Tuesday, April 30, 2013
Editorial :: It's time for AllTrials registered and reported - The Cochrane Library
It's time for AllTrials registered and reported
- By: Tracey Brown
- On: April 30, 2013, 12:53
The Cochrane Collaboration has become a lead partner in the AllTrials initiative (AllTrials.net), a campaign to ensure that all clinical trials are registered and the results reported, for all treatments in current use. Cochrane joins Sense About Science, Bad Science, the BMJ, the James Lind Initiative, and the Centre for Evidence Based Medicine in leading this international campaign, which has already signed up over 200 research bodies, regulators, and patient groups, and nearly 50,000 individuals. This, though, is just a beginning.
Everyone involved in medical research knows that we only see parts of the picture of how treatments work and in whom. There are 'known unknowns': studies not yet conducted and comparisons not yet made, for example. We can press for the funds and motivation to do them. There are 'unknown unknowns': limits to our current understanding that we can only guess at, such as the extent to which epigenetics might sweep away working assumptions about how we respond to drug treatments. But medical research is suffering from something far less explicable: 'unknown knowns'. Trials are run and data are gathered, but what many of them found is kept a secret. Researchers, doctors, and patients cannot benefit from knowledge that they are unable to obtain.
Around half of all the clinical trials that have been conducted have not yet been published, and trials with positive results are twice as likely to be published as others.[1] The problem of failure to report the outcomes of trials exists for industry and non-industry trials, internationally, and at all stages of drug development. A cross-sectional analysis of trials registered and completed on the FDA-run registry ClinicalTrials.gov between 1999 and 2007 found that 56% of industry-sponsored trials and 40% of non-industry, non-government-sponsored trials had been published.[2]
Compared to all the other challenges of medicine, the missing information about clinical trials is a routine barrier to knowledge, and its solution is a simple matter of communication about what is known. It is strange that we have lived so long with a problem that can be fixed relatively easily. It is unfair to patients and trial participants, it is frustrating to researchers and medical practitioners, and it is completely unnecessary.
One of the reasons that the problem of missing trials has not been addressed is that discussions have taken place behind closed doors, amid promises that "it is being fixed". Behind those closed doors, arguments to slow and complicate the path to improvement can thrive. These arguments have been redeployed against the AllTrials initiative. The problem is fixed. It shouldn't be discussed in public because it undermines trust in medicine. Publishing research results causes scare stories. The regulator has what it needs, and we should be content with that. Patients are alarmed that their information might be shared. It wastes resources. The problem is being exaggerated. And so on.
These are not, though, the arguments of people with greater insight into the problems of clinical trial reporting. They are the arguments of people who don't want change. The problem is not fixed. We have seen a slow improvement in registration compliance and reporting rates, but the medicines that are currently prescribed for patients already have marketing authorisation. This is why AllTrials is calling for retrospective publication of trials relating to treatments in current use. Talking only about the conduct of future trials is just kicking the ball further up the street, which is what has happened since Iain Chalmers first sounded the alert on the problem of non-reporting 20 years ago.[3] Registering protocols and reporting outcomes do not present insurmountable patient confidentiality issues. GlaxoSmithKline, the first pharmaceutical company to sign up to AllTrials, has agreed to publish the results of all trials going back to its formation as a company, which shows it can be done. Under the glare of the public spotlight now on this issue, the arguments against communicating trial results disappear into the shadows.
AllTrials is an opportunity for us to come together to ensure that this public spotlight continues to shine on the dark corners of missing trials until there is change. There are no new arguments here. Patients have expected and continue to expect their treatments to be based on the best available evidence.[4] Clinical trial participants expect to be contributing to knowledge about their disease and future treatments. Policy-makers expect to be able to make decisions about effective and efficient health care. We all expect researchers to know what is known and to be free to analyse it. All of this underlines the valuable and necessary role of The Cochrane Collaboration in this essential campaign. Please sign up and urge other individuals and organisations to do the same at AllTrials.net.
Tracey Brown
Managing Director, Sense About Science, London, UK. tbrown@senseaboutscience.org
How to cite: Brown T. It's time for AllTrials registered and reported [editorial]. Cochrane Database of Systematic Reviews 2013 Apr 30;4:ED000057. dx.doi.org/10.1002/14651858.ED000057
References:
1. Song F, Parekh S, Hooper L, Loke YK, Ryder J, Sutton AJ, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technology Assessment 2010;14(8):1-220. www.hta.ac.uk/1627
2. Ross JS, Mulvey GR, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Medicine 2009:6:e1000144. dx.doi.org/10.1371/journal.pmed.1000144
3. Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263(10):1405-1408. dx.doi.org/10.1001/jama.1990.03440100121018
4. Haynes RB, Devereaux PJ, Guyatt GH. Physicians' and patients' choices in evidence based practice. BMJ 2002;324:1350. dx.doi.org/10.1136/bmj.324.7350.1350
Competing interests: The author has completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available upon request) and declares (1) no receipt of payment or support in kind for any aspect of the article; (2) no financial relationships with any entities that have an interest related to the submitted work; and (3) no other relationships or activities that could be perceived as having influenced, or giving the appearance of potentially influencing, what was written in the submitted work.
Image credit: AllTrials
Contact the Editor in Chief, Dr David Tovey (dtovey@cochrane.org): Feedback on this editorial and proposals for future editorials are welcome.
Keywords:
Drug donations are great, but should Big Pharma be setting the agenda?
Monday 29 April 2013 12.01 BST
Critics fear that giving out free medicines allows pharmaceutical companies to decide which diseases are treated
Vaccine donations might end after a period of time, leaving governments to pick up the bill. Photograph: Chris Hondros/Getty Images
Adam Robert Green for African Arguments, part of the Guardian Africa Network
In the early 2000s, pharmaceutical companies were high on activists' hit lists, prompted by Big Pharma's ill-advised attempt to sue the South African government for patent infringement on HIV drugs; an attempt to deal with the country's epidemic by allowing cheaper, generic copies to be sold.
Today, the discourse seems merrier. Charities and NGOs sit down with the same companies, discussing how best to confront public health challenges in the developing world. The talk is of partnerships and "win-wins". It isn't all idle chatter. Drug donations, reinvestment of profits in developing countries and a more flexible approach to intellectual property have all signalled a more collaborative approach, with the likes of GlaxoSmithKline, Sanofi, Johnson and Johnson and Merck all performing well in the 2012 Access to Medicine index.
But while talk of a new era of friendship is appealing (not least to the companies), there are still unresolved debates about the role that companies play in shaping the public health agenda in developing countries. Even the most seemingly charitable acts have come under scrutiny.
Take drug donations. While giving people free medicine might seem a sure-fire winner for corporate PR and the world's poor, some practitioners have reservations. Firstly, donations may focus the public health community on interventions for which companies have cures – albeit donated ones – without sufficient consideration of cost effectiveness, opportunity cost or prioritisation. Such factors are relevant, as free donations can lock governments and donors into particular programmes which they later have to fund themselves.
One example is the HPV vaccination programme for cervical cancer in Rwanda, enabled by a donation from Merck. After three years, the freebies expire, but Merck promised to provide Rwanda with a discounted access price to the vaccine. Assuming donors and governments pick up the bill, the donations could be interpreted as market-priming – creating the conditions for adoption – rather than corporate citizenship.
This might not be a problem if it were a drug for TB, malaria or AIDS – but critics of the HPV donation asked why cervical cancer received such a comprehensive effort in Rwanda – reaching 95% for 11-year-old girls when disease incidence lags well behind other vaccine-preventable diseases in the developing world (read the Rwandan health minister's persuasive rebuttal).
Others point out that while Rwanda's HPV coverage rates are laudable, other basic interventions, from tackling diarrhoea or ensuring women are provided with medical experts during childbirth, are still inadequate, raising questions about prioritisation.
As any public health official will tell you, there are no end of worthwhile diseases to tackle. The plight of a health ministry is making the difficult choices about what gets resources, and what does not. Critics say there are no – or not enough – comprehensive cost-effectiveness studies around donations. For cervical cancer, for instance, screening and treatment were considered by some to be more favourable options on a cost-effectiveness basis.
Some public health experts believe that "pull" (incentive) mechanisms might be a better way of bringing the private sector compared to "push" measures such as donation programmes. One example is the Advanced Market Commitment tool, where donors pledge to purchase developing country disease-focused vaccines or medicines, giving companies a commercial buyer and thus a reason to risk their R&D investment and product development. The mechanism "removes uncertainty for donors, governments, and vaccine manufacturers and improves availability and access", says Peter Shelby, associate director of communications at the International Federation of Pharmaceutical Manufacturers and Associations.
GSK's pneumococcal vaccine – introduced in Kenya's national immunisation programme in 2011 – benefited from this tool. But it was already a late-stage product, and the mechanism has not yet been used again. "Channelling such money should not be a problem from a [donor] Ministry of Finance or Treasury point of view, because they are such small amounts of money – you can't imagine the US or UK couldn't do that when the time comes," says Amanda Glassman at the Center for Global Development in Washington.
But for companies to believe the money is real rather than a mere pledge by aid ministers, it has to be locked away safely. In the current climate of austerity, the idea of unused public money is not appealing for western taxpayers, said Glassman. And some governments – notably the US and Japan – have trouble participating in multi-year commitments that represent a fiscal contingency.
No one should expect Big Pharma to act as a charity – for one thing, such behaviour will be superficial and unsustainable. The challenge is to establish where "corporate citizenship" stops and the bottom line starts. As the recent intellectual property rights clash with Novartis in India shows, the "people over profit" debate has not yet been dispensed with.
Adam Robert Green is senior reporter with This is Africa, a publication from the Financial Times
http://m.guardian.co.uk/world/2013/apr/29/drug-company-donations-bigpharma
Critics fear that giving out free medicines allows pharmaceutical companies to decide which diseases are treated
Vaccine donations might end after a period of time, leaving governments to pick up the bill. Photograph: Chris Hondros/Getty Images
Adam Robert Green for African Arguments, part of the Guardian Africa Network
In the early 2000s, pharmaceutical companies were high on activists' hit lists, prompted by Big Pharma's ill-advised attempt to sue the South African government for patent infringement on HIV drugs; an attempt to deal with the country's epidemic by allowing cheaper, generic copies to be sold.
Today, the discourse seems merrier. Charities and NGOs sit down with the same companies, discussing how best to confront public health challenges in the developing world. The talk is of partnerships and "win-wins". It isn't all idle chatter. Drug donations, reinvestment of profits in developing countries and a more flexible approach to intellectual property have all signalled a more collaborative approach, with the likes of GlaxoSmithKline, Sanofi, Johnson and Johnson and Merck all performing well in the 2012 Access to Medicine index.
But while talk of a new era of friendship is appealing (not least to the companies), there are still unresolved debates about the role that companies play in shaping the public health agenda in developing countries. Even the most seemingly charitable acts have come under scrutiny.
Take drug donations. While giving people free medicine might seem a sure-fire winner for corporate PR and the world's poor, some practitioners have reservations. Firstly, donations may focus the public health community on interventions for which companies have cures – albeit donated ones – without sufficient consideration of cost effectiveness, opportunity cost or prioritisation. Such factors are relevant, as free donations can lock governments and donors into particular programmes which they later have to fund themselves.
One example is the HPV vaccination programme for cervical cancer in Rwanda, enabled by a donation from Merck. After three years, the freebies expire, but Merck promised to provide Rwanda with a discounted access price to the vaccine. Assuming donors and governments pick up the bill, the donations could be interpreted as market-priming – creating the conditions for adoption – rather than corporate citizenship.
This might not be a problem if it were a drug for TB, malaria or AIDS – but critics of the HPV donation asked why cervical cancer received such a comprehensive effort in Rwanda – reaching 95% for 11-year-old girls when disease incidence lags well behind other vaccine-preventable diseases in the developing world (read the Rwandan health minister's persuasive rebuttal).
Others point out that while Rwanda's HPV coverage rates are laudable, other basic interventions, from tackling diarrhoea or ensuring women are provided with medical experts during childbirth, are still inadequate, raising questions about prioritisation.
