Prescription for reform?

By Rita Rubin, USA TODAY

Against a backdrop of spiraling prescription drug costs, questions are
mounting about whether drugmakers - and the doctors who test and
prescribe their products - always have patients' best interests in
mind. Increasingly, critics say, money, not medicine, drives drug
development and use.

But recently, there have been signs of a backlash:

· A Food and Drug Administration advisory committee began a meeting
on Monday to discuss whether to require stronger labels warning about
antidepressant use in children. The FDA meeting follows allegations
that drugmakers suppressed unfavorable studies. The Pharmaceutical
Research and Manufacturers Association, or PhRMA, a trade group,
announced last week that it will launch an online, voluntary registry
of clinical trials Oct. 1, but others say it should be mandatory.

In her new book about the drug industry, former New England Journal of
Medicine editor Marcia Angell suggests that consumers ask their doctors
the following questions when prescribed a new medication:
What is the evidence that this drug is better than an alternative drug
or treatment approach?
Has it been published in a peer-reviewed medical journal, or are you
relying on information from drug company representatives?

Is this drug better only because it's given at a higher dose?
Would a cheaper drug be as effective if it were given at an equivalent
dose?

Are the benefits worth the side effects, the expense and the risk of
interactions with other drugs I take?
Is this a free sample? If so, is there a generic drug or other
less-expensive equivalent when the free samples run out?

Source: The Truth About the Drug Companies

· New York Attorney General Eliot Spitzer sued GlaxoSmithKline in
June, alleging that the company withheld studies that showed its
antidepressant Paxil was not effective in children and adolescents and
actually raised the risk of suicidal thoughts and behavior in young
patients. Spitzer dropped the lawsuit last month after Glaxo agreed to
post online the results of all clinical trials of its drugs, not just
those that were favorable.

· At a House Commerce subcommittee hearing last Thursday, an American
Medical Association trustee outlined his group's criteria for a
mandatory national registry that would list the results of all clinical
trials. "Physicians need complete and unbiased information about the
safety and effectiveness of the treatments they prescribe for their
patients," Ronald Davis told the panel. The hearing had been postponed
from July because then-subcommittee chairman Rep. James Greenwood,
R-Pa., who had spearheaded it, announced that he will become head of a
biotechnology trade group - whose members include drug companies -
when his term expires.

· The International Committee of Medical Journal Editors on Wednesday
announced that its 11 journals will publish only studies that had been
entered into a public registry of trials. "Honest reporting begins with
revealing the existence of all clinical studies, even those that
reflect unfavorably on a research sponsor's product," according to the
group's statement.

· Four new books - two by former editors of The New England Journal
of Medicine and two by Harvard-affiliated doctors - slam the drug
industry and doctors who accept its largess for profiting at the
expense of Americans' health.

Focus on profits

PhRMA president Alan Holmer blames the intense scrutiny on the fact
that patients have to pay a bigger chunk out-of-pocket for prescription
drugs than they do for doctor visits or hospital care.

"That's why people are writing these books, and that's why politicians
are beating up on the pharmaceutical industry, because we have a lack
of insurance for these medicines that are becoming an increasingly
important part of our medical system," Holmer says.

PhRMA wrote a 28-page rebuttal to The Truth About Drug Companies: How
They Deceive Us and What to Do About It by former New England Journal
editor Marcia Angell, the only book it obtained before publication.

Angell and her colleagues say the problem is as big as the drug
companies' pockets are deep. Pharmaceutical firms now fund the majority
of U.S. clinical trials. On top of that, it's hard to find a
high-profile researcher who doesn't pad his pay with speaking or
consulting fees from the makers of relevant drugs. Lesser lights accept
meals and other freebies from drug sales reps in exchange for listening
to their spiels.

Harvard clinical professor John Abramson, author of Overdosed America:
The Broken Promise of American Medicine, bluntly assesses the situation
this way: "I've written this book because I want my colleagues to
understand that much of what they believe to be true about the best way
to practice medicine is distorted by commercial interests and has no
more integrity than commercially sponsored infomercials on TV."

