A Doctor Puts the Drug Industry Under a Microscope - Dr. Marcia Angell

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[sSRI-Research] A Doctor Puts the Drug Industry Under a

Microscope - Dr. Marcia Angell

 

 

 

A Doctor Puts the Drug Industry Under a Microscope

 

September 14, 2004

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.