After 5,000 and 8 years of testing
The dietary aid, ephedra, is on the chopping block, about to be banned by the FDA. The agency says that ephedra is too dangerous:
"The federal government is banning the sale of the diet and bodybuilding supplement ephedra early next year and urged consumers Tuesday to immediately stop using the herbal stimulant that has been linked to 155 deaths and dozens of heart attacks and strokes." - Feds ban deadly ephedra, Lauran Neergaard, The Associated Press, Tacoma News Tribune, December 31, 2003
Referring to ephedra as an "amphetamine-like stimulant," authorities indicate that the FDA began receiving reports that ephedra is dangerous some 8 years ago:
"It was the first time the government had banned a dietary supplement, and came eight years after the Food and Drug Administration first began receiving reports that ephedra could be dangerous." - Feds ban deadly ephedra, Lauran Neergaard, The Associated Press, Tacoma News Tribune, December 31, 2003
Eight years is not a long time to conduct an investigation into an herb that has been used for thousands of years:
"The Chinese have used (Ma Huang) for over 5,000 years, particularly to treat asthma and reduce upper respiratory infections. The primary active ingredient of Ma Huang is ephedra. " - History of Ephedra and Mahuang
So, it would be reasonable to take a little time to investigate the safety of something with such a long history.
This is not the first time, however, that the FDA has banned the sale of a legally distributed food supplement. Many people remember that, in 1989, the FDA banned an amino acid called tryptophan (pronounced trip-toe-fan). Until the ban, tryptophan, which is the ingredient in milk that makes us sleepy, was a popular mood-enhancer and sleep aid.
Not the first FDA ban
The reason given for the 1989 ban was that it caused a deadly flu-like condition, called Eosinophilia-Myalgia Syndrome (EMS). But that turned out to be a lie, as just 4 years later a different federal agency said that tryptophan cures EMS:
"On February 9, 1993, a United States government patent (#5185157) was issued to use L-Tryptophan to treat, and cure EMS, the very same deadly flu-like condition which prompted the FDA to take L-Tryptophan off the market in 1989." - The FDA Ban of L-Tryptophan: Politics, Profits and Prozac, Dean Wolfe Manders, Ph.D., Social Policy, Vol. 26, No. 2 Winter 1995
If the FDA's stated reason for the ban was a lie, then why the ban? The timing is suspicious, as it coincided with a marketing blitz to promote Prozac, an often ineffective antidepressant that is supposed to increase the amount of serotonin in our body, the same thing that tryptophan does cheaper and more effectively.
Tryptophan increases the amount of serotonin, the sleep hormone, that the body produces. Prozac, which belongs to a class of drugs called selective serotonin reuptake inhibitors, prevents the body from breaking down the sleep hormone after it's been used. Both increase the amount of the hormone circulating in the blood, but tryptophan does it naturally, without any of the often-deadly side-effects of Prozac.
Prozac received FDA approval in December 1987, and was introduced to the consumer market in 1988. (Source: PPCPs as Environmental Pollutants, by C.G. Daughton, US Environmental Protection Agency, August 13 2001, revised May 29 2002) But it quickly earned a bad reputation when some people, who already had suicidal and homicidal tendencies, began taking the anti-depressant shortly before committing heinous crimes. What's a poor pharmaceutical company to do? Circumstantial evidence indicates that the manufacturer of Prozac, Eli Lilly, pulled some high-placed strings:
"The fact that the FDA ban of L-Tryptophan and the Newsweek Prozac cover story occurred within four days of each other went unnoticed by both the media and the public. Yet, to those who understand the effective properties of L- Tryptophan and Prozac, the concurrence seems 'unbelievably coincidental.'" - The FDA Ban of L-Tryptophan: Politics, Profits and Prozac, Dean Wolfe Manders, Ph.D., Social Policy, Vol. 26, No. 2 Winter 1995
The Eli Lilly Connection: Treating Adult ADHD
The case for collusion regarding tryptophan is strong, and warrants a full scale audit of FDA practices, but what does this have to do with Ephedra? Not surprisingly, it looks like Eli Lilly may be the common thread connecting the two.
Recent attention regarding Attention Deficit Hyperactivity Disorder (ADHD) has focused on adults. Long thought a childhood disorder, during the past decade psychiatrists have diagnosed a growing number of adults with ADHD, typically treating them with stimulants:
"In most cases, adult ADHD responds well to stimulant medications, although most available evidence is limited to studies in children. Several nonstimulant medications are also available, and the FDA is considering a new-drug application for a medication indicated for adult ADHD. Stimulants produce significant improvement in 30% of patients and mixed results in another 40%." - Adult ADHD: Less hyperactivity, but lingering inattention and distress, by Michael Alan Schwartz, MD, Current Psychiatry, October 2002
Ephedra, which has generally been thought of as a weight loss aid and sports performance enhancer, has also been used as an alternative to Ritalin for the treatment of ADHD. This is the point at which the connection between Eli Lilly and the ban on ephedra comes into focus with their recently approved drug, Strattera.
