The following is a collection of articles and communications from Ward Dean MD about the GHB situation in the United States. They include his communication with the various authorities and comments on his court appearances as an expert witness on behalf of the defense. The articles appear in the order of the latest first, so in some cases you may wish to read on to learn of some of the earlier links and references.
Open Letter to the Board of Pharmacy, Florida
From; Ward Dean MD 3579 Highway 50 East Carson City NV89701
April 9, 1999
To; Jerry Hill, R.Ph., C.Ph. Chief, Bureau of Pharmacy Services 2818-A Mahan Drive Tallahassee, Florida 32308
Dear Mr. Hill,
Reference your letter dated April 7, 1999, to Mr. Mitchel Downey (Incl. 1), regarding the current status of gamma butyrolactone (GBL) in Florida. Your letter contains a number of misleading and inaccurate statements that promote the officially cultivated misperception that GBL is currently a controlled substance in Florida.
Your letter mentions a “press release” issued by the FDA on January 21, 1999 advising consumers not to purchase or consume products that contain GBL. I believe you are probably referring to the FDA Talk Paper (T99-5) (Incl. 2). In your letter, you state that the FDA issued this press release on the basis of reports from the Centers for Disease Control of “41 cases of serious GBL toxicity requiring hospitalisations, coma, seizures, and even death.”
Actually, the Talk Paper said FDA had received “reports of at least 55 adverse health effects, including one death.” However, despite these assertions,” we’re not sure
(1) how many people were involved,
(2) where these “reports” allegedly came from, and
(3) whether they are credible. Furthermore, the Talk Paper did not say anything about the Centers for Disease Control (as you stated in your letter).
You wrote, “the FDA considers GBL-containing dietary supplements to be illegally marketed unapproved new drugs.” While FDA may consider GBL-containing dietary supplements to be “new drugs” and therefore unapproved and illegal, this does not necessarily make them so. The Food Drug & Cosmetics Act definition of a dietary supplement, as amended by the Dietary Supplement Health & Education Act (DSHEA) of 1994,
(1) includes both GHB and GBL by two independent standards, and
(2) mandates that the FDA regulate them as foods, NOT DRUGS.
A Federal Court has already overturned the FDA’s application of drug regulations to “Chinese red yeast rice powder” in violation of dietary-supplement regulations. It is quite clear that their “consideration” of GBL-containing dietary supplements is equally illegal under federal law.
The FDA’s “considerations” regarding GBL are of no consequence to citizens of Florida for another reason. The FDA has no jurisdiction within a State, unless the State grants it to them (10th Amendment to the Constitution for the U.S.; Jurisdiction over Federal Areas Within the States – Report of Interdepartmental Committee for the Study of Jurisdiction over Federal Areas Within the States, Vols. I and II, U.S. Government Printing Office, 1956). If the FDA had direct jurisdiction at all, they wouldn’t require the collusion of State and County officials to enforce their press releases and Talk Papers (and since when do press releases have the force of law?).
The most serious lapse in your letter regards the Florida Attorney General’s Emergency Rule 2ER98-1 on 9 November 1999. According to Florida Statute 120.54 (9)(a)3.(c), (Rulemaking Procedures) (Incl. 3), “emergency rules expire after 90 days.” Thus, the Attorney General’s Emergency Rule expired on or about 9 February 1999. Furthermore, this same paragraph states that Emergency Rules “shall not be renewable.” Enforcement of an expired Emergency Rule is
(1) illegal,
(2) a violation of the Florida Constitution, and
(3) a violation of the civil rights of law-abiding citizens engaging in legally protected activities.
Your knowing and official participation in such enforcement exposes you to civil and criminal liability.
It is clear that there is no rule or statute that would preclude anyone from manufacturing, selling or possessing GBL-containing dietary supplements in Florida at the present time, despite the erroneous statements in your letter.
