Thursday, September 30, 2010
Novartis Pays $422.5 Million to Settle Illegal Marketing of Trileptal - NYTimes.com
The Swiss drug giant Novartis has agreed to pay $422.5 million to settle criminal and civil investigations into the marketing of the antiseizure medicine Trileptal and five other drugs, officials said on Thursday.
The action, including a guilty plea to a misdemeanor and a $185 million criminal fine and forfeiture by Novartis Pharmaceuticals, its United States subsidiary, was announced by the United States attorney in Philadelphia, which has specialized in health care fraud. This is the latest in a series of crackdowns by federal prosecutors and states that have been investigating pharmaceutical companies for illegally promoting drugs for uses not authorized by the Food and Drug Administration.
Federal prosecutors said Novartis illegally promoted Trileptal for neuropathic pain and bipolar disease, targeting psychiatrists and pain specialists who were known to use the drug off-label. Physicians are free to use any approved drug for any purpose, but companies are prohibited from promoting them for conditions not approved by the F.D.A.
The government accused Novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals. But aside from pleading guilty to one misdemeanor charge of mislabeling, which Novartis had announced in February and agreeing to pay the $185 million fine, the company denies any other wrongdoing.
In a statement, Novartis said it had cooperated with the investigations since 2005 and already corrected its promotional practices. Andy Wyss, president of Novartis Pharceuticals, said: “We are pleased to have reached resolution on this matter. N.P.C. will continue its commitment to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products.”
In its corporate filing last winter, Novartis said it was increasing reserves by $318 million in the fourth quarter, to a total of $397 million, to pay for pending settlements into past marketing practices of Trileptal.
Its stock fell by about 1 percent an hour before the 1 p.m. announcement in Philadelphia and was trading at $57.49, down 0.85 percent, at 2:10 p.m.
In the agreement settling other parts of the government investigation, Novartis paid $237.5 million to resolve allegations that it had caused illegal claims to be submitted for five other drugs but did not acknowledge any culpability.
They are Diovan, a hypertension drug that is the company’s top-selling product at $6 billion last year; Sandostatin, a drug to treat a growth hormone disorder that had $1.1 billion worldwide sales last year; Exforge, a hypertension drug that sold $671 million; Tekturna, a blood pressure medicine that sold $290 million; and Zelnorm, a medicine for irritable bowel syndrome and constipation.
Novartis joins a growing list of pharmaceutical companies that have settled government investigations into health care fraud in the past few years, including Pfizer, which paid $2.3 billion; Eli Lilly, $1.4 billion; Allergan, $600 million; AstraZeneca, $520 million; Bristol-Myers Squibb, $515 million. Pfizer, Lilly, Allergan and now Novartis pleaded guilty to misdemeanor crimes.
Novartis also signed a five-year corporate integrity agreement with the office of the inspector general at the Department of Health and Human Services.
Warner Chilcott pulls application for female libido patch
Warner Chilcott UK has decided to withdraw its application to extend the treatment scope of its female sexual dysfunction patch Intrinsa (testosterone) in Europe, due to “commercial considerations”.
Intrinsa was approved in July 2006 for the treatment of hypoactive sexual desire disorder in women who have had their uterus (womb) and both ovaries removed, and Warner acquired the product through its £3.1 billion purchase of Procter & Gamble’s pharma unit last year.
In August, the Ardee, Ireland-headquartered group submitted an application to the European Medicines Agency to extend the drug’s license to include the treatment of low libido in menopausal women but, for as yet unspecified reasons, has decided not to proceed at this time.
A company spokesperson could not be reached in time for comment, but the EMA said it would publish Warner’s withdrawal letter shortly, which may shed some more light on the move.
Pfizer Arthritis Drug Tanezumab Quenched Pain Too Well, Leading to Damage - BusinessWeek
This is more potent than any pain medication I have ever had in arthritis,” said Lane, director of the Center for Aging at the University of California at Davis School of Medicine in Sacramento, in a telephone interview. “Because this is a new chapter in controlling pain, we didn’t realize we needed to counsel our patients in using their joints that were still diseased. Now we need to figure out how to use it so the risks don’t outweigh the benefits.
Wednesday, September 29, 2010
UK DoH to cut antipsychotic drugs for dementia | Healthcare Republic
Use of antipsychotic drugs for dementia should be reduced by two thirds in the next two years, the DoH says. The decision follows a report last year warning the drugs were used too frequently in dementia care.
Johnson & Johnson Acknowledges Errors in Recalls
William C. Weldon, the chief executive of Johnson & Johnson, is expected to acknowledge to lawmakers on Capitol Hill on Thursday that the company mishandled the removal of certain medicines from store shelves last year. He also planned to announce that after a recall of children’s liquid medicines, new batches would begin to reach stores as early as next week, according to a copy of his prepared testimony submitted to a House committee.
Mr. Weldon was to appear before the House Committee on Oversight and Government Reform, at a time when the congressional investigators and outside inquiries have highlighted some company problems. As Natasha Singer and I reported in a story on Wednesday, the stakes are high.
In his prepared testimony, Mr. Weldon, who missed the committee’s first hearing on the recall because of back surgery, makes the case that he is committed to fixing whatever went wrong at the company’s McNeil Consumer Healthcare unit, which was responsible for the withdrawal of certain products from the marketplace. “Mr. chairman, I know that we let the public down. We did not maintain our high quality standards, and as a result, children do not have access to our important medicines. I accept full accountability for the problems at McNeil, and I will take full accountability for fixing them,” he said.
