Sunday Settlement and Guilty Plea Roundup

Here we go again. 

AstraZeneca / Seroquel

We have posted frequently about allegations of devious marketing techniques used by AstraZeneca to promote its blockbuster atypical anti-psychotic drug Seroquel (quetiapine.)  See our posts here, here, here, here, and here.  Now, as reported by the New York Times, it is time for AZ to settle with the US government.

AstraZeneca has completed a deal to pay $520 million to settle federal investigations into marketing practices for its blockbuster schizophrenia drug, Seroquel, the Attorney General, Eric Holder, said at a news conference Tuesday afternoon.

'AstraZeneca paid kickbacks to doctors as part of an illegal scheme to market drugs for unapproved uses,' Kathleen Sebelius, secretary of health and human services, said at the event in Washington. She said the company promoted drugs for unapproved uses by children, the elderly, veterans and prisoners.

AstraZeneca agreed to sign a corporate integrity agreement with the federal government over its marketing of Seroquel for unapproved uses, but will not face criminal charges, company and federal officials said.

The company, based in London, has been accused of misleading doctors and patients by playing up favorable research and not adequately disclosing studies that show Seroquel increases the risk of diabetes.

Of course, an AZ spokesperson had a different take on it.

Glenn Engelmann, AstraZeneca’s U.S. general counsel, released a statement saying the company denies the allegations but settled the investigation with the payment.

'It is in the best interest of AstraZeneca to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines — while avoiding the delay, uncertainty, and expense of protracted litigation,' Mr. Engelmann said.

Johnson and Johnson / Topamax

On the other hand, the issue of how Johnson and Johnson marketed Topamax (topiramate), a drug approved for treating seizures, is a new one for Health Care Renewal.  Here is the story, via Bloomberg.

Two units of Johnson & Johnson will pay more than $81 million to resolve criminal and civil claims over illegal promotion of the epilepsy drug Topamax, the U.S. Justice Department said.

Ortho-McNeil Pharmaceutical LLC agreed to plead guilty to a misdemeanor and pay a $6.14 million criminal fine for misbranding the drug, the government said. Ortho-McNeil-Janssen Pharmaceuticals also will pay $75.37 million to resolve civil allegations that it illegally marketed Topamax and caused false claims to be submitted to government health programs.

While the Food and Drug Administration approved Topamax for the treatment of partial onset seizures, Ortho-McNeil Pharmaceutical promoted the drug for unapproved psychiatric uses, the government said. The company hired physicians through its 'Doctor-for-a-Day' program to join sales representatives in visiting doctors and to speak to colleagues about unapproved uses and doses, according to the government.

In this case, the company admitted wrong-doing as part of the specific plea agreement.

Under the plea agreement, Ortho-McNeil Pharmaceutical will admit that from 2001 to 2003 it promoted Topamax 'for certain uses not approved' by the FDA, according to a statement by Ortho-McNeil-Janssen.

The company 'voluntarily discontinued the program at issue before receiving the government’s first subpoena in the investigation,' according to the statement.

Ortho-McNeil-Janssen also will sign a five-year corporate integrity agreement with the U.S. Health and Human Services Department.

Summary

Once more, with feeling ....  We have discussed a series of legal settlements and criminal convictions and guilty pleas resolving cases of alleged wrong-doing by health care organizations. Almost none included any penalties for people who authorized, directed or implemented the bad behavior. None of the financial penalties were so big as to be more than another cost of doing business for the organizations involved. Corporate entities, but very rarely people have pleaded guilty or been convicted (almost always of misdemeanors), Some of the cases included gimmicks, like a subsidiary constructed only to plead guilty, that otherwise seemed to lessen accountability.

If we truly want health care that is accessible, of high quality, at a fair price, and more importantly, if we want health care that is honest and focused on patients, we need to provide health care leaders with clear, rational incentives in these directions, and make them fully accountable for their actions, and the courses of their organizations under their leadership.

ADDENDUM (2 May,2010) - See also comments on the Hooked: Ethics, Medicine, and Pharma blog by Dr Howard Brody on the AZ settlement.

