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Transparency and PhRMA...
Recently, Ben Goldacre has engaged in a public debate with John Castellani of PhRMA over the sharing of clinical trial data:
Head-to-Head with PhRMA on transparency in the BMJ
July 12th, 2013 by Ben Goldacre
This week in the BMJ there’s a head-to-head on trials transparency between me and PhRMA, the pharmaceutical industry representative body in the US. My article is here, PhRMA’s is here, both articles are open access for one week (since it was press released, them’s the rules at the BMJ…) but mine is open access forever, I think, on this link.
The article from PhRMA is remarkable. Firstly, they imply that people like me, who call for all trial results to be reported, also somehow call for the reckless disclosure of individual patients’ electronic health records online. This is untrue.
More disturbing is PhRMA’s suggestion that the problem has already been fixed. For example, John Castellani says that “information on clinical trials for potential new medicines is already required by US law to be posted on ClinicalTrials.gov“. As I explain in my piece, the best available published evidence on compliance with this law comes from Prayle et al, BMJ 2012: in reality, the legislation here has been very widely ignored.
We need to fix the problem of withheld results. Doctors (and patients, and researchers, and payers, and the public) need access to all the results, of all the trials, on all the uses, of all the treatments currently being prescribed, in order to make informed decisions about which is best.
...
http://www.badscience.net/2013/07/head-to-head-with-phrma-on-transparency-in-the-bmj/
July 12th, 2013 by Ben Goldacre
This week in the BMJ there’s a head-to-head on trials transparency between me and PhRMA, the pharmaceutical industry representative body in the US. My article is here, PhRMA’s is here, both articles are open access for one week (since it was press released, them’s the rules at the BMJ…) but mine is open access forever, I think, on this link.
The article from PhRMA is remarkable. Firstly, they imply that people like me, who call for all trial results to be reported, also somehow call for the reckless disclosure of individual patients’ electronic health records online. This is untrue.
More disturbing is PhRMA’s suggestion that the problem has already been fixed. For example, John Castellani says that “information on clinical trials for potential new medicines is already required by US law to be posted on ClinicalTrials.gov“. As I explain in my piece, the best available published evidence on compliance with this law comes from Prayle et al, BMJ 2012: in reality, the legislation here has been very widely ignored.
We need to fix the problem of withheld results. Doctors (and patients, and researchers, and payers, and the public) need access to all the results, of all the trials, on all the uses, of all the treatments currently being prescribed, in order to make informed decisions about which is best.
...
http://www.badscience.net/2013/07/head-to-head-with-phrma-on-transparency-in-the-bmj/
Both arguments can be read at links in the aforementioned article on badscience.net. However, one construction in Castellani's argument stands out. He states the following:
Head to Head
Are clinical trial data shared sufficiently today? Yes
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f1881 (Published 9 July 2013)
Cite this as: BMJ 2013;347:f1881
John Castellani, president and chief executive officer, Pharmaceutical Research and Manufacturers of America (PhRMA)
Contact via Matthew Bennett: MBennett@phrma.org
...
Mandatory public disclosure of intellectual property, confidential commercial information, and proprietary scientific methods found in clinical trials could stifle discovery and open the possibility of competitors or unscrupulous actors using the information for their own products in other markets or countries. Without appropriate protection for intellectual property to incentivize the enormous investment risk involved, biopharmaceutical companies will be discouraged from investing in the next generation of new medicines, leading to patients and physicians being deprived of innovative therapies to tackle the serious and life threatening diseases of the 21st century.
...
http://www.bmj.com/content/347/bmj.f1881
Are clinical trial data shared sufficiently today? Yes
BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f1881 (Published 9 July 2013)
Cite this as: BMJ 2013;347:f1881
John Castellani, president and chief executive officer, Pharmaceutical Research and Manufacturers of America (PhRMA)
Contact via Matthew Bennett: MBennett@phrma.org
...
Mandatory public disclosure of intellectual property, confidential commercial information, and proprietary scientific methods found in clinical trials could stifle discovery and open the possibility of competitors or unscrupulous actors using the information for their own products in other markets or countries. Without appropriate protection for intellectual property to incentivize the enormous investment risk involved, biopharmaceutical companies will be discouraged from investing in the next generation of new medicines, leading to patients and physicians being deprived of innovative therapies to tackle the serious and life threatening diseases of the 21st century.
...
http://www.bmj.com/content/347/bmj.f1881
The idea that science should be proprietary is wholly wrong-headed. Science requires an open pursuit of the truth. Pharmaceutical companies should only be allowed to exist as corporations if they agree to share all of the data that results from their clinical trials.
This is a matter of scientific integrity and public safety.
