via advfn.com
Wednesday, March 31, 2010
Big Pharma’s solution for our health woes: more and more pills for the elderly
DRUG BUST by Alan Cassels
via commonground.ca
Pfizer is latest to disclose payments to docs - MSN Money
The Associated Press
(AP) - Four major companies have made voluntary disclosures about payments to doctors, hospitals and other medical professionals under pressure for more openness about the practice. Critics say such payments can influence doctors' decisions about drugs and other treatments.
Drugmakers will be required to make such disclosures in 2013 for payments made in 2012 under the health overhaul law that President Barack Obama signed last week.
A brief overview of major drugmakers' disclosures:
— Pfizer Inc. said Wednesday that it gave doctors and teaching hospitals a total of $34 million in the last half of 2009 for services ranging from speaking to other doctors about the company's products to running studies of its experimental drugs.
—Britain's GlaxoSmithKline PLC in February 2009 posted fourth-quarter 2008 grants and contributions to hospitals and other health care organizations, then began posting quarterly payments to physicians for speaking to other doctors and for consulting services, starting with the second quarter of 2009.
—Eli Lilly & Co. began disclosing how much money it paid to individual doctors for advice, speeches and other services on July 31, 2009. It reports payments exceeding $500 every quarter.
—Merck & Co. announced in February that it paid doctors and nurses a total of $9.4 million in the third and fourth quarters of 2009 to give talks to colleagues about the drugmaker's products and other health topics.
— Johnson & Johnson, the world's biggest maker of health care products with more than $60 billion in annual revenue, has said its pharmaceutical business will begin reporting physician payments in the first half of this year. That will later expand to include its medical devices and diagnostics unit.
___
Source: AP reporting.
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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Boehringer's Flomax Relief goes on sale in UK pharmacies | Reuters
via reuters.com
Flomax Relief, or tamsulosin hydrochloride, for benign prostatic hyperplasia (BPH), will cost 16.99 pounds ($25.54) for a pack of 28 capsules lasting four weeks, maker Boehringer Ingelheim of Germany said.
It is the first time the medicine has been made available without prescription anywhere in the world.
The launch also represents a first in bringing a product for men's health into the over-the-counter (OTC) arena, although Pfizer has been exploring a non-prescription version of its popular impotence drug Viagra.
Risks Seen in Wider Use of Statins Like Crestor - NYT
Some medical experts question whether this is a healthy move.
They point to mounting concern that cholesterol medications — known as statins and already the most widely prescribed drugs in the United States — may not be as safe a preventive medicine as previously believed for people who are at low risk of heart attacks or strokes.
Statins have been credited with saving thousands of lives every year with relatively few side effects, and some medical experts endorse the drug’s broader use. But for healthy people who would take statins largely as prevention — which would be the case for the new category of Crestor patients — other experts suggest the benefits may not outweigh any side effects.
Among the risks raising new concerns, recently published evidence indicates that statins could raise a person’s risk of developing Type 2 diabetes by 9 percent.
“It’s a good thing to be skeptical about whether there may be long-term harm from healthy people taking a drug like this,” said Dr. Mark A. Hlatky, a professor of health research and cardiovascular medicine at the Stanford University medical school.
There is also debate over the blood test being used to identify the new statin candidates. Instead of looking for bad cholesterol, the test measures the degree of inflammation in the body, but there is no consensus in the medical community that inflammation is a direct cause of cardiovascular problems.
The Food and Drug Administration approved the new criteria last month for Crestor, which is made by AstraZeneca and is the nation’s second best-selling statin, behind Lipitor by Pfizer. AstraZeneca plans soon to begin a new marketing and advertising campaign for Crestor, based on the new F.D.A.-approved criteria.
Under those criteria, an estimated 6.5 million people in this country who have no cholesterol problems and no sign of heart problems will be deemed candidates for statins. That is in addition to the 80 million who already meet the current cholesterol-based guidelines — about half of whom now take statins.
The new Crestor label says it may be prescribed for apparently healthy people if they are older — men 50 and over and women 60 and over — and have one risk factor like smoking or high blood pressure, in addition to elevated inflammation in the body.
Some patients have long complained of muscle aches from taking statins. And doctors periodically check patients on the drugs to make sure liver enzymes are not abnormally high. Doctors, though, have generally seen those risks as being more than offset by the drugs’ benefits for people with high levels of “bad” cholesterol and a significant risk of cardiovascular disease.
But then came the unexpected evidence linking statins to a diabetes risk, reported last month in the British medical journal The Lancet. That report was based on an analysis of most of the major clinical studies of statins — including unpublished data and the results of the Crestor study that the F.D.A. reviewed. “We’ve had this drug for a while, and we’re just now finding out that there’s this diabetes problem with it?” said Dr. Hlatky.
The F.D.A. acknowledged the diabetes risk, and told AstraZeneca to add it to Crestor’s label. But the agency nonetheless approved the new use on the basis of the clinical study, which showed a small but measurable reduction of strokes, heart attacks and other “cardiovascular events” among people taking the statin, compared with patients taking a placebo.
“It’s an important milestone for the company and for the patient,” said Jim Helm, AstraZeneca’s vice president for cardiovascular products. “We are already discussing this with physicians.”
Dr. Eric C. Colman, a deputy director of the F.D.A. center for drug evaluation, said the decision provided an option, not a mandate, for doctors and patients. “It’s good to hear that physicians are debating the potential benefits and risks of drugs,” Dr. Colman wrote via e-mail on Tuesday.
An F.D.A. advisory committee had voted 12-4 in favor of expanding the usage in December, with some dissenters questioning the value of the test measuring elevated levels of inflammation.
The new Crestor guidelines continue a steady expansion of the number of people considered candidates for statins over the last decade. The recommendations and guidelines have been expanded by various advisory panels — many of whose members have also done paid consulting work for the drug industry.
Another of those panels is now preparing statin guidelines due next year, which are expected to further expand the number of candidates for the drugs.
