[Ip-health] Avorn on drug research funding

[Benjamin Krohmal]

JERRY AVORN
Rethinking research funding

By Jerry Avorn  |  May 7, 2007

THE BIOTECHNOLOGY Industry Organization is holding its annual mega
meeting in Boston this week at a pivotal time in the industry's
history. Medically, biotech is at the growing edge of therapeutics.
Most older, conventional drug companies have become massive marketing
engines with a dulled innovative edge -- only 18 new drugs were
approved by the FDA in all of 2006. By contrast, many biotech
companies retain their roots as research-based operations where the
scientists' agenda can still compete with that of the sales
department. Some of the most exciting new treatments for cancer,
autoimmune diseases, and even vision loss are emerging from this
creative new sector.

But amid the breakthrough findings, lavish entertainment, and self-
congratulation that will fill the convention attendees' schedules
this week, some important worries may not get the attention they
merit. The first relates to costs. Not the cost of the luxury harbor
tours and exorbitant meals that participants will enjoy in the coming
days; I'm referring to what patients (or taxpayers) have to pay to
get access to these wondrous discoveries.

Regimens that can cost tens of thousands of dollars a year per
patient can cloud the moral judgment of those who purvey them. For
example, a confluence of interests among biotech giant Amgen, for-
profit dialysis centers, and kidney disease consultants seems to have
led to substantial over prescribing of the company's flagship blood-
building product, erythropoietin -- a lucrative practice that
probably increases the risk of side effects and even death. Another
dilemma: A new biotech product, Lucentis, can reverse the vision loss
caused by macular degeneration, a devastating cause of blindness. But
the drug costs $2,000 for each monthly injection. Many
ophthalmologists are convinced that equally miraculous results could
be provided to far more patients with use of a very similar biotech
product, Avastin, at only $50 per dose. Yet Genentech, which makes
Avastin, has not agreed to sponsor a clinical trial to study this
possibility, which could also save Medicare hundreds of millions of
dollars in the coming years. That's probably because Genentech makes
both Lucentis and Avastin, and use of the more affordable drug would
cut into the more expensive drug's expected profits.

Biotech has brought to market a number of important new cancer
treatments. But pricing a lifesaving cancer regimen at over $50,000
is guaranteed to put that treatment beyond the reach of many
patients. It doesn't cost anywhere near that much to produce these
drugs. Rather, the industry argues that these sky-high prices are
justified to fuel the expensive research it performs. But many
biotech advances are heavily based on publicly funded research
supported by the National Institutes of Health and by foundations.
Current policies allow companies to charge whatever they want for a
new drug, with no payback required for most of the indispensable,
taxpayer-supported basic research that made it possible. With the
federal deficit threatening to flatline the NIH budget for the first
time in a generation, and venture capital speculators increasingly
preferring to fund safer "late-stage" companies with nearly
marketable products, savvy conventioneers this week must be worried
about where the next decade's miracle cures will come from -- as we
all should be.

The breathtaking five-figure prices that some biotech drugs command
per course of therapy warrant a rethinking of this "trickle-down"
approach to supporting science -- a strategy that amounts to the
growing privatization of medical research. The example of biotech's
older, flabbier siblings is not encouraging: Only about 14 cents of
every dollar paid for Big Pharma's products makes its way back into
research and development, according to the companies' own figures.

A safer course for the nation would be to take some of the billions
the nation is paying for these expensive products and use it to rev
up NIH funding, protecting the flow of scientific innovation on which
new biotech products depend. The companies could then come in and do
the hard work needed to bring those discoveries to market. They
should be rewarded fairly, even handsomely for that important work --
but not at levels that will pauper the rest of us or the federal
treasury. And we need a better way to provide reasonable compensation
for the taxpayer-supported research on which breakthrough products
are based. Public funding of university-based research, not
extortionate drug prices, is the safest way to guarantee "the miracle
cures of tomorrow." It might make for fewer luxury harbor cruises at
future BIO conventions, but we can live with that.

Dr. Jerry Avorn, a professor of medicine at Harvard Medical School
and Brigham and Women's Hospital, is author of "Powerful Medicines:
the Benefits, Risks, and Costs of Prescription Drugs."