Doctors & (HIGH) Profits ~ NYTimes ~ Gina Kolata

Date: Tue, 7 Dec 1999 01:35:11 -0700

~~~ great article Henrietta. thanks so much.

The following one i'm sending is on Dr. Healy of Cleveland Clinic and what she doesn't tell about her position on the Board of Directors of Medtronics, Silicone Device manufacturer. ~~~

Date: Sun, 05 Dec 1999 17:32:20 -0800

From: Henrietta Farber

SEVERAL ARTICLES ON WHEN DRS GO FOR THE PROFITS--NY TIMES

When Physicians Double as Entrepreneurs

By KURT EICHENWALD and GINA KOLATA

Thousands of heart specialists watched on closed-circuit television monitors at the Washington Convention Center as a tiny device was implanted in a patient's coronary artery. The doctors heard the voice of Dr. Martin Leon, a prominent cardiologist who was describing the operation taking place in a hospital many miles away.

"This is the Paragon stent," Dr. Leon said, as the names of the device and its manufacturer scrolled across the screen. "It's a very nice stent."

Dr. Leon, who conducted research on the experimental device, enthusiastically described its soft feel, its flexibility and its similarity to a top-selling stent. The remarks seemed the perfect endorsement from an objective scientist.

But Dr. Leon was anything but a disinterested observer. What he did not tell the assembled doctors on that day in the fall of 1997 was that he was an investor in the company that manufactured the stent, a tiny wire cage that can hold blocked arteries open. And after a merger of the company announced just that week, he would be among a group of about 100 investors who stood to share in as much as $75 million in stock -- provided that the company hit certain business goals, including sales targets for the stent he had so eagerly recommended.

Dr. Leon is not the only one to wear many hats in the world of medical devices. There, inventors are researchers. Researchers are promoters. Promoters are investors. And, finishing the circle, investors are inventors. Rare is the truly disinterested researcher, with no stake in the outcome of a study. It is a phenomenon found in every medical treatment using devices, from laser surgery to gene therapy.

In the end, scientists on the front line of such medical research, whose work can help determine treatment options for countless Americans, often can earn vast wealth so long as their results are positive. It is an immense financial pressure that would be unacceptable in most any other field of medical research.

To better understand the influence of these conflicts, The New York Times examined interventional cardiology, a specialty where some of the most rapid development of devices has occurred.

The field has emerged over the last 20 years, using tiny devices to remove the coronary vessel obstructions that can lead to chest pain. Some 12 million Americans now suffer from coronary disease -- the nation's top killer.

To profit from this huge market, companies are scurrying to set up professional and financial relationships with cardiologists who invent and promote devices.

"If you are an interventional cardiologist and you are working hand in glove with the companies and you might have a financial interest, what else is new?" said Dr. David Hillis, a cardiologist at the University of Texas Southwestern Medical Center. "If you have no conflict of interest, then you would stand out like a sore thumb."

But the examination by The Times found that those financial ties have transformed the traditional system of objective medical research and review. Now, the system used to determine which device is best for heart patients can be influenced as much by personal financial interests as by scientific data.

This troubles some doctors. "I treat a disease that's going to kill half of all people in America," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic. "How I treat that disease ought not to be decided by who's lining someone else's pocket."

Other cardiologists were less concerned and said they feared changing the system to eradicate conflicts would slow the progress of a field that has been a miracle, providing simple procedures that alleviate often crippling pain.

"I just don't know of any other option," said Dr. Paul S. Teirstein, director of interventional cardiology at the Scripps Clinic and Research Foundation in La Jolla, Calif. "If you want to ban us from the research, that would crimp development. We supply a lot of the creativity and push behind these projects."

But even Dr. Leon expressed regret that what he described as inattentiveness to potential conflicts would sully the reputation of his medical specialty. Often, he said, doctors are unaware of their own financial incentives -- for example, he said he had no idea he was a beneficiary of a sales incentive for the Paragon stent, and said that he later did not hesitate to present disappointing data on the device at a medical meeting.

"We tend to do well on the big things -- taking care of patients," Dr. Leon said after being presented with findings from the examination by The Times. "We do less well on the fine details, and the fine details are becoming important components as to how we behave. It's important to rededicate ourselves and perhaps redefine what the standards should be."