As any public health official will tell you, there are no end of worthwhile diseases to tackle. The plight of a health ministry is making the difficult choices about what gets resources, and what does not. Critics say there are no – or not enough – comprehensive cost-effectiveness studies around donations. For cervical cancer, for instance, screening and treatment were considered by some to be more favourable options on a cost-effectiveness basis.
Some public health experts believe that "pull" (incentive) mechanisms might be a better way of bringing the private sector compared to "push" measures such as donation programmes. One example is the Advanced Market Commitment tool, where donors pledge to purchase developing country disease-focused vaccines or medicines, giving companies a commercial buyer and thus a reason to risk their R&D investment and product development. The mechanism "removes uncertainty for donors, governments, and vaccine manufacturers and improves availability and access", says Peter Shelby, associate director of communications at the International Federation of Pharmaceutical Manufacturers and Associations.
GSK's pneumococcal vaccine – introduced in Kenya's national immunisation programme in 2011 – benefited from this tool. But it was already a late-stage product, and the mechanism has not yet been used again. "Channelling such money should not be a problem from a [donor] Ministry of Finance or Treasury point of view, because they are such small amounts of money – you can't imagine the US or UK couldn't do that when the time comes," says Amanda Glassman at the Center for Global Development in Washington.
But for companies to believe the money is real rather than a mere pledge by aid ministers, it has to be locked away safely. In the current climate of austerity, the idea of unused public money is not appealing for western taxpayers, said Glassman. And some governments – notably the US and Japan – have trouble participating in multi-year commitments that represent a fiscal contingency.
No one should expect Big Pharma to act as a charity – for one thing, such behaviour will be superficial and unsustainable. The challenge is to establish where "corporate citizenship" stops and the bottom line starts. As the recent intellectual property rights clash with Novartis in India shows, the "people over profit" debate has not yet been dispensed with.
Adam Robert Green is senior reporter with This is Africa, a publication from the Financial Times
http://m.guardian.co.uk/world/2013/apr/29/drug-company-donations-bigpharma
Monday, April 29, 2013
We The People vs. The Pharmaceutical Industry - Bernard Munos
The pharma industry is in a pickle. It is losing all its friends and handing over sticks to its enemies. In the last few weeks:
Novartis lost a major patent dispute in India
Merck was denied an injunction against a generic Januvia
South Africa announced plans to tighten its patenting requirements to deny IP protection to incremental innovations, often used by drug companies to “evergreen” their patents
Germany extended the application of its much-hated pricing formula to the country’s most popular drugs
100 leading oncologists have risen against drug prices, accusing the industry of having lost its moral compass, and demanding major price cuts
All this adds up to a giant pushback against the astronomical drug prices that are becoming commonplace. It seems that price tags of $100,000 or above are becoming the norm. Of 12 cancer drugs approved in 2012, 11 cost more than that. As more drugs are offered at that level and their sponsors get away with it, it seems to set a floor that emboldens drug companies to push the envelope. They are badly misjudging the brewing anger.
The industry’s standard defense has been to run warm-hearted stories about the wonders of biomedical innovation, and to point out that drugs represent only 10% of healthcare costs. Both arguments miss the point. Everyone loves biomedical innovation, but the industry’s annual output of 25 to 35 new drugs is a lousy return for its $135 billion R&D spending. And pointing out that there is a worst culprit on the block is no comfort to patients getting stuck with a $20,000 co-pay.
Perhaps the mood would be different if the industry was a model of efficiency, but this is hardly the case. Examples of massive waste are on display everywhere: Pfizer wants to flatten a 750,000-square-foot facility in Groton, CT, and won’t entertain proposals for alternative uses. Lilly writes off over $100 million for a half-built insulin plant in Virginia, only to restart the project a few years later in Indiana. AstraZeneca shutters its R&D labs at Alderley Park and goes on to spend $500 million on a new facility in Cambridge.
For American patients, what must be called executive incompetence is part and parcel of drug unaffordability. And every product recall and billion dollar fine compounds the anger, not to mention the oversized compensation of the CEOs responsible for this mess.
It is ironic that Novartis is the focus of the latest outcry, as it has done more than its share to champion innovation. Ten years ago, as uninspired CEOs unleashed six sigma onto their scientists, Novartis was the only company to denounce the ineptitude of regimenting science and basing R&D investment on bogus forecasts and NPV calculations. It broke ranks with its peers, and returned to its scientists the freedom to pursue unfettered breakthrough innovation. It is now the company that derives by far the greatest percentage of its sales from new products. Perhaps this gives it an opportunity to make history again.
What if it decided to abandon the industry’s pricing madness, and make its drugs affordable? Wall Street would probably not like it, but it would like even less the devastation it would wreck on its competitors, half of which have been weakened by years of poor leadership, and can ill-afford to follow suit. We have lost 6 big pharma since 2000, and are likely to lose another 3 or 4 within the next few years. Pricing leadership from Novartis would give its products choice placement on formularies, and speed the demise of drugs that can no longer compete. It would also help wring out the enormous waste that undermines the industry. Mr. Jimenez has vowed to control R&D costs. Noble goal, but easier said than done. Perhaps the imperative of heading off a clash with society can help him win over the skeptics and muster the support he needs to keep Novartis in the vanguard of transformational change, for our collective benefit.
http://www.forbes.com/sites/bernardmunos/2013/04/29/the-pharmaceutical-industry-vs-society/
Novartis lost a major patent dispute in India
Merck was denied an injunction against a generic Januvia
South Africa announced plans to tighten its patenting requirements to deny IP protection to incremental innovations, often used by drug companies to “evergreen” their patents
Germany extended the application of its much-hated pricing formula to the country’s most popular drugs
100 leading oncologists have risen against drug prices, accusing the industry of having lost its moral compass, and demanding major price cuts
All this adds up to a giant pushback against the astronomical drug prices that are becoming commonplace. It seems that price tags of $100,000 or above are becoming the norm. Of 12 cancer drugs approved in 2012, 11 cost more than that. As more drugs are offered at that level and their sponsors get away with it, it seems to set a floor that emboldens drug companies to push the envelope. They are badly misjudging the brewing anger.
The industry’s standard defense has been to run warm-hearted stories about the wonders of biomedical innovation, and to point out that drugs represent only 10% of healthcare costs. Both arguments miss the point. Everyone loves biomedical innovation, but the industry’s annual output of 25 to 35 new drugs is a lousy return for its $135 billion R&D spending. And pointing out that there is a worst culprit on the block is no comfort to patients getting stuck with a $20,000 co-pay.
Perhaps the mood would be different if the industry was a model of efficiency, but this is hardly the case. Examples of massive waste are on display everywhere: Pfizer wants to flatten a 750,000-square-foot facility in Groton, CT, and won’t entertain proposals for alternative uses. Lilly writes off over $100 million for a half-built insulin plant in Virginia, only to restart the project a few years later in Indiana. AstraZeneca shutters its R&D labs at Alderley Park and goes on to spend $500 million on a new facility in Cambridge.
For American patients, what must be called executive incompetence is part and parcel of drug unaffordability. And every product recall and billion dollar fine compounds the anger, not to mention the oversized compensation of the CEOs responsible for this mess.
It is ironic that Novartis is the focus of the latest outcry, as it has done more than its share to champion innovation. Ten years ago, as uninspired CEOs unleashed six sigma onto their scientists, Novartis was the only company to denounce the ineptitude of regimenting science and basing R&D investment on bogus forecasts and NPV calculations. It broke ranks with its peers, and returned to its scientists the freedom to pursue unfettered breakthrough innovation. It is now the company that derives by far the greatest percentage of its sales from new products. Perhaps this gives it an opportunity to make history again.
What if it decided to abandon the industry’s pricing madness, and make its drugs affordable? Wall Street would probably not like it, but it would like even less the devastation it would wreck on its competitors, half of which have been weakened by years of poor leadership, and can ill-afford to follow suit. We have lost 6 big pharma since 2000, and are likely to lose another 3 or 4 within the next few years. Pricing leadership from Novartis would give its products choice placement on formularies, and speed the demise of drugs that can no longer compete. It would also help wring out the enormous waste that undermines the industry. Mr. Jimenez has vowed to control R&D costs. Noble goal, but easier said than done. Perhaps the imperative of heading off a clash with society can help him win over the skeptics and muster the support he needs to keep Novartis in the vanguard of transformational change, for our collective benefit.
http://www.forbes.com/sites/bernardmunos/2013/04/29/the-pharmaceutical-industry-vs-society/
Novartis speaks out after second kickbacks lawsuit
>via pharmatimes.com
The lawsuits also noted one dinner for three, including the speaker, at a Washington DC restaurant which cost over $2,000. At another programme held on Valentine’s Day in 2006, Novartis paid $3,127 for a meal for two, while the DoJ also cites data which shows that during January 2002 to November 2011, nearly $65 million was spent and more than 38,000 speaker programmes were conducted for the three aforementioned drugs.
In September 2010, the company signed a corporate integrity agreement with US authorities agreeing to implement a rigorous compliance programme. This was agreed after Novartis paid $422.5 million to settle allegations that it marketed the epilepsy drug Trileptal (oxcarbazepine) and five other drugs for unauthorised use in the USA.
Drug industry ‘profiteering’ threatens lives, say doctors - Telegraph
via telegraph.co.uk
Some 11 of the 12 drugs approved by the Food and Drug Administration in the US in 2012 were priced above $100,000 (£65,000) per patient per year, with the price of existing drugs that have proven effectiveness rising by up to threefold, the Independent reported.
Sunday, April 28, 2013
Meet Nurse Ashleigh - Novartis took doctors to Hooters, lawsuit says
Have you ever received a prescription that you didn't think you needed for some hardcore Novartis drugs? Bad news: your doctor may have sold you out for a Hooters waitress and some crispy chicken wings.
Novartis plied physicians with dinners, speaker fees, fishing trips and outings at Hooters restaurants to get them to prescribe patients more Novartis drugs, the US government alleges. The US made the claims in a lawsuit filed in Manhattan federal court.
“Novartis corrupted the prescription drug dispensing process with multimillion-dollar ‘incentive programs’ that targeted doctors who, in exchange for illegal kickbacks, steered patients toward its drugs,” Manhattan US Attorney Preet Bharara said in a statement to reporters.
The charges were first made by a former Novartis employee turned whistle-blower. The whistle-blower filed the lawsuit in 2011, the New York Times reported, but the federal government has only recently joined it.
In an email, Novartis told the Wall Street Journal that physician speaker programs are an "accepted and customary practice in the industry," which will probably not improve your faith in the drug industry or your doctor.
http://www.globalpost.com/dispatch/news/business/130427/novartis-took-doctors-hooters-lawsuit-says
Takeda loses cancer suit over Actos
LOS ANGELES – Takeda Pharmaceutical Co. owes $6.5 million in damages to a California man who said Asia’s largest drugmaker failed to warn consumers its Actos diabetes drug could cause cancer, a jury said in the first of more than 3,000 lawsuits over the medication to go to trial.
http://www.japantimes.co.jp/news/2013/04/29/national/takeda-loses-cancer-suit-over-actos-2/#.UX1LFny9KK0
http://www.japantimes.co.jp/news/2013/04/29/national/takeda-loses-cancer-suit-over-actos-2/#.UX1LFny9KK0
Six ways Big Pharma manipulates consumers - Salon
This article originally appeared on AlterNet.
The blockbuster pill profit party is over for Big Pharma. Bestselling pills like Lipitor, Seroquel, Zyprexa, Singular and Concerta have gone off patent and sites which their ads sustained are withering on the vine. WebMD, for example, the voice of Pharma on the Web, with a former Pfizer exec serving as CEO, announced it would cut 250 positions in December.
But don’t worry, Wall Street. Pharma isn’t going to deliver disappointing earnings just because it has little or no new drugs coming online and has failed at the very reason for its existence. Here are six new Pharma marketing initiatives that are guaranteed to keep investor expectations high along with our insurance premiums. The secret? Recycling old and discredited drugs and marketing diseases to sell the few new ones.
