Thursday, December 31, 2009
2010 - Ten New Year's Resolutions for Big Pharma - as suggested by Martha Rosenberg
1. Our reps will wait their turn in medical offices and refrain from waltzing in front of ailing patients because they think their time is more valuable. They will NOT get their own room in medical offices with laptop stations, ice water, and swivel chairs or chatter about the stress of sales quotas on their cells in the waiting room. Female reps will not "sell" with cleavage and spike heels. Male reps will not high five each other or call the doctor "dude." Reps who sold drugs that were later withdrawn will be banished.
2. In addition to admitting to the Justice Department that we mismarketed Seroquel, Zyprexa, Risperdal, and Geodon and looted Medicaid budgets, we will cease selling the actual drugs. We admit that even though forgiveness is cheaper than permission for us, it isn't for the millions of children, poor and institutionalized people who develop lifelong diabetes and metabolic disorders from the drugs.
3. We will stop upgrading anxiety to depression, depression to bipolar disorder and bipolar disorder to "treatment resistant depression" to sell drugs. We will admit that studies are beginning to show that the reason depression is sometimes treatment resistant is because it wasn't depression to begin with but consumer advertising. We will admit our cocktails of depression/bipolar/mood brightener/mood stabilizer drugs occlude the fact that none work individually, raise insurance rates, and create withdrawal symptoms in patients who might have been fine before.
4. We will admit hormone therapy increases the risk of breast cancer by 26 percent, heart attacks by 29 percent, stroke by 41 percent and doubles the risk of blood clots and dementia. We will further admit hormone therapy is associated with lung, ovarian, endometrial and gall bladder cancer, malignant melanoma, asthma, lupus, scleroderma, non-Hodgkin's lymphoma, urinary incontinence, and hearing loss -- and the only researchers promoting it are making money off it.
5. We will stop trying to replace the hormone market with a thinning bones market through an osteoporosis scare campaign and admit that we made up the term "osteopenia" at the same time we planted bone density measuring machines in medical offices. Nor will we keep recommending seizure drugs for fibromyalgia pain women don't know they have yet to make up for shrinking hormone and antidepressant markets.
6. We will stop replacing $600 a month blockbuster drugs insurers no longer wave through with vaccines and biologics no one wants or needs. We will give up the attempt to vaccinate boys with Gardasil when it didn't even work with girls or ship it to poor countries plagued with HIV, malaria, or dengue fever. We will stop selling biologics such as Humira that cause cancer and infections such as TB to perfectly healthy college kids with Crohn's disease scare campaigns.
7. We will buy every child under 12 in America a bicycle or skateboard as reparations for our reign of terror treating them for depression, bipolar disorder, ADD, ADHD, mixed manias, oppositional and conduct disorders, sleep and mood disorders, schizophrenia, agitation, anxiety and other "psychopathologies" they may not have even had.
8. Instead of storming Capitol Hill when the government threatens to cut off our livestock antibiotics gravy train, we promise to develop safe antibiotics for people. And speaking of safe, we will renounce the hormones, growth enhancers and pesticides we dump on factory farms that sicken the animals, environment, farm workers, and food consumers.
9. We will stop insulting the public's intelligence by claiming that everyone including people without high cholesterol should take Crestor because we want to sell statins. We will stop implying Vytorin works just because some have forgotten we sat on studies that show it doesn't work in a multi-year con.
10. We will stop rolling out celebrities such as Sally Field and Brooke Shields to hawk drugs and acknowledge the celebrity drug spokesmen the public remember most are Michael Jackson and Anna Nicole Smith.
Source
2. In addition to admitting to the Justice Department that we mismarketed Seroquel, Zyprexa, Risperdal, and Geodon and looted Medicaid budgets, we will cease selling the actual drugs. We admit that even though forgiveness is cheaper than permission for us, it isn't for the millions of children, poor and institutionalized people who develop lifelong diabetes and metabolic disorders from the drugs.
3. We will stop upgrading anxiety to depression, depression to bipolar disorder and bipolar disorder to "treatment resistant depression" to sell drugs. We will admit that studies are beginning to show that the reason depression is sometimes treatment resistant is because it wasn't depression to begin with but consumer advertising. We will admit our cocktails of depression/bipolar/mood brightener/mood stabilizer drugs occlude the fact that none work individually, raise insurance rates, and create withdrawal symptoms in patients who might have been fine before.
4. We will admit hormone therapy increases the risk of breast cancer by 26 percent, heart attacks by 29 percent, stroke by 41 percent and doubles the risk of blood clots and dementia. We will further admit hormone therapy is associated with lung, ovarian, endometrial and gall bladder cancer, malignant melanoma, asthma, lupus, scleroderma, non-Hodgkin's lymphoma, urinary incontinence, and hearing loss -- and the only researchers promoting it are making money off it.
5. We will stop trying to replace the hormone market with a thinning bones market through an osteoporosis scare campaign and admit that we made up the term "osteopenia" at the same time we planted bone density measuring machines in medical offices. Nor will we keep recommending seizure drugs for fibromyalgia pain women don't know they have yet to make up for shrinking hormone and antidepressant markets.
6. We will stop replacing $600 a month blockbuster drugs insurers no longer wave through with vaccines and biologics no one wants or needs. We will give up the attempt to vaccinate boys with Gardasil when it didn't even work with girls or ship it to poor countries plagued with HIV, malaria, or dengue fever. We will stop selling biologics such as Humira that cause cancer and infections such as TB to perfectly healthy college kids with Crohn's disease scare campaigns.
7. We will buy every child under 12 in America a bicycle or skateboard as reparations for our reign of terror treating them for depression, bipolar disorder, ADD, ADHD, mixed manias, oppositional and conduct disorders, sleep and mood disorders, schizophrenia, agitation, anxiety and other "psychopathologies" they may not have even had.
8. Instead of storming Capitol Hill when the government threatens to cut off our livestock antibiotics gravy train, we promise to develop safe antibiotics for people. And speaking of safe, we will renounce the hormones, growth enhancers and pesticides we dump on factory farms that sicken the animals, environment, farm workers, and food consumers.
9. We will stop insulting the public's intelligence by claiming that everyone including people without high cholesterol should take Crestor because we want to sell statins. We will stop implying Vytorin works just because some have forgotten we sat on studies that show it doesn't work in a multi-year con.
10. We will stop rolling out celebrities such as Sally Field and Brooke Shields to hawk drugs and acknowledge the celebrity drug spokesmen the public remember most are Michael Jackson and Anna Nicole Smith.
Source
Wednesday, December 30, 2009
Introducing The Qui Tam Team Blog
http://quitamteam.com/blog/
The Qui Tam Team is a nationally renowned association of lawyers founded by former federal prosecutors who have spent their careers dedicated to public interest fraud litigation and trial work.
Sun, sea, sand and sh*t!
A US vaccine manufacturer has come up with a novel way to tempt young people to test its drugs: free holidays to Mexico.
Intercell is offering free flights and hotel accommodation up to the value of £1,400 to 900 volunteers who are prepared to test a remedy for one of the most common holiday afflictions – travellers' diarrhoea.
