Princess Health and British Government Concludes GSK Suppressed Paxil (Seroxat) Data. Princessiccia

Princess Health and British Government Concludes GSK Suppressed Paxil (Seroxat) Data. Princessiccia

clinical trials GlaxoSmithKline Paxil pharmaceuticals SSRIs suppression of medical research

Gusty 13:30 Add Comment

Last year, we summarized the results of a BBC investigation broadcast on the television program Panorama that charged that GlaxoSmithKline "distorted trial results of an anti-depressant, [Seroxat in the UK, Paxil in the US, chemical name paroxetine] covering up a link with suicidal teenagers." (See also the links in that post to extensive discussion on the Clinical Psychology and Psychiatry Blog.)

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just completed an investigation, and it is fitting to quote the BBC story about its results.

It comes after the drugs regulator announced GlaxoSmithKline would not face criminal proceedings over claims it withheld information on Seroxat.

But they warned GSK should have been quicker to raise the alarm on the risk of suicidal behaviour associated with the antidepressant in the under-18s.

GSK has rejected claims it improperly withheld drug-trial information.

The Medicines and Healthcare products Regulatory Agency (MHRA) received data from clinical trials in May 2003 showing that patients under 18 had a higher risk of suicidal behaviour if they were treated with Seroxat than if they received a placebo.

Data also showed that Seroxat was not effective for treating depression in children and adolescents.

But Professor Kent Woods, MHRA chief executive said they were disappointed GSK had not given them information earlier and that drugs firms had an "ethical responsibility".

"I remain concerned that GSK could and should have reported this information earlier than they did.

"All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them.

The government decided not to pursue criminal charges, mainly because of "important weaknesses in drug safety legislation in force at the time."

Also,

Health minister Dawn Primarolo said the government would take immediate steps to secure a strengthening of the law in the UK and Europe.

She also said they wanted to make it clear to all pharmaceutical companies that, "notwithstanding the limitations that may exist in the law, they should disclose any information they have that would have a bearing on the protection of health".

The Guardian reported the forceful opinions of the [UK] Mental Health Foundation chief executive, Andrew McCulloch,

It is totally unacceptable to hear that, when information can be made available at speed, young people may have taken their own lives due to a lack of transparency by a pharmaceutical company.

Woods further commented in another article in the Guardian,

I really feel there is an ethical obligation that pharmaceutical companies ought to recognise and it seems to have been lost. Twenty years ago I was a prescribing doctor and I took it for granted that if there was information relevant to the drug I was going to prescribe, then it would be available. We're talking about something which has direct relevance to health and safety.

The Guardian also noted that Woods "could not rule out the possibility that other companies were sitting on unpublished data that could cause them commercial damage."

So, in case there was any doubt, based on this UK government report, it seems very clear that GSK suppressed data about the adverse effects of Seroxat in an effort not preserve sales. This was a blatant effort to put company profits ahead of patient well-being and a slap at the integrity of the clinical science data base. This has hardly been the only case of suppression of clinical research data because it reflected poorly on some company's products or services.

And pharmaceutical executives wonder why no one trusts them anymore?

I doubt there is any way to secure the integrity clinical research short of banning all involvement by corporations with vested interests in having specific research studies come out in ways that favor their products or services.

See also the forceful comments by Dr Aubrey Blumsohn on the Scientific Misconduct Blog. He called it "a day of shame."

Princess Health and Fat Chance: Conflicts of Interest and Calorie Counting. Princessiccia

Princess Health and Fat Chance: Conflicts of Interest and Calorie Counting. Princessiccia

conflicts of interest GlaxoSmithKline medical organizations obesity Sanofi-Aventis

Gusty 11:08 Add Comment

Stephanie Saul in the New York Times, and Karl Stark in the Philadelphia Inquirer have covered the curious story of the downfall of the president-elect of the Obesity Society. Last month, Ms Saul set the stage,

New York City�s new rules for menu labels at chain restaurants have set off a food fight among the nation�s obesity experts.

Most support the theory of the city�s health commissioner that forcing chain restaurants to list the calories alongside menu items � flagging that a Double Whopper With Cheese has 990 calories, for example � will make patrons think twice about ordering one. The rules are set to take effect at the end of March.

There is a countertheory, however, set forth by Dr. David B. Allison, the incoming president of the Obesity Society, a leading organization of obesity doctors and scientists. An affidavit he recently submitted to the United States District Court for the Southern District of New York has ignited a controversy within his organization.

