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Critics say drug trials often a marketing tool
By Alice Dembner, Globe Staff, 6/25/2002
 HICAGO
- Drug manufacturers spent $1.5 billion in 2000 to test medicines already
approved by the Food and Drug Administration primarily so they could make
new marketing claims to sell their products, industry specialists said this
week. Critics say the trend inflates health care costs while undercutting
the integrity of research.
Spending on these ''post-approval'' drug studies tripled in the last half
of the 1990s, growing faster than any other clinical drug research,
according to CenterWatch, a Boston-based firm that presented the data at the
national meeting of the Drug Information Association. CenterWatch, which
monitors the pharmaceutical industry, said approximately 700,000 patients
completed post-approval studies last year.
''What used to be a scientific purpose - clarifying effectiveness and
safety in a larger population - has turned into a commercial purpose,'' said
conference speaker Nayan Nanavati, a vice president at Parexel, an
international company based in Waltham that conducts studies for drug firms.
''However, it must still be supported by a scientific need.''
These studies can yield important new information on safety and uses of
drugs, such as a 2000 study that found the hypertension drug Ramipril could
reduce the risk of heart attacks. But regulators and consumer advocates say
the studies are helping increase health care costs, can put some patients at
risk, and may taint the public's view of safety testing necessary to get new
drugs on the market.
''If studies are done primarily for marketing purposes, are they serving
the interests of the public?'' asked Dr. Greg Koski, director of the federal
Office for Human Research Protections. ''It could undermine the integrity of
the scientific enterprise.''
Before medicines can be marketed, they must be extensively tested in
people to ensure that they are safe and effective. Pre-market studies are
closely regulated by the FDA and tend to involve fewer than 1,000 patients
per study. When the FDA has further questions about a drug's safety, the
agency requires more testing after approval.
But the bulk of testing after FDA approval is being done so companies can
differentiate their drugs from competitors' and generate more demand, the
conference panelists said. The panelists, speaking in two separate sessions,
mentioned studies of drugs for Alzheimer's disease, hypertension, arthritis,
and heart disease as examples of marketing-driven research.
Some studies are also used to hint at a new use for a drug - and
encourage doctors to prescribe it for that purpose - without going through a
lengthy FDA review, the speakers said. Nonetheless, the studies must have
some valid scientific purpose or they may be halted by federal regulators.
''It's a crowded market, so it's critical to position your drug,'' said
Nanavati, adding that most drug companies will not acknowledge the major
role marketing plays in their studies.
In most post-approval studies, hundreds of doctors are paid to prescribe
new medications to thousands of patients, who receive the drugs for free.
While many of these patients might get the drug anyway outside the study,
others may get a more expensive drug than their doctor would otherwise
prescribe. The studies themselves typically cost between $10 million and $40
million, the speakers said.
It's unclear whether drug makers directly pass these costs on to
consumers. However, advocates say the studies do inflate overall health care
costs.
''This is a high-class version of free samples, and like free samples it
gets people hooked on a drug,'' said Dr. Sidney Wolfe, director of the
Health Research Group of Public Citizen, who did not attend the conference.
''It's good for the companies, but often not for the individual patients,
who can't afford to pay for the drugs or can't afford to pay for their
insurance premiums because they're being driven up by drug expenditures.''
In addition, the studies are designed to get hundreds of doctors in the
habit of prescribing a certain drug, said another panelist, Robert Deininger,
executive vice president of AAI International of Natick, which also conducts
these trials for drug companies. ''It's also a platform for
direct-to-consumer advertising.''
Deininger said the most effective studies from a marketing perspective
are typically those backed by the best science. As a result, he said, he
believes companies have little incentive to lower research standards in the
post-approval trials despite their commercial motives.
Post-approval studies are being driven by economic pressures on the
companies, the speakers said. Major drug companies stand to lose billions of
dollars in sales in the next five years as patents expire and they face
generic competition. At the same time, development costs are rising and
fewer new drugs are being approved. ''Companies need to double or triple
their revenue to maintain the profit margin that Wall Street is demanding,''
said Joan Kroll, director of marketing and sales for CenterWatch.
For example, Merck and Pharmacia did extensive post-approval studies to
show that their arthritis pain medications, Vioxx and Celebrex, were easier
on the stomach than older, cheaper painkillers. Merck's study, involving
more than 8,000 adults, showed Vioxx causes fewer stomach complications than
the painkiller naproxen, but also found it increases the risk of heart
attacks. Both facts were widely reported in medical journals and the media,
and the company has stepped up promotion of the drug's safety since the FDA
added that information to the drug's label.
Likewise, Pharmacia circulated preliminary results suggesting that its
study of more than 8,000 patients showed that Celebrex was easier on the
stomach than ibuprofen. But, in the end, the FDA ruled that the study showed
no such benefit and the British Medical Journal criticized the company for
''distributing overoptimistic short term data'' from its study.
Officials from both Merck and Pharmacia said the primary purpose of the
studies was to answer important scientific questions. And Pharmacia
officials still maintain their drug is safer than ibuprofen.
The risks to patients are generally low if the studies are conducted
carefully, because many side effects are known from pre-approval testing.
Like pre-approval studies, the trials must be reviewed by oversight
committees and must include only patients who agree to participate,the
speakers said. The studies are typically not monitored as carefully by
either the FDA or by the companies themselves, they said. In addition, the
speakers said companies can probably get away with not fully collecting and
reporting to the FDA the occurrence of side effects already listed on the
drug's label, a tactic that others suggest could keep important information
from the public.
But the studies are not risk-free. Some serious side effects only come to
light after approval when a drug is used more widely. This has led some
doctors to shy away from prescribing new drugs in the first few years
they're on the market. However, CenterWatch found that doctors who test
drugs post-approval are nearly 60 percent more likely to prescribe them to
their other patients than doctors not involved in the studies.
Alice Dembner can be reached at
dembner@globe.com.
This story ran on page A1 of the Boston Globe on
6/25/2002.
© Copyright
2002 Globe Newspaper Company.
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