It might be wise for you to personally review the pharmacology of GBL and GHB. GBL is among the safest substances known. Enclosed is a copy of an article I wrote, based on information from a U.S. government Website (OSHA), concerning the overwhelming safety of long-term high-dose GBL consumption in several species of experimental animals (Incl. 4).
Also enclosed is a copy of my Freedom of Information Act (FOIA) request (Incl. 5) to the FDA for substantiation of their allegations of “55 adverse effects, including one death.” The HHS FOIA office responded (Incl. 6) stating that “we have no data in our adverse event file pertaining to your [my] request.”
Clearly, it appears that you and the Attorney General have been “had” by an out-of-control federal agency, which has made reckless and unsubstantiated allegations regarding an extremely safe and highly beneficial natural substance. I trust that you will send Mr. Downey a correction.
Yours truly,
Ward Dean MD
GHB and Junk Science; The Making of a Myth
Ward Dean MD
The vast majority of those who have either not used gamma hydroxy butyric acid (GHB) responsibly, or studied the scientific literature (or my book, GHB, The Natural Mood Enhancer), “know” that GHB is an illicit designer substance that is highly toxic and is widely used by unscrupulous criminals as a “date-rape drug.” The motivation for the viciousness of the “establishment” in propagating erroneous information and vilifying this highly beneficial natural substance is really no puzzle. GHB (and its dietary supplement precursors, gamma butyrolactone [GBL] and 1,4 butanediol [BD]) is often a better antidepressant than Prozac ®, Paxil ® or Zoloft; a better anti-anxiety agent than Valium or Ativan; a better relaxant and euphoriant than alcohol; and a better sleep-inducing substance than Dalmane or Restoril. GHB is stepping on some very large financial toes. Thus, the motive for GHB demonization is clear. However, the mechanics and coordination behind the demonization and prosecution/persecution of GHB manufacturers, salespeople and consumers was not, until recently, altogether clear.
However, this murky situation began to clear up to me as a result of a recent trial in which I testified for the defence in Deadwood, South Dakota. A Denver gym owner was accused of using GHB to facilitate rape. The defendant admitted that he had given GHB to a number of people at a party, after carefully advising everyone of the effects it might have on them. He also admitted having sexual relations with the complainant. The only point of contention in the case was whether the sexual relations were consensual or not, and whether GHB had incapacitated the complainant beyond her ability to resist. After hearing from all witnesses, who described the pre- and post- GHB “coming on” of the complainant, the issue was resolved by the jury after 20 minutes of deliberation “not guilty” on all counts. Normally, this trial would have been fairly routine, not worthy of mention in local papers. However, because the notorious “date-rape drug” was involved, the story became front-page news.
Gun for Hire
The prosecution had hired Jo Ellen Dyer, a pharmacist for the San Francisco, California Poison Control Center. I was vaguely familiar with Ms. Dyer’s background. I knew of her as a third coauthor of one of the first articles to describe GHB as a dangerous substance. I was unaware, however, of her central role in the criminalization of GHB which resulted in the prosecution of many GHB manufacturers and retailers.
As part of her packet to substantiate her qualifications as an Expert Witness, she was required to submit her CV (curriculum vitae). Gary Colbath, the defense attorney in the case, handed me her CV, and said “one thing for sure, she sure knows how to create “a CV.” As I perused her CV, the picture became very clear. Dyer was clearly a “hired gun” for the government. Among her “Public Service” credits were appearances on the Oprah Winfrey, Geraldo Rivera, and CNN’s notoriously inaccurate Impact shows. Her “Professional Activities,” since 1990, included being a consultant to: (1) the Food and Drug Administration (FDA); (2) the Drug Enforcement Administration (DEA); (3) the FBI; (3) the US Dept. of Justice; (4) the Michigan State Police; (5); Representative Sheila Jackson Lee (author of the notorious “Hillory Farias Date Rape Drug” bill; Ironically, Hillory Farias had not consumed GHB nor had she been raped); and (6) the Florida Legislature, Senate Criminal Justice Committee; etc.; etc. Not exactly an unbiased background.