In the testimony, Mr. Weldon promises consumers will start seeing McNeil liquid children’s products back on the shelves as soon as next week.
Mr. Weldon also offers a mea culpa of sorts about the so-called “phantom recall” of certain vials of Motrin pills, an action taken by an outside contractor that went to convenience stores and bought up the product. That has continued to bother some lawmakers, who first criticized the practice at a May hearing. “Based on what I have learned since the May hearing about the way the Motrin retrieval was handled, including the points that this committee brought to light, it is clear to me that in retrospect, McNeil should have handled things differently. And going forward, if similar situations arise, they will be handled differently,” he says in his testimony.
Colleen A. Goggins, the senior Johnson & Johnson executive who was in charge of all the company’s consumer businesses, will also be making a return performance. Ms. Goggins, who has since announced she is leaving the company, is expected to testify about, among other things, the phantom recall. She pleaded ignorance at the time. “At the time of the hearing in May, I had no personal knowledge of and had not seen the contractor or McNeil instructions. Since then, however, I have reviewed the McNeil instructions to the contractor that instructed the contractor to purchase the product without engaging in discussions with the store personnel. Based on what I have learned since May, I believe that McNeil should have handled things differently. We, as a company, have learned from this process,” she says in a copy of her prepared testimony.
The Weldon statement. The Goggins prepared statement.
If you were sitting on the congressional panel, what questions would you ask the top executives after these recalls?
While Avandia patients died, drugmaker schemed how to turn drug’s side effects into profits «
Last week, the Food and Drug Administration took the inadequate measure of restricting the sale of the dangerous diabetes drug Avandia. Public Citizen has long been pushing the FDA to ban Avandia, much like its European counterparts recently did.
Now comes this troubling look at the extent to which GlaxoSmithKline, the maker of Avandia, covered up the life-threatening side effects of its diabetes medication. Paul Thacker, who was the leading investigator for Sen. Chuck Grassley’s Finance Committee, writes in Mother Jones what he learned during his three-year investigation:
During that time, my colleagues and I combed through over 250,000 pages of internal GSK documents and interviewed dozens of witnesses and whistleblowers. What emerged was a troubling picture of a company that had placed corporate profits over patient safety. While suppressing inconvenient evidence about the risks of its top-selling drug, the company even began to develop another drug to treat the very side effect Avandia has been linked to.
Yes, you read that right — Instead of recalling Avandia, which was linked to causing heart attacks in patients, GlaxoSmithKline decided the better thing to do was to develop another drug that could treat the condition caused by Avandia.
t r u t h o u t | Big Pharma: Reports of Its Demise Have Been Greatly Exaggerated
If the current trend continues, a tipping point will be inevitable - one path will lead to increasing challenges and diminishing returns, the other toward a thriving industry connected through open access and profit sharing to provide "medicine for the people.
AstraZeneca faces fourth pension walkout - Wigan Today
Workers at drugs giant AstraZeneca's Macclesfield site will stage a fourth day of strike action on Thursday in a dispute over pensions.
Members of the GMB union at the site are already banning overtime, and will take part in further stoppages unless the row is resolved.
Workers voted to go on strike in protest at plans for "savage cuts" to their final salary pension scheme.
GMB official Allan Black said: "The company has made no attempt to negotiate or even discuss the matter with the GMB, and we again call for a return to negotiations to resolve this issue.
"This is a case of boardroom greed and a culture which is summed up by 'do as I say, not as I do'."
Will the Swedes come out in sympathy?
Lundbeck picks Alliance Healthcare as sole UK distributor - Chemist + Druggist
29/09/2010Lundbeck picks Alliance Healthcare as sole UK distributor
Global pharmaceutical giant Lundbeck has appointed Alliance Healthcare as the sole distributor of its products in the UK.
In a statement, Lundbeck, which specialises in pharmaceuticals for the treatment of disorders including depression, schizophrenia, Alzheimer’s disease, Parkinson’s disease, Huntington's disease, epilepsy and insomnia, said it chose Alliance Healthcare to improve supply chain efficiency.
Lundbeck said that Alliance Healthcare was a distributor with a tried and tested infrastructure and extensive knowledge of pharmaceutical wholesale. Under the deal, pharmacies will get twice daily deliveries of Lundbeck products.
Lundbeck managing director Stephen Turley said: “Over the past year there have been challenges in ensuring effective supply to UK patients. We have spoken with a number of stakeholders, including government, pharmacists and prescribers in order to understand how we might address this. We are confident these new distribution arrangements will go a long way towards achieving this.”
Alliance Healthcare commercial healthcare director Mark Stephenson said: “We are delighted to be working with Lundbeck as their distribution partner for this range of specialist medicines. Customers should be assured that we are committed to maintaining the highest levels of service on Lundbeck products and we will be communicating full details of this latest supply chain change in preparation for go-live on 1 November 2010.”
In Northern Ireland, Alliance Healthcare has sub-contracted the delivery of Lundbeck products to Sangers (NI). Alliance Healthcare and Sangers will also be communicating directly with customers in this region to confirm specific ordering processes via Sangers.
