Tuesday, August 31, 2010
Article > US patients “wary of drugmakers’ influence over doctors”
Article > US patients “wary of drugmakers’ influence over doctors”: "69% of Americans currently taking medication say drugmakers have too much influence over doctors’ prescribing decisions and half say that doctors are too eager to prescribe a drug when other non-drug options are available for managing a condition, according to a new survey.
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The Forgotten Patients - Forbes.com
The mental health industry ignores the 35,000 people a year who commit suicide. A few researchers are trying to change that.
via forbes.com
AstraZeneca - Seroquel: I'll sleep when I'm dead!
Andrew White returned from a nine-month tour in Iraq beset with signs of post-traumatic stress disorder: insomnia, nightmares, constant restlessness. Doctors tried to ease his symptoms using three psychiatric drugs, including a potent anti-psychotic called Seroquel.
Thousands of soldiers suffering from PTSD have received the same medication over the last nine years, helping to make Seroquel one of the Veteran Affairs Department's top drug expenditures and the No. 5 best-selling drug in the nation.
Several soldiers and veterans have died while taking the pills, raising concerns among some military families that the government is not being up front about the drug's risks. They want Congress to investigate.
In White's case, the nightmares persisted. So doctors recommended progressively larger doses of Seroquel. At one point, the 23-year-old Marine corporal was prescribed more than 1,600 milligrams per day - more than double the maximum dose recommended for schizophrenia patients.
A short time later, White died in his sleep.
via ap.stripes.com
Johnson & Johnson CEO admits letdown - postandcourier.com
We've learned a lot of lessons. They've been very painful," Weldon said Friday, adding that he has received a number of letters from consumers, "some supportive and some not.
Monday, August 30, 2010
Genzyme rejects Sanofi-Aventis 'bear hug' | Business | The Guardian
"The Genzyme board is not prepared to engage in merger negotiations with Sanofi based on an opportunistic proposal with an unrealistic starting price, that dramatically undervalues our company," Genzyme said.
A fight between the companies broke into the open after several months of behind-the-scenes machinations as Sanofi tried to get Genzyme involved in friendly takeover talks.
Yesterday, Sanofi went public with its all-cash offer, in a move dubbed a "bear hug" that ratchets up pressure on Genzyme to negotiate.
via guardian.co.uk
"The number of new medicines is at an all-time low and is as low as it has been since the Second World War," - The Independent
The "patent cliff" is the chief challenge facing the industry, although some companies will be affected more than others. Patents can sometimes be extended by making slight changes to the chemical composition, for example – a process called "evergreening".
However, some analysts argue that the search for new blockbuster drugs is not good value for money.
PricewaterhouseCoopers (PwC), in its report Pharma 2020: The Vision, says that industry leaders' revenues "have come at a very high price". It notes that between 1985 and 2000 the industry's market value increased 85-fold, outpacing the stock market as a whole. But in the six years to 30 March 2007 the FTSE global pharmaceuticals index rose just 1.3 per cent, while the Dow Jones World Index rose by 34.9 per cent. Additionally, it says that only five of the top companies worldwide generate more than 10 per cent of their revenues from products launched since 2001. "Even allowing for inflation, the industry is investing twice as much in R&D as it was a decade ago to produce two-fifths of the new medicines it then produced," it says.
Thursday, August 26, 2010
Wednesday, August 25, 2010
Takeda’s Actos Has Same Heart Risks as Glaxo’s Avandia - BusinessWeek
Patients taking Avandia or Actos were 4 percent more likely to experience heart attacks, heart failure or die, according to the study published yesterday in the American Heart Association journal, Circulation.
Actos become the market leader after a 2007 study showed a 43 percent higher chance of heart attacks from Avandia, which generated $3.3 billion of sales before the findings. The latest study, the first to compare the drugs, suggests the risks are tied to that category of medicine, Jenny Gunton, a diabetes researcher at the Garvan Institute of Medical Research, said.
“It just maybe increases the worry of using either of the drugs,” Gunton, who wasn’t involved in the study, said in a telephone interview from Sydney. A rate of 4 percent is “pretty high” given the short study period, she said.
via businessweek.com
Is It OK For Pfizer To Pay For Reporters To Learn About Cancer? : Shots - Health News Blog : NPR
Dr. Joseph Hammang, senior director of worldwide science at Pfizer speaks
Question: But Pfizer has paid billions in fines for illegal, off-label marketing [prodding doctors to prescribe drugs for uses that were not approved by the FDA]. Don't these fines feed the perceptions that the doctors and the pharmaceutical companies are prescribing us medicine that we don't need?
Answer: People make mistakes. We've been fined. And we're making reparations for those mistakes. But they're really, really isolated. You have to understand that the vast majority of the people who work in the industry are doing it for all the right reasons. ... But yes, it absolutely, positively fuels that stuff you read on the Internet. But like so many things, it's blown way, way, way out of proportion.
via post-gazette.com
Tuesday, August 24, 2010
Pfizer's Wonder Drug That Wasn't
After multiple failures on its own and in combination with other drugs, expanding into breast cancer doesn't seem likely. There may be some hope for Sutent as a lung cancer treatment because the drug was able to extend the time it took for the tumors to resume growing. If the drugmaker can find a subset of patients with a certain genetic makeup that makes their tumors more responsive to Sutent, Pfizer could get approval for treating just that subset of patients.
Pfizer will need to run another clinical trial, but the financial benefits could be worth the added cost. Any added revenue would make this wonder drug a little more wonderful.
via fool.com
Interactive Investor - AstraZeneca staff set 3 strike dates in September
The action will involve three two-hour strikes on September 8, three four-hour strikes on September 15 and a 24-hour strike starting at 6 a.m. on September 22. Further action will be announced in due course, the GMB added in a statement.
via iii.co.uk
Six methods used to influence people to do things that aren't necessarily in their best interest
1. Reciprocity -- People tend to return favors out of a sense of obligation. Influencers exploit this by extending a small favor (buying them a Coke from a vending machine) in order to get a bigger favor back (having you buy a car from them).
2. Scarcity -- When people are made to believe something is rare ("a limited time offer!"), they will desire it more. In Influence, Cialdini writes about an Indian jewelry store that attempted to get rid of a line of jewelry by lowering the price. Nobody bought it even though the store lowered the price again and again. But when a new salesperson misread the price tags and told customers that the jewelry cost 10 times as much, the items quickly sold out.
3. Liking -- People like other people who are members of their "tribe." Influencers seek to find common interests with their victims, tell jokes, and pay compliments. Flattery, Cialdini found, will get you everywhere.
4. Authority -- Influencers who convince their clients, customers, or marks that they are authorities or experts can gain control over them. That's why they hang diplomas (not always genuine) and pictures of themselves posing with famous people on their walls.
5. Social proof -- People are herd animals. They copy each other. When a magazine salesman came to my door a few years ago, he showed me a stack of subscriptions cards that "people in the neighborhood" had filled out. He pointed out that most people bought subscriptions to three different magazines. Fortunately I had recently read Cialdini's book and I knew he was using the "social proof" technique. I didn't buy anything. (And I'll bet most of the subscription cards were fake.)
6. Commitment/consistency -- People like to behave in a consistent manner. Cialdini recounts a personal experience he once had with a young woman with a clipboard who approached him and asked him if he was a patron of the arts. He said yes. She then said she was selling membership to a club that offered discounts to different kinds of artistic events. Cialdini wrote, "I bought the entertainment package, even though I knew I had been set up. The need to be consistent with what I had already said snared me."
