First is the editorial by Drs. Hoofnagle and Sherker—
http://www.nejm.org/doi/full/10.1056/NEJMe1401508----that talks about what would ordinarily be considered unalloyed good news elsewhere in the issue. Hepatitis C, which up till now has been quite resistant to treatment, appears to be well controlled by a new family of antiviral medications, with a minimum of side effects. This indeed appears to be one of those all-too-rare-today “breakthroughs” in drug treatment.
So what’s not to like? As the editorialists explain, the
price tag. A complete course of one of the drugs comes in at $84,000, which
works out to $1000 per tablet. The authors note a collision course between
newly expanded public health efforts to do a better job of detecting the
additional 1.6 million Americans who have Hep C and don’t know it, so that they
can get this wonderful new treatment, which then many of them will not be able
to afford—or if we could provide it for them, would break the bank of what the
authors delicately call an “already overburdened medical care system.”
The authors work for the NIH and as dutiful government employees are apparently
discouraged from saying anything bad about the pharmaceutical industry, so they
offer no ideas on what might be done about this problem.
Now jump to two “Perspectives” pieces in the same issue. One
is from our good friends at the Harvard-Brigham and Women’s program in
Pharmacoepidemiology and Pharmacoeconomics, including Dr. Jerry Avorn:
http://www.nejm.org/doi/full/10.1056/NEJMp1400488
The P&P gang describes what has happened under a program
begun by the FDA in 2007, the Risk Evaluation and Mitigation Strategy. The idea
when this passed Congress was to speed the entry onto the market of useful new
medications that also posed safety issues. If the company could come up with a
special plan to limit the use of the drug in such a way as to lower the risk of
adverse reactions, then the drug could go on the market. But the proviso added
on was that this plan ought not be used as a way to stop generic products from
entering the market later.
Unfortunately the amendments that passed Congress also
included a monkey wrench that was virtually guaranteed to undermine this intent
(assuming that Congress intended what they said, and that Pharma lobbyists did
not rewrite the law in the back room). The company that developed this special
safety plan for the new drug could also patent the plan.
So Dr. Avorn and colleagues list several cases where the
drug company has sued generic competitors claiming patent infringement if the
generic guys use the same safety plan, and also filing suit to stop any generic
that uses a different safety plan as raising the risk level for the public
unacceptably. The only sensible way to fix this problem, say the Harvard guys,
is to use the same safety plan for all versions of the drug regardless of
manufacturer, but to make this happen Congress would probably have to amend the
2007 act. Bottom line—a policy that was intended to allow patients access to
drugs while assuring safety, that was not supposed to interfere with generics
entering the market, is being used by Pharma precisely as an “evergreening”
tool to prevent generic competition.
Now we come to another Perspectives article authored by Drs.
Sham Mailankody and Vinay Prasad:
http://www.nejm.org/doi/full/10.1056/NEJMp1400104
They also address the cost of new drugs, in this instance
for cancer. Their basic point is—there are newly developed drugs for cancer treatment
that provide small but apparently real benefits, such as an average extension
of life by a few months. These drugs work by mechanisms very similar to old,
generic drugs. (They give the example of the new drug abiraterone, which works
in much the same way as an old anti-fungal antibiotic, ketoconazole.) So the
ideal scientific question now to be asked is how well these same cancer
patients would do if instead of getting the very expensive new drug, they got
the very cheap old drug, ketoconazole. They might do just as well, or it might
be that the new drug has some advantage—until we did the study we wouldn’t
know.
The kicker that Mailankody and Prasad now note is—how would
this new study be paid for? No way that the drug company that’s making a mint off
abiraterone is going to bankroll a study that might pull the rug out from under
its golden goose. So suppose some neutral investigators try to organize the
study? Well, assuming that for the very same reasons, the manufacturer won’t
just give away abiraterone for free (especially knowing for what purpose it’s
going to be used), the investigators would have to pay market price and buy the
drug. And the authors calculate that for a study large enough to answer the
question of non-inferiority of ketoconazole, the cost of the drug alone—forget
the rest of the cost of the study—would be about $69 million. In other words,
no study of this sort will ever be done.
These authors also work for the NIH, and so are also
apparently leery of saying anything controversial, and so don’t offer any
proposals for a solution to this problem.
OK, so we have three articles in the same issue of NEJM, all of which have the same basic theme—in the name of profits, the drug industry is working contrary to the public health and the advancement of science. This is what old-time economist Kenneth Arrow famously called the market failure of health care—it simply does not follow the laws of supply and demand. Those who continue to extol the supposedly “free” market as the right way to manage all of our affairs, pharmaceuticals and health included, have to stick their heads in the sand and pretend that market failure never happens. As this blog has shown extensively, it happens all the time.
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