AstraZeneca Settles

Here is the latest in the parade of legal settlements of cases of alleged wrong-doing by health care organizations.  As reported by Duff Wilson in the New York Times,

The pharmaceutical company AstraZeneca said Thursday that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.

One of the investigations related to 'selected physicians who participated in clinical trials involving Seroquel,' AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.

Seroquel was the top-selling antipsychotic drug in America. It had $17 billion in sales in the United States since 2004, according to IMS Health, a research firm.

Tony Jewell, a company spokesman, declined to be more specific about the physicians or clinical trials under investigation. He said the company was in final negotiations to settle the whistle-blower suits and reach a corporate integrity agreement with the Justice Department.

The name of the whistle-blowers and other details of the suits remained sealed in federal court. Stephen A. Sheller, a lawyer in Philadelphia for the whistle-blowers, and Patricia Hartman, a spokeswoman for the United States attorney in Philadelphia, both declined to comment.

Here we go again. As the Times article noted,

AstraZeneca, based in Britain, joins a list of drug makers that have paid billions to settle inquiries initiated by complaints from former company insiders.

Earlier this year, Eli Lilly & Company paid $1.4 billion over its marketing of Zyprexa, another antipsychotic drug. And Pfizer announced it would pay $2.3 billion, including a record $1.195 billion criminal fine, mostly over its painkiller Bextra, which has been withdrawn from the market.

Does anyone really still believe that integrity agreements, and settlements assessed against huge corporations deter such profitable bad behavior? A half a billion dollar one-time settlement is just a small cost of doing business for a company that sold $17 billion worth of the offending drug in the last five years. As in the case of many other previously announced settlements, it appears that nobody who authorized, directed, or implemented the bad behavior that led to the settlement will suffer any sort of negative consequences.

We previously discussed allegations that AstraZeneca manipulated and suppressed clinical research, and organized deceptive marketing campaigns in support of Seroquel sales (here, and here).  If we do not discourage such practices, they will continue to bias the clinical evidence making expensive drugs and devices seem more effective and less dangerous than they really are.  Is it any wonder that we over-use and over-pay for these products?  Anyone seriously interested in reforming health care to improve quality and access while moderating costs ought to pay attention to behavior that leads to such over-use and over-payment. 

(However, there may be hope.  Perhaps in the future there will be more effective deterrence.  A recent indictment named not only the device company Stryker Biotech (a subsidiary of Stryker Corporation), but also its former CEO and three managers.)

Nemeroff, Seroquel, and ACCME

Nemeroff, Seroquel, and ACCME

Roy Poses has discussed the atypical antipsychotic drug Seroquel (quetiapine) several times on this site, pointing out manipulation of clinical research results to enhance the appearance of efficacy, and suppression of studies with unfavorable results. I call this augmenting the marketed profile of the drug. Daniel Carlat has commented on published Seroquel data here and ClinPsych here.

AstraZeneca, the marketer of Seroquel, has also been busy with continuing medical education (CME) programs that augment Seroquel’s profile. Last December 8, one such program went on line, aired by the provider CME Outfitters. The program’s title was “Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough.” The corporate logo for CME Outfitters is Education with Integrity. I will allow readers to decide if the company is meeting its mission statement in this respect.

The key opinion leader engaged by CME Outfitters to discuss Seroquel and other atypical antipsychotic drugs was Charles Nemeroff of Emory University. He was joined by 2 KOLs-in-training, whom I will not name. The corporate sponsor that paid CME Outfitters and, indirectly, these presenters was AstraZeneca. I do not need to rehearse here the ethical issues that have surrounded Dr. Nemeroff for the past several years. Suffice it to say that, as a result of those issues, Dr. Nemeroff is no longer chair of the department of psychiatry at Emory University, he is no longer editor-in-chief of the ACNP journal Neuropsychopharmacology, he was removed from involvement with ongoing federally funded research grants at Emory University, and he was put on a short leash by the Emory administration.

