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ANALYSIS by Paul Anacker, J.D.
The FDA is a rogue, out-of-control bureaucracy. In the past, in its war against dietary supplements, it has threatened people with criminal prosecution for claiming that anti-oxidants prevent disease. It has made giant food companies take words as innocuous as "ask your doctor" off cereal boxes. It has instigated guns-drawn, Gestapo-like raids on 80-year old health food store owners.
The American people might have thought they finally put an end to that absurd oppression and won the war with the DIETARY SUPPLEMENT HEALTH & EDUCATION ACT (DSHEA). But, for the FDA that was only a challenge to find new ways to subvert the will of the American people.
Now the FDA has falsely taken the role of protector of date-rape victims in a cold and calculated strategy to use the basic human revulsion for a despicable crime of violence in order to further its agenda. It has been waging a campaign of lies and mis-information to create emotional hysteria in order to get Congress to do politically what it can't do legally - classify a dietary supplement, gamma-hydroxybutyrate (GHB), curiously both as Schedule I (meaning it has no medical use) and Schedule III (requires a prescription), in a "DATE-RAPE DRUG ACT."
You can fool some of the people. The FDA has fooled the media with cleverly worded press releases about GHB and its related products, gamma-butyrolactone (GBL) and 1,4-butanediol (BDO). It has fooled most members of 21 state legislatures by making sure only its "experts" presented testimony at hearings. Now it's trying to fool Con-gress by making sure the only information members receive is from FDA-invited "experts."
But the FDA has not fooled everyone. In a series of FDA lawsuit losses, federal courts have lambasted the FDA's reasoning; calling it "absurd" and "almost frivolous." 1 The Government Accounting Office (GAO) has questioned FDA regulations because of the "limitations and uncertainties associated with the agency's scientific and economic analyses."2 The Honorable F. James Sensenbrenner, Jr. (R-WI), Chairman of the House Science Committee, recently stated, "I am concerned about the apparent lack of scientific data behind the FDA's actions."
Chairman Sensenbrenner further stated, "(T)o use such poor science for a dietary supplement raises warning flags for the other products the agency regulates." 3 GHB is a product for which the warning flags should be raised about FDA "science."
Here are some FDA lies about GHB:
FDA Lie #1 - GHB is a drug
GHB is a simple carbohydrate found naturally in every cell of the human body. GHB is both a metabolite of and precursor to an amino acid consumed daily by millions of Americans - gamma aminobutyric acid (GABA). DSHEA clearly states that metabolites of amino acids are dietary supplements. The FDA's label of GHB as a "drug" is a lie. The language it uses, to lead the media to label GHB as a "synthetic designer" or "date-rape" drug, is gross misinformation.
FDA Lie #2 - GHB has no medical uses
The FDA "experts" know they're telling a lie when they state GHB has no medical uses. In 1974, the FDA approved an Investigational New Drug (IND) application for GHB that discussed 15 medical uses. GHB has been used safely to treat cataplexy, insomnia, narcolepsy, depression, alcoholism, and opiate addiction, and to stimulate natural growth hormone release, to name a few.
FDA Lie #3 - GHB is hazardous
Patients in the IND trials are handed large containers of GHB; told to take doses of 2 to 8 grams; and to come back when they need more. Something the FDA would NOT allow if it truly believed GHB was "hazardous."
Substance Tylenol EtOH NaGHB
Std. dose 1 gm 2 oz 2 gm
Lethal dose 10 gm 20 oz 300 gm Safety Factor 10:1 10:1 150:1
The comparative safety of GHB is shown in the table at the top of this column. The data (from Medline research) is from scientists doing primary research; unlike FDA "experts" who give opinions based merely on anecdotal reports. The data shows sodium-GHB (NaGHB) is far safer than acetaminophen (Tylenol) or alcohol (EtOH).
National Toxicology Program reports on the GHB related substances GBL and BDO contradict the FDA's "science."
FDA Lie #4
Even the FDA contradicts the FDA. It has released a number of "Talking Papers" stating it has received reports of adverse events and deaths "associated" with GHB, GBL and BDO. When Freedom of Information Act (FOIA) requests have been made for copies of those reports, the FDA's FOIA office has written that the FDA has no such reports.
FDA Lie #5 - GHB is highly addicting
The 30 years of primary research reports prior to 1990 and the IND reports all state GHB is non-addicting. In the FDA-supervised studies on narcolepsy, no patient has ever become addicted to GHB. The scientific record is clear:
When GHB is used responsibly it's not addicting. In fact, it is used to treat addiction to alcohol and narcotics.