At bottom, some cardiologists fear that the influence of potential riches has distorted medicine's search for truth.

"The science has been lost in the rush for money," Dr. Nissen of the Cleveland Clinic said. "We've lost our way. We've terribly, terribly lost our way."

The Problem: Conflict of Interest? According to Whom?

Dr. David Brown could scarcely control his anticipation when the business plan finally arrived from the company developing his new medical device. But when he flipped through the document on that day in 1997, he was aghast.

There, on the 10th page, was a list of shareholders in the company, including partners Dr. Brown had known nothing about. But he certainly knew their names. They included Dr. Leon, who runs one of the world's most prestigious educational meetings for interventional cardiologists, and Dr. Teirstein, whose West Coast meeting is a close competitor in influence. The two men together owned more than five times the shares allocated to Dr. Brown, the interventional cardiologist who had invented and patented the device, a probe designed to detect a condition that leads to heart attacks.

What would the prominent doctors be doing for their shares? According to the plan, they would conduct the critical clinical trials on patients, despite owning stakes in the company, called Medivas/Intravas. On top of that, the documents said, they would promote the device at the medical meetings they controlled.

Through the two men, the plan says, the company "has an ideal forum to provide visibility for the projects to potential strategic partners." Troubled by the ethics of the arrangement, Dr. Brown, then at the University of California at San Diego, turned it down.

Dr. Brown had just received a crash course in the workings of the interventional cardiology business. With billions of dollars pouring into the field, companies are finding ways to use prominent doctors to promote and market their products.

In interviews, Dr. Leon and Dr. Teirstein said that they had no idea of the role the business plan said they were supposed to play and that they would not preferentially feature one company over another at their meetings.

Kenneth W. Carpenter, president and chief executive of Medivas, said the business plan, which he said was confidential, was never formally approved by the company.

To deal with conflicts, interventional cardiologists have adopted a loose policy of voluntary disclosure. Doctors who write for medical journals or make presentations at educational forums are expected to disclose to their colleagues every financial conflict that might influence their judgment.

But such disclosures often are haphazard and incomplete. For example, neither Dr. Leon nor Dr. Teirstein revealed his stake in Medivas in disclosure statements that are a routine part of medical meetings. Many speakers, writers and investigators failed to disclose their patents, investments and other corporate conflicts.

Dr. Teirstein said he did not mention his stake in Medivas because there was no reason to -- the disclosure statements simply ask doctors to tell of conflicts that are directly related to talks they are giving, and Medivas products, a confidential list, were not the subject of his talks.

Dr. Leon said that even when he explicitly asked doctors to disclose their conflicts, many did not. "There were people who claimed no conflict of interest who own companies," he said. Others, he said, do not even return the disclosure forms they receive for his meeting.

Experts said such poor disclosure was a prime example of the flaws in a system that relies on individual conscience to counter possible scientific bias. "Voluntary disclosure is not a very high standard," said Marc A. Rodwin, an associate professor of law and public policy at the School of Public and Environmental Affairs at Indiana University who has studied financial conflicts in medicine.

He added: "You can't have this up to the individual. The fact that you have a conflict of interest means that you are not in a good position to judge these kinds of issues, that your judgment is compromised. That is the defining part of having a conflict."

Financial conflicts emerge at every stage of the scientific process.

For example, Dr. Maurice Buchbinder, then a doctor at the University of California at San Diego, served as a principal investigator in studies in the early 1990's examining the Rotablader, a tiny drill used to remove plaque from arteries. But at the same time, Dr. Buchbinder held a stake worth millions of dollars in Heart Technologies, the company that sold the device.

The independence of his studies eventually came under attack. A 1993 Food and Drug Administration audit of Dr. Buchbinder's research found significant deficiencies, including failures to conduct proper follow-up or to appropriately report problems experienced by patients. The university subsequently banned him from performing other experiments on patients.

Dr. Buchbinder, who continues to play a significant role in research as director of interventional cardiology at Scripps Memorial Hospital in San Diego, did not return telephone calls seeking comment.