On December 23, 2008 I filed a formal complaint about Dr. Nemeroff’s program with ACCME. My bill of particulars was lengthy, detailed, and backed up by extensive
materials. In due course, ACCME investigated the complaint and found that the program did violate ACCME standards. With respect to content, ACCME determined that Dr. Nemeroff’s program lacked sufficient information about possible adverse effects of treatment with atypical antipsychotic drugs; and failed to emphasize sufficiently the efficacy of alternative treatments. With respect to commercial bias, ACCME determined that bias existed as a result of the absence of contrasting therapy data, and through downplaying the drawbacks related to treatment with atypical antipsychotic drugs in depressed patients.

Following these findings by ACCME, the provider was notified of the violations in early September 2009, and the program was removed from the provider’s website. The sanitized statement of violations determined by ACCME does not capture the nuances of deceit, ineptitude, and deficient educational content in Dr. Nemeroff’s program. One remarkable example was Dr. Nemeroff’s citation of data, from one of his own publications, that were previously retracted. Did he think no one would notice?

A second example involved biased presentation of the sponsor’s data for Seroquel. Two doses of Seroquel (150 mg and 300 mg) were tested. Only the results for the 300 mg dose were statistically significant. Nevertheless, in the video presentation one of the junior presenters stated very clearly that there was “significant improvement in both response and remission with both doses” of Seroquel. That is a falsification of the scientific record. That falsification does not meet ACCME requirements for fair, balanced, truthful, and honest teaching. As moderator, Dr. Nemeroff was required to correct this false statement made by his junior assistant, but Dr. Nemeroff failed to do so.

The negative findings and sanction by ACCME against Dr. Nemeroff’s program are welcome, though I have to say it took ACCME an inordinately long time to complete their work. I also presented ACCME with several follow-on questions, which the Council is now considering. These are:

• Did ACCME notify the presenters that their program violated ACCME policies? If not, why not?

• Will CME credits be clawed back from physicians and other professionals who obtained credits through the noncompliant program? If not, why not? I believe this would be an effective form of negative feedback to the provider and the presenters.

• Does ACCME have a process to require the provider and presenters to ascertain whether any patients were injured as a result of the violations that created biased and deficient information in this program? If not, why not?

• Does ACCME require the provider to notify physicians and other professionals who completed the noncompliant program that the provider was sanctioned for violation of ACCME standards? If not, why not?

• Does ACCME require the provider to furnish corrective materials to such professionals in order to remedy the bias and incompetence to which they were subjected through violation of ACCME standards, and thereby to remove potential danger to future patients? If not, why not?

• Why did ACCME allow the noncompliant program to remain available long after the complaint was filed? I suggest that ACCME needs to place a hold on programs that are subject to active complaint. Had such a policy been in effect in December 2008, the violating program would not have been re-aired by the provider in early 2009, it would not have remained on-line for 9 months, and the damage to the continuing education community would have been contained.

• Will ACCME issue a public listing of sanctions it has enforced against providers and presenters? If not, why not? State medical boards do exactly that in relation to physicians and other professionals who violate standards of practice.

• Finally, I reminded ACCME that its primary constituents are patients, physicians and other professionals, not commercial or academic CME providers. It seems to me that ACCME was altogether too laissez-faire and dilatory in the way it handled this matter. At the time of my initial complaint last December, I requested expedited review precisely because additional airings of this violating program were scheduled.

The good news is that ACCME seems to have got the message that things need to change. As one of their officers wrote to me recently, “We sincerely appreciate the time and effort you have put into participating in our complaints and inquiries process. You have raised important issues that the ACCME will review and address.” I await their next communications on the remaining questions.

As for Dr. Nemeroff, he is yesterday’s news. The adverse findings by ACCME about his program serve as a reminder to corporate sponsors and CME companies that Dr. Nemeroff is so compromised by now that he has lost effectiveness as a front man for Pharma. Indeed, he is so toxic that he now glows in the dark.

More on the Misleading Promotion of Seroquel

Previous posts (here and here) noted internal documents from AstraZeneca made public during litigation about its blockbuster atypical antipsychotic drug Seroquel (quetiapine) suggesting that the company's marketers manipulated clinical research results to make them appear more favorable to the product, and suppress studies with unfavorable results that could not be easily manipulated.

This week, Bloomberg News reported testimony from one trial about other aspects of Seroquel's marketing. The marketers' claims were at odds with the company's own research results:

AstraZeneca Plc advised its sales force to promote the antipsychotic drug Seroquel as 'weight neutral' four years after company research found 'clinically significant' weight gains in users, internal documents show.