I was also unaware of the price she charged. Although I have testified five times on behalf of defendants in GHB cases, I usually charge only my travel expenses, because (1) usually, the lawyers have already gotten all the money from the now-destitute defendants; and (2) I don’t like to see honest people sent to prison (Recently, VRP has been charging the defense the cost of my salary to recover their expenses for the days I am lost to VRP due to the trial). I was as surprised as the jury (their jaws dropped collectively) when Ms. Dyer smugly announced that she charged $300/ hour for 30 hours (i.e., $9,000 to the taxpayers South Dakota) for her approximately one hour on the stand (Nice pay if you can get it. This does not, in my mind, result in unbiased testimony). I doubt if she makes that much answering the telephone for the Poison Control Center in San Francisco.
In addition to her media appearances, and the articles I knew about, in her CV Dyer also claimed authorship of four additional early articles that were heretofore either attributed to others or were anonymously written (#s 1, 2, 4, and 5, below).
After 30 years of safe over-the-counter and clinical use of GHB for surgery, addiction treatment, relaxation and enhancement of natural sleep, the situation changed dramatically. Almost overnight, GHB has become a substance with allegedly little or no therapeutic value (in the states where GHB was labelled a Schedule I substance). Deep sleep was now redefined as “coma” (My patients on GHB now laughingly tell me how much they appreciate being able to “go comatose” every night). But the redefining of the positive effects of GHB with negative connotations is not a joke. By legislative fiat, our legislatures are now criminalizing many otherwise honest citizens, as well as depriving many people whose lives have been dramatically improved from obtaining this highly beneficial substance.
Bibliography of GHB-Demonizing Articles
Dyer’s articles formed the foundation of the paradigm-shift. Review of adverse articles about GHB reveals that they have all been launched from the platform of her articles. Unfortunately, her articles are, however, masterpieces of fiction and contradiction. The articles below represent the entire body of scientific literature that describes GHB in an adverse light (with the exception of #6, which is a response to an adverse article, pointing out errors). We addressed in depth the veracity and/or significance of a number of these articles (designated by an asterisk) in our book (Dean, Morgenthaler and Fowkes, 1997). Such analysis will not be repeated here in order to maintain brevity. The articles are numbered in order of their dates of publication (i.e., earliest first, most recent last). Articles which were authored by Jo Ellen Dyer are in boldface type. My comments are enclosed in [brackets]. All adverse articles (with the exception of newspaper stories) that are cited as references in each article are listed within {curved brackets} for each article.
It can be seen that the first fourteen articles (remember, #6 was a response) to be published that portrayed GHB in an adverse light were authored by Dyer or used articles by Dyer as their sole adverse reference. Beginning with #16, non-Dyer-authored adverse articles began to be cited. Note, however, that even these non-Dyer articles used only Dyer articles as their references. So it becomes clear that what we have is a created paradigm-shift based on a “feeding frenzy” of cross- and self-citation/referencing, resulting from bad science that was largely the work of one woman with an agenda.
1. Grigg, Bill, and McLearn, Donald. GHB Warning. FDA Press Release, P90-53, November 8, 1990. [Dyer’s CV states, “I (she) identified GHB as an over-the-counter nutritional supplement causing coma and seizures in 1990. My (her) reports to the FDA resulted in a ban on over the counter sales of this unapproved drug and removal from the shelves in California.”]*
2. Anonymous [Dyer] Multi-state Outbreak of Poisonings Associated with illicit use of gamma hydroxy butyrate. MMWR, 1990, 39: 47, 861-863. {1}
3 Nightingale, Stuart L. Warning about GHB. JAMA, 1991, 265: 14, 1802. {No refs.} [Nightingale is the FDA’s Associate Commissioner for Health Affairs. I wonder if he really wrote this article].