1) Repurposing Ritalin
Now that Pharma’s succeeded in getting five million children and four to eight million adults diagnosed with ADHD, it’s looking for new markets for the drugs. One new use for Ritalin (methylphenidate), the grandfather of ADHD drugs, could be for eating disorders.Researchers say a woman who suffered from bulimia nervosa, bipolar I disorder, cocaine and alcohol dependence, attention-deficit hyperactivity disorder and panic disorder “achieved a sustained (>1 year) remission” when methylphenidate was added to her other drugs.
Then there’s pregnant women. A new paper suggests that taking away a women’s methylphenidate during pregnancy may “may present a significant risk” and that, “In all cases, children developed normally and no adverse effects were reported,” though they were exposed in utero. Yes, kids can be given ADHD meds at even younger ages–as fetuses.
Pharma is also looking at the elderly as a new market for ADHD drugs. Methylphenidate may “improve gait function in older adults,” researchers wrote recently. And a major clinical trial sponsored by Johns Hopkins Bloomberg School of Public Health is underway to see if methylphenidate can reduce apathy in Alzheimer patients. Of course many Alzheimer patients don’t have apathy but agitation and aggression; they will be excluded.
2) Male Hormone Replacement
Women over 40 might feel a rush of medical justice over the big push to treat men’s “Low T,” a recent “disease” now aggressively marketed, with replacement testosterone. For over 50 years, medical journals were relentless in telling women they were “outliving their ovaries” (a real ad) and the only hope to keep their looks, their husbands and their sanity was hormone replacement. Now men are hearing that their decreased sex drive and energy, reduced muscle and growing fat put them in the same position. Missing in both marketing campaigns is the fact that people don’t get old because they lose hormones; they lose hormones because they get old.
Many testosterone replacement products have been approved by the FDA from pills, injections and patches to gels and solutions that are applied topically. In November, the first underarm testosterone replacement product was approved which is applied like deodorant.
The male HRT products are not without their risks. They can worsen benign prostate problems, heart failure, sleep apnea, cause liver toxicity and possibly stimulate prostate cancer though it remains a theoretical risk. Injected testosterone has been associated with embolisms and extreme allergic reactions (anaphylaxis) both of which can be fatal. Men who take Propecia for hair loss can especially have low testosterone, which may not be reversible, because it reduces an enzyme involved in testosterone synthesis.
3) Calling Alcoholics and Addicts Mentally Ill and In Need of Vaccines
One of the few good things about alcoholism and drug addiction is they can be treated for free. Twelve-step programs like Alcoholics Anonymous use peer support instead of drugs, trained personnel or insurance — and they work. It’s no surprise that the millions of people recovering without Pharma’s help are its latest target as it tries to shore up revenues. Pharma is increasingly pressuring rehab facilities and doctors to add a mental illness diagnoses to recovering patients to sell expensive pills. Ka-ching!
Worse, Nora Volkow, the head of the National Institute on Drug Abuse, is conducting cruel experiments on primates to develop a vaccine for alcoholic or addicts. Is there an alcoholic or addict in the world who would take such a vaccine? Doesn’t she know that drinking and drugging are fun (until they aren’t) and that no one wants to quit before the party’s over? Doesn’t she know that when drinking and drugging cease to be fun, a thing called denial kicks in and alcoholics and addict still won’t take her vaccine?
These alcoholic/addict vaccines will be marketed for people “at risk” of addiction on the basis of their family histories and brain scans which sounds a little, well, non-voluntary. Marketing early aggressive treatment for diseases people don’t even have yet (“pre-osteoporosis,” “pre-diabetes,” “pre-asthma” and “pre” mental illness) is a foolproof business model for Pharma because people will never know if they even needed the drugs–or need them now.
4) Pathologizing Insomnia
Insomnia has been a goldmine to Big Pharma. To goose the insomnia market, Pharma has created subcategories of insomnia — chronic, acute, transient, initial, delayed-onset and middle-of-the-night as well as early-morning wakening non-restful sleep. Your insomnia is as unique as you are! It is also no coincidence that “wakefulness” medications cause insomnia and insomnia drugs, because of their hangover, create a market for wakefulness drugs.
Now Pharma is announcing that insomnia is actually a “risk” factor for depression and “that treating insomnia can help treat depression.” The American Psychiatric Association’s new Diagnostic and Statistical Manual (DSM-5) due in May also newly pathologizes sleep. Considered the Bible of psychiatric drug treatments that end up being funded by insurers, the latest DSM has revised the way insomnia is diagnosed and classified. “If sleep disturbance is persistent and impairs daytime functioning, then it should be recognized and treated,” write authors in a paper in the December issue of the Journal of Clinical Psychiatry.
5) ”Selling” Chronic Immune Disorders
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis are rare disorders, but you wouldn’t know it from Pharma’s latest marketing efforts. The autoimmune conditions are increasingly treated with genetically engineered, injected drugs like Humira, Remicide, Enbrel and Cimzia which can make Pharma $20,000 per year per patient. No wonder a recent ad campaign tries to convince people with back pain “that doesn’t go away” that they really have ankylosing spondylitis. No wonder “RA” (rheumatoid arthritis) ads are everywhere and ads for plaque psoriasis drugs promise “clearer skin” like beauty creams. In Chicago, ads for the expensive, injected drugs have appeared in college newspapers, as if they are for the general population instead of people with uncommon diseases.
Because such drugs, called TNF blockers, suppress the immune system, they invite super bacterial and fungal infections, herpes and rare cancers, the latter especially in children. They are linked to increasing hospitalizations, extreme allergic reactions and cardiovascular events, all of which Pharma tries to downplay. TNF blockers are also marketed for thinning bones and asthma, conditions that would rarely warrant their risks. Xolair, marketed for asthma despite its FDA warnings. has recently gotten buzz as a great treatment for chronic itch.
6) Recycling Neurontin
The seizure drug Neurontin (gabapentin) has not been Pharma’s finest hour. A division of Pfizer Inc., pleaded guilty in 2008 to illegally promoting it for bipolar disorder, pain, migraine headaches, and drug and alcohol withdrawal when it was only approved for postherpetic neuralgia, pain after shingles and epilepsy, paying $430 million. Oops. Pfizer actually promoted the illegal uses while under probation for illegal activities related to Lipitor and later promoted illegal uses for a similar drug, Lyrica, while under the Neurontin agreement! See: incorrigible.
To sell Neurontin, Pfizer’s Parke-Davis launched an elaborate “publication plan” to get marketing papers disguised as science in medical journals. In just three years, Parke-Davis planted 13 ghostwritten articles in medical journals promoting off-label uses for Neurontin including a supplement to the prestigious Cleveland Clinic Journal of Medicine that Parke-Davis made into 43,000 reprints for its reps to disseminate. See Doc, it says right here….
And there was more duplicity. In 2011, three years after its $430 million settlement, Pfizer’s STEPS trial (“Study of Neurontin: Titrate to Effect, Profile of Safety”) was reported to also be a con and not a scientific study; it was a sales tool created to inspire the 772 investigators participating in the trail to personally prescribe Neurontin. Recently, the new uses of Neurontin for chronic cough, menopause and insomnia are appearing in scientific literature. Why does no one seem to believe them?
http://www.salon.com/2013/04/28/six_ways_big_pharma_wants_to_profit_from_your_health_concerns_partner/singleton/
Saturday, April 27, 2013
GSK and Roche tell MPs that more clinical trial data should be published -BMJ
By Adrian O’Dowd
Two of the world’s largest drug companies have told MPs in parliament that they support a policy of publishing all clinical trial data.
A leading academic and clinician has, however, questioned their assertions and challenged them over how closely their promises would manifest into action.
MPs on the House of Commons Science and Technology Committee held an evidence session on 22 April for their inquiry into clinical trials. The inquiry is in the context of the European Commission’s proposal to revise the clinical trials directive that regulates trials in the United Kingdom and comes after concerns raised about transparency and disclosure of all trial data: drug companies are entitled to conduct numerous clinical trials on drugs but publish selectively.
MPs asked witnesses whether all clinical trials funded by drug companies were published.
James Shannon, chief medical officer at GlaxoSmithKline, giving evidence, said, “If a phase III trial or programme were to fail at any part of the process, and there was no evidence of efficacy, we would most likely not submit an application for a product licence.
“The clinical study reports in those cases would not necessarily be submitted to a regulator, because we are not applying for a product licence. However, all of those studies would be published in a peer reviewed journal.”
Ben Goldacre, a research fellow in epidemiology at the London School of Hygiene and Tropical Medicine and author of the book Bad Pharma, which highlighted the practice of drug companies choosing which trials to publish, also giving evidence, questioned that assertion.
“That may be true for GSK,” he said, “but I am not sure it would be universally true that trials which weren’t part of a marketing authorisation package would be made publicly available. Quite commonly, they’d be withheld.
“What we need to practise medicine in a safe and informed fashion is to have all the results of all the trials for all of the uses of all of the treatments that we are currently prescribing, and we don’t have that at the moment.”
Fellow witness William Burns, member of the board of directors at Roche, said, “This is a heavily regulated industry. What we’ve seen is an increasing requirement over recent years for more stakeholders to have more access to the data, and if society wants that to happen, then we have to respond. We believe this is a correct response to what society is looking for, but we should not underestimate that we should be working with the multiplicity of regulatory authorities.
“Probably the two companies sitting here are the first two out of the gate actually saying we will have a new policy going forward with greater disclosure than we’ve ever had in the past.”
Goldacre replied, “If we look at some of the biggest problems that have been spotted in the evidence base for medicines over the past few years . . . those problems were not spotted by regulators but by independent doctors and academics reviewing data that they had to fight to get hold of.
“In December 2009 Roche made a commitment to share all the clinical study reports on Tamiflu, and that promise has still not been paid out on.
“My concern is that Roche are making exactly the right kind of noises that we would like to hear about sharing clinical study reports, but in their specific interactions with the Cochrane [Collaboration] so far they have fallen well short of those aspirations.”
Shannon said, “We 100% agree with Dr Goldacre that the more eyes that are put on data, the better. That’s why GSK has taken the lead to commit to both patient level data transparency as well as clinical study reports.”
Burns added, “The same is true for Roche.”
Notes
Cite this as: BMJ 2013;346:f2639
Footnotes
The BMJ has been campaigning for fuller disclosure of trial data. See bmj.com/tamiflu.
Two of the world’s largest drug companies have told MPs in parliament that they support a policy of publishing all clinical trial data.
A leading academic and clinician has, however, questioned their assertions and challenged them over how closely their promises would manifest into action.
MPs on the House of Commons Science and Technology Committee held an evidence session on 22 April for their inquiry into clinical trials. The inquiry is in the context of the European Commission’s proposal to revise the clinical trials directive that regulates trials in the United Kingdom and comes after concerns raised about transparency and disclosure of all trial data: drug companies are entitled to conduct numerous clinical trials on drugs but publish selectively.
MPs asked witnesses whether all clinical trials funded by drug companies were published.
James Shannon, chief medical officer at GlaxoSmithKline, giving evidence, said, “If a phase III trial or programme were to fail at any part of the process, and there was no evidence of efficacy, we would most likely not submit an application for a product licence.
“The clinical study reports in those cases would not necessarily be submitted to a regulator, because we are not applying for a product licence. However, all of those studies would be published in a peer reviewed journal.”
Ben Goldacre, a research fellow in epidemiology at the London School of Hygiene and Tropical Medicine and author of the book Bad Pharma, which highlighted the practice of drug companies choosing which trials to publish, also giving evidence, questioned that assertion.
“That may be true for GSK,” he said, “but I am not sure it would be universally true that trials which weren’t part of a marketing authorisation package would be made publicly available. Quite commonly, they’d be withheld.
“What we need to practise medicine in a safe and informed fashion is to have all the results of all the trials for all of the uses of all of the treatments that we are currently prescribing, and we don’t have that at the moment.”
Fellow witness William Burns, member of the board of directors at Roche, said, “This is a heavily regulated industry. What we’ve seen is an increasing requirement over recent years for more stakeholders to have more access to the data, and if society wants that to happen, then we have to respond. We believe this is a correct response to what society is looking for, but we should not underestimate that we should be working with the multiplicity of regulatory authorities.
