Dr. Ray Greek
Scientific Advisor, NAVS
President, Americans For Medical Advancement (AFMA)
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
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.
Go on to International
Foundation for Ethical Research Alternatives in Scientific Research
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