Source
2. Scarcity -- When people are made to believe something is rare ("a limited time offer!"), they will desire it more. In Influence, Cialdini writes about an Indian jewelry store that attempted to get rid of a line of jewelry by lowering the price. Nobody bought it even though the store lowered the price again and again. But when a new salesperson misread the price tags and told customers that the jewelry cost 10 times as much, the items quickly sold out.
3. Liking -- People like other people who are members of their "tribe." Influencers seek to find common interests with their victims, tell jokes, and pay compliments. Flattery, Cialdini found, will get you everywhere.
4. Authority -- Influencers who convince their clients, customers, or marks that they are authorities or experts can gain control over them. That's why they hang diplomas (not always genuine) and pictures of themselves posing with famous people on their walls.
5. Social proof -- People are herd animals. They copy each other. When a magazine salesman came to my door a few years ago, he showed me a stack of subscriptions cards that "people in the neighborhood" had filled out. He pointed out that most people bought subscriptions to three different magazines. Fortunately I had recently read Cialdini's book and I knew he was using the "social proof" technique. I didn't buy anything. (And I'll bet most of the subscription cards were fake.)
6. Commitment/consistency -- People like to behave in a consistent manner. Cialdini recounts a personal experience he once had with a young woman with a clipboard who approached him and asked him if he was a patron of the arts. He said yes. She then said she was selling membership to a club that offered discounts to different kinds of artistic events. Cialdini wrote, "I bought the entertainment package, even though I knew I had been set up. The need to be consistent with what I had already said snared me."
Source
Roche's Avastin again spurned by UK's NICE | Reuters
Roche's Avastin again spurned by NICE | Reuters: "Andrew Dillon, NICE chief executive, noted the cost watchdog recommended several other drugs for bowel cancer, including Merck KGaA's Erbitux, but said Roche failed to show its 'complex' price scheme would make Avastin cost-effective.
'We have to be confident that the benefits justify the considerable cost of this drug,' Dillon said in a statement.
Roche originally proposed a patient access scheme that would supply Avastin at 20,800 pounds per patient for one year, after which it would be free. The cost of accompanying oxaliplatin chemotherapy would also be reimbursed by Roche.
The new offer would have included these elements plus an additional upfront payment to the National Health Service (NHS) for each person starting on Avastin.
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'We have to be confident that the benefits justify the considerable cost of this drug,' Dillon said in a statement.
Roche originally proposed a patient access scheme that would supply Avastin at 20,800 pounds per patient for one year, after which it would be free. The cost of accompanying oxaliplatin chemotherapy would also be reimbursed by Roche.
The new offer would have included these elements plus an additional upfront payment to the National Health Service (NHS) for each person starting on Avastin.
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Carlat on CAFE
The Carlat Psychiatry Blog: "Making a Killing": New Carl Elliott Article in Mother Jones: "I had read the CAFE study before, but as I was preparing this post, I noticed aspects of the design that had not struck me in the past. The study was truly manipulated in order to make Seroquel look good. In my next post I will delve into the specifics, so stay tuned.
Monday, August 23, 2010
Jazz shares fall after negative FDA panel vote - Yahoo! Finance
Shares of Jazz Pharmaceuticals Inc. plunged Monday after a panel of Food and Drug Administration experts recommended the company's proposed chronic pain disorder treatment not be approved.
THE SPARK: On Friday, the panel said sodium oxybate shouldn't be approved as a treatment for the chronic pain condition fibromyalgia because of risks that it could be dangerously abused. The drug is already approved under the name Xyrem to treat excessive sleepiness. It is considered a "controlled substance," by the U.S. drug enforcement authorities because its active ingredient has been used as an illegal stimulant and as a date rape drug.
AstraZeneca - Seroquel: Lies, damned lies ... and the results of clinical trials
By Andrew Jack at The FT:
There are lies, damned lies and ... the results of clinical trials. That might be the conclusion from internal AstraZeneca documents made public during litigation on its antipsychotic drug Seroquel, which is now coming to a close.
They highlight apparent efforts by the group to communicate favourable data selectively to boost prescriptions. Their full context may never be fully scrutinised because of out-of-court settlements being finalised with US patients and prosecutors.
AstraZeneca said: “Selected documents produced in connection with the Seroquel product liability litigation do not provide a fair and accurate picture. The company has worked diligently with the US Food and Drug Administration to ensure that the safety profile of Seroquel is reflected appropriately in the prescribing information.”
While denying the allegations, it has reached a $520m (£335m) settlement with the Department of Justice and two whistleblowers, related to past marketing practices. It will soon pay $198m to thousands of patients who developed diabetes, and has won one case after arguing that it had not been proved that the drug caused the condition.
In 1997 AstraZeneca launched Seroquel, known generically as quetiapine, to treat schizophrenia and marketed it as causing fewer side effects than existing medicines, notably extrapyramidal symptoms (EPS) such as muscle spasms.
Through additional clinical trials to persuade regulators of wider-ranging efficacy and few side effects, and aggressive marketing to make a similar case to doctors, the drug became a $1bn-a-year “blockbuster” by 2002. It has generated more than $25bn in sales over the past decade and $4.5bn last year alone.
In February 1997, Richard Lawrence, Seroquel’s marketing manager, raised the results of “this cursed” Study 15, a clinical trial that was never published but showed no advantage of Seroquel over Haldol, a rival treatment. It was one of several studies that the company cited selectively in marketing materials.
“I am not 100 per cent comfortable with this data being made publicly [sic] available at the present time,” he wrote. “However, I understand that we have little choice ... Lisa has done a great ‘smoke-and-mirrors’ job!”
In 2000, an internal “meta analysis” comparing different studies on the efficacy of Seroquel and other antipsychotics showed no significant benefit over the alternatives. Geoffrey Birkett, an AstraZeneca executive, characterised the findings for Seroquel as “unsurpassed” – a word he defined to lawyers suing the company as “possibly better ... possibly equivalent”.
One of AstraZeneca’s pivotal marketing claims to doctors was that Seroquel resulted in less weight gain than other antipsychotics. Yet as the drug became more widely used, doctors and patients reported just such effects, resulting in diabetes.
As early as August 1997, Lisa Arvanitis, a researcher at the company, warned colleagues about going “ballyhoo” on Seroquel’s lower weight gain. “We know we have weight gain but is it limited to the short-term treatment?” she wrote in an e-mail. “I’m not sure there is yet any type of competitive opportunity, no matter how weak.”
In February 1999, Nick Hough, another executive, warned on one study suggesting patients on Seroquel lost weight: “We must not get too carried away with ‘weight loss’ when we know the rest of our data appears to point in the other direction.”
In December, employees debated whether they should sanction publication of a study called COSTAR, which showed statistical equivalence at best when comparing Seroquel with the rival drug Risperdal.
“I think that we are still not comfortable about communicating the overall results of this study,” wrote Martin Jones. “Are we sure that ... we can present the EPS data in isolation given the nature of the other results?”
John Tumas replied: “There has been a precedent set regarding ‘cherry picking’ of data ... Thus far, we have buried Trials 15, 31, 56 and are now considering COSTAR ... We must find a way to diminish the negative findings. But in my opinion we cannot hide them.”
Jim Galvin warned: “Selectively using (for example) the EPS data from COSTAR is pushing it too far ... and would destroy our current high standing in the publishing industry.”
Other AstraZeneca documents show that the company was cautious about research conducted by Michael Reinstein, a psychiatrist in Chicago, who was a strong advocate of Seroquel. But – recognising him as “possibly our most important single customer” – it paid him almost $500,000 over a decade in fees and costs to present his research at conferences, and circulated his findings to doctors.