“Probably the two companies sitting here are the first two out of the gate actually saying we will have a new policy going forward with greater disclosure than we’ve ever had in the past.”
Goldacre replied, “If we look at some of the biggest problems that have been spotted in the evidence base for medicines over the past few years . . . those problems were not spotted by regulators but by independent doctors and academics reviewing data that they had to fight to get hold of.
“In December 2009 Roche made a commitment to share all the clinical study reports on Tamiflu, and that promise has still not been paid out on.
“My concern is that Roche are making exactly the right kind of noises that we would like to hear about sharing clinical study reports, but in their specific interactions with the Cochrane [Collaboration] so far they have fallen well short of those aspirations.”
Shannon said, “We 100% agree with Dr Goldacre that the more eyes that are put on data, the better. That’s why GSK has taken the lead to commit to both patient level data transparency as well as clinical study reports.”
Burns added, “The same is true for Roche.”
Notes
Cite this as: BMJ 2013;346:f2639
Footnotes
The BMJ has been campaigning for fuller disclosure of trial data. See bmj.com/tamiflu.
Friday, April 26, 2013
U.S. files second lawsuit accusing Novartis of kickbacks
via dailypress.com
The government accused Novartis of causing the Medicare and Medicaid programs to pay millions of dollars in reimbursements based on kickback-tainted claims for drugs such as hypertension drugs Lotrel and Valturna and diabetes drug Starlix.
Docs call drugmakers 'profiteers' for costs of cancer meds - FiercePharma
via fiercepharma.com
The doctors called out as an example, Novartis' ($NVS) Gleevec, a treatment for chronic myeloid leukemia. They pointed out that it came on the market at a cost of $30,000 a year in 2001 and now runs three times that even though it now has competition.
Read more: Docs call drugmakers 'profiteers' for costs of cancer meds - FiercePharma http://www.fiercepharma.com/story/docs-call-drugmakers-profiteers-costs-cance...
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Trying to Burnish Its Image, Johnson & - Johnson Turns to Emotions
The company’s McNeil Consumer Healthcare unit recalled more than 280 million packages of over the counter medications like Motrin, children’s Tylenol liquid and Benadryl in 2010, and the same year, its DePuy Orthopedics unit recalled two popular artificial hip replacement models.
About 10,000 lawsuits have been filed involving those artificial hip devices and while a Chicago jury this month rejected claims of wrongdoing by Johnson & Johnson in one suit, another lawsuit in March yielded a less favorable outcome when a Los Angeles jury ordered the company to pay more than $8.3 million in damages to a Montana man.
In the midst of that turmoil — and perhaps to distance itself from the bad press of product recalls and pending litigation — the company on Thursday is introducing its first corporate branding campaign in more than 10 years. The company will announce the campaign, called For All You Love, at its annual shareholder meeting in New Brunswick, N.J.
The cornerstone of the campaign, a 60-second black and white video, begins with a shot of a sleeping baby about to get a gentle kiss from its mother. In the background, a softer, almost childlike version of the Guns N’ Roses song, “Sweet Child O’ Mine” plays.
“Love,” says a woman’s voice. “It’s the most powerful thing on the planet.” Happy clips from everyday life — a father bathing with his baby, a grandfather playing piano with his granddaughter and a teacher playing with her students — are seen during the spot, as is the occasional Johnson & Johnson product like Band-Aids and baby shampoo.
“Love is family,” says the voice-over. “Love is the reason you care for the tiny and the fragile.”
The campaign was created by TBWA/Chiat/Day, part of TBWA Worldwide, a division of the Omnicom Group. It is the first time the agency has worked with Johnson & Johnson.
“This is the chance to reassert this very iconic brand to the world,” said Rob Schwartz, the global creative president of TBWA Worldwide. The creative team at the agency was inspired by a company statement produced in 1943 that highlighted its responsibility to its consumers, employees, communities and stockholders. Mr. Schwartz described the statement as “one of the best corporate documents ever.”
Based on that, the agency created a manifesto about love that will appear in print publications, including The New York Times and People magazine on May 10. Television commercials and digital ads will begin appearing on May 6 during shows like “Modern Family” on ABC, “The Voice” on NBC and “American Idol” on Fox, and on Web sites like abcnews.com. The videos feature real people and real relationships, not actors, Mr. Schwartz said. Subsequent videos for the campaign will also focus on the philanthropic work the company supports. The campaign is estimated to cost $20 million to $30 million through the end of the year.
While a Johnson & Johnson spokeswoman declined to comment on the company’s recalls or the lawsuits it faces, Michael Sneed, the company’s vice president for global corporate affairs, said the goal of the campaign was “to continue to reconnect with all of the people who come into contact with J.& J. in their daily lives.”
A campaign focused on love creates a sense of trust with the brand, said Kapil Bawa, a marketing professor at the Zicklin School of Business at Baruch College, part of the City University of New York. “Corporate branding tries to instill a sense of trust in the company and for J.& J., given the kind of products it makes, that trust is very, very critical,” Mr. Bawa said.
Mr. Sneed agreed. “I do think people want to understand what’s behind the brand,” he said. “They want to understand what they value.”
Many brand campaigns of late have included a major emotional hook, including a Procter & Gamble campaign from last summer’s Olympics about mothers and their athlete children and a Dove campaign about a forensic sketch artist drawing women based on their own descriptions. “They are trying to humanize the corporate entity,” Mr. Bawa said. “That’s why emotion is so important.”
Emotion was also present at the ad agency table, Mr. Schwartz said. “The smell of the baby powder, the scent of the shampoo, everybody got very emotional just from our meetings,” he said. “This is a very emotional brand, so we’ve got to deliver a very emotional idea.”
via nytimes.com
http://www.nytimes.com/2013/04/25/business/media/trying-to-burnish-its-image-...
Treasure Ireland no more?
Troika tells health chiefs to cut €2bn drug spend
Michael Brennan Deputy Political Editor – 26 April 2013
THE troika has increased the pressure on health chiefs to reduce the €2bn annual drugs bill.
Staff from the European Commission, IMF and European Central Bank raised the issue again with the HSE in Dublin this week.
The troika has consistently complained drug prices are far too high in comparison with other EU countries.
At the Dail's Public Accounts committee, HSE chief operations officer Laverne McGuinness said the troika "were very interested in the potential for further drugs savings".
The committee heard that drug costs account for 17pc of the HSE's €14bn budget – but just 9pc of the budget for the National Health Service in Britain. The troika has ordered a report from the ESRI into the cost of drugs, which is due to be finished shortly.
Labour TD Robert Dowds said it was a "scandal" so much money was wasted on drugs when it that could be used elsewhere in the health service.
He said it was "incredible" a drug for treating schizophrenia cost almost €100 here but €4.10 in Britain.
HSE director general Tony O'Brien said analysis had shown that GPs were more likely to prescribe the dearest rather than the cheapest drug.
"The aim here is to switch prescriber behaviour to the drugs which have equal clinical value but a much lower cost," Mr O'Brien said.
He said the HSE had got a good response from GPs to its new prescriber scheme, which was alerting them to the cheapest and most effective drugs.
Mr O'Brien also confirmed that there were benefits for pharmacists in prescribing the most expensive branded drugs because they would get a higher profit margin from them.
But he said the new reference pricing legislation going through the Dail would have a big impact.
This will ensure that medical card patients can only get the most cost-effective drug – and will have to pay the difference themselves if they want a branded drug.
And pharmacists will have to tell private patients if there is a more cost-effective drug than the one prescribed by their doctor.
http://www.independent.ie/irish-news/troika-tells-health-chiefs-to-cut-2bn-drug-spend-29223111.html
Michael Brennan Deputy Political Editor – 26 April 2013
THE troika has increased the pressure on health chiefs to reduce the €2bn annual drugs bill.
Staff from the European Commission, IMF and European Central Bank raised the issue again with the HSE in Dublin this week.
The troika has consistently complained drug prices are far too high in comparison with other EU countries.
At the Dail's Public Accounts committee, HSE chief operations officer Laverne McGuinness said the troika "were very interested in the potential for further drugs savings".
The committee heard that drug costs account for 17pc of the HSE's €14bn budget – but just 9pc of the budget for the National Health Service in Britain. The troika has ordered a report from the ESRI into the cost of drugs, which is due to be finished shortly.
Labour TD Robert Dowds said it was a "scandal" so much money was wasted on drugs when it that could be used elsewhere in the health service.
He said it was "incredible" a drug for treating schizophrenia cost almost €100 here but €4.10 in Britain.
HSE director general Tony O'Brien said analysis had shown that GPs were more likely to prescribe the dearest rather than the cheapest drug.
"The aim here is to switch prescriber behaviour to the drugs which have equal clinical value but a much lower cost," Mr O'Brien said.
He said the HSE had got a good response from GPs to its new prescriber scheme, which was alerting them to the cheapest and most effective drugs.
Mr O'Brien also confirmed that there were benefits for pharmacists in prescribing the most expensive branded drugs because they would get a higher profit margin from them.
But he said the new reference pricing legislation going through the Dail would have a big impact.
This will ensure that medical card patients can only get the most cost-effective drug – and will have to pay the difference themselves if they want a branded drug.
And pharmacists will have to tell private patients if there is a more cost-effective drug than the one prescribed by their doctor.
http://www.independent.ie/irish-news/troika-tells-health-chiefs-to-cut-2bn-drug-spend-29223111.html
BMJ's Too much medicine campaign
The BMJ's Too Much Medicine campaign aims to highlight the threat to human health posed by overdiagnosis and the waste of resources on unnecessary care.
There is growing evidence that many people are overdiagnosed and overtreated for a wide range of conditions, such as prostate and thyroid cancers, asthma, and chronic kidney disease.
Through the campaign, the journal plans to work with others to increase awareness of the benefits and harms of treatments and technologies and develop ways to wind back medical excess, safely and fairly. This editorial by BMJ editor in chief Fiona Godlee and overdiagnosis researcher Ray Moynihan, senior research fellow at Bond University, Australia, explains more about the campaign:
Dr Godlee said: "Like the evidence based medicine and quality and safety movements of previous decades, combatting excess is a contemporary manifestation of a much older desire to avoid doing harm when we try to help or heal.
"Making such efforts even more necessary are the growing concerns about escalating healthcare spending and the threats to health from climate change. Winding back unnecessary tests and treatments, unhelpful labels and diagnoses won’t only benefit those who directly avoid harm, it can also help us create a more sustainable future."
Next steps
The BMJ is a partner in the forthcoming international scientific conference, Preventing Overdiagnosis, to be held in September 2013 in Hanover, New Hampshire. The conference seeks to bring together the research and the researchers, advance the science of the problem and its solutions, and develop ways to better communicate about this modern epidemic. Registration is now open at www.preventingoverdiagnosis.net
As part of the campaign the BMJ will produce a theme issue in early 2014, featuring the best papers from the conference.
The BMJ and the Consumer Reports journal will launch a series on how the expansion of disease definitions is contributing to overdiagnosis, featuring common conditions including pulmonary embolism, chronic kidney disease and (pre)dementia. Underscoring the need for caution, each article will feature a limitations section, highlighting the caveats accompanying this evolving and complex science.
Your feedback
Share your thoughts on overdiagnosis by responding to this editorial
http://www.bmj.com/too-much-medicine
Doctors Denounce Cancer Drug Prices of $100,000 a Year
With the cost of some lifesaving cancer drugs exceeding $100,000 a year, more than 100 influential cancer specialists from around the world have taken the unusual step of banding together in hopes of persuading some leading pharmaceutical companies to bring prices down.
Prices for cancer drugs have been part of the debate over health care costs for several years — and recently led to a public protest from doctors at a major cancer center in New York. But the decision by so many specialists, from more than 15 countries on five continents, to join the effort is a sign that doctors, who are on the front lines of caring for patients, are now taking a more active role in resisting high prices. In this case, some of the specialists even include researchers with close ties to the pharmaceutical industry.
