Docs reject Harvard jobs because of conflict of interest policy?

Well, that’harvard meds  what Dr. Peter Slavin, president of Massachusetts General Hospital, told STAT news in a story about Harvard’s revised conflict of interest policy:

Slavin said the change may help with a recruitment problem: “Some faculty don’t come because they perceive that Harvard Medical School has rules that are much too restrictive.”

Or they leave, according to Gretchen Brodnicki, dean for faculty and research integrity.

 Brodnicki said she has heard anecdotes of faculty leaving, or being unable to conduct specific studies, because of the rule, though she said the impact is hard to measure.

Here’s the new rule:

First, the school is raising the thresholds: Faculty will have to receive at least $25,000 in income (up from $10,000), or hold $50,000 in equity of a publicly traded company (up from $30,000) to trigger the prohibition on clinical research. Faculty still cannot hold any equity in a privately held company if they want to do clinical trials on that company’s product.

Second, the school will now allow faculty to petition for an exemption if they’re over those thresholds and still want to do the research.

 

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Avandia, the Duke Clinical Research Institute and conflict of interest

The  debate over potential bias at the Duke Clinical Research Institute emerging fro  this morning’s Avandia hearing inspired a trip to the archives. This story looked at many of the same issues, which came up when  the Duke clinical trials operation was young.

By Tinker Ready

from The Raleigh News & Observer

Genentech and university researchers wanted to ensure that a study of the comparative effectiveness of  tPA was definitive. Critics say they failed.

By TINKER READY and TRISH WILSON

STAFF WRITERS

THE NEWS & OBSERVER

 3/31/1994  

All corporate research spending on campus isn’t aimed at inventions. Sometimes the goal is to torpedo a competitor.

That was the hope of Genentech, a San Francisco biotechnology company. It paid $55 million for a study comparing its heart attack drug to a far cheaper drug cornering the market for thrombolytics. The drugs dissolve blood clots and reopen arteries after a heart attack.

The study — completed last year — was coordinated at Duke University, where researchers said their goal was to determine which method of using the two drugs would save more lives.

Genentech’s sponsorship of the massive study raised eyebrows, but the company tried to reassure the medical community that the study would be unbiased. A previous tPA study had been dogged by charges of conflict of interest, and Genentech wanted to avoid a replay.

The company chose Duke University to coordinate the research because it had a relationship with Duke scientists and their collaborators, who had worked with tPA in the past.

“If Genentech was forking over the money, they wanted someone to run the study who they trusted, ” said Robert Califf, a Duke cardiologist and the study’s clinical director.

The company also had reason to trust Ralph Snyderman, the top administrator at Duke’s medical center and former Genentech executive. Snyderman left Duke to join Genentech in 1987 as director of research and development. While there, he successfully ushered tPA through a long and contentious Food and Drug Administration approval process before returning to Duke in 1989.

In the end, Genentech’s study paid off. After examining medical records of 41,000 heart attack patients in 15 countries, researchers announced that Genentech’s tPA (about $2,200 a dose) was superior to streptokinase (about $300 a dose). They concluded that the prompt use of tPA could reduce by 14 percent the number of people who died from heart attacks.

Eric J. Topol — a cardiologist at the Cleveland Clinic Foundation and chairman of the study — claimed victory for tPA.

“We have to put to rest this battle of the thrombolytics, ” Topol said at an April 1993 news conference in Washington. “Accelerated tPA was significantly better.”

That day, the price of Genentech stock jumped $4.75 a share to $37.50.

Not everyone shared the stock market’s optimism. Some doctors thought the results were ambiguous and failed to reflect tPA’s risks, particularly a higher incidence of stroke among users.

One member of the steering committee — streptokinase advocate Victor Marder — said Genentech had generated what it wanted.

“On the face of it, Genentech was not part of the decision-making apparatus, ” said Marder, the chief of hematology at the University of Rochester medical school.

