Harvard doctors punished over pay, 3 accused of not disclosing consulting fees

**HoustonTX** · 07-03-2011, 03:27 PM

By Liz Kowalczyk
Globe Staff / July 2, 2011

Concluding a three-year investigation, Massachusetts General Hospital and Harvard Medical School sanctioned renowned child psychiatrist Dr. Joseph Biederman and two colleagues after finding they violated conflict of interest rules.

In a letter to coworkers yesterday, Biederman and Drs. Thomas Spencer and Timothy Wilens said the hospital and medical school “have determined that we violated certain requirements’’ of the institutions’ policies.

They did not specify the nature of the violations. But in 2008, Senator Charles Grassley, an Iowa Republican, accused the three doctors of accepting millions of dollars in consulting fees from drug makers from 2000 to 2007, and of failing for years to report much of the income to university officials.

Officials at Harvard and Mass. General released the letter to the Globe, but would not answer questions about the probe. Biederman, Spencer, Wilens, and their lawyers did not return phone calls and e-mails. Grassley’s office did not return calls seeking comment.

Physicians are required to disclose payments from pharmaceutical and medical device companies so that hospital and university officials can police potential conflicts of interest that may create bias in research or in the treatment of patients, or the appearance of bias.

Grassley’s investigation sparked the Mass. General and Harvard inquiries.

The three psychiatrists apologized in their letter for the “unfavorable attention that this matter has brought to these two institutions.’’ They called their mistakes “honest ones’’ but said they “now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.’’

They said the institutions imposed remedial actions, requiring them to refrain from all paid industry-sponsored outside activities for one year, with an additional two-year monitoring period during which they must obtain approval before engaging in paid activities. They were also required to undergo unspecified additional training and suffer “a delay of consideration for promotion or advancement.’’

Physicians said it is difficult to know if the sanctions are appropriate without knowing the Harvard and Mass. General findings.

“It’s hard for me to make that judgment, but this all sounds like a little slap on the wrist,’’ said Dr. Jerome Kassirer, a Tufts University School of Medicine professor and outspoken critic of close ties between the drug industry and physicians. He pointed out that Biederman is a full professor at Harvard Medical School, so it’s unclear how a delay in promotion or advancement would affect him. Also, Biederman severed his industry ties soon after Mass. General and Harvard began their separate but coordinated investigations.

But Dr. Benjamin Liptzin, chairman of psychiatry at Baystate Medical Center in Springfield, said he believes the actions “send a serious message that the hospital and medical school take this seriously.’’

Doctors agreed that since the mid-2000s physicians, particularly psychiatrists, are more cautious about taking money from drug companies, and about disclosing the money they do earn. Responding in part to public distrust, hospitals and universities - including Mass. General and Harvard - have further limited how much money doctors can accept and are more stringently enforcing disclosure requirements.

Biederman is the country’s most prominent advocate of diagnosing bipolar disorder in children, even in those under age 6, and using antipsychotic drugs to treat many of them. He became one of the central figures in the growing legal and political backlash against potential conflicts of interest in medicine.

Congressional investigators led by Grassley accused Biederman, Spencer, and Wilens of failing to disclose more than $1 million each in payments they received from industry over the eight years. In addition, documents in a lawsuit portrayed Biederman as courting drug company money by promising that his work at Mass. General would help promote the use of antipsychotic drugs for youngsters - a characterization Biederman has said is untrue.

Liptzin said that, during those years, it was common for companies to fund clinical trials of psychiatric drugs and then hire the physician investigator as a consultant to speak about the results across the country.

“It’s very seductive because doctors were able to make substantial money,’’ he said. Liptzin said he became uneasy when, after giving talks, drug sales people would tell him “you could have made more nice statements about the drug.’’

Now, he said, “far fewer doctors accept payments, and those that do are far more careful about disclosure. People understand that we need to be as objective as possible in advancing our knowledge.’’

Dr. Daniel Carlat, a psychiatrist, Tufts medical school professor, and critic of the drug industry, said “it was almost expected that if you were an academic that you were working with industry.

If you were at a very high level institution like Harvard, there was almost a sense that you were entitled to receive a lot of perks and money for various activities from industry,’’ he said.

“When I get on the phone now and talk to a colleague about a study that just came out, there is much more talk about, ‘Was this industry funded, and can we trust the study?’ ’’

Source: http://www.boston.com/lifestyle/heal...nsulting_fees/

Why should you care about this Biederman guy, you ask? Because the surge in bipolor diagnoses in children is in large part thanks to this "research." And, because you are paying out the arse for all the children to be blitzed on antipsychotics.

**Macadoo** · 07-03-2011, 06:19 PM

What's worse, the Brit Doctor that ginned up peer reviewed 'research' on connections between autism and vaccinations at the behest of lawyers or these 'Doctors' who's 'research' will have hundreds of thousands if not millions of people hooked on psychotropic drugs? Of course we don't really know the scope of this one yet because of the fear of litigation. The irony of it is, after it's all said and done, probably the only ones that will come out ahead will be the lawyers with their class action suits. Also kinda calls into question the peer review process at medical and scientific journals if the deck is stacked with sympathetic reviewers.

**HoustonTX** · 07-04-2011, 01:10 PM

Yeah, the lawyers are already cashing in on this. Have you noticed all the fines paid over the past several years for off label promotion of meds for psych use?

