Showing posts with label Procter and Gamble. Show all posts
Showing posts with label Procter and Gamble. Show all posts

Wednesday, February 15, 2012

Logical Fallacies in Defense of Conflicts of Interest Employed by a Leader of Academic Medicine

We have repeatedly discussed the adverse effects of conflicts of interest on health care.  Recently, I argued that the most pernicious are conflicts of interest created as an incentive for trusted health care leaders, usually respected health care professionals or academics, to promote the vested interests of those who pay them, in the guise of the leaders' professional roles.  In this capacity, the leaders are often dubbed "key opinion leaders" by those who employ them, but may be regarded as mere "salesmen" by the corporate personnel who recruit them. (See posts here and here)  These relationships may be hidden, often behind confidentiality agreements, unless revealed by litigation.  Documents revealed by discovery in legal actions showed how companies planned other organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

However, defenses of conflicts of interest continue to appear regularly.  The latest example, which incorporates an important twist, appeared in yesterday's Wall Street Journal.  It was in the form of a "Boss Talk"  interview with a leader of a major health care organization (whose identity we will discuss later.)

The title of the interview indicated that the interviewee was not "worried about industry ties" of academia or of health care professionals.  Conflicts of interest were clearly its main focus.  For example, it began,
Many universities are wringing their hands over the increasing coziness of medical schools and their corporate partners.

Then it stated that the interviewee:
has no such qualms.

The defense of this lack of qualms was heavily based on logical fallacies.

Biased Sample or Hasty Generalization

The main reason for this lack of concern appeared to be complete disregard of the more serious kinds of conflict of interest briefly described above. The interviewer asked:
What are the trickiest conflicts of interest to navigate?

The answer was:
Surgery is particularly challenging. Let's say you're a physician and you come up with a new hip replacement. You invented it so you're going to make a lot of money. But if you're going to do my surgery, I want you to put in the device you think is best. How do you separate that, when the person is the inventor and the great technician?
This may be tricky, but is arguably not the most tricky kind of conflict of interest.

The trickier example of the key opinion leader hired as a salesman was not raised by the interviewer or the interviewee. Such a case was graphically revealed by testimony of the aborted TMAP trial which implicated the former state mental health director as hired by Johnson and Johnson subsidiary Janssen to "promote ­Risperdal as a safe and effective medication." (See this post.)

Industry spokespeople and key opinion leaders themselves tout KOLs as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There have been  documented instances (e.g., see posts here and here) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post here).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post here about marketing of Lexapro, and here about Neurontin).

Perhaps the interviewee was unaware of these issues.  Whether due to ignorance or deliberate avoidance, failing to consider the full spectrum of conflicts of interest, and specifically ignoring those with the greatest likelihood of adverse effects, appears to be a logical fallacy in this instance.  If deliberate, it appears to be reasoning from an (intentionally) biased sample, if not, it appears to be a hasty generalization.

The interview also included a few other choice logical fallacies that went unchallenged by the interviewer.

False Dilemma

The interviewer asked:
What do you tell professors who won't work with drug or biotech companies?

The response was:
I think that's a huge mistake. If you're a professor now, and you want to get your discovery to society, you either need to start a company or work with a company to commercialize a product.

Of course, in the "good old days," academic researchers got their "discoveries to society" simply by publishing them. Developing and marketing products based on their discoveries, while worthwhile undertakings in their own rights, were not considered part of the academic mission. Professors could still do this, if their goal was not to get rich. Yet the Bayh-Dole act allowed academic institutions to make money from their professors' discoveries, and the rush to commercialize the university has been on ever since. So while professors and academic institutions who are motivated mainly by money might not consider just putting the knowledge they discover in the public domain, that course remains possible, just not so lucrative.

The assertion that the only way to get a "discovery to society" is to start or work with a company is simply false, and using this assertion in an argument appears to be an example of a false dilemma.

