PharmaGossip

Why French Kids Don't Have ADHD

2013-05-18T20:28:00.001+01:00

In the United States, at least 9% of school-aged children have been diagnosed with ADHD, and are taking pharmaceutical medications. In France, the percentage of kids diagnosed and medicated for ADHD is less than .5%. How come the epidemic of ADHD—which has become firmly established in the United States—has almost completely passed over children in France?
Is ADHD a biological-neurological disorder? Surprisingly, the answer to this question depends on whether you live in France or in the United States. In the United States, child psychiatrists consider ADHD to be a biological disorder with biological causes. The preferred treatment is also biological--psycho stimulant medications such as Ritalin and Adderall.

French child psychiatrists don't use the same system of classification of childhood emotional problems as American psychiatrists. They do not use the Diagnostic and Statistical Manual of Mental Disorders or DSM.

According to Sociologist Manuel Vallee, the French Federation of Psychiatry developed an alternative classification system as a resistance to the influence of the DSM-3. This alternative was the CFTMEA (Classification Française des Troubles Mentaux de L'Enfant et de L'Adolescent), first released in 1983, and updated in 1988 and 2000. The focus of CFTMEA is on identifying and addressing the underlying psychosocial causes of children's symptoms, not on finding the best pharmacological bandaids with which to mask symptoms.

To the extent that French clinicians are successful at finding and repairing what has gone awry in the child's social context, fewer children qualify for the ADHD diagnosis. Moreover, the definition of ADHD is not as broad as in the American system, which, in my view, tends to "pathologize" much of what is normal childhood behavior. The DSM specifically does not consider underlying causes. It thus leads clinicians to give the ADHD diagnosis to a much larger number of symptomatic children, while also encouraging them to treat those children with pharmaceuticals.

http://www.psychologytoday.com/blog/suffer-the-children/201203/why-french-kids-dont-have-adhd

Wealth but not health in the USA

2013-05-18T19:50:00.001+01:00

The Lancet

Last week, American people, health-care workers, and policy makers received shocking news. Despite spending more on health care per person than other high-income countries, Americans die sooner, are least likely to reach the age of 50 years, and have higher rates of disease or injury. When judged by health alone, Americans are less healthy from birth to 75 years of age than people in 16 other economically wealthy countries, and this health disadvantage has been getting worse for 30 years, especially among women.

In a report released on Jan 9 from the US National Research Council and Institute of Medicine, U.S. Health in International Perspective: Shorter Lives, Poorer Health, comprehensive mortality and morbidity data are presented, comparing the USA with affluent democratic countries including Australia, Canada, France, Italy, most of the Nordic countries, Spain, and the UK. Life expectancy is shorter at birth for American men than for men in any of the other 16 countries, and American women fare little better—Denmark is the only country that has a lower life expectancy for women at birth. In nine key areas of health, Americans fare least well, or are near the bottom of the tables. These areas are: infant mortality and low birthweight; injuries and homicides; teenage pregnancies and sexually transmitted infections; HIV/AIDS prevalence; drug-related deaths; obesity and diabetes; heart disease; chronic lung disease; and disability. This health disadvantage applies to those with health insurance, a college education, higher incomes, and healthy behaviours as well as to those without.

US health spending was US$2·7 trillion in 2011, which is $8700 for every person in the country, and represents 17·9% of the economy—far greater than any other economically advanced country. But spending on health care bears little relation to good health.

To promote and inform continuing debate, health in the USA will be the theme of a Series in a special issue of The Lancet in 2014. In conjunction with Tom Frieden and Harold Jaffe at the Centers for Disease Control and Prevention, we will publish papers reviewing new opportunities to substantially improve health in the era of the Affordable Care Act. Planned topics include more on premature mortality in the USA, the impact of violence and injury, the challenges of non-communicable diseases and infections, public health and biosecurity, and the role of the USA in global health.

The USA is one of the world's wealthiest countries; it should be one of the world's healthiest.

For the report on US health disadvantage see http://www.nap.edu/catalog.php?record_id=13497

For the US prevention strategy see http://www.healthcare.gov/prevention/nphpphc/strategy/report.pdf

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)60069-0/fulltext?elsca1=

ETOC-LANCET&elsca2=email&elsca3=E24A35F

Royal College of Physicians support AllTrials

2013-05-18T14:06:00.001+01:00

Royal College of Physicians statement

The Council of the Royal College of Physicians (RCP) has agreed to support the principles of the ‘All trials registered, all trials reported’ campaign.

This reflects the RCP’s commitment towards delivering greater transparency for the benefit of patient care. Greater clinical trials transparency will aid scientific progress and in turn benefit patient care.

In signing up to the campaign, the RCP is keen to stress the urgency with which the community must determine how clinical trial transparency should be delivered. There are important questions around the appropriate scope, range, regulation and enforcement of disclosure.* As a profession, physicians must get these answers right to maximise the benefits of greater transparency around clinical trials.

The RCP believes that the best way to address such issues is to work together. The organisation is committed to the work of the Ethical Standards in Health and Life Sciences Group (ESHLSG), which takes a collaborative approach to developing the relationship between health professionals and industry.

* To fully realise the goal of all trials registered and reported, we would ideally see consensus on exactly what we are referring to and how it should be delivered. For example, in terms of scope and range, we’d ideally see agreement on which trials should be included (e.g. academic/industry), how far back retrospective publication of data should go and how data should be reported (e.g. journal publications/clinical study reports/anonymised patient data). In terms of regulation and enforcement, an important issue to resolve is how to fully achieve this. As the all trials campaign has highlighted, there are a number of mechanisms in place, but to date, no study has shown that 100% of trials are fully registered and reported. Many of these questions are currently being discussed by individuals and organisation within the research community, healthcare professions and industry, and the House of Commons Science and Technology Committee is considering the topic as part of an ongoing inquiry.

Sweden's drug testing industry plummets

2013-05-18T10:08:00.001+01:00

Sweden's once flourishing pharmaceutical testing industry has been decimated in recent years, suffering an 85-percent drop according to new figures that industry experts describe as "deeply troubling".

AstraZeneca hit by steep drop in profits (25 Apr 13)
'Anxiety drugs making Swedish fish go rogue' (15 Feb 13)
Wallenbergs give new life to Södertälje research (25 Jan 13)

In 2005, more than 9,000 people in Sweden participated in clinical trials of new pharmaceuticals. Last year, however, only 1,300 people participated in such trials, corresponding to an 85-percent drop, new statistics from LIF, the trade association for Sweden's research-based pharmaceutical industry.

In addition, the number of clinical trials carried out in Sweden has been cut in half in the last ten years, with phase-1 trials, where drugs are tested on humans for the first time, dropping by 90 percent.

"This is deeply troubling," LIF head Anders Blanck said in a statement.

"This means that fewer Swedes are gaining access to new treatments and that the health care system misses out on the knowledge created through fully-financed clinical trials."

Since 2004, the number of people employed in the drug testing industry has dropped by nearly half, with 7,000 jobs disappearing from Sweden's pharma industry during the same period.

In previous decades, major pharmaceutical giants like Pharmacia and Astra brought a number of successful drugs to market following testing in Sweden, Sveriges Television (SVT) reported.

However, lower costs associated with testing new drugs in other countries, including Poland and Hungary, as well as India and China, has prompted pharmaceutical firms to cut back on testing in Sweden.

"Obviously, cost is an important factor when you're doing research. Developing drugs is really expensive. If you can find different ways of doing it cheaper, we are certainly going to do it," Anders Ekblom, head of AstraZeneca's operations in Sweden, told SVT.

http://www.thelocal.se/47970/20130517/

Oz Court rejects Merck deal over Vioxx

2013-05-17T11:55:00.001+01:00

A Federal Court judge has refused drug company Merck's $540,000 settlement with Australians who claim its drug Vioxx caused them a heart attack, labelling the deal an "obvious injustice".

More than 1700 people joined a class action against the Australian arm of the international pharmaceutical company, claiming their heart trouble stemmed from taking its arthritis drug.

The parties reached a $540,000 settlement last month, subject to Federal Court approval, which would have resulted in the proceedings being dismissed and the matter finalised, meaning no future claims could have been brought against Merck over the drug.

Justice Christopher Jessup refused to approve the settlement on Friday, having last month expressed concern about its fairness.

The court had heard successful applicants would receive a maximum of $2000 if they were alive, and their estate would get $1500 if they were dead.

If the total payout for living claimants was to exceed $497,500, that figure would be divided equally among them.

The maximum payout for dead claimants would be $45,000.

It was estimated that only 200 to 300 claimants would meet the eligibility criteria, which required them to prove they suffered a heart attack after taking Vioxx for a certain period.

The lead plaintiff, Victorian grandfather Graeme Peterson, was awarded $330,000 in 2010 after Justice Jessup found Vioxx caused him to have a heart attack.

That decision was overturned on appeal to the Full Court but the judgment still allowed others to continue legal action over Vioxx.

Justice Jessup said the settlement had "very obvious advantages" for Mr Peterson, who would be relieved of hefty legal costs he owes to Merck after losing his case.

He said the claimants' law firm Slater and Gordon, who have spent millions of dollars on the case but will not receive any payment for their services, also "have a very real interest in securing the settlement".