In the "Trek Study", willing backpackers who develop travellers diarrhoea will be paid to attend a clinic and injected with a new agent to see how they react, the Independent reports.
Volunteers will stay in three-star hotels but can choose where they go and what they eat and drink, provided they do not stray more than three hours' travelling time from one of the centres in Mexico or Guatemala where they are required to attend for blood tests and to provide stool samples if they develop an upset stomach.
A second study is planned of travellers to India.
MoreTuesday, December 29, 2009
Gilead grief
Gilead Sciences (GILD) received a major pipeline setback with disappointing results from a phase III trial of darusentan in which it failed to achieve its primary endpoint. The drug was being studied under an international clinical trial (DAR-312) for the treatment of resistant hypertension. As a result of the setback, Gilead is considering the option of dropping the program so that its resources can be utilized for other potential candidates rather than conducting another intensive phase III study.
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Monday, December 28, 2009
Tighter rules sought for anti-psychotic drug use in nursing homes -
TRIBUNE WATCHDOG Compromised Care
Tighter rules sought for anti-psychotic drug use in nursing homes
Report shows elderly, frail patients are being 'chemically restrained' with powerful medication
By Sam Roe and Christina Jewett Tribune reporter ProPublicaDecember 20, 2009
Health advocates are calling for tough new rules on the use of anti-psychotic drugs in Illinois nursing homes, including tighter controls on doctors who prescribe the powerful medications."Medical care should help you get better, not get worse," said Wendy Meltzer of Illinois Citizens for Better Care, an advocacy group for nursing home residents.
A Tribune investigation recently showed how many frail and vulnerable Illinois nursing home residents have been unnecessarily dosed with anti-psychotics, leading to harm and an increased risk of death. One psychiatrist, the Tribune found in a joint investigation with ProPublica, provided assembly-line care to thousands of mentally ill patients.
The advocates want Gov. Pat Quinn's Nursing Home Safety Task Force to address these problems. While the task force has focused on violent felons housed in nursing facilities, chairman Michael Gelder said the group will also target the misuse of psychotropic drugs.
"We want people to be safe and cared for in nursing homes, not threatened or unwillingly sedated," he said.
Reforming the system likely will be challenging. The FDA has approved anti-psychotic drugs to treat serious mental illnesses, such as schizophrenia, but doctors may also prescribe them to geriatric patients with other conditions, such as dementia, in a common but controversial practice called "off-label" use.
Meltzer said one way to stop nursing home doctors from using the drugs to "chemically restrain" residents is for the state to refuse to pay for certain medications.
For example, if a nursing home doctor wrote a prescription for an anti-psychotic that can be injected -- suggesting the medication is being used to sedate a resident -- the pharmacist would not fill the order unless the physician received permission from the Illinois Department of Healthcare and Family Services. Meltzer also said the state should not pay for multiple antipsychotics for the same resident or for psychotropics at dosages over recommended limits without prior approval.
In addition, Meltzer called for Illinois to require nursing homes to use standardized consent forms for each psychotropic drug. Documents show that hundreds of nursing residents have been given psychotropics without their permission since 2001. In other cases, facilities downplayed the dangers.
Nursing homes, Meltzer said, should have a formal process of explaining the benefits and risks of taking psychotropics. Right now, she said, the goal of many nursing homes is to simply get residents to sign the forms as opposed to explain the options.
Other possible reforms address problems raised by the ProPublica-Tribune investigation of Chicago psychiatrist Dr. Michael Reinstein.
Illinois law requires psychiatric hospitals to report patient deaths, but three deaths of people under Reinstein's care were never reported, said Illinois Department of Public Health spokeswoman Melaney Arnold. The agency grants and revokes the licenses of psychiatric hospitals, but it cannot levy penalties for lax death reporting because that law is on another agency's books.
Advocates said this inconsistency should be fixed, but Arnold characterized the problem as beyond the scope of her agency. "If (legislators) want to make a change to the law, they are welcome," she said.
Mark Heyrman, a University of Chicago law professor and mental health advocate, called on Medicaid to consider a doctor's cumulative disciplinary record when weighing sanctions. The agency, records show, has taken repeated action against Reinstein but has not punished him as a repeat offender. Rather, it has looked at him one audit at a time.
Heyrman said he wondered if it was wise for Medicaid to give tax dollars to doctors who have had repeated run-ins with the agency. "It seems to me there should be a higher standard for that," he said.
But overall, he said, Medicaid pays psychiatrists too little. "If we want decent care we have to raise the payments," Heyrman said.
Advocates also said Illinois should require drugmakers to publicly disclose payments to doctors so that their patients can be aware of possible conflicts of interest. One pharmaceutical company gave Reinstein nearly $500,000 to promote a drug that Medicaid records suggest he prescribed 41,000 times. Reinstein has disputed Medicaid's prescribing figures.
State Rep. Jack Franks, D-Marengo, has pushed a bill since 2005 requiring drugmakers to report the amount of money and gifts they give to doctors, nursing homes and hospitals. The bill has not passed, but he said he plans to re-introduce it next session.
He called Reinstein "the poster child for why we need this law."
Reinstein, through his attorney, said he agrees that drugmakers should disclose payments. He said he no longer accepts payments from pharmaceutical manufacturers, and if any are sent to him, he donates them to charity.
He also said he would cooperate and assist the task force if asked.
Sam Roe is a Tribune reporter. Christina Jewett is a reporter for ProPublica, an independent, nonprofit investigative newsroom in New York. Funded primarily by the Sandler Foundation, ProPublica publishes its work at propublica.org and through partnerships with the Tribune and other media. sroe@tribune.com
Copyright © 2009, Chicago Tribune
FYI the pharma company mentioned is AstraZeneca and the product is Seroquel.
Sunday, December 27, 2009
Friday, December 25, 2009
Thursday, December 24, 2009
And it came to pass
WASHINGTON -- In a rare Christmas Eve Vote, the Senate passed a massive healthcare overhaul bill by a 60-39 margin. The legislation, which would expand healthcare coverage to an additional 31 million people and require most people to carry insurance, now must be reconciled with a House bill that differs on several key points.
Sanofi-Aventis - Multaq: not worth it!
Sanofi-Aventis has failed to win early support from the UK's health costs board NICE for its Multaq heart drug on the state-run National Health Service because it is too pricey and no better than existing treatments.
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Wednesday, December 23, 2009
AstraZeneca's French Connection
AstraZeneca has agreed to acquire Novexel, in a deal that adds to its pipeline of potential new drugs to tackle infections. The deal centers on Paris-based Novexel's two most advanced drug-development programs, CAZ104 and CEF104.
Tuesday, December 22, 2009
Is debarment "a punishment that fits the crime!"?
General counsel at major corporations are closely watching a case filed in federal district court in New Haven, Conn. The case -- records of which were just unsealed on Dec. 7 -- involves an appeal by Howard Udell, the first general counsel known to have been debarred from working at companies that do business with federal agencies.
