3. Spitzer v. GSK Consent Order
August 26, 2004
Nissen and Wolski
May 2007 (e-pub)
4. “As described on the FDA Web site, the published CLASS trial differs
from the original protocol in primary outcomes, statistical analysis, trial
duration, and conclusions. In particular, the unpublished data show that by
week 65, celecoxib was associated with a similar number of ulcer
complications as diclofenac and ibuprofen.”
Hrachovec JB, Mora M. JAMA. 2001;286(19):2398-2400.
2000-2001
5. Doshi P, Dickersin K, Healy D, Vedula SS, Jefferson T. Restoring invisible and
abandoned trials: a call for people to publish the findings. BMJ. 2013 Jun 13;346:f2865.
6. John Castellani is the President
& Chief Executive Officer of the
Pharmaceutical Research and
Manufacturers of America
(PhRMA).
Ben Goldacre is a
best-selling author,
broadcaster,
campaigner,
medical doctor and
academic
7. Reactive release of documents
The Agency has been releasing documents [>1.9
million pages so far] submitted as part of
applications for marketing authorisation on request
since November 2010 … including clinical-trial
reports, once the decision-making process for the
medicine in question has been completed.
Proactive publication of data
The Agency has committed to the proactive
publication of the data from clinical trials
supporting the authorisation of medicines. This will
enable the independent re-analysis of the evidence
used by the Agency's committees to determine their
benefits and risks and is expected to lead to public-
health benefits.
10. Arguments against sharing data
• Industry
• Misleading analyses
• Commercial confidential information
• Patient privacy/confidentiality
• Too much work
• Not everybody needs so much detail
• Academics
• Too much work
• No money
• Unclear how to share
• Promotion/career
12. Publication and access to
clinical-trial data
June 24, 2013
http://www.ema.europa.eu/docs/en_GB/docu
ment_library/Other/2013/06/WC500144730.p
df
16 pages
“The Agency respects and will not
divulge commercially confidential
data or information. In general,
however, CT data cannot be
considered CCI; the interests of
public health outweigh
considerations of CCI.”
“Access to CT data … will make
drug development more efficient …
learn from past successes and
failures … develop new knowledge
in the interest of public health …
promote better-informed use of
medicines … enable third parties to
verify the regulatory authority’s
positions and challenge them where
appropriate.”
Deadlineforcomments:Sep30
2013
13. “The contribution of patients who participate in clinical
trials should be maximized for the benefit of society.”
“We note that this proposal contemplates the availability
of certain data after appropriate steps have been taken
to de-identify it and remove the data's link to a specific
product, study, or application. This proposal does not
pertain to unmasked safety and effectiveness data, (i.e.,
data that can be linked to a specific, identified
application) including full study reports”
14. The New York Times
June 30, 2013 p.B1
July 5, 2013 p.A18
Misreporting. Paints a distorted story.Invisibility and Distortion are all over the literature – many diseases, many drugs.There is a need for access to trial data.
Explain: data under waterline is data from patients, recorded onto CRF, then into database. De-identified, but patient level.Invisibility (Nissen) & Distortion (Celebrex)
Castellani makes several points.Clinical Trials are important. “Clinical trials are essential for the successful development of new medicines that save and improve lives and provide hope for millions of patients.”Pharma is the innovator. “Since 2000, PhRMA member companies have invested about $550bn (£330bn; €390bn) in research and development, including clinical trials, in the search for new treatments and cures. No government or academic institution has the resources or multidisciplinary expertise to conduct the clinical trials needed to develop the new medicines patients need.”The system is working. “The modern clinical trial system and associated sharing of information led to more than 340 new medicines approved by the FDA over the past decade”Pharma already shares data. “The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information. … the current biomedical research system includes wide sharing of trial results with government regulators, academic and medical communities, and physicians through submissions to the US Food and Drug Administration (FDA) and other international regulatory bodies, presentations at medical conferences, and publication in peer reviewed journals.”Data are dangerous. “Dumping millions of pages of clinical trial information into the public domain without providing appropriate scientific and clinical context or guidelines for meta-analysis could lead to second guessing of the expert decisions of national regulators worldwide, undermining patient trust and confidence in the safety and effectiveness of approved medicines.”
400 patients in this trial.With funding, access to the CSR would allow for checking to ensure the published record is accurate.Even without funding, just the threat of being able to check serves as a deterrent to misreporting.
Good news? EMA forging ahead despite court case
Bad news? FDA way behind.Why this matters? EMA is incomplete.
Good news? Tide of public opinion is turning
Bad news? This may not be an easy fight.http://www.guardian.co.uk/business/2013/jul/21/big-pharma-secret-drugs-trialsTHE FOUR PRONGED STRATEGY1. "mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data".2,3. Two other strands of the campaign include discussions with scientific associations about the risks of data sharing, and work with other businesses that are concerned about the release of trade secrets and confidential data. 4. final strand calls, in the long term, for a network of academics across Europe that can be called on to correct false interpretations of the data. "That is deemed to be happening in any case," the memo concedes.http://www.eatg.org/news/168640/Official_EPF_Statement_to_clarify_The_Guardian%27s_article_%E2%80%9CBig_pharma_mobilising_patients_in_battle_over_drugs_trials_data%E2%80%9D