The clinical trial on which the F.D.A. approved the new Crestor use was a global study of nearly 18,000 people. It looked only at patients who had low cholesterol and an elevated level of inflammation in the body as measured by a test called high-sensitivity C-reactive protein, or CRP.
It was the inventor of the CRP test, Dr. Paul M. Ridker, a Harvard medical professor and cardiologist at Brigham and Women’s Hospital in Boston, who persuaded AstraZeneca to pay for the statin study, which he then led.
Dr. Ridker said his proposals for such a study had been turned down by the National Institutes of Health and at least two other companies. One was Pfizer, whose statin Lipitor will lose patent protection next year and will be sold in inexpensive generic forms. The other was Bayer, whose statin Baycol was removed from the market in 2001 after it was linked to 52 deaths from a rare muscle disorder.
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via nytimes.com
A song for the Pfired
It's nine o'clock on a Tuesday
The regular crowd shuffles in.
There's some people, sitting in a cubicle,
Logging into their Outlook accounts.
It says, "Hi, can you see me this morning”
I'm not really sure what it’s for.
But it's sad and it's fast and I knew it’s complete
It’s that my boss just has shown me the door."
la la la, di da da
La la, di di da da dum
Chorus:
Sing us a song, you're the Hatchet Man
Sing us a song today
Well, we're all in the mood for some Bad News,
And Jeff’s got us, All feelin' up tight.
Now John at the bench is a friend of mine
He’s new and he works with me.
And he’s fast as the rest and he'll clean up your mess
But there's some place that he'd rather be
He says, "Bill, I believe this is killing me."
As his smile ran away from his face
"Well I'm sure that I could be a good scientist,
If I could get out of this place"
Oh, la la la, di da da
La la, di da da da dum
Now Paul is a Ph.D. Chemist
Who never had time for a wife
And he's talkin' with Mary, who's still is contrary,
And probably she will be for life.
And the Director is practicing politics
As the manager slowly gets told,
Yes, Frank’s selling a plan called Path Forward,
But it's leaving us out in the cold
Chorus
Sing us a song, you're the Hatchet Man
Sing us a song today
Well, we're all in the mood for some Bad News,
And Jeff’s got us, All feelin' up tight.
It's a pretty good crowd for a Tuesday.
And the manager gives me a frown.
'Cause he knows that it's me they've been comin' to see,
To tell us our jobs were let go.
Though the layoffs, it seems like eternity.
And the manager, he looks really tired.
And they sit at their desk and tell me I’m gone
And say, "Man, you are done and you’re Pfired”
Oh, la la la, di da da
La la, di da da da dum
Chorus:
Sing us a song, you're the Hatchet Man
Sing us a song today
Well, we're all in the mood for some Bad News,
And Jeff’s got us, All feelin' up tight.
Thieves Eye Pharma Drugs for Millions - CBS News
via cbsnews.com
Close to $300 billion in prescription drugs are sold in the United States each year, making it a big business that's become a big target for thieves.
In the last year, there have been five major heists, each netting at least $10 million. When a drug warehouse in Virginia was recently robbed, authorities believed it was the act of a major prescription drug theft ring, reports CBS News correspondent Manuel Gallegus.
Drug firm Amphastar investigated FDA officials
via politico.com
For more than two months in late 2008, private investigators working for a drug company gathered information on a high-ranking official at the Food and Drug Administration – unearthing details about her husband, two daughters, and in-laws, and re-tracing her steps on a business trip she took to Thailand.
The drug company, Amphastar Pharmaceuticals Inc., paid more than $100,000 to Kroll, the New York-based private investigative firm, to uncover the information about Janet Woodcock (pic), director of the FDA’s Center for Drug Evaluation and Research, who overees the agency’s new-drug approvals.
Tuesday, March 30, 2010
FDA seeks more detail on Astra/Abbott cholesterol drug - NewsFlash
US seeks more detail on Astra cholesterol drug
3/30/2010, 9:12 a.m. EDT The Associated Press
(AP) — LONDON - AstraZeneca PLC and Abbott Laboratories said Tuesday that the U.S. Food and Drug Administration has asked for more information about their Certriad cholesterol drug before approving it for sale.
The companies said that FDA has sought more data in a so-called complete response letter (CRL) to their new drug application, which combines their cholesterol pills TriLipix and Crestor.
Abbott's TriLipix is part of a class of drugs called fibrates that raise "good" HDL cholesterol while reducing triglycerides and "bad" LDL cholesterol. AstraZeneca's Crestor is a statin drug that lowers bad cholesterol while raising good cholesterol.
Studies conducted by the companies compared the combination pill versus separate treatment with statin and fibrate drugs.
The companies' application to the FDA seeks approval to treat dyslipidemia, a disorder characterized by elevated cholesterol and triglycerides, a type of fat found in the blood stream. More than 100 million adults in the U.S. have the disorder, according to the American Heart Association.
The companies said they will continue discussions with the FDA to "determine the next steps," while responding to the request for more information.
via silive.com
Staffer: FDA suppressed imaging safety concerns
A former Food and Drug Administration scientist said Tuesday his job was eliminated after he raised concerns about the risks of radiation exposure from high-grade medical scanning. Dr. Julian Nicholas told an audience of imaging specialists that he and other FDA staffers "were pressured to change their scientific opinion," by managers in the agency's medical device division. Nicholas, now a physician at the Scripps Clinic in San Diego, said he and eight other staffers raised their concerns with the division's top director last September. "Scientific and regulatory review process for medical devices was being distorted by managers who were not following the laws," Nicholas said. A month later Nicholas' position was "terminated," he said.
via boston.com
Monday, March 29, 2010
If we’re well, we simply don’t need medicine - Dr James Le Fanu
via telegraph.co.uk
James Le Fanu accuses pharmaceutical companies of fuelling the demand for 'lifestyle’ drugs .
Forest - Celexa: The Dr. Anne-Liis von Knorring Affair
The U.S. Department of Justice has sued the pharmaceutical company Forest Labs about the marketing of the antidepressant Celexa for use by children. It’s an affair about bribery, illegal marketing and cover-up of a drug trial with negative results. The company has set aside $170 million to settle the civil aspects of the matter with the government. That does not cover the potential criminal law violations. What has not been told is the important role played by the renowned European Professor of Psychiatry Dr. Anne-Liis von Knorring in this affair. She not only helped the company to cover up the bad results of her clinical trial of Celexa, she also actively misled doctors and the public about it.