But the settlement did not make an "important discrimination" between group members like Mr Peterson who had other risk factors when they had their heart attack, and those who had no other risk factors other than taking Vioxx, he said.

"For a group member who might, consistently with the reasons of the Full Court, anticipate a favourable judgment, the settlement would represent an obvious injustice," Justice Jessup said.

"(Mr Peterson) has taken upon himself the burden of conducting a representative proceeding.

"(It would) make it both unfair and unreasonable of him now, in effect, to walk away from the claims of those group members on the strength only of being able to settle the claims of the less deserving group members."

Claimant Trevor Whitehead, who objected to the settlement, said he was pleased there was potential for a better outcome.

"This case is complex and the settlement offer will also need to be complex in nature if the individual class members have any chance of receiving a fair and reasonable settlement for themselves," he told AAP.

The judgment means the parties can either try to renegotiate a new deal or take the case back to trial with a new lead plaintiff.

A Slater and Gordon spokesman said the firm was considering the judgment and would get instructions about options for the future of the proceedings.

Comment was sought from Merck.

http://www.sbs.com.au/news/article/1767610/Court-rejects-Merck-deal-over-Vioxx?

The Outcomes Era

2013-05-16T18:16:00.001+01:00

Pharma must provide convincing evidence of drug value

The pharmaceutical industry has now entered the Outcomes Era where compounds must supply convincing evidence of a new drug’s value, with proof of the best possible health outcomes and additional benefits if it is to achieve attractive price and reimbursement levels, says new research.

As many as 60% of pharmaceutical executives surveyed for the report agree that, in the Outcomes Era, product launches can no longer be driven by a blockbuster mindset focused solely on regulatory approval pre-launch and a strong salesforce post-launch. Yet as many as 30% of the respondents – working mainly in drug companies located in the USA and Europe – said they expect to continue to launch new products in the blockbuster style, with little change to the launch process, says the report, from Camelot Management Consultants.

Worryingly, respondents do not expect to see an increase in the number of new drug introductions – yet the industry needs to be increasing the number of truly innovative launches and introducing them more speedily if the sector is not to shrink, the firm warns.

Moreover, approval by the regulatory agencies is no longer the only concern – today it is about market access, acceptance and usage, says Camelot. The major challenge facing life sciences companies as they prepare to launch a novel drug today is “how to satisfy different stakeholder needs at the same time”, the survey shows.

Looking at how these developments are playing out around the world, Camelot notes that among the mature markets, the German system, for example, now draws a direct connection between additional benefit and reimbursed price – setting off a domino effect beyond Germany, as lower prices are adopted through international reference pricing – while the UK plans to introduce value-based pricing for new drugs from next year.

Further afield, emerging markets such as the BRIC (Brazil, Russia, India and China) nations are adapting both to FDA/EMA standards and to recent pricing and market access developments. The Brazilian Government already manages its healthcare spending by relating market prices to reference prices in other countries, and has now launched the National Commission for Incorporation of Technologies in the Unified Healthcare System (CONITEC), a health technology assessment body that bases its strict reimbursement requirements on a product’s safety, efficacy, cost-effectiveness and impact on the national drugs budget against comparators.

Within this new stakeholder-driven environment, says Camelot, successful product launches will need to:

• Expand the market, rather than just gain market share

• Re-define therapy guidelines

• Develop excellent cross-functional collaboration and teamwork

• Develop smarter pre-launch activities, with increased investment in the early launch phases

• Have stakeholders awaiting the product and its differentiated positioning at launch

• Win recognition for creating multi-stakeholder value

• Exceed peak sales expectations.

Companies must also be “highly alert” to the fact that their environment will be undergoing continuous change, and this will inevitably force the launch process to adapt, Camelot advises.

http://www.pharmatimes.com/mobile/13-05-15/pharma_must_provide_convincing_evidence_of_drug_value.aspx?r=1

Bayer buying

2013-05-16T15:46:00.001+01:00

(Reuters) - Germany's largest drugmaker Bayer said it agreed to buy privately held Steigerwald Arzneimittelwerk GmbH, a maker of herbal treatments.

Bayer said on Thursday that Steigerwald, based in Darmstadt, Germany, generated sales of 61.3 million euros ($78.8 million) in 2012 with 180 staff. It did not disclose financial terms of the takeover.

http://uk.reuters.com/article/2013/05/16/us-steigerwald-bayer-idUKBRE94F0HF20130516

How Drug Companies Keep Medicine Out of Reach - The Atlantic

2013-05-15T16:36:00.001+01:00

http://www.theatlantic.com/health/archive/2013/05/how-drug-companies-keep-medicine-out-of-reach/275853/?

Reuters

For almost a decade, the United States has been standing in the way of an idea that could lead to cures for some of the world's most devastating illnesses. The class of maladies is known as neglected diseases, and they almost exclusively affect those in the developing world. The same idea, if realized, might also be used in more affluent nations to goad the pharmaceutical industry into producing critical innovations that the free market has yet to produce - things like new antibiotics, which are likely to be used judiciously, and are unlikely to be wildly profitable.

But the idea, which advocates have outlined as a treaty, and which will have its fate decided next week at the World Health Organization (WHO) where it has languished for years amid bureaucratic tumult, is "good enough to be dangerous," in the words of one person close to the negotiations. It has thus drawn the fierce opposition of those who benefit most from the status quo, the pharmaceutical giants and the nations that claim them.

"It's a precedent. It's a competing paradigm," Jamie Love, 63, the director of Knowledge Ecology International, a progressive group agitating in favor of the idea, told me. "And the Obama administration, instead of wrapping its arms around it and trying to breathe some life into the future so we don't have $200,000 drugs, is killing it."

When I met Love in February at his office in Washington, D.C., he had just returned from Geneva, where the World Health Organization (WHO) is based, and he planned to be on a return flight shortly. Coach class, he assured me. Love has a boyish face with pale blue eyes and an inscrutable energy about him. The energy, according to those who know him, is nothing new. As a young man, he dropped out of college in Washington and moved to Alaska, where he became a longshoreman and cannery worker and opened two small NGOs. The work drew the attention and support of Ralph Nader, and, in 1980, Love moved to Boston on a fellowship to Harvard's Kennedy School. He added a second Master's degree from Princeton, where he studied with Joseph Stiglitz.

"Part of the problem is that nobody understands what we're talking about," Love told me in his office, a small loft beneath a gabled roof on Connecticut Avenue. "There's really only twenty or thirty of us who understand what we're trying to do with this."

Bill Gates, speaking to the Royal Academy of Engineers in London last March, managed to capture the problem that Love's idea would be leveled against: "Our priorities are tilted by marketplace imperatives," Gates said. "The malaria vaccine, in humanist terms, is the biggest need, but it gets virtually no funding. If you are working on male baldness or the other things you get an order of magnitude more researching funding because of the voice in the marketplace."

This fact -- that research-based pharmaceutical companies focus on the most lucrative products, rather than the most needed -- is particularly damning for the global poor, whose diseases will never be profitable enough to attract the industry. The WHO has recognized 17 such diseases, known as either type III or neglected tropical diseases (NTDs). Almost all of them edge on biblical in both scope and horror.

"The needs are pervasive because these diseases have been so understudied," said Peter Hotez, the founding dean of the National School of Tropical Medicine at Baylor University. "Look at a disease like hook worm infection. Well we now know that single dose mebemindizole doesn't work against Nacator americanus, which is the major hookworm. Why is that? We really don't know," Hotez said. "The WHO I think did us a disservice a few years back when they coined the term 'tool ready' versus 'tool deficient' diseases. All neglected tropical diseases are tool ready, and those same diseases are tool deficient," Hotez said, meaning drugs exist to fight all of the conditions, but many are met by severe resistance and others are poorly adapted for low-resource settings.

The WHO list of NTDs includes Chagas disease, which has a burden of disease five times that of malaria in Latin America, and Dengue fever, which 40 percent of the world's population remains at risk of acquiring. It also includes river blindness, which affects 20 million people in sub-Saharan Africa and leads to infections that itch so severely -- as worms die in the flesh -- that sufferers turn to nails, scalding water, and other violent means to numb the sensation. The existing drug for the disease, Ivermectin, requires six doses over three years to be effective, a regiment that would be difficult to deliver in affluent countries with robust health systems, and is nearly impossible to accomplish in rural Africa.

Neglected diseases, even when coupled with type II diseases, things like malaria and tuberculosis that primarily affect the global poor, receive less than two percent of the $160 billion spent on medical research and development (R&D) each year.

The idea, which has gained the support of a range of academics and economists from around the world, as well as Doctors Without Borders/Médecins Sans Frontières (MSF), Oxfam, Health Action International (HAI), and DNDi, aims to develop new cures for those diseases, and to manufacture the drugs and vaccines at prices affordable to the global poor.

It hinges on the incredible discrepancy between the cost of developing a drug or vaccine -- an expensive and risky enterprise -- and the actual cost of manufacturing a drug, which is often astoundingly cheap.

"Once you sort of turn that corner and you realize that intellectual property rights are really man made policies ... then it just opens your mind up."