4. Anonymous. [Dyer] Gamma hydroxybutyrate GHB poisoning. The Medical Letter, 1991, 33: 836. {No refs.}
5. Anonymous. [Dyer] Multi-state outbreak of poisonings associated with illicit use of gamma hydroxybutyrate. JAMA, 1991, 265: 4, 447. {1}
6. Lane, Rosemary. Gamma hydroxybutyrate (GHB). JAMA, 1991, 265: 22, 2959. [Response to previous article, citing safety and efficacy of GHB in pediatric anaesthesia]. {5}
7. Dyer, Jo Ellen. Gamma hydroxy butyrate: A health food product producing coma and seizure like activity. Am J Emerg. Med., 1991, 9: 321-324. {5} * Chin, Ming-Yan, and Kreutzer, Richard A. Acute poisoning from gamma hydroxybutyrate in California. [Unpublished draft of the following article (#9) prior to Dyer being added as third author. There were several extremely significant differences between these two papers. In this draft, ten subjects were described all but one recovered with no adverse effects. The one patient who died succumbed to a bleeding esophageal varicose vein. This is a common result of hepatitis or alcohol-induced cirrhosis. The patient was taking a number of other herbal supplements, all intended to support the liver. GHB is used in Europe for withdrawal from alcohol addiction. Naturally, GHB was blamed for the death. The other significant difference was the report of one patient who accidentally consumed 15 tablespoons of GHB (that’s about 75-85 grams, nearly a whole bottle!) who was discharged from the hospital 24 hours later with no ill effects! This report was deleted from the following paper]. {No refs.}*
9. Chin, Ming-Yan, Kreutzer, Richard A., and Dyer, Jo Ellen. Acute poisoning from gamma hydroxybutyrate in California. [This report mentioned only five patients (the worst five) including the one who died from the bleeding esophageal varicose vein (the remainder recovered spontaneously without ill effects). It also deleted any mention of any positive effects of GHB]. Western Journal of Medicine, 1992, 156: 4, 380-384. {{2, 7}*
10. Einspruch, Burton C., and Clark, S. Michael. Near fatality results from health food store sleeping potion. Texas Medicine, 1992, 88: 12, 10. {2}
11. Luby, Stephen, Jones, Jeffrey, and Zalewski, Alan. GHB use in South Carolina. American J Public Health. 1992, 82: 1, 128. {2}
12. Adornato, Bruce T., and Tse, Victor. Another health food hazard– gamma hydroxybutyrate-induced seizures. Western Journal of Medicine, 1992, 157: 471. {9}
13. Mack, Robert. Love potion number 8½. North Carolina Medical Journal, 1993, 54: 5, 232-233. {7}
14. Dyer, JE, Isaacs, SM, and Keller, KH. Gamma hydroxybutyrate (GHB)-induced coma with serum and urine drug levels. Vet Human Toxicol, 1994, 36: 4, 348. {No refs.}
15. Galloway, Gantt P., Frederick, S.L., and Staggers, Frank. Physical dependence on sodium oxybate. The Lancet, 1994, 343: 57. {7}
16. Stephens, Boyd C., and Baselt, Randall C. Driving under the influence of GHB? J Analytical Toxicology, 1994, 18: 257-358. {5, 11, 3}
17. Ferrara, Santo D., Tedeschi, Luciano, Frison, Giampietro, and Rossi, Alessandra. Fatality due to gamma-hydroxybutyric acid (GHB) and heroin intoxication. [The causes of death were clearly described in this article. The pathological findings were all consistent with heroin use and intoxication. They were not in accordance with the known clinical effects of GHB. The individual was in a drug treatment program in which his GHB was prescribed for heroin addiction]. J Forensic Sciences, 1995, 40: 3, 501-504. {2, 7, 9}*