Udell's appeal, expected to be argued next spring or summer, stems from a May 2007 settlement between the U.S. Attorney for Western Virginia and three top executives at Purdue Frederick Co. Inc., over the misbranding of the addictive painkiller OxyContin. Udell was one of those executives. The government claimed that Purdue Frederick misled patients and doctors about the drug's dangers and addictiveness.
Purdue Frederick, a subsidiary of Norwalk, Conn.-based Purdue Pharma L.P., pled guilty to felony misbranding as part of the settlement, and, by federal law, was automatically debarred from getting any new government contracts. The parent company, which avoided criminal charges by striking a nonprosecution agreement with authorities and agreeing to pay $634.5 million in fines, is still eligible to receive such contracts.
As part of the case, the U.S. Attorney also convicted the former executives, including Udell, on a criminal misdemeanor, based on the legal theory of strict liability. Under the theory, "responsible corporate officers" who fail to prevent, detect, or correct federal drug violations can be held strictly liable for failing to act on their authority -- without proof of any misconduct on their part.
All three executives pleaded guilty and, in exchange for no jail time, agreed to pay hefty fines; Udell's was $8 million. At the time, U.S. Attorney John Brownlee said only, "It was important to have individuals charged as well as the company."
Then came a surprise -- personal debarment. Although federal law does not require it, the Department of Health and Human Services' office of inspector general decided to debar the three execs through an administrative order -- effectively ending their careers in the health care sector.
Court documents indicate this is the first time the federal government has ever imposed such an exclusion based on a "responsible corporate officer" misdemeanor. Debarred along with Udell were Purdue Frederick chief executive Michael Friedman and science chief Dr. Paul Goldenheim. All three appealed their debarment in federal district court, which sealed the record and sent the trio back to HHS to exhaust their administrative remedies.
After losing that round last January, they filed a new appeal in federal court in October. Udell's attorney, Andrew Ceresney of Debevoise & Plimpton, responded to questions about the case by releasing the following statement on Friday: "The decision to exclude Mr. Udell and two others based on strict liability, no intent misdemeanors, resulting solely from their status as officers of Purdue at a time when others engaged in conduct of which they were unaware, was arbitrary, unfair, and exceeded the inspector general's statutory powers."
Udell's complaint states that the record contains no evidence that he "committed any unlawful act or [was] aware of any unlawful act committed by other Purdue employees." He seeks a declaratory judgment that the debarment was arbitrary, capricious, and contrary to law. He also asks the court to vacate and enjoin his exclusion.
http://www.law.com/jsp/article.jsp?id=1202437125589&rss=newswire
Udell's appeal, expected to be argued next spring or summer, stems from a May 2007 settlement between the U.S. Attorney for Western Virginia and three top executives at Purdue Frederick Co. Inc., over the misbranding of the addictive painkiller OxyContin. Udell was one of those executives. The government claimed that Purdue Frederick misled patients and doctors about the drug's dangers and addictiveness.
Purdue Frederick, a subsidiary of Norwalk, Conn.-based Purdue Pharma L.P., pled guilty to felony misbranding as part of the settlement, and, by federal law, was automatically debarred from getting any new government contracts. The parent company, which avoided criminal charges by striking a nonprosecution agreement with authorities and agreeing to pay $634.5 million in fines, is still eligible to receive such contracts.
As part of the case, the U.S. Attorney also convicted the former executives, including Udell, on a criminal misdemeanor, based on the legal theory of strict liability. Under the theory, "responsible corporate officers" who fail to prevent, detect, or correct federal drug violations can be held strictly liable for failing to act on their authority -- without proof of any misconduct on their part.
All three executives pleaded guilty and, in exchange for no jail time, agreed to pay hefty fines; Udell's was $8 million. At the time, U.S. Attorney John Brownlee said only, "It was important to have individuals charged as well as the company."
Then came a surprise -- personal debarment. Although federal law does not require it, the Department of Health and Human Services' office of inspector general decided to debar the three execs through an administrative order -- effectively ending their careers in the health care sector.
Court documents indicate this is the first time the federal government has ever imposed such an exclusion based on a "responsible corporate officer" misdemeanor. Debarred along with Udell were Purdue Frederick chief executive Michael Friedman and science chief Dr. Paul Goldenheim. All three appealed their debarment in federal district court, which sealed the record and sent the trio back to HHS to exhaust their administrative remedies.
After losing that round last January, they filed a new appeal in federal court in October. Udell's attorney, Andrew Ceresney of Debevoise & Plimpton, responded to questions about the case by releasing the following statement on Friday: "The decision to exclude Mr. Udell and two others based on strict liability, no intent misdemeanors, resulting solely from their status as officers of Purdue at a time when others engaged in conduct of which they were unaware, was arbitrary, unfair, and exceeded the inspector general's statutory powers."
Udell's complaint states that the record contains no evidence that he "committed any unlawful act or [was] aware of any unlawful act committed by other Purdue employees." He seeks a declaratory judgment that the debarment was arbitrary, capricious, and contrary to law. He also asks the court to vacate and enjoin his exclusion.
http://www.law.com/jsp/article.jsp?id=1202437125589&rss=newswire
Monday, December 21, 2009
Ex drug rep Natalie White wins Survivor Samoa
Natalie White, 26, a former pharmaceutical sales rep from Arkansas, won "Survivor Samoa's" $1 million prize.
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Sunday, December 20, 2009
GE Healthcare - Omniscan: misuse of British libel laws?
Two years ago in a conference room in the Randolph hotel in Oxford, Henrik Thomsen gave his inside account of a medical “nightmare”.
In a presentation to about 30 colleagues, Thomsen, one of Europe’s leading radiologists, revealed how patients treated at his hospital had subsequently contracted a rare and potentially fatal disease.
Thomsen and other doctors at his Copenhagen University hospital were baffled as to why 20 kidney patients who had been given routine scans were afflicted by a disorder — nephrogenic systemic fibrosis (NSF) — in which the skin gradually swells, thickens and tightens. Some sufferers were confined to wheelchairs. At least one died. There was no known cure.
Then, in March 2006, there was a breakthrough. It was confirmed that all those who had fallen ill with NSF had been given the same drug in advance of a magnetic resonance imaging (MRI) scan.
Omniscan was used to enhance the images produced by the scan. The product was sold around the world and was manufactured by GE Healthcare, a subsidiary of General Electric, one of the world’s largest corporations.
Thomsen’s presentation lasted no more than 15 minutes, with the final slide reading: “I hope none of you meets a similar medical hurricane.”
The quietly spoken 56-year-old, director of the department of diagnostic sciences at the University of Copenhagen, is part of a small group of clinicians credited with alerting patients and regulators to the potential risks of Omniscan for renal patients.
The Medicines and Healthcare Products Regulatory Agency this weekend said there had been 20 reports in the UK of NSF after patients were given Omniscan. Five of the patients died.
Last month, European medical regulators recommended that anybody who needed an MRI scan should be given a check to ensure their kidneys were healthy if they were to be given Omniscan or two similar products. In America, the Food and Drug Administration (FDA) is reviewing its advice.
