Policy and Medicine

Conflict of Interest Inquisition: Scary Implications

The national press has been implying that interactions between physicians and pharmaceutical companies are sinister.   The tactic has evidently been to scare patients and show that politicians can come to the rescue.  Yet the effect of this approach may be much scarier than the supposed problem they're shining the limelight on.

 Paul Rubin, Emory Professor of Economics and Law, wrote in the Atlanta Journal Constitution this week that:

..there is no evidence at all that any of the alleged interactions between doctors and pharmaceutical companies has had any harmful effect on any patient. Here is a direct quote from one of the leading articles on the issue: “No study used patient outcome measures.” In other words, no one has actually looked at the effect of pharmaceutical marketing on the welfare of patients. Indeed, some of the researchers writing in this area profess not to care about patient outcomes. In an interchange I had with two authors in this tradition (in the Journal of the American Medical Association) they said that “this fact [that pharmaceutical promotion influenced physicians’ drug choices] rather than the possible merits of the choices themselves, should concern us as physicians.” So we have a set of policies based on an unproven assumption.

The article gives an interesting perspective on the Nemeroff situation at Emory.  To clarify this statement, according to the reports Nemeroff failed to follow an agreement that was made with NIH to disclose conflicts of interest, thus he failed to comply with the rules.   Rubin points out that this focus on conflict of interest will push physician researchers to avoid seeking NIH grants, thus less basic research.

Frank Lichtenberg, a health economist at Columbia University, has shown that newer drugs tend to reduce total health care costs and improve patient outcomes better than older drugs. The policies at issue here may reduce the availability and use of newer drugs because they will make it more difficult for academic physicians to undertake research on drugs and for physicians to learn about newer drugs that are developed. If this happens, patients will suffer — a perverse outcome for policies ostensibly designed to improve patient care.

Now this is a scary scenario

Atlanta Journal Constitution: If politician’s war on drugs continue, patients will suffer

Business Week -- Pfizer's Fallout

Political fallout from the Pfizer decision not to fund medical communication companies (MECC's) in July, includes a Business Week article titled: Teaching Doctors—or Selling to Them? This is basically a rehash of the Pfizer MECC decision along with some free PR for Danny Carlat, MD, the gadfly anti MECC blogger (who by the way has no conflicts of interest except that his CME newsletter business will increase if he gets his way and ends commercial support of CME – update according to Dr. Carlat it was disclosed just left out by Business Week). In the interview for the article Carlat is quoted of the Pfizer decision: “It sends out a message that there’s a level of distrust about the way they (the marketing firms) operate.”

So, was Pfizer trying to send a message to all those who faithfully deliver unbiased CME? Perhaps they should have thought about their move a little closer.

The article describes a $1.2 billion dollar industry with MECC’s getting half of that and that this is a profitable sector.  I have no idea where they are getting their information, but CME has never been a very “profitable” business and the reports given to the ACCME have been skewed by about $400 million because include sponsorships to medical societies and hospitals for things like bag sponsorship and booth space which have little or nothing to do with CME. 

Also, industries of this size are by no means big industries.  When you throw numbers around you can make something sound really big when in reality it is small potatoes.

The article at the end (it is always at the end of an article that you let the guys you have been trashing get a couple of lines) outlines how several firms including Vox and ICHE have created firewalls internally by banishing them to another wing of the building, so as to avoid any conflict of interest.  Perhaps next time Business Week writes their article they will be a little less bias.  (That’s right only CME providers are required to be unbiased, how could I forget?).

Conflict of Interest Disclosure: Why All the Fuss

We think it is interesting that this past week we have seen a plethora of articles and news stories promoting the Physician Payment Sunshine Act as one of the answers to the nation’s health problems.  One example is this weekend’s series in the Philadelphia Inquirer, Implant firms pay doctors millions. This is mostly a re-hash of the September 2007 settlement the US Attorney of New Jersey completed with five orthopedic device manufactures.  If you are unfamiliar with the case it provides a good analysis of the basic structure of the settlement.   

As part of the settlement the companies disclose on websites their payments to physicians.  As discussed earlier this year by one proponent of disclosure laws Disclosure = Wanted for Intimidation, these disclosures will be used by journalist in unflattering stories and by the “legal profession”.

Here is what they found nationwide in 2007: fifty one physicians received more than one million each; 29 Philadelphia doctors received a total of $7.9 million which went to two busiest and most prominent orthopedic surgeons Richard Rothman, MD and Robert Booth, MD both of which receive royalty payments for devices they helped design and one holds 8 patents.  At the University of Pennsylvania those payments are disclosed to patients.  As part of their treatment they sign a form stating: “I am further aware that my surgeons may receive compensation” from the manufacturer.

Both Penn and Jefferson have policies so that physicians cannot receive royalties from products purchased by their systems.

The physicians are contributing to the development of these devices, and it is only natural that they would be compensated for their contributions.

As part of the article, the solution may be in better disclosure according to quotes from Senator Kohl to the Inquirer:

“Collaboration between device companies and surgeons can lead to medical innovation, so we’re not interested in severing those ties completely” (notice the word completely, sort of like saying we are not interested in severing your leg completely). “Our hope is that requiring these relationships to be transparent will serve as a litmus test for legitimacy”.

Several things came out of the article reading it through lines:

A)   The US Attorney of New Jersey and the HHS OIG are now focusing on doctors and smaller manufactures

B)   The Cardiac Device industry is getting a closer look (heart device makers have been asked to supply information to the US Senate)

C)   One former prosecutor said that the shear size of the orthopedic deals raises questions about whether doctors decisions were tainted.

They also took the time to outline the details of the Physicians Payment Sunshine Act sponsored by Senator's Kohl and Grassley.  This sudden focus on old news (2007 settlement) is not by accident and there will be more such articles in the coming weeks.

For a list of the disclosure of Payments to physicians by the Orthopedic Companies:

Biomet Inc.

Depuy Orthopaedics

Stryker Corp.

Smith & Nephew

Zimmer Holdings Inc.

Doctors Under the Influence -- CBS

click to play video

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

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