Petition by Professor David Healy - please sign if you agree

Let us see Drug Data! Drug hazards are not “trade secrets”!

Drug companies maximize the sales of new drugs by hyping their benefits while downplaying significant risks. In 2010 the European Medicines Agency began releasing patient-level data from the clinical trials used to approve new medicines in Europe – a development hailed by American, and European researchers and researchers around the world as a major step towards drug safety.

This process has been shut down by a lawsuit taken by two American corporations – AbbVie, makers of Humira, the number one selling medication in the world with projected sales of $10 billion in 2013; and InterMune, whose pulmonary-fibrosis drug Esbriet has recently been approved in Europe at a cost of over $40,000 per year.

AbbVie and InterMune have filed suit to deny access to the data from their trials on the benefits and harms of these drugs, claiming these vital facts are “trade secrets” whose release would harm their profits. Their action has led to the shutdown of the entire public-access program, leaving millions of patients worldwide, and their doctors, in the dark.

We call on AbbVie and InterMune to drop their European Union lawsuit and release all patient level data on Humira, Esbriet and their other products. Vital data on drug safety should never be hidden as a “trade secret.” By copying this petition to President Barack Obama and members of his Cabinet we call on them to ensure that meaningful public access to clinical trial data becomes the policy of the FDA and is written into any international trade agreements governing the sale of prescription drugs and devices.

Copies to: 
President Barack Obama; 
Margaret Hamburg, M.D., Commissioner, Food & Drug Administration; 
Secretary General Ban Ki Moon, United Nations; 
World Health Organization Director Dr Margaret Chan.

To: 
Richard Gonzalez, c/o Gregory Miley, Group Head, External Communications, AbbVie 
Daniel Welch, c/o Jim Goff, VP Corporate Communications

Please drop your legal action blocking access to EMA clinical trial data. 

Sincerely, 
[Your name]

http://www.change.org/petitions/richard-gonzalez-of-abbvie-and-daniel-w

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Peter C Gøtzsche, Professor of Clinical Research Design and Analysis, and Director, The Nordic Cochrane Centre, and Chief Physician, Rigshospitalet and the University of Copenhagen, Denmark

http://www.amazon.co.uk/Deadly-Medicines-Organised-Crime-healthcare/dp/1846198844

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1boringoldman explains data transparency

http://1boringoldman.com/index.php/2013/09/14/a-bottom-line/

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AllTrials Update

Dear Friends

Support for AllTrials around the world is growing and we need to keep it that way as we reach some crucial debates.

The European Medicines Agency’s proposed policy on publishing and sharing information from clinical trials is open for comment until 30^th September. Many of you have been involved in getting your organisations to sign up in support of AllTrials for all trials registered and all results reported. The EMA’s proposals will help to make that happen. But organisations that want to slow or restrict transparency are already making their views known. Please send comments to the EMA before the deadline. Even if you can only comment briefly, please do. It is vital that they hear from the range of bodies and individuals who want an end to hidden trials. We will publish our response next week and share it with you in case that helps.

Last month we published the AllTrials manifesto, which sets out challenges that regulators, companies, researchers, professional bodies, journals and others are addressing (or should be) to make sure that all trials are registered and results reported. There have already been meetings, discussions and documents enlarging on some of the points in there, such as how registries can work together to cross reference registered trials and what journals, funders and ethics committees can do to check up on registration.

We’re going to link these into the document and map out progress in different parts of the medical research system. Meantime, here is some of the news:

• In the UK, the Health Research Authority is about to implement its new policy to ensure all UK clinical trials are registered in a publicly accessible database. From 30th September it will be a breach of good research practice to fail to register a clinical trial.

• PLOS Medicine announced that it will now consider retrospectively registered trials for publication.

• The British Pharmacological Society and the American Society for Pharmacology and Experimental Therapeutics have announced their support for the publication of negative findings from early clinical trials.

• A new paper in the BMJ shows that only 28% of medical journals require a clinical trial reported in their pages to be registered.

• Trial registries around the world are going to work together to identify practicable ways to complete missing trial information.

We put campaign news onto our website at www.alltrials.net every day. We are just about to move on making the website, which we put up in a rush at the start, a more rapid and comprehensive way to keep up with the campaign developments across the world. If you have been visiting it and have suggestions please email in the next few days.

Best wishes                                                                        

Síle

  
www.alltrials.net

Please donate at https://www.justgiving.com/alltrials

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Ketamine, A Darling of the Club Scene, Inspires Next-Generation Antidepressants [Part 3]

Recent experimental research showing that ketamine, an anesthetic and club drug (Special K), can relieve depression quickly has intrigued a number of major pharmaceutical companies. Depression, it goes without saying, affects huge numbers and a fundamentally new and effective pharmaceutical approach to treating the disorder hasn’t emerged in decades.