Thomsen, however, now refuses to speak anywhere in England on the possible risks of Omniscan. The reason is that he faces another kind of storm: GE Healthcare is suing him in the High Court for libel.
The company claims his presentation in Oxford, entitled Management Aspects of NSF, was highly defamatory.
GE has already racked up costs of more than £380,000 pursuing the respected academic, who has authored or co-authored nearly 400 papers and delivered countless presentations to his peers. Thomsen will have to pay the firm’s costs if he loses the case.
In recent weeks, The Sunday Times has highlighted how London’s draconian libel laws are being used to silence critics of the rich and the powerful.
In a number of cases, both claimants and defendants have little apparent connection with Britain.
Campaign groups have warned that vital scientific and medical work is being threatened because of the danger of libel actions.
Thomsen, who was in London last week meeting Carter-Ruck, his lawyers, has no doubt about the driving force behind his case. “I believe that the lawsuit is an attempt to silence me,” he said.
IN October 2003 General Electric, one of the most watched companies on Wall Street, made a successful £5.7 billion bid for Amersham, the British healthcare company that had been privatised by Margaret Thatcher.
GE has a finger in many corporate pies, from manufacturing lightbulbs to insurance sales, but this appeared a particularly good business fit. GE Medical Systems made scanning equipment and Amersham made the products used to make medical imaging more effective. The combined business — GE Healthcare — had its headquarters in Buckinghamshire and was expected to generate about $13 billion (£8 billion) annually, representing about 10% of GE’s revenue at that time.
One of its products was Omniscan, which is among a small group of products administered to patients before an MRI scan. It is a so-called “contrast agent” whose properties enhance the differences between fluids and structures in the body when they appear on scans, making diagnosis easier. To date, it has sold more than 48m doses worldwide, including 620,000 in the UK. Such products sell at about $30 a dose.
There was, however, a problem. A small number of kidney patients injected with Omniscan and other products were falling ill with NSF, a horrific disease that first attacks the skin and can then attack organs. Those with healthy kidneys were unaffected and the product has been safe for more than 99% of patients.
NSF was first identified in the United States in 1997, more than five years after the contrast agents were introduced, and doctors were initially mystified as to what caused it.
One victim, Celeste Castillo Lee, from North Carolina, who gave evidence earlier this month to a FDA hearing, described how the disease migrated through her body, causing agony. “Seventy-five per cent of us [NSF victims] are in wheelchairs,” she said. “It’s actually a torture.”
She said swelling, which started in her ankles, moved through her limbs and then attacked her insides. Her bones, she said, felt like they were in a vice.
In British hospitals doctors were also finding cases of the new and strange condition. Giles Roditi, a consultant radiologist at Glasgow Royal Infirmary, said his hospital had 16 cases of NSF in renal patients.
What was causing it? In early 2006 Thomsen had turned clinical detective to try to answer this question.
After he was told that every kidney patient at his hospital who was diagnosed with the disease had been given a drug for a MRI scan, he and his colleagues alerted the medical authorities and then embarked on a review of all known cases of NSF.
Every patient out of the 150 cases that he found had been given a contrast agent for an MRI. About 90% had been given Omniscan. It was not proof that the drug caused NSF, but it was enough evidence for Thomsen never again to give it to any kidney patient.
Omniscan is one of several competing MRI agents that contain the rare-earth metal gadolinium, which is potentially toxic. The metal is chemically protected in its various drug forms and is quickly flushed out of the body by patients with healthy kidneys.
However, regulators believe the chemical structure of Omniscan, and another similarly constructed product, make them less stable and potentially dangerous for those suffering from renal problems.
The Danish Medicines Agency was the first to sound the alarm, highlighting 25 cases linked to Omniscan in a notice in May 2006.
Many of the Danish patients filed claims with a Danish government insurance agency, which pays benefits if it decides that a drug was a likely cause of inquiry or death.
In one of those cases, involving a 55-year-old woman who died from a lung embolism in 2003, the insurance agency concluded the side effects of Omniscan had “caused” her immobilisation, which, in turn, “caused” her deadly embolism. GE declined to comment on this case last week.
In June 2007, the Commission on Human Medicines in the UK advised doctors not to use Omniscan in patients with severe renal problems along with two other products, Magnevist, manufactured by Bayer HealthCare, and Optimark, produced by Covidien. It advised that other products containing gadolinium should not be used for kidney patients unless essential.
GE Healthcare appears to have reacted promptly to concerns about its product, but it objects to some of Thomsen’s work and the decisions by the European regulators. While it does not deny that there is an association between its product and NSF, it felt that to classify its drug as particularly risky was unfair.
It insists that a causal link to NSF has “not been established”. It believes a reporting bias may account for the high number of NSF cases linked to its product.
GE’s arguments helped sway regulators in the US, the biggest market for Omniscan. Doctors there have been warned of an association between contrast agents and NSF, but the FDA until recently said the data was too limited to classify some of the products as more risky than others.
The FDA has also not so far recommended doctors to stop using any of these products in kidney patients, but has simply issued safety warnings.
FDA’s staff has been revisiting the evidence. This month the FDA said it now believes that Omniscan, Optimark and Magnevist pose higher risks. An FDA advisory panel went further: they recommended that Omniscan and Optimark should not be given to patients with severe kidney disease.
This represents a victory of sorts for Thomsen and may mean less chance of kidney patients suffering from this disease in the future. But his mind is now on another looming battle with GE in the High Court.
Academics and radiologists who attended Thomsen’s presentation say it is “ludicrous” that he faces a potentially ruinous legal action and are writing letters of support for him in the action. His PowerPoint presentation is summarised in the writ and appears to be an objective analysis of the association between Omniscan and NSF.
GE Healthcare said this weekend it believed the presentation was defamatory because it accused the firm of suppressing information and marketing its product when it was aware of possible problems.
Last week, however, a spokeswoman was unable to highlight any part of Thomsen’s presentation in which this allegation was made. The writ says the defamation may have been “by way of innuendo”.
Carter-Ruck, defending Thomsen on a no-win, no-fee basis, says the action should be struck out because the words complained of in the writ are clearly not defamatory.
GE Healthcare is also suing over an article that appeared under Thomsen’s name in Imaging Management, a medical journal, published in Belgium, which referred to rumours that the company had been warned about possible problems with its product.
Thomsen says he did not “write or publish” the words that are the subject of the complaint and that they were written by a journalist. He denies libel.
The GE Healthcare spokeswoman said the company supported scientific debate and sued Thomsen only as a “last resort” because it felt it was being defamed. It says it always reacted quickly and in the best interests of patients to any possible side-effects of Omniscan. It reiterated that the product was still safe to use for the vast majority of patients.
THOMSEN’S case, however, is merely the latest example of the courts being used against scientists who scrutinise drugs and treatments. Simon Singh, a science writer, is being sued by the British Chiropractic Association for describing some of their treatments as “bogus”.
Another victim of the libel laws is Peter Wilmshurst, a consultant cardiologist at Shrewsbury hospital. He is being sued by an American company, NMT Medical, after he questioned the effectiveness of a new heart implant device.