PharmedOut's Adriane Fugh-Berman writes:
A few items that may be of interest:
Our article about the educational intervention PharmedOut developed, Why Lunch Matters, was published yesterday in the Journal of Continuing Education in the Health Professions.Here's a link to download the article: https://www.yousendit.com/download/aHlUZm1jTkxqY3J2Wmc9PQ The presentation Why Lunch Matters is now available for download at our website, http://pharmedout.org. Also, Pharmalot's coverage of Wyeth's letter to PloS Med regarding my ghostwriting article: http://www.pharmalot.com/2010/09/pfizer-attacks-journal-for-undisclosed-conflicts/ Responses from PLoS, Carl Elliott, and me to Wyeth's letter http://www.plosmedicine.org/annotation/listThread.action?inReplyTo=info%3Adoi%2F10.1371%2Fannotation%2F9615f3f1-520f-43cd-a825-8afcab3c26d4&root=info%3Adoi%2F10.1371%2Fannotation%2F9615f3f1-520f-43cd-a825-8afcab3c26d4
Weldon, J. and J.’s Chief, Set to Testify Before Congress
And on Thursday, the executive, William C. Weldon, is expected to appear at a Congressional hearing, for the first time providing his own account to lawmakers of the manufacturing problems that led to the recalls. Mr. Weldon has asserted that missteps at the company’s McNeil Consumer Healthcare unit, which was responsible for the withdrawal of certain products from the marketplace, have been contained.
“From Johnson & Johnson’s perspective, our response to this issue was the most responsible it could possibly be,” Mr. Weldon said in a recent telephone interview. After months of silence, he has also appeared on CNBC and has toured the company’s own sites to talk about McNeil. “We want to ensure nothing like this happens again,” he said.
His testimony before Congress comes as the company confronts other highly publicized problems that have swirled around Mr. Weldon’s stewardship and the once unassailable integrity of one of the world’s most respected companies.
In recent months, the company has recalled tens of thousands of artificial hips as well as several million contact lenses, made by distinct units. The company is also the subject of numerous government inquiries and a spate of consumer lawsuits. In McNeil’s case, the unit recalled about 136 million bottles of liquid infants’ and children’s medicines in April, and millions of bottles of Tylenol and other pills for adults earlier in the year.
“These problems are accumulating,” said Les Funtleyder, who invests in health care stocks for Miller Tabak & Company in New York. “At some point, investors are going to start to question J.& J.’s management.”
Representative Darrell Issa, the ranking Republican on the House Committee on Oversight and Government Reform, which is holding Thursday’s hearing, said in a telephone interview that the company had failed to adequately oversee the McNeil unit and did not correct the manufacturing problems there quickly.
“Does Johnson & Johnson oversee its divisions properly, or do they have too much autonomy?” Mr. Issa asked. “Does the big name — Johnson & Johnson — mean quality, or do you have to judge each division separately?”
Both Democratic and Republican lawmakers plan to delve into communications between corporate executives and the Food and Drug Administration as recalls were considered or taking place, including attempts by the company to buy back certain vials of Motrin pills rather than formally recall them from the shelves.
Mr. Weldon said in the interview earlier this month that the company had acted quickly to recall the products, inform consumers and explain that the medicines posed no serious health hazard. While the company has temporarily shut the plant in Fort Washington, Pa., that manufactured the children’s over-the-counter products for an overhaul, Mr. Weldon said the company planned to reintroduce certain products later this year.
“We have a standard and we hold all our companies to that standard,” Mr. Weldon said, adding that he took full responsibility for McNeil’s problems. Johnson & Johnson has also announced a series of moves meant to address the concerns over the quality of its products.
In addition to a systemic review of the manufacturing operations at all of its units, the company has overhauled and centralized its quality control operations. This month, it also said Colleen A. Goggins, the senior executive who was in charge of all of Johnson & Johnson’s consumer businesses, would leave. Ms. Goggins also is expected to testify at Thursday’s hearing, her second appearance before the committee on these issues.
To date, some people fault the company’s response as inadequate.
“It’s too little, too late,” said Erik Gordon, a business professor at the University of Michigan. Mr. Weldon had an obligation to address the concerns about McNeil and the decentralized nature of the company earlier this year, he said. The company has long prided itself on, and derived strong yearly profit growth from, its decentralized management structure. By having a diverse array of companies, with more than 250 separate units, the company has managed to innovate and prosper despite its size.
“J.& J. has been a master of that,” said Richard N. Foster, a former McKinsey partner who has written about Johnson & Johnson. “There are very few companies in J.& J.’s class.”
Until the first quarter of 2009, for example, Johnson & Johnson had managed to increase its earnings, adjusted for special items, for 94 consecutive quarters.
The company has also been smart and aggressive about acquisitions, including a recent bid for Crucell, a leading vaccine company in which J.& J. already owns a stake, said Michael Weinstein, an analyst at J. P. Morgan. Even with the hip implant recall, the company’s medical device franchises remain strong, he said, and its pharmaceutical group has promising products like an antistroke drug and an experimental drug for prostate cancer in development.
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Tuesday, September 28, 2010
Nestlé to take on pharmaceutical sector
Nestlé is challenging the global drugs industry with plans to invest SFr500m ($510m) over the next decade to support the creation of a standalone health science business to tackle obesity and chronic disease.
The Swiss food group, which announced the move on Monday, appointed Luis Cantarell, one of its most experienced executives, to “pioneer a new industry between food and pharma” that will develop products to combat diabetes, heart problems and Alzheimer’s.
US high court to consider case on Baycol cholesterol drug - Yahoo! News
WASHINGTON (AFP) – The US Supreme Court will take up a case filed by alleged victims of the anti-cholesterol drug Baycol seeking a class-action suit, after the drug was taken off the market in 2001 by German pharmaceuticals giant Bayer.
Baycol went on the US market in 1997 and was blamed for the deaths of 31 Americans four years later due to side effects including fatal muscle toxicity leading to kidney failure.
