Policy and Medicine

JAMA: Everyone's a little bit biased (Even the JAMA Editor)

What do studies on important medical topics, such as the percentage of African countries that belong to the United Nations, a US News and World Report study on who should pay legal costs, counting coins and accounting decisions, doing in JAMA? 

The answer is simple. The Editor of JAMA, Katherine De Angelis, MD thinks this unrelated research means that doctors are corrupted by physician-pharmaceutical relationships. 

In a commentary published this week in the JAMA tilted: Everyone’s a little bit biased (even physicians)

“Medical schools and professional medical associations have developed policies and guidelines in response to increasing concerns over potential conflicts of interest.

While many physicians agree with these concerns, some view conflict-of-interest policies as affronts to their integrity and an indictment of the ethical conduct of the profession as a whole. These individuals believe that their training as scientists and their devotion to professionalism protects them from external influences that might bias their opinions.

However, this view may be based on an incorrect understanding of human psychology. Conflicts of interest are problematic, not only because they are widespread but also because most people incorrectly think that succumbing to them is due to intentional corruption, a problem for only a few bad apples.

In this Commentary, we argue that succumbing to a conflict of interest is more likely to result from unintentional bias, something common in everyone. We review studies in neuropsychology, behavioral economics, cognitive psychology, and clinical epidemiology to illustrate this point.

What this commentary and all others on this issue have failed to point out, is why only conflicts of interests due to interaction with commercial interests are the only ones that are “problematic”.  They all ignore all the other biases that may exist. We should consider other biases before we call for the elimination of just one type:

A)   the bias for ordering patient tests and procedures to prevent lawsuits

B)   the bias for staying on managed care formulary to avoid additional paperwork (regardless of whether the patient may be served by another treatment)

C)   the bias of those physicians who are serve as paid legal witnesses either for the plaintiffs or the defendants

D)   the bias to gain an NIH grant

E)   the bias by faculty to publish regardless of weather or not they have anything important to say

F)    the bias by the government purchasers to save money on medical expenditures

G)   the bias created by physicians in managed care organizations to follow “prescribed medicine”

H)   bias to prescribe or perform procedures based on what you learned in medical school, regardless of how long ago that was

I)     the bias created by being part of a group, taken to resort location at the expense of foundation to specifically write a report against bias

J)    the bias of a doctor with a small prescription CME business, who advocates elimination of commercial support of CME, which in the end would help his business

This is by no means an exhaustive list.  Is there any logical reason why these biases should not be considered as “problematic”?

For instance, once I took my son to a day clinic for an ear infection. The physician (must have been 80 years old) pulled out a card with 10 drugs listed on it (apparently whatever you come in with to his practice you get one of the 10 drugs). He wrote him up for Accute Otitis Media and sent me home with a prescription for a strong anti-biotic, which I threw in the trash and the ear ache resolved on its own.  That doctor had a bias towards those ten drugs. Does that make him evil? It is doubtful that any of those drugs were pushed on him by a pharmaceutical rep at least for a very long time.

I agree, everyone has biases, but I think that it is ridiculous to think that they can’t be managed. 

If we were to spend all our time trying to eliminate bias, we would not be able to live, as we would say: hey I have a bias against spinach….

One very amusing instance is that I won’t wear pink shirts. Yesterday, I was away at a meeting and wanted to work out. I forgot to pack my t-shirt.  I was on the way out the door of the hotel where I was staying to go buy a t-shirt down the street. A colleague offered to loan me an extra polo shirt he had.  After dinner he loaned me the shirt to use and yes, it was a pink polo. The next morning I worked out rather uncomfortably in the pink polo. I was uncomfortable at first but got over it. I have overcome that bias (at least for the time I worked out) needless to say we can all manage our bias. That is what we do every day. 

The article goes on to challenge disclosure as a means of managing conflict and quotes the study on students counting coins and estimating them as justification for why disclosure is inadequate.