The Libel Reform Campaign is now urging capped damages, stricter controls on costs and a stronger public interest defence. John Kampfner, chief executive of Index on Censorship, which is among a number of groups supporting the campaign, said: “[Thomsen’s case] appears to be yet another shocking example of multinational corporations going after academics and scientists working in the public interest.”
Sir Ken Macdonald, the former director of public prosecutions, has already called for reform. “The idea that we are becoming an international haven for people to attack scientists is something that we should not be proud of,” he said.
The culture, media and sport committee of the House of Commons is compiling a report that is expected to recommend change in the country’s libel laws. Jack Straw, the justice secretary, has already announced a review.
Colin Blakemore, professor of neuroscience at Oxford University and an adviser to Sense about Science, which promotes the use of good science in public debates, said any review should ensure the libel courts are never used as forum for assessing the risks of a treatment. “The risk is that the party with the most money will always win in what should be a dispassionate assessment of evidence,” he said.
GE, along with other manufacturers of contrast agents, now faces action in the American courts over its drug. A writ filed in the northern district of the Ohio federal court by lawyers acting for almost 500 plaintiffs says Omniscan was “routinely administered to kidney patients for years without warnings”.
These actions mean the debate over the side-effects of Omniscan and other products is likely to continue for many years to come.
Thomsen’s concern is about medical researchers who will need to highlight possible risks from drugs in the future. He says it is essential that they are not cowed by the prospect of appearing before the libel courts in London.
“It’s dangerous for the patient if we can’t frankly exchange views,” he said.
Jeff Gerth is a senior reporter at ProPublica (www.propublica.org), a US-based independent, non-profit newsroom that produces investigative journalism in the public interest.
Additional reporting: Jon Ungoed-Thomashttp://business.timesonline.co.uk/tol/business/law/article6962816.ece
Saturday, December 19, 2009
Pharma Giles writes.... a Christmas Carol
What better way to celebrate the festive season then to join the Great and Good in a rousing Christmas Carol to celebrate their achievements this year?
Altogether now…
(To the tune of “God Rest Ye Merry Gentlemen”…)
God rest us, pharma CEOs, let nothing we concern
Ineptitude will not reduce the millions that we earn
Our management is failing yet we think we need not learn
No tidings of comfort or joy
Comfort or joy
For the scientists we used to employ
God bless ye, Jeffrey Kindler, Pfizer’s dubious accolade
A corporate malfeasance fine, the largest ever paid
Regarded as a simple cost of business, I’m afraid
Sad tidings of marketing fraud
Marketing fraud
Sad tidings of marketing fraud
Financial joy for Fred Hassan, now Schering Plough’s been sold
His second mega-golden parachute can now unfold
And twenty thousand Pharma hands once more are on the dole
Schering Plough’s gone the same as Pharmacia
Pharmacia
Cut and run marks out good ol’ Fred’s career
God help thee AstraZeneca, pharma’s Titanic liner
It’s shutting down it’s First World sites and shipping them to China
For short term savings now - what motivation could be finer?
Sad tidings of jobs gone abroad
Jobs gone abroad
For the benefit of members of the Board
God rest our Pharma industry, it hasn’t got a prayer
Now run by greedy plutocrats who simply do not care
About the science or the ethics of human healthcare
Downsizings for comfort and wealth
Personal wealth
Downsizings for personal wealth
So spare a thought this Xmas for all those made unemployed
To boost the wealth of plutocrats whose greed is unalloyed
Because of them the Western pharma trade will be destroyed
Mad tidings of Money For The Boys
Cash For The Boys
Slash and burn is making Money For the Boys…
Jim Edwards brings us seasonal tidings of festive axe-swinging…
Friday, December 18, 2009
Business ethics - ask John Kopchinski
John Kopchinski, the whistleblower whom Phillips & Cohen LLP represented in a successful, record-setting "qui tam" case against Pfizer Inc., has been named as the most influential person in business ethics for 2009.
Ethisphere, a think tank that focuses on business ethics, corporate social responsibility, anti-corruption and sustainability, compiles an annual list of the 100 most influential people in business ethics. The group named Kopchinski number one on its 2009 list.
A former sales representative for Pfizer, Kopchinski exposed the company's illegal sales and marketing campaign for the prescription painkiller Bextra for uses and in doses that endangered patients' health and lives. (See http://www.phillipsandcohen.com/CM/NewsSettlements/NewsSettlements531.asp)
Pfizer paid $1.8 billion in September to the government to settle Kopchinski's qui tam lawsuit and a related criminal charge. The company settled four other whistleblower lawsuits at the same time, bringing the total settlement to $2.3 billion. It was the largest healthcare fraud settlement ever and the largest criminal fine ever imposed in the U.S.
"John Kopchinski wasn't seen as a team player and ultimately lost his job at Pfizer," said Erika Kelton, a Washington, DC, attorney with Phillips & Cohen. "But the happy ending to his story and the recognition this honor bestows should give other whistleblowers hope."
Kopchinski "officially turned whistleblowing into big business," said Ethisphere. He received more than $70 million as a reward for the work he and his attorneys did on the Pfizer case. The False Claims Act requires the government to award whistleblowers a percentage of the funds the government recovers as a result of their qui tam cases.
Phillips & Cohen specializes in representing whistleblowers in cases involving fraud against the government, tax matters and securities violations. Cases brought by the firm's attorneys have recovered more than $5.3 billion in civil and criminal penalties for the government. For more information about whistleblowers and qui tam cases, see www.phillipsandcohen.com.
For more information about the Pfizer qui tam case and settlement, see http://www.phillipsandcohen.com/CM/NewsSettlements/NewsSettlements536.asp
SOURCE Phillips & Cohen LLPThe WaPo nails it on drug reimportation
On the campaign trail, Barack Obama vowed to take on the drug industry by allowing Americans to import cheaper prescription medicine. "We'll tell the pharmaceutical companies 'thanks, but no, thanks' for the overpriced drugs -- drugs that cost twice as much here as they do in Europe and Canada," he said back then.
On Tuesday, the matter came to the Senate floor -- and President Obama forgot the "no, thanks" part. Siding with the pharmaceutical lobby, the administration successfully fought against the very idea Obama had championed.
"It's got to be a little awkward," said Sen. Tom Carper (D-Del.).
It's even more awkward for millions of Americans who are forced to pay up to 10 times the prices Canadians and Europeans pay for identical medication, often produced in the same facilities by the same manufacturers, simply because the U.S. government refuses to rein in drug prices.
Those favoring cheaper prescriptions amassed an impressive ideological coalition, from socialist Sen. Bernie Sanders (I-Vt.) to conservative Sen. David Vitter (R-La.). But they were no match for industry-friendly senators backed by the administration, who on Tuesday night easily voted down "reimportation," as it is called.
No surprise here: Lawmakers, and the White House, are addicted to drug money. The industry has pumped upwards of $130 million into federal elections over the past decade and is now among the top 10 donors, according to the Center for Responsive Politics. At the same time, the White House needed the industry to spend its millions of dollars in advertising money on support of the health-care legislation, not against it.