Several cases lodged over the drug, also known by its chemical name cerivastatin, were put together in a federal court in Minnesota but in the case delivered to the high court the plaintiffs were from West Virginia.
They are seeking damages for the financial hardship they say they faced due to the effects of the drug.
Bayer, however, argues that their class-action suit cannot proceed because the judge in charge of cases in Minnesota banned such suits, also sought by West Virginia plaintiffs, back in August 2005.
The nine Supreme Court justices will review the case in early 2011 and rule by June at the latest.
Chief Justice Roberts Sells Pfizer Shares, Can Participate In Cases
Roberts' participation means the court will not be as short-handed in the upcoming Pfizer cases, in which the court's newest justice, Elena Kagan, is recused. Kagan is sitting out several cases this term because she was involved in them previously when she served as U.S. solicitor general.
The chief justice's involvement, however, means eight justices will hear the two cases, raising the possibility that one or both could result in a 4-4 tie.
Roberts' most recent financial disclosure form, for the 2009 calendar year, indicated that he held $15,000 or less of Pfizer stock, a financial position that has forced him to recuse from previous high court matters involving the New York-based drug maker.
Dan Abshear writes about whistleblowing
In the year 2003, I discovered CafePharma. CafePharma is basically an online venting board for pharmaceutical representatives. Such representatives who post on this board often do so with overt anger and disgust. My uneasiness about bribing doctors was validated by what representatives from many pharmaceutical companies wrote on this board. The money we paid targeted doctors are kickbacks. By paying such doctors, we as sales representatives are violating the federal anti-kickback statute.
At this time, I suffered from pharmaceutical representative schizophrenia. One personality of me I expressed was the perfect sales representative, who always spent the promotional budget, and became elated at hearing that various disease states for which the promoted products would treat were expected to increase. The one who acquired and hired doctors targeted by Novartis. The one who believed in bribing and threatening doctors on the payroll of Novartis.
Source
Neuroskeptic: Cherry Picking 101 - the GSK way
Neuroskeptic's analysis of a dodgy GSK paper on how to improve clinical trial design - prespecifiy in your protocol a plan to throw out all the patients who respond well to placebo!
Simples.
Pfizer slims down pipeline | InPharm
Projects in phase I will bear the brunt of the cuts, accounting for 15 programmes out of a total of 31 that have either been halted completely or cut back as the company takes a hard look at which drugs will help it manage a number of looming patent expiries.
Tales from the PMCPA - The case of the anonymous complainant
The complainant noted that the representative stated that a pressurised metered dose inhaler (pMDI), with good technique, delivered only 10-15% of the dose to the lungs compared with 30% achieved with the Turbohaler. The impression given was that the Turbohaler always achieved better lung deposition than an MDI. A leavepiece, entitled 'Clinically Effective Inspiratory Flow', stated: 'Turbohaler is effective at a peak inspiratory flow (PIF) of around 30L/min, delivering 15% of dose to the lung (a pressurised MDI, with good inhalation technique, delivers 10 -15%).' and 'Doubling the PIF to 60L/min increases the lung deposition to about 30%'.
The complainant looked into the matter and noted that lung deposition with MDIs containing ciclesonide was over 50% and with beclometasone was either 36% or 52%, depending on whether the MDI was Clenil or Qvar. Consequently, the complainant was very cautious about the information provided by AstraZeneca and its representative.
The detailed response from AstraZeneca is given below.
The Panel noted AstraZeneca's submission that the bracketed part of the claim 'Turbohaler is effective at a peak inspiratory flow (PIF) of around 30L/min, delivering ~15% of nominal dose to the lung (a pressurised MDI, with good inhalation technique, delivers 10-15%)' was true for the majority of pMDIs used in the UK but not for Alvesco, Clenil and Qvar. The claim, however, was not qualified, it appeared that no pMDI delivered more than 10-15% of the nominal dose which was not so; Alvesco delivered over 50%, Clenil 36% and Qvar 52%.
The Panel did not accept AstraZeneca's submission that, taken in its entirety, health professionals would understand the claim to mean that at a PIF of around 30L/min the amount of medicine delivered to the lung by a Symbicort Turbohaler was comparable to that of the more common pMDIs. It appeared that at a PIF of around 30L/min the dose delivered from the Turbohaler was comparable to that delivered by all pMDIs which was not so. The Panel considered that the claim as a whole presented a misleading comparison which could not be substantiated. Breaches of the Code were ruled.
The Panel noted that the claim 'Doubling the PIF to 60L/min increases lung deposition to about 30%' was true for the Turbohaler. However, given the context in which it appeared ie immediately below the comparative claim discussed above, it appeared that at a PIF of 60L/min lung deposition with a Turbohaler would be better than with all pMDIs which was not so. Breaches of the Code were ruled.
The Panel noted its rulings above and considered that high standards had not been maintained. A breach of the Code was ruled which was upheld on appeal by AstraZeneca.
The Panel noted that the complainant alleged that the representative had stated that a pMDI with good technique delivered only 10-15% of the dose to the lungs compared with 30% achieved with the Turbohaler. The Panel considered that it was difficult to know what had been said between the parties; a judgement had to be made on the available evidence. The complainant was anonymous and non-contactable and had not identified the representative. The Panel considered that the statement allegedly made by the representative was misleading. Nonetheless, it was based on the claims in the leavepiece and, in that regard, the representative was only following his/her brief. The Panel considered that the matter was covered by its rulings of breaches of the Code above and thus the Panel ruled no breach of the Code.
http://www.pmcpa.org.uk/files/2320%2028%20September.pdf
Drug shortage prompts U.S. executions "Russian roulette" - latimes.com
OKLAHOMA CITY (Reuters) - Two convicted killers are scheduled for the death chamber and only one dose of the drug needed to execute them is available.