"Researchers believe that as many as 4% or 5% of U.S. adults have ADHD, but perhaps only 15% to 25% of them know it. Awareness has increased in the past year as a result of the heavy marketing of Strattera, the first medication to receive Food and Drug Administration approval for treating adult ADHD. ... Besides being the only ADHD drug approved for adults, Strattera also is the only one that is not a stimulant, and, therefore, is not a controlled substance." - ADHD focuses on adults, by Rita Rubin, USA TODAY, December 2, 2003
A selective norepinephrine reuptake inhibitor, Strattera received FDA approval in December 2002. Since then, the attacks on ephedra, which was already under fire from anti-citizen's choice groups, such as Ralph Nader's League of Fans and Public Citizen organizations, escalated until, after 5,000 years of use, it was banned.
The powerful Liberal voices are all over this, using it as an opportunity to demand more layers of government bureaucracy to burden supplement companies, whose products, such as ephedra, have often been in use for thousands of years, to conform to the same regulatory standards as drug makers:
"It took an unconscionably long time, but the federal government has finally managed to ban an unsafe dietary supplement before it can harm or kill any more unwary users. ... That was the only sensible response ... the tortuous course of this regulatory crackdown underscores the dangerous weakness of a 1994 law that allows the supplement industry to market products whose safety and effectiveness have never been proved. When Congress returns for its next session, it needs to revise the ill-conceived 1994 legislation. (Congress) should require the manufacturers to prove the safety and efficacy of their products before those products are allowed on the market." - The Ephedra Ban Is Not Enough, New York Times Opinion, January 5, 2004
But ephedra is not alone.
From aspirin to peanuts, ephedra is not alone
The risks associated with ephedra are undeniable. For some people, it's very bad. But so are peanuts:
"Allergies to peanuts (a legume) are responsible for nearly 100 deaths and 15,000 visits to emergency rooms -- about half the deaths and emergency room visits caused by all food allergies -- each year, according to FAAN." - Peanut Allergies in Children Have Doubled in Last Five Years, Food Allergy & Anaphylaxis Network, December 9, 2003
Peanuts kill: just as ephedra was implicated in the 2003 death of 23-year-old Baltimore Orioles pitching prospect Steve Bechler (source: Coroner finds 'significant amounts' of diet supplement, Sports Illustrated, Thursday March 13, 2003 ), peanuts were implicated in the death of 21-year-old Scottish hurdler Ross Baillie. (Source: Peanut allergy athlete dies , BBC News Online: Sport, Friday, June 18, 1999).
Aspirin is another killer.
"By some estimates, aspirin-related deaths alone number more than 1,000 per year." - Institute of Health Sciences, L.L.C., July 22, 2003
Like peanuts and aspirin, ephedra has risks. Also like aspirin, however, ephedra provides significant benefits. But we don't see the FDA making any moves to ban aspirin, perhaps because, unlike ephedra, it is manufactured by drug companies.
There's no such thing as a risk-free life, no matter how hard the Liberal lackeys of the drug manufacturing companies try to make it otherwise when it comes to herbal remedies and nutritional supplements. Risk is part of life. We can, as a nation and as individuals, take prudent measures to reduce risk, but the more laws we pass and the more regulations we impose, the less freedom we will have. And as the evidence proves, when it comes to ephedra, what most Americans want is freedom:
"Products with names like Speed Stack, Ripped Force, TrimSpa and Kranker started flying off the shelves at the Lo Fat Know Fat Gourmet Cafe after the Food and Drug Administration announced plans to ban the dietary supplement ephedra in two months." - Disappointment, resignation, hoarding in response to ephedra ban, by Jennifer Peter, Detroit Free Press, January 1, 2004
References and Recommended Reading
FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra, Official FDA Site
The FDA Ban of L-Tryptophan: Politics, Profits and Prozac, by Dean Wolfe Manders, Ph.D.
Ephedra: The Controversy, Creighton University School of Medicine
Proposed Amendment of Monograph for OTC Bronchodilator Drug Products , Emord & Associates, P.C., September 27, 1995
Ephedra Recall, InjuryBoard.com, December 2003
The Story behind Prozac: The Killer Drug, by Thomas G. Whittle and Richard Wieland, Campaign Against Fraudulent Medical Research Newsletter, Spring-Summer 1994
ADHD focuses on adults, by Rita Rubin, USA TODAY, December 2, 2003
Adult ADHD: Less hyperactivity, but lingering inattention and distress, by Michael Alan Schwartz, MD, Current Psychiatry, October 2002
ADHD Is Real: Millions of Adults Are Taking Medication for Attention Disorder, The Atlanta Journal-Constitution, September 13, 2003
Adult ADD: Common disorder or marketing ploy?, HealthyPlace.com