For other doctors, clinical trials can serve as a form of investment research. For example, Dr. Richard A. Schatz, who directs research in interventional cardiology at the Scripps Clinic and Research Foundation, is now testing a new treatment, gene therapy, using a method developed by a small company, Vascular Genetics.

After treating six patients, Dr. Schatz said he was sure the treatment was working. Now, he said, "I've invested in the company myself."

Vascular Genetics was founded by Dr. Jeffrey Isner, an interventional cardiologist at Saint Elizabeth's Medical Center in Boston. Dr. Isner, who is also a major shareholder in the company, directs the company's clinical trials. He said his multiple roles did not pose a problem.

"I'm not trying to dismiss this out of hand," Dr. Isner said. "But I'm not going to be a wimp and roll over because someone is projecting a concern. I understand what the arguments are, but, quite frankly, I don't agree with most of them."

Some investigators are also on the boards of companies that manufacture devices they are testing. For example, Dr. Leon is a director of Angiosonics Inc., a device company based in Research Triangle Park, N.C., while Dr. Buchbinder is on the board of Radiance Medical Systems of Irvine, Calif.

As directors, both men have a fiduciary obligation to shareholders. But as clinical investigators, their role is to be neutral about the outcome of tests on the companies' products. Those two responsibilities, experts said, cannot be reconciled.

Dr. Leon said he now thought he should never have served in dual roles, and that if he was going to be on the board, he should not have been an investigator. "In retrospect, that wasn't a good idea," he said.

Other investigators with serious conflicts limit the amount of research they will conduct. For example, Dr. Spencer King 3rd, director of interventional cardiology at Emory University and past president of the American College of Cardiology, conducted studies to determine the feasibility of a device he invented called the Beta-Cath System. The device irradiates arteries to prevent the return of coronary blockages pressed open by balloons.

Dr. King had numerous conflicts. Besides being the inventor of the device, he was a large shareholder in Novoste, the company that held the rights to the product. In addition, he had a marketing deal with Novoste that could pay him as much as $5 million if the device was ever approved for sale.

Faced with those conflicts, Emory ruled that Dr. King could conduct the early studies, but could play no role in large-scale trials that would be used by the government to determine whether to approve Beta-Cath for sale. Still, even Dr. King's limited role brought him potential benefits: On the day Novoste announced the results of his study, the company's stock climbed as much as 55 percent.

Dr. King acknowledged that conflicts in the field had to be handled carefully. "It's obviously an issue," he said. For trials used to approve a device, "you cannot have the people collecting and publishing the data being the same people with the vested interest; this is a conflict that is real."

The conflicts are not limited to investigators. Sometimes, the doctors with conflicts are the same people who make presentations at important medical meetings on the quality and importance of a device.

For example, Dr. Mark Wholey of the Pittsburgh Vascular Institute was a featured speaker in September of last year at a prominent medical meeting, Transcatheter Cardiovascular Therapeutics, universally known by cardiologists as the T.C.T. The program is the meeting organized by Dr. Leon.

Dr. Wholey spoke enthusiastically about using stents to open blocked carotid arteries in the neck, in the hope of preventing strokes. But, he cautioned, there was a danger: shards of debris from the procedure could lodge in the brain and cause a stroke. The way to prevent that complication, he said, was to use a high-technology filter.

What he did not disclose -- in either his lecture or in the meeting's disclosure form -- was that he had helped develop such a filter and was a director of Angioguard, a Minnesota company preparing to market it. The company was acquired last July by a division of Johnson & Johnson for an undisclosed sum.

Dr. Wholey said he saw no reason to disclose his relationship with Angioguard, in part because many companies make similar filters. And after all, he said, his talk was about carotid stenting -- not the filters that can make it better.

But some experts were dismayed by the standards in the field.

"The conflicts are just overwhelming," said Dr. John Wasson, a professor of medicine at Dartmouth Medical School, when told details of the findings by The Times. "If you can't trust the opinion leaders, and the so-called experts, and even worse, in some cases, the studies themselves, what happens to the profession and what happens to the patients?"

Continued: The System: Industry Sees Need to Enlist Doctors

THERE WILL BE SEVERAL ARTICLES INCLUDING ONE CO WRITTEN BY GINA KOLATA---CAN WE CAPITALIZE ON THAT ????