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Heart Society’s Tip Sheets Fail To Mention Risks

The Heart Rhythm Society says the financial support it receives from drug and medical-device makers plays no role in its advocacy for certain treatments. Information sheets published by the group do not mention potential risks from implanted defibrillators or cardiac catheter ablation.

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Diagram from Gray's Anatomy.

For patients researching solutions for scary, often debilitating irregular heartbeats, the information sheets on the Heart Rhythm Society website offer reassuring remedies.

Implantable cardioverter defibrillators—devices that automatically deliver shocks to restore normal heart rhythms—are “99% effective,” one sheet says. The sheet doesn’t mention that the devices may also deliver unnecessary and painful jolts, which can damage a patient’s quality of life.

Nor does the sheet say that sicker and older patients were underrepresented in clinical trials of the devices, even though they are more likely to have heart rhythm problems, according to cardiologists who reviewed the information sheet for ProPublica.

“Even advertisements on TV run through the side effects real quick at the end of the ad,” said Dr. David Mann, an electrophysiologist in Louisville, Ky.

Another society tip sheet says that cardiac ablation, in which catheters are used to destroy abnormal heart tissue, is “an effective treatment for many types of arrhythmias. It is successful in 90 to 98 percent of cases, eliminating the need for open-heart surgery or long-term drug therapy.”

But it too lists no limitations or risks—though they include blood clots, damage to the heart’s electrical system and even puncture of the heart.

Among the society’s biggest funders are makers of defibrillators and catheters used during cardiac ablation. Nearly half of the $16 million in annual revenues last year came from the device and drug industries, according to records on its website.

While there is no evidence of a quid pro quo, those who study conflicts of interest in medicine say industry money may subtly affect what groups say—or don’t—about the products made by their financial supporters.

In a statement to ProPublica, society President Douglas Packer and President-elect Bruce Wilkoff said industry support does not influence educational offerings or the group’s positions on appropriate treatments.

“The risks and limitations of treatments are best conducted between a patient and his/her physician,” they said. A disclaimer on the group’s website also advises patients to consult a doctor.

In an interview Thursday at the society’s annual meeting, Wilkoff defended the tip sheets. “Putting out a list (of side effects) doesn't really inform,” he said. “It just produces anxiety."

Lobbying Medicare

The society’s enthusiasm for certain treatments is not always shared by others. Take cardiac catheter ablation.

Representatives of the society appeared before a federal Medicare committee in October 2009 to urge that the program continue to pay for ablation for seniors with atrial fibrillation, a rapid and irregular heartbeat.

“Patients benefit from it tremendously, the waiting lines are long, and I think the Heart Rhythm Society feels strongly” that procedure should be covered under Medicare, society board member Dr. Hugh Calkins said at the meeting.

Calkins, a professor of medicine and cardiology at Johns Hopkins University, was a paid consultant for at least two companies that make catheters used in the procedure, according to his disclosure on the society’s website.

Committee members determined there wasn’t enough scientific evidence that the procedure worked in elderly patients. The panel, which advises Medicare on coverage issues, also recommended more research to see if ablation reduces the risk of stroke or death in patients.

In an interview, Calkins stood by his comments at the meeting and said there are a lot of patients who could be helped by ablation after other treatments have failed.

Heart Drug Controversy

Some members of the society and those who write about conflicts of interest also faulted a website that was jointly developed by the society and the American College of Cardiology.

The site, created last year to educate physicians about atrial fibrillation, features an audio and slide presentation by a prominent society member advocating for broad use of the anti-arrhythmic drug Multaq.

But initially, the site failed to mention that the physician was also a paid consultant for Sanofi-Aventis, the drug's maker and site sponsor. Only after the editor of another cardiology website flagged the omission did the site add the disclosure.

Cardiologist Steven Nissen, who writes about conflicts of interest in medicine, faulted the society at its conference last year during a debate about the influence of money on medicine.

“The Heart Rhythm Society Gets Caught in an Industry Scam,” one of Nissen’s slides bluntly said.

Officials of the Heart Rhythm Society attributed the lack of disclosure to a “production flaw” and said it was quickly fixed.

The drug Multaq—which costs $9 per day—was predicted to be a blockbuster but has been dogged by concerns about safety and effectiveness since going on the market in 2009. In January, the Food and Drug Administration issued a warning after two patients on the drug suffered liver failure and required transplants.

John Mandrola, a Louisville, Ky., electrophysiologist who blogs about heart rhythm issues, said he is disappointed that the society “so embraced a drug that really doesn’t work.”

“There’s no doubt the Multaq thing has given me a lot of reason to be more skeptical of these opinion leaders and thought leaders,” said Mandrola, who said he turned down an opportunity to consult for Sanofi on the drug.

Dr. Eric Prystowsky, the Indianapolis lecturer criticized by Nissen, said he disclosed his relationships in advance and that the societies chose not to publish them initially. His position that the drug is a viable treatment option was subsequently adopted by two medical expert committees that drafted guidelines for atrial fibrillation, he said.

A Sanofi official said the firm had no influence over the joint website but stood by the safety and effectiveness of Multaq. The company gave the society a total of $935,000 in fiscal 2010 for ads, exhibits and courses at the group’s annual conference.

Some society members are urging more caution.

“We need to take a far more conservative approach of recommending procedures for patients when there is no data that those procedures are beneficial,” said Dr. Nicholas Stamato, an electrophysiologist in Johnson City, N.Y.

“I’m not so sure we’re keeping the patients’ interests at heart.”

