National Institute of Health Should Be a Check
for Drug Companies
A provocative article appeared online on SLATE last month, that
should stir public health policy makers -in particular NIH officials-- to
re-think its research agenda so that it better conforms with its public interest
mission. The article points out that there are discoveries waiting to be made
which will not be made unless NIH conducts the kind of necessary research that
pharmaceutical companies won't. For example, there is a need to test old, and
reliable cheap drugs against new, expensive ones because chances are they will
prove to be MORE EFFECTIVE than the new drug. And, they may even hold promise
for conditions they had not been tested for. Long-term drug effects are not
being studied by drug manufacturers--who are not eager to find out the drugs may
be hazardous. Why, for example, isn't NIMH examining the long-term consequences
of psychotropic drugs that millions of children are being exposed to?
http://slate.msn.com/default.aspx?id=2066600
Teaching Old Drugs New Tricks
Pharmaceutical companies won't study whether cheap old drugs work better than
expensive new ones. But NIH should.
By Emily Yoffe
Wednesday, June 5, 2002, at 11:48 AM PT
Suppose a researcher discovered that some cheap, long-available drug could treat
a devastating disease. Patients wouldn't need exorbitantly priced new drugs, and
they might be able to avoid surgery. Insurers and hospitals would save millions
by adopting the economical new treatment.
It would be great news for everyone-except pharmaceutical companies.
They don't care if old, off-patent drugs have novel uses. Their profits depend
on new, expensive, patented drugs. They're not about to undertake costly testing
to prove that a discount drug whose patent has expired works as well a pricey
new one.
Since the pharmaceutical companies are the economic engine behind drug
development, and since there is no incentive for them to find new uses for old
drugs, such research is no one's mission. A Wall Street Journal story last month
nicely illustrated the problem, describing the inability of Dr. G. Umberto
Meduri to get sufficient backing for a major study to prove what his small,
promising studies have indicated: Low doses of common steroids can help prevent
death by sepsis, an often deadly bloodstream infection. The steroids, no longer
under patent, cost about $50 per course of treatment. Eli Lilly & Co., the
Journal points out, has just released a new sepsis drug that costs $7,000 per
course. And Lilly is spending millions to promote its drug. This would seem like
a job for the National Institutes of Health. It's in the United States'
financial interest-as well as public health interest-to see whether steroids
work on sepsis. If they're effective, taxpayers could save millions in Medicare
and Medicaid reimbursements. But so far Meduri has failed to get federal
funding. A spokesman for NIH says the vast majority of applicants do not get
funded, and it's true that even the best system is going to leave some worthy
studies undone. But Meduri's case and others suggest that novel uses of existing
compounds-therapies that could improve lives at little cost-often have a hard
time getting attention at NIH, especially if they contradict prevailing medical
opinion.
NIH's main mission is-and should be-basic biomedical research, understanding how
the human body functions at a molecular level. NIH is also a center for clinical
research, but clinical trials receive only one-sixth the funding that basic
science does, frustrating investigators who say clinical research deserves to be
treated with more urgency. For example, promising findings that the amino acid
homocysteine might be as good as, or possibly better than, cholesterol at
predicting heart disease languished for more than a decade because of lack of
funding.
Drug companies avoided studying homocysteine for an obvious reason: The
treatment for elevated homocysteine is folic acid and B vitamins, which cost
next to nothing. No pharmaceutical company wanted to test whether lowering
homocysteine is as important as lowering cholesterol. Cholesterol-lowering
drugs, after all, earn billions for the pharmaceutical companies.
Again, NIH was the obvious place to turn, but it wasn't interested.
According to a New York Times article on the controversy, NIH was long
considered "a kind of ground zero for the cholesterol camp." Dr. Kilmer McCully,
the doctor credited with discovering the homocysteine connection, lost his
funding and his position at Harvard Medical School for advocating a line of
inquiry so contrary to accepted medical belief. Today, there is powerful
evidence that homocysteine levels are a marker not only for heart disease, but
also for stroke and Alzheimer's. Yet, even today, as an NIH Web site points out,
"Clinical intervention trials are needed [emphasis added] to determine whether
supplementation with vitamin B6, folic acid, or vitamin B12 can help protect you
against developing coronary heart disease."
When a pair of Australian researchers, Barry Marshall and Robin Warren,
presented findings in the early 1980s showing that the bacterium Helicobacter
pylori, not stress and excess stomach acid, caused most peptic ulcers, they were
derided by the medical establishment. At the time, the drug companies were
introducing new acid reducers, the staggeringly profitable drugs now available
over the counter as Tagamet and Zantac. As the Journal points out, drug
companies are often the primary suppliers of information about drugs to
physicians. So for years doctors gave little credence to the bacterial infection
theory of ulcers.
Such a theory would mean that patients could be cured with a short-course of
antibiotics, rather than merely receive symptomatic relief from long-term
treatment with costly acid reducers. It wasn't until 1994 that the NIH convened
a panel that accepted the infection theory. This is not to say NIH rarely does
clinical studies; it does many. Nor does NIH always fail to notice promising
uses for old compounds. Right now NIH is recruiting patients for a massive study
on whether selenium and vitamin E can prevent prostate cancer, and it's even
investigating whether the spice turmeric can prevent colon cancer. (NIH is doing
another kind of research drug companies won't: studying the long-term effects of
the most popular prescription drugs. Click here for more.)
Finding significant, unexpected uses for drugs has a long history. Some major
discoveries in the treatment of mental illness resulted from seeing surprising
benefits in mood or behavior in patients who were treated with drugs for purely
physical ailments. At the recently concluded meeting of the American Society of
Clinical Oncology, the New York Times wrote, "There were particularly promising
reports involving new uses for old drugs."
NIH's budget has doubled in the last five years to $27 billion. Now that it's so
flush with cash, it's time for the NIH to search more systematically for
potential lifesavers that are already on the pharmacy shelves.
Pharmaceutical companies are understandably reluctant to study long-term
effects of their most profitable drugs: The studies are expensive and run the
risk of turning up bad news. But the NIH is doing some of this. For example, its
huge Women's Health Initiative is examining the actual risks and benefits of
hormone replacement therapy. For years women have been told that HRT can reduce
the risk of heart disease, but preliminary study results suggest that women on
the hormones have an increased incidence of heart attack, stroke, and blood
clots. Similarly, the National Institute of Mental Health is comparing the
effectiveness of available anti-psychotics in treating schizophrenia. Both
studies are highly worthy, though extremely late. HRT, after all, has been
prescribed for 50 years to millions of women.
