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Why the FDA requires animal testing
Dr. Ray Greek
Scientific Advisor, NAVS
President, Americans For Medical Advancement
Pharmaceutical companies continue to test on animals and the Food and
Drug Administration continues to require it, but not for the reasons you might suspect. It is not that the information garnered from
animal models is necessarily accurate or predictive, and certainly not that it protects consumers. Often, in fact,
animal-modeled data works to human detriment. Sometimes, drugs are approved too quickly
based on positive results in animals. Then patients who are taking them fall ill and may die as a result.
So, why does use of the animal model continue in drug development and
approval? The answer has three parts.
Animal models allow pharmaceutical companies to hasten drugs through
approval, thus minimizing the expensive development process that is also fraught with unforeseeable challenges. That lab animals can be
contained, controlled and monitored renders them ideal little drug factories, and though the drugs produced may work in the animals, it
does not necessarily follow that they will benefit a completely different species. It just "appears" that it will. Anita O'Connor of
the FDA once said, "most of the animal tests we accept have never been validated. They evolved over the last twenty years, and the FDA
is comfortable with them." Lab animals do produce hard data upon which researchers and the FDA can agree. However, the truth is that
the data is really only relevant to the species it depicts. Second, animal models furnish pharmaceutical companies with liability
protection. If a drug harms a human, company representatives can testify that it tested safe on animals. Having done this due
diligence often decreases the judgment amount due the plaintiff.
Juries usually cannot understand high-tech tests such as the in-vitro
and computer-modeled techniques that are based on humans. But they do
understand if something kills a rat, it may be harmful for humans, or if a rat thrives, a human may do likewise. Animal models are a simple
solution - too simple to be accurate.
The third reason animal testing continues has to do with a growing
complicity between pharmaceutical companies and the FDA.
Pharmaceutical companies are big campaign finance contributors having
given $44 million over the last ten years. FDA scientists who approve drugs or decide upon regulations are also current, past or future
employees of the drug industry. They are inextricably tied to the industry that they are supposed to be policing. What this means is that the FDA is effectively financed and staffed by the
pharmaceutical industry. The agency "works for" the industry, not for consumers, because consumers are not making campaign contributions;
nor are they arbiters of job security.
Rezulin—A Case Study
In recent years, pharmaceutical companies have exerted huge pressure
on the government to speed the drug-approval process. And the government accommodates them. In 1988, the FDA approved only four
percent of new drugs introduced into the world market. In 1998, the FDA's first-in-the-world approvals spiked to sixty-six percent. What
this means is mammoth domestic sales, which would be great if the drugs were needed to save lives. But they do not necessarily save
lives, and in some cases, may actually do more harm than good.
In a recent Los Angeles Times article seven drugs approved by the FDA
were withdrawn, cited as suspects in over a thousand deaths. Of these, six were never proved to offer lifesaving benefits and the
seventh, an antibiotic, was unnecessary because other, safer antibiotics were available. Positive animal-model results allow FDA
personnel the "proof" they require in order to commend drugs such as
these that obviously demand more careful scrutiny.
Though there are innumerable incidences of animal testing working
against consumer benefit, Warner-Lambert's anti-diabetes drug Rezulin
is a glaring example of the FDA's "fast-track" approval process in action. Rezulin lowered blood sugar in rats without hurting them..
But according to articles in the Los Angeles Times, Warner-Lambert
also knew Rezulin could compromise the human liver well before the approval process began. Prior to submitting Rezulin for FDA review,
Warner-Lambert removed a recommendation for monitoring the liver from
the labeling. Had the recommendation remained, it would have slowed the drug-approval process. Company press and officials also claimed
that the drug was the first anti-diabetic drug to target insulin resistance and that it was virtually free of side effects. Soon after
Warner-Lambert submitted for FDA review in the summer of 1996, Dr.
John L. Gueriguian, the medical officer assigned to examine it, cited Rezulin's potential to harm the liver and the heart. Gueriguian also
questioned its viability in lowering blood sugar for patients with adult-onset diabetes.
According to the Los Angeles Times, Dr. Murray M. "Mac" Lumpkin (now
being considered for appointment as FDA commissioner) and Dr. Henry G. Bone III, chairman of the FDA advisory committee quietly
collaborated with Warner-Lambert. Under pressure from Warner-Lambert, Gueriguian was stripped of the assignment in November 1996. The FDA
staff withheld the existence of Gueriguian's review from the advisory committee that would decide on the drug, Warner-Lambert officials did
not reveal that liver injuries in patients taking Rezulin were nearly four times as likely as for those given placebos, and the FDA
approved it in January 1997.
Liver failures occurred immediately. Despite this, Warner-Lambert
launched a nationwide marketing campaign that included sales training
seminars with actors playing physicians. The company became involved in the National Institutes of Health's nationwide diabetes study.
Leading the $150 million study was Dr. Richard C. Eastman, who also served as a paid consultant to pharmaceutical companies. Eastman
received $78,455 in 1997 from Warner-Lambert alone. The manufacturer also generated funding or compensation for at least twelve of the
twenty-two scientists selected for the NIH study. Seven obtained up to $300,000 in grants, speakers' fees of $1000 per address, and
other stipends. These researchers instructed physicians nationwide to prescribe this dangerous and not necessarily effective drug as part
of the study - all this under the auspices of venerable science.
Coincidentally, Warner-Lambert awarded funding that could total fifty
million to Dr. Jerrold M. Olefsky's team at University of California, San Diego. Olefsky is an inventor of
Rezulin. He is also a founding co-chairman of the National Diabetes Education Initiative, a group
established and financed by Warner-Lambert that also drove physicians
to prescribe Rezulin. Meanwhile, thanks to a slick ad campaign, Rezulin was performing as the Warner-Lambert mission demanded - "not
missing an opportunity to reach the market."
Back at the FDA, re-examination of the drug was sluggish. On the eve
of a hearing to reassess the diabetes pill, the FDA appointed two new members to the advisory panel. Both had received income during the
last two years as leaders of a diabetes education group funded exclusively by Warner-Lambert and its Japanese partner. Though
Rezulin killed hundreds of people and obliged many more to undergo liver transplants, Warner-Lambert made over two billion dollars
before it was withdrawn in 2000.
Though reliance on the animal model did not by itself cause this
corruption and tragedy, it very definitely contributed. Eliminate the tool - in this case, animal testing, and fewer people will die, and
researchers will be challenged to develop more effective and safe means of testing.
Of course, simply stopping the animal testing will not ensure that
all new drugs are safe. But it will help. Pharmaceutical companies and government officials will have to rely on human-based methods and
will hopefully expand testing to assure consumer health.