The drug-money addiction could explain why the administration struck a sweetheart deal with the industry, which offered to give up $80 billion in revenue in exchange for an understanding that the government would not push for deeper concessions. The White House was determined not to go back on the deal -- even though the industry had demonstrated bad faith by raising prescription prices nearly 10 percent this year. So when Sen. Byron Dorgan (D-N.D.) brought his reimportation proposal to the floor, the administration pushed back with a letter from Food and Drug Administration chief Margaret Hamburg warning of "significant safety concerns."
One after the other, the drug industry's friends from pharmaceutical-manufacturing states New Jersey, Delaware and North Carolina went to the floor Tuesday to cite the FDA letter.
Sen. Robert Menendez (D-Bristol-Myers Squibb) warned that "you may have a heart attack" because of counterfeit medicine from abroad.
"This is a matter of life or death," agreed Sen. Frank Lautenberg (D-Merck).
Carper (D-AstraZeneca) cited "remaining safety and soundness and health concerns," while Sen. Kay Hagan (D-GlaxoSmithKline) voiced "serious doubts that we can adequately ensure the safety of the drug supply."
These arguments don't hold up well, considering that 40 percent of the active ingredients in American prescription drugs come from India and China, and that the latter slipped tainted heparin past the FDA. But fright was about the best argument opponents could use to defeat a popular proposal that would save the federal government $19 billion over 10 years, according to the Congressional Budget Office. Consumers would save many times that.
That's why the drug industry has been fighting for a decade against congressional efforts to allow reimportation. Obama co-sponsored one such proposal in the Senate. He also said during his presidential campaign that he wanted to "let Medicare negotiate for lower prices" for drugs. White House Chief of Staff Rahm Emanuel, when he was in Congress, also championed reimportation. Yet now, after their successful battle against it, the two are expected to fight off a similar legislative effort to allow Medicare to negotiate for lower drug prices.
Even before the vote came, it had become clear that President Obama's aides had the votes to kill the proposal Senator Obama once co-sponsored. This, said Sen. John McCain (R-Ariz.), "contributes to the enormous cynicism on the part of the American people about the way we do business here." To Dorgan, he pledged: "I will be by his side as we go back and back and back again on this issue until justice and fairness is done and we defeat the special interests of the pharmaceutical industry which have taken over the White House and will take over this vote."
Dorgan, on the verge of losing another reimportation battle, raised his voice as he pleaded with colleagues. "The pharmaceutical industry has a lot of clout. I know that," he said. "I hope the American people have the ability to expect some clout on their behalf in the chamber of the United States Senate."
Tuesday's final clout tally wasn't even close. The drug companies won with nine votes to spare.Campaign Contributions to Senators from Pharmaceutical Manufacturing Interests, January 1, 2003 - August 12, 2009
| Senator | Party | State | Amount from pharma interests | Vote on allowing imports |
| Akaka, Daniel | D | HI | $4,000 | No |
| Alexander, Lamar | R | TN | $108,950 | Yes |
| Barrasso, John | R | WY | $55,500 | No |
| Baucus, Max | D | MT | $261,020 | No |
| Bayh, Evan | D | IN | $144,072 | No |
| Begich, Mark | D | AK | $7,500 | Yes |
| Bennet, Michael | D | CO | $10,750 | Yes |
| Bennett, Robert | R | UT | $124,000 | No |
| Bingaman, Jeff | D | NM | $48,500 | Yes |
| Bond, Christopher | R | MO | $99,003 | Yes |
| Boxer, Barbara | D | CA | $35,900 | Yes |
| Brown, Sherrod | D | OH | $17,300 | Yes |
| Brownback, Samuel | R | KS | $28,250 | No |
| Bunning, Jim | R | KY | $64,250 | No |
| Burr, Richard | R | NC | $301,898 | No |
| Burris, Roland | D | IL | $0 | No |
| Byrd, Robert | D | WV | $32,100 | Not voting |
| Cantwell, Maria | D | WA | $22,400 | No |
| Cardin, Benjamin | D | MD | $40,850 | No |
| Carper, Thomas | D | DE | $135,700 | No |
| Casey, Robert | D | PA | $34,750 | No |
| Chambliss, Saxby | R | GA | $83,949 | No |
| Coburn, Thomas | R | OK | $44,051 | Yes |
| Cochran, Thad | R | MS | $69,000 | No |
| Collins, Susan | R | ME | $70,500 | Yes |
| Conrad, Kent | D | ND | $83,000 | Yes |
| Corker, Bob | R | TN | $65,200 | Yes |
| Cornyn, John | R | TX | $119,700 | Yes |
| Crapo, Michael | R | ID | $64,580 | Yes |
| DeMint, Jim | R | SC | $40,000 | Yes |
| Dodd, Christopher | D | CT | $174,525 | No |
| Dorgan, Byron | D | ND | $12,500 | Yes |
| Durbin, Richard | D | IL | $28,600 | No |
| Ensign, John | R | NV | $89,950 | No |
| Enzi, Michael | R | WY | $146,500 | No |
| Feingold, Russell | D | WI | $6,200 | Yes |
| Feinstein, Dianne | D | CA | $39,500 | Yes |
| Franken, Al | D | MN | $2,500 | Yes |
| Gillibrand, Kirsten | D | NY | $44,400 | No |
| Graham, Lindsey | R | SC | $55,250 | Yes |
| Grassley, Charles | R | IA | $103,700 | Yes |
| Gregg, Judd | R | NH | $122,500 | No |
| Hagan, Kay | D | NC | $4,650 | No |
| Harkin, Thomas | D | IA | $81,800 | Yes |
| Hatch, Orrin | R | UT | $262,950 | No |
| Hutchison, Kay | R | TX | $29,250 | Yes |
| Inhofe, James | R | OK | $20,250 | No |
| Inouye, Daniel | D | HI | $200 | No |
| Isakson, John | R | GA | $126,599 | No |
| Johanns, Mike | R | NE | $43,100 | Yes |
| Johnson, Tim | D | SD | ($1,500) | Yes |
| Kaufman, Edward | D | DE | $0 | No |
| Kerry, John | D | MA | $21,170 | No |
| Kirk, Paul | D | MA | $0 | No |
| Klobuchar, Amy | D | MN | $2,290 | Yes |
| Kohl, Herbert | D | WI | $0 | Yes |
| Kyl, Jon | R | AZ | $117,350 | No |
| Landrieu, Mary | D | LA | $89,550 | No |
| Lautenberg, Frank | D | NJ | $97,550 | No |
| Leahy, Patrick | D | VT | $46,600 | Yes |
| LeMieux, George | R | FL | $0 | Yes |
| Levin, Carl | D | MI | $1,000 | No |
| Lieberman, Joseph | I | CT | $199,540 | No |
| Lincoln, Blanche | D | AR | $100,750 | Yes |
| Lugar, Richard | R | IN | $51,850 | No |
| McCain, John | R | AZ | $7,000 | Yes |
| McCaskill, Claire | D | MO | $6,050 | Yes |
| McConnell, Mitch | R | KY | $225,900 | Yes |
| Menéndez, Robert | D | NJ | $196,452 | No |
| Merkley, Jeff | D | OR | $18,500 | Yes |
| Mikulski, Barbara | D | MD | $70,995 | No |
| Murkowski, Lisa | R | AK | $63,050 | Yes |
| Murray, Patty | D | WA | $144,400 | No |
| Nelson, Ben | D | NE | $138,098 | Yes |
| Nelson, Bill | D | FL | $38,600 | Yes |
| Pryor, Mark | D | AR | $31,000 | Yes |
| Reed, John | D | RI | $34,100 | No |
| Reid, Harry | D | NV | $74,800 | No |
| Risch, James | R | ID | $22,100 | Yes |
| Roberts, Pat | R | KS | $80,650 | No |
| Rockefeller, John | D | WV | $44,000 | No |
| Sanders, Bernard | I | VT | $420 | Yes |
| Schumer, Charles | D | NY | $54,900 | No |
| Sessions, Jefferson | R | AL | $45,000 | Yes |
| Shaheen, Jeanne | D | NH | $2,250 | Yes |
| Shelby, Richard | R | AL | $25,000 | Yes |
| Snowe, Olympia | R | ME | $4,000 | Yes |
| Specter, Arlen | D | PA | $353,550 | Yes |
| Stabenow, Debbie Ann | D | MI | $39,134 | Yes |
| Tester, Jon | D | MT | $14,000 | No |
| Thune, John | R | SD | $45,300 | Yes |
| Udall, Mark | D | CO | $102,275 | No |
| Udall, Tom | D | NM | $15,300 | Yes |
| Vitter, David | R | LA | $17,050 | Yes |
| Voinovich, George | R | OH | $63,750 | No |
| Warner, Mark | D | VA | $84,950 | No |
| Webb, Jim | D | VA | $8,750 | Yes |
| Whitehouse, Sheldon | D | RI | $11,800 | No |
| Wicker, Roger | R | MS | $67,600 | Yes |
| Wyden, Ron | D | OR | $27,800 | Yes |
Source - WaPo
Thursday, December 17, 2009
Cancer - a breakthough Big Pharma may not like!