AstraZeneca’s 'global strategy is to demonstrate to consumers that Seroquel has a weight-neutral profile,' Debbie Holdsworth, a marketing official, wrote in a 'dear colleague' letter dated May 14, 2001. The document was produced during a pretrial examination of former executive John Patterson.

'If 45 percent of patients gained significant weight in a year, how could that be weight-neutral?' patient attorney Ed Blizzard asked Patterson, citing a internal 1997 e-mail written by an AstraZeneca doctor, at a hearing in Orlando Oct. 5.

Also, evidence was presented that suggested that company marketers consciously promoted the drug for off-label indications over several years:

Patterson was asked about a 'Seroquel Strategy Summary' issued in December 2000, which described the broadening of Seroquel use 'on and off label' as a sales goal. While doctors are free to prescribe any medicine to treat a given condition, it is illegal for drug companies to promote medicines for uses not approved by the U.S. Food and Drug Administration.

'The company has standards and procedures to ensure its sales representatives do not promote off label,' Patterson testified. Still, the goal of off-label promotion remained in strategy summaries for the years 2001 or 2002, he acknowledged.

Coupled with previous revelations (see posts noted above), it looks like the marketers were employing an integrated strategy combining a variety of deceptions, the sort of broad based stealth marketing approach we have seen employed to promote other health care products.

Such strategies undoubtedly have lead to the prescribing of expensive drugs when other treatments, or no treatment would be better, and have helped support the high prices charged for products that are not necessarily so good for the many patients who have ended up getting them. Of course, the money thus generated has let many executives of the companies that employ such marketing strategies become rich. As Bloomberg reported:

Patterson, who reported directly to AstraZeneca’s chief executive officer, was paid more than $1 million at one point during his tenure at the company. He retired April 1 as executive director of product development, and is the highest- ranking AstraZeneca executive to testify in open court in lawsuits claiming the company withheld information about the risks of Seroquel.

In my humble opinion, if we really want to reform health care in the US (and around the globe), we need to challenge how health care organizations have used their ability to sponsor medical research to manipulate its design, implementation, analysis and dissemination, and when necessary, to suppress its results to favor their vested interests. We also need to challenge systematically deceptive marketing practices designed to make products and services appear more useful than they really are, thus supporting exaggerated prices and prompting overuse. Unless we challenge these and some other causes of excess prices and excess use, attempts to provide universal health insurance and access will bankrupt us all.

(And to preempt anyone in the audience who may recoil from anything that restricts the freedom of action of health care corporations - tell me how manipulation of research, suppression of research, and deceptive marketing is necessary for innovation or for adequate revenues to support good products? I am not arguing for hamstrung companies. I am arguing for honest business practices.)

Hat tip to PharmaGossip.

More Documents About the Selling of Seroquel Show How Research Was "Subordinated to Commercial Goals"

We posted earlier this year about how documents produced on discovery and recently unsealed during litigation suggested how AstraZeneca handled clinical research data in the marketing of its atypical anti-psychotic drug Seroquel (quetiapine). A new crop of documents has just been released, providing yet more insights, as reported by the St Petersburg (Florida) Times:

Behind the scenes at the global pharmaceutical company AstraZeneca, the team in charge of the blockbuster antipsychotic Seroquel had one mission: make the multibillion-dollar seller even bigger.

To that end, internal company documents released Wednesday show how the British drugmaker hid unfavorable study results, promoted unapproved uses and even considered pitching the drug as less likely to lead to suicidal thinking than competitors'.

In particular,

Documents suggest Seroquel studies were repeatedly subordinated to commercial goals.

When a study in 2002 failed to show that Seroquel's sustained release formula was any more effective than a placebo in treating schizophrenia, orders from the top were to keep the results 'in strictest confidence.'

When a scientist in England wanted to study the weight gain in rats on Seroquel, AstraZeneca declined to fund the research, saying 'we could wind up with results that are not clearly advantageous.'

In one discussion, it was suggested that authors of potentially helpful research reports who raised too many questions, slowing publication, should be asked to step down.