On the other hand, he said, the test was not a fair comparison. It compared a hyped-up dose of tPA to a standard dose of streptokinase, Marder said. In addition, he said, he did not think the study properly accounted for the disproportionate number of tPA patients who might have done better because they had undergone heart bypass operations.

When he tried to raise these issues to the steering committee, “everybody got really angry, ” Marder said.

Marder thinks the study fails to prove that tPA is better.

“I don’t think it’s dishonest, he said. “I think it was an exaggerated conclusion made to influence people.”

Califf said that Marder is off the mark. The comparison between the two drugs was valid, he said, and the study accounted for the bypass operations.

Soon, Marder and other critics will be able to see that for themselves, because all the data is about to be published in 40 manuscripts.

“Anyone can look at it and draw their own conclusions, ” Califf said.

Califf doesn’t deny that Genentech had a huge stake in the outcome. But he vehemently denies that the study was designed with a foregone conclusion.

The project began when Califf and Topol — who had done research with tPA — began talking to Genentech about a larger study. At the time, the company was trying to cope with 1990 Italian study that found no significant difference in tPA and streptokinase.

By the time a second damaging European study came out in 1992, Genentech was ready. The company promised that a new, bigger study would definitively prove whether tPA was safer and more effective than its low-cost rival.

That study — know as GUSTO for Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries — was headed by Topol. Duke, with its massive cardiac computer data bases, served as a data clearinghouse.

“They needed to do this study, ” Califf said. “They were losing market share. We were very concerned that the European studies had missed the point.”

Both the company and the researchers wanted to make sure the findings were above question, he said.

The company had good reason to expect skepticism. In 1989, a congressional investigation found that 11 of the researchers involved in the original, federally sponsored studies of tPA owned Genentech stock. That stock became much more valuable when the FDA approved the drug.

So, when GUSTO trials came along, Genentech set up an independent steering committee to run them. None of the researchers could own Genentech stock, nor could they consult for the company until at least a year after release of the final results.

Genentech staff say that Snyderman played no role in bringing the study to Duke. Snyderman said in a recent interview that he still consults for Genentech and will continue to do so for the next couple of months.

“There was absolutely no conflict of interest, ” Snyderman said.

Califf called GUSTO’s ethical precautions “draconian.” Genentech staff saw none of the data and had no role in running the study, he said.

“The risk that Genentech had to take is that they had no control over this trial, ” he said.

Califf said his goal was not to compare the clot busters — it was to find out if a doctor can save more lives if he moves faster to open arteries after a heart attack.

Still, if the study also proved that Genentech makes a better drug, and its corporate fortunes turned around, more power to the company.

“I will not make apologies for industry being involved, ” Califf said. “That’s the American way.”

A closer look at the downside of the Vertex – Cystic Fibrosis Foundation deal

And some comments from the Knight Science Journalism Tracker: 

A new cystic fibrosis drug–the first to be developed based on understanding of the genetics of the illness–is an orphan drug that can help only about 4 percent of patients with cystic fibrosis. Its financial toxicity is such that it can destroy the finances of those whose lives it saves: It costs $307,000 per year. And it sits in the center of a swarm of conflicting interests involving a pharmaceutical company, a non-profit patients’ organization, and researchers who have taken their money

This comes from John Fauber of the Milwaukee Journal-Sentinel, whodescribes a disturbing case 

VertexLogoSOP

Click here for the MJS story:

What happens when a disease-fighting charity dives into venture capitalism?

In the first case of its kind, the results include one of the planet’s most expensive pills, huge sales projections for a drug company and windfalls for executives who sold stock in the glow of enthusiastic news releases abo

ut the drug.

downloadKalydeco is a breakthrough drug designed from knowledge of the genetic roots of cystic fibrosis, a lung disease that kills most victims before they reach middle age. Developed by Vertex Pharmaceuticals with a $75 million investment from the Cystic Fibrosis Foundation, it is an early example of “venture philanthropy,” where a nonprofit helps finance development of a treatment in return for a cut of sales.