Full disclosure, by itself, may have the perverse effect of making professionals more biased rather than less. This is not to say that conflicts of interest should be hidden but rather that disclosure may not be the solution. Even where disclosure does not make advice worse, the huge body of research on anchoring (where advice is often disclosed as being randomly generated, yet it still impacts judgment) suggests that disclosure is often unlikely to serve as sufficient warning. If a disclosure that some advice is randomly generated does not completely undo the influence of that advice, other disclosures (especially those in fine-print legalese) might similarly fall short. Moreover, even where disclosure is better than no disclosures, it may cause indirect harm by replacing more effective solutions. Surowieki¹³ summarized this problem by noting, "Transparency is well and good, but accuracy and objectivity are even better. [The profession] does not have to keep confessing its sins. It just has to stop committing them."

Unfortunately the evidence they provide has very little do with physicians and practice. Sort of like saying that the results of a study of mechanics show they like 57 Chevy’s and this translates that all doctors (male or female) like 57 Chevy’s.

The writers go one to summarize that:

“Bias is not a crime, is not necessarily intentional, and is not a sign of lack of integrity; rather, it is a natural human phenomenon. Like the research participant with the split brain, everyone is likely capable of rationalizing beliefs and denying influences that bias them. The most important action physicians can take as a profession is to recognize this.

So now that we have established that everyone has biases, that it is not a crime (oh, how benevolent of them to do so) that it is a “natural human phenomenon”, perhaps we should all take a deep breath and say hey, I can overcome that bias and I don’t have to eat that spinach after all.

This article is not exactly the kind of research or commentaries one would expect from a serious journal such as JAMA, but perhaps the editor Katherine DeAgelis, MD may be a little bit bias herself. Just a little.

JAMA Ghosts = Invisible News

A couple of weeks ago, we covered the release of the JAMA Ghost writing article JAMA articles on Ghost writing and Study Results draws attention, later we discussed that one of the authors had been caught with his finger in the cookie jar. JAMA: Ghost Author's Skeletons.

Today Nature’s editorial board -- Nothing to See Here -- writes that there was nothing new about ghost writing, that this is not unlike in other team efforts “in which everyone in the team has different jobs. Some people do clinical research, others write papers. Not necessarily a big deal, or a big surprise.”

The second problem with the article is that JAMA did not apprise Merck of the release of the article, or opportunity to respond.  “That left the company with only the press to air their side of the story, certainly not any way to get to the bottom of the issue or promote a healthy exchange of views”.

According to Nature, it does not reflect the current practices at Merck, as the paper was based on five year and older data. “Indeed, no one at JAMA bothered to find out that Merck adopted as its policy for authorship the International Committee of Medical Journal Editors’ guidelines (http://www.icmje.org/)”

“But the JAMA editorial then goes too far, leaping on the findings to make recommendations that are unwarranted, not to say discriminatory, against the body corporate.”

In recommendation 5, the JAMA editors call for sponsored research not to be solely in the hands of the sponsoring company. Rather, they propose that academic researchers who are not employed by the company should bear primary responsibility for collecting, analyzing and reporting data. So, who would these academics be, and what constitutes ‘being in the employ’? How would this work for companies that don’t partner with academics? Would accepting research support disqualify academics? Would receiving honoraria disqualify them?

According to Nature, "The editors of JAMA and other journals would do well to focus on content, not process. JAMA’s attack casts a cloud over the entire industry."

JAMA Editor Catherine D. DeAngelis, MD is known to be a long time critic of pharmaceutical, biotech and device industries and private companies' involvement in conducting research and CME, and she regularly goes out of her way to attach her agenda to almost any issue.   The ghost writing articles are just one more example in a long line of editorials critical of everyone who does not espouse her agenda.  (For more on Catherine’s philosophy in her own words: The Influence of Money on Medical Science)

JAMA’s editorial staff is using flimsy evidence to support an agenda, an agenda where they suggest academics control all aspects of clinical trials with no financial interest.  But the problem is that without financial interest there is no incentive to fund the research in the first place.   

http://www.nature.com/nbt/journal/v26/n5/abs/nbt0508-476.html

This philosophy is several millenniums old, and it didn’t work in Athens, Rome or Moscow, it is not going to work today.

