[Ip-health] JAMA on Novartis's exaggerated claims regarding its role in the development of Gleevec.

Jamie Love james.love at keionline.org
Wed Apr 3 04:45:54 PDT 2013


In 2003 Alexander Tsai posted to ip-health this JAMA book review
focusing on Novartis's exaggerated claims regarding its role in the
development of Gleevec.

http://lists.essential.org/pipermail/ip-health/2003-October/005475.html

Relman, A. (2003). Book Review: Magic Cancer Bullet: How a Tiny Orange
Pill Is Rewriting. Medical History. JAMA, 290: 2194-2195

Its title and subtitle accurately convey this book's message. This is
essentially a puff piece for Novartis, the Swiss pharmaceutical giant
that made such a splash with its introduction of Gleevec, the
breakthrough drug for chronic myelogenous leukemia (CML). Daniel
Vasella, MD, chairman and CEO of the company, with the help of
professional writer Robert Slater, gives us his version of how it all
happened. And to hear him tell the story, the new drug was primarily the
product of wise corporate management (his) and the contributions of a
host of company scientists and technicians, whose work he encouraged.

Vasella does briefly acknowledge the nearly 40 years of basic research
on CML that resulted in the discovery of its cause-the BCR-ABL oncogene
and its abnormal tyrosine kinase protein product. But his story focuses
mainly on his company's role in synthesizing tyrosine kinase inhibitors
and then formulating, testing, and manufacturing the most promising
candidate (STI 571 [imatinib mesylate], Gleevec, Glivec outside the
United States) so that it could rapidly be put into clinical trials.
Readers are left with the impression that the new treatment was
Novartis' idea. The company recently ran a series of ads in the popular
media that featured pictures of patients who experienced dramatic
remissions of an unnamed cancer, thanks to Novartis' research. The ads
do not mention the drug or the disease, but presumably they are
referring to Gleevec and CML. According to the ads, "Novartis is proud
to be the innovative force that's bringing new optimism and hope to
patients and their families."

The facts, however, tell a different story. Novartis was not "the
innovative force." Not only was all the basic research done in academic
institutions, but so were the initial clinical investigations that
showed STI 571 to be specifically effective against CML cells in vitro
and in vivo. In fact, it took a few years for Brian Druker, the
investigator most responsible for these latter studies, to convince
Novartis that it should invest in a crash program to develop Gleevec and
to undertake large-scale clinical trials. There is plenty of credit to
go around, and Novartis certainly deserves its share for finally putting
the development and production of Gleevec into high gear, despite the
relatively small market it might have. But to claim that Gleevec was
primarily the company's innovation, without full recognition of all the
preceding, largely publicly supported work that made the development of
Gleevec possible, is to distort the facts and claim much more for
Novartis than is justified.

Despite this distortion, I recommend this volume to all who would
understand the pharmaceutical industry today. Dr Vasella's book has
several important lessons. First, as explained above, it illustrates the
industry's habit of exaggerating its own relatively limited scientific
contributions to the discovery of important new drugs. Second, the story
of Gleevec is a good example of the industry's outrageous pricing
policies. As Vasella tells us, Novartis decided to set one world-wide
price for Gleevec-approximately $27 000 per year. The decision, he says,
was based in part on the price of interferon, the next best available
drug treatment, and in part on the "hundreds of millions" of dollars
Novartis claims to have spent in developing, manufacturing, and
clinically testing the drug. But, Vasella never tells us exactly what
Novartis actually spent, nor does he mention the financial benefit to
the company of the tax deductibility of its research and development
expenditures. Moreover, Gleevec was granted "orphan drug" status by the
US Food and Drug Administration (FDA), and he does not mention that by
law Novartis was eligible for federal tax rebates equal to one-half the
cost of clinical testing.

Yet another lesson of the Gleevec story is this: When a new drug is
clearly effective against a serious disease-as is the case here-there is
no need for the usual marketing blitz that accompanies the launch of so
many "me-too" products. As Vasella describes, word of Gleevec's
extraordinary effectiveness against CML was quickly spread by scientific
reports of its initial trials. Even before accelerated FDA approval was
granted, the company was inundated with requests for the drug from
patients and their doctors. Most of the huge advertising budget of the
pharmaceutical industry is devoted to promotion of other types of drugs
that, unlike Gleevec, do not sell themselves to physicians simply by the
unequivocal evidence in the medical literature of their effectiveness
and safety.

Novartis' problem when first marketing Gleevec was not to convince
doctors and the public that it worked, but to overcome the outcry
against its staggering price. To do that, Novartis decided to establish
a discounting policy for all CML patients of limited means. That sounds
fine, but according to a recent article in the New York Times,1 the plan
has not worked very well so far, particularly in poor countries, where
only a handful of patients have received the drug free. According to
Vasella, Gleevec has already become profitable despite its limited
market. That is hardly surprising, given its relatively low costs of
manufacturing, distribution, and marketing and the exorbitant price it
commands.

Profits, of course, are necessary to keep the pharmaceutical industry
going. But how much is enough, especially when most of the critical
early work is done at the taxpayers' expense and when companies are
virtually guaranteed profits by patent protection, tax breaks, and
freedom to set their own prices? That, it seems to me, is a question for
government to decide. So, what may be the most important lesson of the
Gleevec story is that the future development of innovative new drugs
like Gleevec will depend on more than just cooperation between
tax-supported basic research and the pharmaceutical industry. To make
that cooperation serve the public interest and to ensure that drugs are
affordable also will require more government regulation than either Dr
Vasella or his industry are likely to welcome.

Arnold S. Relman, MD, Reviewer
Channing Laboratory
Harvard Medical School
Boston, Mass


-- 
James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.
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