Look at all the books that have come out by these folks encouraging the bipolar kid fad (probably the same thing for autism). Is your child irritable? Might be bipolar disorder...

http://1boringoldman.com/index.php/2...-irritability/

**Macadoo** · 07-04-2011, 05:44 PM

Makes you wonder how much of this stuff is ginned up so that all the coverage creates controversies that can be taken advantage of. You can't be cynical enough these days and all such 'studies' should be viewed with jaundiced eye.

**Macadoo** · 09-10-2011, 06:16 PM

An array of errors
Investigations into a case of alleged scientific misconduct have revealed numerous holes in the oversight of science and scientific publishing
Sep 10th 2011 | from the print edition

ANIL POTTI, Joseph Nevins and their colleagues at Duke University in Durham, North Carolina, garnered widespread attention in 2006. They reported in the New England Journal of Medicine that they could predict the course of a patient’s lung cancer using devices called expression arrays, which log the activity patterns of thousands of genes in a sample of tissue as a colourful picture (see above). A few months later, they wrote in Nature Medicine that they had developed a similar technique which used gene expression in laboratory cultures of cancer cells, known as cell lines, to predict which chemotherapy would be most effective for an individual patient suffering from lung, breast or ovarian cancer.

At the time, this work looked like a tremendous advance for personalised medicine—the idea that understanding the molecular specifics of an individual’s illness will lead to a tailored treatment. The papers drew adulation from other workers in the field, and many newspapers, including this one (see article), wrote about them. The team then started to organise a set of clinical trials of personalised treatments for lung and breast cancer. Unbeknown to most people in the field, however, within a few weeks of the publication of the Nature Medicine paper a group of biostatisticians at the MD Anderson Cancer Centre in Houston, led by Keith Baggerly and Kevin Coombes, had begun to find serious flaws in the work.

Dr Baggerly and Dr Coombes had been trying to reproduce Dr Potti’s results at the request of clinical researchers at the Anderson centre who wished to use the new technique. When they first encountered problems, they followed normal procedures by asking Dr Potti, who had been in charge of the day-to-day research, and Dr Nevins, who was Dr Potti’s supervisor, for the raw data on which the published analysis was based—and also for further details about the team’s methods, so that they could try to replicate the original findings.

A can of worms

Dr Potti and Dr Nevins answered the queries and publicly corrected several errors, but Dr Baggerly and Dr Coombes still found the methods’ predictions were little better than chance. Furthermore, the list of problems they uncovered continued to grow. For example, they saw that in one of their papers Dr Potti and his colleagues had mislabelled the cell lines they used to derive their chemotherapy prediction model, describing those that were sensitive as resistant, and vice versa. This meant that even if the predictive method the team at Duke were describing did work, which Dr Baggerly and Dr Coombes now seriously doubted, patients whose doctors relied on this paper would end up being given a drug they were less likely to benefit from instead of more likely.

Another alleged error the researchers at the Anderson centre discovered was a mismatch in a table that compared genes to gene-expression data. The list of genes was shifted with respect to the expression data, so that the one did not correspond with the other. On top of that, the numbers and names of cell lines used to generate the data were not consistent. In one instance, the researchers at Duke even claimed that their work made biological sense based on the presence of a gene, called ERCC1, that is not represented on the expression array used in the team’s experiments.

Even with all these alleged errors, the controversy might have been relegated to an arcane debate in the scientific literature if the team at Duke had not chosen, within a few months of the papers’ publication (and at the time questions were being raised about the data’s quality) to launch three clinical trials based on their work. Dr Potti and his colleagues also planned to use their gene-expression data to guide therapeutic choices in a lung-cancer trial paid for by America’s National Cancer Institute (NCI). That led Lisa McShane, a biostatistician at the NCI who was already concerned about Dr Potti’s results, to try to replicate the work. She had no better luck than Dr Baggerly and Dr Coombes. The more questions she asked, the less concrete the Duke methods appeared.

In light of all this, the NCI expressed its concern about what was going on to Duke University’s administrators. In October 2009, officials from the university arranged for an external review of the work of Dr Potti and Dr Nevins, and temporarily halted the three trials. The review committee, however, had access only to material supplied by the researchers themselves, and was not presented with either the NCI’s exact concerns or the problems discovered by the team at the Anderson centre. The committee found no problems, and the three trials began enrolling patients again in February 2010.

Finally, in July 2010, matters unravelled when the Cancer Letter reported that Dr Potti had lied in numerous documents and grant applications. He falsely claimed to have been a Rhodes Scholar in Australia (a curious claim in any case, since Rhodes scholars only attend Oxford University). Dr Baggerly’s observation at the time was, “I find it ironic that we have been yelling for three years about the science, which has the potential to be very damaging to patients, but that was not what has started things rolling.”

http://www.economist.com/node/21528593

**HoustonTX** · 09-11-2011, 02:04 AM

Yeah, results kind of need to be reproducible or you've got problems, unless it's psychiatric research and then they just blame the ineffective drugs on the patient, calling them treatment resistant.

**Macadoo** · 09-11-2011, 04:01 AM

Originally Posted by HoustonTX

Yeah, results kind of need to be reproducible or you've got problems, unless it's psychiatric research and then they just blame the ineffective drugs on the patient, calling them treatment resistant.

And none of the academic types picked up on this one:

He falsely claimed to have been a Rhodes Scholar in Australia (a curious claim in any case, since Rhodes scholars only attend Oxford University).

The popular terminology now is 'credentialed, not educated'.....