As one AstraZeneca employee put it while dispatching a copy to a colleague in Sweden in 2005: “Goes to show you that if there’s a huge need for data to support a message, the data will find its way out (despite our guidance to the contrary).”
The same could be said for the internal e-mails – something likely to make users far more cautious in future as to what they commit to computer.
http://www.ft.com/cms/s/0/9d45a982-ae0c-11df-bb55-00144feabdc0.html
There are lies, damned lies and ... the results of clinical trials. That might be the conclusion from internal AstraZeneca documents made public during litigation on its antipsychotic drug Seroquel, which is now coming to a close.
They highlight apparent efforts by the group to communicate favourable data selectively to boost prescriptions. Their full context may never be fully scrutinised because of out-of-court settlements being finalised with US patients and prosecutors.
AstraZeneca said: “Selected documents produced in connection with the Seroquel product liability litigation do not provide a fair and accurate picture. The company has worked diligently with the US Food and Drug Administration to ensure that the safety profile of Seroquel is reflected appropriately in the prescribing information.”
While denying the allegations, it has reached a $520m (£335m) settlement with the Department of Justice and two whistleblowers, related to past marketing practices. It will soon pay $198m to thousands of patients who developed diabetes, and has won one case after arguing that it had not been proved that the drug caused the condition.
In 1997 AstraZeneca launched Seroquel, known generically as quetiapine, to treat schizophrenia and marketed it as causing fewer side effects than existing medicines, notably extrapyramidal symptoms (EPS) such as muscle spasms.
Through additional clinical trials to persuade regulators of wider-ranging efficacy and few side effects, and aggressive marketing to make a similar case to doctors, the drug became a $1bn-a-year “blockbuster” by 2002. It has generated more than $25bn in sales over the past decade and $4.5bn last year alone.
In February 1997, Richard Lawrence, Seroquel’s marketing manager, raised the results of “this cursed” Study 15, a clinical trial that was never published but showed no advantage of Seroquel over Haldol, a rival treatment. It was one of several studies that the company cited selectively in marketing materials.
“I am not 100 per cent comfortable with this data being made publicly [sic] available at the present time,” he wrote. “However, I understand that we have little choice ... Lisa has done a great ‘smoke-and-mirrors’ job!”
In 2000, an internal “meta analysis” comparing different studies on the efficacy of Seroquel and other antipsychotics showed no significant benefit over the alternatives. Geoffrey Birkett, an AstraZeneca executive, characterised the findings for Seroquel as “unsurpassed” – a word he defined to lawyers suing the company as “possibly better ... possibly equivalent”.
One of AstraZeneca’s pivotal marketing claims to doctors was that Seroquel resulted in less weight gain than other antipsychotics. Yet as the drug became more widely used, doctors and patients reported just such effects, resulting in diabetes.
As early as August 1997, Lisa Arvanitis, a researcher at the company, warned colleagues about going “ballyhoo” on Seroquel’s lower weight gain. “We know we have weight gain but is it limited to the short-term treatment?” she wrote in an e-mail. “I’m not sure there is yet any type of competitive opportunity, no matter how weak.”
In February 1999, Nick Hough, another executive, warned on one study suggesting patients on Seroquel lost weight: “We must not get too carried away with ‘weight loss’ when we know the rest of our data appears to point in the other direction.”
In December, employees debated whether they should sanction publication of a study called COSTAR, which showed statistical equivalence at best when comparing Seroquel with the rival drug Risperdal.
“I think that we are still not comfortable about communicating the overall results of this study,” wrote Martin Jones. “Are we sure that ... we can present the EPS data in isolation given the nature of the other results?”
John Tumas replied: “There has been a precedent set regarding ‘cherry picking’ of data ... Thus far, we have buried Trials 15, 31, 56 and are now considering COSTAR ... We must find a way to diminish the negative findings. But in my opinion we cannot hide them.”
Jim Galvin warned: “Selectively using (for example) the EPS data from COSTAR is pushing it too far ... and would destroy our current high standing in the publishing industry.”
Other AstraZeneca documents show that the company was cautious about research conducted by Michael Reinstein, a psychiatrist in Chicago, who was a strong advocate of Seroquel. But – recognising him as “possibly our most important single customer” – it paid him almost $500,000 over a decade in fees and costs to present his research at conferences, and circulated his findings to doctors.
As one AstraZeneca employee put it while dispatching a copy to a colleague in Sweden in 2005: “Goes to show you that if there’s a huge need for data to support a message, the data will find its way out (despite our guidance to the contrary).”
The same could be said for the internal e-mails – something likely to make users far more cautious in future as to what they commit to computer.
http://www.ft.com/cms/s/0/9d45a982-ae0c-11df-bb55-00144feabdc0.html
The Professional Guinea Pig
About The Author
Roberto Abadie is a visiting scholar with the Health Sciences Doctoral Programs at the Graduate Center, City University of New York.
http://www.dukeupress.edu/Catalog/ViewProduct.php?productid=18847
Sunday, August 22, 2010
AstraZeneca gets Verus suit dropped
AstraZeneca gets suit dropped
AstraZeneca Plc won dismissal of a lawsuit in which it was accused of backing out of a deal with Verus Pharmaceuticals Inc. to develop a children’s asthma drug and instead aligning with competitor Map Pharmaceuticals Inc.
Verus sued in May 2009, seeking at least $280 million in compensatory damages and $1 billion in punitive damages from AstraZeneca, the U.K.’s second-biggest drug maker. Verus claimed that once AstraZeneca entered a deal with Map, it sought to kill any competition by destroying Verus’ ability to develop the drug on its own.
“Verus’s causes of action fail to state claims for which relief can be granted,” U.S. District Judge Barbara S. Jones in Manhattan said in an Aug. 16 order dismissing the case. She didn’t rule on the merits of Verus’ accusations.
AstraZeneca Plc won dismissal of a lawsuit in which it was accused of backing out of a deal with Verus Pharmaceuticals Inc. to develop a children’s asthma drug and instead aligning with competitor Map Pharmaceuticals Inc.
Verus sued in May 2009, seeking at least $280 million in compensatory damages and $1 billion in punitive damages from AstraZeneca, the U.K.’s second-biggest drug maker. Verus claimed that once AstraZeneca entered a deal with Map, it sought to kill any competition by destroying Verus’ ability to develop the drug on its own.
“Verus’s causes of action fail to state claims for which relief can be granted,” U.S. District Judge Barbara S. Jones in Manhattan said in an Aug. 16 order dismissing the case. She didn’t rule on the merits of Verus’ accusations.
Saturday, August 21, 2010
Friday, August 20, 2010
AstraZeneca - Seroquel: Disturbing suicide tale: U of M professor reexamines ethics questions of drug trial
Update -In the September issue of Mother Jones magazine, Dr. Carl Elliott, a professor of bioethics at the University of Minnesota, writes about the suicide in 2004 of 26-year-old Dan Markingson, who was enrolled at the time in a U of M industry-funded clinical trial of the antipsychotic drug Seroquel (quetiapine).
It’s a disturbing tale (the unsuccessful efforts of Markingson's mother to get her son released from the trial and into other treatment are particularly heartbreaking) and one that, as Elliott acknowledges, was first told in the Pioneer Press by Jeremy Olson and Paul Tosto.
But Elliott’s purpose in writing the article wasn’t only to revisit the tragic details of Markingson's story. “[T]he more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported,” he writes. “The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.”
Those hazards include questionable informed consent (is a young man who’s experiencing psychotic episodes competent to give his consent?) and financial conflicts of interest. According to Elliott, the U of M psychiatry department earned $15,648 for each person it enrolled in the Seroquel study. In addition, the study’s two U of M investigators, Drs. Charles S. Schulz and Stephen C. Olson, personally earned a combined $811,045 between 2002 and 2008 from Big Pharma, including $261,364 from AstraZeneca, the maker of Seroquel.
