US: Drug Companies to Reveal Grant Practices

Publisher Name: 
The New York Times

WASHINGTON
(AP) -- For years, the nation's largest drug and medical device
manufacturers have courted doctors with consulting fees, free trips to
exotic locales and sponsoring the educational conferences that
physicians attend.

Those financial ties in most cases need not be
disclosed and can lead to arrangements that some say improperly
influence medical care.

Now, under the threat of regulation from
Congress, the two industries are promising to be more forthcoming about
their spending. A dozen of the nation's leading drug and device makers
have told Sen. Charles Grassley,
R-Iowa, that they have plans or are working on plans to publicly
disclose grants to outside groups. The details will be provided on each
company's Web sites.

Watchdog groups say the companies are trying to derail legislation that would require public disclosure of their giving.

''If
they were doing this out of the goodness of their heart, they would
have done so decades ago,'' said Dr. Peter Lurie of the consumer group Public Citizen.

Of
particular interest to Grassley, top Republican on the Senate Finance
Committee, is the money companies spend on continuing medical
education. Physicians attend such conferences to fulfill their license
requirements and to keep up to date with the latest treatment trends.
Professional associations and companies frequently ask drug and device
makers to help pay for the conferences. Recently, Grassley asked 15
companies whether they planned to follow the lead of Eli Lilly &
Co., which now discloses its grants to such programs.

''If your company does not yet have any efforts or plans in place, please explain why not,'' Grassley wrote.

The
responses are in. They are wide-ranging but mostly what the senator
wanted to hear. Indeed, many of the companies said they would go beyond
disclosing grants for medical education. Some companies said they would
also disclose payments to patient advocacy groups such as the American Heart Association
or the American Diabetes Association. Boston Scientific said it was
developing a system that even discloses certain payments to physicians.

Medtronic
Inc. said it will post payments for professional meetings and patient
groups on its Web site beginning May 1. AstraZeneca PLC said it would
do the same on Aug. 1, providing the amount spent and the purpose of
the financing. AstraZeneca gets 4,000 to 5,000 grant applications each
year and funds about a third of them.

Merck and Co. was vague
about its plans, but committed to the concept. ''We are currently in
the process of developing an action plan,'' the company wrote to
Grassley.

Amgen Corp. and Abbott Laboratories said they had formed working groups to determine how to compile and display their grants.

Schering-Plough
Corp., however, told the senator what he didn't want to hear: ''We do
not publish or have plans at the moment to publish a list of charitable
contributions or educational grants that medical organizations have
received from us.''

Grassley said, overall, he was happy with the responses.

''The
way these companies are making information about financial
relationships open to scrutiny is the right thing to do,'' he said.

Two other companies said they already were disclosing third-party payments.

The
two, Zimmer Inc. and Stryker Orthopedics Inc., avoided criminal
prosecution over financial inducements paid to surgeons to use their
products, prosecutors announced last year. The companies agreed to new
corporate compliance procedures and federal monitoring. Zimmer also had
to pay the government $169.5 million.

The hip-and-knee industry
was the subject of a recent Senate Aging Committee hearing titled
''Surgeons for Sale.'' Companies routinely paid doctors $5,000 every
three months for providing information on market trends and
operating-room activity. However, the reports typically offered only
cursory descriptions and often were duplicated from one quarter to the
next. Also, companies sponsored consultant meetings at resort
locations. The meetings lasted just a few hours each day. The
physicians who presented information at the meetings spoke for as
little as 10 minutes.

''Although the remainder of the day was
available for recreational activities paid for by the company, the
consultants were compensated $5,000 for a full day of work,'' said
Gregory E. Demske, an assistant inspector general.

Eli Lilly
began listing its grants last year. It gave $18.9 million in the second
quarter of 2007, according to the Prescription Project, a Boston-based
group that promotes policies to reduce conflicts of interest.

''They support those organizations which they believe will have a positive impact on their drug sales,'' said David Rothman of Columbia University and associate director of the Prescription Project. ''It's self-evident but important.''

If
all of the companies follow through with their commitments to Grassley,
there also would be widespread disclosure of how much money they give
patient advocacy groups. The groups rely on industry for much of their
financing. For example, the American Heart Association said donations
from the pharmaceutical and device industry make up about 6 percent of
its annual income, and totaled $48.3 million in the organization's
latest fiscal year.

''Donations from corporations, including the
pharmaceutical and device industry, allow us to further enhance our
programs and outreach, and to bring objective science and the highest
quality of public education and information to more people,'' said
Maggie Francis, the association's communications manager.

Grassley
and Sen. Herb Kohl, D-Wis., have introduced legislation that would
require drug and device makers to disclose anything of value given to
physicians, such as payments, gifts or travel.

The disclosure of
medical education grants is an extension of that concept. Last year,
the staff for the Senate Finance Committee issued a report that said
the drug industry may be using the ''medical education industry to
deliver favorable messages about off-label uses that the drug companies
cannot legally deliver on their own.''

The committee report noted
that Warner-Lambert, now owned by Pfizer Inc., paid $430 million to
settle claims that medical conferences it sponsored were used to
illegally promote off-label uses of the anti-seizure drug Neurontin. Serono-Laboratories paid $704 million to settle a similar claim concerning the AIDS drug Serostim.

In
a few states, such as Vermont and Minnesota, drug companies must
disclose certain payments to physicians. Baxter International Inc. told
Grassley that it could support legislation setting a national
disclosure standard, but it's critical the standard pre-empt state laws.

''Overlapping
and conflicting state requirements have created, and would continue to
create, duplication, uncertainty, and burden in complying with them,''
a Baxter official wrote.

AMP Section Name:Pharmaceuticals
  • 208 Regulation