The doctors and researchers, who specialize in the potentially deadly blood cancer known as chronic myeloid leukemia, contend in a commentary published online by a medical journal Thursday that the prices of drugs used to treat that disease are astronomical, unsustainable and perhaps even immoral.
They suggested that charging high prices for a medicine needed to keep someone alive is profiteering, akin to jacking up the prices of essential goods after a natural disaster.
“Advocating for lower drug prices is a necessity to save the lives of patients” who cannot afford the medicines, they wrote in Blood, the journal of the American Society of Hematology.
While noting that the cost of drugs for many other cancers were just as high, the doctors focused on what they know best — the medicines for chronic myeloid leukemia, like Gleevec, which is enormously profitable for Novartis. Among the critics is Dr. Brian Druker, who was the main academic developer of Gleevec and had to prod Novartis to bring it to market.
Novartis argues that few patients actually pay the full cost of the drug and that prices reflect the high cost of research and the value of a drug to patients.
Gleevec entered the market in 2001 at a price of about $30,000 a year in the United States, the doctors wrote. Since then, the price has tripled, it said, even as Gleevec has faced competition from five newer drugs. And those drugs are even more expensive.
The prices have been the subject of intense debate elsewhere as well. The Supreme Court in India ruled recently that the drug could not be patented, clearing the way for use of far less expensive generic alternatives.
Some of the doctors who signed on to the commentary said they were inspired by physicians at the Memorial Sloan-Kettering Cancer Center in New York, who last fall refused to use a new colon cancer drug, Zaltrap, because it was twice as expensive as another drug without being better.
After those doctors publicized their objections in an Op-Ed article in The New York Times, Sanofi, which markets Zaltrap, effectively cut the price in half.
What impact the new commentary will have remains to be seen. The authors, however, call merely for a dialogue on pricing to begin.
The leader of the protest is Dr. Hagop M. Kantarjian, chairman of the leukemia department at the prestigious MD Anderson Cancer Center in Houston.
Many of the roughly 120 doctors who were co-authors of the commentary — about 30 of whom are from the United States — work closely with pharmaceutical companies on research and clinical trials. They say they favor a healthy pharmaceutical industry, but think prices are much higher than they need to be to ensure that.
“If you are making $3 billion a year on Gleevec, could you get by with $2 billion?” Dr. Druker, who is now director of the Knight Cancer Institute at Oregon Health and Science University, said in an interview. “When do you cross the line from essential profits to profiteering?”
Gleevec’s sales were $4.7 billion in 2012, making it Novartis’s best-selling drug. A newer Novartis leukemia drug, Tasigna, had sales of $1 billion.
Novartis said in a statement released Thursday: “We recognize that sustainability of health care systems is a complex topic and we welcome the opportunity to be part of the dialogue.”
It said that its investment in Gleevec continued after the initial approval, expanding the drug’s use to other diseases. It also said that it provided Gleevec or Tasigna free to 5,000 uninsured or underinsured Americans each year and to date had provided free drugs to more than 50,000 people in low-income countries.
Novartis and the manufacturers of the other drugs for chronic myeloid leukemia say the prices reflect the value of the drug. While many cancer drugs with equally high prices extend life by only a few months on average, it is widely agreed that Gleevec and rivals are near-miracle medicines that essentially turn a death sentence into a chronic disease like diabetes.
“It is a little surprising that their focus is in a cancer where the small-molecule medicines have had the greatest impact on long-term benefit,” said Dr. Harvey J. Berger, chief executive of Ariad Pharmaceuticals, which sells the newest and most expensive of the leukemia drugs, Iclusig.
http://www.nytimes.com/2013/04/26/business/cancer-physicians-attack-high-drug-costs.html?partner=rss&emc=rss&smid=tw-nytimes&_r=0
Prices for cancer drugs have been part of the debate over health care costs for several years — and recently led to a public protest from doctors at a major cancer center in New York. But the decision by so many specialists, from more than 15 countries on five continents, to join the effort is a sign that doctors, who are on the front lines of caring for patients, are now taking a more active role in resisting high prices. In this case, some of the specialists even include researchers with close ties to the pharmaceutical industry.
The doctors and researchers, who specialize in the potentially deadly blood cancer known as chronic myeloid leukemia, contend in a commentary published online by a medical journal Thursday that the prices of drugs used to treat that disease are astronomical, unsustainable and perhaps even immoral.
They suggested that charging high prices for a medicine needed to keep someone alive is profiteering, akin to jacking up the prices of essential goods after a natural disaster.
“Advocating for lower drug prices is a necessity to save the lives of patients” who cannot afford the medicines, they wrote in Blood, the journal of the American Society of Hematology.
While noting that the cost of drugs for many other cancers were just as high, the doctors focused on what they know best — the medicines for chronic myeloid leukemia, like Gleevec, which is enormously profitable for Novartis. Among the critics is Dr. Brian Druker, who was the main academic developer of Gleevec and had to prod Novartis to bring it to market.
Novartis argues that few patients actually pay the full cost of the drug and that prices reflect the high cost of research and the value of a drug to patients.
Gleevec entered the market in 2001 at a price of about $30,000 a year in the United States, the doctors wrote. Since then, the price has tripled, it said, even as Gleevec has faced competition from five newer drugs. And those drugs are even more expensive.
The prices have been the subject of intense debate elsewhere as well. The Supreme Court in India ruled recently that the drug could not be patented, clearing the way for use of far less expensive generic alternatives.
Some of the doctors who signed on to the commentary said they were inspired by physicians at the Memorial Sloan-Kettering Cancer Center in New York, who last fall refused to use a new colon cancer drug, Zaltrap, because it was twice as expensive as another drug without being better.
After those doctors publicized their objections in an Op-Ed article in The New York Times, Sanofi, which markets Zaltrap, effectively cut the price in half.
What impact the new commentary will have remains to be seen. The authors, however, call merely for a dialogue on pricing to begin.
The leader of the protest is Dr. Hagop M. Kantarjian, chairman of the leukemia department at the prestigious MD Anderson Cancer Center in Houston.
Many of the roughly 120 doctors who were co-authors of the commentary — about 30 of whom are from the United States — work closely with pharmaceutical companies on research and clinical trials. They say they favor a healthy pharmaceutical industry, but think prices are much higher than they need to be to ensure that.
“If you are making $3 billion a year on Gleevec, could you get by with $2 billion?” Dr. Druker, who is now director of the Knight Cancer Institute at Oregon Health and Science University, said in an interview. “When do you cross the line from essential profits to profiteering?”
Gleevec’s sales were $4.7 billion in 2012, making it Novartis’s best-selling drug. A newer Novartis leukemia drug, Tasigna, had sales of $1 billion.
Novartis said in a statement released Thursday: “We recognize that sustainability of health care systems is a complex topic and we welcome the opportunity to be part of the dialogue.”
It said that its investment in Gleevec continued after the initial approval, expanding the drug’s use to other diseases. It also said that it provided Gleevec or Tasigna free to 5,000 uninsured or underinsured Americans each year and to date had provided free drugs to more than 50,000 people in low-income countries.
Novartis and the manufacturers of the other drugs for chronic myeloid leukemia say the prices reflect the value of the drug. While many cancer drugs with equally high prices extend life by only a few months on average, it is widely agreed that Gleevec and rivals are near-miracle medicines that essentially turn a death sentence into a chronic disease like diabetes.
“It is a little surprising that their focus is in a cancer where the small-molecule medicines have had the greatest impact on long-term benefit,” said Dr. Harvey J. Berger, chief executive of Ariad Pharmaceuticals, which sells the newest and most expensive of the leukemia drugs, Iclusig.
http://www.nytimes.com/2013/04/26/business/cancer-physicians-attack-high-drug-costs.html?partner=rss&emc=rss&smid=tw-nytimes&_r=0
Do you smoke?
Smoking may be a sign of psychiatric illness, says report, after a third of smokers are found to have a mental disorder - Health News - Health & Families - The Independent
Smoking may be a sign of psychiatric illness, experts say. Doctors should routinely consider referring people who smoke to mental health services, in case they need treatment, they add.
The controversial recommendation from the British Lung Foundation, a charity, comes in response to a major report, Smoking and Mental Health, published this week by the Royal College of Physicians and the Royal College of Psychiatrists with the Faculty of Public Health. It says that almost one in three cigarettes smoked in Britain today is smoked by someone with a mental disorder. When people with drug and alcohol problems are included the proportion is even higher.
The reason is that smoking rates have more than halved over the past 50 years, but the decline has not happened equally in all parts of society.
“Smoking is increasingly becoming the domain of the most disadvantaged: the poor, homeless, imprisoned and those with mental disorder. This is a damning indictment of UK public health policy and clinical service provision,” the report says.
Of the ten million smokers in Britain, up to three million have a mental disorder, up to two million have been prescribed a psychoactive drug in the past year and approaching one million have longstanding [mental] disease, it says.
While smoking rates among the general public have fallen dramatically, from 56 per cent in men and 42 per cent in women in the early 1960s to 21 per cent in both sexes today, they have hardly changed among people with mental disorders and remain at over 40 per cent.
Professor Stephen Spiro, deputy chair of the British Lung Foundation, said persuading people with mental disorders to give up smoking was a major challenge. But so was identifying smokers who might need psychiatric treatment.
“Routinely considering whether someone presenting with a lung disease, or indeed any patient who smokes, might benefit from referral to mental health services, could make the key difference for many individuals,” Professor Spiro said.
Smoking increases with the severity of mental disorder, and amongst those with a psychotic illness almost all smoke. Nicotine appears to provide some relief from symptoms of anxiety, depression and attention deficit hyperactivity disorder which may explain why people with these conditions become smokers.
http://www.independent.co.uk/life-style/health-and-families/health-news/smoking-may-be-a-sign-of-psychiatric-illness-says-report-after-a-third-of-smokers-are-found-to-have-a-mental-disorder-8554009.html
Smoking may be a sign of psychiatric illness, experts say. Doctors should routinely consider referring people who smoke to mental health services, in case they need treatment, they add.
The controversial recommendation from the British Lung Foundation, a charity, comes in response to a major report, Smoking and Mental Health, published this week by the Royal College of Physicians and the Royal College of Psychiatrists with the Faculty of Public Health. It says that almost one in three cigarettes smoked in Britain today is smoked by someone with a mental disorder. When people with drug and alcohol problems are included the proportion is even higher.
The reason is that smoking rates have more than halved over the past 50 years, but the decline has not happened equally in all parts of society.
“Smoking is increasingly becoming the domain of the most disadvantaged: the poor, homeless, imprisoned and those with mental disorder. This is a damning indictment of UK public health policy and clinical service provision,” the report says.
Of the ten million smokers in Britain, up to three million have a mental disorder, up to two million have been prescribed a psychoactive drug in the past year and approaching one million have longstanding [mental] disease, it says.
While smoking rates among the general public have fallen dramatically, from 56 per cent in men and 42 per cent in women in the early 1960s to 21 per cent in both sexes today, they have hardly changed among people with mental disorders and remain at over 40 per cent.
Professor Stephen Spiro, deputy chair of the British Lung Foundation, said persuading people with mental disorders to give up smoking was a major challenge. But so was identifying smokers who might need psychiatric treatment.
“Routinely considering whether someone presenting with a lung disease, or indeed any patient who smokes, might benefit from referral to mental health services, could make the key difference for many individuals,” Professor Spiro said.
Smoking increases with the severity of mental disorder, and amongst those with a psychotic illness almost all smoke. Nicotine appears to provide some relief from symptoms of anxiety, depression and attention deficit hyperactivity disorder which may explain why people with these conditions become smokers.
http://www.independent.co.uk/life-style/health-and-families/health-news/smoking-may-be-a-sign-of-psychiatric-illness-says-report-after-a-third-of-smokers-are-found-to-have-a-mental-disorder-8554009.html
Thursday, April 25, 2013
AstraZeneca UK plant under US investigation
Macclesfield’s AstraZeneca plant is being investigated by US authorities, it emerged today.
The pharmaceutical giant issued a terse statement alongside its first quarter trading results.