The move towards personalised medicine has catapulted forward after UK scientists identified all mutations in skin and lung cancer and produced the first complete cancer genomes.
The researchers, from the Wellcome Trust’s Sanger Institute in the UK, sequenced and compared the DNA from both normal and cancerous tissues and found more than 23,000 mutations in the lung cancer tumour and more than 33,000 in melanoma. While many of these were harmless, several were in positions that caused or increased the chances of normal cells to turn cancerous. The researchers believe these mutations will not only be used for early diagnosis but will also be important targets for future oncology drugs.
“We have never seen cancer revealed in this form before… By identifying all the cancer genes we will be able to develop new drugs that target the specific mutated genes and work out which patients will benefit from these novel treatments,” the scientists said when the research was published in Nature yesterday.
Further study of the genomes is expected to provide indicators of lifestyle and environmental factors that can trigger the cancers.
The research has been called “groundbreaking” with professor Carlos Caldas, from Cancer Research UK’s Cambridge Research Institute, saying “what is so new in this study is the researchers have been able to link particular mutations to their cause. The hope and excitement for the future is that we will eventually have a detailed picture of how different cancers develop, and ultimately how better to treat and prevent them.”
Other scientists around the world are also working on the genomes of other cancers – Japan is looking at liver, China stomach, and the USA at brain, ovary and pancreas. It is believed cataloguing cancer genes in patients could be commonplace within the next 10 years.
By Katrina Megget
PharmaTimes
The researchers, from the Wellcome Trust’s Sanger Institute in the UK, sequenced and compared the DNA from both normal and cancerous tissues and found more than 23,000 mutations in the lung cancer tumour and more than 33,000 in melanoma. While many of these were harmless, several were in positions that caused or increased the chances of normal cells to turn cancerous. The researchers believe these mutations will not only be used for early diagnosis but will also be important targets for future oncology drugs.
“We have never seen cancer revealed in this form before… By identifying all the cancer genes we will be able to develop new drugs that target the specific mutated genes and work out which patients will benefit from these novel treatments,” the scientists said when the research was published in Nature yesterday.
Further study of the genomes is expected to provide indicators of lifestyle and environmental factors that can trigger the cancers.
The research has been called “groundbreaking” with professor Carlos Caldas, from Cancer Research UK’s Cambridge Research Institute, saying “what is so new in this study is the researchers have been able to link particular mutations to their cause. The hope and excitement for the future is that we will eventually have a detailed picture of how different cancers develop, and ultimately how better to treat and prevent them.”
Other scientists around the world are also working on the genomes of other cancers – Japan is looking at liver, China stomach, and the USA at brain, ovary and pancreas. It is believed cataloguing cancer genes in patients could be commonplace within the next 10 years.
By Katrina Megget
PharmaTimes
Who really runs the USA?
When Pfizer Inc. Chief Executive Officer Jeffrey Kindler saw that health-care legislation unveiled by House Democratic leaders in October threatened to squeeze drugmakers’ profits, he got on the phone with White House Chief of Staff Rahm Emanuel.
Kindler was upset that the House measure would require pharmaceutical companies to forgo $140 billion in revenue over 10 years, said a person familiar with the discussion.
He wanted assurance from Emanuel that the White House would honor an agreement to limit the drugmakers’ cost to $80 billion.
The deal held.
More at Bloomberg
Wednesday, December 16, 2009
Dr Aubrey Blumsohn - PharmaGossip's Person of the Year
Dr Aubrey Blumsohn forfeited his job after going public with concerns about access to Procter and Gamble’s research data on the osteoporosis drug risedronate.
The BMJ's Clare Dyer talks to him about his experience.
Would the US consider reimportation from the UK?
In a PPRS report to parliament released this week, the DH compared the price of the leading 150 branded medicines in 11 European countries, the USA and Australia. The
However, figures from industry body the Association of the British Pharmaceutical Industry (ABPI) for the second quarter of 2009 suggest medicines prices in
Prices have dropped relative to
Click here to view the report.
Tuesday, December 15, 2009
Evelyn Pringle writes in truthout
US Kids Represent Psychiatric Drug Goldmine
Prescriptions for psychiatric drugs increased 50 percent with children in the US, and 73 percent among adults, from 1996 to 2006, according to a study in the May/June 2009 issue of the journal Health Affairs. Another study in the same issue of Health Affairs found spending for mental health care grew more than 30 percent over the same ten-year period, with almost all of the increase due to psychiatric drug costs.
On April 22, 2009, the US Agency for Healthcare Research and Quality reported that in 2006 more money was spent on treating mental disorders in children aged 0 to 17 than for any other medical condition, with a total of $8.9 billion. By comparison, the cost of treating trauma-related disorders, including fractures, sprains, burns, and other physical injuries, was only $6.1 billion.
In 2008, psychiatric drug makers had overall sales in the US of $14.6 billion from antipsychotics, $9.6 billion off antidepressants, $11.3 billion from antiseizure drugs and $4.8 billion in sales of ADHD drugs, for a grand total of $40.3 billion.
