The FDA's 5-HTP Emergency

overnment agencies thrive on emergencies, and war is the ultimate emergency. Whether there is a "good" cause for going to war or not, government always dramatically increases in size to manage the emergency of war. Once the war is "won," government may get a little smaller but rarely returns to its original size. Call it the ratchet effect.

Other emergencies - such as the environmental crisis, the energy crisis, the "war" on drugs, and the "war" on poverty - present government, its bureaucrats and politicians the opportunity to expand their power. Is it any wonder that these crises rarely end? Public servants do not measure their success by "profits" (a dirty word) but by larger budgets and the "growth" of their divisions; more employees, more controls, more regulatory power.

Nobel prize economist James Buchanan is recognized for his findings that government employees don't serve the public but instead serve themselves, their own agenda, and their own bureaucracy.

ANOTHER FDA NUTRIENT EMERGENCY
As of this September, we have the creation of another FDA "emergency." They have declared that the results of a new study by the Mayo Clinic are grounds for alerting the public. In their Talk Paper of August 31, 1998, the FDA states that the Mayo study may have found a link between the single contaminated batch of tryptophan of 1989 and 5-HTP. The link is the presumed discovery of a contaminant called peak x which they claim may be the same contaminant which caused the contaminated-tryptophan epidemic of 1989, EMS (eosinophila myalgia syndrome). However, there is no scientific nor rational evidence to make such a conclusion.

Mayo Clinic researchers parallel the FDA's claims in a letter in the September 1 issue of the journal Nature Medicine. In their letter they offer gratitude to NBC's (the TV network's) Dateline producers, along with the FDA, for their assistance in the procurement of the six 5-HTP samples on which they preformed their analysis. However, obtaining samples via intermediaries is not exactly standard scientific protocol and a questionable practice for reliable results. Such unconventional protocol raises serious questions of ethics and bias for a scientific institution.

FDA AND RESEARCHER ALLIES' POLITICAL BIAS AND LACK OF SCIENCE
The letter to Nature Medicine contains much more speculation than fact. In fact, it is rather debasing when those representing the scientific community put forth such confident and commanding statements regarding a nutrient with no respectable science behind the statements and such blatant and transparent political biases existing.

Michael Q. Ford, the National Natural Food Association's Executive Director states, "My concerns about this article are far greater than any concerns I have about the safety of 5-HTP.

"Even a cursory review of this letter raises serious questions about the conclusions reached by the researchers and their impartiality. It's more politics than science."1

Among the many concerns raised by Ford include:

  • The article begins with an aggressive attack on the Dietary Supplement Health and Education Act (DSHEA) of 1994, showing the authors clear bias against the nutrient industry.
  • The letter sensationalizes the potential dangers from peak x as typifying the dangers of all dietary supplement usage. Again, a demonstration of bias. In fact, the safety record of dietary supplements is enviable by any standards and adverse effects are virtually invisible when compared with that of heavily regulated prescription and over-the-counter medications, which may cause as many as 140,000 deaths per year due to toxic reactions.2
  • The purity of 5-HTP products is being contested, without ascertaining what the appropriate standards for measurement should be.
  • The authors use historical data of one EMS incidence from 1991 (which was connected to 5-HTP usage) as the benchmark against which to measure potential EMS risk in the current samples of 5-HTP. In fact, these two cases represent the only connections reported in the literature of a linking EMS and 5-HTP, and both are inconclusive. In the words of the authors of the 1994 article, "The role of 5-HTP in the eosinophilia (EMS) of this patient is (thus) uncertain." Moreover, it is even more of a stretch to connect currently manufactured 5-HTP to these two historical incidences.
  • To verify the authors' claims about peak x and its 5-HTP contamination, NNFA supplier members had various batches of 5-HTP tested by independent laboratories using the same methodology as the Mayo Clinic researchers. While these laboratories were able to identify a distinct peak, none has been able to replicate the Mayo Clinic's findings that this peak is the same or similar to the contaminant found in L-tryptophan in 1989.
  • The authors concede that "one possible reason" no new cases of EMS-like symptoms have been reported in connection with 5-HTP is due to the low dosage recommendations on the label. Yet they indicate higher dosages are bound to be consumed. Yet there have been no reports of adverse effects with the use of 5-HTP since its widespread consumption began essentially two years ago.
  • The authors quote, but do not identify, Richard Wurtman, Ph.D., as saying that 5-HTP is "another accident (epidemic) waiting to happen." Interestingly, Dr. Wurtman's company, Interneuron Inc, holds the patent on Redux,® a serotonergic drug banned by the FDA last year for causing serious heart valve defects. Using figures and projections from the FDA, Redux may be responsible for more than one hundred thousands cases of heart valve damage, raising serious questions about Wurtman's vested interests and bias.3
From examination of the data thus far presented, Ford concludes, " . . . [It] seems clear that all of the researchers, FDA, Dateline NBC and Wurtman have had a vested interest in a negative outcome in testing 5-HTP. But in the end, any link between alleged contamination of 5-HTP and L-tryptophan remains unproven. This isn't good science and it certainly shouldn't be news."

References:

  1. Anon. Nature Medicine letter on 5-HTP shows political bias and lack of science. BW HealthWire. Aug. 31, 1998: www.healthline.com
  2. Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1997;277:301-306.
  3. Nightingale SL. From the Food and Drug Administration JAMA. 1997;8:1728.

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