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Penalized NIH Researcher Retires
The senior NIH researcher who became a symbol of the agency's improper entanglements with drugmakers - and whose lasting presence on the federal payroll enraged members of Congress -has retired from the government, The Los Angeles Times reports.
Dr. P. "Trey" Sunderland III accepted about $612,000 in consulting and speaking fees from Pfizer and about $200,000 from other companies from 1998 to 2004, all without getting required NIH approvals in advance. He pleaded guilty five months ago to a federal conflict-of-interest charge and agreed to pay $300,000 to the government and to perform community service.
Sunderland's retirement surfaced in a probation report filed Thursday with a U.S. District Court in Baltimore. The probation officer, Rasheed J. Tahir, wrote that Sunderland "is now privately practicing psychiatry." Sunderland has paid the government about one-third of the $300,000 in restitution and performed three-fourths of his required community service, the report said.
Sunderland, 55, a psychiatrist who specialized in researching Alzheimer's disease, had remained on the federal payroll through March. His case was among scores that prompted a sweeping ban of drug-company consulting fees and other industry compensation to NIH employees. The ban, which was ordered in 2005 by the NIH director, was fought by many scientists at the agency who wanted the income from the drug companies.
The timing of the ban is of renewed relevance for Sunderland: He told colleagues at a national psychiatric research conference in December 2006 that he was a consultant to Pfizer and another drug-maker, AstraZeneca. Conference materials also show that Sunderland reported that he had received honoraria, typically fees for speaking or making appearances, from Pfizer, Bristol-Myers Squibb and Janssen Pharmaceuticals, a unit of J&J.
Reached by telephone at the NIH headquarters in Bethesda, Md., Deputy Director Raynard S. Kington declined to say whether the agency had granted Sunderland special permission to accept compensation from any of the four drug companies. Sunderland's lawyer, Robert F. Muse, declined comment on his client's disclosures at the December conference. He also declined to discuss terms of Sunderland's discharge and retirement.
You can read the full story here.
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A Big Spike In Seroquel Lawsuits
In just the last month, plaintiffs have filed more than 350 products-liability cases in Delaware state court against AstraZeneca over its Seroquel schizophrenia drug, a surge exceeding the total number of cases filed there in the last two years.
The National Law Journal reports that plaintiffs lawyers contend that there is nothing behind the uptake - they point out that Delaware is AstraZeneca's home state and the cases would have been filed eventually anyway. But a defense observer believes plaintiffs lawyers may be trying to force an early settlement of the Delaware cases that would influence the settlement of the rest of the litigation - and avoid the federal multidistrict litigation in Tampa - because Delaware is on a fast track for trial and discovery.
The lawyers are posturing nicely. Mike Kelly, managing partner of McCarter & English's Wilmington office, who leads AstraZeneca's Seroquel defense team in Delaware state court, says the drugmaker won't settle. "In boxing terms, we will go toe to toe - no 'rope a dope' here. We stand behind Seroquel, which is a great product that has helped a lot of people."
But Paul Pennock of Weitz & Luxenberg in New York, who is co-lead plaintiffs counsel in the federal Seroquel MDL, lead counsel in New Jersey and also involved in the Delaware litigation, calls AstraZeneca's approach "foolish." "We're going to take scorched earth back at them."
If the surge in Delaware is part of a strategy, its aim is to spread out large numbers of cases to give plaintiffs "as many different pressure points on AstraZeneca as we can obtain," he says.
The litigation arose from a label change ordered by the FDA four years ago, indicating patients are at a heightened risk of contracting diabetes. No link has been proven, but plaintiffs who took the drug before that date claim injury and a lack of adequate warnings.
Pennock notes that Lilly settled litigation over Zyprexa and agreed to pay more than $1 billion to settle 28,500 state and federal claims while denying liability. That litigation has been notable thanks to a controversy over public disclosure of thousands of pages of documents indicating Lilly failed to disclose side effects and improperly marketed its drug to docs.
You can read the full story here.
Hat tip to Furious Seasons.
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Docs Reap Millions From Anemia Drugs
Amgen and Johnson & Johnson are are paying hundreds of millions of dollars to docs every year in return for giving their patients anemia meds, which regulators now say may be unsafe at commonly used doses, The New York Times reports this morning.