Merrill Goozner

May 5, 2011, 10:15 p.m.

I’m surprised you didn’t ask the FDA for a response to the Heart Rhythm Society’s failure to disclose risks on its website. The site seems to suggest it is sponsored by the Heart Rhythm Foundation. If makers of ICDs support the foundation, this is comparable to paid advertising.

The FDA’s Division of Drug Marketing, Advertising and Communication regulates drug advertising to ensure that both benefits and risks are disclosed in any print, television or online advertising. Are there not similar rules for devices, whether the promotional material is directly paid for by a manufacturer or presented as “objective information” by a non-profit like the HRS? Either you’ve uncovered a loophole in the FDA regulations and/or law, or the agency has the responsibility to launch an investigation into the accuracy of the HRS website. I’d give them a call tomorrow if I were you.

Calkins, Petrowsky and the rest of the HRS are beholden to device manufacturers. Catheter ablation for afib is a corporate-driven, risky and ineffective procedure.

Before anyone with afib falls for the hard sell, they should read this history of the evolution of the procedure: http://collateral-damage.net

I have had Soo Many Problems with the health industry that it would take probably 20+ pages to tell my story, but if you can send a reporter to interview me, I’d be thrilled to tell my LONG story, which can be checked against my written medical records. I have a good percentage of them.  I may be near death now but I keep hanging on because I want very much to tell my story so that others can benefit from my experiences with these people who think they’re gods.In 1998 I was a healthy person,  Now, I have left-side weakness, only about 5 of my teeth left, can barely talk, and more.  I’ve spent almost everything I once had—several inheritances, and everything I earned which comes to almost $200,000.00.  Yes, you read that correctly.  There would be even more, if I hadn’t run out of money…And, as you read this, a dentist has sent me to collections for and car wa $65.00—and he didn’t do anything other than refer me to yet another dentist!  The worst thing about this is that I did nothing what so ever to cause my problems—the docs and dentists did all of it.  Did you know that most false teeth are made from the same substance that’s used for floor wax and for artifical finger nail s—-but it’s no longer allowed for the finger nails because it’s to dangerous too use so close to the body.
Why are the fingernails too close, but it’s “okay” to use inside our mouths?  Tell me again how wonderful American drs and dentists are.

Carole from the South.

May 6, 2011, 3:45 p.m.

I spent several hours typing out a comment with one finger because I’m disabled. Then it got wiped out before I could submit it.  Contact me via a living, reporter so I can tell my story about my health as well as my problems trying to write it.  Drs. should be charged with criminal offenses rather than just with civil lawsuits for money. I have about almost 2/3 of my medical records so they can be checked.  In 1998 I was healthy.  Today I can’t get out of bed..And my “wonderful” medical and dental care has only cost me about $300,000.00!!!  PLEASE have a real, live reporter contact me.  I really want my experiences to get out there before they kill me.  I’ll name names, hospitals, dates, as well as the amounts these “gods” were paid (or are owed) and talk about what was or should have been done. I do really good research!!!!

I’m going to get off Multaq, as I know more about it now. My cardiologist’s office never even told me it went on the FDA watch list. So much for information between physician and patient. Another good reason to do research, check out other non-tradional methods and treatments…

I totally have no respect for that doctor Mandrola.  Soon as he said ““so embraced a drug that really doesn’t work.”...

I have read posts from many people who say Multaq DOES work for them.  My mother is currently taking it and it seems to be working.  So how can a doctor sit and say that kind of ridiculous comment unless he has some other motivation for saying it.

The reports of some liver problems does worry me, but I don’t know that there is proof of that.  That FDA report does says its “cases of rare” liver problems.

My husband has one of the ICDs from Medtronics with the bad leads.  There is nothing we can do about it as it is more dangerous to remove the leads then to leave them in.  The survival rate is not good not even at the Cleveland Clinic who are suppose to be the best at this.  We are waiting for the battery to wear down so we can abandon it.  It is doubtful insurance will pay for its removal at that time.  I pray every night he lives.  The really sad part is my husbands ejection fraction after one infarction has recovered to 28%.  It’s questionable if he even needed it.  If you run the quality statistical formulas on failure rates his chances of dying from the ICD going off unnecessarily due to the bad leads are now greater then him dying from a bad heart rhythm. The Supreme Court of the United States aka “the Roberts court” ruled that if the FDA approved the device the manufacturer could not be sued.  I don’t know who I dislike the most—the cardiologists, the manufacturer, the FDA who approved this or the Supreme Court justices.  If you believe in a high power please pray for my husband.  I love him so much and he is such a good person.  He didn’t deserve this.

I need to make a correction to my previous comment.  My husband’s ejection fraction was initially 28% but has improved to 40%.

That’s awful. Can’t they put new leads in?

Arrhythmia? Just got off beta-blockers for it after 4 years with major side effects. Was lucky to accidentally discover that if I take enough calcium, I don’t have arrhythmia (don’t know how much of a role magnesium plays) - I take it, too, but calcium made the difference. None of the 3 cardiologists I saw ever asked me about minerals. I am extremely lucky to have gotten away and gotten my life back.

This article is part of an ongoing investigation:
Dollars for Doctors

Dollars for Doctors: How Industry Money Reaches Physicians

ProPublica is tracking the financial ties between doctors and medical companies.

The Story So Far

ProPublica is investigating the financial ties between the medical community and the drug and device industry. In October 2010, ProPublica compiled the list of payments that drug companies make to physicians and built a publicly searchable database so that patients could look up their doctors.

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