Drug companies have funded studies of their own products for years,
Angell notes. "But it used to be they gave grants at arm's length," she
says. "They had nothing to do with the way the study was done or
whether it was published. Now they are intimately involved in every
detail of the study."

Because the companies decide what gets studied, Angell says, there are
too many "me-too" drugs that are quite similar to six or seven already
on the market. "What I'm most concerned about is the opportunity costs
of all the me-too drugs," she says. "We do have shortages of some
drugs. Too few antibiotics. We have way too few drugs for tropical
diseases and other non-paying customers."

Holmer counters that so-called me-too drugs are usually cheaper and
some patients tolerate them better than older drugs on the market.
Besides, he says, "the government does a lot of good things, but
discovering and, particularly, developing new medicines is not one of
them."

Surprisingly, Peter Rost, a vice president at drug giant Pfizer, sides
with Angell. He posted a 5-star review of her book on Amazon.com.

"It's really hard to find new drugs, and it's getting harder and
harder," Rost, representing himself, not Pfizer, said in an interview.
"There is a lot of low-hanging fruit out there that has been picked
off. It is very, very difficult to really find a breakthrough."
Instead, Rost says, drugmakers focus on tweaking existing drugs to make
money, not to advance science.

Changing principles

Critics say the medical profession deserves part of the blame for drug
companies' ascendancy.

"Gee, journals are not interested in publishing negative studies?" says
Jerome Kassirer, former New England Journal of Medicine editor and
author of Bad Medicine, which will hit bookstores early next month.
"Doctors were involved in those studies. Why weren't they out there
screaming that these studies were no good?"

Editorial writers sharpened their pencils after learning that all but
one author of a July report calling for more aggressive treatment of
high cholesterol have financial ties to companies that make
cholesterol-lowering drugs. While the co-authors might well have based
their advice solely on the science, critics say their industry
connections can't help but raise doubts.

"The problem, of course, is that many of the people with true expertise
in an area are called upon by the pharmaceutical industry to help with
the design of clinical trials and the evaluation of data," says update
co-author Sidney Smith, a University of North Carolina-Chapel Hill
cardiologist.

Smith rejects Angell's suggestion that experts be excluded from writing
practice guidelines because of their conflicts of interest. "If all
this amounted to was analyzing drug trials, then you could have a
biostatistician doing it," he says. But expertise in treating patients
and conducting trials is important, too, Smith says.

Times have certainly changed, Kassirer says. "When I was a fledgling
researcher in the '60s and '70s, if you were taking money from a drug
company to do research, people would look down their nose at you," he
says. "Now ... there's prestige associated with the fact that you've
become a consultant for various companies."

Doctors' role

The drug industry and doctors go way back, notes Catherine DeAngelis,
editor of The Journal of the American Medical Association. To this day,
DeAngelis says, she still feels ashamed about accepting a doctor's
black bag from Eli Lilly at the end of her first year of medical
school. Now, when she unexpectedly finds that a professional dinner to
which she has been invited is being paid for by a drug company,
DeAngelis either pays for the meal herself or only drinks water.

Can gifts and free meals persuade doctors to prescribe a particular
drug? "Probably. To what degree? I don't know. It should be zero,"
DeAngelis says. "To me, it would be a problem if only one physician
were involved. Of course, I know there are many more than one."

No doctor can escape drug companies' attempts to shape prescribing
habits, says Harvard doctor Jerry Avorn, author of Powerful Medicines:
The Benefits, Risks, and Costs of Prescription Drugs.

"We simply can't keep going on the way we have been with the industry
being the main source of information for doctors about the
appropriateness of drugs and the choice of drugs," Avorn says.

That's all going to change this fall in Pennsylvania and Kentucky, when
those states begin sending out their own sales reps to doctors'
offices, Avorn says.

They'll be taking a page from the drug companies' marketing manuals, he
says. For example, if doctors say they don't have time to meet, the
pharmacists will offer to buy them lunch. But, Avorn says, these reps,
mainly pharmacy professors, will be promoting only the most
cost-effective treatments.

"We as prescribers are starved for neutral information," says Avorn,
whose research serves as a basis for the state programs. "I think the
trouble is not that doctors are easy marks, but that there ain't no
alternative."