Neal Barnard wrote one of his boilerplate op-eds filled with nonsense for a pro/con debate in the Orlando Sentinel with Frankie Trull.
There’s the usual nonsense. Barnard keeps claiming for example, that the diet drug combination fen-phen was tested on animals and found to be safe, but later had to be pulled. In fact, fen-phen was an off-label combination of fenfluramine or dexenfluramine and phentermine. The combination was never tested extensively in animals and never approved by the FDA.
And, of course, Barnard conveniently forgets that anyone looking at the animal research on these three drugs would have quickly noticed that the combination was likely to cause problems. Fenfluramine was supposed to be used for only a few weeks at a time, not for the months and years that some patients were on it. Similarly, in approving phentermine, the FDA explicitly noted that there was no safety data available on its usage in excess of 1 year and urged caution.
Yet when the drug was finally pulled, the average length of time patients had been on fen-phen was 9 months. Doctors were routinely ignoring the FDA’s recommendations on fenfluramine and dexenfluramine, and for phentermine as well. The animal and human testing worked fine, physicians simply chose to ignore the limitations on these drugs (and frankly I’m skeptical of claims that fen-phen was dangerous, but that’s a debate for another day).
Barnard also repeats the animal rights nonsense about the U.S. General Accounting Office’s 1990 report, FDA Drug Review: Postapproval Risks, 1976-85 (I’ve placed a copy of the full report on my web site in PDF form here).
According to Barnard,
The U.S. General Accounting Office found that, of all new drugs marketed during a 10 year period, a majority — 52 percent, to be exact — had seriously toxic or even fatal effects that were not predicted by animal tests. And animal tests allow more minor side effects — rashes, nausea, diarrhea, etc. — to slip through routinely.
This is an excellent example of how animal rights activists distort the truth. You’d think from reading Barnard’s article that the GAO report is about animal tests. You would be wrong.
In fact what the GAO report actually focuses on is the amount of time that the FDA spent considering a new drug application. It found, not unsurprisingly, that the odds of a new drug having to be relabelled or recalled was strongly correlated with the amount of time the FDA took to review the new drug application. The longer the FDA spent reviewing the NDA, the less likely the drug was to require relabeling and, conversely, the faster the FDA processed NDAs, the more likely it was that those drugs would later require some label changes.
The reader would also never know from Barnard’s summary that of the 198 drugs that the GAO survey examined, only 6 were withdrawn completely. The rest of the drugs simply had label changes warning specific patient subpopulations to avoid the drug or carefully follow monitoring procedures to prevent adverse events.
The real issue here is one of weighing risks. At one extreme, the FDA could spend two hours reviewing a new drug application and vote to approve or disapprove. This would certainly lead to an unacceptably high level of drugs that caused severe adverse events. On the other extreme, the FDA could require every new drug to undergo a rigorous 25-year testing procedure. Not only would no companies be interested in producing new drugs under that regimen, but many more people would die due to a lack of medications than are put at risk by less extreme measures.
The issue for the FDA and society is how we want to manage that risk and where we draw the line, with the full knowledge that risk cannot be eliminated completely from the calculation.
The FDA report, unfortunately sidesteps this issue in that it never even addresses whether or not the FDA has achieved an adequate balance, but regardless it certainly is not critical of animal research and its conclusions, if anything, would be a call for additional levels of animal testing, not less.
Sources:
Experiments on animals ineffective, unnecessary. Neal Barnard, The Orlando Sentinel, April 7, 2002.
FDA Drug Review: Postapproval Risks 1976-1985. U.S. General Accounting Office, April 1990, GAO/PEMD-90-15.