Life Science Compliance Update

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24 posts from June 2008

June 27, 2008

Doctors Under the Influence -- CBS

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The discussion to promote the Physician Payment Sunshine Act has gone Prime Time on CBS Evening News along with stories running on CBS and Newsweek questioning the ethics of physicians working with pharmaceutical and device manufactures.

In a very unfortunate case, a family who lost their doctor due to suicide and is suing the pharmaceutical company Pfizer for selling Zoloft.  Apparently their physician accepted speaking fees on behalf of Pfizer, the maker or Zoloft.

They quote an unpublished study by the University of Quebec that showed alleges that drug company payments are as high as $57 billion a year, covering consulting fees, speaking fees on drugs, and medical seminars on the benefits of drugs. 

This is quite a high number given the size of the industry. This is a huge exaggeration and quite unlikely to be anywhere near what they are quoting.  But hey, this is CBS news and anything goes.

Apparently Senator Grassley is “also looking at the money drug companies pay doctors for academic research”.  He is investigating some 20 top medical schools -- including Harvard, Stanford, and other Universities.

They quote the Grassley statement a week ago about Joseph Biederman, MD, "who's research has led to huge increases in bipolar diagnosis in children and the prescriptions to treat those children”. He is being asked why he allegedly failed to report $1.6 million in fees from drug companies. Dr. Beiderman noted to CBS that some of the industry money he accepted was "not personal income" and "his life work is devoted solely to rigorous and objective study".

This is an apparent attempt to make the industry as whole look bad.  According to Senator Grassley "it raises a flag to me that they may have something to hide", it raises a flag that the university doesn't care."

According to Senator Grassley, fixing this problem is complicated because "some" relationships between doctors and drug companies are legitimate and necessary to achieve breakthrough therapies.  Senator Grassley says that the answer is more public information.

American researchers are ill prepared for this type of political and media on-sought.

I favor some type of disclosure bill for direct payments to physicians, but this type of political and public humiliation of our top physicians makes me question the long term use of this type of information. As we see more disclosure, are we in for endless floggings in the press of American's top researchers.  This will only undermine researchers and manufactures integrity at the expense of patient care.

The parents of Candace Downing, are dealing with a great loss, and their anger is understandable, but I am not sure that it is not misplaced. In the 90's many of the AIDS activists were angry at the pharmaceutical companies working to develop drugs for AIDS but failing in trials.  There are many other broken parts of our healthcare system including re-imbursement that prevents physicians from spending the necessary time with patients and families to really explore more complicated solutions to complex problems.

Are Perks Compromising MD Ethics? (CBS News)

Doctors Under the Influence? (BusinessWeek)

Doctors Under the Influence -- BusinessWeek

BusinessWeek logo

Doctors Under the Influence? In BusinessWeek a story of two New Jersey based physicians who have worked tirelessly for the last twenty years helping patients quit smoking and are now being questioned on their recent motives.

In a recent Annals of Internal Medicine Article around the long term use of drugs to facilitate smoking cessation, Dr. Michael B. Steinberg and Dr. Jonathan Foulds of UNDMJ disclosed that they are paid by manufacturers of smoking-cessation products for speaking and consulting. Among those companies is Pfizer (PFE), whose controversial drug Chantix the researchers mentioned favorably, along with other treatments.

No Good Deed Goes Unpunished.

These two researchers have for many years toiled in the unglamorous field of smoking cessation, with little personal compensation and continuous exposure to second hand smoke to help patients overcome their smoking habits and ultimately save lives.

Steinberg and Foulds encountered an obstacle that helped inspire their article advocating long-term drug use. They found many insurance companies wouldn't reimburse for Chantix, which costs about $100 a month, or for other less expensive antismoking products.

Steinberg and Foulds reasoned that if they compared nicotine use with diabetes, rather than with alcoholism or other addictions, they might help change insurers' thinking. Diabetes causes many of the long-term problems that nicotine addiction does. "We wanted to compare it to a disease that's well-covered," says Foulds, "and alcoholism isn't well-covered."

According to the article the two physicians gave a dozen or so lectures at $900/each to promote Chantix and received $30,000 for a study.   This does not sound like unreasonable compensation.

In the article BusinessWeek quotes:

Over the past decade, financial ties between doctors and companies have proliferated, prompting concern that treatment is distorted by industry money. The solution that has been widely embraced is disclosure of funding sources. But the rules are inconsistent and mostly voluntary. Moreover, disclosures typically are made in medical journals, conferences, and other venues that patients tend not to see.

Pfizer hasn't taken a formal position on whether doctors should disclose funding sources to patients. Cathryn M. Clary, vice-president for external medical affairs, says she fears too much transparency will create confusion. "The more information that's out there, the more difficult it will be for patients to process," she says. Pfizer instructs the researchers it pays to disclose their compensation when speaking at professional conferences. It also recently began disclosing grants for medical education on its Website.

Smoking is a serious problem. It is the main cause of the two most prolific killers, Heart Disease and Cancer. 

This type of fear mongering is likely to lead to significantly greater deaths than the small number of depressed people as a result of using drugs for smoking cessation.

I am not sure where it will all end but if the media and government wants to stop all clinical trials, speaking and consulting to ensure that the information is pure then perhaps all our clinical research will head east to China and India where the business environment is much more favorable.

In an Opt Ed, BusinessWeek published two opinions on this issue:

Halt the Pharma Freebies

ACCME Senator Kohl Get's in the Act

The ACCME received a letter from Senator Kohl, Chairman of the US Senate Special Committee on Aging, concerned about the size of support of CME from commercial supporters, the perceived influence they may have on physician prescribing patterns.

In particular they are concerned with CME courses to encourage physicians to use their products for potentially controversial medical practices.

Apparently one company is supporting CME around herpes tests for pregnant women, a practice that is not supported by ACOG, CDC or the US preventive services taskforce.  According to the Senator the anti viral therapy is potential dangerous to the baby.

“I am troubled by any attempt to persuade physicians to use a drug treatment for any reason other than the patient's condition and the drug's effectiveness in treating it.”

Therefore, it was with great interest that the Committee took note of the ACCME's credentialing standards and practices for CME courses.

“In an effort to better understand the ACCME's credentialing standards and practices for CME courses, please provide us with the following documentation and information:

1.) a copy and written description of the accreditation process for CME courses;

2.) any criteria the ACCME uses, as part of the accreditation process, regarding the scientific validity of course content;

3.) any mechanisms the ACCME has in place to ensure that no undue influence by any industry is being exerted through CME courses; and

4.) any further plans the ACCME may have in place to develop such mechanisms.

Please respond fully to this request by close of business on Friday, July 7, 2008.”

The ACCME and their providers have gone to great lengths to ensure the scientific validity, and no undue influence by industry and are currently working to strengthen their system even further.  The Senator should be pleased by what he receives from the ACCME.


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