Straw Man

The interviewee worked another argument into the same paragraph:
When professors have told me they won't work with companies anymore because they feel they'll have this scarlet letter, I think: 'Wouldn't that be sad if all the best scientists and clinicians won't work with companies because the public has said they're evil?'

I doubt that any of even the most vociferous critics of the conflicts of interest that now befog health care have claimed that those involved are evil, much less that they are have successfully convinced the whole public at large that anyone who "works with companies" is evil. Implying that this would be the result of criticism of conflicts of interest does not appear to be supported by evidence, and is probably flat wrong. Asserting it here appears to be an example of the straw man fallacy.

Summary

So the Wall Street Journal has added to our collection of defenses of conflicts of interest that seem mainly to be based on logical fallacies. 

We have noted that logical fallacies are increasingly deployed to defend the status quo in health care, and particularly to defend the interests of those who are profiting the most from the current dysfunctional system.  We have noted that several defenses of the conflicts of interest generated by financial relationships between physicians and medical academics on one hand and commercial health care firms on the other, were based on logical fallacies.  (See examples here, herehere, and here.)  I have yet to see a coherent, logical, fact-based argument that the benefits for patients' and the public's health of physicians and medical academics working part-time as consultants, advisers, speakers, and directors of health care corporations outweigh the obvious risks of biasing medical decision making, education and research in favor of vested interests.

In 2011, I noted, "I have also yet to see an argument in favor of conflicts of interest made by anyone who does not have such conflicts."At least, however, up to that point I had not noted any such arguments made by people who had much power to enforce their views, as opposed to the ability to just express them.  The interview discussed above, however, was a person who has such power.

The interview was with Dr Susan Desmond-Hellmann, the relatively new Chancellor of the University of California- San Francisco, who was just named one of the "25 most influential people in biopharma."  She has recently been advocating a change of direction towards commercialization for her campus, one of the most prestigious health care oriented universities/ academic medical centers in the country.  She previously justified this redirection again using logical fallacies (look here). 

She also appears to yet another advocate for conflicts of interest who has her own conflicts.  As we noted here, Dr Desmond-Hellmann had little academic experience before she became Chancellor, but had worked her way up in the corporate pharmaceutical world, leaving her position as President for drug development at Genentech after it was taken over by Roche. 

As we noted previously, even after that, Dr Desmond-Hellmann apparently has not completely left the corporate world.
- A web-site for a speakers' bureau in which she apparently still participates lists her as a current "Advisor of Genentech since April 2009."
- In 2010, Dr Desmond-Hellmann joined the board of directors of Procter and Gamble, a company which makes many health related products, although it sold its global pharmaceutical business. Last year, the company made an agreement with Teva to market over-the counter medications (see this Reuters article). Note that she got this position despite apparently not having any prior personal investment in P&G stock. However, per the company's 2011 proxy statement, she appears to be in line to collect over $250,000 a year in compensation for this position.

It does not seem impossible that these ongoing commercial interests may influence how she acts in her role as Chancellor.  Yet while it may be unsurprising, it is very disappointing that conflicts of interest are now being uncritically and illogically publicly defended by people in positions to exert so much influence on health care.

The noted cognitive psychologists George Loewenstein, Sunita Sah, and Daylian Cain just asserted in JAMA [Loewenstein G, Sah S, Cain DM. The unintended consequences of conflict of interest disclosure. JAMA 2012; 307: 669-670. Link here.]
Conflicts of interest, including fee-for-service arrangements, are at the heart of the astronomical increases in health care costs in the United States, and transparency is not substitute for more substantive reform.

True health care reform requires such substantive reform of the financial arrangements among corporations that sell health care services or products and health care professionals and others who make decisions about patients' or the public's health. To decide how to accomplish such reform, we need a better discussion informed by logic and evidence, sans logical fallacies. Those who lead health care ought to be able to participate in this discussion under these conditions.

