Signed it!

13 Mar 2013 Posted by Daniel Cressey

(London).
… Parliament’s science and technology select committee is investigating whether pharmaceutical companies withhold data that might paint their drugs in a bad light, a subject that is attracting increasing attention in Europe and elsewhere in the world.

“We are eroding belief in medicines because people can’t trust the results that are published,” said Keith Bragman, president of the Faculty of Pharmaceutical Medicine.

Fiona Godlee, editor-in-chief of the British Medical Journal: ..”it’s a problem across the research enterprise.” Godlee is calling for legislation to mandate the publication of trial results and audits to ensure researchers and their funders comply… Godlee told the committee: “We absolutely have to see this as an international problem, and the solutions have to be international.”

… the charity Cancer Research UK said that isolated action by one country simply shifts the research to another country.. any solution must be global.

Mike Rawlins, speaking for the Academy of Medical Sciences, said that the academy was planning to have discussions with the US Institute of Medicine about access to clinical-trial data...

“These are trans-national issues,” he says. “It’s no good one country trying to do its own thing without involving others.”

http://blogs.nature.com/news/2013/03...o-global.html/

Note from Bob:
Parkinson's U.K. was one of the first to sign the Alltrials petition; it would be fitting for American Parkinson's organizations to show British PwP some international support in this battle they have taken on, at the least, American PwP should sign the petition; better still, put it on their websites; better still, actively seek to have many of their members sign.

It would help improve the "optics" as well, as right now it does not feel comfortable watching AbbVie launching lawsuits in Europe for the direct purpose of fighting against the contents of the petition promoted by PwP in Britain; while in the U.S.A. AbbVie wears a different mask, as the Premier Sponsor and Proud Partner of the Parkinson's Unity Walk, raising money that is divided among the major Parkinson's charities, none of whom, it seems, have signed the petition.

AbbVie must be chortling. PwP orgs should react by signing the petition, campaigning for the million signatures; would straighten out the picture a bit
Pharma is multinational, but with the internet, so are we. They use their multinational position to divide and conquer; PwP can use the internet to keep them in line on world-wide issues such as this.
PwP orgs of USA and Canada, what say you? Fight, flee or freeze?

British PwP answer questions from British House of Commons Select Committee on Technology and Science

 
Written evidence submitted by Parkinson’s UK (CT21)

Do the European Commission’s proposed revisions to the Clinical Trials Directive address the main barriers to conducting clinical trials in the UK and EU?

1. Parkinson’s UK welcomes the proposed changes made by the European Commission tothe Clinical Trials Directive. The proposed Clinical Trials Regulation appears to help overcome some of the barriers to conducting clinical trials in the UK and EU and addresses key criticisms of the Directive, such as reducing the administrative burden for clinical trials, clarifying the scope of clinical research so it is not interpreted differently across Europe, and introducing tight deadlines so clinical trials will not be delayed.

2. Introducing the concept of a low-interventional trial is an important step to adopting a risk based approach in clinical trials legislation. This would allow trials of medicines already authorised for use with minimal risk to go ahead more efficiently. This risk proportionate approach would recognise that the requirements associated with application and
monitoring processes of a trial can be reduced for medicines with well-known safety profiles without compromising the safety of participants.

3. It is still unclear how the Regulation will reduce the requirements for trials of marketed products used for a new purpose, which are not included in the low-interventional trial category. Trials of these products are particularly important for Parkinson’s research. Drug repositioning (finding new uses for previously authorised drugs) has great promise for quickly bringing new treatments to people with Parkinson's. Trials are currently underway to examine the effects of isradipine (an anti-hypertensive drug) and desferrioxamine (a drug to decrease blood iron levels) on Parkinson’s. As these are drugs that are currently in routine clinical use in the UK, it is vital that any beneficial effects are \translated as fast as possible into the clinical arena.

4. A single application portal with a single application dossier is particularly attractive to streamlining and harmonising the application process for clinical trials. This will reduce the administrative work of sponsors who would otherwise have to submit the same documentation to all the Member States separately.

5. Efficient operation of the IT systems associated with a single European portal will be crucial to the success of all of the measures set out in the Regulation. The Commission should outline how it will go about creating and implementing the IT systems associated with the Regulation.