A researcher who pressed for results of an unfavorable trial was rebuffed for weeks before being given 'three or four sentences describing high-level results.'

AstraZeneca marketers were jealous of what they saw as competitor Lilly's ability to cast questionable study results in a positive light. 'They (Lilly) are able to spin the same data in many different ways through an effective publications team,' according to a 2003 memo. 'Negative data usually remains well hidden.'

As Seroquel's sales soared, documents reflect an ongoing struggle between the safety and marketing teams over the potentially damaging issue of weight gain. In 2000, the company's scientists said data did not support the marketing claim that Seroquel resulted in only 'limited' weight gain. Close to 23 percent of the people who took the drug gained more than 7 percent.

Despite the safety team's objections, the word 'limited' remained on Seroquel's label for two more years.

This is a reminder how beleaguered we advocates of evidence-based health care (EBHC) have become. The idea of EBHC was that health care decisions for individual patients, and policies for groups of patients ought to be guided by critical review of the best available evidence from clinical research, guided by knowledge of biology and the biopsychosocial context of health, and informed by patients' values and preferences. The idea still makes sense to me, but it only works if physicians, patients and policy-makers have access to an unbiased sample of clinical research studies, so that studies with are not selectively suppressed to support vested interests. Although critical review can account for inevitable trade-offs, compromises, and errors in how studies are designed, implemented, and analyzed, the clinical epidemiological methods it uses are really not designed to root out falsehoods and deliberate deception.

However, the ongoing story of Seroquel, and many other cases discussed on Health Care Renewal suggest that when clinical research is sponsored by those who can profit from the product or service it evaluates, that research is prone to suppression and manipulation. Although I believe there are many honest scientists who work for pharmaceutical, biotechnology, device, health information technology and other health care corporations, it seems they often have to answer to marketers whose only goal is to sell more product.

As long as clinical research is sponsored and run by the people who can profit directly from selling the products and services the research is meant to evaluate, the ideal of evidence-based health care becomes less attainable.

As we have said before, suppression and manipulation of research amounts to post-hoc abuse of research subjects who volunteered their participation believing that it would advance science and health care.

Furthermore, suppression and manipulation of research can deceive physicians into prescribing tests and treatments that will fail to help, or even harm patients, and deceive patients into thinking that they are getting the best possible tests and treatments, when, again what they are getting is ineffective or even harmful.

In my humble opinion, there is an increasingly strong argument that clinical research should not be controlled, and probably should not be done at all by organizations with vested interests in the research producing results favorable to their products.

BLOGSCAN - The Over-Selling of Seroquel

The anonymous blogger on the Clinical Psychology and Psychiatry blog has been hard at work on the story of how research on Seroquel (quetiapine, by AstraZeneca) was manipulated and oversold. His latest effort is here. Once again, a major theme is how a "key opinion leader," that is, a prominent medical academic lavishly paid as a consultant or speaker, became overly enthusiastic about his employer's product. Unforunately, academic medicine is now rife with well-paid key opinion leaders. I suspect many may have cause in the future to feel sheepish about their former enthusiasms. Meanwhile, beware marketers in academics' clothing.

"Buried Data," a "Smoke-and-Mirrors Job" and a "Positive Spin" on a "Cursed Study"

Documents produced on discovery and recently unsealed during litigation suggested how AstraZeneca handled clinical research data in the marketing of its atypical anti-psychotic drug Seroquel (quetiapine). As reported by Bloomberg,

AstraZeneca Plc 'buried' unfavorable studies on its antipsychotic drug Seroquel, according to an internal e-mail unsealed as part of litigation over the medicine.

The drugmaker failed to publicize results of at least three clinical trials of Seroquel and engaged in 'cherry picking' of data from one of those studies for use in a presentation, an AstraZeneca official said in a December 1999 e-mail unsealed yesterday under an agreement between the company and lawyers for patients. The London-based company faces about 9,000 lawsuits claiming it failed to properly warn users that Seroquel can cause diabetes and other health problems.

'The larger issue is how we face the outside world when they begin to criticize us for suppressing data,' John Tumas, an AstraZeneca publications manager, told colleagues in the e-mail.