Friday, February 19, 2010

Deja Vu All Over Again - Sheffield Researcher Under Threat for Trying to Present Data that Offends Research Sponsor

It's deja vu all over again.  A case reported (so far only) in the UK Times Higher Education Supplement of a biomedical researcher apparently threatened because she tried to present data that did favor a particular commercial health care product. Here is the summary:
An academic has risked the wrath of her university by submitting results to a forthcoming conference without permission.

The University of Sheffield has claimed that the submission has been made in breach of a contract it has with a pharmaceutical company, which funds work in the scholar's field.

Guirong Jiang, a research radiologist who has worked at Sheffield for 13 years, is due to face a disciplinary hearing over her actions this week.

Her findings - submitted to a symposium of the European Calcified Tissue Society (ECTS), to be held in Glasgow in June - add to the debate over what some have claimed is a distortion in the field of osteoporosis caused by the over-diagnosis of vertebral fractures.

Here are more particulars:
Sheffield has censured her for making the submission without the consent of her supervisor, Richard Eastell, head of Sheffield's Academic Unit of Bone Metabolism.

It said her actions breached the terms of a 2007 contract the unit has with pharmaceutical manufacturer Sanofi-Aventis to conduct studies relating to the osteoporosis treatment risedronate, which is sold as the drug Actonel.

It also said Dr Jiang failed to follow 'reasonable requests' to withdraw the submission.

Dr Jiang said she believed her results should be published as they had not been reflected in the unit's previous output.

She added that last December she was informed that her contract would not be renewed when it came to an end this March, which she said had prompted her to throw caution to the wind and publish without permission.

She has queried whether her work is bound by Sheffield's Sanofi-Aventis contract, which stipulates that the company must be allowed to review manuscripts and abstracts prior to publication.

She pointed out that the work was carried out in 2002 when the unit's risedronate work was funded by Procter & Gamble in partnership with Aventis. Dr Jiang added that she had not seen or signed the full Sanofi-Aventis contract.

Dr Jiang is still under threat:
The disciplinary hearing, scheduled to take place on 18 February, will consider the allegation that Dr Jiang 'acted inappropriately in making a direct submission of an abstract to a journal outside unit protocol and in contravention of the terms of the research contract'.

It will also consider the charge that she 'failed to follow a request by her head of unit and head of department to rectify her actions', which 'aggravated a situation which otherwise could have been quickly resolved'.

A long time ago, in a galaxy far, far away, academics had the expectation that they could publish or present their research without first acquiring the express approval of their academic superiors (at least as long as their work was original, the research project was under their control, and that they had properly protected the rights of any human subjects). Furthermore, in at least the US, academics are citizens who expect to have free speech.

But as academic institutions became more enamored of and dependent on "external funding," faculty were increasingly pressured to do only sponsored research. The growing dependence on sponsored research allowed the sponsors to try to get more control over how research was done.

In the 1990s, there were several important cases in North America in which academic researchers tried to present or publish results that clashed with their research sponsors' vested interests. Doing so resulted in lesser or greater threats to the faculty. Two of the classic cases of research suppression in the 1990's demonstrated this issue.


* In the "David Kern case," a textile manufacturer, Microfibres Inc., tried to prevent Dr. David Kern, a general internist and occupational medicine physicians at Memorial Hospital of Rhode Island and faculty member at Brown University, from presenting an abstract that described a case-series of a new pulmonary disease, flock-workers lung, that affected workers at Microfibres Inc. factories. Kern did present the abstract, but under a threat, never carried out, of law-suit, Memorial Hospital of Rhode Island removed Kern as head of the Occupational Medicine program, and refused to renew his contract, even though he was an Associate Professor. Brown University was unable to reverse these moves by the hospital, and Brown officials blamed Kern for signing an agreement to protect trade secrets, even though the agreement was unrelated to the research Kern did on the disease, and his research did not obviously reveal any trade secrets. [1-4]