In the filing, Dr. Allison argues that the new rules could backfire � whether by adding to the forbidden-fruit allure of high-calorie foods or by sending patrons away hungry enough that they will later gorge themselves even more.

It might be only a scientific debate among nutrition experts, except for the fact that Dr. Allison was paid to write the document on behalf of the New York State Restaurant Association, which is suing to block the new rules.

Dr. Allison�s role in the debate has angered some members of the Obesity Society, setting off an e-mail fury since word of his court filing began to circulate. Some have pointed to Dr. Allison�s other industry ties, which have included advisory roles for Coca-Cola, Kraft Foods and Frito-Lay.

Many of the group�s 1,800 members are �completely mad that a president-elect of the Obesity Society, an organization that cares about obesity and cares about healthy eating, wants to hold back information from people that helps them make healthy choices,� said Dr. Barry M. Popkin, a member of the organization, who is director of the Interdisciplinary Obesity Center at the University of North Carolina, Chapel Hill.

Dr. Allison, a professor of biostatistics and nutrition at the University of Alabama, Birmingham, is scheduled to start a one-year term as president of the Obesity Society in October. He has defended his affidavit. In a telephone interview, he said he did not take a position for or against menu labeling in the document but merely presented the scientific evidence that the labeling might deter over-eating but might not and, in fact, might be harmful.

He also defended his work for the restaurant industry, but would not disclose how much he was paid for his efforts.

�I�m happy to be involved in the pursuit for truth,� Dr. Allison said. �Sometimes, when I�m involved in the pursuit for truth, I�m hired by the Federal Trade Commission. Sometimes I help them. Sometimes I help a group like the restaurant industry. I�m honored that people think my opinion is sufficiently valued and expert.�

The executive vice president for the restaurant association�s metropolitan New York chapters, E. Charles Hunt, said that Dr. Allison was retained by the association�s lawyers. �Obviously, a lot of it was in favor of our position,� Mr. Hunt said, �although he didn�t come right out and say that.�

So this sounds like yet another story about conflicts of interest, and their possible effects influencing the publicly expressed opinions of a prominent academic. As usual, the conflicted party angrily denied that his financial relationships could have affected his scientific judgment. As we have noted before, this is undoubtedly a sincere belief, but psychological evidence and common sense suggests that having financial ties to organization x may influence one to take positions in line with organization x's interests, even if these influences do not reach conscious thought.

The variant here seems to be that the academic had a financial relationship not with a drug, biotechnology or device company, the usual suspects, but with an association of restauranteurs.

But wait, Mr Stark added more in his story in the Philadelphia Inquirer,

The relationship between academic researchers and industry is a front-burner issue in many fields. Several congressional inquiries are looking at drug-firm support for the American College of Cardiology, the national cardiology group, and the American Heart Association.

Compared with those groups, the Obesity Society, based in Silver Spring, Md., would seem like a tiny outpost with its $2.1 million budget. But the group's 1,800 members include many influential researchers, physicians and dietitians.

The society relies heavily on industry money, raising about $1 million in the last year from various companies, said Morgan Downey, the group's executive vice president. The biggest corporate donors were drugmakers sanofi aventis, GlaxoSmithKline and Allergan as well as the health-care conglomerate Covidien, he said.

About $230,000 of the corporate money funded a conference in September for health advisers to presidential candidates, Downey said.

Fast forward to this week, when Ms Saul reported in the New York Times that Dr Allison is giving up his leadership position for the Obesity Society,

A dispute over food industry influence has resulted in the resignation of the incoming president of the Obesity Society.

Dr. David B. Allison, who was to take over the society, a national group of obesity doctors and researchers later this year, submitted his resignation from that position on Friday.

So what happened? Did the Obesity Society cast out a leader because he had conflicts of interest that interfered with his ability to advance science, education and clinical practice? Or did the Obesity Society cast out a leader because he was aligned with commercial interests opposed to the commercial interests that provide most of the society's support? That is, was he cast out not because he had conflicts of interest, but because he did not have the same conflicts of interest as the society?

Who can tell?

Once again, this case is an illustration of the pervasiveness of conflicts of interest affecting health care organizations. It also shows how the pervasiveness of such conflicts sometimes makes it impossible to discriminate debates about science and health policy from the claims of conflicting pitchmen.

Full disclosure of these conflicts beforehand would at least have given warning that the nature of the debate was ambiguous.

But to figure out the best answer in the current policy debate, that is, whether it really is a good idea to have legislation to put calorie counts on restaurant menus, would really require the input from people who are not paid by either restauranteurs, or those selling obesity treatments. Fat chance that will happen soon.