Former New England Journal of Medicine editor Marcia Angell criticizes
costs, research and marketing.
By Peter Jaret Special to The
Times
August 9, 2004
For more than a decade, physician Marcia
Angell served as executive editor and then editor in chief of the New England
Journal of Medicine, one of the country's most prestigious medical journals.
Under her watch, the journal published hundreds of studies of new drugs. It also
published blunt editorials harshly critical of the pharmaceutical industry and
the way drugs are tested and approved in the United States.
Angell left
the journal's editorship in 2000, and is now a senior lecturer at Harvard
Medical School. She has written a scathing critique of the pharmaceutical
industry, "The Truth About the Drug Companies: How They Deceive Us and What to
Do About It" (Random House, 2004). In a recent conversation, she talked about
why so many of the drugs on the market are so costly, and also about her
contention that many of them are not as effective as they're promoted to
be.
*
Question: We all know drugs are expensive.
But doesn't that reflect the high cost of researching and developing new
drugs?
Answer: No. That's what the drug makers would
like you to think. But it's simply not true. In 2002, the biggest drug companies
spent only about 14% of sales on research and development and 31% on what most
of them call marketing and administration. They consistently make more in
profits than they spend in R&D. And their profits are immense. In 2002, the
combined profits of the 10 drug companies in the Fortune 500 were $35.9 billion.
That's more than the profits for all the other 490 business put together, if you
subtract losses from gains.
*
Q: The system may
be flawed, but hasn't it generated hundreds of new
medications?
A: That's another myth the drug makers
would like you to believe. In fact, the number of truly innovative new drugs is
quite small. True, many drugs are coming to market. But most of them aren't new
at all. They are minor variations of bestselling drugs that are already on the
market.
There are dozens of examples of these "me-too" drugs. There are
now six different statins to lower cholesterol. The first, Mevacor, which was
approved in 1987, was indeed an innovative drug. Other companies wanted to
capitalize on this extremely lucrative market and they began creating other
statins. Lipitor is now the biggest-selling drug in the world. But it's a me-too
drug. There's little scientific evidence that any of them is better than the
others in comparable doses.
*
Q: Doesn't the Food
and Drug Administration require new drugs to be safer and more effective than
drugs already on the market?
A: It should, but it
doesn't. Drug makers are only required to show that a new medication is more
effective than a placebo, or sugar pill. If a drug works better than a placebo
and is safe, the FDA approves it, and it can enter the market. The result is
that doctors don't know if a new drug that comes along is any better or worse
than the drugs they're already using.
A dark fear I have, in fact, is
that drugs are getting progressively worse. There's some basis for that concern.
The first drugs used to lower blood pressure were diuretics. Then new drugs for
hypertension came along and were heavily marketed, and many doctors stopped
using diuretics. In a study published in 2002, researchers compared the old
drugs to the new ones, and guess what — the old drugs turned out to be just as
good for lowering blood pressure and even better than the new drugs for
preventing some of its complications.
*
Q: Why
do drug makers churn out new drugs when older ones work perfectly
well?
A: Because patents run out on older drugs and they
can then be sold as generics at as little as 20% of the price [they sold at
while still under patent]. Pharmaceutical manufacturers need a constant supply
of new drugs that have patent protection so they can charge whatever they
want.
*
Q: Isn't it useful to have a variety of
drugs to choose from, in case a patient doesn't respond to the
first?
A: That's an argument the pharmaceutical industry
makes — that it's good to have six cholesterol-lowering drugs, or five selective
serotonin reuptake inhibitors (SSRIs), the antidepressants that include Prozac,
Zoloft and Paxil. But if that's true, then the companies should be required to
test a new me-too drug in people who failed to respond to the first drug. And
they don't do that. My guess is that if the first drug doesn't work, the second
one won't work either, since me-too drugs are so similar. But no one can say for
sure.
*
Q: What about competition? Do me-too
drugs help keep prices down?
A: Probably not. When did
you see a drug company advertise that its drug is cheaper than another drug? You
don't see ads that promote Lipitor as cheaper than Zocor. Or Zoloft as cheaper
than Paxil. I can't think of any other industry where price is almost never
mentioned. Drug companies compete by implying that their new drug is better. And
also by making more people think they need drugs.