At the time Markingson entered the Seroquel study, reports Elliott, the investigators were having serious problems recruiting subjects. Did that factor lead them to enroll someone into the study who shouldn’t have been?
“Even by the standards of a fairly ugly history [of clinical drug trials with ethical breaches] in medical history — even by those standards, this [case] jumps up,” Elliott told me in an interview last week. “There were so many things that went wrong — the consent process, the commitment order under which [Markingson] was recruited into the trial, the financial incentives of the university, the financial incentives of the investigators, and the sheer worthlessness of the trial. Anyone who looked into this and knew anything about clinical research would say this is terrible.”
Elliott sees the trial's worthlessness as a particularly abhorrent part of the story. The Seroquel study was designed as a marketing tool, he suggests, not as a true scientific inquiry. Such studies, he writes, present a huge ethical problem that isn't being properly addressed by the oversight systems currently in place:What is simply assumed [when bioethicists and regulators debate the risks of a clinical trial], without much consideration at all, is that the research is being conducted to produce scientific knowledge. This assumption is codified in a number of foundational ethics documents, such as the Nuremberg Code, which was instituted following Nazi experiments on concentration camp victims. … But what if a research study is not really aimed at producing genuine scientific knowledge at all? The documents emerging in litigation [involving various prescription drugs] suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to “generative commercially attractive messages”?Or, as Elliott told me: “I don’t think anybody who enrolls in a clinical trial thinks, “I know this study is risky, but I think it’s worth it to help Pfizer or AstraZeneca market their drug.”
Elliott said he’s been astonished by how few people at the U of M have bothered to examine too closely the university’s role in the Markingson case. “What’s amazing is that everybody who has looked at it has just concluded that we did everything right here,” he said. “It’s true that the university has had one conflict of interest scandal after another," he added, "but with all of those, you’re just talking about money. You’re not talking about a death in a clinical trial. Usually, when someone dies, people pay attention.”
Markingson’s mother, Mary Weiss, sued the U of M, AstraZeneca, Olson and Schulz, but, as Elliott points out, her case never went to trial. It was dismissed in 2008 with a partial summary judgment. The judge ruled that Weiss' lawyer had not shown any evidence linking Seroquel to Dan’s suicide. Furthermore, he said, her lawyers (and the judge’s own independent research efforts) had failed to point to any case or statute that would support the contention that AstraZeneca — or any pharmaceutical company — had a duty to put the interests of its research subjects above those of the company. The malpractice suit against Schulz was also dismissed, and that against Olson was eventually settled for $75,000, which was insufficient to even cover Weiss' legal costs, says Elliott.
But the legal matters didn’t end there. The U of M has sued Weiss to recover its own costs. “After it’s all done," said Elliott, "after this poor woman has had her son die in a research study, to turn around and sue her....” He paused. "I would like to know who made that decision — and why,” he said.
The Mother Jones article reaches subscribers’ mailboxes today. Everybody else will have to wait until it hits the newsstands on Aug. 31.
Here it is
via minnpost.com
The FDA’s New Power - Matthew Herper - The Medicine Show - Forbes
Risk Evaluation and Mitigation Strategies (REMS) were originally developed for drugs that cause birth defects, like Roche’s acne medicine Accutane or Celgene’s cancer pill Thalomid, also known as thalidomide. But now they have become the new hurdle for companies hoping to market medicines.
via blogs.forbes.com
Secrets of 'magic' ketamine antidepressant revealed
The team discovered that ketamine acts on a pathway that rapidly forms new synaptic connections between neurons -- a process called "synaptogenesis."
"The pathway is the story. Understanding the mechanism underlying the antidepressant effect of ketamine will allow us to attack the problem at a variety of possible sites within that pathway," Aghajanian said.
The team identified a critical point in the pathway, the enzyme mTOR, which controls protein synthesis required for new synaptic connections. There are already promising leads on ways to sustain the initial rapid effect of ketamine by intervening at specific downstream targets.
via sciencedaily.com
More drug price cuts in Greece
Greece has announced that the price of certain drugs are to be reduced 10.41% and that it is drawing up a second list of medicines which will no longer be eligible for reimbursement.
The 10.41% retail price cuts announced by the economics ministry will be for a range of drugs used in the treatment of serious diseases, licensed for hospital use or prescribing by specialists only, and provisions will be put in place to enable patients to obtain them from pharmacies. The drugs involved have not been identified, but analysts at IHS Global Insight suggest that they will include biotechnology drugs used in the treatment of cancer, and possibly some orphan products. What is certain, they add, is that products whose prices are now to be cut will not be those which were included in the average 27% across-the-board price cut introduced by the government on a temporary basis in May.
via pharmatimes.com
Glaxo’s Summary of a Hearing on Avandia Is Challenged - NYTimes.com
Dr. David Graham, an F.D.A. medical officer, made an impassioned presentation at the advisory hearing arguing that the study should be stopped because thousands of patients in the trial were being exploited. None of these arguments were mentioned in GlaxoSmithKline’s letter.
“This summary is biased, misleading and not truthful,” Dr. Graham said in an interview. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”
Several members of the advisory committee complained that the company’s letter was biased.
“This letter is really deceptive,” said Dr. Clifford J. Rosen, a panel member. He added that the letter also did not refer to a presentation at the hearing by members of an Institute of Medicine study panel that said observational studies could be useful.
Dr. Curt D. Furberg, also a panel member, described the letter as a “very Avandia friendly” document that ignored much of the discussion criticizing the validity of GlaxoSmithKline’s studies. Other panel members expressed similar reservations.
via nytimes.com
Thursday, August 19, 2010
The Man Who Predicted Eli Lilly’s Alzheimer Failure - Robert Langreth - Treatments - Forbes
All along, a handful of researchers have predicted that amyloid-blocking drugs could actually make the disease worse. One critic is Mark Smith at Case-Western-Reserve University in Cleveland. He is on vacation abroad now, but here is what he said in 2008:
Others say the Alzheimer’s field has it backwards. Far from being harmful, amyloid is “actually a response to injury that the brain secretes to protect itself, like a scar,” argues Mark Smith, a neuroscientist at Case Western Reserve University. By removing it, “you will make the disease worse.” Amyloid deposits are often found near cerebral blood vessels, hinting that amyloid may act as a sealant for damaged blood vessels.
via blogs.forbes.com
Law.com - Judge Dismisses $280 Million Drug Development Suit Against AstraZeneca
We can only imagine how excited the folks at a small pharmaceutical development company called Verus were when they signed a deal with the mighty AstraZeneca in the spring of 2007. AstraZeneca agreed to pay Verus $30 million to develop its early-stage pediatric asthma drug, with an eye toward a preliminary October 2008 meeting with the Food and Drug Administration to receive approval for clinical testing. If all went well, AstraZeneca would then pay Verus another $280 million to acquire rights to the drug.
All didn't go well. Early testing on rats and dogs revealed serious safety issues. By September 2008, AstraZeneca was talking about discontinuing animal testing. In fact, at a Sept. 18 meeting, someone from AstraZeneca asked Verus if the company planned to repurchase development rights to its drug, under a contractual agreement that permitted Verus to reacquire rights for $1.