"So there is the idea that there are gaps in research," Love told me in February, "and the second idea is that linking the cost of R&D to the price of the drug through the grant of a monopoly is inherently problematic, and the problems are diverse." The existing system relies on the promise of drug sales under patent to incentivize innovation -- an effective monopoly on production, typically lasting more than a decade. That system leads drug makers to set prices at whatever level they think the market can bear, regardless of the cost of manufacture or even the cost of development. The point was driven home last year, when Memorial Sloan-Kettering Cancer Center, in New York, refused a new colorectal cancer drug priced at over $130,000 per year. The drug maker, Sanofi, promptly cut the price in half.

The point is also particularly egregious in the case of lifesaving antiretroviral drugs (ARVs) for those suffering from HIV/AIDS. The fight to make those medications accessible to the global poor was another battle in which Jamie Love was intimately involved.

"If you're looking for sort of the intellectual driver for the idea, it's undoubtedly Jamie," said Robert Weissman, who now runs the storied advocacy group Public Citizen. Weissman was alongside Love in 2001 when Love made the most important play of his career: He asked Yusef Hamied, a chemist and the director of the Indian pharmaceutical manufacturer Cipla, for a rock-bottom price to produce a cocktail of ARVs. At the time, the pill regiments were selling for over $10,000 per year under patent-protected prices. Hamied said that Cipla could produce the drugs for a dollar a day per person.

"Jamie got that it had to be a dollar a day, that it wasn't $400 a year, that the price of a dollar a day would move the whole debate," Weissman said.

Hamied's offer made headlines around the world. It set a floor in the market and lead the prices for name brand drugs to fall precipitously.

"Before all this, we had a meeting with the U.S. Trade Representative and we were talking about how keeping these prices and patents in place was costing millions and millions of lives in Africa," Weissman recalled, referring to Love and himself. "And the Trade Rep. said to us -- I'll never forget this -- 'I don't work for millions of people in Africa.'"

The $10,000 that pharmaceutical companies were willing to charge for ARVs -- and that their US government was willing to defend as reasonable at the WTO -- was egregious in part because the drugs can be produced so cheaply, as Cipla proved. But the prices were also impossible to justify because the development cost for the first generation of ARVs was close to nothing for private industry. The drugs, known as dideoxynucleotides, were almost all developed in the 1960s at Wayne State University under National Institutes for Health (NIH) grants to research cancer therapies. And, in the 1980s, it was again NIH researchers who thought to test the compounds against the AIDS virus.

Love traces the genesis of the idea to a similar situation, this one involving cancer drugs. In the early 1990's, Love began investigating Taxol for Senator Ron Wyden of Oregon. The drug is used to treat breast and ovarian cancer, and was developed by the NIH and produced for less than a dollar per milligram for clinical trials. Bristol-Meyers Squibb, once effectively given the patent, sold the drug for $4.87 per milligram, roughly moving the price from $100 per dose to $850 per dose.

"I do a lot of historical research on the things I do. I like to go back and look at earlier disputes and case studies on particular drugs or legislation or just try to figure out how we got where we are," Love said. One of the cases Love climbed into involved Cisplatin, the drug that saved Lance Armstrong's life. The drug was also developed within NIH and effectively handed to Bristol-Meyers.

"In the old days, the government would grant five year monopolies on government-funded inventions that were done by NIH or universities or something, but if you wanted more than five years, you could ask the government to extend the monopoly," Love said.

In the Cisplatin case, when Bristol-Meyers wanted to extend the patent, the government negotiated a 30 percent drop in the drug's price, and for Bristol-Meyers to contribute $40 million in grants to research of the NIH's choosing.

The case fundamentally changed how Love thought about intellectual property.

"Once you sort of turn that corner and you realize that intellectual property rights are really man made policies and they're designed to do something, and there's other ways to induce that same thing that can compete those ideas, then it just opens your mind up."

Love's idea suggests the use of cash prizes -- rather than patents -- to incentivize research; say, $2 billion for an effective therapeutic drug for Chagas disease. A cure, once developed, proven, and awarded a prize, would then exist as open-access intellectual property, with manufacturers around the world competing to produce the drug in the most cost effective manner. Implementing the idea, Love said, "is effectively leveraging the power of the free market twice, once to produce the thing you want and then again to manufacture it as economically as possible." The concept is known as delinking.

The prospect also has interesting second-order effects. "The numbers have to be big enough," Love said. "You can't replace monopolies that involve billions of dollars with prizes that involve thousands of dollars, but it's financially easy to do that because the savings from delinking are so big." Because drug makers are no longer dependent on sales, delinking would relieve huge strains on budgets beyond research and development; the industry only spends about 16 cents on the dollar for R&D. Massive ad campaigns, for instance, would become obsolete in such a system, because the innovator's profits are no longer tethered to sales, the same for gifts and meals to woo physicians.

Love's concept of delinking is outlined in a proposal for an R&D treaty, which remains in limbo at the WHO in Geneva. It will have its fate decided in late May, at the annual World Health Assembly (WHA), the democratic forum of members states that governs the WHO.

The proposal adds a second, equally powerful idea to Love's, one inspired by open-source software models.

A post-doctoral student in Edinburgh, Scotland, who had been tracking the project's open lab books online, produced a compound that Todd's own lab couldn't figure out how to synthesize.

Historically, basic research and drug innovation has been in done in silos, with little communication across companies and labs. That isolation guarantees that researchers repeat failures that have already occurred elsewhere, a problem that becomes glaring in the case of neglected diseases, where the total research investment is a fraction of what it is for profitable diseases. The lack of information sharing also guarantees that some labs remain stymied by problems that researchers in other places may know how to solve.

"The existing funding structures are competitive, national grant based," said John Wilbanks, who works at the non-profit Sage Bionetworks and is a fellow at the Kauffman Foundation. "So, for most people, the rational economic decision is not to share, not to collaborate, in order to obtain additional taxpayer grants to continue the research and to keep employment."

Wilbanks's background is largely in tech, and the group he works for is building a platform for computational biology akin to GitHub, a system that lets computer programmers track their contributions to open-source code.

"The fear is that by spending my time working on your project, for which I don't have a system to get credit that the existing system recognizes, I will be less competitive over time than someone who participates in the traditional system of information hoarding and publication," Wilbanks said. "We're trying to fix that problem through openness, similar to the R&D treaty."

To combat the problem, the R&D treaty would create an observatory, an open platform for researchers in disparate corners of the globe to pool data and coordinate their work. Grants given to fund their studies would come with provisions requiring that the research exist on that public, cloud-based observatory.

Such an open system also means that help can come from unexpected places. Mathew Todd, a chemistry professor and researcher in Sydney, is currently running an open-source malaria project. He explained how a post-doctoral student in Edinburgh, Scotland, who had been tracking the project's open lab books online, produced a compound that his own lab couldn't figure out how to synthesize.

"The chemistry wasn't working out, and we were being open with this," Todd said. "And he looked at it and said, 'Well I can make that.' And so he went off and made it, and we were interacting with him by Twitter, sort of following his progress and he was posting his experimental data to our lab books online, and he made it."

"It's that kind of example where you think, 'Well if everything's open and it's clear what needs to be done and anybody can chip in, then that means you're going to attract the expertise you need without actually knowing who those people are," Todd said.

Todd told me he's put forward a proposal to host a panel focused on the future of intellectual property and drug development at the February meeting of the American Association for the Advancements of the Sciences. "I think the time is right to have that discussion about whether the patents are working, and whether they're necessary for drug discovery," Todd said. "I want to hear on from people from on both sides. I think we just have to have that conversation."

***

Last November, the Obama administration made its most strident effort to date to stall the idea. Because successive U.S, administrations have stonewalled the process so effectively, negotiations on actual language for an R&D treaty have never begun. That hasn't prevented the intellectual scaffolding beneath the idea from developing, though.

To fund the system -- research grants and an observatory to produce and coordinate the foundational science, and prizes to incentivize the pharmaceutical industry to spring off of that basic research -- the treaty would commit member states to spending 0.01 percent of GDP on neglected diseases each year. The U.S. already spends at that level, and would have no further financial obligations. No other country comes close.

Nonetheless, the idea of binding financial commitments by way of treaty has been a centerpiece of US opposition.

"They are using a process argument, saying we are against the form, but in fact what they are opposing is the content of the negotiations," said Judit Rius, the U.S. manager of Doctors Without Borders/Médecins Sans Frontières Essential Medicines Campaign. "When governments get serious about an issue, they agree to binding global norms and they agree to be held accountable. And that's what we want," Rius said. "What the U.S. is really opposing is a conversation about the how this funding should be spent. They are protecting the current business model, the status quo innovation models."

At the November meeting, the U.S. hammered through a resolution effectively neutering the idea in a late night vote. It was held four hours after simultaneous translation of the debate ceased, with only 25 of the original 194 member state representatives remaining in the negotiating hall.

"At least with the Bush guys you could have a conversation with them about this kind of stuff."

"I've never seen something like that happen in an international negotiation," Carolos Correa, the representative from Argentina, told me. "The meeting should have been terminated, because clearly some of the delegations were not able to follow the debate. In these cases, the governments generally say, 'Well this is not possible to go on, so we'll finish and inform the assembly there was no conclusion.'"