Read the full story on http://jannel.se/celexa-cover-up.pdf
Source
Novartis / Antisoma : ASA404 - clinical trials, ain't they a bitch!
Antisoma's ASA404 doesn't show a survival benefit in a Phase III lung cancer study. The drug was one of company's two key late-stage products. ASA404 was being developed with Novartis.
via uk.reuters.com
THE INFLUENCE GAME: Lobbying pays off as drug industry hits jackpot with health overhaul.
"Pharma came out of this better than anyone else," said Ramsey Baghdadi, a Washington health policy analyst who projects a $30 billion, 10-year net gain for the industry. "I don't see how they could have done much better."
Expensive treatments lacking clinical evidence « The Science Business
In the latest print issue of Forbes, check out Pricey Little Pill, an essay on the history of Nexium from a health insurance and health dollars point of view. The story focuses on Rx spending, which is actually growing less rapidly than other health categories, at least for the moment. Back in the early part of the decade drug spending caused major heartburn, putting up double-digit annual growth figures that are similar to hospital rate increases today. The broader point is that whether it's Nexium or an expensive but dubious surgery--the health overhaul will do little to contain unnecessary spending.
Here are other Forbes stories in the "waste genre"--about expensive treatments lacking clinical evidence:
When to Say No to Your Doctor Find out how much of the $2.5 trillion we spend on health care goes down the drain for tests and treatments that don't help--and may even cause harm.
Not Hot Enough: Ultrasound beams will someday replace painful surgeries, but not until the practice gains trust.
Back Surgery on Trial: Does back surgery really work?
Pill Pushers: How the drug industry abandoned science for salesmanship.
via blogs.forbes.com
Sunday, March 28, 2010
Pharma Giles writes .... Don Kindlero - The Drugfather
So I have been-a da Big Cheese of da Pfizer family for da last four or five years or so. Da Pfizer Family issa one-a big a-happy Family, and issa also a Family dat a-makes a lotta money for me anna da boys an’ girls.
Like-a all da big Families, da Pfizer Family has a-values. One of da big a-values we have is a-Respect for People. We are verra big onna Respect for People. So when I pick uppa da newspaper an see dat dere seems to be dis guy who is a costin’ da Family a whole lotta bread, I am notta so happy, you see? Zis guy is not showin’ a-Respect, I am a-thinkin’ to myself, an’ guys who do not show a-Respect, well, dey are verra soon gonna get “Adapted To Scale” if you know what I am a-sayin’.
So I pick uppa da phone an’ I ringa ma lawyer, Amy. Me anna Amy go a-way back, she is like a sister to me.
“Amy,” I say, “Don Kindlero here. Now tella me, Amy, who issa dis guy Rico and why has he justa costa me $142 million?”
“Don Kindlero,” Amy says to me, “issa good to hear a-from you. I love you like-a my own a-father…”
“Amy, Amy,” I say to her, “cutta da Family crapola and tell me about-a dis Rico, won’t you?”
And Amy says to me, “Don Kindlero, I think you misunderstand…”
“Amy, what is there not to understand?” I say to her. “$142 million, I understand verra well. Why do you not show me no a-Respect, Amy? Maybe I should have you Adapted To Scale or something, perhaps? Please, show me some a-Respect…”
“Don Kindlero, this Rico, he is not a man,” says Amy, “RICO is the legal shmegal for the Racketeer Influenced and Corrupt Organizations Act. You remember? Neurontin?”
It was then I remembered da Family history. Papa Steere and the Lipitor heist. $400 million fines for off-label marketing. The Warner-Lambert Family was gunned down years ago, but still the off-label marketing scams still live on even today.
“Amy, why do you not tella me dese tings?” I say to her. “I am a-thinkin’ that maybe Rico was another whistleblower we have to make-a life hard for, now you are telling me RICO issa just another corporate malfeasance fine we a-have to pay? For racketeering? Racketeering? You make us sound like a two-bit Sicilian mob instead of the biggest corporate criminals in the US, Amy.”
“I am ashamed, Don Kindlero,” says Amy. “$142 million is peanuts compared to the $2.3 billion we went down for the Bextra marketing scam.”
“Amy, Amy, donta remind me,” I say to her. That was a billion-dollar hangover from another Family hoist, Uncle Hank’s Pharmacia take-over. “What bum was the General Counsel who overlooked the hidden liabilities for that takeover?” I asked her.
“I think you were, Don Kindlero,” Amy says.
Isn’t Family embarrassing?
What nasty surprises are lurking under the Wyeth rock, I wonder…?
Saturday, March 27, 2010
All quiet on major deal front for drugmakers
* Remaining players seen avoiding big deals for now
* Patent cliff puts focus on Bristol, Lilly, Astra, Sanofi
Hospital wards to shut in secret NHS cuts - Telegraph
via telegraph.co.uk
The plans are contained in a series of internal NHS documents uncovered by The Daily Telegraph.
The final details of the plans are not due to be announced until the autumn, well after the country has gone to the polls for the general election.
What Do Pfizer and the Mafia Have in Common?
Pfizer has joined the Gambino crime family in the ranks of those who've lost a lawsuit under the Racketeer Influenced and Corrupt Organizations Act (RICO).
Answer
via fool.com
Friday, March 26, 2010
TED and Jamie
Today, Friday, TED Prize winner Jamie Oliver's Food Revolution comes to America. His show premieres on ABC tonight. The show is *awesome*. If people watch it, it's going to change their lives.
Here's what I need you to do:
Here's what I need you to do:
- If you're in America, please watch or record the show. I promise you won't regret it. Here are the program times. Here's the trailer.
- Whether or not you're in the US, please encourage your American friends to watch. Forward this email to at least five people. They will thank you for it.
