Late last week, the nonprofit investigative news organization ProPublica published the latest installment of its “Dollars for Doctors” series, which has been examining the financial ties between physicians and medical companies.

This time, reporters Charles Ornstein and Tracy Weber honed in on professional medical groups that take money — big money — from such companies. Their specific focus: the Heart Rhythm Society, whose 5,000-plus members include physicians who treat abnormal heart rhythms (arrhythmias).

According to Ornstein and Weber, almost half of the society’s $16 million 2010 budget came from companies that make devices and drugs that treat arrhythmias, including two Minnesota-headquartered medical device companies, Medtronic and St. Jude Medical.

Dr. Packer

In addition, 12 of the society’s 18 board members have personal financial ties to medical device or drug companies, and the society’s outgoing president, Dr. Douglas Packer of the Mayo Clinic in Rochester, has research ties to such companies, report Ornstein and Weber.

Billions of dollars at stake
Packer and other officials at the Heart Rhythm Society told ProPublica that money doesn’t buy influence with the society. Yet, as one expert on the impact of industry money noted in the article, the bankrolling of physicians’ groups by drug and device companies “has a not very subtle effect on medicine.”

“The Heart Rhythm Society’s 5,100 members represent a particularly lucrative market,” write Ornstein and Weber. “One implantable cardioverter defribrillator — a device that jolts the heart back to a normal beat — can cost more than $30,000. A single electrophysiologist, a physician specializing in heart-rhythm disorders, can implant dozens a year. World sales of the devices totaled $6.7 billion last year, according to JPMorgan.”

Nor are these devices — and some of the actions of the companies that make them — without controversy, as Orstein and Weber also report:

As competition among cardiac-device makers has intensified, so have questions about whether their products are being used and marketed appropriately.

In January, a study in the Journal of the American Medical Association [JAMA] found that more than one in five patients who received cardiac defibrillators did not meet science-based criteria for getting them.

Weeks later, the Heart Rhythm Society disclosed it was assisting a U.S. Justice Department investigation of the issue.

Two of the society’s biggest funders — Boston Scientific and St. Jude Medical — have paid millions since 2009 to settle federal allegations that they improperly paid kickbacks to unidentified physicians to use their cardiac devices. Neither company admitted wrongdoing.

Top [Heart Rhythm Society] sponsor Medtronic also has disclosed to shareholders that the Department of Justice is investigating the advice it gave purchasers on how to bill Medicare for defibrillators and payments it made to buyers of the devices.

Risks go unmentioned
The JAMA finding — that people are receiving these devices when they may not need them — is a serious matter, for cardiac defibrillators (which automatically deliver shocks to correct irregular heart beats) are not risk-free. They can, for example, deliver shocks when they aren’t needed, which can be painful and even damaging to the heart. Yet, as Ornstein and Weber point out, the Heart Rhythm Society does not disclose these and other potential risks in the information it provides to consumers on its website.

Nor does it mention the risks and limitations of another treatment for certain types of arrhythmias, catheter ablation. This surgical procedure uses catheters to go into the heart and destroy tissue that is causing the abnormal heart rhythm. Although the Heart Rhythm Society's patient information sheet states that the procedure “is successful in 90 to 98 percent of cases,” it doesn’t mention the risks, which include blood clots and puncture of the heart.

Dr. Bruce Wilkoff

In a statement to ProPublica, Packer and the society’s incoming president, Dr. Bruce Wilkoff, said, “The risks and limitations of treatments are best conducted between a patient and his/her physician.”

Wilkoff also told Ornstein and Weber that “putting out a list [of side effects] doesn’t really inform. It just produces anxiety.”

(Interestingly, this is the same approach that Wilkoff’s own institution, the Cleveland Clinic, takes on its website. Risks are not listed there, either; patients are simply told to bring them up with their physician. However, Packer’s institution, the Mayo Clinic, does list the risks of both cardiac defibrillators and cardiac ablation on its website.)

Managing, not eliminating conflicts
Last Thursday, on the final day of its 2011 annual meeting (and the day that the ProPublica series was published), the Heart Rhythm Society announced a new policy that would require more disclosure of board members’ industry ties.

“This is our business,” said Wilkoff. “We either get out of the business or we manage these relationships. That’s what we’ve chosen to do.”

There is much, much more in the ProPublica investigation. It includes an interactive graphic that shows how much money Medtronic, St. Jude and other companies spent at the Heart Rhythm Society’s 2010 meeting to advertise their wares, as well as the written responses from Packer and Wilkoff to ProPublica’s questions.