiting, slow breathing and slow heart rate. There are reports of at least 5 children under 18 years of age who have been injured or who have suffered these kinds of effects.
When taken orally, GBL is converted in the body to gamma hydroxybutyrate or GHB. GHB is very potent unapproved drug. It is currently being investigated under the supervision of doctors for the treatment of narcolepsy. Because of its serious side effects, GHB should not be taken unless in the context of these FDA approved investigations. FDA and the Justice Department have ongoing criminal enforcement actions against GHB, GBL should not be taken.
Products containing GBL are sold in liquid and powder form. They are sold via the Internet, in some health food stores, and in some gymnasiums and fitness centers.
Consumers are advised to dispose of any products of this type in their possession. If they have experienced adverse health problems from use of these products, they should promptly contact a physician. FDA requests consumers and physicians to report adverse events to the FDA’s MEDWATCH 1-800-332-1088.
The Trimfast Group, Inc. has agreed to recall the product Revivarant, 32 ounces of liquid in a plastic bottle, and Revivarant G, 200 grams of powder in a pill bottle. Other companies manufacturing products containing GBL are being asked by the FDA to voluntarily recall them.
FDA is considering all potential regulatory actions at
its disposal if products containing GBL are not recalled. The agency will
act expeditiously to protect the public health.
Fig. 1. Talk Paper issued from the FDA
Ward Dean, M.D.
3579 Highway 50 East
Carson City, NV 89701
(775) 884-1300
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Dear Sir,
On January 21, 1999, the FDA released Talk Paper T99-5, "FDA Warns about products containing gamma butyrolactone or GBL and asks companies to issue a recall." The Talk Paper states that there have been 55 adverse health effects, and one death associated with GBL related health products.
However, I have been unable to verify these reports. The FDA’s website (where I was advised to go to obtain the information) only lists ten adverse events, including one death which involved the coingestion of other products.
In order to scientifically evaluate the contribution of GBL products to these events, under the provisions of the Freedom of Information Act (FOIA) I request complete copies of the adverse event reports, including related medical histories, lab reports, and (in the case involving the death) the autopsy report.
In order to protect privacy of those involved, I understand that identities may be deleted. Furthermore, I believe that this information is not: (1) related solely to FDA’s internal rules and practices; (2) information that is prohibited from disclosure by other laws; (3) a trade secret or confidential commercial or financial information; (4) related to interagency and/or intra-agency communications; (5) likely to interfere with law enforcement proceedings.
I am willing to pay fees incurred in obtaining this information.
Yours truly,
Ward Dean, M.D.
Fig. 2. A Freedom of Information Act (FOIA) request from Dr. Ward Dean.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Center for Drug Evaluation and Research
Office of Training and Communication
Freedom of Information Staff HFD-205
5600 Fishers Lane 12 B 05
Rockville, Maryland 20857
In Response Refer to File: F99-5081
Ward Dean, M.D.
3579 Highway 50 East
Carson City, NV 89701
Dear Dr. Dean:
This is in response to your request of 2/19/99, in which you requested adverse events associated with the use of GBL. Your request was received in the Center for Drug Evaluation and Research on 3/4/99.
Please be advised that we have no data in our adverse event file pertaining to your request.
Charges of $3.50 (Search $3.50, Review $0, Reproduction $0, Computer time $0) will be included in a montly invoice. DO NOT SEND ANY PAYMENT UNTIL YOU RECEIVE AN INVOICE.
If there are any problems with this response, please notify us in writing of your specific problem(s). Please reference the above file number.
This concludes the response for the Center for Drug Evaluation and Research.
Sincerely,
Hal Stepper
Freedom of Information Technician
ffice of Training and Communications
Freedom if Information Staff, HFD-205
GHB Articles by Dr. Ward Dean