JAMA: Ghost Author's Skeletons

We recently reported about a paper published in JAMA titled Guest Authorship and Ghostwriting in Publications Related to Rofecoxib. One of the co-authors, we discovered through some simple research is someone who’s made a good living as an expert witness suing drug companies. In fact, he’s been so devoted to that cause that according to a New York Judge he arranged to steal documents under sealed court order and leak them to the New York Times Doctor Who Leaked Documents (September 8, 2007). He ended up being soundly chastised by a federal judge, and he was required by that judge to pay the company he stole the documents from, Eli Lilly & Co., $100,000, the judge called these actions "reprehensible".

This co-author was Dr. David Egilman, a professor at Brown University in community health, (as noted on his website, he has no research or clinical trial experience to earn a place publishing in JAMA). He has according to one Texas newspaper, earned millions testifying as an expert witness in about 100 personal injury trials; he’s been deposed hundreds of times – generally for the plaintiffs.

In fact, he may have a particular interest in derailing a Merck Vioxx settlement, which the publication of the critical report in JAMA at this time might contribute to. He is a serial plaintiff witness in the Merck Vioxx trials and JAMA should have seen these as serious conflict of interest, an even greater conflict of interest than any of the alleged ghost writers he criticized.

It’s possible the personal stakes for the authors of the JAMA piece are enormous. After all, the longer the case goes on, the bigger the fees for the attorneys involved – and their expert witnesses!

Of course, we don’t know the real amount of Dr. Egilman’s earnings – that’s confidential!

In the JAMA editorial accompanying the paper, Katherine DeAngelis’s, MD Editor of JAMA stated “"To maintain a healthy distance from industry influence, professional organizations and providers of continuing medical education courses should not condone or tolerate for-profit companies having any input into the content of educational materials or providing funding or sponsorship for medical education programs."

Perhaps this would be a more appropriate editorial “To maintain a healthy distance from being duped by trial lawyers JAMA should not condone or tolerate for-profit plaintiff witnesses having any input into the content or trial attorneys providing funding or sponsorship for “peer reviewed” papers, which condemn those they are suing, especially if the author has leaked confidential information to the press been chastised by judges and forced to pay six figure fines.

I challenge the board of JAMA to investigate the “Peer Review” process for this series of articles and at the very least chastise their editor for poor author checking (a simple Google search of David Egilman and Merck and this only scratches the surface)

For more about Doctor Egilman and his exploits “Without Fear or Favor” or simply type his name on Google, it is amazing what you will find…

Question of Bias

Recently, the New England Journal of Medicine published a paper from Cornell University researchers on the value of spiral CT scans for early detection of lung cancer.

This finding is what could be considered breakthrough medicine, as early detection of lung cancer is so difficult, and once lung cancer is advanced the prognosis is more often than not death.

Last month the New York Times (Cigarette Company Paid for Lung Cancer Study) published a report that the funding for this study came from a foundation connected to the Liggett Company (a tobacco company) . The article includes quotes from several medical leaders condemning the acceptance of such monies for research even if the results of the research contributed to improved outcomes in public health!

This was an article about research, yet the article included quotes from Murray Kopelow, Executive Director of ACCME (Accreditation Council for Continuing Medical Education).

"An increasing number of doctors and institutions are setting up foundations to accept money from companies without having to disclose its source," said Dr. Murray Kopelow, chief executive of the ACCME.

“This is the third time in the past few weeks that one of these has been identified to us,” said Dr. Kopelow, whose organization is investigating how widespread the practice is.

This week Thomas Stossel, MD, and David A. Shaywitz, MD, wrote a joint editorial on this subject for Weekly Standard titled: Attack of the Pharmascolds.  In addition Sally Satel, MD, published an editorial titled: Source of Medical Research Funding.  The bottom line message in both editorials is the same question, "What is more important: Improving Patient Outcomes or Source of Funding?" 