The company said it had received a subpoena from the US Attorney’s Office in Boston, Massachusetts seeking documents and records related to “manufacturing, quality or good manufacturing practices at its Macclesfield facility”.
It added: “AstraZeneca is coordinating its response to the subpoena and intends to cooperate with the inquiry.”
The company recently announced the downsizing of its facility at Alderley Edge, moving most of the research work to Cambridge.
Drug reps. The sinister side-effects of drug marketing By Alan Cassels
It sometimes takes a long time to discover environmental hazards, and even longer to do something about them once discovered.
Second-hand smoke, leaded gasoline and asbestos were all deemed bad for our health many years ago, yet the lag between discovering those hazards and doing something to eliminate them covered many years and cost many lives.
This week a study concerning the world of prescription drug information identified a new and potentially deadly hazard: the pharmaceutical sales rep visit. This study, published in the Journal of General Internal Medicine and carried out by researchers in Canada, the U.S. and France, asked the question: When a drug sales rep has a private one-to-one conversation with a doctor, what kind of drug information does the physician actually receive?
If you’ve ever seen the well-dressed men and women with iPads and nice shoes in your doctor’s waiting room, you’ll know what a drug sales rep looks like. Working on behalf of pharmaceutical companies, they visit our doctors on an individual basis, dropping off free samples of medications, talking up the company’s products and otherwise schmoozing our physicians, often promoting the newest and most expensive medicines.
The study found that in nearly 60 per cent of promotional visits, sales representatives failed to provide any information about common or serious side-effects of the promoted drug, and also failed to inform doctors about the types of patients who should not use the medicine.
In Vancouver and Montreal, two-thirds of the promotional visits involved absolutely no mention of a drug’s potential harmful effects.
Probably most worrisome is that across all three countries, serious drug harms were mentioned in only six per cent of the promotions, even though more than half of the medications being promoted in these office visits were drugs that came with U.S. Food and Drug Administration ‘black box’ or Health Canada boxed warnings — ones that are reserved only for the most serious and potentially fatal drugs.
Barbara Mintzes, an expert in drug advertising at the University of British Columbia and a co-author of the study, said she’s concerned that such a situation leaves doctors and patients in the dark and can seriously jeopardize patient safety. Despite laws in all three countries requiring sales representatives to provide information on the potential harms as well as the benefits of drugs, she says, “no one is monitoring these visits and there are next to no sanctions for misleading or inaccurate promotion.”
The study reinforces the conclusions of a recently published systematic review of a wide body of international research showing that physicians who are exposed to more drug-company-sponsored information tend to prescribe costlier drugs and more drugs in total, and have lower-quality prescribing practices.
This earlier study examined all the research in the area and failed to find net improvements in prescribing practices resulting from drug-company visits. Instead, they recommend that physicians “follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies.”
This might be the take-home message from the new three-country study as well. All medicines can harm as well as help; doctors need to know about both effects. Incomplete information on a drug’s safety is likely to lead to harm, akin to an environmental toxin.
So, now the real question is: How long will it take before public authorities determine people are being harmed? And what regulations will they put in place to make sure our physicians receive balanced information about the benefits and harms of our pharmaceutical drugs?
http://www.ipolitics.ca/2013/04/22/how-drug-marketing-can-be-bad-for-your-health/
Second-hand smoke, leaded gasoline and asbestos were all deemed bad for our health many years ago, yet the lag between discovering those hazards and doing something to eliminate them covered many years and cost many lives.
This week a study concerning the world of prescription drug information identified a new and potentially deadly hazard: the pharmaceutical sales rep visit. This study, published in the Journal of General Internal Medicine and carried out by researchers in Canada, the U.S. and France, asked the question: When a drug sales rep has a private one-to-one conversation with a doctor, what kind of drug information does the physician actually receive?
If you’ve ever seen the well-dressed men and women with iPads and nice shoes in your doctor’s waiting room, you’ll know what a drug sales rep looks like. Working on behalf of pharmaceutical companies, they visit our doctors on an individual basis, dropping off free samples of medications, talking up the company’s products and otherwise schmoozing our physicians, often promoting the newest and most expensive medicines.
The study found that in nearly 60 per cent of promotional visits, sales representatives failed to provide any information about common or serious side-effects of the promoted drug, and also failed to inform doctors about the types of patients who should not use the medicine.
In Vancouver and Montreal, two-thirds of the promotional visits involved absolutely no mention of a drug’s potential harmful effects.
Probably most worrisome is that across all three countries, serious drug harms were mentioned in only six per cent of the promotions, even though more than half of the medications being promoted in these office visits were drugs that came with U.S. Food and Drug Administration ‘black box’ or Health Canada boxed warnings — ones that are reserved only for the most serious and potentially fatal drugs.
Barbara Mintzes, an expert in drug advertising at the University of British Columbia and a co-author of the study, said she’s concerned that such a situation leaves doctors and patients in the dark and can seriously jeopardize patient safety. Despite laws in all three countries requiring sales representatives to provide information on the potential harms as well as the benefits of drugs, she says, “no one is monitoring these visits and there are next to no sanctions for misleading or inaccurate promotion.”
The study reinforces the conclusions of a recently published systematic review of a wide body of international research showing that physicians who are exposed to more drug-company-sponsored information tend to prescribe costlier drugs and more drugs in total, and have lower-quality prescribing practices.
This earlier study examined all the research in the area and failed to find net improvements in prescribing practices resulting from drug-company visits. Instead, they recommend that physicians “follow the precautionary principle and thus avoid exposure to information from pharmaceutical companies.”
This might be the take-home message from the new three-country study as well. All medicines can harm as well as help; doctors need to know about both effects. Incomplete information on a drug’s safety is likely to lead to harm, akin to an environmental toxin.
So, now the real question is: How long will it take before public authorities determine people are being harmed? And what regulations will they put in place to make sure our physicians receive balanced information about the benefits and harms of our pharmaceutical drugs?
http://www.ipolitics.ca/2013/04/22/how-drug-marketing-can-be-bad-for-your-health/
Wednesday, April 24, 2013
Pharmed Out's conference. "Medical Behavior in a Commercial World: Who Is Responsible?", June 6-7, 2013 at Georgetown University.
Pharmed Out's highly-acclaimed annual CME conference. "Medical Behavior in a Commercial World: Who Is Responsible?", will be held on June 6-7, 2013 at Georgetown University.
This year, we will explore the ethical responsibilities of health care providers, medical journals, industry and payers on therapeutic choices, and the public health implications of pharmaceutical and medical device marketing. We will have a surprise guest: a former pharmaceutical executive from a top 5 company who will be discussing ethical conflicts inside the industry.
Our all-star lineup also includes:
- Marcia Angell MD, author of The Truth About Drug Companies: How They Deceive Us and What to Do About It; former editor-in-chief, NEJM
- Virginia Barbour MD, chief editor, PLoS Medicine
- Elizabeth Loder MD, editor, BMJ
- Carl Elliott MD PhD, author of White Coat, Black Hat: Adventures on the Dark Side of Medicine and Better Than Well
- Charlie Ornstein, Senior Editor, ProPublica
- Diana Zuckerman PhD, president of the National Research Center for Women and Families
- Daniel Carlat MD, director of the Pew Prescription Project
- A ghostwriter describing how he helped sell Low Testosterone Syndrome (?Low-T?)
It's a wonderful, interdisciplinary, international conference that receives no industry funding and provides up to 9.5 CME credits. The agenda and flyers for posting are available at http://pharmedout.org/2013Conference.htm.
This year, we will explore the ethical responsibilities of health care providers, medical journals, industry and payers on therapeutic choices, and the public health implications of pharmaceutical and medical device marketing. We will have a surprise guest: a former pharmaceutical executive from a top 5 company who will be discussing ethical conflicts inside the industry.
Our all-star lineup also includes:
- Marcia Angell MD, author of The Truth About Drug Companies: How They Deceive Us and What to Do About It; former editor-in-chief, NEJM
- Virginia Barbour MD, chief editor, PLoS Medicine
- Elizabeth Loder MD, editor, BMJ
- Carl Elliott MD PhD, author of White Coat, Black Hat: Adventures on the Dark Side of Medicine and Better Than Well
- Charlie Ornstein, Senior Editor, ProPublica
- Diana Zuckerman PhD, president of the National Research Center for Women and Families
- Daniel Carlat MD, director of the Pew Prescription Project
- A ghostwriter describing how he helped sell Low Testosterone Syndrome (?Low-T?)
It's a wonderful, interdisciplinary, international conference that receives no industry funding and provides up to 9.5 CME credits. The agenda and flyers for posting are available at http://pharmedout.org/2013Conference.htm.
Registration is here:https://secure.alumni.georgetown.edu/olc/pub/GTW/event/showEventForm.jsp?form_id=146269.
Contact Nicole Dubowitz atnzd2@georgetown.edu or (202) 687-7845 with questions.
Adriane Fugh-Berman MD
Associate Professor
Department of Pharmacology and Physiology
Georgetown University Medical Center
(202) 687-7845 or (202) 687-1191
ajf29@georgetown.edu
nzd2@georgetown.edu
Associate Professor
Department of Pharmacology and Physiology
Georgetown University Medical Center
(202) 687-7845 or (202) 687-1191
ajf29@georgetown.edu
nzd2@georgetown.edu
When is a rebate a kickback?
Manhattan U.S. Attorney Files Healthcare Fraud Lawsuit Against Novartis Pharmaceuticals Corp. For Orchestrating A Multi-Million Dollar Prescription Drug Kickback Scheme
Tuesday, April 23, 2013
Suit Alleges Novartis Induced Pharmacies to Switch Thousands of Transplant Patients to One of Its Drugs with Kickbacks Disguised as Rebates and Discounts, Resulting in Medicare and Medicaid Paying Tens of Millions of Dollars in Kickback-Tainted Reimbursements
Preet Bharara, the United States Attorney for the Southern District of New York, and Ronald T. Hosko, the Assistant Director of the Federal Bureau of Investigation, Criminal Investigative Division (“FBI”), announced today that the United States has filed a civil healthcare fraud lawsuit against NOVARTIS PHARMACEUTICALS CORP. (“NOVARTIS”). The Government’s Complaint seeks treble damages and civil penalties under the False Claims Act against Novartis for giving kickbacks, in the form of rebates and discounts, to 20 or more pharmacies in exchange for their switching transplant patients from competitor drugs to NOVARTIS’s drug, Myfortic. The lawsuit alleges that, as a result of NOVARTIS’s kickback scheme, Medicare and Medicaid have issued tens of millions of dollars in reimbursements based on false, kickback-tainted claims.
Manhattan U.S. Attorney Preet Bharara said: “As alleged, using the lure of kickbacks disguised as rebates, Novartis co-opted the independence of certain pharmacists and turned them into salespeople for one of its drugs. And by allegedly hiding this illegal quid pro quo from physicians, patients, and federal healthcare programs, Novartis caused the public to pay tens of millions of dollars for kickback-tainted drugs that were dispensed by pharmacists who were in cahoots with the company. Novartis, as we allege, is a repeat offender, having settled healthcare fraud charges based on kickbacks less than three years ago.”
FBI Assistant Director Ronald T. Hosko said: “The FBI takes these allegations very seriously because of the potential impact to the nation’s healthcare system and to the public. These cases are one of the highest priorities of the FBI’s health care fraud program. We have established a centralized unit called the Major Provider Response Team to provide nationwide investigative assistance given the complexity of such investigations.”
The following allegations are based on the Complaint filed today in Manhattan federal court:
NOVARTIS markets and manufactures Myfortic, an immunosuppressant drug approved for use by patients who have undergone kidney transplants. NOVARTIS markets Myfortic to hospital centers and pharmacies that serve these transplant patients. Since 2005, NOVARTIS has orchestrated a scheme whereby it offered kickbacks, disguised as “performance” rebates and discounts, to 20 or more pharmacies with influence over prescription decisions. In exchange, those pharmacies committed to use that influence to “convert” (i.e., switch) patients to Myfortic from competitor drugs and/or to oppose the use of a cheaper, generic immunosuppressant drug.
