[indigogo]

Drug Companies Promise More Data Transparency

New York Times today
http://www.nytimes.com/2013/07/25/bu...src=rechp&_r=0

Representatives of the world’s biggest pharmaceutical companies pledged on Wednesday to release detailed data about their drugs to outside researchers, a move that was applauded by some but also seen as an effort to head off more extensive disclosure requirements that are under review in Europe.

The announcement, made jointly by the two major pharmaceutical trade groups in the United States and Europe, signals a shift for the industry, which in the past has resisted calls to systematically share its data. The proposal was unanimously approved by member companies and is to take effect on Jan. 1. It would apply to all new drugs and all new uses for existing drugs, whether approved in the United States or the European Union..........

.......... Proponents say doctors and patients need independent information — not just that provided by manufacturers — about the risks and benefits of drugs.

But as recently as February, PhRMA issued a statement criticizing proponents of data sharing, saying that releasing what’s known as “patient-level” clinical data would be irresponsible and encourage second-guessing of regulatory agencies, “which would be disastrous for patients.” Both industry groups have opposed a plan by the European Medicines Agency, which oversees approvals in Europe, to make trial data public whenever a drug is approved. A similar effort to require such data disclosure is under way in the European Parliament. On Monday, the British newspaper The Guardian reported on a leaked e-mail that detailed plans by the two trade groups to enlist the help of patient groups to try to kill the efforts in Europe.

Mr. Castellani said the plan released Wednesday should be seen as an alternative to the proposals being considered in Europe, which would have fewer restrictions on the data. Drug makers have raised concerns that patient privacy could be compromised if the data were not properly redacted, and that competitors could mine the documents to gain an advantage. Under the industry plan, companies would set up outside panels to consider requests from “qualified” researchers for a range of data and dossiers that drug companies keep on their drugs. They would also have to provide plans for how they planned to use the data.

Some researchers questioned whether the companies’ review boards would be truly independent, and bristled at what they described as restrictive requirements. But Mr. Castellani said such provisions were necessary. “Putting this out is what we think is a responsible way to meet the researchers’ needs,” he said.

[Bob Dawson]

In just a week, Pharma moved off its hardline policy of refusing to share data. They did so because their position was ludicrously untenable, unethical, and stupid.
Their new policy is a step in the right direction, but will not succeed completely in eliminating the moral hazard, whereby the only way to win is to cheat. They will end up having to concede further.

But the anxiety level has gone through the roof, in the same week, because GSK getting busted for bribery in China, at this time, and in that way, and with that inside information, was a major Dirty Trick timed to discredit GSK's revolutionary new management.

[Tupelo3]

This is a link to the data sharing Principles that the pharmies have agreed to abide by. I have only been able to glance through them. However, my first impression is that they are a very watered down version of the AllTrials campaign goals. I guess one can say that something is better than nothing. On the other hand, if these "Principles" are enough to remove the current pressure from open-data advocate groups, we may not see stronger rules for big pharma to comply to for a long time, if ever. I wouldn't count on seeing much additional research data from the industry.

For what it's worth:

http://phrma.org/sites/default/files...ataSharing.pdf

[Bob Dawson]

European Patients’ Forum:
http://www.alltrials.net/wp-content/...2.07.20131.pdf

We strongly believe that any results, even of trials that failed or produced unexpected or inconclusive outcomes, contribute to the totality of the evidence base on therapies, and can help target future research to where it is needed.

EPF further acknowledges the benefits of sharing raw data from clinical trials to enable researchers to revisit and reanalyse these data. This is in the interest of good science, patients, and the public.

European Aids Treatment Group:
http://www.eatg.org/news/168638/EATG...gs_trials_data

We believe that patients do a great service, willingly participating in clinical trials for the benefit of medical science and the greater good. (Sometimes of course for their own good too!) It is a travesty of justice that this data is then considered to be ‘private.’ It should be in the public arena all to see - easy to access and free for all.

This is not a complicated position – it is however a position that we hold to with great conviction. Any consultant or company trying to engage us in a lobby against this position would be worse than pointless - it would be counterproductive.

ECPC:

Brussels, 25 July 2013 – The European Cancer Patient Coalition was greatly concerned by the content of article The Guardian on July 22, 2013, published on its website “Big pharma mobilising patients in battle over drugs trials data” (http://www.guardian.co.uk/business/2...t-drugs-trials) with the subtitle “The pharmaceutical industry has “mobilised” an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.”

We condemn the generalized and unsubstantiated accusation that “an army of patients groups” are being “mobilised by Pharma to lobby against plans to force companies to publish secret documents on drugs trials”. ECPC is funded, among others, by the pharmaceutical industry as well as several of its more than 300 members across 42 countries in Europe and beyond. However, ECPC supports the publication of all results, positive or negative, of all clinical trials, irrespective of how they are funded. Patients by their enrolment in clinical trials contribute to research and societal good and therefore, they should have equal access to all results of all trials, as these results concern their own health and life.

ECPC supports alltrials.net petition for all clinical trials to be registered and reported regardless of their outcomes. In clinical trials, ECPC supports the registration of all trials by researchers and sponsors prior to the patient enrolment, rapid review processes, sound scientific scrutiny by researchers and clinicians and the use of open access web-based resources and methods, enabling patients and their clinicians to be informed about potential new therapies and all trials results.

ECPC, the European Cancer Patient Coalition was established in 2003, under the slogan “Nothing About Us, Without Us” as a non-profit organization to act as an umbrella cancer patient group. Over the last ten years, ECPC has grown in size and scope, and we are now the only European organization governed by cancer patient groups.

For more information please contact Prof. Francesco de Lorenzo, ECPC President, Francesco.delorenzo@ecpc-online.be, tel. +39335409663 or the Mrs. Kathi Apostolidis, Vice President, kathi.apostolidis@ecpc-online.org tel. +30-6977340758

All American and Canadian groups:
What, me worry?

[Bob Dawson]

… “The pharmaceutical industry has “mobilised” an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials.”

We asked pharmaceutical companies to confirm whether or not they support the strategy of their own lobby groups, EFPIA in Europe and PhRMA in the U.S.A., to mobilise patient groups in the debate about clinical trial transparency, as reported in the Guardian article.

These are the responses from companies so far:

GSK said: “This is not something we are doing. One of the reasons we’re involved in Alltrials is we want more companies to move towards greater transparency. I don’t think it’s for us to be mobilising patient groups to campaign on a negative level.”

A Roche spokesperson said the company consulted patient groups to understand their concerns about clinical trials, but “to our knowledge Roche has not been involved in any activity in mobilising patient groups…”.

A Lilly spokesman said: “Lilly is committed to working with Europe-based patient advocacy organisations for the benefit of patients in a way that is true to the code of practice and Lilly’s integrity in business policy.”

Sanofi told us: “I would rather say that Sanofi believes in discussing with patient groups to better understand what their concerns and needs are, and to ensure they are aware of the growing commitment of the biopharmaceutical industry to share data with researchers and patients.”

Boehringer Ingelheim: “I can confirm that there is NO strategy of Boehringer Ingelheim to mobilize patient groups in the discussion on clinical trial transparency, in particular, into lobbying against the EU plans on clinical trial data publication.”