One unsealed document showed AstraZeneca officials considered Trial 15, one of the studies Tumas described as 'buried,' to be a problem because it didn’t produce favorable results on the issue of weight gain for patients taking the drug. Gaining weight can be a factor in the development of diabetes.

Richard Lawrence, an AstraZeneca official, said in a February 1997 e-mail that the company had engaged in a 'great smoke-and-mirrors job' in dealing with U.S. and Canadian investigators on the trial’s results.

'Adopting the approach Don has outlined should minimize (and dare I venture to suggest) could put a positive spin (in terms of safety) on this cursed study,' Lawrence said in the e- mail. It isn’t clear from the e-mail which person Lawrence is referring to.

In his December 1999 e-mail, Tumas said that AstraZeneca had 'buried trials 15, 31, 56,' and was considering a study listed as COSTAR. Details of the trials weren’t specified in the e-mail.

Tumas chastised colleagues for using favorable data produced by Trial 15 without disclosing the full study results, according to his unsealed e-mail.

'There has been a precedent set regarding ‘cherry picking’ of data,' which was used in “the recent Velligan presentations,' he said. 'Thus far, I am not aware of any repercussions regarding interest in the unreported data.'

The publications manager indicated that AstraZeneca had a favorable reputation for engaging in 'ethical behavior' when it came to disclosing study results on its drugs.

'We must decide if we wish to continue to enjoy this distinction,' Tumas wrote.

'The reporting of the COSTAR results will not be easy,' he added. 'We must find a way to diminish the negative findings. But, in my opinion, we cannot hide them.'

So here we have more evidence about a big pharmaceutical company suppressing and manipulating data from the clinical research when its results proved unfavorable to its product. The unsealed evidence, when added to many other cases we have discussed, suggest that manipulation and suppression of clinical research data to support companies' vested interests is a common practice by commercial health care firms, including but not restricted to pharmaceutical, biotechnology, and device companies.

As we have said before, suppression and manipulation of research amounts to post-hoc abuse of research subjects who volunteered their participation believing that it would advance science and health care.

Furthermore, suppression and manipulation of research can deceive physicians into prescribing tests and treatments that will fail to help, or even harm patients, and deceive patients into thinking that they are getting the best possible tests and treatments, when, again what they are getting is ineffective or even harmful.

In my humble opinion, there is an increasingly strong argument that clinical research should not be controlled, and probably should not be done at all by organizations with vested interests in the research producing results favorable to their products.

See additional comments about the Seroquel litigation on the Clinical Psychology and Psychiatry blog here, and the Carlat Psychiatry Blog here.

ADDENDUM (2 March, 2009) - See detailed comments on the apparent manipulation of a meta-analysis of Seroquel versus a "typical" anti-psychotic, haloperidol, on the Clinical Psychology and Psychiatry Blog.

Is Nothing Sacred? - Questions of Commercial Influence on the Awarding of the Nobel Prize for Medicine

Many news outlets, but few in the US, have reported concerns about the integrity of the Nobel Prize in Physiology or Medicine. As reported by the Toronto Star,

Swedish anti-corruption agents are investigating allegations that pharmaceutical giant AstraZeneca influenced the awarding of this year's Nobel Prize in medicine.

'I have formally instigated, or started, a criminal investigation,' Swedish anti-corruption prosecutor Nils-Erik Schulz told the Star in a telephone interview from Stockholm yesterday.

Schulz's investigation was sparked by claims in the European press that AstraZeneca's sponsorship of two Nobel promotional companies – Nobel Media and Nobel Web – influenced the choice for this year's prize in medicine. As well, two Swedish academics on the committee have close ties to AstraZeneca – one sits on the company's board of directors, while the other was a former consultant to the pharmaceutical company.

Part of the Nobel Prize in Physiology or Medicine was awarded this fall to Harald zur Hausen, a German scientist who discovered the links between human papilloma viruses and cervical cancer. The discovery could be a financial bonanza for AstraZeneca, which holds the patents on ingredients in the vaccines used to fight the viruses.

AstraZeneca stands to make millions from Gardasil, made by Merck, as well as GlaxoSmithKline's Cervarix, thanks to patents it holds.

