I have just finished a book called _The Truth About the Drug
Companies_ by Dr. Marcia Angell, former executive editor of the
New England Journal of Medicine.

This book made me very angry.  What follows may appear to be an
off-topic rant to some of you.  I personally think it's on topic
for all people suffering with life threatening diseases.
However, if you think this is off-topic, please do not read on.

The facts that Dr. Angell presents are pretty disturbing.  In
2002, the top 10 American drug companies made more profit than
all of the remaining 490 companies in the Fortune 500 put
together.

By their own accounts, the drug companies spend far more money on
marketing than on research.  But if you look at their accounts,
you find that even a great part of the money they include in the
category of "research" is really marketing.

Also in 2002, the last year for which Dr. Angell had full data,
78 new drugs were approved by the FDA.  Of them, only 7 were "new
molecules" that represented a significant improvement over
previous treatments.  Not one of the seven was developed by a
drug company.

There are now 88,000 drug company salespeople in the United
States.  According to Google, there are now 301,000 physicians.
That means that a full time salesperson is effectively dedicated
to every 3.4 physicians.

Drug companies are not investing much in new drugs.  Their main
thrust is in what Angell calls "me-too" drugs.  After the first
statin drug became a best seller, five more statins were
developed by competing companies.  Most are small variations on
the original molecule.  Not one has demonstrated greater
effectiveness than any other.

After Viagra became a blockbuster drug, Cialis and Levitra were
developed.  As with the statins, no clinical trials have ever
been conducted to prove that one of these drugs is better than
the others.  One might be better, but we don't know, and don't
know which.  For all we know, the first one developed could be
the best.

Similar "me-too" drugs have been developed for selective
serotonin re-uptake inhibitors (Prozac, Paxil, Zoloft, etc.)
heartburn, blood pressure, and other conditions.  All of these
drugs have been developed and marketed at huge expense, but with
no evidence presented that any of the me-too drugs are more
effective than any others.

More drugs are developed for long term ills, like high cholesterol,
depression, and heartburn than for cancer, heart attack, and
other more acute killers.  Profits are better with patients who
don't die off or get better and stop buying.

The drug companies claim that we need the me-too drugs because
some people respond to some better than others.  But no clinical
trial has ever demonstrated that.  It is a claim based on, at
best, anecdotal evidence.  At worst, it is simply a made up claim
that serves the interest of the companies but has no basis at all
in fact.

With all of the me-too drugs, one might think that prices would
come down.  Competition is supposed to do that, isn't it?  But
the drug companies don't compete on price.  Even though Viagra is
sold for many, many, many times the cost of manufacturing, and
even though all R&D costs were recovered years ago, the cost of
Viagra, Cialis and Levitra are all pegged at the original Viagra
cost.  We still pay top prices.  The same is true for statins,
SSRI's, and other high profile blockbuster drugs.

The government is in collusion with the companies in all of this
profiteering.

There is now more than one drug company lobbyist in Washington
for each and every Senator and Congressman.  Drug company
contributions to the politicians are among the biggest in the
country.

In return for these bribes, the drug companies have won the
following concessions in the last 25 years:

   NIH funded research can be patented and owned by drug
   companies.  Our tax dollars develop drugs but we don't own
   them.

   Patent protection can be set at 20 years and extended by a
   variety of horrible schemes, such as patenting trivial
   variations on the drug or its usage or packaging, by testing
   in children (PMS drugs are tested in children because the
   government allows an extra 6 months of patent protection if
   the trials are done with children), and by tying up generic
   drug makers in court.

   It is illegal to import drugs from Canada, even though there
   have been more cases of drug counterfeiting in the U.S.
   (where profits from counterfeiting are much higher) than in
   Canada.

   The Medicare Drug Benefit boondoggle makes it illegal for
   Medicare to pay less than full retail price for drugs, even
   though all of the other big purchasers (including the VA) pay
   much less.

   FDA drug approvals, from being slower than other countries,
   have now become the fastest in the world, compromising safety
   in a number of high profile documented cases.

   Direct to consumer advertising, illegal in every other
   advanced country, has become commonplace in the U.S.

   Gifts, kickbacks, resort travel, bogus consulting fees, and
   other payments to doctors who prescribe a company's drugs are
   extraordinarily common in the U.S., with little or no
   attempts by government to stop them.

Dr. Angell offers many ways to curb the power of the companies
and make drugs more affordable and research more productive.  One
of those ways is an incredibly simple plan for making things
better.  Just this one change would make a huge difference in the
cost of drugs and the benefits of research.

   She proposes that a drug only be approved for sale if a valid
   clinical trial demonstrates that it is more effective than
   the current treatments.

Right now, a company need only demonstrate that its drug is
better than a placebo.  It need not demonstrate that it's better
than other drugs.  It can be worse.  That's fine.  No problem.
It can be worse than standard over the counter medications like
aspirin or ibuprofen or Tylenol or Tums, and have far more
serious side effects.  But if it is better than a placebo and
doesn't kill people, it will be approved and can be marketed
as the next wonder drug.

If we make that illegal, all of the huge marketing, patent
protection and, yes, even research costs for developing me-too
drugs will go away.  All of the recruiting for clinical trials
for me-too drugs will go away and the small pool of available
trials patients can be steered into real trials.  If a drug is
demonstrated as better than other drugs, it won't need marketing
or advertising.  Doctors will hear about it and prescribe it - as
they did for the revolutionary cancer drug Gleevec, which was
never promoted by the company that secured the rights to it (it
was developed, of course, by a scientist named Goldwasser in
Chicago who never made, or asked for, a penny out of it.)

I urge everyone to go down to your public library or book store
and take a look at _The Truth About Drug Companies_.  Then
contact your congressional representatives and demand change.

   Alan