Monday, September 27, 2010
A Guided Tour of Modern Medicine’s Underbelly - NYT
“Adventures on the dark side of medicine” — now that sounds like a lot of fun. A few juicy stories about black-market organs, fingerprint erasure, murder and mayhem in the I.C.U. would make a welcome change from the usual humdrum stuff of hospital and clinic, where the big events are a drug that doesn’t work properly, or a visit from a pharmaceutical salesman that screws up the entire afternoon schedule. But no: In Dr. Carl Elliott’s survey of all that is shifty in modern medicine, those humdrum events are exactly what make up medicine’s dark side. And, indeed, Dr. Elliott’s entertaining and extremely readable essays will have you convinced that in comparison to the shenanigans that go into the creation of a single prescription pill, fingerprint erasure might actually be a little dull. After all, what is more sinister than the dubious mechanics of the ordinary, the sausage factory behind the breakfast special?
A physician who specializes in philosophy and ethics, Dr. Elliott hails from that quiet zone of medicine where much of the job involves thinking about, talking about and doling out medications. Hence his primary focus is on the ever-evolving relationship between the high art of medicine and the big business of drugs.
Some of his material has, at this point, been reviewed ad nauseam in the daily press and in books by others, so most readers will be familiar with the bad habits of Big Pharma when it comes to subtle data manipulation, high-pressure salesmanship and lavish gifts. Mighty and expensive are the efforts to guide the hands that write the prescriptions. But Dr. Elliott also spends time in places where few other authors have ventured.
Doctors get pens and trinkets, football tickets, junkets to beach resorts. Less visible are the large sums handed over in “I’m going to make you a star” projects to groom them as trusted faces and voices in the service of some drug. Education and advertisement merge in these elaborate ventures, as the paid professor travels the country, lecturing about disease and, incidentally, the treatment thereof.
These “key opinion leaders” are bad enough, but who would ever imagine that the curricula vitae of many academic physicians (those on a medical school faculty) are packed with journal articles actually written by ghostwriters sponsored by pharmaceutical companies?
“Nobody expects American politicians to write their own speeches anymore,” Dr. Elliott reminds us, “and nobody expects celebrities to write their own memoirs.” Apparently doctors have now joined the ranks of the charismatic talking heads, mouthing the words of others.
And just as “professor” generally describes someone who writes his or her own sentences, “ethicist” generally describes someone who dwells (or at least works) on an unusually high moral plane. But Dr. Elliott also takes a brief and very informative excursion into the world of the medical ethicists. Once they were highly principled, underpaid gadflies, trying to sort out medical decision making. Now they are part of a booming industry, and, speaking of industry, their ties to the pharmaceutical industry are many and complex. Many companies now hire their own ethicists. But who guards those guards?
Meanwhile, at the bottom of the pharmaceutical totem pole are the folks who make it all happen: the people who volunteer to test new chemicals for safety before they are let loose on the general public.
John le Carré’s book “The Constant Gardener” touched on some of the issues that arise when big companies pay very poor people to test their drugs. Dr. Elliott didn’t have to head to Africa to report this story, however: the Northeast corridor provided ample material.
In Philadelphia he found a group of professional “guinea pigs,” as they call themselves, sequestered in a hospital’s clinical research unit while they were testing a prospective new drug. It was one long pajama party: “We were just gorging ourselves at 2 a.m. on Cheez Doodles,” one guinea pig told him. Only one problem: Those were contraband doodles. The drug under investigation required stringent dietary restrictions, which the subjects were systematically violating. So much for the science of drug evaluation.
Some guinea pigs are activists — one has founded an industry magazine, Guinea Pig Zero. Probably more typical, unfortunately, are the subjects who spent time in a drug testing site in Miami, the largest in the country until it was shut down for fire and safety violations. Many of them were illegal immigrants, packed into shabby, overcrowded rooms with minimal supervision.
“Guinea pigs do not do things in exchange for money so much as they allow things to be done to them,” Dr. Elliott points out. “There are not many other jobs where this is the case.” Yet for all the job’s built-in vulnerability, there is little monitoring of either the subjects’ health or the data’s validity.
What a world, what a world, as the melting witch said in “The Wizard of Oz.” But there is one small consolation: at least Dr. Elliott didn’t have to call his book “White Coat, Black Heart.” Now that would have been depressing. The bottom line is that much of what he describes is simply the big business of medicine as we have allowed it to take shape. His bad actors are mostly just that: actors caught up in a script not of their own devising. They all come home in the evening, take off their black hats and hang up their white coats, just regular working stiffs out to make a buck.
Scientists raise new questions over Tamiflu - Channel4 News
An international group of scientists has today raised further concerns about the lack of evidence supporting the safety and effectiveness of the blockbuster anti-flu drug Tamiflu.They criticised the drug's Swiss-based manufacturer, Roche, for still not making available clinical trial data used to get the drug licensed. The company had promised to give the medical community access to the data following an investigation in December by Channel 4 News.
"We get the impression that the drug companies are being at best tardy," says Chris Del Mar from Bond University in Australia, who leads the Cochrane influenza review team. "Roche promised this information publically in December and we still don't have it."
