[Bob Dawson]

AbbVie, prime sponsor of the World Parkinson’s Congress in Montreal, says info on adverse side effects of their drugs is commercially confidential

On the one hand, some companies such as GSK and Roche are putting a lot of work into making a change to culture and practice that would see transparency become the global norm in drug trials. On the other hand, there are other companies suing the European Medicines Agency to prevent release of clinical trial information. One of those companies, AbbVie, prime sponsor of major Parkinson’s events world-wide, and makers of Duodopa, has just argued that information about adverse effects of their drugs “is confidential commercial information because if released other companies could use it to help them get products approved.” Watch Neal Parker of AbbVie say this at a meeting hosted by EFPIA, the European pharmaceutical industry body, in Brussels:
http://youtu.be/54OY1auPQqU
The Head of the Dutch medicines evaluation board asked Parker in response “You think that adverse events are commercially sensitive information? … You are aware that you are working in the healthcare industry, with patients and human beings?”

Hans Georg Eichler, the EMA’s senior medical officer, said “I have been a regulator for many years and I am totally flabbergasted.”
If the views of those like AbbVie prevail and information from drug trials is kept behind closed doors doctors won’t know it, researchers won’t know it and patients will suffer.

British and American Pharmacology Orgs. support publication of negative findings from earlier clinical trials
13th September 2013
The British Pharmacological Society (BPS) and the American Society for Pharmacology and Experimental Therapeutics (ASPET) have announced their support for the publication of negative findings from early clinical trials. Their jointly published journal, Pharmacology Research & Perspectives, is at the same time launching a new method for researchers to publish negative findings.
Síle Lane, Sense About Science, said: “The announcement from BPS and ASPET is very welcome international leadership from societies who want to ensure clinical trial information is published. The results of around half of all trials are not published – this information is kept from doctors, researchers and regulators; resources are wasted repeating research that has been done and participants in further clinical trials are misled.”

12th September 2013
The Health Research Authority (HRA) is implementing its plan to ensure UK clinical trials are registered in a publicly accessible database. From 30th September registration of the trial within 6 weeks of the first patient being recruited will be a condition of a favourable ethical opinion.

Failure to comply with this requirement will be a breach of good research practice and will be dealt with by research ethics committees in line with other breaches. The HRA developed these plans in response to a public consultation looking at how to improve transparency of research in the UK and to improve patient and public confidence in health research.
EMA wants to hear from you

The European Medicines Agency wants to hear opinions on its proposed policy on sharing and publishing information from clinical trials. The Agency has committed to proactively publish information from clinical trials submitted in support of a marketing authorisation application, once the decision-making process has ended, and sets out a model for sharing commercially confidential information and personal data about patients.
Janet Wisely, Chief Executive of HRA said: “We are fully committed to the principles of transparency in health research. Including a requirement for registration as a condition of the favourable ethical opinion is a significant step towards this”.
The Agency has defined three categories of clinical-trial data corresponding to different levels of access.

Category 1: ‘commercially confidential information’

This category covers clinical-trial data, information or documents that may contain commercially confidential information. These include, for example, the details of the investigational medicinal product itself, some in vitro studies or bioanalytical data characterising the product.

Category 2: ‘open access’

This category covers any clinical-trial data, information or documents that do not contain patients’ personal data. This information will be downloadable from the Agency’s website, at the time of publication of the European public assessment report (EPAR) for positive decisions, negative decisions or withdrawals.

Category 3: ‘controlled access’

This category covers clinical-trial data, information or documents containing patients’ personal data. These include individual patient data sets, individual patient line-listings, individual case report forms, and documentation explaining the structure and content of data sets. Protection of personal data is a fundamental right of European Union (EU) citizens, enshrined in EU legislation. For this category, two complementary levels of protection are foreseen to provide the best possible assurance against retroactive patient identification. Firstly, data will need to be adequately de-identified according to a recommended minimum standard. Secondly, access to these data will only be granted after the requester has fulfilled a number of requirements, including the signing of a data-sharing agreement.
“The European Patients’ Forum (EPF) is pleased to join the All Trials campaign. Since the beginning of our involvement with EU the clinical trials legislation, EPF has called for the publication of all results of all clinical trials in a timely manner, regardless of the outcomes. Ensuring that after a research project finishes, the results are promptly published is, according to our members, as important as the approval of a trial in the first place…

“Any results – even of trials that “failed” or produced unexpected or inconclusive outcomes – add to the totality of the evidence base on therapies, and can help target future research to where it is needed” explained Nicola Bedlington, EPF Executive Director

Patients are increasingly becoming active participants in their own care. Patient involvement is recognised as a vital element to ensure the future sustainability of European healthcare systems; nevertheless in practice there is wide divergence across the EU in the level of patient involvement. In order to implement patient-centred care and empower patients to make fully informed decisions in partnership with their health professionals, it is vital that both clinicians and patients have access to all the relevant information needed to make those decisions.

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. However, the sharing of patient-level data is a complex issue which requires thorough reflection involving all the stakeholder groups to consider the implications and potential consequences of data sharing. EPF therefore welcomes the recent initiative by the European Medicines Agency, to open a public discussion on how to best share data from clinical trials. We are committed to participating in public debates at the European level and will undertake further work with our membership in order to identify solutions that serve both scientific and public interests, while affording appropriate protections to trial participants.”