18. Ross, Tracy McIntyre, Gamma hydroxybutyrate (GHB) overdose: Two cases illustrate the unique aspects of this dangerous recreational drug. J Emerg Nurs, 1995, 21: 374-376. {2, 9, 15}
19. Steele, Mark T., and Watson, William A. Acute poisoning from gamma-hydroxybutyrate (GHB). Missouri Medicine, 1995, 92: 7, 354-357. {7, 4, 2, 9, 1, 13}*
20. James, Charose. Another case of gamma hydroxybutyrate (GHB) overdose. J Emerg Nurs, 1996, 22: 97. {18}
21. Friedman, Joseph, Westlake, Robert, Furman, M. “Grievous bodily harm:” Gamma hydroxybutyrate abuse leading to a Wernicke-Korsakoff syndrome. Neurology, 1996, 46: 469-471. [Claims GHB contributed to Wernicke-Korsakoff syndrome, a condition caused by alcohol abuse and vitamin B1 deficiency] {2, 9, 7, 12}*
22. Carrazanna, Enrique J. Grievous Bodily Harm. 1996, Neurology, 47: 1351. [Challenges role of GHB in previous article by Friedman, et al. Points out that the condition referred to was rapidly reversed with appropriate dosage of vitamin B1]. {21}
23. Galloway, Gantt P., Frederick, S.L., Staggers, Frank E., Gonzales, Marco, Stalcup, S. Alex, and Smith, David E. Gamma-hydroxybutyrate: An emerging drug of abuse that causes physical dependence. Addiction, 1997, 92: 1, 89-96. {7, 11, 2, 9,10, 15}*
24. Louagie, Henk K., Verstraete, Alain G., De Soete, Christophe J., Baetens, Dimitri G., and Calle, Paul A. A sudden awakening from a near coma after combined intake of gamma-hydroxybutyric acid (GHB) and ethanol. Clinical Toxicology, 1997, 35: 6, 591-594. {5, 7, 19, 9, 17, 21, 16}
25. Tunniclliff, Godfrey. Sites of action of gamma hydroxybutyrate (GHB) – A neuroactive drug with abuse potential. Clinical Toxicology, 1997, 35: 6, 581-590. {7, 9, 19, 15, 23, 21}
26. Sanguineti, Vincenzo, R., Angelo, Anita, and Frank, Marion Rudin. GHB: A home brew. Am J Drug Alcohol Abuse, 1997, 23: 4, 637-642. {9}
27. Anonymous: Gamma hydroxybutyrate use; New York and Texas, 1995-1996. MMWR, 1997, 46: 13, 281-282. {2}
28. Bismuth, Chantal, Dally, Sylvain, and Borron, Stephen W. Chemical submission: GHB, benzodiazepines, and other knock out drops. Clinical Toxicology, 1997, 35: 6, 595-598. {23, 27}
29. Anonymous: Gamma hydroxybutyrate use; New York and Texas, 1995-1996. JAMA, 1997, 277: 19, 1511. {“3 available” but not listed}
30. Marwick, Charles. Coma-inducing drug GHB may be reclassified. JAMA, 1997, 277: 19, 1505-1506. {No refs}
31. Chin, Rachel L., Sporer, Karl A., Cullison, Brian, Dyer, Jo Ellen, and Wu, Thomas D. Clinical course of gamma-hydroxybutyrate overdose. Annals of Emergency Medicine, 1998, 31: 6, 716-722. {5, 7, 9, 10, 18, 20, 16, 14, 13, 19, 11, 21, 25, 17, 12}
32. Li, James, Stokes, Sharon Arnaud, and Woeckener, Anna. A tale of novel intoxication: Seven cases of gamma hydroxybutyric acid overdose. Annals of Emergency Medicine, 1998, 31: 6, 723-728. {2, 11, 17, 18}
33. Li, James, Stokes, Sharon Arnaud, and Woeckener, Anna. A tale of novel intoxication: A review of the effects of gamma hydroxybutryic acid with recommendations for management. Annals of Emergency Medicine, 1998, 31: 6, 729-736. {2, 17, 11, 18, 19, 10, 15}
34. Hernandez, Michael, McDaniel, Charles H., Costanza, Christopher D., and Hernandez, Oscar J. GHB-induced delirium: A case report and review of the literature on gamma hydroxybutyric acid. Am J Alcohol Abuse, 1998, 24: 1, 179-183. {4, 2, 19, 7, 17, 9}
35. Hodges, Barbara, Everett, James. Acute toxicity from home brewed gamma hydroxybutyrate. J Am Board Fam Pract, 1998, 11: 2, 154-157. {30, 21, 19, 10, 18, 16, 9, 2, 7, 17, 15, 13, 11}