* In the "Nancy Olivieri case," Apotex, a pharmaceutical company, acted against Dr. Nancy Olivieri for revealing preliminary data from a trial of deferiprone, a chelating agent for the treatment of iron overload in thalassemia, suggesting that the drug was often ineffective in treating iron overload, and appeared to be associated with hepatic fibrosis. Ultimately, a report by the Canadian Association of University Teachers also held that her academic freedom was abridged, in the context of a negotiation between the University of Toronto and Apotex over a large donation, and that the hospital harassed Dr. Olivieri during her dispute with Apotex (link here for report)
 
In the early 21st century, there was a case in the UK with spooky similarites to the present case: at the same university involved in the present case, and with at least one participant in common with that case.  About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest. Our most recent summary of the case was here. Dr Blumsohn was also doing clinical research on the drug Actonel, again at the University of Sheffield.  He was denied access to the very data he had collected, and to analyses of the data by Procter and Gamble, the then manufacturer of the drug and sponsor of the research.  Dr Blumsohn found that Procter and Gamble seemed to be arranging for ghost-writers to author abstracts about the research based on these hidden analyses.  After he complained to numerous officials at Sheffield, including Dr Richard Eastell, to no avail, he spoke to the press, and thereafter lost his academic position.  The case was just recapped in an interview of Dr Blumsohn published in the British Medical Journal(5).
 
So we seem to have made little progress.  Most clinical research at academic medical institutions is sponsored by firms that make drugs and devices.  The firms try to secure contracts that give them control over most aspects of the research.  Thus, they can determine how the research is designed, implemented, ana analyzed.  If the resulting manipulation still does not yield results that make the firms' products look good, the sponsors can then just suppress them.  Academics who naively think it is their duty to find and disseminate the truth are in jeopardy when they attempt to present or publish results that challenge their research sponsors' vested interests.
 
Suppression of clinical research, however, is bad for patients and honest health care professionals, since it misleads about the benefits and harms of tests and treatments.  Suppression of clinical research dishonors research subjects who volunteer for studies, often at risk to themselves, thinking they may help to advance science and clinical care.  Suppression of clinical research undermines the fundamental mission of academia: to seek out and disseminate the truth.
 
Those who truly want better health care, here in the US and globally, should advocate for clinical research done without the influence of those with vested interests in how the research comes out. 
 
Thanks to an anonymous Health Care Renewal scout who located the Times article. 
 
References


1. DG Kern, RS Crausman, TH Durand et al. Flock worker's lung: chronic interstitial lung disease in the nylon flocking industry. Ann Intern Med 1998; 129: 261-272. (link here)
2. Shuchman M. Secrecy in science: the flock worker's lung investigation. Ann Intern Med 1998; 129: 341-344. (link here)
3. Marsh DJ. Intimidation of researchers by special interest groups. N Engl J Med 1997; 337: 1317-1318. (link here)
4. Shuchman M. Consequences of blowing the whistle in medical research. Ann Intern Med 2000; 132: 1013-1015. (link here)
5.  Cyer C. Aubrey Blumsohn: academic who took on industry. Brit Med J 2009; 339:b5293. (link here)

Wednesday, December 16, 2009

British Medical Journal Interviews Dr Aubrey Blumsohn

About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest.  Our most recent summary of the case was here.  The case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.

The case was just re-capped in some detail on the occaision of an interview of Dr Blumsohn published in the British Medical Journal, just available on-line yesterday.  [Cyer C. Aubrey Blumsohn: academic who took on industry.  Brit Med J 2009; 339:b5293.  Link here.]  Dr Blumsohn's final words in the interview were:
It’s hard to encourage anyone to speak out about poor practice in the current environment. This case sums up what has gone wrong with systems set in place to ensure safety and integrity in scientific medicine. It would help if regulators put as much effort into responding to serious critics and whistleblowers as they do producing glossy brochures and yet more guidance.

My hat is off to Dr Blumsohn for his determination to pursue this case, and to the British Medical Journal for getting it into the "main-stream" health care literature.

Hat-tip to PharmaGossip.