Consider psychiatric
drugs. If you can define everyone who has the blues as having depression that
needs to be treated, you've created a huge market. If you define everyone who is
shy as having social anxiety disorder, that enlarges the market. There's
probably not a soul alive who hasn't felt shy. If you listen to the
pharmaceutical industry, many of the ordinary discontents of life are medical
conditions that require drugs.
You see the same thing with erectile
dysfunction. Any episode of impotence, no matter how mild, how rare, becomes a
condition, erectile dysfunction, that can be treated. It's no coincidence that
the people in those ads tend to be middle aged or even younger. Pushing the
disease is a big part of pushing the drugs. The result is that many Americans
are probably on too many medications, with all the risks of side effects and
drug interactions that implies.
*
Q: If new drugs
aren't necessarily better than old ones, why do doctors prescribe
them?
A: Part of the answer is marketing. New me-too
drugs are heavily marketed to patients and doctors. Look at the ads on
television. Look at the endless parade of drug representatives marching through
doctors' offices. Pharmaceutical companies spend billions and billions to make
us think that new drugs are better than old ones. They have to. If you had a
drug that was important and unique, you wouldn't have to advertise it very much.
If you came out with a cure for cancer, the world would beat a path to your
door.
So you have to ask, why are drug companies spending so much on
marketing? The answer is that they have to convince us that their me-too drugs
are better than the others. And that takes a heap of marketing, because there's
usually no scientific evidence to back up the claim.
*
Q:
It's easier to imagine patients being fooled — but doctors?
A: People don't realize that the pharmaceutical
industry supports most of the continuing medical education programs in this
country. These are the programs doctors are required to attend to update their
knowledge. Drug makers fund the programs, so it's not surprising that they
promote a drug-intensive style of medicine.
In their offices, doctors are
visited by swarms of company sales representatives who bring packages of free
samples — about $10-billion worth a year — of the newest brand-name drugs. The
doctors get used to prescribing them, the patients get used to taking them, and
when the free samples run out, someone has to start paying for the drug.
Whether these new drugs are actually better than older generic drugs
never crosses the doctor's mind or the patient's mind. They confidently believe
that newer is better.
*
Q: What about clinical
trials? Don't they provide evidence about how well drugs work?
A: Research is biased in favor of the drugs and drug
makers. The pharmaceutical industry spends a great deal to influence people in
academic medicine and professional societies. It does a super job of making sure
[that] nearly every important person they can find in academic medicine [who] is
involved in any way with drugs is hired as a consultant, as a speaker, is placed
on an advisory board — and is paid generous amounts of money.
Conflicts
of interest are rampant. When the New England Journal of Medicine published a
study of antidepressants, we didn't have room to print all the authors'
conflict-of-interest disclosures. We had to refer people to the website. I wrote
an editorial for the journal, titled "Is Academic Medicine for Sale?" Someone
wrote a letter to the editor that answered the question, "No. The current owner
is very happy with it." That sums up the situation
nicely.
*
Q: What can be done to fix the
system?
A: The single most important change that should
be made — and it could be made tomorrow — is for Congress to redefine what safe
and effective means, to insist that the FDA require manufacturers to test new
drugs not just against placebos but against existing drugs. After all, the
relevant issue isn't whether a new drug works better than nothing; it's whether
it's better than older drugs already in use.
That's why so many clinical
trials published are of no use to doctors. Doctors don't want to know if this
new drug is better than a sugar pill. They want to know if it's better than the
drug they're already using. The FDA should require manufacturers to compare new
drugs head to head, at equivalent doses. Only drugs that are safer, more
effective, or significantly more convenient, should be approved.
We also
need to make the FDA more independent. The FDA has 18 advisory committees, and
many of the members of those committee have financial ties to the drug industry.
That's wrong.
Finally, university medical centers and medical societies
and the people who run them need to stop fooling themselves into thinking they
can take huge sums of money from drug makers and still remain objective and
independent.
*
Q: Is there anything patients can
do?
A: Ask questions. If your doctor prescribes a
medication, ask about the evidence that shows it is effective. Ask why your
doctor is prescribing this particular drug. Ask if there are older, less
expensive drugs that might work just as well. A few questions from patients
might begin to make [doctors] think about what they're doing. Finally, ask your
doctor whether you really need a drug at all. Maybe a lifestyle change would be
better, or maybe the illness is mild and will go away on its own.
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