6. We strongly support the provision that the patients’ views must be sought in this process – it is crucial in order to assess the relevance of the trial to patients’ needs, and to obtain an accurate risk-benefit assessment. Patients, who ultimately bear the personal risks of participation in research, have the right to be involved in assessing its risks. They may be more willing to take up higher risks for different benefits, such as quality of life. For example, Parkinson’s UK surveyed our Research Support Network to ask if having to have a lumber puncture (spinal tap) would stop them from taking part in a drug trial. Whilst 50.4% of respondents agreed that it would put them off, 29.8% responded that they would still take part despite this invasive procedure. One respondent commented, “A lumbar puncture is nothing compared to slogging it out with Parkinson for 11 years plus”. Whilst another respondent said “Depends on whether the drug trial would be likely to make substantial strides towards a cure”. Patients with serious conditions will very often have a different perception of risk compared to that of investigators or regulators.
 
7. Patient involvement is also shown to contribute to better protocol design and the identification of new issues that researchers may not have considered. These can include for example practical questions such as treatment schedules or transportation that may affect patients’ participation and drop-out rate.

8. We welcome the provision for the publication of summary results of trials, but this should in be more strongly and precisely framed. We recommend that clear standards should be developed for what the summary needs to contain e.g. descriptions of the methodology, the way the researchers eliminated or minimised biases, blinding and randomisation arrangements etc. These standards should be developed with the involvement patient organisations and researchers, to ensure they address all groups’ information needs.

What is the role of the Health Research Authority (HRA) in relation to clinical trials and how effective has it been to date?

9. The process of obtaining research permissions from NHS Trusts has been identified as a significant barrier to research projects and trials in the UK, introducing delays and increasing costs. This process remains the responsibility of NHS providers which can result in submitting separate applications at each site. We welcome action taken by the NIHR and HRA to streamline this process.

10. We welcome the role of the Health Research Authority (HRA) to promote a unified and fair approach for approving research and producing standards for compliance for researchers.

11. As the HRA has only been in place since December 2011, we feel it is too soon to identify how effective it has been to date with regards to enabling clinical trials to take place.

12. Metrics will need to be developed to measure the effectiveness of the HRA. Researchers and patient organisations should also be consulted to gain an understanding of the level of the HRA’s effectiveness.

What evidence is there that pharmaceutical companies withhold clinical trial data and what impact does this have on public health?

13. It is crucial to research that there is transparency regarding how trials are conducted. Ensuring results are published provides essential information to future research, helping researchers learn and make further advances. Data from trials must be published to help future research build on results and improve treatments based on new discoveries. For example, recently the British Biotech company Phytopharm announced their new Parkinson’s drug Cogane failed in Phase 2 clinical trials. In week 28 participants taking Cogane showed no benefit compared to those taking a placebo. Whilst these results are disappointing, they have been crucially been people affected by Parkinson’s so they are available for others to learn from.

How could the occurrence and results of clinical trials be made more open to scrutiny? Who should be responsible?

14. Pharmaceutical companies should have a legal responsibility to publish all trial data regardless of findings. However, it is important that the data is published in a useful format. For example, ensuring confidentiality issues are adhered to and published results should be clear and accessible.

15. The EU Clinical Trials Regulation should include measures that ensure registration and reporting of trials takes place.

16. The HRA should work alongside other bodies to ensure transparency.

Can lessons about transparency and disclosure of clinical data be learned from other countries?

17. We are currently unaware of other countries having improved transparency protocols. As we all come under the EMA umbrella, our national agencies fall under the same level of European law regarding disclosure. We are not aware of any that insist on the release of
more data than is required by law.

Note from Bob: The day will come when every trip to the doctor, every contact between patients and the medical industry, every Google search for medical information, every posting frenzy on a forum such as this, every blaze of twittering about health, will be part of a massive perpetual world-wide clinical trial, involving “data mining” from the digital trails left by tens of millions of people…

...it is already starting… the white mice are taking over the experiment, as foreseen by Reverett 123 and Aunt Bean and JohnT and many other home-made citizen scientists…

Have doctors ever heard of this new-fangled ee-lectrical type-writer thingy called “the internet”; plus added features such as “cloud computing” (I used to think it meant going outside and counting the clouds).

Well here it comes, wake up, Big Pharma. Even King Canut would not attempt turn this tide… and it is a tide that bodes well for noble and serf alike. It’s what’s happening, Dudes and Dudettes. Are you on the bus, or off the bus?

Be there or be square. It’s a new scene, Dean. Stop putting that greasy kid’s stuff in your hair. Brylcream - A little dab will do ‘ya. She will love to run her fingers through your hair.