During the swine flu pandemic last year courses of Tamiflu were handed out to anyone with symptoms calling the government's National Pandemic Flu Service. In the first two weeks of the pandemic, 500,000 courses of the drug were prescribed nationwide. The government spent more than £500 million stockpiling antiviral drugs like Tamiflu in preparation for a pandemic.
Last year, the Cochrane Collaboration, an international group of public health specialists found, during a routine review of flu drugs, that there was insufficient evidence in the public domain to account for Tamiflu's effectiveness as a pandemic flu drug. They particularly criticised a key paper used to justify Tamiflu's use during pandemics to international regulatory authorities.
"Roche promised this information publically in December and we still don't have it." Chris Del Mar, Bond University, AustraliaIn an interview with Channel 4 News in December 2009 Dr David Reddy, pandemic taskforce leader at Roche, said that to satisfy any concerns the medical community had, the company would make available "full study reports" from clinical trials carried out while bringing Tamiflu to market.
Earlier this year the Cochrane scientists were given access to a block of data about the drug but they say there is more.
"They promised us ‘full study reports' and they made available one - of what we think are ten study reports in existence," says Dr Tom Jefferson a member of the Cochrane review team based in Rome.
What's more, the data on Tamiflu that Roche did make available appears to raise serious questions about the data that is in the public domain.
For example, in the previously confidential trial data supplied by Roche to the Cochrane Collaboration "serious adverse events" were reported in ten patients. The data indicates the illnesses in three patients could have been caused by the drug itself. However in a subsequent publication about the drug - including one used by governments to support the stockpiling of the drug for Pandemics - it was declared the drug caused no serious side-effects.
While there is no evidence that the drug is harmful, there is a lack of available evidence to show otherwise, the Cochrane review team says. "The apparent contradictions in the data we have undermine the integrity of the data we have," says Jefferson.
In a statement today, Roche told Channel 4 News that it had already supplied 3200 pages of data to the Cochrane scientists. "Roche will consider providing additional information only once the Cochrane Group has provided us with its detailed analysis plan for review by our scientists and physicians."
In response to questions about serious adverse events appearing in trial data but missing from reports put into the public domain, the company said: "It is likely that the authors of the publication used their own medical judgment after examining the case in detail and arriving at their statement that "there were no drug-related serious adverse events".
International drug regulators, who approve medicines like Tamiflu should have been given access to all the clinical trial data on Tamiflu - including reports of any serious adverse events.
However in recent years a number of high-profile drugs have been later withdrawn despite having once cleared regulatory hurdles. Just last week, Avandia, a top-selling diabetes drug made by British company GSK was withdrawn from the market after regulators agreed with independent scientists that the medicine carried an unacceptably high risk of causing heart attacks.
The Cochrane group is also requesting more data from GSK which supported the approval of its anti-flu drug Relenza.
One million US kids on antipsychotics - an increase of 22% over the past 5 years.
- That same year, one million individual children were prescribed these anti-psychotics (19 percent of the total of 5.5 million individuals). Here are the numbers, by age group:
- 1,770 children aged 0-2 64,664 children aged 3-6 414,451 children aged 7-12 540,760 children aged 13-17
W5 Investigates: Pills, Patients and Profits - CTV News
Just over a year ago, Dan Childerhose, of Dorchester, Ont., was diagnosed with multiple myeloma, a rare blood cancer. Childerhose successfully underwent radiation, chemotherapy and a stem-cell transplant treatment. The cancer went into remission but concerned about the possibility of a relapse his doctor prescribed a course of Thalidomide, as a good maintenance drug for those suffering from the life-threatening blood disorder.
Thalidomide is best known as a drug with a notorious past. In the 1950s and 1960s it was given to pregnant women to treat nausea but tragically caused birth defects. Thalidomide was responsible for thousands of children being born without arms or legs. The drug was ultimately banned around the world, but in recent years scientists discovered that it could be used for the treatment of leprosy, childhood leukemia and multiple myeloma.
Only available in Canada through a special access permit, Childerhose met the criteria to obtain the drug, but was told he would have to pay for it himself, as no provincial government was covering the drug's cost. Childerhose soon discovered that paying out of pocket would cost him a fortune, up to $4,000 per month.
'I wouldn't be able to afford that,' said Childerhose. 'I have some pension money and I would have to cash in my pension.'
He applied to Celgene, the drug manufacturer, to obtain Thalidomide on compassionate grounds. Although Celgene told W5 that at least 60 per cent of Canadians who take the drug are given it free of charge, Childerhose didn't meet their criteria of financial need and his application was refused.
Rehabilitating Thalidomide
Dr. Bart Barlogie runs the Institute for Myeloma Research and Therapy in Little Rock, Arkansas. He discovered Thalidomide's benefits in treating multiple myeloma back in the 1990s, after consulting with a scientist who had been using the drug to treat childhood leukemia. Barlogie's own research showed some patients given Thalidomide had a dramatic reversal in their disease.
'When that happened I knew this was truly miraculous,' said Barlogie. His findings were published in the New England Journal of Medicine in 1999.
According to Barlogie, that groundbreaking research, which led to the expanded uses for Thalidomide, was primarily funded through the National Cancer Institute and American government grants.
According to a 2001study by Donald Light, a professor at the University of Medicine and Dentistry of New Jersey, whose specialty is the economics of drugs, that public funding model is very common when new drugs are developed – or in the case of Thalidomide new uses are discovered. Light determined that 84.2 per cent of drug research money around the world comes from public and charitable sources.