After a series of communications between the companies in October -- when, in more optimistic days, they'd anticipated an FDA meeting -- Verus sent AstraZeneca what it called a "notice of election to exercise repurchase option," in which it asked AstraZeneca to guarantee the assets Verus would reacquire didn't include liabilities in excess of $200,000. AstraZeneca said Verus' proposed terms went beyond the 2007 deal and weren't acceptable. Then, to complete its rejection of Verus, AstraZeneca announced in December 2008 that it had entered into an agreement with a different small pharma company to develop a competing pediatric asthma treatment.
With great fanfare, Verus sued AstraZeneca in New York state Supreme Court for $1.28 billion -- the $280 million it alleged it was due under its contract with AstraZeneca, plus $1 billion in punitive damages. Verus' lawyers at Fensterstock & Partners accused AstraZeneca of breach of contract, fraud, conversion, unjust enrichment and breach of the implied covenant of good faith.
On Monday, Manhattan federal district court Judge Barbara Jones, who took over the case when AstraZeneca had it removed to federal court, dismissed every one of Verus' claims (pdf). She found that AstraZeneca had honored all of its contractual obligations to Verus under the development, asset purchase and repurchase deals the companies signed in 2007.
"The ruling couldn't be more of an across-the-board vindication for AstraZeneca," said AstraZeneca lead counsel Aaron Rubinstein of Kaye Scholer. "It says there was no basis for the contractual obligations Verus asserted."
Jones noted twice in her ruling that Verus did not contest AstraZeneca's assertions of safety problems with its pediatric asthma drug. Rubinstein said those safety issues precluded further development of the product. "We weren't going to push for an FDA meeting that would have been an absolute waste of time," he told us. "AstraZeneca wasn't going to ask that humans be subjected to this product that wasn't safe." And if AstraZeneca considered Verus' product worthless, he added, the company certainly wasn't going to pay $280 million for it, despite Verus' breach of contract assertions. "AstraZeneca isn't going to just roll over and throw money at them when it believes it acted properly," Rubinstein said.
Verus counsel Blair Fensterstock, however, told us that Jones erred in her interpretation of AstraZeneca's obligations under the development deal. AstraZeneca, he said, was bound to prepare the drug for a preliminary FDA meeting, and failed to honor that obligation. AstraZeneca's purported safety concerns, he said, were "a ruse"; according to Fensterstock, AstraZeneca was aware of the safety issues before it signed the 2007 agreements with Verus. Moreover, he said, those concerns were not serious enough to preclude a meeting with the FDA to discuss clinical testing on people.
And Jones, Fensterstock said, should not have assumed facts about the products safety in a dismissal ruling. "The evidence to support our case has yet to be before the judge," he said. "She was wrong to rule with regard to safety."
Versus, he added, intends to appeal.
This article first appeared on The Am Law Litigation Daily blog on AmericanLawyer.com.
via law.com
Tales from the PMCPA contd. - Bringing discredit upon and reducing confidence in the pharmaceutical industry.
ProStrakan Group plc, Cephalon UK Limited and GlaxoSmithKline Consumer Healthcare have each breached the ABPI Code of Practice for the Pharmaceutical Industry. To highlight these breaches, all are the subject of advertisements in the medical, pharmaceutical and nursing press.
ProStrakan – Case AUTH/2235/5/09
For making claims about Abstral that were misleading and did not comply with a previous undertaking, ProStrakan was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon and reducing confidence in the
pharmaceutical industry.
Clause 3.2 - Making claims that were inconsistent with the summary of
product characteristics.
Clause 7.2 - Making misleading claims.
Clause 9.1 - Failing to maintain high standards.
Clause 25 - Failing to comply with an undertaking.Cephalon – Case AUTH/2295/1/10
For providing free stock of Effentora, a Schedule 2 controlled drug, without sufficient controls, Cephalon was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon and reducing confidence in the
pharmaceutical industry.
Clause 9.1 - Failing to maintain high standards.
Clause 15.2 - Representative failing to maintain high standards.GlaxoSmithKline Consumer Healthcare – Case AUTH/2298/2/10
For making claims about NiQuitin that were misleading and did not comply with previous undertakings, GlaxoSmithKline Consumer Healthcare was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon and reducing confidence in the
pharmaceutical industry.
Clause 7.2 - Making misleading claims and comparisons.
Clause 7.3 - Using misleading comparisons.
Clause 9.1 - Failing to maintain high standards.
Clause 25 - Failing to comply with an undertaking.Under provisions in its Constitution and Procedure, the Prescription Medicines Code of Practice Authority (PMCPA) advertises brief details of all cases where companies are ruled in breach of Clause 2 of the Code, are required to issue a corrective statement or are the subject of a public reprimand.
The advertisements will appear in the BMJ and The Pharmaceutical Journal on 21 August 2010 and in The Nursing Standard on 25 August 2010.
via pmcpa.org.uk
Pfizer Menopause Drug Didn’t Cause Cancers, Jury Says - BusinessWeek
Wyeth has lost seven of the 12 Prempro cases decided by juries since trials began in 2006. The drugmaker got some of those verdicts thrown out at the post-trial stage or had awards reduced.
A judge in Philadelphia refused in May to throw out a $9.4 million jury award to a woman who blamed Prempro for her breast cancer. The case is on appeal.
via businessweek.com
Wednesday, August 18, 2010
PharmaTimes | Industry News | World News | Lilly hit by spectacular failure of Phase III Alzheimer’s candidate
PharmaTimes | Industry News | World News | Lilly hit by spectacular failure of Phase III Alzheimer’s candidate: "There was more bad news for Eli Lilly following the spectacular failure of its late-stage Alzheimer’s disease candidate, and a new question mark over the future of Cymbalta in chronic pain.
The group’s shares closed down nearly 3% last night as shareholders mulled over news that the company is pulling the plug on semagacestat for Alzheimer’s disease, after the experimental drug disappointed in Phase III trials.
Preliminary findings show that not only did semagacestat, a gamma secretase inhibitor, fail to slow disease progression, but that it was actually associated with “worsening of clinical measures of cognition and the ability to perform activities of daily living”.
In addition, the data showed that patients taking Lilly’s drug had an increased risk of skin cancer compared with those in the placebo arm, putting the final nail in the clinical programme. But the company will continue collecting follow-up data for at least six months, “for the benefit of future Alzheimer’s research”.
The group’s shares closed down nearly 3% last night as shareholders mulled over news that the company is pulling the plug on semagacestat for Alzheimer’s disease, after the experimental drug disappointed in Phase III trials.
Preliminary findings show that not only did semagacestat, a gamma secretase inhibitor, fail to slow disease progression, but that it was actually associated with “worsening of clinical measures of cognition and the ability to perform activities of daily living”.
In addition, the data showed that patients taking Lilly’s drug had an increased risk of skin cancer compared with those in the placebo arm, putting the final nail in the clinical programme. But the company will continue collecting follow-up data for at least six months, “for the benefit of future Alzheimer’s research”.
PharmaTimes | Industry News | World News | Bayer reportedly settles Trasylol suits for $60m
PharmaTimes | Industry News | World News | Bayer reportedly settles Trasylol suits for $60m: "German drugmaker Bayer AG has reportedly pulled $60 million out of its wallet to settle around 150 lawsuits relating to its blood loss agent Trasylol, which was yanked from the market in 2007 on safety concerns.
People close to the case (but not authorised to speak about it) claim that Bayer has agreed pay each patient around $400,000 to settle this particular batch of suits relating to Trasylol (aprotinin), Bloomberg reported yesterday.
People close to the case (but not authorised to speak about it) claim that Bayer has agreed pay each patient around $400,000 to settle this particular batch of suits relating to Trasylol (aprotinin), Bloomberg reported yesterday.
