Undermines J&J, Abbott, Boston Scientific (Update2)
By Alex Nussbaum
and Catherine Larkin
29, 2008 (Bloomberg) -- A $1.8
billion market for metal tubes used to clear blocked arteries
outside the heart may be upended by a U.S. probe into marketing
Johnson & Johnson,
Boston Scientific Corp. and
The Food and Drug Administration
says the device makers have already curtailed what the government
views as improper sales practices since the
Justice Department notified
them of the inquiry earlier this summer. The companies are
seeking new studies to justify implanting similar stents in veins
and arteries, and face a slowdown in sales that have reached $900
million with the unauthorized uses.
While the FDA approved the stents
only for clearing bile ducts
in liver cancer patients,
unsanctioned uses for keeping
veins and arteries unclogged
increased revenues 10-fold,
research published in the American
Journal of Therapeutics. At that rate, J&J in June estimated
a $1.8 billion market for the stents by 2012, which now seems unlikely,
said Frost & Sullivan Inc. analyst Venkat Rajan.
``If they want to expand this market
beyond what it has been, then it's now going to involve new trials,''
Rajan, based in San Antonio, said in an Aug. 21 telephone interview.
The FDA warned device makers about
promoting Biliary stents for uses other than treating cancer during
a March 2007 meeting, said Ann Simoneau, an FDA attorney.
In one case, an unidentified manufacturer's
Biliary Web site included a graphic diagram of the circulatory system
and no mention of the liver or pancreas, Simoneau said in an Aug.
21 telephone interview. The agency also asked companies to revise
brochures and to stop pitching the stents at meetings for vascular
doctors, she said.
``If you're at a conference where
the primary audience is not gastrointestinal or interventional radiologists,
which would be the people that you'd expect to use these products,
then it gives the impression that you're trying to reach another
audience,'' Simoneau said.
The FDA has identified safety risks
with unapproved use of Biliary stents, agency spokeswoman
Karen Riley said in a phone interview yesterday.
90 percent of Biliary stent
injuries or malfunctions reported to the FDA from 2001 to
2006 involved off- label use, according to an agency
study in the July issue of the Journal of Vascular and Interventional
Radiology. The number of annual injuries or malfunctions more than
tripled during this time frame, to 339 in 2006. A total of
14 deaths from off-label
use were reported to the FDA in the six-year period.
Applications by the companies to
conduct clinical trials for stents to treat so-called peripheral
vascular disease are up since the meeting, and companies seem to
have cleaned up their marketing, Simoneau said.
Peripheral vascular disease affects about 125 million people
J&J promotes its products ``only
for the FDA-cleared indications,'' said spokeswoman
Carol Goodrich. Representatives for Boston Scientific and Abbott
declined to discuss the investigation or their marketing practices.
The three companies do not break out individual sales for the devices.
While doctors can employ a drug
approved by the FDA for any purpose, so-called
off-label use can't be legally
promoted by companies. The U.S. Attorney's Office also declined
to comment. J&J, Boston Scientific and Abbott announced the investigation
in regulatory filings in July and August.
``The majority of use for the stents
is off-label,'' said
Jan David Wald, an analyst who covers the device makers for
Stanford Group Co. in Boston, in a telephone interview Aug. 27.
If there is a federal crackdown on how the stents can be promoted,
the market may hold at about $900 million, or about half J&J's June
estimate, he said.
The non-sanctioned use ``isn't
built into the forecast'' of any of the companies' performance,
Wald said. ``What we'd be looking for is some kind of a decision
or an event where it's a high probability'' of new restrictions
or guidelines, such as regulators convening an advisory panel on
the issue, he said.
Approved Without Trials
Biliary stents, used to clear bile ducts blocked by tumors that
cause pain and discomfort in terminal cases, were approved without
human trials for humanitarian reasons, said
William Maisel, a Harvard University cardiologist who consults
on stents for the FDA, in an Aug. 22 telephone interview.
Stents implanted in locations away
from the heart help prevent the body from forming clots that can
spur heart attacks and strokes. For such a use, the FDA traditionally
requires trials that can take two to three years to conduct, add
``tens of millions'' of dollars to the cost of product development
and risk failure, Maisel said.
No one doubts terminal cancer patients
deserve quick access to new medical technology, he said. ``The problem
is the industry recognized and appreciated this
was a backdoor to
get some other devices approved.''
Companies have contacted the FDA
to discuss clinical trials for new stents to treat peripheral artery
disease, said agency spokeswoman Riley. For competitive reasons,
the agency doesn't disclose if companies have applied to hold trials
or if they have sought device approvals.
J&J hasn't sought or received approval
for new biliary stents or trials in the past year, spokeswoman Goodrich
said in an e-mail. The company has finished enrolling patients in
a previously approved study of a stent for treating obstructive
superficial femoral artery disease, she said.
Abbott is working on three studies
of stents for peripheral artery disease, said spokesman
Jonathon Hamilton in a phone interview.
Paul Donovan, a spokesman for Boston Scientific, declined to
Doctors have implanted 1 million
Biliary stents for unsanctioned uses over the last four years, 90
percent of all implants during that time, according to Maisel's
study published in the American Journal of Therapeutics in January.
Physicians have used Biliary stents
for peripheral vascular disease for more than a decade, said
Frank Pomposelli, a surgeon at Beth Israel Deaconess Medical
Center in Boston, in an Aug. 22 phone interview. Veins and arteries
in the legs and elsewhere are larger than ones around the heart,
requiring larger devices.
While company sales representatives
are careful to state the product is approved only for use in the
bile duct, they ``let you know they're being used'' elsewhere too,
Biliary stents, which are larger
than similar devices made to be used near the heart, have ``revolutionized
the treatment of peripheral vascular disease,'' he said. ``They've
allowed us to get away from surgery, which allows less pain, less
To contact the reporters on this
Alex Nussbaum in New York
Catherine Larkin in Washington at
Last Updated: August 29, 2008