While the research that led to Thalidomide being used to treat multiple myeloma was primarily paid for with public funds, the benefits and profits from that discovery were quickly seized by Celgene, the company which has the rights to sell Thalidomide in Canada and the United States. Celgene's reaction to Barlogie's miraculous discovery was to dramatically raise the price of Thalidomide.
When Barlogie's study was published in 1999, the B.C. Cancer Agency was paying about $400 for a month's supply of Thalidomide. Within six years the price had soared to $3,600 per month – a 900 per cent increase.
In an e-mail to W5, Celgene refused to discuss pricing issues: 'It is not our policy to participate in interviews around ongoing regulatory and reimbursement reviews.'
However during a brief interview with W5's Victor Malarek, Celgene Canada's general manager, Kevin Leshuk, said: 'On a compassionate basis 60 per cent of Canadians have been getting it free on a compassionate basis. The value is there within the product. I think that's well established.' He also indicated that pricing is set in the United States.
In a second, later e-mail, Leshuk wrote: 'Companies such as Celgene assume extraordinary risks and costs to develop promising compounds and future disease-altering therapies for patients with rare diseases, such as multiple myeloma.'
Prescription for profit
From the pharmaceutical industry's perspective, high costs are an unavoidable part of doing business. According to Russell Williams, president of Rx&D, the association that represents pharmaceutical companies in Canada, developing new drugs is very expensive.
'It costs our industry to develop one of our products approximately, and these are rounded figures, slightly over a billion dollars to discover that product and make it available,' said Williams.
That billion-dollar figure is regularly quoted by the drug industry to support high drug costs and is based on a 2002 study conducted by researchers at Tufts University in Boston. Using data provided by the drug companies, the Tufts study concluded that 'total R&D cost per new drug is $802-million (U.S. dollars).' In the intervening eight years that figure has been rounded up to a billion dollars.
'If we want to continue to bring new medicines that will save lives and improve the quality of life, we're going to need an environment in which we can create the revenues to keep reinvesting in research,' said Williams.
But critics believe the billion-dollar price tag is fictitious.
'Those figures come from industry supported economists using confidential data submitted in secret by companies to their leading policy research centre at Tufts University that no one else can see except those economists,' explained Light. 'They essentially take what they claim to be $71 million of direct costs and inflate them up to $1.3 billion.'
'They're trying to convince people that they have to pay high prices for prescription drugs to cover the R and D costs. That simply isn't true,' said Dr. Marcia Angell. She is the former Editor in Chief of the prestigious New England Journal of Medicine and the author of 'The Truth about Drug Companies.' 'The best charitable guess would be about $100-million per new pill,' she said.
Angell believes the reason for high drug costs can be found in the bottom line for all drug companies. 'Every year they are in the top couple of companies in terms of most profitable industries in the United States,' she said.
According to Forbes magazine's list of 2,000 multinational companies, the average annual profit margin is about eight percent, but for the top pharmaceutical countries the average profit margin is about 20 per cent. Celgene's profit margin rose from 16 per cent in 2007 to 29 per cent in 2009.
Critics of the profit margins believe that patients are being forced to pay the high prices for drugs because they are a captive market. Donald Light recounted an interview with the retired head of a pharmaceutical marketing department who called that 'the exploitative marketing model.'
'Exploit very sick people with very high prices because they're desperate and don't have a choice,' said Light.
Russell Williams, the president of Rx&D, insists the manner that pharmaceutical drugs are priced is entirely reasonable. 'We set prices in a way that is considered very fair on international norms,' he said. Dan Childerhose disagrees. While he would like to take Thalidomide to ensure his cancer remains in remission, he can't afford the $3,600 a month price tag for what is a repurposed 60-year-old drug. Which leaves him considering an uncertain future.
'It's like Russian roulette,' said Childerhose. And, the one holding the gun? 'The pharmaceutical company,' he said.
Danish Drugmaker Faces Hefty Fine | Business | The Moscow Times
The Federal Anti-Monopoly Service accused Danish pharmaceutical company Novo Nordisk of violating anti-monopoly legislation on Friday and said the firm might face a fine of up to 15 percent of its Russian revenue.
The watchdog said Novo Nordisk, the world's largest producer of diabetes drugs, refused to sign supply contracts with some drug distributors, restricting competition on the pharmaceutical market.
“The violation was in the company's unjustified avoidance and refusal to sign agreements with some buyers and discriminating against some potential partners in favor of existing ones, which has led to limited competition,” the Federal Anti-Monopoly Service said in a statement on its web site.
The statement also said the anti-monopoly service would send Novo Nordisk an order to stop violating the law. The service began a probe into the company's activities in July.
Under Russian law, a company that "occupies a dominant position" on a market is not allowed to refuse, without cause, to sign a contract with a partner, said Yevgenia Borzilo, head of the anti-monopoly group at law firm Goltsblat BLP.
Provenge - $93,000 for four extra months with prostate cancer: How much is a life worth? - Yahoo! Finance
BOSTON (AP) -- Cancer patients, brace yourselves. Many new drug treatments cost nearly $100,000 a year, sparking fresh debate about how much a few months more of life is worth.
The latest is Provenge, a first-of-a-kind therapy approved in April. It costs $93,000 a year and adds four months' survival, on average, for men with incurable prostate tumors. Bob Svensson is honest about why he got it: insurance paid.
"I would not spend that money," because the benefit doesn't seem worth it, says Svensson, 80, a former corporate finance officer from Bedford, Mass.
His supplemental Medicare plan is paying while the government decides whether basic Medicare will cover Provenge and for whom. The tab for taxpayers could be huge -- prostate is the most common cancer in American men. Most of those who have it will be eligible for Medicare, and Provenge will be an option for many late-stage cases. A meeting to consider Medicare coverage is set for Nov. 17.
