Former Editor Of NEJM Speaks Out About Drug Companies

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Friday, August 20, 2004 10:22 AM

PPEN # 136: Big Pharma's Deceptive Nature

 

 

Preventive Psychiatry E-Newsletter # 136

 

 

Former editor of New England Journal of Medicine speaks out about

drug companies

 

http://www.businessweek.com/technology/content/aug2004/tc20040818_7567

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121.htm

 

BUSINESS WEEK - AUGUST 18, 2004

 

Drugmakers " Blackmail the Public "

 

Author Marcia Angell says her research shows their huge influence

over Congress, the FDA, and doctors is harming Americans

 

After she stepped down in June, 2000, as interim editor-in-chief of

the New England Journal of Medicine (NEJM), Dr. Marcia Angell decided

to write a book about biases in clinical trials. As she was doing her

research and writing, she realized that " all roads led back to drug

companies. "

 

 

Angell decided there was a bigger story to tell -- about the vast

influence the pharmaceutical industry has over how medicine is

practiced today.

 

During her 20-year career at NEJM, Angell had watched drugmakers

expand their sway. They became the main sponsors of clinical testing

and physician education and are also a critical source of funding for

the Food & Drug Administration. " I finally decided just to bite the

bullet and write about [the industry]. " The result is The Truth about

Drug Companies: How They Deceive Us and What to Do About It, which

arrives in bookstores in late August.

 

The book provides a detailed account of the intimate interconnections

between drug companies and every other player in the health field --

including medical journals, doctors, government agencies, Congress,

universities -- and how such relationships harm the public. Dr.

Angell recently spoke with Business Week Online reporter Amy Tsao.

Edited excerpts of their conversation follow:

 

Q: You give a very troubling account of the drug industry's

practices. What, in your view, are the big truths that it doesn't

want the public to understand?

A: I would say they're threefold. One, they spend relatively little

on R & D -- less than they make in profits and far less than they spend

on marketing and administration. What the industry does is

essentially to blackmail the public. It says: " We're the source of

your miracles, of your innovative drugs, and therefore don't mess

with us. "

 

The second truth is that they're not particularly innovative. Their

major product is " me-too " drugs -- and even the innovative drugs that

they do produce are almost always based on research that's been done

at taxpayer expense [and] funded by the NIH [National Institutes of

Health].

 

The third truth is that they have pretty much had their own way

because of their control and influence over the institutions in

society that really ought to be checking them. They have pretty much

bought and paid for Congress. They have a lot of influence over the

FDA through user fees they pay [to have their drugs reviewed by the

agency], and they have way too much influence over doctors and the

medical profession generally.

 

Q: You mentioned that in other countries drug companies can sell

medication for a profit, [but] there are price controls. What's the

difference between the profit margins in the U.S. vs. countries where

there are price controls?

A: I don't know the answer to that. That's another way they're very

secretive. We do know that they make a profit in other countries

because they aren't charities. They don't give drugs away. But let's

assume that they did.

 

Look at the year 2002, when the profit margin for the 10 [drug]

companies on the Fortune 500 list was 17% of sales, and sales in this

country amounted to about half of their worldwide sales. You can

calculate even if they made no profit whatsoever in the rest of the

world, they would still come out with at least an 8.5% profit margin.

And that would be higher than the median of the other Fortune 500

companies that year, which was 3.1%.

 

Q: What role should physicians play in curbing some of the industry's

marketing influence?

A: I think my harshest criticism, perhaps, was not for the industry

but for my fellow physicians and the medical profession. After all,

the industry is in business to make money, but that isn't what

doctors and medical schools should be doing. They don't have to be in

bed with the drug companies. But they are.

 

Drug companies finance most of the continuing medical education of

doctors, as well as meetings of professional societies. They lavish

all manner of gifts on doctors in practice, including dinners in

luxurious restaurants and trips (ostensibly for educational purposes)

to exotic resorts. And they provide speakers and meals for interns

and residents in teaching

hospitals. The profession should acknowledge that this is all a form

of marketing, which adds to the prices of prescription drugs. Doctors

should take responsibility for their own education and buy their own

meals.

 

Q: What about medical journals? Are there enough safeguards in place

to make sure that the right research is published?

A: There are two issues in that question. One, is the research valid,

and can we trust it? And I'm concerned that increasingly, we can't -

that the sponsors introduce all kinds of bias in the designs and

analyses of the study and that some of the more interesting data are

suppressed.

 

The second issue is whether journals are publishing the most

medically and scientifically important research or whether they're

publishing studies that are preferentially favorable to the industry.

The answer depends a lot on the journal.

 

I don't think the big distinguished journals, the reputable journals,

like the New England Journal of Medicine or the Journal of the

American Medical Assn. are selecting papers to publish because

they're favorable to sponsors. Not at all. [but] I think many

journals are publishing papers that are favorable to the industry

because they're totally dependent on the industry for advertising

revenues.

 

Q: We're seeing many individuals -- even whole states -- buying drugs

from abroad. What will be the impact of this?

A: I think the industry is going to use trade agreements to force

other countries to let their prices rise. This is something that Mark

McClellan, former FDA commissioner, talked about last year. Already,

a recent trade agreement with Australia was designed to do that, and

it gives the drug companies the right to prevent importing drugs from

Australia. I think the intention is for other bilateral trade

agreements do the same thing.

 

The real answer is to regulate prices here in some way, not to

require them to go up [elsewhere].

 

Q: Is that a possibility?

A: Not as long as the pharmaceutical industry has the largest lobby

in Washington and contributes so generously to political campaigns.

 

Q: What about legislative solutions?

A: The most important and most doable solution in many ways is to

require that companies, to get FDA approval, have to compare [the new

product] with older drugs already in the market, not just with

placebos. The new drug should be shown to be superior in some way to

existing treatments - more effective, safer, or substantially more

convenient. This would pull the rug out from the me-too industry.

 

Q: What about the recent talk of clinical trial registries. Is that a

solution?

A: All clinical trials should be registered in one central place. It

should be a condition of enrolling human subjects. After all, human

subjects don't sign onto clinical trials just for fun. They are

hoping that this will yield knowledge. If that knowledge is

suppressed, then they've been used in a misleading way. Research must

be registered, and it should be done so at the inception of the

study. The reason for registering it at the beginning is that it

doesn't allow companies to shift the goal post as the trial goes on.

 

Q: What can individuals do to fight back?

A: One recommendation is to be aware that this industry speaks

through many voices, and whenever anyone makes a pronouncement about

drug prices or anything else dealing with prescription drugs, people

ought to ask themselves if there is a conflict of interest. Often

there is.

 

Patients have to become much more skeptical about claims that drugs

will cure whatever ails them. There's reason to believe that some new

drugs are not nearly as good as they're claimed to be, that doctors

believe the claims as much as their patients do, and we have to

remember that almost any drug has a risk of side effects. This isn't

to say that there aren't

important drugs on the market. They can be very helpful and even life-

saving.

 

I'm not trying to say never take a drug -- but I'm saying that people

should be reluctant to take drugs unless they're pretty sure that

they're needed.

 

Edited by Thane Peterson

 

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Related story: http://www.alternet.org/envirohealth/19537/