According to delegates present at the meeting, which took place behind closed doors, it was clear from the outset that the U.S. had no intention of negotiating in good faith. "The U.S. was delaying the issue and opposing it totally," one negotiator said. "Very little real negotiation, they were very radical. They were even insisting on some ideas that were not totally correct."

The resolution that emerged from the November session will be taken up in late May, at the annual meeting of the World Health Assembly. If the measure is adopted, further consideration of the idea will be pushed until at least 2016. The resolution also includes the unusual provision of being sealed, barring any further discussion at the WHA.

The document also suggests the creation of a pilot program and an observatory to monitor research, but does so without allocating funds, and with such vague language as to render the resolution moot.

The U.S. has promised to bury the resolution altogether if other countries try to reopen negotiations in May.

"We saw in January that the U.S. negotiator said publically what we had been told he was saying in November behind closed doors, which is that, 'If you change even one comma, we'll kill it altogether," Rius said.

Early in the November meeting, the U.S. moved to quiet a Colombian negotiator. Nils Daulaire, the lead U.S. representative in Geneva, has made a habit of using backchannels to sideline other delegates voicing positions he does not share.

The negotiator in question declined several requests for comment for this piece.

"She was very well prepared, and she was taking the floor several times during the first day," another delegate told me. "And I saw that the U.S. delegation was a little bit nervous, because usually Colombia -- in the last years -- they never take the floor on these issues and they always support the U.S. position. Around four o'clock on the afternoon of the first day, she was called outside the room, and one hour after she came back to the room and she never took the floor again in the next two and a half days. She stayed until two o'clock in the morning the last day, but she never took the floor again."

Nils Daulaire [Wikimedia Commons]

In March, when I spoke with Daulaire, an assistant secretary for global affairs at the Department of Health and Human Services (HHS), I asked what had provoked his complaint. His response took the kind of emphatic tone that conveys both displeasure and the desire to say a great deal more: "I'm not familiar with any formal diplomatic complaint against the Colombian representative," he said. "I don't know where that comes from." Daulaire struck the same tone later in our conversation, when I asked at what level within the Obama administration the U.S. position had been crafted. "I do not discuss internal administration processes," he said.

Daulaire has a round nose and soft chestnut hair with a beard and glasses, lending the overall affect of a college dean. He is -- according to his official biography -- the speaker of seven languages, and a graduate of both Harvard College and Harvard Medical School. He is known as exceedingly ambitious, and is rumored to have put himself forward to replace Eric Goosby as U.S. AIDS Coordinator. The position is one of the most vaulted in the field of global health.

"He is very trenchant in his views, and I'm not sure whether that is because he's hearing that from the industry or whether he's hearing that from the administration, but he's looking at where the political wind is going," one source with intimate knowledge of the debate said.

Daulaire's efforts to derail the November meeting started more than a month before he and his staff arrived in Geneva. His office sent representatives to a WHO regional meeting in Angola to discourage support for the treaty amongst African states, and Daulaire himself made bilateral calls to number of negotiators and ministers of health. On the calls, he asked whether the officials were prepared, at the November meeting, to commit their governments to financing the treaty. None of the officials Daulaire called have the power to make such a commitment, nor does Daulaire himself. Moreover, the treaty he asked them to commit to financing has not yet been written, largely because of Daulaire's own intransigence.

"Nils says, 'The U.S. is the biggest funder of R&D, and we don't think anyone else is going to put up the money,'" one civil society member said. "But the bizarre thing about that is when developing countries said, 'We will put some money up, whether we will reach sort of figure that the experts came up with, we might not but we're prepared to do it incrementally,' he just said, 'No I don't believe you, let's just take the whole thing off the table.' It's very strange to me that the U.S., being the largest funder, is actively undermining putting pressure on other countries to step up to the plate."

"I was sort of looking forward to working with the guy," Jamie Love said of Daulaire. "Everybody knew that he was close to the industry, but that's not necessarily a bad thing. But he really changed when he got the job [at HHS]. At least with the Bush guys you could have a conversation with them about this kind of stuff."

Daulaire's deputy at HHS, Holly Wong, previously worked for the drug industry's main lobby group, PhRMA, and as director of public affairs at Schering-Plough Pharmaceuticals. The company was acquired by Merck in 2009.

Before his appointment to HHS, Daulaire ran a nonprofit called the Global Health Council (GHC) for close to a decade. The group was based in White River Junction, Vermont, where Daulaire lived. The organization had an annual budget of close to $7 million, although it didn't actually provide any health services. After Daulaire left, the organization was handed off to Jeff Sturchio, a former Vice President at Merck. Sturchio drove the group into the ground in less than three years. "It was really a lobby group," one observer said, speaking of the GHC. "At the World Health Assembly meetings they would rent huge halls in the Intercontinental with very expensive food and drinks," another recalled.

The GHC's main function appears to have been providing briefings for incoming members of Congress and new presidential administrations. "I don't think anyone has filled that role," Jonathan Quick, who is trying to revive the GHC, told me. Quick spent eight years working at the WHO as the Director of Essential Drugs and Medicines Policy.

Quick and several others in the global health space pushed back against questions about GHC's lobbying, arguing that the organization served as a kind of hub for advocates of greater U.S. involvement in global health. I asked Quick about his thoughts on the U.S. opposition to the R&D treaty, and whether he, having worked at the WHO, had misgivings about U.S. negotiators having such strong ties to the pharmaceutical industry.

"The U.S. is interesting, having seen it from the WHO side," Quick said. "Most countries when they come to the World Health Assembly lead with their health policies. And they bring to the WHA the values and policies they have at home. There are a few countries where that's difficult, because there are such strong commercial interests that there's a tension. That's always been a very difficult challenge for people representing the U.S. in the international health sphere."

Page 2 of 2

Medical Humor

2013-05-14T13:50:00.001+01:00

Ranbaxy pleads guilty and agrees to $500 million penalty

2013-05-14T13:43:00.001+01:00

LProsecutors say guilty plea by Ranbaxy is largest financial penalty against a generic drug company

Washington: A subsidiary of India’s largest pharmaceutical company has agreed to pay a record $500 million (Dh1.83 billion) in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the US

Federal prosecutors say the guilty plea by Ranbaxy USA Inc represents the largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.

The deal, announced Monday, concludes a years-long federal investigation into Ranbaxy’s manufacturing deficiencies. The Food and Drug Administration in 2008 barred from Ranbaxy from importing more than 30 different drugs made at factories in India and, two years ago, struck a deal that required the company to ensure that data on its products is accurate, undergo extra oversight and review from a third-party and improve its drug making procedures.

The subsidiary of Ranbaxy Laboratories Limited pleaded guilty to federal criminal charges and the company separately agreed to resolve civil claims with all 50 states and the District of Columbia. The company had earlier set aside $500 million to cover potential criminal and civil liability stemming from the Justice Department investigation.

Article continues below

It admitted as part of the deal that it sold adulterated batches of drugs - including an antibiotic and generic versions of medications used to treat severe acne, epilepsy and nerve pain - that were developed at two manufacturing sites in India. It’s not known whether the problems with the drugs led to any health issues. The problems were largely revealed by a whistleblower in a federal lawsuit filed in Maryland in 2007. The government’s allegations against the company make no claims that the drugs, whose strength, purity or quality differed from the specifications, harmed anyone.

The company admitted to a wide range of deficiencies, including improperly storing drug samples that awaiting testing, continuing to sell a medication in the US even after it had failed purity tests and delaying a voluntary recall of medication that it knew would not maintain its expected its expected shelf life.

Ranbaxy also admitted making false statements to the FDA in 2006 and 2007 annual reports about dates of tests that are designed to detect drug impurities and determine appropriate storage conditions. In some cases, the tests were done weeks or months after the company said they’d been performed. Or the tests were done on the same day - or within days of each other - instead of months apart, the prescribed interval.

The company said in a written statement that it had fully cooperated with the investigation, which it said involved actions from several years ago, and expects “future growth in the US and around the world with a robust pipeline of important products.”

“While we are disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy’s stakeholders” the conclusion of the DOJ investigation does not materially impact our current financial situation or performance,” Ranbaxy CEO and managing director Arun Sawhney said in a statement.

The company had faced scrutiny in recent years. Apart from the federal investigation, Ranbaxy Pharmaceuticals Inc - also a subsidiary of Ranbaxy Laboratories Limited - halted in November of generic cholesterol drug Lipitor while it investigated how tiny glass particles got into dozens of recalled batches. The FDA determined at the time that the risk to patients was very low.

The case comes as federal regulators and prosecutors focus attention on the quality of ingredients of generics and other drugs manufactured overseas, said Allan Coukell, an expert on drug safety at The Pew Charitable Trusts. He said the 2008 deaths linked to tainted batches of the blood-thinner heparin that were imported from China served as a “wake up call” about just how much of the nation’s drug supply comes from overseas.

“Over the last few years, the FDA and others have been increasingly focused on the risks associated with global drug manufacturing. The agency now has new authority and new resources which should result in an increased scrutiny on the highest-risk facilities,” he said.