In one case, according to a NOVARTIS manager, NOVARTIS offered a pharmacist in Los Angeles a “bonus” rebate equal to 5% of that pharmacist’s annual Myfortic sales, amounting to several hundred thousand dollars, to induce the pharmacist to “shoulder the burden” of switching 700 to 1,000 transplant patients to Myfortic. NOVARTIS found that it was highly profitable to pay pharmacies even 10% or 20% in kickbacks in exchange for switching transplant patients to Myfortic because, in the words of a Novartis manager, the “short term cost” bought NOVARTIS “a long term annuity.”
In an effort to actively conceal the quid pro quo, NOVARTIS documented its relationships with the pharmacies in rebate and discount contracts that omitted the agreements between NOVARTIS and the pharmacies to switch patients to Myfortic or keep them from switching to competitor drugs. For example, in discussing a potential kickback relationship with a national pharmacy, NOVARTIS and the pharmacy recognized that, although a basic objective of that relationship was the “conversion” of patients to Myfortic, NOVARTIS “cannot put this in writing.” Further, the pharmacies hid the financial benefits they stood to gain from physicians, patients, and the federal healthcare programs, and instead, presented their efforts to switch patients to Myfortic as unbiased professional judgments.
NOVARTIS’s kickback scheme violated the federal anti-kickback statute, which prohibits the offer or payment of rebates and other types of remuneration to induce the purchase or recommendation of any drug or service covered by Medicare, Medicaid, or another federal healthcare program. By orchestrating this scheme, NOVARTIS further caused the pharmacies to submit tens of thousands of claims to Medicare and Medicaid, resulting in those programs paying out tens of millions of dollars in reimbursements based on false claims tainted by kickbacks.
* * *
The Complaint seeks treble damages and penalties under the False Claims Act, 31 U.S.C. §§ 3729 et seq., for the tens of millions of dollars in reimbursements that Medicare and Medicaid paid for Myfortic shipments that resulted from NOVARTIS’s kickback scheme. In addition, the United States seeks compensatory damages under the common law theory of unjust enrichment for the tens of millions of dollars in profits that NOVARTIS has obtained as result of Medicare and Medicaid reimbursements for Myfortic.
Mr. Bharara praised the investigative work of the FBI’s Major Provider Response Team. He also thanked the Office of Inspector General at the U.S. Department of Health and Human Services and the Commercial Litigation Branch of the U.S. Department of Justice’s Civil Division in Washington D.C., for their extraordinary assistance in this case.
The case is being handled by the Office’s Civil Frauds Unit. Mr. Bharara established the Civil Frauds Unit in March 2010 to bring renewed focus and additional resources to combating healthcare and other types of frauds. Assistant U.S. Attorneys Li Yu, Ellen M. London, and Rebecca C. Martin are in charge of the case.
13-145
U.S. v. Novartis Pharmaceuticals Corporation - Complaint in Intervention (11 Civ 8196)
http://www.justice.gov/usao/nys/pressreleases/April13/NovartisLawsuitPR.php
Tuesday, April 23, 2013
Suit Alleges Novartis Induced Pharmacies to Switch Thousands of Transplant Patients to One of Its Drugs with Kickbacks Disguised as Rebates and Discounts, Resulting in Medicare and Medicaid Paying Tens of Millions of Dollars in Kickback-Tainted Reimbursements
Preet Bharara, the United States Attorney for the Southern District of New York, and Ronald T. Hosko, the Assistant Director of the Federal Bureau of Investigation, Criminal Investigative Division (“FBI”), announced today that the United States has filed a civil healthcare fraud lawsuit against NOVARTIS PHARMACEUTICALS CORP. (“NOVARTIS”). The Government’s Complaint seeks treble damages and civil penalties under the False Claims Act against Novartis for giving kickbacks, in the form of rebates and discounts, to 20 or more pharmacies in exchange for their switching transplant patients from competitor drugs to NOVARTIS’s drug, Myfortic. The lawsuit alleges that, as a result of NOVARTIS’s kickback scheme, Medicare and Medicaid have issued tens of millions of dollars in reimbursements based on false, kickback-tainted claims.
Manhattan U.S. Attorney Preet Bharara said: “As alleged, using the lure of kickbacks disguised as rebates, Novartis co-opted the independence of certain pharmacists and turned them into salespeople for one of its drugs. And by allegedly hiding this illegal quid pro quo from physicians, patients, and federal healthcare programs, Novartis caused the public to pay tens of millions of dollars for kickback-tainted drugs that were dispensed by pharmacists who were in cahoots with the company. Novartis, as we allege, is a repeat offender, having settled healthcare fraud charges based on kickbacks less than three years ago.”
FBI Assistant Director Ronald T. Hosko said: “The FBI takes these allegations very seriously because of the potential impact to the nation’s healthcare system and to the public. These cases are one of the highest priorities of the FBI’s health care fraud program. We have established a centralized unit called the Major Provider Response Team to provide nationwide investigative assistance given the complexity of such investigations.”
The following allegations are based on the Complaint filed today in Manhattan federal court:
NOVARTIS markets and manufactures Myfortic, an immunosuppressant drug approved for use by patients who have undergone kidney transplants. NOVARTIS markets Myfortic to hospital centers and pharmacies that serve these transplant patients. Since 2005, NOVARTIS has orchestrated a scheme whereby it offered kickbacks, disguised as “performance” rebates and discounts, to 20 or more pharmacies with influence over prescription decisions. In exchange, those pharmacies committed to use that influence to “convert” (i.e., switch) patients to Myfortic from competitor drugs and/or to oppose the use of a cheaper, generic immunosuppressant drug.
In one case, according to a NOVARTIS manager, NOVARTIS offered a pharmacist in Los Angeles a “bonus” rebate equal to 5% of that pharmacist’s annual Myfortic sales, amounting to several hundred thousand dollars, to induce the pharmacist to “shoulder the burden” of switching 700 to 1,000 transplant patients to Myfortic. NOVARTIS found that it was highly profitable to pay pharmacies even 10% or 20% in kickbacks in exchange for switching transplant patients to Myfortic because, in the words of a Novartis manager, the “short term cost” bought NOVARTIS “a long term annuity.”
In an effort to actively conceal the quid pro quo, NOVARTIS documented its relationships with the pharmacies in rebate and discount contracts that omitted the agreements between NOVARTIS and the pharmacies to switch patients to Myfortic or keep them from switching to competitor drugs. For example, in discussing a potential kickback relationship with a national pharmacy, NOVARTIS and the pharmacy recognized that, although a basic objective of that relationship was the “conversion” of patients to Myfortic, NOVARTIS “cannot put this in writing.” Further, the pharmacies hid the financial benefits they stood to gain from physicians, patients, and the federal healthcare programs, and instead, presented their efforts to switch patients to Myfortic as unbiased professional judgments.
NOVARTIS’s kickback scheme violated the federal anti-kickback statute, which prohibits the offer or payment of rebates and other types of remuneration to induce the purchase or recommendation of any drug or service covered by Medicare, Medicaid, or another federal healthcare program. By orchestrating this scheme, NOVARTIS further caused the pharmacies to submit tens of thousands of claims to Medicare and Medicaid, resulting in those programs paying out tens of millions of dollars in reimbursements based on false claims tainted by kickbacks.
* * *
The Complaint seeks treble damages and penalties under the False Claims Act, 31 U.S.C. §§ 3729 et seq., for the tens of millions of dollars in reimbursements that Medicare and Medicaid paid for Myfortic shipments that resulted from NOVARTIS’s kickback scheme. In addition, the United States seeks compensatory damages under the common law theory of unjust enrichment for the tens of millions of dollars in profits that NOVARTIS has obtained as result of Medicare and Medicaid reimbursements for Myfortic.
Mr. Bharara praised the investigative work of the FBI’s Major Provider Response Team. He also thanked the Office of Inspector General at the U.S. Department of Health and Human Services and the Commercial Litigation Branch of the U.S. Department of Justice’s Civil Division in Washington D.C., for their extraordinary assistance in this case.
The case is being handled by the Office’s Civil Frauds Unit. Mr. Bharara established the Civil Frauds Unit in March 2010 to bring renewed focus and additional resources to combating healthcare and other types of frauds. Assistant U.S. Attorneys Li Yu, Ellen M. London, and Rebecca C. Martin are in charge of the case.
13-145
U.S. v. Novartis Pharmaceuticals Corporation - Complaint in Intervention (11 Civ 8196)
http://www.justice.gov/usao/nys/pressreleases/April13/NovartisLawsuitPR.php
Which Big Pharma is the only drug company in this list?
Hint - look at number 15.
http://www.forbes.com/pictures/mef45kghl/which-corporations-pay-the-highest-taxes/
http://www.forbes.com/pictures/mef45kghl/which-corporations-pay-the-highest-taxes/
Tuesday, April 23, 2013
"Treasure" Ireland launches first "preferred drugs" list
Ireland has launched the country's first "preferred drugs" list, which identifies lansoprazole as the preferred proton pump inhibitor (PPI) and simvastatin as the preferred statin.
Products for the country's first-ever preferred drug initiative have been selected by Health Service Executive (HSE)'s recently-established Medicines Management Programme. The HSE says it is asking doctors to prescription lansoprazole (Takeda's Zoton FasTab) and simvastatin (Merck & Co's Zocor) in order to save money, both for patients who pay for their medications and to deliver savings of an estimated 15 million euros for the taxpayer.
PPIs and statins account for up to 15% of the HSE's drug budget, which is forecast to rise to 2 billion euros this year if no action is taken to curb spending. "By changing existing patients to the preferred drug, and by prescribing these drugs for new patients, significant savings can be achieved," says the Executive.
It estimates that if 50% of all PPI prescriptions were written for lansoprazole instead of the other PPIs on the market, the HSE would save in the region of 7.5 million euros on the drugs budget in 2013, while by switching just 25% of all prescribed statins to simvastatin, it could make savings of around 8 million euros.
Patients who do not have a medical card and purchase their drugs privately could save more than 300 euros a year if they switched to the preferred drugs, says the HSE, and it advises patients to discuss their suitability for changing to the preferred drug with their doctor.
At present, there are five PPIs on the market in Ireland. Following a review of these products, the MMP has reported that they differ significantly in price but little in terms of efficacy. Switching to lansoprazole from a more expensive PPI would result in a saving of more than 300 euros per annum per individual, it says.
There are also current five statins on the Irish market, and these products again can vary significantly in terms of price. Patients who do not have a medical card and who pay for their medicines, and who are suitable for treatment using the preferred drug, could make savings in the region of 130 euros per annum by switching to simvastatin, it adds.
"Using the preferred drugs identified by the Medicines Management Programme makes sense for the patient, prescriber and the taxpayer," commented Professor Michael Barry, clinical lead for the Programme, which is aiming to secure savings totalling 20 million euros this year. The HSE emphasises that savings achieved in this way do not impact on the provision of front-line healthcare services.
According to Prof Barry, the vast majority of patients should have no problem switching to the preferred drugs, and he added that 80% of people currently taking PPIs are on doses which are too high.
The Executive also points out that last year its drugs budget exceeded 1.7 billion euros under the Community Drugs Schemes (CDS), and that this represents a greater than five-fold increase over the past decade. "Against this background, it is essential to ensure that the prescribing of medicines is safe, effective and cost-effective," it says.
http://www.pharmatimes.com/Article/13-04-22/Ireland_launches_first_preferred_drugs_list.aspx?
Monday, April 22, 2013
Is LaMattina pitching for Castellani's job?
An Open Letter To The PhRMA CEO On Pharma's Image
I, like many others, am very concerned about the poor image of the pharmaceutical industry. This open letter to PhRMA CEO, Mr. John Castellani, expresses these concerns and offers suggestions on how to improve things. Here’s what I have to express:
Dear Mr. Castellani:
We have never met, but I am a veteran of big pharma. I spent 30 years at Pfizer PFE +1.54% in the R&D part of the organization. Since leaving Pfizer, I have spent a good deal of time defending the pharmaceutical industry, having written a couple of books and by writing the occasional piece for Forbes.com. Given my background, I am at times dismissed as a big pharma shill by those who have negative views of pharma. But I can deal with that. Not many have had the chance to see the good that this industry does.