Yet it costs each patient $307,000 a year to take two Kalydeco pills a day – a price borne by taxpayers through Medicaid and other government programs and by the workers and companies who finance employee health insurance plans.
Much of the initial science behind Kalydeco involved nonprofit research universities and hospitals, with funding from the Cystic Fibrosis Foundation and by taxpayers through the National Institutes of Health.

In 2012, with less than a full-year on the market, Vertex sold $172 million worth of Kalydeco and the foundation cashed in by selling future royalties from the drug to an undisclosed firm for $150 million. The foundation is investing that money with Vertex and other companies to develop more new drugs.

For more on the links between patient advocacy groups and drug companies, see TR’s  2006 Washington Post story:

Some groups’ Web sites feature the names of their corporate donors, but often these names appear only in an annual report. Exact donation amounts are rarely listed, though some groups are willing to provide numbers on request.

People who look to these groups for independent information may never learn about their financial ties to drug makers. That needs to change, say some consumer advocates, now that nonprofits are playing a larger role in drug safety debates. When disease advocacy groups weigh in on a drug up for review by the FDA’s Drug Safety and Risk Management Advisory Committee, they say, the public may be unaware of potential conflicts of interest.

 

Harvard Pilgrim for Governor

     It does have the magic “H” word in its name. (Not the be confused with   Harvard Vanguard, a group of now unrelated clinics and health centers.) From today’s Globe:

A Boston Globe analysis of contributor reports shows that in seven months (Republican Charlie) Baker’s campaign raised more than $122,000 in contributions tied directly to Harvard Pilgrim (health insurer.) This includes not only $43,000 in contributions from Harvard Pilgrim’s employees, directors, and affiliated companies, but also a broad array of vendors: its accountants, auditing firm, advertising agency, information technology providers, and consultants.

In backlash news, see the item in the NY Times Prescriptions blog/column on how no one loves the Mass plan anymore.  

   Health care legislation in Washington may be stalled, but that has not stopped  legislatures in more than two-thirds of the states from objecting to one of its central planks: a requirement that everyone buy health insurance.

The objections, many of them driven by the Tea Party movement, may turn out to be largely symbolic. But they nonetheless serve notice to President Obama and the Democrats of real anger over their health care plans and signal the potential for political upheaval down the road.

These measures, which are in various stages of ripening in about 36 states, could also pave the way for a major court challenge.

Tufts doc warns of industry influence on health reform

The pharma watchdogs at Gooz News point out that: 

The latest New England Journal of Medicine contains a scathing perspective denouncing the Senate’s health care reform bill for giving industry too much control over a new comparative effectiveness research (CER) agency, an issue I tried to call attention to in Health Tech Review (Sept. 28, 2009). The Senate bill guarantees at least three of 15 slots on the new CER agency’s board to industry representatives, and would involve those board members in designing studies.

For the uninitiated, comparative effectiveness research (CER) is the study of what works and what doesn’t in health care. So, while industry should have a seat at the table, know that they are likely to take this position — the stuff I sell works. 

One of the authors is Dr. Harry Selker  of Tufts, who “studies the factors that affect clinical care and its outcomes, and develops treatment strategies, decision aids, and computer-based systems for improving care.  He is known for a series of studies of the factors influencing emergency cardiac care, including clinical, socioeconomic and gender issues, and is particularly known for the development of cardiac “clinical predictive instruments.”  These decision aids provide emergency physicians with predictions of their patients’ key outcomes for real-time use in clinical care.”

 So, he knows this stuff and it may have saved you life if you ended up in the New England Medical Center with a heart attack

 Here’s what he says in NEJM.

 If health care reform legislation does not promote CER that is free of the potential taint of commercial and political meddling, the public will have little confidence in the results of such research. This outcome would be extremely unfortunate, since such research has the potential to improve patients’ lives by leading to more effective medical care. The U.S. biomedical research enterprise has a long and storied history that has made it a model for other countries. It would be a tragedy if we were to squander its achievements for political expediency, in the service of short-term commercial interests. The current proposals for controlling CER in a manner unlike anything we have seen in federally sponsored biomedical research therefore should be rejected.