The company agreed as part of Monday’s deal to a fine and forfeiture of $150 million as well as an additional $350 million penalty to settle civil claims that it submitted false statements to Medicaid, Medicare and other government health care programs. Nearly $49 million of that penalty will go to a former Ranbaxy executive, Dinesh Thakur, who acted as a whistleblower by filing a federal lawsuit accusing the company of knowingly falsifying drug data, prosecutors said.

Thakur said in a statement that the company had been notified of the problems, and “when they failed to correct the problems, it left me with no choice but to alert healthcare authorities.”

“He was the source, the original source, of the information to the government that ultimately led to the government’s earlier actions,” said Andrew Beato, one of Thakur’s lawyers. 

http://gulfnews.com/business/general/drug-manufacturer-agrees-to-500-million-penalty-1.1183142?

Ve haf vays of making you guinea pigs!

2013-05-13T02:43:00.001+01:00

Leading Western pharmaceutical companies paid millions of pounds to former Communist East Germany to use more that 50,000 patients in state-run hospitals as unwitting guinea pigs for drug tests in which several people died, it was revealed today.

An investigation by the German magazine Der Spiegel said international conglomerates such as Bayer, Hoechst, Roche, Schering and Sandoz carried out more than 600 tests on patients, mostly without their knowledge, at hospitals and clinics in the former Communist state.

The companies were said to have paid the regime the equivalent of €400,000 (£338,000) per test. Schering, a concern which now belongs to Bayer, was said to have offered East Germany the equivalent of €3m to carry out a series of tests at an East Berlin hospital.

The case of one unwitting East German woman who died in 1986 aged 30 after being treated with pharmaceuticals for skin cancer was cited by the magazine. Nicole Preiss, her daughter , said: “There are so many secrets surrounding my mother’s death – I want to know which drugs and which companies were involved.”

Der Spiegel said it gained the information from Stasi secret police files and hitherto unpublished East German health ministry and pharmaceutical institute records. Western pharmaceutical companies are known to have turned to cash-strapped Eastern Bloc countries in their search for human guinea pigs after the 1960s thalidomide scandal which obliged them to carry out rigorous tests on their products before they could be sold.

In the West, the law stipulated that any patients taking part in such tests had to be fully informed of the risks involved. However, in East Germany such restrictions were waived or “modified” in an increasingly desperate effort to procure enough hard currency to rescue an ailing economy.

The records show a concern which now belongs to Roche tested the “blood-booster” Epo on 30 premature babies. Bayer was also revealed to have tested Nimodipin – a drug designed to improve blood circulation in the brain– on a group of alcoholics who were suffering from such acute delirium that they could not give their consent.

Two unwitting patients also died in East Berlin hospitals after being subjected to tests involving Trental. The drug improves blood circulation and was then being developed by the West German company Hoechst, which has since merged with Sanofi. A statement issued by Hoechst in 1989, nine months before the fall of the Berlin Wall, stressed that the drug manufacturer’s information sheet concerning its products remained with East German testers and “ is not given to the patient”.

It added that “the patient’s consent is confirmed with a signature from the doctor and a witness”.

Der Spiegel said that when it contacted the drug companies concerned most stressed that the trials happened a long time ago and that in principle strict protocols were always followed. The German Federation of Pharmaceutical Producers said: “ There is currently no reason to suspect that anything irregular happened.”

http://www.independent.co.uk/news/world/europe/

drugs-giants-used-communist-east-germany-for-illegal-trials-8612929.html

The Fantastic Mr Feynman, BBC Two, review - Telegraph

2013-05-13T02:28:00.001+01:00

http://www.telegraph.co.uk/culture/tvandradio/10050264/The-Fantastic-Mr-Feynman-BBC-Two-review.html

Bringing trial data out of the shadows

2013-05-13T02:22:00.001+01:00

All sectors have their own mood music, unobtrusive much of the time, but occasionally brought to startling effect into the foreground, dominating all else. The pharmaceutical industry is no different, and at present there is one insistent theme: transparency.

And if there is one area of this debate behind which chords are starting to swell loudly it is the availability of clinical trial data. Unflattering or disappointing trial outcomes have been routinely unpublished, pharma's critics claim, which means patients taking part in trials can be exposed to ineffective or even dangerous products because previous negative research is unavailable.

Clash of opinions

For its part, pharma denies there is a problem. At present, companies operating in the UK, for example, are expected – though not obliged - to register current and future trials within 21 days of enrolling the first patient, with results published within one year of marketing authorisation.

This does not go far enough, according to some. The European Commission, for instance, is in the process of revising the Clinical Trials Directive (2001/20/EC), and putative changes would require a results summary to be put on to the EU's clinical trial database within a year of the end of the relevant trial. The lead legislator on the revision process is Labour MEP Glenis Willmott, who wants a pan-European database, with full publication of trials - and financial penalties for firms which delay.

“Too many results from clinical trials are misleading, biased or missing,” she said. “It is time that all pharmaceutical companies and researchers made the full results of studies on new and existing drugs publicly available.”

Others agree with her. In January this year, the AllTrials initiative was launched by the British Medical Journal (BMJ), the James Lind Initiative, the Centre for Evidence-Based Medicine and Ben Goldacre, author of industry critique Bad Pharma.

The campaign, backed by heavyweights such as the Wellcome Trust and the National Institute for Health and Care Excellence (NICE), wants governments, regulators and research bodies to ensure the methods and results of all trials, past and present, are published in full. Making available clinical study reports (CSRs) – the formal documents detailing the design, methods and results of trials, which form the basis of submissions to regulators – will improve transparency and aid research, AllTrials says. Summaries alone are not enough.

The idea is that researchers would benefit because they have access to everything relevant that has gone before their project, perhaps allowing them to spot pitfalls or find shortcuts and leading to more rigorous science. The chief beneficiaries would be patients since they will get better medicines, brought to market more quickly and cheaply because research is not being duplicated, leading to better health and wellbeing outcomes.

Spirit of the age

So why is all this happening now? In the last couple of years a number of cases have created an atmosphere in which pharma is open to accusations of needing to be more clear about how it operates, the most high profile of which culminated in a $3bn fine imposed on GlaxoSmithKline (GSK) by the US government for fraud.

There is also a philosophical level to the drive for openness, with transparency mirroring the mood of the times, since the ubiquity of the internet means accessing and publishing data have never been easier. In the UK, it is perhaps not stretching a point to suggest that health issues, which are no fault of pharma, such as the Francis Report's findings of abominable mistreatment of patients at Mid Staffordshire NHS Foundation Trust, help add to a feeling that anything less than full disclosure is a bad thing.

Whatever the motivation, Goldacre says that at present only about half of all trial data is ever published – a figure the Association of the British Pharmaceutical Industry (ABPI) and the Pharmaceutical Research and Manufacturers of America (PhRMA) dispute, suggesting the figure is closer to 80 per cent in Europe and the US.

Even so, it is clear that not all trial data is out there. “Biased under-reporting of data is real,” says Dr Fiona Godlee, editor-in-chief of the BMJ. “Data suppression is fraud. I fear we make too much of the complexity issues. Lots of good things are happening in pharma but the industry has shown it can't be trusted.”

Data disputes

Anyone searching for reasons for the current focus on issues of transparency could do worse than look at two things: one, the publication last year of Bad Pharma; and two, Roche's refusal to lay on the table all data for its influenza drug Tamiflu. The latter is a particular bugbear for the Cochrane Collaboration, which seeks to provide third party, evidence-based analyses of drugs and went public in challenging Roche. Tamiflu was stockpiled at great cost by western governments – the bill for the NHS alone was £500m - to guard against a flu pandemic, but concerns emerged that the drug was no better than placebo after summary results and CSRs appeared to suggest different things.

That debate rumbles on [the most recent development being Roche's announcement it intends to release Tamiflu data to Cochrane], but meanwhile the ABPI has argued that it has been looking at transparency for far longer than AllTrials, which it has also dismissed as a “PR-driven initiative”. ABPI chief executive Stephen Whitehead pointedly said: “We were on this journey before Bad Pharma was a twinkle in Ben Goldacre's eyes.”

It's time pharma made results of studies on new and existing drugs publically available

The ABPI line is that summary trial evidence should be made available for both new and existing medicines and it insists mechanisms for doing so are still being finalised. In the US the website ClinicalTrials.gov is the vehicle by which this currently happens, but PhRMA has been scathing in its response to the debate, accusing critics of cherry-picking examples of poor practice and making damaging allegations.

“The demands by Dr Goldacre and the BMJ to release patient-level clinical trial data are irresponsible with potentially harmful consequences for future medicine development,” said PhRMA executive vice president Josie Martin. “The recommendations would jeopardise patient privacy and could serve as a deterrent to individuals considering participation in trials.”

Leading the pack

Be that as it may, one pharma company has decided to take the plunge. GSK – putting the recent past behind it - has signed up to AllTrials. As yet the only pharma company to do so, GSK is pledging to publish trial data and CSRs dating back to the company's formation in 2000 for all its medicines, once they have been approved or discontinued from development and the results have been published. No small job, GSK is giving priority to CSRs for its most commonly-prescribed drugs.

All companies, academics and researchers “have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit,” explained Patrick Vallance, GSK's president, pharmaceuticals R&D. It is fair to say that this puts GSK some way ahead of the pack but Godlee has suggested other firms need to think hard about their own positions.