FDA Lie #6 - GHB is a "date-rape" drug
Date rape is a very serious subject. So, it's important to use science and reason when discussing it. However, it's such a traumatic topic that most people are more influenced by emotional hysteria than reason. The FDA knows this and plays upon that hysteria.
The use of any substance to facilitate date rape should be a crime. And that's already the law in many states. GHB and many other substances the FDA has approved for insomnia can be (but rarely have been) used to facilitate date rape since they can cause a deep sleep. But that's no reason to label GHB a "date-rape" drug any more than Nytol, Tylenol PM, or Benadryl.
There are a few substances which truly should be labeled as "date-rape" drugs. They enable a perpetrator to keep a victim conscious, but easily compelled to engage in sex. They cause a victim to forget what happened while under their influence. And they clear from the body fairly quickly, making their detection difficult.
The only attribute GHB has in common with those substances is it clears from the body quickly (and safely), as carbon dioxide and water. But, GHB does NOT cause a person to remain conscious, engage in sex, and then not remember what they did.
The FDA's constant and repetitive linking of GHB together with those substances diverts attention from counseling people on the real dangers of the substance used most often to facilitate date rape, alcohol. The FDA's single-minded focus on GHB demeans victims by ignoring far more serious and more wide-spread risks. It is tokenism the FDA uses in a very base manner to further its agenda.
FDA synthetic designer "science"
In the 1980s, GHB was available in health food stores. GHB containers had labels with dosage instructions and warnings. People were using it safely for many health purposes.
In 1990, a private-sector pharmacist made an "amazing" discovery. Just 3 years after finishing her residency, Ms. Jo Ellen Dyer "discovered" what world-class scientists had "missed" for 30 years - "GHB poisoning!" What she really "discovered" was alcohol poisoning. Alcohol and GHB are metabolized in the body by the same enzyme, alcohol dehydrogenase. If GHB and alcohol are co-ingested, the toxic effects of alcohol are increased. Alcohol poisoning, NOT "GHB poisoning" (sic) causes coma and seizure. [State prosecutors pay Ms. Dyer up to $9,000 (taxpayer dollars) as a fee for an hour of testimony about her "discovery." Not much incentive to want the truth known about GHB.]
Without holding hearings to ascertain the validity of this "discovery," the FDA simply issued a press release "ban" of GHB on Nov. 8, 1990. Fearing FDA Gestapo-like raids, health food store owners took it off their shelves.
Unable to obtain GHB in health food stores, people bought "street" GHB. It didn't come with labels. Without the benefit of the labels, more people unwittingly took high doses of GHB with excessive amounts of alcohol and ended up in hospital emergency rooms.
Doctors, "educated" by the FDA about GHB symptoms, made reports of "GHB poisoning" that were more "politically correct" than scientifically accurate.
The FDA used those reports and its press release "ban" as the basis of briefings for state legislatures and law enforcement personnel. It made sure non-scientific people got the "right" picture. And the FDA hit upon its unsavory strategy of "associating" GHB with "date-rape" drugs.
Suggested Congressional action
A rush to schedule a dietary supplement, under the guise of a "date-rape" bill, without scientific debate, is a poor basis for public policy. Before depriving millions of Americans of dietary supplements sold in hundreds of health food stores, Congress should take the time to listen to testimony from experts knowledgeable about the full scientific record on GHB. The requests of those experts to be heard have been ignored by the FDA. If Congress doesn't take the time, the FDA will have succeeded in manipulating Congress into doing politically what the FDA couldn't do scientifically. This will make a mockery of DSHEA and all the work the American people put into getting it passed.
References:
1 see, e.g., Pearson v. Shalala 164 F3d 650.
2 "Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids" (available at gao.gov).
3 Press Release 106-71, 1999 Aug 4.
4 Toxicology Reports TR-406 and TOX-54 at http://ehis.niehs.nih.gov/ntp/docs/
5 Private correspondence of Ward Dean, M.D.
6 "Prevalence of drugs used in cases of alleged sexual assault" J. Anal. Toxicol. 1999 23(3), 141-146. Preston Publications.
The writer of this message, Paul Anacker, J.D., is a private attorney. He is a former Chairman of Lawyers in Mensa International (1979-1991). He has been a consultant to several dozen MDs and JDs on the medical and legal aspects of GHB and related substances. He has received no payment from anyone for writing this message (except contributions to subsidize the cost to place it).
More details of FDA lies about GHB are in "GHB: The Natural Mood Enhancer" co-authored by Ward Dean, M.D.,a West Point graduate and former flight surgeon for Delta Force.
Information can be found at http://www.ceri.com
and http://www.smart-publications.com
ANALYSIS by Paul Anacker, J.D.