As a reminder, America, along with much of the rest of the world, is suffering an obesity epidemic. Millions of people are literally in danger of eating themselves to death. Jamie Oliver's food revolution tackles this head on... by helping families rediscover the thrill of delicious, healthy, freshly-cooked food. He is a magnetic spokesman for one of today's most important issues.
Please help make a TED Prize wish come true.
Very best,
Chris Anderson, TED Curator
P.S. While you're at it, please add your name to Jamie's petition. We'd love to get to a million signatures within the next six weeks.
Roche cuts 500 jobs
Roche plans to eliminate 500 positions in New Jersey by the end of this month, related to last year's acquisition of Genentech Inc., and plans to cut another 100 jobs in the state by June.
The moves, detailed in a notice filed in late January with the state's Department of Labor and Workforce Development and obtained by Dow Jones Newswires, are due to the Swiss drug maker "permanently shutting down or reducing in size certain operations" in Nutley and Clifton.
About a year ago, Roche paid $46.8 billion to acquire the 44% of Genentech Inc. that it didn't already own. Roche projected some job cuts would occur from merging its Nutley operations with those of Genentech in South San Francisco, as well as the planned phase out of manufacturing operations in Nutley.
Roche spokesman Alfred Wasilewski said the N.J. notice covers those moves, but it doesn't account for jobs added to the Nutley campus from the relocation of some research operations from a Roche facility in Palo Alto, Calif.
"During the same time period, as the Nutley campus is shifting in emphasis to becoming a major research and development hub for Roche, the company added approximately 200 positions in the sciences," he said.
Roche, which had 2009 revenue of about $45.9 billion, employs more than 80,000 people worldwide.
Source
The moves, detailed in a notice filed in late January with the state's Department of Labor and Workforce Development and obtained by Dow Jones Newswires, are due to the Swiss drug maker "permanently shutting down or reducing in size certain operations" in Nutley and Clifton.
About a year ago, Roche paid $46.8 billion to acquire the 44% of Genentech Inc. that it didn't already own. Roche projected some job cuts would occur from merging its Nutley operations with those of Genentech in South San Francisco, as well as the planned phase out of manufacturing operations in Nutley.
Roche spokesman Alfred Wasilewski said the N.J. notice covers those moves, but it doesn't account for jobs added to the Nutley campus from the relocation of some research operations from a Roche facility in Palo Alto, Calif.
"During the same time period, as the Nutley campus is shifting in emphasis to becoming a major research and development hub for Roche, the company added approximately 200 positions in the sciences," he said.
Roche, which had 2009 revenue of about $45.9 billion, employs more than 80,000 people worldwide.
Source
Health Law Surprise Is Page 1,617 Demanding Which Drugs Work
via bloomberg.com
The overhaul creates an institute, funded with $500 million or more annually, to spur studies of which drugs, devices and medical procedures work best. The boost for comparative- effectiveness research, as the field is known among health experts, will increase scrutiny on treatments used by millions of Americans, including cholesterol drugs led by Pfizer Inc.’s Lipitor and heart stents from Medtronic Inc., said John Sullivan, an analyst at Leerink Swann & Co.
The findings may add scientific rigor to doctors’ decisions sometimes influenced more by marketing, said Jeffrey Lerner of the ECRI Institute, a nonprofit that conducts such research. In a health overhaul attacked by critics as too pricey, it’s one of the few measures with a chance to rein in U.S. medical spending that soared to $2.5 trillion last year, Sullivan said.
Still, “the savings can be substantial if you’re drawing a clinical study conclusion that a generic drug works as well as a branded drug,” said Leerink Swann’s Sullivan, offering one example of research that may be done. Therapies used by large numbers of people are likely to be investigators’ first targets.
Pfizer Loses Lipitor Patent Suits in South Korea, Court Says
Pfizer Loses Lipitor Patent Suits in South Korea, Court Says
By Sangim Han
March 26 (Bloomberg) -- Pfizer Inc. lost patent suits in South Korea relating to the cholesterol pill Lipitor, the world’s bestselling drug, ending an almost two-year legal battle in the Asian country.
The Supreme Court of Korea upheld lower courts’ rulings in favor of six local pharmaceutical companies, saying a patent on Lipitor wasn’t being infringed, said Shin Dong Hoon, director for public relations at the court, in a telephone interview today. The patent is owned by Warner-Lambert Co., the New York- based developer of Lipitor, which Pfizer bought for $115 billion 10 years ago.
“We are very disappointed with the court’s decision as it disregards the value of innovative drugs and discourages the patent protection environment in Korea,” said Dong-Soo Lee, representative director of Pfizer Pharmaceuticals Korea Ltd., in an e-mailed statement today.
The six Korean pharmaceutical companies include CJ Corp., Dong-A Pharmaceutical Co. and Boryung Pharmaceutical Co., according to the court’s Web site. Eight other Korean drugmakers will also benefit from the ruling, Shin said.
To contact the reporters on this story: Sangim Han in Seoul at sihan@bloomberg.net
Last Updated: March 25, 2010 22:08 EDT
via bloomberg.com
Pfizer Told to Pay $142.1 Million for Neurontin Marketing Fraud - BusinessWeek
By Bob Van Voris and Janelle Lawrence
March 26 (Bloomberg) -- Pfizer Inc. violated U.S. racketeering law in the marketing of its epilepsy drug Neurontin and should pay $142.1 million in damages, a jury decided.
Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals claimed in a monthlong trial in federal court in Boston that Pfizer illegally promoted Neurontin for unapproved uses. The insurer said it was misled into believing migraines and bipolar disorder were among the conditions that could be treated effectively with Neurontin, approved in 1993 by the U.S. Food and Drug Administration for epilepsy.
“The jury found Pfizer engaged in a racketeering conspiracy over a 10-year period,” Tom Sobol, a lawyer for Kaiser, said after yesterday’s verdict. “That bodes well for future cases.”
U.S. District Judge Patti Saris, who presided over the trial, is overseeing federal lawsuits from throughout the U.S. targeting Pfizer with injury claims and allegations of fraudulent sales and marketing of the drug. In a ruling last year, Saris said that fraud findings against Pfizer in the case decided yesterday could be binding against it in future trials.