Five out of six new prescription drugs don't work, doctor claims - Telegraph
Five out of six new prescription drugs don't work, doctor claims - Telegraph
Prof Light argued: "Current incentives for research produce a few [drugs] that substantially improve patients' chances of getting better or avoiding death but a large number of barely innovative drugs each year.
"These new drugs of little benefit consume about four-fifths of all drug costs."
He accused companies of swamping drugs regulators with large numbers of "incomplete, partial, sub-standard clinical trials".
"The result is that drugs get approved without anyone being able to know how effective they really are or how much serious harm they will cause," he said.
When patients complained of adverse reactions, studies showed doctors were likely to dismiss them, he said.
If you've got lemons.......
The global pharmaceutical industry is little more than a "market for lemons" that dupes doctors and patients about the effectiveness of its products, a report has said.
Professor Donald Light made a series of controversial allegations against so-called "Big Pharma" in his report, "Pharmaceuticals: A Two-Tier Market for Producing 'Lemons' and Serious Harm", in which he accused pharmaceutical companies of downplaying the side effects of drugs while over-promoting their benefits.
The industry enjoys the safety of the specialist knowledge that goes into producing drugs and exploits it to its advantage, making it simply a "market for lemons", he said.
Prof Light, a professor of comparative health policy at the University of Medicine and Dentistry in New Jersey, said: "Sometimes drug companies hide or downplay information about serious side effects of new drugs and overstate the drugs' benefits.
"Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It's really a two-tier market for lemons."
The author made the accusations at the American Sociological Association's annual meeting in Atlanta, Georgia, during which he also accused "Big Pharma" of owning independent drug testing companies and hiding behind legal "firewalls" that protect them from questions over the effectiveness of their products.
He said 85% of new drugs pose more harm than good to patients, adding that the "relatively low bar" for effectiveness means that drug companies can push through drugs for approval too easily.
Source
Judge: FTC's Subpoena of Watson Pharma CEO Should Be Enforced
After taking the rare step of ordering the FTC to respond to interrogatories about why it wanted to subpoena the CEO of Watson Pharmaceuticals regarding a reverse-payment settlement the company entered with Cephalon Inc., the same judge has now recommended the court enforce the subpoena.
In his report and recommendations to the U.S. District Court for the District of Columbia in FTC v. Bisaro, Magistrate Judge Alan Kay said the court must enforce a subpoena, despite allegations the agency improperly issued it, as long as a proper purpose also exists.
Kay ruled last month that Watson CEO Paul Bisaro presented a "colorable claim" that the FTC may have exceeded its authority by using its investigative powers to pressure generic drug company Watson to relinquish exclusivity rights it had regarding a generic form of Cephalon's sleep disorder drug Provigil and enter a deal with third-party generic Apotex. The FTC suggested it would have to reopen a front office investigation of Watson if it didn't enter the deal, according to court filings.
"While Mr. Bisaro initially made a colorable showing that the FTC shared confidential information with Apotex, he has subsequently failed to prove those allegations," Kay said in his report Tuesday.
He said subsequent facts provided to the court do not establish a direct attempt by the FTC to harass Bisaro or that the investigation was conducted for an improper purpose.
"To be sure, the undersigned disagrees with the way the FTC conducted this aspect of its investigation -- in particular, the FTC's attempts 'to use its investigative power to pressure a company to waive statutory rights it had legitimately acquired or to enter into a business deal with a competitor,'" Kay said. "However, enforcement of a subpoena is called for as long as a proper purpose does exist."
http://www.law.com/jsp/article.jsp?id=1202470027894
In his report and recommendations to the U.S. District Court for the District of Columbia in FTC v. Bisaro, Magistrate Judge Alan Kay said the court must enforce a subpoena, despite allegations the agency improperly issued it, as long as a proper purpose also exists.
Kay ruled last month that Watson CEO Paul Bisaro presented a "colorable claim" that the FTC may have exceeded its authority by using its investigative powers to pressure generic drug company Watson to relinquish exclusivity rights it had regarding a generic form of Cephalon's sleep disorder drug Provigil and enter a deal with third-party generic Apotex. The FTC suggested it would have to reopen a front office investigation of Watson if it didn't enter the deal, according to court filings.
"While Mr. Bisaro initially made a colorable showing that the FTC shared confidential information with Apotex, he has subsequently failed to prove those allegations," Kay said in his report Tuesday.
He said subsequent facts provided to the court do not establish a direct attempt by the FTC to harass Bisaro or that the investigation was conducted for an improper purpose.
"To be sure, the undersigned disagrees with the way the FTC conducted this aspect of its investigation -- in particular, the FTC's attempts 'to use its investigative power to pressure a company to waive statutory rights it had legitimately acquired or to enter into a business deal with a competitor,'" Kay said. "However, enforcement of a subpoena is called for as long as a proper purpose does exist."
http://www.law.com/jsp/article.jsp?id=1202470027894
Tuesday, August 17, 2010
Prof Ian Gilmore: Legalise heroin and cocaine to cut crime and improve health | Mail Online
'I personally back the chairman of the UK Bar Council, Nicholas Green QC, when he calls for drug laws to be reconsidered with a view to decriminalising illicit drugs use,' he said.
'This could drastically reduce crime and improve health.'
via dailymail.co.uk
Double standard for pharma bribes - Aug. 17, 2010
Double standard for big pharma bribes
By Shelley DuBois, reporterAugust 17, 2010: 11:44 AM ET
FORTUNE -- Legally, of course, companies can't bribe anyone to do anything, whether the kickback is taking place on domestic or international grounds. But the act that guides the Department of Justice's international jurisdiction -- called the Foreign Corrupt Practices Act (FCPA) -- specifically prohibits bribery to officials of foreign governments to procure business.
That law, however, creates a strange quirk in the sytem, thanks to the predominance of state-run health care world wide: many doctors in other countries are considered government employees. Thus, the DOJ has launched several investigations into the world's largest pharmaceutical companies for FCPA violaitons. If any of these companies are found guilty of bribery, it could be a good opportunity for the DOJ to take a fresh look at routine interactions between doctors and drug companies back here in the United States.
One of the big hurdles in FCPA investigations is proving straight bribery: I give you x dollars, you give my company a big contract or order a lot of my product. Most pharmaceutical companies don't cut checks to doctors with the explicit demand that they prescribe certain drugs. But they do cut checks to them, here and abroad, for medical conferences, meals, flights, research and speaking engagements.
Even though doctors still receive a significant amount of information about the medications they are prescribing straight from drug representatives, these transactions aren't considered, under current interepation of the law, to be bribes. It's difficult to legally prove a link between, say, buying flights for doctors to attend meetings and influencing them to push one brand of drug over a different one, or that they prescribe drugs they otherwise wouldn't. Under the FCPA, investigators have to prove corrupt intent in order to accuse companies of wrong-doing. Evidence for "intent" is only available in egregious examples of bribery.
That's exactly what spurred the need for the FCPA in the 1970s. SEC investigations turned up $300 million in bribes that US companies had paid to foreign government officials. So in 1977, the Department of Justice set up the FCPA as a guideline for companies dealing with foreign officials. Basically, the act states that companies can't pay them for anything that would give their business an edge.
But there are nuances to the physician-pharma relationship that only big scandals tend to bring out. Take Merck's anti-inflammatory drug Vioxx, pulled from the market in 2004 for increasing patients' risk of a heart attack. In 2005, U.S. Representative Henry Waxman published an article in the New England Journal of Medicine, partially blaming the Vioxx scandal on the fact that doctors get so much of their information about new drugs from representatives employed by the company making them.