“GSK is getting all the credit, which doesn't seem fair,” she said. “Other pharma companies can claim that high ground. A call for transparency does not threaten the pharma industry.”

Susie Hackett, director of communications at Roche UK, has already admitted that the company was tardy in taking hold of the Tamiflu situation. “Roche is listening and recognises calls for our industry to be more transparent,” she said. “We could have been more active and engaged in the debate.”

Roche's compromise on Tamiflu data sees the company proposing to allow access to anonymised patient-level data on a case-by-case basis only. Requests would be evaluated by the company and an independent body, after the completion of regulatory reviews in the US and EU. Critics have been underwhelmed.

Call and response

So how would releasing more data actually work? Three problems have got pharma particularly steamed up: how to protect patient anonymity, how to guard intellectual property (IP) and how to ensure commercial confidentiality.

The European Medicines Agency (EMA) is working on how it will release clinical trial data from 2014, and reports from its working parties on this are expected shortly. One thing Europe's pharma trade body, the European Federation of Pharmaceutical Industries and Associations (EFPIA), is sure of is that it is dead against “indiscriminate” transparency. “We believe it is both feasible and necessary to balance the needs of personal privacy and commercial confidentiality, while providing the level of transparency needed to support public health decision-making,” the organisation said.

EFPIA board member Roch Doliveux, who is also chief executive of biopharma firm UCB, voiced the concerns of many in the sector. “I support the notion of transparency, but I don't support the notion of voyeurism,” he said. “There has to be complete transparency with regulatory authorities and every expert authority in the field. But the idea of posting on the net even patient level data – that is overload of information and it leads to misinformation and it is really, really bad for patients.”

The political and commercial winds are blowing in the direction of greater transparency

Goldacre is impatient with this attitude, saying that patients can be trusted to make up their own mind. “People aren't stupid,” he said. “It is okay [for pharma] to share complexities and shortcomings.”

Protecting IP is still a major worry for firms though. “Transparency in the competitive phase of trials would be destructive for research,” suggested Doliveux.

The resources that it will require to publish all this information is another big issue. For example, GSK will redact patient data in the CSRs and their appendices to ensure confidentiality, but has admitted it will take a dedicated team “a number of years” to do this.

There are also legitimate caveats over the issue of publishing historical data – which could perhaps lead to retrospective class actions against companies shown to have been in some way complicit.

Building momentum

Yet for all this, the mood music is getting steadily louder. Much of pharma has been hostile to Goldacre, accusing him of aggressive self-promotion, of simplifying complex issues and even of scaremongering. However, as Cochrane founder Sir Iain Chalmers - a veteran of the battle to get pharma to publish more of its data - said recently: “Thirty years of having a gentlemanly discussion have done bugger all”.

What Bad Pharma and AllTrials have undoubtedly done is to turn up the volume. The discussions may still be on the gentlemanly side, but publicity has given them greater impetus and exposure. The political and commercial winds seem to be blowing gently in the direction of greater transparency – although whether this movement is, as Goldacre believes, an unstoppable “juggernaut” remains to be seen.

http://www.pmlive.com/pharma_news/bringing_trial_data_out_of_the_shadows_476021?

Actavis in talks to buy Warner Chilcott

2013-05-11T23:09:00.001+01:00

By David Welch and Drew Armstrong – 11 May 2013

The largest US maker of generic drugs, Actavis, is in talks to buy Ireland-based Warner Chilcott.

Warner Chilcott emerged out of Northern Ireland's Galen in 2004 and is valued at about $3.76bn (€2.8bn).

A tie-up with Dublin-based Warner Chilcott would lower global giant Actavis's tax burden over time, and would help the generics maker expand in women's health, said one person close to the deal.

The discussions come just a few weeks after Actavis weighed a merger with fellow generics maker Valeant Pharmaceuticals International, said the sources, who asked not to be named because the negotiations are private. There's no guarantee a deal will emerge.

"It would make sense," Kevin Kedra, an analyst with New York-based Gabelli & Co, said. "There's a lot of overlap, with where Actavis is trying to go on the branded size and with Warner Chilcott's women's health franchise."

http://www.independent.ie/business/irish/actavis-in-talks-to-buy-warner-chilcott-29258274.html

Sales rep sues Merck, alleges sex discrimination

2013-05-10T09:40:00.001+01:00

YORK - A Merck & Co. sales representative is suing the drugmaker for at least $100 million, saying it does not give women equal opportunities for advancement and punishes employees for maternity leave.

Kelli Smith, who has worked at Merck since 2004, says in the lawsuit that the company's sales plans create incentives to discriminate against women, that women are discouraged from advancing their careers and are told they have to choose between being mothers and taking bigger roles at the company, and that men get more opportunities to meet senior managers and develop important contacts. She said the company retaliated against her for drawing attention to the issues.

http://www.philly.com/philly/business/20130510_Sales_rep_sues_Merck__alleges_sex_discrimination.html

Getting to the Right Relationship Between Doctors and Drug Companies by David A Shaywitz

2013-05-09T03:30:00.001+01:00

dvortygirl/Flickr

The pharmaceutical industry is held in remarkably low esteem right now. It's seen as a bunch of nefarious pushers who pay off vulnerable doctors to prescribe their latest expensive, mediocre product. Physicians who work with pharma companies areconsidered especially suspect, routinely described as "cozy," "in bed with industry," and "on the take."

Wanting to develop important new medicines that improve health and save lives is what gets every industry researcher I know up in the morning.

CEO of Kaiser Permanente Robert Pearl wrote last month in a Wall Street Journal commentary, "Patients will continue to be at risk for potential harm until physicians themselves stop participating in these relationships [with industry]." He added that Kaiser, a managed care consortium of almost 15,000 physicians and 9 million patients, prohibits physicians from "being paid to 'consult' with drug and device companies."

I think they have it backwards, though. Drug companies -- at least every one that I've worked for or consulted with -- would like to develop important new medicines that improve health and save lives. That's what gets every industry researcher I know up in the morning, and what keeps them going through the many highs and lows that characterize the scientific process.

While the biological foundation that enables most contemporary drug discovery was largely built in academic labs, moving from research publication to validated drug is long, difficult, expensive, and very tricky -- not least because many academic findings turn out not to be robust enough to support new drug development.

To advance even a solid idea requires, ideally, close communication between industry and outside experts: university researchers, who often developed the science and understand it the best; practicing clinicians, who can describe where the medical needs are the greatest, and what properties an ideal therapeutic would have; and patients, of course, who understand better than anyone else what they need, and where existing approaches may fall short.

We should strive to cultivate, not demonize, these sorts of interactions.

The signaling problem that's developed is especially unfortunate: we're taught to distrust the physicians and university researchers who consult the most with industry, yet it's often these experts who are the smartest scientists or the most experienced clinicians -- that's why companies seek them out. In essence, we're stigmatizing (and increasingly, seeking to exclude) experts who are arguably the most worthy of our admiration.

It's true that industry has seen its share of bad actors; so has academia; yet in both cases, we should be careful about generalizing from sensationalized examples to condemn everyone who works in pharma -- or in universities, for that matter.

We're taught to distrust the physicians and university researchers who consult the most with industry, yet it's often these experts who are the smartest scientists or the most experienced clinicians

It's also true that drug companies seek to turn profits, which many seem to regard as fundamentally incompatible with wanting to do good. But Whole Foods CEO and "Conscious Capitalism" champion John Mackey has it right when he explains , "Making high profits is the means to the end of fulfilling Whole Foods' core business mission. We want to improve the health and well-being of everyone on the planet though higher quality food and better nutrition, and we can't fulfill this mission unless we are highly profitable." I enjoy farm-raised salmon and oven-roasted kale as much as any Californian, but I'd like to think that the pursuit of new medicines represents at least as worthy an endeavor.

Looking ahead, many worry that increased focus on cost will further fray doctor/industry relationships, but I see a far more hopeful future.

Increasingly, everyone in health care -- providers as well as medical products companies -- will be asked to demonstrate the valueof their goods and services, asked to prove that they are really making a difference.

Doctors who are paid based on quality metrics, or who are "accountable," and own some of the risk, will be highly motivated to think especially critically about their therapeutic choices, and are likely to discover many instances where a powerful new medicine turns out to provide the best, most economical option -- when total costs are considered.

Medical products companies will also be under tremendous pressure to deliver medicines capable of rigorously demonstrating value . To understand what would be worthy of use, drug companies will need to speak to clinicians; rather than stick their heads in the sand, Kaiser physicians should engage with medical product companies, participate in this dialog, and help increase the chances that they'll be able to prescribe better medicines to patients in the future. Participating experts also deserve to be compensated for their time, as Kaiser can both well appreciate and precisely calculate.

Emerging information technologies are likely to play increasingly important roles in both assessing and enhancing value . Not surprisingly, leading academic digital health initiatives -- including both the Center for Assessment Technology and Continuous Health (CATCH) at MGH and MIT, which I co-founded, and therecently announced Center for Digital Health Innovation (CDHI), at UCSF, both explicitly seek to cultivate partnerships with industry, in particular the tech powerhouses of Cambridge and Silicon Valley.