Oakland, California-based Kaiser, the first insurer to try a Neurontin case against the world’s biggest drugmaker, claimed it was forced to pay $90 million more than it should have for Neurontin.
The jury, which deliberated for two days, found that New York-based Pfizer violated the federal Racketeer Influenced and Corrupt Organizations Act, or RICO, and California’s Unfair Competition Law. Under RICO, the amount of actual damages found by the jury, $47.36 million, will be tripled.
‘A Triumph’
“This is a triumph for evidence-based medicine over marketing-based medicine,” said Thomas Greene, a Kaiser lawyer.
Pfizer made no offer to settle the case before trial, Greene said.
“We are disappointed in this verdict,” said Chris Loder, a Pfizer spokesman. Pfizer will file post-trial motions challenging the verdict and plans to appeal, he said.
Pfizer fell 22 cents to $17.39 yesterday in New York Stock Exchange composite trading.
During the trial, Pfizer argued that Kaiser doctors continued to prescribe the drug even after the health insurer sued Pfizer in 2005. The insurer’s Web site also still lists Neurontin as a drug for neuropathic pain, Pfizer lawyers said in closing argument.
“We took that into consideration,” said Danielle Hurley, a 22-year-old artist who sat on the jury. “Kaiser was proactive, but could have been more proactive.”
Shocked by Evidence
Hurley said she was shocked by evidence that Pfizer knowingly marketed Neurontin for off-label uses without proof that it was effective.
All of the five jurors interviewed after the verdict said they agreed that Pfizer had demonstrated “a pattern of fraud” in marketing the drug.
“It was clearly a snow job,” said juror Paul Anderson, a technical writer.
“The message, if there was a message, is that they acted in a fraudulent manner,” said Hank Pierotti, foreman of the eight-person jury. “If you’re fraudulent, you deserve to be punished.”
Kaiser claimed Neurontin was wrongly prescribed for off- label uses, including treatment of neuropathic pain, and in dosages larger than the maximum approved by the FDA.
Jurors yesterday found that Pfizer violated racketeering laws with respect to four of the five off-label uses in question.
Company’s Studies
The company’s own studies showed that Neurontin was no more effective than a placebo in treating those conditions, though Pfizer never told doctors or patients about the findings, Kaiser said.
Several jurors said they were strongly influenced by the testimony of former FDA Commissioner David Kessler and Kay Dickerson, a Johns Hopkins epidemiologist whose article casting doubt on clinical studies of Neurontin appeared in the New England Journal of Medicine last year. Both testified on behalf of Kaiser.
“Dr. Dickerson was the lynchpin,” jury foreman Pierotti said.
Pfizer argued that Kaiser didn’t present testimony from any doctors claiming they wouldn’t have prescribed the medication if they had known better, Pfizer’s lawyer argued.
“No doctor wants to admit they were defrauded,” Pierotti said.
Warner-Lambert
Warner-Lambert Co. developed and marketed Neurontin for several years before Pfizer acquired the company in 2000. Four years later, Warner-Lambert pleaded guilty and agreed to pay $430 million to resolve off-label marketing allegations by the U.S. Justice Department.
Saris permitted jurors to hear evidence of the settlement during the trial.
“That helped a lot,” said juror Anderson.
The Justice Department claimed in a 2004 sentencing memorandum that Warner-Lambert’s marketing increased off-label sales from 15 percent of all Neurontin prescriptions in 1994, its first year on the market, to 94 percent, or $2.12 billion, of Pfizer’s Neurontin sales in 2002.
In 2002, responding to press reports of Pfizer’s allegedly fraudulent Neurontin marketing, Kaiser began an information campaign that led to a 34 percent drop in Neurontin prescriptions to its members, according to Saris.
Product Liability Suits
Among the cases in Saris’s court are product-liability suits claiming the drug is linked to an increased risk of suicide. The first trial in one of those, over the suicide death of a 39-year-old woman, ended when her family dropped the case. A second trial, involving the suicide of a 57-year-old Massachusetts man, is scheduled to begin next week in Boston.
In January, Saris dismissed fraud claims by Aetna Inc. and Guardian Life Insurance Co. against Pfizer. Unlike those companies, Kaiser showed it had considered Pfizer’s allegedly false claims and data in deciding to pay for off-label Neurontin prescriptions, Saris ruled before the trial.
The case is In re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629, U.S. District Court, District of Massachusetts (Boston).
--With assistance from Margaret Cronin Fisk in Southfield, Michigan and Jef Feeley in Wilmington, Delaware. Editors: Peter Blumberg, Mary Romano
To contact the reporters on this story: Bob Van Voris in New York at rvanvoris@bloomberg.net; Janelle Lawrence in Boston at rvanvoris@bloomberg.net.
To contact the editor responsible for this story: David E. Rovella at drovella@bloomberg.net.
via businessweek.com
Thursday, March 25, 2010
US jury's Neurontin ruling to cost Pfizer $141 mln | Reuters
NEW YORK, March 25 (Reuters) - Pfizer Inc (PFE.N) violated federal racketeering law by improperly promoting the epilepsy drug Neurontin, a Boston jury found on Thursday, and the world's largest drugmaker was ordered to pay $47 million in damages. Under federal RICO law (Racketeer Influenced and Corrupt Organizations act) the penalty is automatically tripled, so the finding will cost Pfizer $141 million.
via reuters.com
Posted via web from Jack's posterous
AstraZeneca - Nexium ; Little Pricey Pill - a parable of what's wrong with health care
Along with so many other things, keeping a lid on spending seems to have gotten lost in the health care overhaul. Individuals lose some incentive to save a couple of bucks by having fewer tax-free dollars in their health savings accounts. A panel to oversee Medicare disbursements based on the cost of clinical effectiveness of treatments--zapped, thanks to intense lobbying by drugmakers, doctors and every other medical interest group. That leaves medical providers and health plans, which have little motivation, unless the employers who buy insurance turn the screws.
