A Doctor Puts the Drug Industry Under a Microscope

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http://www.nytimes.com/2004/09/14/health/policy/14conv.html?fta=y

 

September 14, 2004

A CONVERSATION WITH | MARCIA ANGELL

 

A Doctor Puts the Drug Industry Under a Microscope

By CLAUDIA DREIFUS

 

WASHINGTON - In many ways, Dr. Marcia Angell is an unlikely muckraker.

A pathologist by training, she is the former editor in chief of The

New England Journal of Medicine. She is also a senior lecturer at

Harvard Medical School.

 

But just days short of her 65th birthday and her first Social Security

check, Dr. Angell is taking on the American pharmaceutical industry

with a new book, " The Truth About the Drug Companies: How They Deceive

Us and What to Do About It " (Random House). " I don't worry about

labels, " Dr. Angell said in an interview at the Hotel Monaco, where

she stopped during a book tour.

 

In a 1996 book, she noted, she argued " that there wasn't a shred of

evidence that the breast implants were causing all the disease they

were said to. "

 

" I was said to be a tool of the pharmaceutical and device companies, "

Dr. Angell recalled. " I call them as I see them. "

 

Q. Why produce an investigative book on the pharmaceutical industry?

 

A. Because everyone knows that prescription drug prices are sky-high.

Americans pay far more for our drugs than people in other countries.

The drug companies say, " We need high prices to cover our staggering

research and development costs, and if you do anything to squeeze our

prices, it will stifle innovation. " The book was written to examine

that argument.

 

Q. The pharmaceutical companies say their prices are steep because

they spend somewhere in the neighborhood of a billion dollars per drug

bringing them to market. Did your research support this assertion?

 

A. A group of economists - mainly funded by the drug companies - came

up with the widely quoted figure on this. They said that it cost $802

million to bring a drug out. They, however, were looking at the most

expensive drugs to develop: new chemical compounds developed entirely

in house. Most new drugs aren't that at all. Most are what people call

" me too " drugs, which are slight variations of older drugs already

being sold.

 

According to these economists, the real cost of bringing out those

rare original drugs is actually around $403 million. But they doubled

it by factoring in how much money the companies might have earned if

they'd invested that $403 million. Moreover, the economists did not

figure into their total the many generous tax breaks these companies

receive for doing research and development. This is a highly inflated

figure.

 

The fact is that for the last two decades the drug companies have been

hugely profitable. Last year there was a little wiggle downward, but

in 2002, the 10 biggest American drug companies had a median profit of

17 percent of sales compared to a median of 3 percent for the other

Fortune 500 companies. In the 1990's, profits ran between 19 and 25

percent. Prices are high to keep profits high.

 

Q. Exactly what are these " me too " drugs you argue against?

 

A. They are minor variations of old drugs already on the market.

Sometimes a company creates a " me too " drug as a way of extending a

patent on an older one. For example, AstraZeneca created Nexium to

replace the virtually identical Prilosec when its patent was about to

expire. By putting out these me-too's, the companies can get new

exclusive marketing rights on what are essentially the same old drugs.

 

Other companies come in with their own me-too's because markets are

expandable. It's been shown that when you advertise one me-too drug,

you increase the sales of all of them.

 

Q. Why do you have a problem with this?

 

A. The prevalence of the me-too's really says an awful lot about the

lack of innovation within the pharmaceutical industry. If you look at

the new drugs marketed over the last six years, 78 percent weren't

even new chemical compounds. They were just new combinations or

different formulations of old drugs. And 68 percent were classified by

the F.D.A. as unlikely to be improvements over drugs already on

pharmacy shelves.

 

At the same time, there are shortages of some important drugs that the

pharmaceutical companies aren't much interested in making because they

are not as profitable as the me-too's. But the companies don't have to

turn out needed drugs, if they are not lucrative. And they don't.

 

Q. How much of the high cost of drugs is the result of marketing and

sales expenditures?

 

A. The companies spend over 30 percent of their revenues on marketing

and administration. Their marketing budgets are so enormous because

they have to persuade doctors and patients to prescribe one me-too

drug over another. If you had a truly innovative drug - a cure for

cancer, for instance - you wouldn't have to market it much. The world

would beat a path to your door.

 

Q. Was there anything in your life that pushed you to write this book?

 

A. As a journal editor, I witnessed a disturbing trend in

pharmaceutical research. Twenty years ago, most drug trials were

conducted at academic medical centers and the pharmaceutical companies

tended to stand back during the testing period. However, in recent

years, the companies have succeeded in attaching strings to research

contracts, often designing the studies themselves, keeping the data

in-house and deciding whether or not to publish the results. They also

began to contract with private research companies for testing.

Moreover, the medical schools and even individual researchers began to

enter into entrepreneurial arrangements with the drug companies.

 

While all this was occurring, I began to see bias creep into medical

research. And I saw a lot of it. The most obvious example were studies

comparing a new drug to a placebo. That may be enough to get a drug

F.D.A. approval, but it should not be enough for The New England

Journal of Medicine. Doctors don't want to know whether a drug is

better than nothing. They want to know if it's better than what they

are already using.

 

Q. You've written that " because most medical journals are dependent on

drug ads for their survival, it probably also influences what they

publish. " Were you speaking of The New England Journal of Medicine there?

 

A. No. That's because the Journal was virtually unique. We had a real

wall between the advertising people and the editorial offices. But

many other medical journals - and there are thousands of them - are

little more than vehicles for advertisements. Still others, while they

are not quite that, will put out occasional sponsored supplements,

which I wouldn't have any confidence in whatsoever.

 

Q. You left the editor's chair at The New England Journal of Medicine

in 2000. Have there been any big changes there since your departure?

 

A. There's only one I know of - we had a policy that review articles

and editorials could not be written by anyone with any financial

connection to a company whose product was featured in that article. We

said that disclosing the connection was not enough.

 

When we printed papers on original research and there were often

conflicts of interests, we published those articles with disclosures.

It's my understanding that the policy on reviews and editorials is no

longer in place. I'm sorry they made that change. But they say it's

too hard to find a prominent author who doesn't have a conflict of

interest.

 

Q. The first phase - the discount card phase - of the new Medicare

drug benefit is about to go into effect. Do you, as a newly minted

senior, believe it will make prescription drugs more affordable?

 

A. It's not going to have a major effect. These discounts are very

small, maybe 10 to 15 percent. At the rate of inflation of drug

prices, they'll be overtaken in a very short time.

 

Now, the main Medicare drug benefit that goes into effect in 2006 is

designed to funnel billions of dollars to the pharmaceutical industry.

It's an absolute bonanza for it. The pharmaceutical industry's

lobbyists made certain that the legislation contained a provision

barring Medicare from negotiating drug prices.

 

Interestingly, the federal government negotiates drug prices for the

Veterans Affairs system and gets very low prices because it is a bulk

purchaser. And Medicare would have been the biggest bulk purchaser of

all - so it could have negotiated very low prices. That provision

allows the drug companies to continue raising their prices faster than

the inflation rate, and the drug benefit will soon become unaffordable.

 

Copyright 2004 The New York Times Company