"Previously, faculty struggled to bring promising concepts to fruition," explained CDHI director Dr. Michael Blum. "Good ideas will no longer die on the vine."

That's ultimately the key issue here: interdependence. Like digital health, drug development is far too important, and far too difficult, for anyone to do by themselves. To have even a fighting chance, stakeholders -- pharma companies, university researchers, clinicians, and patients -- need to work together, and collaborate as if our future health depends upon it. It probably does.

http://www.theatlantic.com/health/archive/2013/05/getting-to-the-right-relationship-between-doctors-and-drug-companies/275605/

The Drug Industry’s Invisible Influence on Prescribers: Key Opinion Leaders and Publication Planning -by Andrea Tarr

2013-05-09T03:17:00.001+01:00

Two of the speakers at the ISDB symposium in Vancouver—Sergio Sismondo (Professor of Philosophy, Queen’s University, Kingston, Ontario) and Adriane Fugh-Berman (Georgetown University Medical Center, Pharmacology and Physiology, Washington, DC)—highlighted techniques in knowledge manage- ment used by the drug industry to promote their products.
In the pharmaceutical industry, knowledge is a resource to be accumulated, shaped and deployed to best promotional effect.

To this end, the industry produces an abundance of special-purpose knowledge, flooding the markets it is most interested in, and distributing it via its most effective channels. This activity includes managing the production of published articles (ghost management) and using third parties, including influential physicians (known as key opinion leaders) to convey marketing messages.

Ghost management of articles is the process by which companies and their agents produce and release articles in medical journals and posters at meetings to establish key marketing messages.

1. Sismondo, S. Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med 2007 4(9): e286. doi:10.1371/journal.pmed.0040286.
2. Fugh-Berman A, McDonald CP, Bell AM, Bethards EC, Scialli AR. Promotional tone in reviews of menopausal hormone therapy after the Women’s Health Initiative: an analysis of published articles. PLOS Med 2011; 8(3). http://www.plosmedicine.org/article/info%3A- doi%2F10.1371%2Fjournal.pmed.1000425.
3. Fugh-Berman AJ. The haunting of medical journals: how ghostwriting sold “HRT’’. PLoS Med 2010; 7(9). e1000335. http://www.plosmedicine.org/article/info%3A- doi%2F10.1371%2Fjournal.pmed.1000335.

http://www.isdbweb.org/publications/download/176

J&J Corporate Image Campaign Fails to Talk the Walk

2013-05-08T12:17:00.007+01:00

The company is running some serious heartwarming, slice of life feel-good TV and print this week, and plans to spend between $20 and $30 million telling us that Johnson & Johnson JNJ is “for all you love” Forbes previewed it when it was announced at the company’s shareholder meeting in late April.

Marketers would do well to understand the rationale for the campaign, and then make sure they don’t repeat the mistake.
http://www.forbes.com/sites/jonathansalembaskin/2013/05/08/jj-corporate-image-campaign-fails-to-talk-the-walk/?

Baxter's Alzheimer's disease drug fails in late-stage trial

2013-05-08T09:06:00.001+01:00

JULIE STEENHUYSEN
In a blow for Alzheimer's patients, Baxter International Inc said it will scrap late-stage trials of its antibody treatment for the disease after the drug failed to improve cognitive decline and functional ability in patients.

Baxter's treatment, known as Gammagard, did show a benefit in some patients with moderate disease and in those who are carriers of a gene known as ApoE4 that raises the risk of Alzheimer's. The company said it will continue to analyse results in these populations, but more trials would be needed to support the drug's approval.

An earlier study of the treatment released last summer showed the drug help stabilise the disease in four patients for at least three years, raising hope that the drug from Baxter International Inc will prove effective in larger trials. Most Alzheimer's patients typically decline over three to six months.

http://www.stuff.co.nz/national/health/8646139/?

The Apprentice - Anyone know who drug rep Rebecca Slater from Wigan worked for?

2013-05-07T21:24:00.001+01:00

http://www.bbc.co.uk/programmes/p017h0j7/profiles/rebecca-slater

Introducing FindZebra - The search engine for difficult medical cases.

2013-05-07T17:15:00.001+01:00

http://findzebra.compute.dtu.dk/FindZebra/default/index

FindZebra is fast, intuitive, and simple to use, with an interaction modeled on familiar web search engines. We strive to accomodate the busy medical professionals through the optional clustering of search results by medical condition and the availability of a mobile version accessible on phones and tablets.

Canada - Fired doctor sues B.C. Liberal government, claims interference to protect party donors

2013-05-07T06:51:00.001+01:00

The claim was made by Dr. William Warburton, an expert in health-data research who was previously under contract with the Ministry of Health investigating the effects of atypical antipsychotic medications.

Warburton is arguing that the Ministry’s alleged wrongful termination of his contract caused him a loss of more than $100,000 and that comments attributable to MacDiarmid were made “falsely and maliciously” and amount to defamation.

None of the allegations contained in the claim’s statement of facts have been proven in court. The defendants have yet to file a statement of defence.

The court file states: “The Province's acts against Dr Warburton are part of a bad faith program by the Defendants to end the investigation of harmful effects of drugs which risk leading to diminishing payments to their political contributors.”

It notes that Warburton was investigating “harmful side-effects, including mortality, and risk assessment of drugs purchased by the Province through its programs,” and that his findings “had the potential of disrupting financially significant payments to large pharmaceutical companies, many of whom were major contributors to the Liberal Party”.

Warburton’s contract was terminated in relation to an ongoing investigation into how some ministry staff shared pharmaceutical data. According to a January 14, 2013, government media release, “personal health data was accessed for research purposes without authorization”.

That document states that none of the information in question included individuals’ names or social-insurance numbers and that “the ministry’s investigation has concluded that there is a minimal, if any, risk of inappropriate use of personal information.”

To date, the Ministry has fired seven people as a result of the investigation. Subsequently, at least three lawsuits claiming wrongful dismissal have been filed against the ministry. One of the fired researchers, Roderick MacIsaac, committed suicide in January, according to an article in Vancouver magazine.

In reference to that investigation, Warburton’s claim states: “The Province knew or ought to have known that its investigation was flawed, superficial, politically motivated and conducted by novice, unqualified, inexperienced investigators.”

In addition to the ministry’s termination of contracts, the B.C. Liberal government has eliminated funding for the Therapeutics Initiative, a renowned independent pharmaceutical watchdog that has operated out of UBC since 1994. On May 1, the Straight reported on what health-care workers described as a provincial clampdown on research data that amounts to a threat to public safety. That story detailed how the ministry has placed a lock on pharmaceutical data and cut researchers’ access to information that could be useful in saving lives.

The Ministry of Health and the B.C. Liberal Party did not make a representative available for an interview by deadline. In recent weeks, the Straight has made numerous requests to interview MacDiarmid with both the Health Ministry and the B.C. Liberal Party; those invitations have been refused or gone unanswered.

Warburton’s claim includes a list of pharmaceutical manufacturers that might have been affected by his findings. It names Bristol Myers Squibb, AstraZeneca Canada Inc., Eli Lilly Canada Inc., Janssen Inc., Pfizer Canada Inc., and Novartis Pharmaceuticals Canada Inc.

Alan Cassels, a drug-policy researcher at the University of Victoria, recently did an analysis of pharmaceutical corporations’ and drug lobby groups’ campaign donations to the B.C. Liberals and the provincial NDP. He told the Straight that he found pharmaceutical companies collectively gave more than $546,000 to the Liberals from 2005 to 2012 (the most recent year for which data is available). That number is 11 times what it is for the B.C. NDP, Cassels noted (although the NDP data covered only the years 2009 to 2012).

http://www.straight.com/news/379156/fired-doctor-sues-bc-liberal-government-claims-interference-protect-party-donors

Pfizer goes online with Viagra, potentially changing pharmaceutical supply-chain dynamics

2013-05-06T15:50:00.001+01:00

Pfizer said Monday that it would begin selling its iconic erectile dysfunction drug Viagra online - a prescription is still required - in hopes of boosting profits and thwarting counterfeit online pharmacies.

As noted in Linda Johnson's Associated Press story, the pharmaceutical industry will watch this closely because it could change the dynamics of how drugs are delivered through the many layers of the current system.

Pfizer will market the drug through viagra.com, but CVSCaremark will handle the online processing. Patients must still get a doctor's prescription and the web site walks patients through the paperwork (insurance, billing information) required.

http://www.philly.com/philly/business/homepage/Pfizer-goes-online-with-Viagra-potentially-changing-pharmaceutical-supply-chain-dynamics.htm

Asthma drug Singulair linked to suicidality

2013-05-06T14:07:00.001+01:00

Monday, 6 May 2013, 12:58 pm
Article: Martha Rosenberg
Asthma drug Singulair linked to suicidality

by Martha Rosenberg
May 6, 2013

World sales of Merck's blockbuster asthma drug, Singulair, were about $5 billion a year until last year when its patent expired in the United States. But the drug also has a darkening cloud over it. The Australian medicine watchdog has received 58 reports of adverse psychiatric events in children and teenagers taking Singulair since 2000 and reports have also surfaced in the US.