[Bob Dawson]

There is a crack in everything
(That's how the light gets in)

I am making a unilateral declaration of victory; a partial, but substantial victory, of the Alltrials campaign. Basically set in motion by 3 people, with no budget, and entirely without the help of Vladimir Putin, Wikileaks, or Alice in Wonderland.

The issue of transparency in medical science is now being debated in the U.K. House of Commons, the European Medicines Agency (their FDA, more or less), and more panel discussions, TV interviews, and op-eds than you can shake a stick at; or as we say in the north country, you can’t swing a cat by the tail without hitting it.

Other than isolated pockets at Yale and Dartmouth, no one in the USA is talking about it, as the situation is hunky-dory just as it is and has always been; the only problem being that patients don’t raise enough money or provide enough volunteers.
In Canada, the government quietly passed a new law, effective immediately, requiring registration of medical trials and publication of all results, but they were very careful not to tell anybody about, in case it might provoke contemplation or discussion, never desirable in a colonial monarchy built around a tar-sands pit.

But with the U.K. and the European Union working towards a compromise agreement, it is clear that all future studies WILL be registered and published – that is no longer even debated. It is no longer a question of IF medical science will become transparent; it is a question of who, what, where and when and how.

So I advise the Alltrials advocates to declare victory, occupy the territory, run up the flag, and have a Guinness.

But it ain’t over yet. There are archive warehouses packed with the 50% of studies that were buried, because they revealed side effects or uselessness of the drugs being tested. Those hidden documents should be released.
And the major problem still lingers: how to remove the moral hazard from medical research, when the way to win is to cheat. You work 10 years on a drug, spend a billion dollars - and then there is some new study saying your drug causes harm and provides no benefit - quick, deep-six that study and never tell anyone about it. And your competitors are hiding their studies; to compete, you have to lie and cheat more than they do.
That’s the moral hazard. It is not resolved by Pharma saying “Trust us”.

It might be resolved if all medical science info is available to everyone. There would be no use cheating if you were sure to get caught.

GSK and Roche, two of the biggest, are opening up their archives. AbbVie leads the counter-attack, their predator lawyers going to court in Europe to get injunctions against release of their data.

AbbVie has succeeded in persuading people that SOME data is corporate property, which could be; but they want to be the ones who decide what data to release, on a case-by-case basis; and they have not helped their cause by saying that adverse side effects can be kept secret, if they themselves so decide among themselves. “Trust us.”

Riiiiight.

But anyway, Alltrials, with basically no resources, moved the mountain quite a bit. Alltrials intends to continue the campaign, until all medical info around the world is made open.

Probably there will be a compromise now, and then it will lurch back into action again when scientists and Pharma discover what the soft-ware industry knows – open data, open access, and transparent truthfulness speed up the research and produce more, not less, profits.

So thank you, U.K. (with a special mention of Parkinson’s U.K., for their presentation to the House of Commons).

It’s a victory, and I expect your next victory will be in winning the release of the tens of thousands of medical trial results that are still hidden from everyone. Hiding the results is so unethical, and such a betrayal of patients’ trust, that it cannot stand.

Thank you to those who supported the Alltrials campaign, and please continue to support them. Their website will soon be renovated. You can follow them on that site;

http://www.alltrials.net/

Myself, I do not expect to report on it any more.
Over and out.
May you always be righteous, stand upright and be true.

[Bob Dawson]

Well glory be !!!. Canada’s nation-wide PD group agrees with the Alltrials petition .! I take back my nasty remarks about Canada!

Just received this e-mail:

Sorry for the delay; but wanted to let you know that we have posted an article on our web site re AllTrials petition; which includes PSC’s position:
http://www.parkinson.ca/site/c.kgLNI...s_Campaign.htm
Barbara Snelgrove
Director, Education & Services
416-227-3381; 1-800-565-3000 ext. 3381
barbara.snelgrove@parkinson.ca
Advancing science. Inspiring hope. Building community.
http://www.parkinson.ca

Parkinson Society Canada Supports the AllTrials Campaign

Parkinson Society Canada is dedicated to funding Parkinson’s disease and related disorders research. We fully support the AllTrials campaign calling for unrestricted access to the results of all research studies including clinical trials. Openness and transparency are essential in research so that patients, policy makers and health professionals can make decisions vital to health care based on sound evidence. Transparency will support and accelerate research and ultimately lead to improved treatments for patients.

Launched in January 2013, the AllTrials campaign aims to collect one million signatures for their online petition. AllTrials is campaigning for governments, regulators and research bodies to mandate the publication of all clinical trial results. As highlighted by AllTrials, around half of all clinical trial results have not been published, and trials with negative results are even less likely to be made public.

Parkinson Society Canada recognizes the importance of transparency and unrestricted access to clinical trial results. We are pleased to sign the AllTrials petition and support this important initiative.

If you would like to learn more about the AllTrials campaign or would like to sign the online petition, please click here for more information: http://alltrials.net/