Not surprisingly, AstraZeneca and the Nobel Foundation denied doing anything wrong,

'Because the Nobel Committee of Karolinska Institute, and not the Nobel companies, elects candidates for the prize, AstraZeneca will not be able to influence who will be awarded the Nobel Prize, nor do we ever seek to,' Laura Woodin, manager of media relations for AstraZeneca in the U.S., said in a statement to the Star. Nobel Foundation director Michael Sohlman was equally adamant about the strict separation between fundraising and the selection of Nobel laureates.

'The foundation has 100 per cent confidence in the integrity of the Nobel Assembly at the Karolinska Institute, as we have in the other prize-awarding institutes,' Sohlman said in a telephone interview from Stockholm yesterday.

In my humble opinion, both these denials begged the question. At the least, it appears that at least one member of the committee that awards the prize in medicine is on the board of directors of AstraZeneca, a pharmaceutical company. Specifically, "Nobel Assembly member Bo Angelin sits on the company's board of directors, which pays $50,000 (Cdn) a year." As we have discussed in the past, beyond being remunerative, sitting on the board of directors of a for-profit company implies a duty to the stock-holders to maximize the profits of the company. Such a duty could create a conflict for someone who also votes on the awarding of a lucrative and extremely prestigious prize for medical scientific discoveries that could relate to the marketing of such a company's products. The presence of Dr Angelin on the committee which chose the Nobel Prize winners suggests at least the possibility that commercial concerns could affect the selection process. Furthermore, his presence suggests that there is no prohibition of directors of for-profit health care corporations from sitting on this committee. There may have been other committee members with other conflicts that further suggests commercial influence on the awarding of this most prestigious prize.

Is nothing sacred? It appears that the web of conflicts of interest in medicine and health care has spread to even the most renowned of its institutions. And now we must wonder whether even the Nobel Prize has been turned into a marketing opportunity.

See also comments by David Williams on the Health Business Blog, and the anonymous blogger on PharmaGossip.

MISSING in ACTION on MEDSCAPE

MISSING in ACTION on MEDSCAPE

Charles Nemeroff has been in the news lately, under investigation by Senator Grassley for allegedly violating NIH regulations on conflict of interest and disclosure. The fallout to date includes his severance from several NIH-funded projects at Emory University School of Medicine, a freeze of NIH funding for a major center grant, and his stepping down from Emory’s chair of psychiatry while an internal investigation proceeds. Some amazing documents were released by the Senator. Among other surprises, they contained a scathing critique of a Nemeroff publication by Emory’s Dean Claudia Adkison, and evidence that Dr. Nemeroff tried to get himself off the hook within Emory by smearing third parties and blaming them for harassment. Now that these internal documents have been released by the Senate Committee on Finance and then appeared in The New York Times, Dr. Nemeroff will have even more explaining to do.

The word is finally out. Dr. Nemeroff’s credibility is under a cloud, to say the least, and his influence is rapidly waning. After all, who wants to be associated with a suspect and a loser? In the hardnosed, commercial world of Continuing Medical Education, for instance, the signs are that Dr. Nemeroff is toast. Whereas he once coordinated multi-city traveling CME road shows and a parade of spots on CME websites like Medscape, his profile now is suffering. Go to this Medscape website, for instance. You will find that his current Expert Viewpoint spots are missing, replaced by the message, “This article is temporarily unavailable.”

Well, good for Medscape. They came in for their share of criticism, here and here, a while back. Now they deserve credit for displaying ethical standards. Meanwhile, we are waiting for another company called CME Outfitters to get the message. Dr. Nemeroff is slated to moderate a raft of new programs for this company in the coming weeks, sponsored by corporations like Pfizer, AstraZeneca, and Ortho-McNeil Janssen. CME Outfitters' logo, after all, is Education with Integrity. Sooner or later the pharmaceutical corporations, like the CME companies, will understand that they are not helping themselves by trotting out a shopworn and sleazy KOL figurehead like Nemeroff for their marketing efforts. And other KOLs who up to now were willing to "wet their beaks" in these CME forums controlled by the Boss of Bosses Nemeroff will now be leery of associating with him.

The fallout continues.

Bernard Carroll