Where were we? Oh yes, data mining. Ya’ load 16 tons and whaddya’ get?

As I was saying before you interrupted with your hare-brained critique:

HERE IT IS – Data mining has begun; Jill Wechsler reports:….. scientists at Microsoft Research, Stanford, and Columbia University, published in the Journal of the American Medical Informatics Association (March 6, 2013), found that Internet searches on drug use uncovered previously unrecognized adverse events. Here, queries from six million people in 2010 searching for information on antidepressant Paxil and cholesterol treatment Pravachol disclosed a greater incidence of high blood sugar in patients taking the two drugs.


Just the Tip of the Iceberg: Pharma and Full Disclosure
By Jill Wechsler April 10, 2013

… …The new “Sunshine” law — requiring drug companies to report virtually every penny they transfer to physicians and teaching hospitals, whether for conducting research, consulting, or providing free lunches — is just the tip of the iceberg.

…Now regulators and health advocates seek to expand disclosure to include findings on all clinical trials, even those for drugs that fail to gain market approval. Leading medical journals are working with European Union officials to promote the AllTrials effort to register and disclose results from all clinical trials around the world. Trial summaries are not enough; safety advocates and industry critics seek disclosure of patient level data and case report forms so that they can verify the sponsor’s research results and product claims.

This call for greater data transparency reflects charges that sponsors have hidden important safety information from regulators and the public. Pharma companies counter that full disclosure can raise patient privacy issues and lead to misinterpretation of findings by non-experts.

Abbott’s pharma spin-off AbbVie has filed suit to prevent the European Medicines Agency from releasing patient-level clinical trial data, as has InterMune of California. (Bob: good ol' AbbVie just can't figure out what the People with Parkinson's are moaning and groaning about.)

….Price transparency? An equally important goal of transparency advocates is to reduce healthcare spending through competition generated by broader disclosure, online, of prices for healthcare services and medical products. …'

…Social media exposure? … much information on pharma research and prices will become public with the expansion of global search engines able to tap into millions of queries and postings on medical treatments and healthcare costs. A recent study by scientists at Microsoft Research, Stanford, and Columbia University, published in the Journal of the American Medical Informatics Association (March 6, 2013), found that Internet searches on drug use uncovered previously unrecognized adverse events. Here, queries from six million people in 2010 searching for information on antidepressant Paxil and cholesterol treatment Pravachol disclosed a greater incidence of high blood sugar in patients taking the two drugs.
It’s not hard to imagine similar analyses of consumer searches for lower drug prices, product safety reports, and complaints about pharma marketing and advertising from health professionals and the public.

http://blog.pharmexec.com/2013/04/10...ll-disclosure/

Jill Wechsler is Pharm Exec’s Washington correspondent. She can be reached at jwechsler@advanstar.com.
THANK YOU JILL WECHSLER
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Bear witness

You don't have to have Paarkinson's to add your name

This is for all..............I signed

http://www.nytimes.com/2012/04/11/op...cret.html?_r=0

New York Times

Drug Data Shouldn’t Be Secret April 10, 2012
By PETER DOSHI and TOM JEFFERSON

IN the fall of 2009, at the height of fears over swine flu, our research group discovered that a majority of clinical trial data for the anti-influenza drug Tamiflu — data that proved, according to its manufacturer, that the drug reduced the risk of hospitalization, serious complications and transmission — were missing, unpublished and inaccessible to the research community. From what we could tell from the limited clinical data that had been published in medical journals, the country’s most widely used and heavily stockpiled influenza drug appeared no more effective than aspirin…

After we published this finding in the British Medical Journal at the end of that year, Tamiflu’s manufacturer, Roche, announced that it would release internal reports to back up its claims that the drug was effective in reducing the complications of influenza. Roche promised access to data from 10 clinical trials, 8 of which had not been published a decade after completion, representing more than 4,000 patients from every continent except Antarctica…

….In the case of Tamiflu, some of these assumed properties led to stockpiling at great taxpayer expense — more than $1.5 billion. ..

…. the data point to a drug of minimal benefit. In accordance with the F.D.A.’s findings, it appears to shave a day off the duration of influenza symptoms, but we found no decrease in risk of hospitalization and no evidence that it could stop the spread of the virus. More worrisome, we found suggestive evidence that Tamiflu interfered with the body’s ability to produce antibodies against influenza — which could affect the body’s response to influenza vaccine and its ability to fight off future influenza infections. But to do a complete analysis, including evaluating Tamiflu’s potential harms, we need the remainder of the data — the full “clinical study report” — promised by Roche, but never delivered..