36. Gamma hydroxybutyrate, American Family Physician, 1998, 57: 9, 2078-2079.
Antidote Never Mentioned
In all these articles, Dyer and her accomplices express their concern for the “victims” of GHB overdoses. However, their motives may be suspect when it is learned that not one of these articles discuss the antidote for GHB-induced sleep, including the one article that purports to describe therapeutic protocols for management of GHB overdose (# 33). They all repeat the myth that “there is no way to awaken someone from GHB-induced sleep.”
On the contrary, GHB-induced sleep can be rapidly reversed by using a drug that is readily available in every emergency room. The use of physostigmine to awaken surgical patients from GHB-induced anaesthesia has been known for over 20 years! In 1976, Henderson and Holmes reported that 2 mg of physostigmine administered intravenously resulted in awakening of their patients in 2-10 minutes. Only one patient in 25 failed to regain consciousness within ten minutes. This patient required a second dose of physostigmine, and awakened uneventfully. There were no adverse effects reported when using this regimen. Nevertheless, this safe, effective procedure is not mentioned once in any of the above articles perhaps because the perception that there is no antidote (even though not usually necessary) makes the offending substance seem even more dangerous.
References:
Dean, Ward, Morgenthaler, John, and Fowkes, Steven Wm. GHB, The Natural Mood Enhancer, 1997, Smart Publications, Petaluma, California.
Henderson, R.S., and Holmes, C. McK. Reversal of the anaesthetic action of sodium gamma hydroxybutyrate. Anaesth Intens Care, 1976, 4: 351.
Open Letter to State Representative of Florida regarding GHB
From, Ward Dean MD 3579 Highway 50 East Carson City NV89701
To, Representative Jerry Maygarden Tallahassee, Florida
3 April, 1999
Dear Jerry,
As you know, I have been in contact with Janice Gilley regarding pending legislation regarding scheduling of gamma hydroxy butyric acid (GHB). This legislation calls for scheduling of GHB as Schedule II, as well as any “salt, compound, derivative, or preparation of GHB” to include any “isomers, esters, ethers, and salts of isomers, esters and ethers of GHB,” under FS 893.035, in accordance with a recently-expired Emergency Rule from the Attorney General.
I believe such legislation is ill-advised for a number of reasons.
First, the Attorney General’s Emergency Rule is based on faulty information. It is based entirely on a recently-issued FDA talk paper (Incl. 1). The Talk Paper refers to “55 adverse events including one death” which are allegedly related to the GHB precursor, gamma-butyrolactone (GBL). I attempted to confirm this information with the FDA. I was told by the author of the Talk Paper (Ruth Welch, of the FDA) that the information was available on the FDA’s website. I checked, and found only the sketchiest of information there. Ms. Welch then told me “that is all the information available to the public.” I submitted a Freedom of Information Act (FOIA) request (Incl. 2), and was advised that “we [FDA] have no data in our adverse event file…” (Incl. 3). Thus, the Attorney General apparently used totally unsubstantiated allegations on which to base his Emergency Rule.
Second, I believe that GHB (and its precursors, GBL and 1,4 Butanediol [BD]) are among the safest and most beneficial natural substances known. GHB has a toxicity about 1/3 that of table salt. When used properly, it is highly beneficial to health in general, and as a treatment for a wide variety of clinical conditions, including sleep disorders, fibromyalgia, chronic fatigue, obesity, depression, anxiety, and many others. It is not the toxic, dangerous date rape drug that the media and the Attorney General would have us believe. I am enclosing a copy of an article I wrote about the overwhelming safety of long term use of extremely high doses of GBL
Third, the Attorney General’s Emergency Rule and a similarly-worded statute are clearly so all-inclusive as to be void for vagueness, and therefore, unconstitutional. This broad category of substances which encompassed by the Emergency Rule includes nail polish remover, floor cleaners, engine degreasers, and even alpha-hydroxy acids in apples. Furthermore, we have identified GHB as being a natural constituent in meat, citrus fruits, and other products. Every grocery store owner is therefore in possession of GHB, and undoubtedly has an intent to distribute such products. Such legislation will make unindicted felons of many business owners and may reflect adversely on the wisdom of the Florida State Legislature.
