US: New Rules on Doctors and Medical Firms Amid Ethics Concerns

Publisher Name: 
New York Times

When the sun goes down in Las Vegas, steer clear of doctors.

Those are the marching orders that Smith & Nephew,
a leading maker of artificial hips and knees, has given executives and
sales representatives attending a big meeting of orthopedic surgeons
next month.

The company has told them to limit their interactions with doctors
to 9 a.m. to 5 p.m., the "business" hours of the convention of the
American Academy of Orthopaedic Surgeons.

It remains to be seen whether such seeming magnets as doctors and
sales executives can resist each other. But Smith & Nephew's
convention curfew is a sign of an ethical makeover under way within the
medical device industry, a field that has been troubled by federal
investigations and bad publicity over the volatile issue of frequently
undisclosed financial ties between companies and physicians.

On Thursday, two senators increased the pressure further by
reintroducing legislation that would require device and drug makers to
report all financial links with doctors on a federal Web site.

That bill is known as the Physician Payments Sunshine Act, and a parallel effort is in the House.

"The public is clamoring for transparency," one of the Senate
sponsors, Herb Kohl, a Wisconsin Democrat, said. The co-sponsor is Charles E. Grassley, Republican of Iowa.

The nation's biggest hip and knee makers, including Smith & Nephew, Zimmer Holdings, DePuy and Biomet,
are operating under Justice Department oversight as part of a deal to
resolve allegations they gave doctors illegal inducements to use their

Other sectors of the device industry face continuing federal
inquiries or are voluntarily taking house-cleaning measures. Much of it
involves the public disclosure of information that would be mandated
under the Senate proposal - the names of the doctors who work for
device manufacturers as consultants, lecturers, researchers or
trainers, and how much each one is paid for those services.

Under their Justice Department settlements, the hip and knee makers
are already disclosing such payments on their corporate Web sites. And
seeing the writing on the wall, several other large device companies,
including Boston Scientific and Edwards Lifesciences, recently announced they would do so voluntarily.

Meanwhile, the device industry's main trade group, the Advanced
Medical Technology Association, said it had supported the Senate
measure when it was introduced two years ago.

There is little question that battles over how much companies,
doctors and medical institutions disclose about their financial ties
will continue. But some experts on medical conflicts of interest,
seeing the rapid fall of resistance by most major companies, say that a
turning point has arrived.

"We are definitely moving toward more disclosure and disclosure of
information that is useful to people," said Lisa Bero, a pharmacy
professor at the University of California, San Francisco.

Recently, several big pharmaceutical companies have also said they
plan to release the names of doctors they use as consultants. But the
ties between medical device makers and physicians are often more
entangled and can have a bigger impact on both patient care and product

For one, doctors may be involved in the design of a medical device
and can hold a patent on it. Further, device makers also hire surgeons
to train other doctors on how to implant their products. And hospitals often give doctors a large say in determining the suppliers of products like artificial hips or heart defibrillators - companies with which those same doctors may have financial relationships.

Some hospital systems, including the big Kaiser Permanente network,
bar physicians from taking industry money and now require device
suppliers to compete on the same basis on which most medical products
are purchased - price.

In recent months, the ground has shifted so rapidly under device makers that companies find themselves scrambling to keep up.

Take Edwards Lifesciences, a producer of heart valves and other
devices. Last year, the company's chief executive, Michael A.
Mussallem, decided that Edwards would voluntarily disclose all its
payments to doctors.

Mr. Mussallem said that the decision came from the push for federal
legislation and the passage in Massachusetts last summer of a state law
requiring drug and device companies to disclose all payments to doctors
in excess of $50.

Edwards, like other device makers, has also been the subject of
media articles raising questions about the motives of physicians with
financial ties to the company.

"We make our living on innovation," said Mr. Mussallem, who is also
the current president of the Advanced Medical Technology Association.
"But every time we turned around there was a story that made this seem
negative rather than positive."

But gathering that physician data is proving easier said than done.
For instance, Edwards officials soon discovered that each company
division had used a different process to account for its doctor
payments, and technological havoc resulted when they tried to pull the
data together.

"You couldn't tell if Dr. Jones and Dr. Jones were the same guy," or
different ones, said Dirksen Lehman, the company's vice president for
government affairs.

Edwards hopes to resolve those issues in time to meet its
self-imposed deadline of making physician disclosures public by
December, he said.

For years, both device makers and their consulting doctors insisted
that money did not affect how the physicians treated patients. And
device makers rebuffed efforts to disclose such ties.

But the Justice Department changed all that through its
investigation of orthopedics companies, which was headed by the United
States attorney in Newark. Although federal prosecutors said they found
that most financial ties between companies and doctors were legitimate,
there was enough evidence of illegal sales inducements and sham
consulting contracts to warrant filing charges.

To avoid prosecution, the companies, without acknowledging
wrongdoing, entered settlements in 2007 under which they agreed, among
other things, to submit all their doctor ties to an outside monitor for
review. They also agreed as a group to limit daily consulting payments
to most doctors to $500, and to justify such expenses.

More recently, two companies involved in the Justice Department
action, Zimmer Holdings and Biomet, said separately that they would no
longer give educational funds directly to medical schools, but instead would give them to professional organizations, which would decide how they should be distributed.

The federal inquiry has also had an impact on surgeons who
specialize in hip and knee replacements. Company-sponsored work on new
products has largely been at a standstill since 2007, several doctors
said. And other types of consulting relationships are just starting to
resume under the new disclosure rules.

For instance, Dr. Michael C. Raklewicz, an orthopedic surgeon in
Kingston, Pa., said he was notified just a few weeks ago by Zimmer
Holdings, the biggest orthopedic implant maker, that it would again
retain him to train other surgeons on the use of its products.

"All I knew was that I had a few teaching sessions left and they
were canceled" back in late 2007, said Dr. Raklewicz. "Then, it was
like, 'Hold on, hold on, we'll get back to you' and finally they did."

The possibility of similar Justice Department action may also be
facing other companies that have declared themselves converts to the
concept of disclosure.

Since 2005, for example, the Justice Department has been
investigating ties between doctors and makers of heart pacemakers and
defibrillators. The companies involved deny any wrongdoing. But two of
them - Medtronic and St. Jude Medical - have said they support federal disclosure legislation.

A third big producer, Boston Scientific, has gone a step further.
The company, which acquired the heart device business of the Guidant
Corporation in 2006, recently said that it planned this year to
publicly release data about its financial links to doctors among all
its business units.

AMP Section Name:Regulation
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