Singulair, a leukotriene receptor antagonist or LTRA, is one of several "add-on" asthma drugs that were debuted in the last decade. Patients are supposed to add the new, "asthma controller" drugs to their regular rescue inhalers and inhaled corticosteroids not replace them. Ka-ching.

In the US, Singulair was heavily marketed for minor childhood allergies, in addition to asthma, and sold in a cherry-flavored chewable formulation. Merck had marketing partnerships with Scholastic, a leading educational publishing group, and the American Academy of Pediatrics, reported the US' Fox News.

Sales pieces from the Scholastic/ Merck partnership cajoled parents, "When your child breathes in an asthma trigger, such as pollen from trees or weeds, the body releases leukotrienes (loo-ko-TRY-eens)" which Singulair blocks. But they also told parents their children could experience, "hallucinations (seeing things that are not there), irritability, restlessness, sleepwalking, suicidal thoughts and actions (including suicide), trembling, and trouble sleeping," on the drug. At least they wouldn't be sniffling.

In 2009, after 15-year-old Cody Miller of Queensbury, NY was given Singulair for hay fever and took his own life 17 days later, the US Food and Drug Administration (FDA) gave Singulair a stronger warning for "neuropsychiatric" side effects. The next year, Fox TV, a leading US television network, reported that children on Singulair are being diagnosed with ADHD, Tourette Syndrome and serious behavioral and neurological conditions caused by the drugs. Most are "cured" when they go off the drug but some are not and are then given other damaging pediatric behavioral drugs.

Over 100 parents on the popular US drug-rating web site askapatient.com, corroborate the evidence, reporting that Singulair caused hyperactivity, tantrums, depression, crying, school trouble, facial tics, strange eye movements and self-harm in their children, some as young as one year old. Many of the children were prescribed Singulair for sniffles and wheezing which were called early symptoms of asthma, commensurate with Pharma's "early treatment" business model.

"Last night was a complete meltdown over every single thing that could have possibly been a minor annoyance, such as not being able to squeeze enough toothpaste out of the tube, which culminated in a 30-minute screaming and crying bonanza," writes the mother of a 7-year-old who has been on Singulair for six months. "I was reading stories to her tonight, and she must have popped her jaw open at least 40 times over the course of two
books (mouth open wide like a yawn in fast-forward). I was keeping an eye on her, and a few times I asked her why she kept doing that and she said she didn't know, and she thought maybe her mouth was 'itchy.'"

"Do NOT recommend this drug to other parents," writes another mother. "4 year olds that suddenly talk about killing themselves are influenced by a DRUG!!"

Even adults are put on Singulair for minor reasons with major consequences. "I was perfectly healthy prior to taking this drug," reports a 53-year-old woman about Singulair on the askapatient web site. "Doc noticed I had a little wheeze and prescribed Singulair. I began to have the dreams, insomnia and depression after the first few days," which led to "suicidal thoughts," she says.

Like many of Big Pharma's blockbuster drugs, Singulair made billions by selling "diseases"--in this case childhood allergies and asthma. And like many blockbuster drugs, the true dangers have only emerged since the drug went off patent and the profit potential was gone.

*************
Read more about underreported prescription drug dangers in Martha Rosenberg's acclaimed expose, Born with a Junk Food Deficiency, available in bookstores, libraries, and online.

http://www.scoop.co.nz/stories/HL1305/S00036/asthma-drug-singulair-linked-to-suicidality.htm?

Happy Fiftieth Birthday Valium - by Will Nicholl

2013-05-05T15:33:00.000+01:00

A recent report published by the charity MIND – which paints a troubling, and important portrait of Britons driven to alcohol, cigarettes and prescription medication to differing extents by the stress of working-life – makes it a prescient moment to cast the mind back to a series of very strange goings-on.

The time was the late 1950s, the place a hospital canteen in the North of England. Perhaps pickings in that week’s British Medical Journal had been lean – or patients that day exasperating – because the topic of conversation was a newspaper article about a Swiss circus-master who had found a drug to calm his tigers.

A series of regrettable decisions – which still piece together to make faint sense, like fragments of an argument remembered after a long lunch – prompted one young doctor to phone the drug’s manufacturer. His offer was to test the compound, and its predecessor, on the then unwitting inhabitants of Sheffield. After he, and others, relayed the positive results to Hoffman La Roche, Valium – a drug which might otherwise have remained the preserve of big cats – was marketed in the UK in 1963.

Few decisions have proved more detrimental to the reputation of young doctors – or damaging to popular culture – than this show of youthful over-enthusiasm.

Still known as Mother’s Little Helper – but more likely to be given to nervous air passengers, than the anxious housewives who The Rolling Stones describe in their song – Valium has been eschewed, for the most part, by modern society. The drug peaked in popularity in the late 1970s, before tumbling from grace in the largest ever class-action lawsuit attempted against drug manufacturers in British history.

Anyone who asks a doctor for the drug is likely to be brow-beaten – while any prescription will be issued with a whispered caution – or at worst a mild ticking-off. On account of the tranquilizer’s ‘pleasant side-effects’ – which led its inventor’s wife to forbid him from taking it – Valium is now widely abused. Yet it is remembered as the first blockbuster drug – a wonder pill, sold aggressively using gender stereotypes usually confined to cave-art.

One advert, entitled ’35, single and Psychoneurotic’ describes ‘Jan’ – a frail, wholesome lady, resembling Betty Crocker – who has ‘never found a man to match up to her father’. Jan’s big problem is that she ‘realises that she’s in a losing pattern – and may never marry’.

Considerably fewer adverts seem aimed at men – but one, ‘Women dominate his universe – psychic tension can rule his life’, shows, using a series of stern matriarchs – complete with crimped care and pantomime pouts – how nagging wives and mothers-in-law might drive the modern man to Valium.

If Roche’s adverts seem more concerned with bumblingly undoing every victory in the drive for gender-equality since female suffrage, then its legacy – in the way we use medication – remains wide-reaching and troubling. Valium may be waning – but its sales, which exceeded one billion dollars, reveal a link between over-medication and over-consumption, which lingers to this day.

Commenting in its inventor’s obituary for The New York Times, Dr. Jeffrey A. Lieberman describes how Valium constituted a milestone in psychopharmacology, by helping to create generations of drugs which were more precise and selective in their activity. These drugs now exist, but the way we use them – writing 46.7 million prescriptions in 2011 – represents an approach to depression in Britain, which, 35 years after Valium’s heyday, is no less glum or scattergun.

The new antidepressants – or Selective Serotonin Re-uptake Inhibitors – work differently to tranquilizers like Valium, but have replaced them as the weapons of choice for treating anxiety. Prozac, which recently celebrated its 25^th birthday, is the most distinguished – and arguably as notorious. Troubled journalist Elizabeth Wurtzel wrote about it. American psychiatrist Peter D. Kramer listened to it. British politician Nick Clegg complained about it, in a speech to The Guardian Public Services Summit in 2008.

In the speech, Clegg made some excellent points about Britain’s overreliance on medication, and how it features too prominently in our treatment of mental-health problems, when for many therapy would be more effective. Yet Clegg – like many others – misses the point. The rate at which we prescribe these drugs does not necessarily mean that we are lacking psychological services – though we certainly are – but that we are over using drugs which don’t work.

Professor Malcolm Lader, Emeritus Professor of Clinical Psychopharmacology at King’s College London – who was first to warn of Valium’s dangers – was keen to place the problem of the tranquilizers, and the SSRIs, within the same curve.

‘This is not one problem,’ Professor Lader said. ‘It’s part of a general over-reliance on psychotropic medication, particularly for people who are less ill, or who may, in fact, be within normal limits. They are unhappy, haven’t got help with things or haven’t got social support, and they don’t have access to psychological treatments, which are usually very effective for them.’

It’s critical to point out that the SSRI antidepressants are indispensable to those suffering from serious anxiety disorders, but the evidence that they work for others – who may fall within normal ranges of emotion – is at very best, scant. In short, if like most, you lead a busier life – involving more debt, less fun, demanding children, and a house which is depreciating in value at the same pace as a Greek time-share – an antidepressant is unlikely to help.

Like Valium – which first gave lie to the belief that drugs could comfortably ameliorate all worry without serious consequences – there is also an increasingly robust body of evidence against the SSRIs. Many of their problems relate to their ability to cause, or worsen, suicidal feelings, particularly in the young. Each drug has been implicated in scandal – most notably Paroxetine, or Seroxat.

Though cheap, a large number of the 46.7 million prescriptions written in 2011 may not have actually helped anyone – which means our use of them to treat those experiencing life’s ups-and-downs equates to behaviour which is baffling and recalcitrant. The saddest thing, though, is that we are giving false hope to those who are suffering – when it may actually be kinder, if harder – to tell them that antidepressants won’t help.

Mother’s Little Helper is synonymous with mass-medication – but on its 50^th‘birthday’ we prescribe antidepressants at a far higher rate than we ever did at the height of its popularity. By convincing us that happiness can be bought safely and easily with a pill, the drug constitutes a work of nefarious genius.

http://blogs.spectator.co.uk/coffeehouse/2013/05/valiums-50th-birthday-little-to-celebrate/?