The path to child drugging in the US started with providing adolescents with stimulants for ADHD in the early 80s. That was followed by Prozac in the late 80s, and in the mid-90s drug companies started claiming that ADHD kids really had bipolar disorder, coinciding with the marketing of epilepsy drugs as "mood stablizers" and the arrival of the new atypical antipsychotics.
Parents can now have their kids declared disabled due to mental illness and receive Social Security disability payments and free medical care, and schools can get more money for disabled kids. The bounty for the prescribing doctors and pharmacies is enormous and the CEOs of the drug companies are laughing all the way into early retirement.
More
Tiger Woods naked!
Tiger Woods is in the news for yet another scandal. This time, The New York Times has published a report linking him to a Canadian sports medicine doctor who administers banned substances to athletes in order to speed their recovery from surgery. According to the story, Mr. Woods’ sports agents at IMG referred him to this doctor after his knee was recovering too slowly from surgery in 2008.
To be fair to Mr. Woods, the article does not say that he took HGH or steroids, but rather a platelet derived growth factor, Actovegin, to help with ligament and tendon healing. Giving this product a drug name makes it seem more sinister than it actually is. Actovegin is simply bovine platelet-rich fluid made from centrifuged blood. The theory is to collect the growth factors known to speed healing found in platelets. Small centrifuge machines made for the operating room that spin the patient’s own blood are available in the U.S. now and sold by Johnson and Johnson as the Symphony device. Regranex is an actual drug containing Platelet Derived Growth Factor (PDGF), also sold by JNJ.
The HCC interviewed knee surgeon, Sharon Hame, MD, of UCLA, to discuss Tiger Woods specific type of knee surgery and his prospects for a full recovery and ability to beat Jack Nicklaus’ record of 18 majors. The video may be viewed now.
The Healthcare Channel on http://thehcc.tv
Get yer knowledge here
Clinical Knowledge Summaries (CKS) has been updated in December 2009 for the following clinical areas:
- Fibroids (new)
- GORD in children (new)
- Mumps (new)
- Premenstrual syndrome (new)
- Restless legs syndrome (new)
- Retinal detachment (new)
- Rubella (new)
Just as PharmaGossip predicted!
Last month!
Serge Weinberg will replace Jean-Francois Dehecq as non-executive chairman of Sanofi-Aventis, according to French daily Le Figaro. The move will be effective after the company’s shareholders meeting in the second quarter of 2010.
Monday, December 14, 2009
GSK - Paxil: "To have three significant problems with one drug is really unusual.”
Dec. 14 (Bloomberg) -- GlaxoSmithKline Plc has paid almost $1 billion to resolve lawsuits over Paxil since it introduced the antidepressant in 1993, including about $390 million for suicides or attempted suicides said to be linked to the drug, according to court records and people familiar with the cases.
As part of the total, Glaxo, the U.K.’s largest drugmaker, so far has paid $200 million to settle Paxil addiction and birth-defect cases and $400 million to end antitrust, fraud and design claims, according to the people and court records.
The $1 billion “would be worse than many people are expecting,” said Navid Malik, an analyst at Matrix Corporate Capital in London. “I don’t think this is within the boundaries of current assumptions for analysts.”More
Pfizer - how to police a recidivist offender
Pfizer general counsel will no longer oversee its compliance programme under the terms of the $2.3bn (£1.4bn) settlement resolving allegations of illegal marketing of painkiller Bextra and several other drugs, writes Corporate Counsel.
Instead, the chief compliance officer at the world's largest drug maker will report directly to the chief executive. The move is required by Pfizer's corporate integrity agreement with the office of the inspector general of the US Department of Health and Human Services (HHS), part of the company's civil and criminal settlement with the Department of Justice.
The agreement will be watched closely as compliance functions at US and UK companies are commonly overseen by legal teams.
The change is intended to eliminate conflicts of interest, and prevent Pfizer's in-house lawyers from reviewing or editing reports required by the agreement, said Lewis Morris, chief counsel for the inspector general's office. Officials at Pfizer did not respond to requests for comment.
"The lawyers tell you whether you can do something, and compliance tells you whether you should," Morris added. "We think upper management should hear both arguments."
Pfizer's historic settlement, the largest in the US for claims of off-label marketing practices, has fueled calls for changing how drug companies do business.
A "corporate integrity agreement" is an administrative alternative to excluding Pfizer from participating in US federal health care programmes, such as Medicare and Medicaid, Morris said. Many large drug companies have also entered into corporate integrity agreements, such as Schering-Plough, Eli Lilly, and Bristol-Myers Squibb.
Excluding a drug giant like Pfizer from such programmes would not just be a death knell for the company, said Morris. It would also have a profound adverse impact on the health and welfare of the people who need Pfizer's drugs.
This is Pfizer's fourth settlement with the Justice Department over illegal marketing activities since 2002, and its third corporate integrity agreement. The other agreements were similar in most respects, Morris said. But this is the first one that compels Pfizer's chief compliance officer to report to the company's chief executive, instead of the general counsel.
Pfizer will have to hire an independent review organisation, such as an accounting auditing, consulting firm, to perform reviews required by the agreement. The inspector general's office has the right to reject the organization's work if it's found to be inadequate.
Corporate Counsel is a US sister title of Legal Week.
Instead, the chief compliance officer at the world's largest drug maker will report directly to the chief executive. The move is required by Pfizer's corporate integrity agreement with the office of the inspector general of the US Department of Health and Human Services (HHS), part of the company's civil and criminal settlement with the Department of Justice.
The agreement will be watched closely as compliance functions at US and UK companies are commonly overseen by legal teams.
The change is intended to eliminate conflicts of interest, and prevent Pfizer's in-house lawyers from reviewing or editing reports required by the agreement, said Lewis Morris, chief counsel for the inspector general's office. Officials at Pfizer did not respond to requests for comment.
"The lawyers tell you whether you can do something, and compliance tells you whether you should," Morris added. "We think upper management should hear both arguments."
Pfizer's historic settlement, the largest in the US for claims of off-label marketing practices, has fueled calls for changing how drug companies do business.
A "corporate integrity agreement" is an administrative alternative to excluding Pfizer from participating in US federal health care programmes, such as Medicare and Medicaid, Morris said. Many large drug companies have also entered into corporate integrity agreements, such as Schering-Plough, Eli Lilly, and Bristol-Myers Squibb.
Excluding a drug giant like Pfizer from such programmes would not just be a death knell for the company, said Morris. It would also have a profound adverse impact on the health and welfare of the people who need Pfizer's drugs.
This is Pfizer's fourth settlement with the Justice Department over illegal marketing activities since 2002, and its third corporate integrity agreement. The other agreements were similar in most respects, Morris said. But this is the first one that compels Pfizer's chief compliance officer to report to the company's chief executive, instead of the general counsel.
Pfizer will have to hire an independent review organisation, such as an accounting auditing, consulting firm, to perform reviews required by the agreement. The inspector general's office has the right to reject the organization's work if it's found to be inadequate.
Corporate Counsel is a US sister title of Legal Week.
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