EDITORIAL: Faltering Cancer Trials

The government’s system for judging the clinical effectiveness of cancer treatments, now in “a state of crisis,” must be repaired.

http://nyti.ms/dgUbDk

‘Informed Consent’ and the Ethics of DNA Research

There is a lot scientists can do with a swab. But their research subjects have begun to question the locked lab door.

http://nyti.ms/aiBp01

Doctor groups set new policy to curb industry sway

http://m.apnews.com/ap/db_15264/contentdetail.htm?contentguid=gLnnC9MX&src=cat&dbid=15264&dbname=Health&detailindex=0

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 products.

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 sales.

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.

Read at NYT…

Of 33 new drugs approved by the Food and Drug Administration in 2001 and 2002, one-fifth of supporting clinical trials were not published in medical journals, according to a new study. And those results that were published were often more positive than what companies presented to the FDA in their applications. As a result, potentially unreliable data is being used to promote drugs on which billions of dollars and thousands of lives may ride.

“Some studies aren’t published at all. Then, when they are, there are little changes that make the papers look more favorable towards the product,” said review co-author Lisa Bero, a University of California, San Francisco health policy expert.

If new — and typically more expensive — drugs are only slightly better than existing drugs, but otherwise are comparable, this is largely an ethical and financial problem. But if the drugs later prove harmful, the damage can be profound.

In 2004, Merck’s blockbuster anti-inflammatory drug Vioxx was pulled from the market after killing an FDA-estimated 27,000 people. The drug doubled heart attack risk — a side effect that critics say was glossed over in the company’s studies, which in retrospect were partly marketing propaganda. Another Merck blockbuster, the cholesterol-lowering drug Vytorin, has proven ineffective. GlaxoSmithKline’s best-selling diabetes drug Avandia was allowed to remain on the market, but only with a label stating its apparent cardiovascular risks.

Keep reading at Drug Companies Cook Books, Misleading Doctors | Wired Science from Wired.com#more#more