It's a common argument. Doctors and pharma critics made similar claims following the recent FDA investigation of GlaxoSmithKline's diabetes drug Avandia, which has been linked to increased risk of hearat attacks and strokes in patients. Even though GSK debated the risks internally, they didn't present their full findings to the FDA, and didn't alter their marketing program to doctors or the public. But there's still no clear-cut way to launch an investigation into this -- it's such a mess that the FDA also withheld data from the public, according to TIME.
The current DOJ probe is investigating possible bribes of foreign officials from Bristol-Myers Squibb (BMY, Fortune 500), Eli Lilly (LLY, Fortune 500), AstraZenca (AZN), and Merck (MRK, Fortune 500), among other pharmaceutical companies and manufacturers of pharmaceutical devices. Just because the companies are being investigated doesn't mean they've done anything wrong. And many of the companies have been forthcoming about investigations. One of which is Merck, which might have decided to be so open about the investigation because it's already on high alert for previous conduct.
The Department of Health & Human services can enter into a corporate integrity agreement, or CIA, with any company. As part of the agreement, the company promises to become more transparent and straighten up and fly right. Merck has a corporate integrity agreement with the government. Other big drug companies on the CIA list include Pfizer (PFE, Fortune 500), AstraZeneca and Eli Lilly.
Still, pharma companies get a lot of legal legroom. The Department of Health and Human Services offers guidelines about how pharmaceutical companies should behave, in the form of the Compliance Program Guidance for Pharmaceutical Manufacturers. Companies are encouraged to develop ethical practices based on the document, but legally, it's a suggestion.
These current probes could turn up real legal allegations and lead to big settlements. Critics argue the DOJ and Obama administration are taking away companies' ability to do business abroad by cracking down this way, but in fact, by more closely monitoring American businesses' overseas behavior, we're becoming better members of the international community.
More importantly, as the results of the investigations are revealed, it will be informative to see whether big pharma is actually engaged in underhanded behavior, or if it's just been snagged in a law that creates a double standard for its business practices -- one that says it's ok for companies to wine and dine doctors in the US, but illegal for it to do so for doctors abroad. The results can and should raise the question of whether an overhaul of the ethics under which pharmaceutical companies interact with doctors in the US should be next on the regulatory reform agenda.
via money.cnn.com
What the FDA isn't telling. - By Jeanne Lenzer - Slate Magazine
Meanwhile, my sources (sorry, they're gun-shy and anonymous) were telling me that duloxetine caused suicidal tendencies in patients who took the drug for incontinence—and who were not depressed. That news was potentially explosive. In the face of questions about a link between antidepressants and suicide, industry experts have long insisted that it's depression, not the drugs used to treat it, that causes patients to kill themselves. Johnson's death appeared to call that claim into question. She entered the clinical trial as a healthy, nondepressed volunteer in order to help pay her college tuition. And she was only approved for the study after undergoing thorough medical testing to screen out depression or suicidal tendencies.
via slate.com
Is prescribing of ezetimibe a rational use of NHS resources? « NPCi blog
A recent editorial in the Drug and Therapeutics Bulletin questions whether adding ezetimibe to simvastatin▼ is a cost-effective or outcome-based intervention, and whether the increasing monies being spent on ezetimibe (more than £70million in 2009) is a rational use of NHS resources.
via npci.org.uk
FDA Questions Wider Approval of Lilly's Cymbalta - ABC News
Federal health scientists are questioning whether the antidepressant Cymbalta is safe and effective enough to be approved for use against chronic pain.
The Food and Drug Administration has posted its review of Eli Lilly and Co.'s application to market the drug for a range of pain ailments, including lower back pain. FDA reviewers have questions about the statistical methods used to study the drug and liver side effects.
via abcnews.go.com
Monday, August 16, 2010
GMB Pensions Strike At Astra Zeneca
GMB has announced that 70% of its members who voted in a ballot at Astra Zeneca the giant pharmaceutical company have supported the call for strike action as urged by their Union.
via gmb.org.uk
Report: FDA is Investigating Whether GlaxoSmithKline Held Back Avandia Data - Health Blog - WSJ
Just when you thought there was nothing new to say about Avandia, Time magazine reports — citing deputy FDA commissioner Josh Sharfstein — that the agency is investigating whether Glaxo broke the law by holding back from the FDA data indicating the drug carried an increased risk of heart attacks.
via blogs.wsj.com
PharmaTimes | Industry News | World News | US Justice Departments investigates pharma for corruption
In a statement to PharmaTimes World News, AstraZeneca confirmed that it is part of the DoJ and SEC investigation into adherence with the FCPA, and that is is "co-operating with inquiries". However, the company added that it did not think it is appropriate "to comment at this time on matters that are the subject of the DOJ and SEC inquiries.”A spokesperson for GSK told PharmaTimes World News that it indeed received a letter relating to the investigation back in April, but stressed that in this particular instance, and from a GSK perspective, the enquiries are very much at a preliminary stage, whereas other drug companies already have ongoing interactions with the DoJ and SEC. Merck also disclosed that it has received inquiry letters in relation to activities in a number of countries in a recent quarterly SEC filing.
via pharmatimes.com
BBC News - Prescription drug vending machine on trial
BBC News - Prescription drug vending machine on trial: "- Sent using Google Toolbar"
LOLPharma contd. - here comes trouble
"As I mentioned in a speech last week to the Pharmaceutical Regulatory and Compliance Congress, one area of focus will be overseas sales in the pharmaceutical industry. In some foreign countries and under certain circumstances, nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product may involve a "foreign official" within the meaning of the Foreign Corrupt Practices Act. The depth of government involvement in foreign health systems, combined with fierce industry competition and the closed nature of many public formularies, creates, in our view, a significant risk that corrupt payments will infect the process. Our remarkable FCP A unit and our terrific health care fraud unit will be working together to investigate FCP A violations in the pharmaceutical industry in an effort to maximize our ability to effectively enforce the law in this high-risk area. Looking ahead, our FCP A unit will be looking at other areas and industries for stepped-up enforcement where we deem appropriate."
http://www.nytimes.com/2010/08/14/health/policy/14drug.html?_r=1&partner=rss&emc=rss
TIMELINE - Key dates in Genzyme's manufacturing crisis - London South East
2009:March 2 - Company discloses FDA warning letter identifying manufacturing deficiencies at Allston, Massachusetts plant.
June 16 - Discloses viral contamination leading to shutdown and severe shortages of key drugs Cerezyme and Fabrazyme.
July 16 - Due to Cerezyme shortage, Shire gets FDA fast track designation for experimental Gaucher treatment.
July 31 - FDA says will reinspect Allston after company fails to take sufficient action on process control problems.
Aug. 14 - Only those in most need get Cerezyme in Europe
.
Aug. 25 - FDA grants fast track review to Protalix BioTherapeutics experimental Gaucher disease drug to help address shortage; Pfizer later acquires rights.
Nov. 13 - FDA says five drugs made at Allston have unacceptable levels of steel fragments, other contaminants.
Dec. 1 - Newly made Cerezyme begins shipping from Allston.
2010:
Jan. 4 - Genzyme announces deal for Hospira Inc to take on some filling and packaging for several products.
Jan. 7 - Genzyme agrees to appoint activist investor Ralph Whitworth of Relational Investors to board; reports surface that billionaire investor Carl Icahn may mount a proxy battle.
Jan. 8 - Ron Branning appointed to head global quality.
Jan. 12 - Newly made Fabrazyme beings shipping.
Feb. 3 - Company appoints former Eli Lilly executive Scott Canute as global manufacturing chief.
Feb. 22 - Company receives notice that Icahn intends to nominate four candidates to board.
Feb. 26 - FDA approves Shire Gaucher disease drug.