The FDA is a rogue, out-of-control bureaucracy. In the past, in its war against dietary supplements, it has threatened people with criminal prosecution for claiming that anti-oxidants prevent disease. It has made giant food companies take words as innocuous as "ask your doctor" off cereal boxes. It has instigated guns-drawn, Gestapo-like raids on 80-year old health food store owners.
The American people might have thought they finally put an end to that absurd oppression and won the war with the DIETARY SUPPLEMENT HEALTH & EDUCATION ACT (DSHEA). But, for the FDA that was only a challenge to find new ways to subvert the will of the American people.
Now the FDA has falsely taken the role of protector of date-rape victims in a cold and calculated strategy to use the basic human revulsion for a despicable crime of violence in order to further its agenda. It has been waging a campaign of lies and mis-information to create emotional hysteria in order to get Congress to do politically what it can't do legally - classify a dietary supplement, gamma-hydroxybutyrate (GHB), curiously both as Schedule I (meaning it has no medical use) and Schedule III (requires a prescription), in a "DATE-RAPE DRUG ACT."
You can fool some of the people. The FDA has fooled the media with cleverly worded press releases about GHB and its related products, gamma-butyrolactone (GBL) and 1,4-butanediol (BDO). It has fooled most members of 21 state legislatures by making sure only its "experts" presented testimony at hearings. Now it's trying to fool Con-gress by making sure the only information members receive is from FDA-invited "experts."
But the FDA has not fooled everyone. In a series of FDA lawsuit losses, federal courts have lambasted the FDA's reasoning; calling it "absurd" and "almost frivolous." 1 The Government Accounting Office (GAO) has questioned FDA regulations because of the "limitations and uncertainties associated with the agency's scientific and economic analyses."2 The Honorable F. James Sensenbrenner, Jr. (R-WI), Chairman of the House Science Committee, recently stated, "I am concerned about the apparent lack of scientific data behind the FDA's actions."
Chairman Sensenbrenner further stated, "(T)o use such poor science for a dietary supplement raises warning flags for the other products the agency regulates." 3 GHB is a product for which the warning flags should be raised about FDA "science."
Here are some FDA lies about GHB:
FDA Lie #1 - GHB is a drug
GHB is a simple carbohydrate found naturally in every cell of the human body. GHB is both a metabolite of and precursor to an amino acid consumed daily by millions of Americans - gamma aminobutyric acid (GABA). DSHEA clearly states that metabolites of amino acids are dietary supplements. The FDA's label of GHB as a "drug" is a lie. The language it uses, to lead the media to label GHB as a "synthetic designer" or "date-rape" drug, is gross misinformation.
FDA Lie #2 - GHB has no medical uses
The FDA "experts" know they're telling a lie when they state GHB has no medical uses. In 1974, the FDA approved an Investigational New Drug (IND) application for GHB that discussed 15 medical uses. GHB has been used safely to treat cataplexy, insomnia, narcolepsy, depression, alcoholism, and opiate addiction, and to stimulate natural growth hormone release, to name a few.
FDA Lie #3 - GHB is hazardous
Patients in the IND trials are handed large containers of GHB; told to take doses of 2 to 8 grams; and to come back when they need more. Something the FDA would NOT allow if it truly believed GHB was "hazardous."
Substance Tylenol EtOH NaGHB
Std. dose 1 gm 2 oz 2 gm
Lethal dose 10 gm 20 oz 300 gm Safety Factor 10:1 10:1 150:1
The comparative safety of GHB is shown in the table at the top of this column. The data (from Medline research) is from scientists doing primary research; unlike FDA "experts" who give opinions based merely on anecdotal reports. The data shows sodium-GHB (NaGHB) is far safer than acetaminophen (Tylenol) or alcohol (EtOH).
National Toxicology Program reports on the GHB related substances GBL and BDO contradict the FDA's "science."
FDA Lie #4
Even the FDA contradicts the FDA. It has released a number of "Talking Papers" stating it has received reports of adverse events and deaths "associated" with GHB, GBL and BDO. When Freedom of Information Act (FOIA) requests have been made for copies of those reports, the FDA's FOIA office has written that the FDA has no such reports.
FDA Lie #5 - GHB is highly addicting
The 30 years of primary research reports prior to 1990 and the IND reports all state GHB is non-addicting. In the FDA-supervised studies on narcolepsy, no patient has ever become addicted to GHB. The scientific record is clear:
When GHB is used responsibly it's not addicting. In fact, it is used to treat addiction to alcohol and narcotics.