This is a powerful question, and if you wife has undetected lung cancer, what would your answer be?

JAMA articles on Ghost writing and Study Results draws attention

Among other things the editorial calls for: 

"To maintain a healthy distance from industry influence, professional organizations and providers of continuing medical education courses should not condone or tolerate for-profit companies having any input into the content of educational materials or providing funding or sponsorship for medical education programs."

These papers are based on the authors having testified in Vioxx trials and having access to vast volumes of discovery.  One paper claims that Merck found academic and company ghostwriters who had no involvement in the research.  The other alleges that Merck fiddled with the definition of deaths attributed to the drug in a Vioxx dementia trial. One of the papers is authored by Harlan Krumholz, MD a well paid expert witness for the plaintiff attorneys in these cases. He's published in the BMJ that Merck is guilty, contrary to the results of the majority of trials. 

Response from a friend....This is old news:

• If academics were ghost authors, that arguably is fraud (fabrication), and their institutions should discipline them appropriately;

• If one were to troll any research project, commercial or academic, with such retrospective detail, I shudder to think what could be found;

• The hysterical response from JAMA is absurd; two papers, even if true, do not document "increasing evidence of misrepresentation etc," and the severe oversight recommendations proposed by its editors.

• Bottom line is that if we are suffering from an epidemic of corruption, how could Merck have introduced statins, Gardasil, ARVs, etc., that seem to be effective and safe.

• If the "vast number of researchers are honest," why do we have to "distance commercial support from CME?"

Unfortunately the fuss inflames the COI witch hunt.

It took less than twenty four hours from release of the embargoed press release for members of the US Senate to issue press statements and letters to industry on articles printed in Today’s JAMA.

Senators Grassley and Kohl issued dueling press releases under the premise that this article proves the need for the Physician Payment Sunshine Act and the need for more transparency. (see attached)

Grassley went one step further in requesting information from the company (Merck) and their publication planning company on the practices that include perceived ghost writing.

The two Senators, Kohl and Grassely, have taken this opportunity to show the need for the Physician Payment Sunshine Act.  The timing of these and other recent articles is no doubt in preparation for a change in the White House, which ho doubt would aid passage of the PPSA.

Links to articles about issue in the Washington Post, the Wall Street Journal the Boston Globe, and the New York Times

Links to JAMA Papers:  Ghost  Writing, Mortality Data , Editorial Integrity in Science.

Merck’s Response

Bellow are the Senate Press Releases by Senators Kohl, and Grassley:

Jama Editorial Senator Kohl Press Release 4-15-08

Jama Editorial and letter to Merck - Senator Grassley press release 4-15-08.

In case you didn’t pick up a recent newspaper JAMA has just published a series of articles and an editorial concerning academic and company involvement in clinical trials, focused on data collected in the Merck Vioxx discovery by trial attorneys.

New England Journal –Says no to Journal Article Distribution

In preparation for the FDA call for comments (due April 21st) on Journal Article distribution the New England Journal of Medicine published the following article Pharmaceutical Promotion to Physicians and First Amendment Rights by Aaron S. Kesselheim, M.D., J.D., and Jerry Avorn, M.D (that’s right last month Avorn was the key promoter on capitol hill on academic detailing, this week he is an expert on constitutional law, he is such a diverse guy).  The writing team of Avorn and Kesselheim in 2006 recommended government takeover of patents by eminent domain. (Biomedical patents and the public's health: is there a role for eminent domain?  JAMA. 2006 Jan 25;295(4):434-7).

FDA Draft Guidance for Industry: Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices (See FDA Press Release and Draft Guidance)

There are some very heavy weight constitutional lawyers working on a rebuttal it will be interesting to see if they too get a sounding board on NEJM.  Do you thing NEJM will stop selling reprints -- we may want to ask their advertising department.