March 24 - Genzyme says FDA to take enforcement action, likely including imposing fines, over manufacturing crisis.
April 15 - Whitworth joins board in move to rebuff Icahn.
April 21 - Genzyme says expects to pay $175 million penalty from past profits and possibly future fines under draft consent decree deal; discloses a March
power outage affecting water at Allston, worsening Cerezyme and Fabrazyme supply shortage.May 6 - Under pressure from investors Genzyme says will look into selling three non-core businesses -- genetic testing, diagnostic products and pharmaceutical materials.
May 17 - Icahn doubles stake to about 10.5 million shares.
May 24 - Consent decree finalized. In addition to $175 million penalty, company to move filling and packaging out of Allston, place manufacturing under oversight of a third party.
May 26 - Icahn urges board to remove CEO Henri Termeer.
June 9 - Icahn reaches accord with Genzyme, abandons proxy fight and gets two representatives on board.
June 29 - Still struggling with supply shortages, Genzyme says expects to meet 50 percent of Cerezyme demand for July.
July 21 - Genzyme takes $21.9 million write-off in second quarter due to products discarded over quality issues.
July 23 - Sources tell Reuters that French drugmaker Sanofi-Aventis made acquisition approach to Genzyme.
July 28 - Sanofi votes to move ahead with formal offer of up to $18.7 billion to acquire Genzyme, sources say.
Aug. 2 - Sanofi sends $69/share takeover proposal to Genzyme, sides discussing offer, sources say.
Aug. 9 - Company discloses additional $6.5 million write-off for discarded products due to quality issues that turn second quarter results from flat to a loss.
Aug. 10 - Company says it will take three to four years to rectify manufacturing problems at Allston.
via lse.co.uk
Separate doctors from industry - The Boston Globe
The medical/pharmaceutical industry influence on academic medicine is ubiquitous. In 2007, a survey of academic department chairs published in the Journal of the American Medical Association revealed that 60 percent reported some form of personal relationship with industry, including as a consultant, paid speaker, officer, founder, or member of a board.
While many of these relationships are appropriate, an increasing number go off-track. Later that same year, the Department of Justice filed criminal complaints against four of the five medical device manufacturers in New Jersey, alleging that the companies used consulting agreements with orthopedic surgeons as inducements to use a particular company’s products. According to Justice, the investigation revealed it was common practice that surgeons “were paid tens to hundreds of thousands of dollars per year for consulting contracts and were often lavished with trips and other expensive perquisites.’’
More recently, Senator Charles Grassley of Iowa has investigated research conflicts of interests at numerous teaching hospitals and academic medical centers, including Harvard Medical School. In October of 2008, an article in the the New York Times noted that Grassley’s findings “suggest that universities are all but incapable of policing their faculty’s conflicts of interest.’’ Eric Campbell, a health policy researcher at Mass General and Harvard Medical School, called these consulting arrangements, “one of the great wink-winks of all time.’’
via boston.com
Sanofi-Aventis Told by Court to Restart Job-Cuts Procedure, Les Echos Says - Bloomberg
Sanofi-Aventis SA has been told by a court in Nanterre that it must restart the procedure under which it aims to cut jobs in France, daily Les Echos reported, without citing anyone.
The court decided that Sanofi has not been specific enough about which jobs it wants to cut, according to the newspaper.
via bloomberg.com
UK drug firms put under microscope over 'bribery' - The Independent
The world's largest pharmaceutical companies are facing a corruption investigation in the United States over claims that the hospitality lavished on those who prescribe their treatments could constitute bribery.
Britain's two biggest drug groups, GlaxoSmithKline (GSK) and AstraZeneca, are among those facing the investigation, which is being carried out jointly by the Department of Justice (DoJ) and Securities and Exchange Commission (SEC). The investigation is thought to centre around allegations that drugs companies might have contravened the Foreign Corrupt Practices Act (FCPA), which limits their ability to spend on such "soft' inducements" as hospitality, charitable donations and other non-business activities.
The list of the companies under investigation contains many of the global pharma industry's biggest names: Pfizer, Bristol-Myers Squibb and Eli Lilly are among those under the spotlight.
The DoJ is looking into claims that the industry has for years ignored obligations under anti-bribery legislation, and that the situation is so stark, some of the hospitality extended to those that buy treatments could amount to bribery.
The probe is into activities outside the US. If found guilty, the industry could face fines totalling millions of dollars.
Both GSK and AstraZeneca acknowledged the investigation yesterday. It is understood that GSK received a letter at the end of April, which said that the DoJ was making preliminary inquiries under the FCPA.
"GSK confirms that investigations by the US Department of Justice and the Securities and Exchange Commission regarding the sales and marketing of pharmaceutical products outside of the USA have commenced," the group said in a statement. "These inquiries relate to the USA Foreign and Corrupt Practices Act. GSK has been contacted by these agencies in this context and is helping with the preliminary inquiries."
A spokesman for AstraZeneca, said: "AstraZeneca plc has received inquiries from the US Department of Justice and the Securities and Exchange Commission in connection with an investigation into Foreign Corrupt Practices Act issues in the pharmaceutical industry. AstraZeneca is cooperating with their inquiries."
Sunday, August 15, 2010
FDA approves new morning-after pill | Philadelphia Inquirer | 08/14/2010
FDA approves new morning-after pill | Philadelphia Inquirer | 08/14/2010: "WASHINGTON - The Food and Drug Administration on Friday approved a new type of morning-after contraceptive that works longer than the current leading drug on the market.
The pill ella from HRA Pharma reduces the chance of pregnancy up to five days after sex. Plan B, the most widely used emergency contraceptive pill, begins losing its ability to prevent pregnancy within three days of having sex.
The FDA approved the drug as a prescription-only birth-control option. The ruling clears the way for U.S. sales of the drug, which is already approved in Europe.
Morristown, N.J.-based Watson Pharmaceuticals will market the drug in the United States under an agreement with HRA. Watson said it will launch the pill in the fourth quarter.
Studies of ella by the manufacturer showed it prevented pregnancies longer and more consistently than Plan B.
In a head-to-head trial between the two drugs, women who took ella had a 1.8 percent chance of becoming pregnant, while women who took Plan B had a 2.6 percent chance. Experts tracked nearly 1,700 women who randomly received one of the two pills within three to five days of having unprotected sex.
Plan B is made by Teva Pharmaceuticals and is also marketed in several generic versions.
Unlike ella, Plan B and other generic versions are available without a prescription for women 17 and older.
Paris-based HRA Pharma did not request over-the-counter status for its drug.
- Sent using Google Toolbar"
The pill ella from HRA Pharma reduces the chance of pregnancy up to five days after sex. Plan B, the most widely used emergency contraceptive pill, begins losing its ability to prevent pregnancy within three days of having sex.
The FDA approved the drug as a prescription-only birth-control option. The ruling clears the way for U.S. sales of the drug, which is already approved in Europe.
Morristown, N.J.-based Watson Pharmaceuticals will market the drug in the United States under an agreement with HRA. Watson said it will launch the pill in the fourth quarter.
Studies of ella by the manufacturer showed it prevented pregnancies longer and more consistently than Plan B.
In a head-to-head trial between the two drugs, women who took ella had a 1.8 percent chance of becoming pregnant, while women who took Plan B had a 2.6 percent chance. Experts tracked nearly 1,700 women who randomly received one of the two pills within three to five days of having unprotected sex.
Plan B is made by Teva Pharmaceuticals and is also marketed in several generic versions.
Unlike ella, Plan B and other generic versions are available without a prescription for women 17 and older.
Paris-based HRA Pharma did not request over-the-counter status for its drug.
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