The negative public opinion that exists with regard to the pharmaceutical industry is sad and depressing. I personally experienced this negativity when I was on The Dr. Oz Show with industry critic, Dr. John Abramson. The audience clearly took as gospel all that Drs. Oz and Abramson said. I wasn’t shocked by this. However, I was stunned by how little credence the audience gave to my examples of the value that pharma brings. Their view was that, based on my experience, I couldn’t be trusted.
I shouldn’t have been totally surprised by the reception that I’ve gotten. The pharmaceutical industry has fallen pretty far from the public esteem it once enjoyed. I often get a surprised reaction when I talk of how pharma companies were routinely listed among the world’s most admired. I realize that you have been trying to restore pharma to those better days. However, what you’re doing doesn’t appear to be working. For example, you periodically put out press releases about PhRMA member pipelines and the impressive number of compounds in clinical development. The most recent one showed that there are over “400 innovative medicines in development for top chronic diseases affecting older Americans”. Now, you and I appreciate the hard work that has gone into the discovery of these compounds and the hopes that PhRMA companies have that these compounds will become important medicines. The problem is that this press release is meaningless to the general population. First of all, we both know that 80% of these won’t make it to patients due to the well-known pitfalls of drug development. So, while PhRMA can offer hope, it can’t guarantee that patients with these chronic diseases will soon have a treatment that will help them.
But the bigger issue is that, even for those compounds that become drugs, patients still won’t give PhRMA credit for discovering and developing them. Unfortunately, the general public believes that the real science involved in drug R&D is done by the NIH and academic institutions. They think that pharma companies simply manufacture these drugs and then charge exorbitant prices for them. You need to put more of a human face on the R&D process. So, here’s a thought for you. The FDA has approved more than 70 drugs over the last two years. Many of these are important and valued new medicines. Why not put together a group of PhRMA scientists who were key members of the teams that produced these drugs? Then, pair them up with patients who have personally benefited from these breakthroughs and ask that they give talks or meet with the media in cities throughout the U.S. I have found that, while many members of the pharma industry are viewed with skepticism, scientists still have a good deal of credibility. In addition, it is impossible not to be moved by patients whose lives have been changed by a new drug.
My next thought stems from a recent experience I had involving Dr. Ben Goldacre, author of Bad Pharma. I recently heard Goldacre speak at the New York City Skeptics Society. He proved to be quite engaging. The overflow crowd heard him expound on key themes from his book, particularly his strident view that the pharmaceutical industry hides negative clinical data. The audience hung on his every word and, as evidenced by the Q&A session afterwards, people were outraged at our industry as it was portrayed by Goldacre.
Goldacre isn’t the only one hammering pharma on the issue of clinical trial transparency. The British Medical Journal has also been critical and both cite data that the industry has only reported clinical trial study results for 22% of studies within one year of the trial’s completion. This is not a simple issue. It involves not only the release of clinical trial results but also access to patient-level trial data. In confronting this charge, PhRMA stated that:
“[Demands] to release patient-level clinical trial data are irresponsible with potentially harmful consequences for future medicine development. The recommendations would jeopardize patient privacy and could serve as a deterrent to individuals considering participation in trials.”
Unfortunately, the validity of this claim must be questioned as one of PhRMA’s own members, GlaxoSmithKline (GSK), has already agreed to make these data available. Surely, GSK must believe that it can successfully operate in such a transparent environment.
Thus, here are two steps that you should take. All PhRMA members need to replicate GSK’s position. In addition, it would be powerful if you could stand up and say that PhRMA commits to 100% reporting of clinical trial results by 2015. This would require extra resources expended by your member companies to meet these goals. However, doing this would eliminate claims that the industry is hiding negative clinical trial data – a major issue that PhRMA faces in the eyes of the public.
Finally, another hot button that exists is around payments to physicians. Now, you and I know the important role that physicians play across the entire spectrum of the pharmaceutical business. Physicians are invaluable in terms of offering advice on clinical trials, leading these trials, publishing and discussing the results, etc. Doctors justifiably expect to be paid for this work. While these payments had long been hidden, the recently enacted “Sunshine Act” will require disclosure of all physician-pharmaceutical industry ties. Such data will be eye-opening to the public. I believe that the vast majority of these payments are justified. But it would behoove PhRMA to look at those costs with the view to how they would be perceived. It’s one thing for a physician to receive a large amount of funding to run a clinical trial. However, an all expenses paid trip for a physician and family to attend a conference in an exotic location for the purpose of hearing about a new drug won’t be well perceived. Medical education is important. But it would be great for PhRMA members to adopt a policy that would minimize the trips and trinkets and focus more on the science and content of such meetings.
I believe that the greatest challenge that the pharmaceutical industry now faces is overcoming its poor image. There are millions of people who believe that real innovation is done outside of pharma labs, that the industry hides any negative clinical trial data, and that the industry pays off doctors to prescribe drugs. You and I know this is all not true. However, unless these beliefs are changed, people will view our products as overpriced drugs with little potential benefit and with hidden safety issues. My suggestions are not a panacea, but they are a step in the right direction.
Sincerely,
John L. LaMattina
http://www.forbes.com/sites/johnlamattina/2013/04/20/an-open-letter-to-the-phrma-ceo-on-pharmas-image/
I, like many others, am very concerned about the poor image of the pharmaceutical industry. This open letter to PhRMA CEO, Mr. John Castellani, expresses these concerns and offers suggestions on how to improve things. Here’s what I have to express:
Dear Mr. Castellani:
We have never met, but I am a veteran of big pharma. I spent 30 years at Pfizer PFE +1.54% in the R&D part of the organization. Since leaving Pfizer, I have spent a good deal of time defending the pharmaceutical industry, having written a couple of books and by writing the occasional piece for Forbes.com. Given my background, I am at times dismissed as a big pharma shill by those who have negative views of pharma. But I can deal with that. Not many have had the chance to see the good that this industry does.
The negative public opinion that exists with regard to the pharmaceutical industry is sad and depressing. I personally experienced this negativity when I was on The Dr. Oz Show with industry critic, Dr. John Abramson. The audience clearly took as gospel all that Drs. Oz and Abramson said. I wasn’t shocked by this. However, I was stunned by how little credence the audience gave to my examples of the value that pharma brings. Their view was that, based on my experience, I couldn’t be trusted.
I shouldn’t have been totally surprised by the reception that I’ve gotten. The pharmaceutical industry has fallen pretty far from the public esteem it once enjoyed. I often get a surprised reaction when I talk of how pharma companies were routinely listed among the world’s most admired. I realize that you have been trying to restore pharma to those better days. However, what you’re doing doesn’t appear to be working. For example, you periodically put out press releases about PhRMA member pipelines and the impressive number of compounds in clinical development. The most recent one showed that there are over “400 innovative medicines in development for top chronic diseases affecting older Americans”. Now, you and I appreciate the hard work that has gone into the discovery of these compounds and the hopes that PhRMA companies have that these compounds will become important medicines. The problem is that this press release is meaningless to the general population. First of all, we both know that 80% of these won’t make it to patients due to the well-known pitfalls of drug development. So, while PhRMA can offer hope, it can’t guarantee that patients with these chronic diseases will soon have a treatment that will help them.
But the bigger issue is that, even for those compounds that become drugs, patients still won’t give PhRMA credit for discovering and developing them. Unfortunately, the general public believes that the real science involved in drug R&D is done by the NIH and academic institutions. They think that pharma companies simply manufacture these drugs and then charge exorbitant prices for them. You need to put more of a human face on the R&D process. So, here’s a thought for you. The FDA has approved more than 70 drugs over the last two years. Many of these are important and valued new medicines. Why not put together a group of PhRMA scientists who were key members of the teams that produced these drugs? Then, pair them up with patients who have personally benefited from these breakthroughs and ask that they give talks or meet with the media in cities throughout the U.S. I have found that, while many members of the pharma industry are viewed with skepticism, scientists still have a good deal of credibility. In addition, it is impossible not to be moved by patients whose lives have been changed by a new drug.
My next thought stems from a recent experience I had involving Dr. Ben Goldacre, author of Bad Pharma. I recently heard Goldacre speak at the New York City Skeptics Society. He proved to be quite engaging. The overflow crowd heard him expound on key themes from his book, particularly his strident view that the pharmaceutical industry hides negative clinical data. The audience hung on his every word and, as evidenced by the Q&A session afterwards, people were outraged at our industry as it was portrayed by Goldacre.
Goldacre isn’t the only one hammering pharma on the issue of clinical trial transparency. The British Medical Journal has also been critical and both cite data that the industry has only reported clinical trial study results for 22% of studies within one year of the trial’s completion. This is not a simple issue. It involves not only the release of clinical trial results but also access to patient-level trial data. In confronting this charge, PhRMA stated that:
“[Demands] to release patient-level clinical trial data are irresponsible with potentially harmful consequences for future medicine development. The recommendations would jeopardize patient privacy and could serve as a deterrent to individuals considering participation in trials.”
Unfortunately, the validity of this claim must be questioned as one of PhRMA’s own members, GlaxoSmithKline (GSK), has already agreed to make these data available. Surely, GSK must believe that it can successfully operate in such a transparent environment.
Thus, here are two steps that you should take. All PhRMA members need to replicate GSK’s position. In addition, it would be powerful if you could stand up and say that PhRMA commits to 100% reporting of clinical trial results by 2015. This would require extra resources expended by your member companies to meet these goals. However, doing this would eliminate claims that the industry is hiding negative clinical trial data – a major issue that PhRMA faces in the eyes of the public.
Finally, another hot button that exists is around payments to physicians. Now, you and I know the important role that physicians play across the entire spectrum of the pharmaceutical business. Physicians are invaluable in terms of offering advice on clinical trials, leading these trials, publishing and discussing the results, etc. Doctors justifiably expect to be paid for this work. While these payments had long been hidden, the recently enacted “Sunshine Act” will require disclosure of all physician-pharmaceutical industry ties. Such data will be eye-opening to the public. I believe that the vast majority of these payments are justified. But it would behoove PhRMA to look at those costs with the view to how they would be perceived. It’s one thing for a physician to receive a large amount of funding to run a clinical trial. However, an all expenses paid trip for a physician and family to attend a conference in an exotic location for the purpose of hearing about a new drug won’t be well perceived. Medical education is important. But it would be great for PhRMA members to adopt a policy that would minimize the trips and trinkets and focus more on the science and content of such meetings.
I believe that the greatest challenge that the pharmaceutical industry now faces is overcoming its poor image. There are millions of people who believe that real innovation is done outside of pharma labs, that the industry hides any negative clinical trial data, and that the industry pays off doctors to prescribe drugs. You and I know this is all not true. However, unless these beliefs are changed, people will view our products as overpriced drugs with little potential benefit and with hidden safety issues. My suggestions are not a panacea, but they are a step in the right direction.
Sincerely,
John L. LaMattina
http://www.forbes.com/sites/johnlamattina/2013/04/20/an-open-letter-to-the-phrma-ceo-on-pharmas-image/
Sunday, April 21, 2013
Jury awards $63M to Samantha Reckis, girl who lost skin after taking Motrin - CBS News
via cbsnews.com
BOSTONA jury has awarded a Massachusetts teenager and her parents $63 million nearly a decade after she suffered a life-threatening drug reaction that caused her to lose most of her skin after taking Johnson & Johnson's children's pain reliever Motrin.
Johnson & Johnson and its McNeil-PPC Inc. subsidiary should pay Samantha Reckis and her parents a total of $109 million, including interest, a Plymouth Superior Court jury decided on Wednesday.
Samantha was 7 when she was given Motrin brand ibuprofen, family attorney Brad Henry said. She suffered a rare side effect known as toxic epidermal necrolysis (TEN) and lost 90 percent of her skin and was blinded, he said.
She suffered brain damage that "thankfully" involved only short-term memory loss, he said, and surgeons had to drill through her skull to relieve some pressure.
The disease also seared Samantha's respiratory system, and she now has just 20 percent lung capacity, Henry said.
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