Most important, their drugs enjoy l7-year (or
longer) patent protection. <br>Once a drug is patented
and given a brand name, no one else may sell it,
<br>and the company is free to charge whatever the market
will bear without <br>fear of competition from
generics. No wonder drug companies fight to extend <br>the
life of their patents and to obtain new patents for
old drugs. That can <br>be done merely by proposing a
new use or a different dosage form, or by
<br>combining two old drugs into a single new pill. The
anti-diabetes drug <br>Glucophage XR, for example, is
Bristol-Myers Squibb's newly patented <br>once-daily
replacement for the twice-daily Glucophage, whose patent
expired <br>last fall. <br><br>The drug companies devote
enormous sums to promoting their interests. They <br>have
the largest lobby in Washington, and contribute
copiously to political <br>campaigns. Half the FDA's budget
for the evaluation of new drugs now comes <br>from
drug company users' fees, making the agency dependent
on the industry <br>it regulates -- an obvious
conflict of interest. The industry also spends
<br>lavishly to influence doctors, who write the
prescriptions, and medical <br>researchers, who test the drugs.
<br><br>Last year drug companies spent more than $8 billion
and employed 83,000 <br>sales representatives to woo
doctors. They provided them with gifts, meals <br>and
trips, as well as another $8 billion worth of free drug
samples. The <br>companies fund and thereby influence much
of the continuing medical <br>education doctors need
to renew their licenses, and they handsomely support
<br>the scientific meetings of medical societies, where
they hawk their wares <br>and often sponsor their own
programs. <br><br>The companies also want to influence
researchers who test drugs in human <br>subjects.
Increasingly, they are entering into financial arrangements
with <br>academic medical centers and their faculties,
arrangements that threaten <br>the objectivity and credibility
of clinical research. A growing number of <br>drug
trials are being managed by investor-owned businesses
that are even <br>more beholden to the drug companies
because the companies are their only <br>clients.
<br><br>Furthermore, in their contracts with academic researchers,
drug companies <br>now often insist on controlling how
the research is done and reported, and <br>whether
the results will even be published at all. Recently,
there have <br>been several widely publicized instances
of drug companies suppressing <br>research results
that were not favorable to their drugs.
<br><br>Prescription drugs are not like discretionary consumer
products. For <br>millions of patients, they are necessary
to health and even survival. Yet, <br>the drug
companies often behave as though their only responsibility
is to <br>their shareholders. <br><br>It's time to
take a hard look at the pharmaceutical industry and
hold it <br>accountable. This is particularly urgent
now, given the move to add a drug <br>benefit to
Medicare. The industry would like to see such a benefit
without <br>any new regulation, but that would cause drug
prices to rise even faster <br>and hand the companies
yet another windfall. Future policy on this and
<br>other matters related to prescription drugs should be
based on a thorough <br>understanding of the industry's
behavior, best achieved through in-depth <br>congressional
hearings. We can't think of a more urgent investigative
<br>assignment for the Senate Committee on Health, Education,
Labor and <br>Pensions. <br><br>Marcia Angell is a
senior lecturer and Arnold S. Relman is professor
<br>emeritus at Harvard Medical School. Both are former
editors-in-chief of the <br>New England Journal of Medicine.
<br><br>© 2001 The Washington Post Company