They rarely do. But Edward Kaplan, a New York City health care consultant, last year came up with a simple way to save a pile of money for a Boston union representing supermarket workers: Its medical plan stopped covering Nexium, saving $133,000. The heartburn medicine is a $5 billion blockbuster for its manufacturer, AstraZeneca ( AZN - news - people ). At $2,000 for a year's supply, it was the union plan's second-most-prescribed pill, accounting for 5% of all drug costs. But its active molecule is almost identical to the one you get in cheap over-the-counter versions of Prilosec.
Prescription drug spending is maybe 10% of the total health pie--$234 billion in 2008--and rising at 3% a year. Still, "cutting Nexium saved a big chunk," Kaplan says.
The journey of a thousand cuts might begin with a little purple pill. It should have started years ago. Nexium launched in 2001, just as the patent for Prilosec, AstraZeneca's original heartburn remedy, was expiring. Intense marketing around Nexium coincided with price increases for Prilosec, pushing many patients to Nexium. Doctors, easy to woo with drug sales reps bearing samples and company-commissioned research reports, were happy to write scripts for the new drug--and oblivious of the economic implications. Insurers and their corporate clients mostly wimped out, paying full freight for Nexium. Nobody wants to be the bad guy with employees' health coverage. But the sum of many dubious coverage decisions adds up; the nation's health spending keeps rising at 5% to 6% a year.
There were a few exceptions. Kaiser Permanente, the California HMO with its own hospitals and docs, kept Nexium off its formulary of approved drugs. By controlling the whole food chain, it reaped the savings. Other insurers took the easy out--even as Thomas Scully, the chief of Medicare and Medicaid, gave 40 or so speeches in 2002 calling Nexium a waste of money. Back then Medicare didn't have a drug plan; Medicaid, he estimates, spent $800 million a year on Nexium. "I just got pissed off that Medicaid was covering a drug with no new benefit," says Scully. "Any doctor that prescribes Nexium should be ashamed of himself." But AstraZeneca complained about Scully to the White House and on Capitol Hill, and Scully says he felt pressure to clam up. Most Medicaid plans still cover Nexium.
In 2003 Prilosec became available as an over-the-counter drug from Procter & Gamble ( - people ) broke with the other big national payers and dumped Nexium from its formulary--saving $100 million overnight--despite pleas and presentations from AstraZeneca. "They made some modifications to the chemical to get a new patent," says UnitedHealth's pharmacy chief, Timothy Heady, who was not impressed. uhc would have cut Nexium sooner, but it took a while to change the legal language in the registration documents for all 50 states. "You can get Prilosec for $13.50 a month at Costco ( COST - news - people )," Heady says. The company has made similar moves since then by knocking other high-cost, low-value drugs out of its formulary, covering 14 million members. The losers include Schering-Plough ( SGP - news - people )'s allergy drug Clarinex and Pfizer ( PFE - news - people )'s growth hormone Genotropin. Others get put in a penalty box; to get GlaxoSmithkline's asthma inhaler Advair patients have to pay $70 a month, several times the normal copay.
Nexium, whose patent lasts until 2014, is still AstraZeneca's biggest seller. The company has always justified the drug by pointing to one study that found Nexium was three percentage points better at preventing a rare form of esophageal damage than Prilosec. "We stand behind the science," says AZ spokesman Blair Hains. "We know that the majority of people who have prescription insurance pay $30 or less for Nexium." But as a nation we're all paying for the rest of it.
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via forbes.com
Genzyme is facing FDA fines - The Boston Globe
via boston.com
The Cambridge biotechnology giant said yesterday that the Food and Drug Administration notified it Tuesday that the agency plans to take “enforcement action’’ against the company.
It marks the first time Genzyme has faced an FDA fine in its 29-year history and comes four months after the company said some of the drugs processed at the plant were contaminated by bits of steel, rubber, and fiber.
U.S. Medicare panel sees anemia drug risks in kidney patients | Reuters
BALTIMORE, Md., March 24 (Reuters) - Use of controversial anemia drugs made by Amgen Inc (AMGN.O) and Johnson & Johnson (JNJ.N) at high levels likely worsen heart problems and possibly chances for survival in kidney patients, a U.S. Medicare advisory panel said on Wednesday, calling for more study. Outside experts on the panel told the Centers for Medicare & Medicaid Services (CMS) that they were confident that use of the blockbuster drugs, called erythropoiesis-stimulating agents (ESAs), in chronic kidney disease patients could cause harm.
via reuters.com
Wednesday, March 24, 2010
Registration is now open for PharmedOut's June 25th conference, "Prescription for Conflict: Should Industry Fund Continuing Medical Education?"
They intend to address the questions:
Does industry funding of CME adversely affect the educational content of CME?
If so, can commercial bias be assessed and mitigated?
Speakers include Paul Thacker, an investigator for Sen. Chuck Grassley (R-Iowa), Edmund Pellegrino, MD, Professor Emeritus of Medicine and Medical Ethics at GUMC, Carl Elliott, MD, PhD, a philosopher at the University of Minnesota and author of "Better than Well," Joel Lexchin, MD, University of Toronto, and several former industry insiders.
They plan to offer continuing education credits to physicians and nurses. The conference, a collaborative effort with the Kennedy Institute of Ethics and the Georgetown University Law Center is open to the public.
Media who wish to attend should contact Karen Mallet at
km463@georgetown.edu or 215-514-9751.
General registration information, the full agenda, and travel
information are available at http://www.pharmedout.org/conference.htm.
We hope you can attend.
Adriane Fugh-Berman, MD, Director
Alicia Bell, MS, Project Manager
Does industry funding of CME adversely affect the educational content of CME?
If so, can commercial bias be assessed and mitigated?
Speakers include Paul Thacker, an investigator for Sen. Chuck Grassley (R-Iowa), Edmund Pellegrino, MD, Professor Emeritus of Medicine and Medical Ethics at GUMC, Carl Elliott, MD, PhD, a philosopher at the University of Minnesota and author of "Better than Well," Joel Lexchin, MD, University of Toronto, and several former industry insiders.