FDA Lie #6 - GHB is a "date-rape" drug
Date rape is a very serious subject. So, it's important to use science and reason when discussing it. However, it's such a traumatic topic that most people are more influenced by emotional hysteria than reason. The FDA knows this and plays upon that hysteria.
The use of any substance to facilitate date rape should be a crime. And that's already the law in many states. GHB and many other substances the FDA has approved for insomnia can be (but rarely have been) used to facilitate date rape since they can cause a deep sleep. But that's no reason to label GHB a "date-rape" drug any more than Nytol, Tylenol PM, or Benadryl.
There are a few substances which truly should be labeled as "date-rape" drugs. They enable a perpetrator to keep a victim conscious, but easily compelled to engage in sex. They cause a victim to forget what happened while under their influence. And they clear from the body fairly quickly, making their detection difficult.
The only attribute GHB has in common with those substances is it clears from the body quickly (and safely), as carbon dioxide and water. But, GHB does NOT cause a person to remain conscious, engage in sex, and then not remember what they did.
The FDA's constant and repetitive linking of GHB together with those substances diverts attention from counseling people on the real dangers of the substance used most often to facilitate date rape, alcohol. The FDA's single-minded focus on GHB demeans victims by ignoring far more serious and more wide-spread risks. It is tokenism the FDA uses in a very base manner to further its agenda.
FDA synthetic designer "science"
In the 1980s, GHB was available in health food stores. GHB containers had labels with dosage instructions and warnings. People were using it safely for many health purposes.
In 1990, a private-sector pharmacist made an "amazing" discovery. Just 3 years after finishing her residency, Ms. Jo Ellen Dyer "discovered" what world-class scientists had "missed" for 30 years - "GHB poisoning!" What she really "discovered" was alcohol poisoning. Alcohol and GHB are metabolized in the body by the same enzyme, alcohol dehydrogenase. If GHB and alcohol are co-ingested, the toxic effects of alcohol are increased. Alcohol poisoning, NOT "GHB poisoning" (sic) causes coma and seizure. [State prosecutors pay Ms. Dyer up to $9,000 (taxpayer dollars) as a fee for an hour of testimony about her "discovery." Not much incentive to want the truth known about GHB.]
Without holding hearings to ascertain the validity of this "discovery," the FDA simply issued a press release "ban" of GHB on Nov. 8, 1990. Fearing FDA Gestapo-like raids, health food store owners took it off their shelves.
Unable to obtain GHB in health food stores, people bought "street" GHB. It didn't come with labels. Without the benefit of the labels, more people unwittingly took high doses of GHB with excessive amounts of alcohol and ended up in hospital emergency rooms.
Doctors, "educated" by the FDA about GHB symptoms, made reports of "GHB poisoning" that were more "politically correct" than scientifically accurate.
The FDA used those reports and its press release "ban" as the basis of briefings for state legislatures and law enforcement personnel. It made sure non-scientific people got the "right" picture. And the FDA hit upon its unsavory strategy of "associating" GHB with "date-rape" drugs.
Suggested Congressional action
A rush to schedule a dietary supplement, under the guise of a "date-rape" bill, without scientific debate, is a poor basis for public policy. Before depriving millions of Americans of dietary supplements sold in hundreds of health food stores, Congress should take the time to listen to testimony from experts knowledgeable about the full scientific record on GHB. The requests of those experts to be heard have been ignored by the FDA. If Congress doesn't take the time, the FDA will have succeeded in manipulating Congress into doing politically what the FDA couldn't do scientifically. This will make a mockery of DSHEA and all the work the American people put into getting it passed.
References:
1 see, e.g., Pearson v. Shalala 164 F3d 650.
2 "Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids" (available at gao.gov).
3 Press Release 106-71, 1999 Aug 4.
4 Toxicology Reports TR-406 and TOX-54 at http://ehis.niehs.nih.gov/ntp/docs/
5 Private correspondence of Ward Dean, M.D.
6 "Prevalence of drugs used in cases of alleged sexual assault" J. Anal. Toxicol. 1999 23(3), 141-146. Preston Publications.
The writer of this message, Paul Anacker, J.D., is a private attorney. He is a former Chairman of Lawyers in Mensa International (1979-1991). He has been a consultant to several dozen MDs and JDs on the medical and legal aspects of GHB and related substances. He has received no payment from anyone for writing this message (except contributions to subsidize the cost to place it).
More details of FDA lies about GHB are in "GHB: The Natural Mood Enhancer" co-authored by Ward Dean, M.D.,a West Point graduate and former flight surgeon for Delta Force.
Information can be found at http://www.ceri.com
and http://www.smart-publications.com
, your unclep
