BusinessWeek: Drugmakers Blackmail the Public

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> SSRI-Research

> Sat, 21 Aug 2004 17:27:03 -0400

> [sSRI-Research] BusinessWeek: Drugmakers

> " Blackmail the Public "

>

> AUGUST 18, 2004

>

> BUSINESSWEEK ONLINE

>

> NEWSMAKER Q & A: TECHNOLOGY

>

> Drugmakers " Blackmail the Public "

>

>

http://www.businessweek.com:/print/technology/content/aug2004/tc20040818_756

> 7_tc121.htm?tc

>

> Author Marica 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 BusinessWeek 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 has

> 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 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 lifesaving.

>

> 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

>