They plan to offer continuing education credits to physicians and nurses. The conference, a collaborative effort with the Kennedy Institute of Ethics and the Georgetown University Law Center is open to the public.
Media who wish to attend should contact Karen Mallet at
km463@georgetown.edu or 215-514-9751.
General registration information, the full agenda, and travel
information are available at http://www.pharmedout.org/conference.htm.
We hope you can attend.
Adriane Fugh-Berman, MD, Director
Alicia Bell, MS, Project Manager
Prescribing Advice for GPs » NICE Guidance – March 2010
NICE Guidance – March 2010
March 24, 2010 at 10:25 am | In Prescribing Extra - Other |The National Institute of Health and Clinical Excellence has published new guidance for the month of March 2010.
This month there are three clinical guidelines that have an impact on primary care. Two guidelines cover assessment and diagnosis of recent onset chest pain or discomfort of suspected cardiac origin (QRG) and early management of unstable angina and non-ST-segment-elevation myocardial infarction (QRG). These guidelines will provide useful information for primary care clinicians.
There is also a guideline for the pharmacological management of neuropathic pain in adults in non-specialist settings (QRG). This guideline replaces previous recommendations for the management of painful diabetic neuropathy and also extends the guidance to cover non-diabetic conditions such as post-herpetic neuralgia and trigeminal neuralgia. The guidance details treatment options and referral to specialist services.
Action: Clinicians should be aware of these guidelines. They will be a useful resource for clinicians who see patients following episodes of cardiac chest pain or with neuropathic pain.
Copyright ©2010 Prescribing Advice for GPs -->
Health Care Renewal: DR. PANGLOSS AS NIH INSTITUTE DIRECTOR
DR. PANGLOSS AS NIH INSTITUTE DIRECTOR
DR. PANGLOSS AS NIH INSTITUTE DIRECTOR
JAMA is out today with a Commentary by Dr. Thomas Insel, Director of the National Institute of Mental Health. Using indirection, Dr. Insel has risen to the defense of seven academic psychiatrists on whom an ethical searchlight has been trained for the past several years by Senator Grassley and others. With ludicrous optimism and a series of straw man discussions, Dr. Insel makes the case that things are not really as bad as they seemed to be or, if they were, then other specialty physicians were doing much the same things. Dr. Insel needs to recalibrate his ethical compass.
Why is an NIH Institute Director issuing this apologia for the corruption of academic psychiatry? Does he not have better things to do, such as ensuring that longstanding NIH regulations on conflict of interest are enforced? Why does an NIH Institute Director presume to speak for academic psychiatry? Where are the leaders of the major professional and scientific organizations like the American Psychiatric Association, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the Society of Biological Psychiatry? Why are they not stepping up publicly to the plate? Perhaps they are confounded by the awkward fact that some of the seven individuals are current and past presidents of these very organizations. Even the Institute of Medicine of the National Academy of Sciences has not sanctioned those of the seven who are Institute members.
Why is an NIH Institute Director downplaying the gravity of the ethical controversies surrounding these compromised individuals like Charles Nemeroff at Emory (now at Miami), and Alan Schatzberg at Stanford? To hear Dr. Insel tell it, all they did was fail to disclose income from pharmaceutical companies. That is not the half of it. Readers can look here and here for much more detail on the activities of Nemeroff and Schatzberg. If Dr. Insel chose to remain ignorant of or to overlook the history of false claims on behalf of pharmaceutical corporations or the concealment of consulting relationships or the complaisance with ghostwriting or the patently misleading “educational” presentations or the cashing in through stock sales or the editorial self dealing, then Dr. Insel’s fitness to serve as an NIH Institute Director needs to be reviewed.
Surely Dr. Insel knows that Nemeroff and the others worked mainly with the marketing personnel within pharmaceutical companies. Nemeroff’s staggering schedule of promotional talks for GlaxoSmithKline, released by Senator Grassley, is testament to that. So is Nemeroff’s record of priming the pump for himself with GSK by giving the corporation unpublished research data from NIMH-funded projects at Emory. In turn, GSK and its medical education communications company, Scientific Therapeutics Information, Inc., incorporated Nemeroff’s privileged material in the training manual for PsychNet – a speaker program designed to build advocacy for GSK’s antidepressant drug Paxil. These issues go well beyond just failing to report income. They signify the corruption of academic psychiatry. Doesn’t Dr. Insel understand that?
In his Commentary, Dr. Insel reported no financial disclosures. This is a good example of the problem that Dr. Insel doesn’t see. Many readers will interpret this Commentary from the Director of NIMH as the opening move in the attempted rehabilitation of Charles Nemeroff by his friends and cronies. Though Dr. Insel spoke in platitudes about the need for transparency as a solution, the spirit of transparency did not move him to disclose that Nemeroff is his former boss at Emory; that Nemeroff found a position for him when Insel was departing the intramural research program at NIMH; that Nemeroff lobbied for Insel’s appointment as NIMH Director; and that Insel appointed Nemeroff as an advisor soon after he moved to NIMH. These are pertinent conflicts of interest that readers of JAMA deserve to know about. Quis custodiet ipsos custodes?
Maybe Dr. Insel should stick to his knitting and resist the impulse to speak for academic psychiatry as a whole. A good place for him to start looking hard would be at the productivity and accounting of the once vaunted Emory-GSK-NIMH Collaborative Mood Disorders Initiative (Principal Investigator Charles B. Nemeroff; 5U19MH069056). One never knows what one will find when the rocks are turned over.
Labels: Alan Schatzberg;, Charles Nemeroff, conflict of interest, JAMA, NIH, NIMH, Thomas Insel
posted by Bernard Carroll at 10:42 PM
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GSK - Avandia: Mike Huckman writes
The editors of one of the most prominent medical journals are taking British drug giant GlaxoSmithKline to task.
More
 |
Source: Ian Wilson GlaxoSmithKline |
A few years ago, the “New England Journal of Medicine", published a study that identified a potential heart risk with Glaxo’s then-blockbuster diabetes pill, Avandia.