The enthusiasm for ketamine is such that physicians, often working out of small clinics, have already started prescribing low doses of the generic anesthetic off-label for fast relief of le cafard—and drug companies are contemplating whether to get into the act by creating new drugs based on ketamine’s biochemistry  (Read part 1 and part 2).

A Johnson & Johnson subsidiary in Europe has gone as far as midstage clinical trials for a ketamine nasal spray. The trial there uses a slightly altered version of ketamine (esketamine, the “s” isomer for techies), which omits part of the molecule and leaves the most pharmacologically active portion in place, enabling less of the compound to be administered, perhaps then lessening any club-drug side effects. “You can get away with a 30 to 40 percent lower dose,” says Husseini Manji who leads neuroscience research at Johnson and Johnson.

The U.S. Food and Drug Administration has put Johnson & Johnson’s version of esketamine on a fast track for approval, although, even if all goes well, patients may still have to wait a few years to get a script. Esketamine, already used as an anesthetic in Europe, is not the only idea on the table. Ketamine appears to work (details still coming in from labs) by blocking a docking site, or receptor, on a neuron—in this case a spot where the essential signaling molecule glutamate attaches. The blockade triggers a complex chemical cascade that ends up restoring an impaired neuron’s ability to communicate with other brain cells.

If that process is multiplied over millions of neurons in two critical brain regions—the hippocampus and the prefrontal cortex—drugmakers hope the blues will lift like a cloud. Johnson & Johnson is working on other projects that tap into ketamine research—one of which is  looking at a wholly new drug that targets selected portions of this glutamate receptor in the hope of fine-tuning the antidepressant effects further. Other large pharmas, including AstraZeneca Merck and Roche, are pursuing similar strategies.

If a formal FDA imprimatur is forthcoming, the issue of off-label prescribing may persist. One issue, which must be resolved through clinical trials, not by trial and error at ketamine clinics, is whether a spray works as well as intravenous infusions. The generic non-isomer form of ketamine is already used off-label as a nasal spray and not all reviews are positive. “It helped but not as much as the infusion,” says Dennis Hartman, a patient with depression who sought help from ketamine-prescribing physicians, one of whom provided a spray.

A ketamine-like drug, if approved, will inevitably be more expensive than the generic anesthetic deployed in upstart depression clinics. Esketamine or one of its FDA-sanctioned cousins will probably be covered via a health insurance plan, but insurers’ love of low-cost generics may mean that consideration could still be given to covering plain-vanilla ketamine, even if it hasn’t run the clinical-trial gantlet. In fact, Carlos Zarate, a leading ketamine researcher who works at the National Institute of Mental Health, has even fielded calls from insurers wanting to know more about the generic drug to determine whether to put it on their formularies.

It is also still unclear whether the medical establishment, with a helping hand from law enforcement, may have to come to terms with what might be described as off–off-label prescribing—the depressed patient without insurance who learns about the possibility of a mood-altering quick fix and engages in the unsupervised self administration of Special K purchased in a club or on the street.

Hartman knows someone who went this route. “This personal friend received a ketamine infusion [from a physician],” Hartman says. He achieved very strong relief, very similar to mine. After he relapsed, he went and sought this illegal form and he did not get the same effect.” If Johnson & Johnson’s esketamine trials result in a salable drug, the company has  plans to safeguard it from the hands of those who want to divert it for recreational use.

What to do about ketamine is a question being posed everywhere, not just stateside. A New Zealand government official issued a report in July that instructed health boards throughout the country to scrutinize off-label prescribing more closely after a complaint lodged against a ketamine-supplying physician.

Inevitably, the grassroots appeal of an old drug with a new use that might provide hope for the deeply depressed is starting to generate its own social networks. As many as 20 physicians involved in prescribing ketamine interact on the Linked-In group called Ketamine for Psychiatry. Hartman is involved with setting up a new Web site, The Ketamine Advocacy Network, to foster activism among patients—another echo of medical marijuana’s legacy.

The desperation to find new antidepressants means that ketamine will remain an object of fascination for mental health professionals and their patients. In the next five years, regulators and physicians are going to have to figure out how, if at all, the drug fits into the psychiatrist’s pharmacopoeia. In the meantime, doctors and patients are increasingly adopting their own home-grown solutions.