"I don't know how they're going to deal with that kind of issue," said Svensson, who was treated at the Lahey Clinic Medical Center in suburban Boston. "I feel very lucky."
Amgen recalls anemia drugs due to glass flakes - Yahoo! Finance
Amgen Inc. is recalling some lots of its blockbuster Epogen and Procrit anemia treatments because the injected drugs may contain glass flakes that could cause blood clots, swelling of veins, immune system reactions and other problems.
The Thousand Oaks, Calif., biotechnology company says the flakes are barely visible in most cases, and they have fielded no complaints or reports about problems that can be directly tied to them. Patients experiencing problems should contact their doctor.
Amgen says the flakes are caused by the interaction of the drug with glass vials over the product's shelf life.
The affected lot numbers and expiration dates can be found on websites for the products, and patients can call 1-800-77-AMGEN to ask questions. Patients harmed by the recalled products, or their doctors, should notify the Food and Drug Administration and either Amgen or Johnson & Johnson's Centocor subsidiary.
Sanofi Seeks More Funding on Genzyme Bid: Report - ABC News
Last month, Genzyme rejected Sanofi's $69 per share offer as dramatically undervaluing the U.S. company and not a bid that justified entering merger talks.
Sources previously told Reuters that Genzyme sought an offer of at least $75 per share before Sanofi could review its books, while some investors want up to $80 a share in a deal.
Sunday, September 26, 2010
FT.com / US regulator sets October GSK deadline
GlaxoSmithKline must by next month provide US regulators with details of how it will investigate concerns of bias in a clinical trial it ran for its diabetes drug Avandia.
By late October, the UK pharmaceutical group must submit a timetable to the Food & Drug Administration for a review by independent experts of the long-running study, called Record, that GSK claimed showed no increased cardiovascular risk to diabetics taking its medicine.The action is one of a number of concerns about the conduct of clinical trials raised by Avandia which will trigger reflection by international drug regulators following a near-blanket ban on the drug imposed last week.
The Record trial has highlighted a rift between regulators. The European Medicines Agency appeared tougher than its US counterpart when it imposed the study a decade ago, designed to identify any safety concerns, as a condition of first approving Avandia.
Yet a detailed analysis by the FDA issued this summer by Thomas Marciniack, its cardiovascular medical team leader, described Record as “a complex, flawed design and a flawed execution”. He said the FDA would never have approved the study and he highlighted “completely unacceptable” issues in the way some patient data were handled, including breaches of “firewalls” designed to ensure independence between GSK and Quintiles, the clinical research consultancy that carried out the detailed data collection.
Whereas the EMA largely relies on summary results of clinical trials prepared by pharmaceutical companies to make its assessments, the FDA has more capacity to study the underlying raw data.
That greater scrutiny allowed Mr Marciniack to identify anomalies, but also required large amounts of time: he was only able to sift through a small quantity of the underlying records.
GSK maintains that the anomalies Mr Marciniack unearthed did not change the overall conclusions of Record which, it argues, remain “robust and reliable.”
Nevertheless, the outcome of its new independent review may spark transatlantic reflection on how exhaustively to analyse the results of trials submitted by drug companies.
A second trial concerning Avandia that has sparked concern was called 172, which was not submitted to the FDA. Some reports suggested GSK had tested its own drug against the rival Actos, found the alternative to be safer and suppressed the results.
In fact, 172 did not directly test Avandia at all. It was a small study designed to see whether a comparative trial would likely find in Avandia’s favour, by studying cholesterol levels in patients treated with Actos and comparing these results with separate studies it had already conducted using Avandia.
That raises an ethical issue of whether companies should provide regulators with all findings of tests they conduct, even when they do not directly relate to their own drug.
A third issue that emerged during the Avandia scrutiny was how far regulators can rely on imperfect evidence. Some research identified at least as early as 2007 a higher risk of heart attacks in patients taking Avandia than Actos.
Such “meta-analyses” – which attempt to tease out findings from other clinical studies never designed for that purpose or directly comparable – are imperfect. Yet the more comprehensive studies concluded in recent months that triggered the regulators to pull Avandia came up with very similar results. That suggests some meta-analysis may need to be taken more seriously.
The option taken by regulators was instead to seek more robust, conclusive evidence by running a first formal trial called Tide, comparing Actos with Avandia to identify any differences in heart attacks. But with the imperfect data already suggesting that Avandia carried a greater risk, scientific outcry led the regulators to suspend the trial.
Waiting for more detailed and reliable analysis before approving Avandia would have required much more time, and would have been so costly that the drug developers might never have agreed to proceed at all.
In the case of Avandia, that might have been a better solution. The downside more generally would be that drugs with potentially great benefits to patients may never make it to the market.
Saturday, September 25, 2010
Thug-hiring prof stripped of duties -- Shanghai Daily | 上海日报 -- English Window to China New
Germany's Merck sees shares slide after setback - BusinessWeek
Shares of German drug maker Merck have fallen sharply after a regulatory setback to a product the company wants to use to treat multiple sclerosis.
Merck shares fell 9.5 percent at euro63.54 ($84.82) in Frankfurt trading Friday.
The company said a committee of the European Medicines Agency opposed an application for authorization to market Cladribine tablets as a treatment for relapsing-remitting MS, arguing the benefits don't outweigh the risks.
Merck said it was "evaluating all options" to gain EU approval and may request its application be re-examined.