We should not have to wait for patients to be hurt by the medications they take, as recently happened with the diabetes drug Avandia…

(Peter Doshi is a postdoctoral fellow in comparative effectiveness research at Johns Hopkins University School of Medicine. Tom Jefferson is an independent epidemiologist with the Cochrane Collaboration, an international nonprofit research organization.)

The Alltrials campaign was started by two people in Britain.

This petition is seeking a million signatures from around the world.

It is difficult to get 10,000 signatures. A million is Mirapexy obsessive.

There is the added difficulty: the topic is obscure to most people. Clinical trials? Is that a court of law? Publish their science papers? Pretty boring stuff.

And yet, we want one million signatures, from around the world, to be presented to every serious government in the world. (We are not going to parachute into North Korea. At least, not on this mission).

Are there a million people willing to stand up and be counted when confronted with unethical and deadly medical fraud? Can we find those people? (Would those people let me be dictator? Just kidding.)

This is just Phase One. You are not ready for Phase II and the ion generator is still under construction underneath the Himalaya’s. Your marching orders will be sent by carrier pigeon.

47,000 people have signed. And a hundred organisations.

The AllTrials petition has been translated into Albanian, Arabic, Basque, Brazilian Portuguese, Catalan, Chinese, Croatian, Czech, Danish, Dutch, Estonian, Finnish, French, German, Greek, Hebrew, Hungarian, Italian, Japanese, Norwegian, Polish, Portuguese, Romanian, Russian, Serbian, Spanish, Swedish and Turkish

And so it begins. It is no longer just British. Every patient organization in the world should sign up; and also, doctors, pharma of the future, caregivers, and just-plain-folks.

COME ON U.S.A. Your future doctors have already joined; your present doctors should join too.

U.S.A.:
American Medical Student Association: AMSA strongly endorses the AllTrials Campaign to make available all clinical trial results for all treatments being currently used. For over a decade, AMSA has been advocating for medical education and practice that is evidence-based, rather than marketing based. Evidence-based medicine, however, is not possible with the continued allowance of pharmaceutical and device industries to hold hostage key clinical trials that may impact a prescriber’s decision-making ability. AMSA signs onto the AllTrials petition as a crucial step to ensure that the lives of our patients and the integrity of our profession are protected.

U.S.A.: SAGE was founded as, and remains, an independent publisher committed to the goal of disseminating usable knowledge that lies at the heart of a healthy society. We publish a range of medical journals, many in association with some of the world’s most prestigious societies, and offer a broad spectrum of options, both open access and traditional, for rapid publication of clinical trials results, welcoming both ‘positive’ and ‘negative’ results. We strongly support the call for all clinical trials to be registered and for the full results to be reported in a timely fashion.

U.S.A.: The SLE Lupus Foundation (New York City) is pleased to support the Alltrails petition for transparency in clinical trials. We are the leading private funder of novel research in the autoimmune disease systemic lupus erythematosus and a strong advocate for patient participation in clinical trials. With a desperate need for new treatments for lupus and insufficient enrollment in clinical trials testing new drugs, access to trials results is extremely important for our community.

GERMANY:
German Institute for Quality and Efficiency in Health Care supports the campaign for all trials to be registered and the full methods and the results to be reported. IQWiG prepares health technology assessments to support decision making in the German health care system. During the past years we have experienced that full availability of all clinical trials and all information on methods and results of these trials is essential for us to provide unbiased and meaningful assessments. Health technology assessment should be based on a full evidence base and thus requires registration and reporting of all trials, regardless of whether they are conducted by industry, academia, governmental organisations or others.

CHINA:
DXY: As the biggest online community for healthcare professionals in China, DXY is devoted to better communication and better quality within the healthcare industry. All clinical trials should be compulsorily registered, and all the individual data should be open for public scrutiny. DXY spares no effort to reveal the truth and propagate its importance and potential benefits to patients, physicians, researchers, and regulators in China.

MedSci signs the petition and strongly endorses AllTrials’ call for all trials to be registered and reported. As the leading academic service provider in China, MedSci offer specific and professional ways that the call can be turned into action. We signed this because we believe that the more comprehensive the data the more effective the healthcare. Science should not be done in secret.