About the Author: Gary Stix, a senior editor, commissions, writes, and edits features, news articles and Web blogs for SCIENTIFIC AMERICAN. His area of coverage is neuroscience. He also has frequently been the issue or section editor for special issues or reports on topics ranging from nanotechnology to obesity. He has worked for more than 20 years at SCIENTIFIC AMERICAN, following three years as a science journalist at IEEE Spectrum, the flagship publication for the Institute of Electrical and Electronics Engineers. He has an undergraduate degree in journalism from New York University. With his wife, Miriam Lacob, he wrote a general primer on technology called Who Gives a Gigabyte? Follow on Twitter @@gstix1.

http://blogs.scientificamerican.com/talking-back/2013/09/13/ketamine-a-darling-of-the-club-scene-inspires-next-generation-antidepressants-part-3/

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Shouldn’t Hip & Knee Replacements Come With Warranties?

(Great Beyond)

Most new products, from cheapo wristwatches to new cars, often come with manufacturers’ warranties. But that isn’t the case for most hip and knee implants, meaning that a growing number of Americans are having expensive devices put in their bodies without any written assurance from the manufacturers.

More than 4 million Americans currently have knee implants, and that number is expected to grow as life expectancy rates improve. In 2011 alone, there were 711,000 knee replacements performed. That same year, around 500,000 Americans received hip replacement implants. The combined annual demand for these two surgeries is expected to reach 4 million by 2030, and more than half of those patients will be under 65 years old, meaning they will likely be living with the implants for quite some time.

Yet, of the six major manufacturers of knee replacement implants — Biomet, DePuy, Smith & Nephew, Stryker, Wright, Zimmer — only one (Biomet) offers any sort of warranty, and that’s only on one partial knee implant model.

According to our coworkers at Consumers Union, between 2003 and 2013, these manufacturers recalled 709 different devices and components. During that same time period, these companies recalled 578 different recalls related to hip implants.

In both types of implant, the overwhelming majority of recalls were considered Class II recalls, which the FDA describes as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

But more than 10% of all hip implant recalls were categorized as Class I, described by the FDA as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Most of the Class I hip implant recalls were for products made by Stryker.

Some patients with metal-on-metal hip implants have experienced debilitating symptoms — including cardiomyopathy and neurological problems — from debris that flakes off the device over time. The FDA has thus proposed a more rigorous review process for metal-on-metal hip implants.

As we’ve mentioned in the past, FDA approval process for many new implanted devices is streamlined so that each new product need not undergo individual review it the manufacturer can demonstrate that the device is “substantially equivalent” to one that’s already on the market. This is similar to the process FDA uses for giving the go-ahead to cigarettes, which implies the agency holds cancer-causing products to the same standards as implanted medical devices.

Given that most new hip and knee implants are very similar to what’s already being used, the devices are fast-tracked without ever being tested to see if they are safe and effective.

In a 2012 poll, the overwhelming majority of American consumers said they believed in a rigorous review process for new devices, and Consumers Union was one of several patient safety groups that urged Congress to require more pre-market testing of implanted devices during last year’s reauthorization of the Medical Device User Fee Act. Alas, patient advocacy once again lost out to the deeper pockets of the well-heeled medical device industry lobbyists.

You may not care about people with implanted devices and you may say that warranties are unwarranted because many patients are not going out of pocket for these surgeries (or the seemingly inevitable replacement surgeries), but for every failed implant that hits the market, there is an impact on the average consumer.

Even if the patient isn’t paying for the surgery, someone is footing the bill — and it’s often quite a big bill. This is compounded each time there is a replacement, as it often costs more to remove and replace an implant than it did to put it in initially. Patients often end up in the hospital for a longer period of time following these later surgeries.

Consumers Union estimates that revisions to hip and knee replacements cost hundreds of millions of dollars a year. Insurance companies aren’t going to shrug that much money off, especially when it seems likely to increase in the coming decade.

“Patients have a right to know how long medical device manufacturers are willing to stand by their products,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project. “While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty.”

“Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe,” said McGiffert. “If that’s the case, they should have no objection to offering warranties to back up those claims. Patients and taxpayers shouldn’t be on the hook for the cost of replacing devices when they fail.”

CU has already written to the manufacturers, urging each to provide a 20-year warranty with their products. The letters also clarified that an ideal warranty would:

*Cover the full cost of replacing the flawed device, including the device, surgeon and hospital costs as well as related patient out-of-pocket costs.

*Establish a clear system for patients to use, including a toll-free phone line and a registration number to track the claims process, with physicians charging the device company, not the patient.

*Not eliminate the patient’s right to sue if they use a warranty.

*Provide the patient with a full explanation if a warranty claim is denied and an appeals process for denials.

*Not disqualify patients across the board if they have specific diseases or illnesses that are not related to the failure of the device.

For those who believe that manufacturers should include warranties with their implanted medical devices, the folks at CU’s Safer Patient project have put together this handy online form to let you voice your opinion to these companies’ chief executives.

http://consumerist.com/2013/09/12/shouldnt-hip-knee-replacements-come-with-warranties/?

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Wise words

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