John Abramson has
done much to expose the abuses of the pharmaceutical industry
over the years. He played a key role in the investigation
of Vioxx and the litigation that eventually led the drug to
be pulled from the market, as well as billions of dollars
to paid in settlements by Merck, its manufacturer. He has
also helped to expose numerous conflicts of interest between
regulators and
medical journals and drug companies. His 2008 book Overdosed
America, helped to call these and other abuses to the
attention of a larger audience.
For this reason,
there is good cause to expect that his new book, Sickening:
How Big Pharma Broke American Health Care and How We Can Repair
It, would make a substantial contribution to the current
debate over controlling drug prices. (Unfortunately, its publication
date is not until February.) The book is indeed useful in
documenting the failures of the pharmaceutical industry, but
it comes up painfully short in the remedies.
The first part
of the book goes over some of the major scandals of the pharmaceutical
industry over the last three decades. It notes the overuse
of statins, a drug designed to lower cholesterol. Abramson
points out that statins are often prescribed for women, based
on clinical trials showing their effectiveness for men. In
spite of the lack of evidence of benefit, expensive statins
have been prescribed for millions of women over the last three
decades.
He also recounts
the history of insulin, where a simple and cheap drug, invented
almost a hundred years ago, has been repeatedly modified in
ways that make it hugely more expensive, with limited, if
any, benefit for most diabetes patients. He also goes over
the story of Vioxx, where the issue was that Merck deliberately
withheld evidence that its new arthritis drug could increase
the risk of heart attacks and strokes for people with heart
conditions. And, he goes through the accounts of how the drug
companies misrepresented the evidence on the addictiveness
of the new generation of opioids, contributing to the opioid
crisis the country has experienced over the last quarter century.
The second part
of the book gives an account of how the drug companies are
able to deceive doctors about the safety and effectiveness
of their drugs. The gist of the story is that the sources
that doctors rely on for information are effectively compromised
by their ties to the industry. For example, the FDA committees
that make recommendations on a drug’s approval typically
include members who have received payments from the company
whose drug they are evaluating.
This turns out
to be the same for medical journals, which often run articles
where the referees and editors do not have full access to
the clinical trial data on which they are based. And, researchers
at universities and other non-profit institutions are heavily
dependent on grants from the pharmaceutical industry.
All the sources
that doctors may turn to for reliable information turn out
to face considerable pressure to push the industry line. As
a result, they routinely end up prescribing expensive new
drugs for conditions where they may not be useful and may
in any case be no more effective than older cheaper drugs.
The first two
parts of the book are very useful and important, it is the
third part, giving remedies, that falls short. Abramson repeatedly
blames the pharmaceutical companies’ pursuit of profit
for the industry’s problems and sees increased government
regulation as the solution.
While all of his
proposals would be positive changes, he somehow misses the
real story. We should take it as a given that drug companies,
like other companies, will pursue profit. The issue is how
the government has structured the industry and its ability
to make profits.
Specifically,
it is government-granted patent monopolies that allow the
industry to make large profits by promoting drugs that are
ineffective or even dangerous. As long as we leave this structure
intact, we will be fighting an uphill battle in containing
abuses. We can think of the effort as being analogous to the
war on drugs or prohibition. If there is a lot of money to
be made by getting around the law, creative and highly motivated
people will find ways to do so.
The obvious alternative
to patent monopoly financing of research is public financing.
It’s not as though the idea of publicly financing of
research is alien to Abramson, he talks about the massive
contribution of publicly funded research to the development
of the mRNA vaccines against Covid in his introduction. But
for some reason, the public alternative to patent monopoly
financed research is missing from his list of remedies.
There are better
and worse ways to structure a system of publicly financed
research, but it should be easy to see that this route would
eliminate pretty much all of the problems identified in the
book. (My preferred route is a system of long-term contracts,
similar to the way the Pentagon pays for the development of
weapons systems. I discuss this in chapter 5 of Rigged.
If the research
is paid for by the government, a condition of the funding
should be that everything is fully public as soon as practical.
A great model here is the Bermuda Principles researchers adopted
in the Human Genome Project. All results were posted nightly.
This one is very
simple and straightforward, if a researcher took the money,
the public owns the results. This means both findings from
pre-clinical research, as well as results from clinical trials.
And, these results mean not just summary data on trial outcomes,
but anonymized data on individual participants, so that other
researchers can freely examine the results and come to their
own assessments.
In this world,
since all drugs would be available as generics from the day
they are approved, no one would have any incentive to make
false claims about the benefits of specific drugs. Doctors
could be confident that the articles they are reading in medical
journals are not biased by financial interests. Similarly,
the FDA would not be facing pressure to approve drugs by someone
with money on the line. Manufacturers of generic drugs make
profits, but they have little stake in pushing one drug rather
than another.
Finally, drugs
would be cheap. It’s very rare that a drug is expensive
to manufacture and distribute. If all drugs were being sold
as generics, we would likely be spending less than 20 percent
of the $500 billion we now pay for drugs each year. The savings
come to roughly $3,000 a year for every family in the country.
Also, patients would not be in a situation where their finances
prevented them from getting a drug that was needed for their
health.
It is frustrating
that someone who has spent so much time researching the pharmaceutical
industry, and is so aware of its problems, as John Abramson,
backs away from the obvious solution. The horrors of the pharmaceutical
industry are the predictable result of how we have chosen
to structure the market. The solution is to structure the
market differently and take away the patent monopolies.