A two-year Senate investigation into Glaxo’s handling of the data recently concluded GSK allegedly tried to downplay Avandia’s safety signals and strong-arm the drug’s critics. Glaxo said the lawmakers’ probe was inaccurate and unbalanced.
But in a scathing editorial in the latest issue of "The Journal of the American Medical Association" or JAMA, Drs. Catherine DeAngelis and Phil Fontanarosa call what happened “a disturbing example of inappropriate conduct surrounding an industry-sponsored clinical trial. The circumstances … represent another serious example of corporate motives apparently outweighing scientific standards and perhaps ethical principles, thereby exposing patients to potential harm.”
They urge all journal editors to require academic researchers to have full access to all clinical trial data and for all company-sponsored studies to be independently reviewed to try to avoid a similar situation from happening again.More
Tuesday, March 23, 2010
JAMA - Psychiatrists' Relationships With Pharmaceutical Companies Part of the Problem or Part of the Solution?
Psychiatrists have rarely enjoyed a surplus of public trust. During the past 3 years, public trust in psychiatry has been further undermined with accusations that several leading academic psychiatrists failed to disclose financial conflicts of interest. Sen Charles Grassley (R, Iowa), ranking member of the Finance Committee, has thus far accused 7 psychiatrists of failing to disclose income from pharmaceutical companies. As public trust in the pharmaceutical industry has plummeted, the close connection between leading psychiatrists and the pharmaceutical industry, once a sign of progress for the profession, is now cited as evidence of corrupt influence.
JAMA
JAMA
Pfizer - Neurontin: "a good drug marketed by some bad people"
March 23 (Bloomberg) -- Pfizer Inc., facing a $300 million fraud claim, defended its epilepsy drug Neurontin at the close of a civil racketeering trial in Boston.
“It’s a good drug that, at one time, at least in some parts of the country, may have been marketed by some bad people,” Pfizer attorney Raoul Kennedy told jurors in a closing argument today.
Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals claimed in a monthlong trial in federal court that Pfizer illegally promoted Neurontin for unapproved uses. Kaiser said it was misled into believing Neurontin was effective for migraines, bipolar disorder and other conditions in addition to epilepsy, for which the U.S. Food and Drug Administration approved the drug in 1993.
Kaiser doctors continued to prescribe the drug in growing quantities even after the health insurer filed suit against Pfizer in 2005, Pfizer lawyers told the jury. The insurer’s Web site also continues to list Neurontin as a drug for neuropathic pain, they said.
“What you’re hearing in this courtroom is not what Kaiser is telling its patients,” Pfizer attorney James E. Hooper said during closing arguments.
$100 Million Sought
Kaiser, the first insurer to try a Neurontin case against Pfizer, is seeking $100 million, an amount that may be tripled under federal civil-racketeering law.
Kaiser, based in Oakland, California, alleges Neurontin was wrongly prescribed for off-label uses, including treatment of neuropathic pain, and in dosages larger than the maximum approved by the FDA. The company’s own studies showed that Neurontin was no more effective than a placebo in treating the condition, though Pfizer never told doctors or patients about the findings.
Pfizer claims Kaiser continues to permit its doctors to prescribe Neurontin for off-label conditions. Kaiser didn’t present testimony from any doctors claiming they wouldn’t have prescribed the medication if they had known better, Pfizer’s lawyer argued.
“This is a plaintiff who has 12,000 supposedly defrauded doctors and hasn’t brought one in here,” Kennedy told the jury.
Kaiser Arguments
Kaiser was presenting closing arguments this afternoon, after which jurors will begin their deliberations.
The trial began Feb. 22 with jury selection under the supervision of U.S. District Judge Patti Saris, who is overseeing federal lawsuits from throughout the U.S. targeting Pfizer with injury claims and allegations of fraudulent sales and marketing of the drug.
A verdict in the case may influence other Neurontin suits against Pfizer, the world’s largest drugmaker. In a ruling last year, Saris said that fraud findings against Pfizer could be binding against the New York-based company in future trials.
Like other third-party payers suing Pfizer, the health insurer claims it would have saved money spent on off-label Neurontin prescriptions if Pfizer hadn’t hidden the truth.
Warner-Lambert Co. developed and marketed Neurontin for several years before Pfizer acquired the company in 2000. Four years later, Warner-Lambert pleaded guilty and agreed to pay $430 million to resolve off-label marketing allegations by the U.S. Justice Department.
‘Academy Awards’
The Justice Department claimed in a 2004 sentencing memorandum that Warner-Lambert’s marketing increased off-label sales from 15 percent of all Neurontin prescriptions in 1994, its first year on the market, to 94 percent, or $2.12 billion, of Pfizer’s Neurontin sales in 2002.
“This is not the FDA proceeding. We lost that one,” Pfizer attorney Kennedy said. “But off-label marketing is not fraud.”
He also suggested Kaiser deserves no damages because they passed the drug costs on to customers by hiking premiums.
“Is Kaiser like those people who come to the Academy Awards and accept for someone who can’t be there?” he asked. “Except Kaiser wants to keep the statue for itself.”
In 2002, responding to press reports of Pfizer’s allegedly fraudulent Neurontin marketing, Kaiser began an information campaign that led to a 34 percent drop in Neurontin prescriptions to its members, according to Saris.
Among the cases in Saris’s court are product-liability suits claiming the drug is linked to an increased risk of suicide. The first trial in one of those cases, over the suicide death of a 39-year-old woman, ended when her family dropped the case.
In January, Saris dismissed fraud claims by Aetna Inc. and Guardian Life Insurance Co. against Pfizer. Unlike those companies, Kaiser showed it had considered Pfizer’s allegedly false claims and data in deciding to pay for off-label Neurontin prescriptions, Saris ruled before the trial.
The case is In re Neurontin Marketing, Sales Practices and Products Liability Litigation, MDL 1629, U.S. District Court, District of Massachusetts (Boston).
To contact the reporters on this story: Bob Van Voris in New York at rvanvoris@bloomberg.net; Janelle Lawrence in Boston at rvanvoris@bloomberg.net.
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