The drug industry has undergone a shift in the recent
decades. The industry now focuses on producing drugs for
chronic conditions like depression and diabetes, as the
industry tries to meet Wall Street's demands for steady
growth in profits.
The many millions of sufferers taking the drugs for long
periods make such drugs very lucrative, however the new
approach has made lawsuits somewhat more likely and has also
increased the pool of potential plaintiffs. And because
clinical trials for new drugs are conducted on only a few
thousand subjects, the tests do not always discover rare but
dangerous side effects that surface after a drug is approved,
according to experts, even at the FDA.
"All drugs have side effects, and even the safest approved
drugs have side effects," said an FDA spokesman. "It is very
likely that the newer classes of drugs in general are safer
than older drugs, but you have to recognize that many more
people are taking medicines now than used to."
There have recently been many suits against drug companies,
some of them involving gigantic sums. One, for example, is
about Rezulin, a diabetes treatment from Pfizer that the US
Food and Drug Administration has linked to liver damage and
is the target of almost 9,000 suits. It is no longer sold.
Other suits name some of the industry's current best sellers,
including Paxil, an antidepressant that plaintiffs contend is
addictive -- a claim denied by the drug's maker,
GlaxoSmithKline.
The lawyers pursuing the suits say that the US Food and Drug
Administration has failed to protect patients from dangerous
drugs, and that the companies have tried to hide side
effects. But the agency says medicines are safer now than
they have ever been.
Within the industry, companies have begun to consider the
threat of lawsuits when deciding which new medicines to
pursue. Companies, for example, have mostly stopped
developing certain medicine types which are very vulnerable
to lawsuits.
The new lawsuits against drug companies are much larger than
ever before, covering more drugs and many more plaintiffs. In
addition to the 8,700 people who have sued Pfizer, the
world's largest drug company, over Rezulin, an additional
32,000 people have said that they may sue, giving notice to
avoid missing the opportunity to eventually file such
claims.
Wyeth, another big drug company, has already set aside $14
billion since 1997 for claims by people who say they were
injured by its diet drugs, and the company has been informed
by an additional 90,000 people that they may sue. Johnson &
Johnson and Bayer have also been named in thousands of suits.
Drugs from Bristol-Myers Squibb, Eli Lilly and Merck have
also been named in lawsuits.
Altogether, the drug makers say that they are now spending
several billion dollars each year to defend themselves from
lawsuits and settle claims.
Another important factor in the lawsuits is the increasing
aggressiveness and wealth of the trial bar. Plaintiffs'
lawyers can now finance enormously complicated suits that
require years of pretrial work and substantial scientific
expertise, in the hope of a multibillion-dollar payoff.
Scores of firms collaborate on a case. At conferences around
the nation, lawyers trade information and legal
strategies.
The plaintiffs' bar has refined a technique in drug lawsuits
that it has used effectively against asbestos companies.
Lawyers file a few cases with very sick plaintiffs in states
and counties considered favorable to plaintiffs, while
building big "inventories" of less seriously ill patients,
and even people who have used the drug but are not sick.
If the lawyers can win large verdicts in the early cases,
they then refuse to settle the claims of their other very
sick clients unless the defendants also agree to pay the
claims of people who are less sick.
The companies then face a difficult choice. If they go to
trial in a case that includes a few seriously injured
plaintiffs and hundreds more who are less affected, they risk
losing hundreds of millions of dollars in a single case,
frightening Wall Street and spurring more suits. But if they
settle cases without a trial, they risk being perceived as an
easy mark for lawyers.
No medicine is completely safe for everyone, said Dr. Kin-
Wei Chan, a Harvard epidemiologist. Because tests are
conducted on a few thousand patients, drug companies cannot
immediately know every side effect of their medicines, Dr.
Chan said, but the family of a person who has been injured or
died after taking a new medicine may have a difficult time
accepting that fact. "For a family it's not one in a thousand
or one in a million, it's one in one," he said. "But from a
public health perspective, and I'm coming from a public
health perspective, this is something we have to live with.
We all have to recognize that we have to live with some
nonzero risk."
A case in point that highlights some other problems with the
new approach is something announced a few weeks ago.
Intravenous infusions of a genetically engineered protein
caused fatty deposits on artery walls to diminish, presumably
reducing the risk of heart attack. The substance contained a
genetically engineered variant of the key protein in high-
density lipoprotein cholesterol, the so- called good
cholesterol.
Pharmaceutical companies have been trying to develop pills to
stimulate the body to produce its own HDL cholesterol, thus
far with no great success. An alternative approach, infusing
HDL cholesterol directly into the body, was shown effective
in animals more than a decade ago, but the industry never
really pursued it. One reason was that companies saw little
economic incentive in using a normal body protein for
therapeutic purposes, since it would be hard to gain patent
protection. A medicine that can be made and sold by anybody
had little potential for profit. The problem was circumvented
in this case by using a mutant form of protein discovered in
a small Italian village. That made the drug unique, and
patentable.
The fact that such a promising treatment was widely ignored
because there was no immediate profit potential is
disturbing. In theory, the nation's great web of government-
financed medical research institutions should step in to
promote development of the kinds of drugs and therapy that
industry regards as unprofitable.