SOUTH AFRICA:
South African Medical Research Council: The vision of the SA MRC is to build a healthy nation through research. Unregistered clinical trials and unpublished, inaccessible results of research pose a barrier to achieving this vision. The SA MRC has long supported the importance of minimising publication bias. We provide a home for the Pan African Clinical Trials Registry (www.pactr.org), a WHO recognised register which has specific capability to serve researchers, decision makers and patients in Africa. We are pleased to add our signature to this AllTrials petition and support the call for open access to the results of all clinical trials.

SPAIN:
Asociación Española de Pediatría de Atención Primaria: representing more than 3000 pediatricians across Spain, is proud to endorse the AllTrials campaign. We are committed to transparency in research so that the best treatments for children can be developed and evaluated, and it is vital that all clinical trials are registered and the results reported.

CANADA:
Canadian Agency for Drugs and Technologies in Health: CADTH is a strong supporter of the AllTrials campaign to have all clinical trials registered and all results reported. CADTH provides decision-makers with the evidence, analysis, advice, and recommendations they require to make informed decisions in health care. These decisions should be informed by a complete evidence 1base which would include the disclosure of all clinical data.

Dietitians of Canada is pleased to sign the AllTrials petition. Like other health professions, dietitians require unrestricted access to valid and unbiased evidence when making recommendations about patient care, policy or community programs.

SWEDEN:
Swedish College of General Practice: SFAM, strongly endorses this campaign. SFAM promotes professional education, research and development in general practice. We work for the practice of evidence based medicine and for rational pharmacotherapy in cooperation with our patients. To achieve this, we regard it as fundamental that all trial protocols and results without exceptions are made publicly available for independent and critical appraisal.

HOLLAND:
The Netherlands Epidemiological Society fully supports the AllTrials initiative and is therefore pleased to sign this petition. Access to results, especially from clinical trials, is needed to reach unbiased conclusions.

NORWAY:
The Norwegian Cancer Society whole-heartedly supports this petition. As a big funder of research, we would like the money to be put to good use. We believe in sharing and documenting results to better advance the research. We believe that easy access to previous research in a timely manner will help the researchers help patients get better treatments quicker. We strongly support the sharing of methodology and results.

IRELAND:
Irish Cancer Society: We are absolute in our belief that all clinical research data be published in order that people who get cancer, or any other medical condition, will have better access to improvements in the diagnosis and treatment of their condition which will lead to better medical care and better outcomes. Cancer patients lives are dependent on this.

PAN-EUROPEAN:
European Federation of Clinical Chemistry and Laboratory Medicine: EFLM represents the National Societies practising Laboratory Medicine in Europe, a specialty said to contribute in up to 70% of medical cases. Thus we affirm that adherence to ethical standards and the dissemination of all scientific data to inform clinical decision making is axiomatic for the provision of the quality health care that patients expect; EFLM fully supports the tenets of Evidence Based Medicine.

The European Public Health Association, representing over 14,000 public health professionals across Europe, is committed to the highest standards in the conduct and reporting of research. We endorse the view that all trial protocols and data are made publicly available for independent and critical appraisal.
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We call on all patient organizations to sign this petition, and get their members to sign. It’s an opportunity to improve the results of medical research. By shaming them into treating us with truthfulness. Release all medical studies on human beings; past, present and future. We ain’t gonna’ STFU until this happens. Just release the documents, that’s all.

Ion generator? Just what is that suppose to do? I thought this was a method of energy for long term space travel. What else are they going to use this for?
Ginnie

That's just me being silly. I figure we may be ordered off this planet by the whales some day.

Thanks for telling me. I am one of those nuts who try to keep up with technology and physics. I thought I missed something big. I keep looking for symetry with the coliders, and have read about Ion energy for space travel. These days with all the big coliders, anything could be discovered. Just wish they could discover the cure for PD and many other illnesses.
You have been talking about trial studies. I now wonder if my trial did any good at all since I was not let in on anything to do with the results of the study. I did this study, because I was afraid for my kids. If they had developed the same disease, I wanted them to know there was some hope that things can be learned by these studies. Never really got any answers to my questions, and the medications, once removed, stopped any progress I made. Through the years, I wonder if it did any good at all. How would I ever know? Am I better today because I did them? Or didn't it make any difference at all? I sure don't know Bob.
Hope you are OK, and that your freeze up north is starting to break. Down on this side of the continent, the water is that aqua blue, which happens only certain times of the year. It is so beautiful....Spent earth day outside in the garden and on the beach enjoying that color. Keep in touch....Did you ever listen to Puscifer "The humbling River" ? It is worth your time to listen. ginnie