[Ip-health] Zeke Emanuel in the New York Times: How to Develop New Antibiotics

Thiru Balasubramaniam thiru at keionline.org
Tue Feb 24 03:18:24 PST 2015


http://www.nytimes.com/2015/02/24/opinion/how-to-develop-new-antibiotics.html
<SNIP>

Let’s use prize money. What if the United States government — maybe in
cooperation with the European Union and Japan — offered a $2 billion prize
to the first five companies or academic centers that develop and get
regulatory approval for a new class of antibiotics? As the XPrize
<http://www.xprize.org/> — a foundation that runs competitions to spur
innovations for difficult problems that often aren’t being addressed — and
others have demonstrated, prizes for lofty goals can catalyze the creation
of hundreds of unexpected research teams with novel approaches to old
challenges. The prestige, bragging rights and renewed sense of mission
created by such a prize would alone make an investment in research
worthwhile.

Because it costs at least $1 billion to develop a new drug, the prize money
could provide a 100 percent return — even before sales. From the government
perspective, such a prize would be highly efficient: no payment for
research that fizzles. Researchers win only with an approved product. Even
if they generated just one new antibiotic class per year, the
$2-billion-per-year payment would be a reasonable investment for a problem
that costs the health care system $20 billion per year.


--
The Opinion Pages <http://www.nytimes.com/pages/opinion/index.html> |
CONTRIBUTING
OP-ED WRITERHow to Develop New Antibiotics

FEB. 24, 2015

THE bacteria are winning.

Every year, according to the Centers for Disease Control and Prevention, at
least two million people are infected with bacteria that can’t be wiped out
with antibiotics
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/antibiotics/index.html?inline=nyt-classifier>,
and as a result, 23,000 people die. Direct health care costs from these
illnesses are estimated to be as high as $20 billion annually.

Just last week, the U.C.L.A. Health System announced that nearly 180
patients may have been exposed to the CRE superbug that was linked to two
deaths
<http://www.nytimes.com/2015/02/20/health/drug-resistant-germ-is-spreading-by-hospital-device-federal-officials-say.html?_r=1>
in
one of its hospitals. Today, 30 percent of severe strep pneumonia
<http://health.nytimes.com/health/guides/disease/pneumonia/overview.html?inline=nyt-classifier>infections
are resistant to multiple drugs and 30 percent of gonorrhea
<http://health.nytimes.com/health/guides/disease/gonorrhea/overview.html?inline=nyt-classifier>infections
are resistant to all antibiotics. And drug-resistant enterobacteriaceae,
enterococcus, acinetobacter and a slew of other unpronounceable bacteria
pose serious threats.

The development of antibiotics has been glacial. We need a completely new
approach.

The number of F.D.A.-approved antibiotics has decreased steadily in the
past two decades. The big pharmaceutical companies have largely stopped
work on these drugs. Pfizer, long the leader in developing antibiotics,
closed its antibiotic research operations in 2011. Smaller biotech
companies now account for 80 percent of antibiotic development. There are
now about 40 new antibiotics in development. That might sound promising —
but not when compared with the 771 new drugs and vaccines in clinical
trials or awaiting F.D.A. review for cancer
<http://health.nytimes.com/health/guides/disease/cancer/overview.html?inline=nyt-classifier>.
And most of these antibiotics are unlikely to come out of the testing
process as F.D.A.-approved drugs.

There are ways, apart from developing new drugs, to combat the problem of
superbugs and drug resistance. One is hand-washing, especially in
hospitals. Another is reversing the overprescribing of antibiotics. It’s
estimated that half of all antibiotics used are unnecessary. Animal feed
accounts for 80 percent of the antibiotics used in the United States and
contributes to antibiotic resistance. We could also fix our antiquated
system for tracking drug-resistant bacteria.

But just as important, we need to develop new treatments. Bacteria figure
out a way to become resistant to every new drug. We are in an endless
life-or-death struggle with bacteria.

The big problem is profitability. Unlike drugs for cholesterol
<http://health.nytimes.com/health/guides/nutrition/cholesterol/overview.html?inline=nyt-classifier>
 or high blood pressure
<http://health.nytimes.com/health/guides/disease/hypertension/overview.html?inline=nyt-classifier>,
or insulin for diabetes
<http://health.nytimes.com/health/guides/disease/diabetes/overview.html?inline=nyt-classifier>,
which are taken every day for life, antibiotics tend to be given for a
short time, a week or at most a few months. So profits have to be made on
brief usage. Furthermore, any new antibiotics that might be developed to
fight these drug-resistant bacteria are likely to be used very sparingly
under highly controlled circumstances, to slow the development of resistant
bacteria and extend their usefulness. This also limits the amount that can
be sold.

Even though antibiotics are lifesaving, they do not command a premium price
in the marketplace. As a society we seem willing to pay $100,000 or more
for cancer drugs that cure no one and at best add weeks or a few months to
life. We are willing to pay tens of thousands of dollars for knee surgery
that, at best, improves function but is not lifesaving. So why won’t we pay
$10,000 for a lifesaving antibiotic?

The reasons are unclear. Maybe it is that they were initially developed in
the 1940s, ’50s and ’60s, when prices for health care services were lower
and the idea that they should be cheap stuck. And maybe we have become
complacent about being able to fight infections. We know people who have
died of heart attacks, cancer and Alzheimer’s. We fear these diseases for
ourselves. But maybe because few of us fear dying from bacterial
infections, we don’t seem willing to pay large sums for their treatment.

Congress has tried to address the problem. In 2012, it passed an act that
expedited F.D.A. review and gave drug companies five more years of market
exclusivity without generic competition. That has increased drug company
interest in developing antibiotics, but not enough. Let’s use prize money.
What if the United States government — maybe in cooperation with the
European Union and Japan — offered a $2 billion prize to the first five
companies or academic centers that develop and get regulatory approval for
a new class of antibiotics? As the XPrize <http://www.xprize.org/> — a
foundation that runs competitions to spur innovations for difficult
problems that often aren’t being addressed — and others have demonstrated,
prizes for lofty goals can catalyze the creation of hundreds of unexpected
research teams with novel approaches to old challenges. The prestige,
bragging rights and renewed sense of mission created by such a prize would
alone make an investment in research worthwhile.

Because it costs at least $1 billion to develop a new drug, the prize money
could provide a 100 percent return — even before sales. From the government
perspective, such a prize would be highly efficient: no payment for
research that fizzles. Researchers win only with an approved product. Even
if they generated just one new antibiotic class per year, the
$2-billion-per-year payment would be a reasonable investment for a problem
that costs the health care system $20 billion per year.

Ezekiel J. Emanuel is an oncologist and a vice provost at the University of
Pennsylvania.



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