This is what the story says: The payments are in the form of rebates and are legal, but very few people outside of the docs who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give docs an incentive to prescribe the meds at levels that might increase patients’ risks of heart attacks or strokes.
Industry analysts estimate that such payments — to cancer doctors and the other big users of the drugs, kidney dialysis centers — total hundreds of millions of dollars a year and are an important source of profit for docs and centers. The payments have risen over the last several years as the drugmakers compete for market share and try to expand their business.
Neither Amgen nor Johnson & Johnson has disclosed the total amount of the payments. But documents given to The New York Times show that at just one practice in the Pacific Northwest, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of its drugs last year.
Yesterday, the FDA medical reviewers released a report suggesting usage may need to be curtailed in cancer patients. They cited a lack of evidence to indicate the drugs either improve quality of life or extend survival, while several studies suggest the drugs can shorten a patient's life when used at high doses. The FDA already issued Black Box warnings in March, and a panel meets tomorrow to review usage.
Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, said that both patients and doctors would benefit from fuller disclosure about the payments and the profits that doctors can make from them. “I suspect that Medicare is going to take a very careful look at what is going on here.”
Federal laws bar drugmakers from paying docs to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs.
The rebates inevitably encourage use of the drugs, said Michael Sullivan, who for nine years worked as a business manager for the group of six cancer docs in the Pacific Northwest, before losing his job last year. He provided The Times with documents showing the size of the rebates.
“Personally, I think rebates should go away,” says Sullivan, whose father was a kidney dialysis patient who died of a heart attack while taking one of the anemia drugs. “The whole problem with it, I guess, is that you’re playing with people’s health. It’s not the same as buying widgets.”
Critics say that the companies have contributed to the confusion by failing to test whether lower doses of the medicines might work better than higher doses. “The burden of proof is for companies and industry to demonstrate that a drug is safe at a certain level,” says Ajay Singh, an associate professor at Harvard Medical School.
As Pharmalot has indicated previously, the issue is further clouded by ties some docs have to the manufacturers. For instance, the National Kidney Foundation panel that recently issued guidelines boasts nine of 16 members with financial links to Amgen. And two months ago, the Renal Physicians Association, which is funded, in part, by Amgen and J&J, urged members to be cautious about the FDA warnings.
Lichtenfeld of the ACS tells the Times: “We shouldn’t condemn every oncologist; we shouldn’t condemn the drugs, because of the situation we’re in now.” He's right. But there's absolutely no oversight and patients are relying on their docs to make the best choices based on health, not incentives. Some of these docs and their professional groups appear to be out of control.
You can read the full story here (registration required).
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The golden needle
Two of the world's largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.
The payments are legal, but very few people aside from the doctors who receive them are aware of their size.
Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously, in physicians' offices or dialysis centers.
Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a mark-up over the doctor's purchase price.
Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients' risks of heart attacks or strokes.
Industry analysts estimate that such payments - to cancer doctors and the other big users of the drugs, kidney dialysis centers - total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers.
The payments have risen over the last several years, as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand the overall business.
Neither Amgen nor Johnson & Johnson have disclosed the total amount of the payments. But documents given to The New York Times show that at just one practice in the Pacific Northwest, on the West Coast of the United States, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of the company's drugs last year.
More
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Pfizer Won’t Forget UK’s Aricept Snub
In a first for the UK health system, Pfizer and its marketing partner, Eisai, are taking the National Institute for Health and Clinical Excellence, or NICE, to court next month over the agency's decision to ban Alzheimer's drugs for newly diagnosed National Health Service patients. The court date has been fast-tracked and is set for June 25.
NICE believes drugs like Aricept don't make enough of a difference to be used at all stages of Alzheimer's disease. In the future, the government watchdog wants such meds to be prescribed only for a minority of patients with a moderately severe diagnosis.
Anti-cholinesterase drugs such as Aricept can help but not cure some Alzheimer's patients. They are widely used in other countries, such as the US, but NICE experts calculate that the cost - around $1,994 per patient a year - means they are not cost-effective for most patients.
Hmm....yes, it's a litigous world, but what's next? Will a drugmaker go to court if a government agency declines to approve a drug?
Source: Reuters
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