I request that hearings be scheduled prior to voting or enacting into law such a poorly-written and ill-advised statute as has been proposed by the Attorney General and his legislative henchmen. I believe that the “other side” of the GHB story needs to be told, which is far different from the one portrayed by the media and the Attorney General. I have nearly three filing cabinet drawers full of scientific articles and Investigational New Drug (IND) studies from the FDA confirming the overwhelming safety and efficacy of GHB and its precursors. I and a number of other physicians and satisfied users of GHB and its precursors are anxious to testify before the Legislature, to tell the truth about this remarkable substance.
Please let me know how you intend to proceed on this important issue (aren’t they all?).
Yours truly,
Ward Dean MD
FDA Talk Paper on Dangers of RenewTrient Appears to be Without Foundation
Ward Dean MD
On January 16, 1999, The FDA issued a “Talk Paper” (T99-5) (Fig. 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 (after all, the government wouldn’t lie, would it?) 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 I am not professionally an investigative reporter, I think I have already investigated this matter in more depth than our mainstream, orthodox press. These are the folks that believed Clinton when he wagged his finger at us and said, “Now listen to me. I’m only going to say it once. I did not have sex with that woman!”
We’ve just had the FDA wag its finger at us
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 the 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 it’s 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 website (www.fda.gov/foods/dietarysupplements/specialdietarysupplements/). However, when I went to the website, 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 “BlueNitro, an Explosive Media Campaign” in this Supplement. Consequently, I submitted a Freedom of Information Act (FOIA) request to the FDA 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.”
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 Fowkes, Steven Wm. . Stop the FDA: Save Your Health Freedom, Health Freedom Publications, Menlo Park, 1992.
Contact State Representative to block GHB and related legislation in your state.
Contact U.S. Representative to investigate the deceptive press releases of the FDA
“BlueNitro” – An Explosive Media Campaign Or, Gamma Butyrolactone – A Legal Precursor for GHB With Multiple Therapeutic Uses
by Ward Dean MD
“BlueNitro Worries Poison Experts” screamed the headline of the San Francisco Examiner on Monday, January 11, 1999. The active ingredient in BlueNitro is butyrolactone (GBL), which is readily converted by the body into GHB (gamma hydroxybutyric acid). The same article states, “Medical professionals are warning that the chemical composition of the liquid creates more risks than benefits.” Although this is the view of GBL that propagated by the media, there is another view that has a much more positive outlook.
The following article was written by Dr. Dean prior to the current excitement. As this issue goes to press (January 14, 1999), law enforcement officers have raided at least one manufacturer of GBL-containing nutritional supplements in Florida. The Attorney General of Florida has determined that butyrolactone (the active ingredient in RenewTrient) is within the purview of his new “Emergency Order” which makes “isomers, esters, ethers, salt isomers and ethers of GHB” a controlled substance (Schedule II) in Florida.
While this broad (overbroad, we believe) edict includes substances like RenewTrient, it also includes gasoline, paint thinner, nail polish remover, polyester and even apples. However, so far, this far-reaching provision has only been selectively applied in Florida against manufacturers of GBL-containing nutritional supplements.
For more information on GHB, see Dr. Dean’s book, GHB, The Natural Mood Enhancer, and previous articles in VRP Nutritional News “A call to action-Stop Criminalization of GHB!” (April 1997); “VRP ‘crashes’ secret meeting to outlaw GHB” (Septe