Pharmalotby Ed Silverman09/09/2013Five years after the Innovative Medicines Initiative was launched with big hopes of regenerating drug development and discovery in Europe [back story], a high-profile clash has broken out among some of the participants – one of the world’s largest drugmakers and a medical institute – that may test the limits of collaboration between industry and independent research groups.
The spat involves GlaxoSmithKline and the Mario Negri Institute for Pharmacological Research, a non-profit based in Italy, which has withdrawn its involvement in an antibiotic resistance study. The institute is publicly objecting to the protocol design the drugmaker established and conditions for accessing data and publication. And in public remarks, the institute believes Glaxo has been inflexible and hypocritical.
A failed attempt at collaborationby Silvio Garattini, Vittorio Bertele, and Guido BertoliniBMJ 2013;347:f5354.The Mario Negri Institute for Pharmacological Research, a non-profit independent foundation, has withheld its involvement in an Innovative Medicines Initiative project that included clinical research and development of a product owned by GlaxoSmithKline. Although we fully support the idea of further collaboration with industry, on this occasion the cooperation was not quite what we had hoped for. GSK set down the protocol for the clinical research in the partnership, and when we questioned some of the company’s methodological choices — such as the comparator drug and sample size — it became clear that these were not open for discussion. A project agreement written by GSK and attached to the study protocol set out dozens of pages of rules and conditions that would effectively have made this a study controlled by GSK and not a collaborative study. GSK outlined a complex structure for governance of the trial with committees and boards and voting rules that effectively gave the drug company total control…
They also chide Glaxo for its decision which, they write, is “even more inappropriate when publicly funded or independent, non-profit institutions are contributing to the development of a drug and patients are generously volunteering to participate. Secrecy definitely sounds paradoxical when EU funds support the clinical research, as with IMI projects”… And the project is seen as symbolic of the role potentially beneficial role the IMI can play in public health. Antibiotic resistance has seen limited commercial development despite growing concerns over antibiotic resistance. As BMJ notes, the IMI has gradually shifted its focus from biomarkers to later-stage clinical development of experimental medicines.
For its part, Glaxo deflected the criticism. “Public partners are playing a leading role in the protocol design, site selection and data analysis as part of this collaboration – aspects of clinical studies that would normally reside just with the sponsoring company. There is an unprecedented level of academic representation through the team,” says Scott White, who is in charge of the Glaxo project, in a statement. “We’re sharing the costs with society and they need to be part of the decision making. There is a large component of sharing what data we can. But industry has to work within a certain regulatory framework. To preserve the integrity of data submissions, we have limits on what we can share.”
"Unless we can find a solution to the commercial incompetence problem, we have to recognize that the pharmaceutical industry has an irreducible conflict of interest in relation to the way it represents its drugs, in science and in marketing. And unless we can resolve this in a way that is more in the public interest and in patients’ interest, I would argue that drug companies should not be allowed to evaluate their own products."
In a person, repetitive paradoxical patterns sometimes reflect unconscious conflict, structural problems, or even traumatized sectors of the persona. In other situations, they’re just learned bad habits. But their illogical nature is neither always stupidity nor evil, it’s a reflection of two mutually exclusive conflicting motivational systems trying to live in the same box – an irreducible conflict…. In a giant corporation, the possible meanings of such paradoxical patterns like this increase geometrically, but figuring out such things is really none of our business. The best advice for our team is probably something as simple as "the best predictor of future behavior is past behavior," and leave our analysis at that.
The current solution being offered to PHARMA is data transparency – the AllTrials movement, the RIAT proposal, the EMA’s [currently blocked] data transparency proposal, the TEST Act, Clinical Trial registration, etc. The collective we are saying that you can’t hide your sheenanigans behind a wall of data secrecy anymore. We see where that has taken us, and it’s not a viable place and unjustified. What PHARMA hasn’t yet recognized is that data transparency is actually a generous offer. The alternative hinted at by Dr. Godlee is more stringent, and equally justifiable, "You’ve proven that you can’t be allowed to even evaluate your own drugs." And that may well be where things end up if they keep holding out for some version of the status quo.
This action by the Mario Negri Institute for Pharmacological Research reflects an increasingly prevalent attitude that I would only see as becoming more common or perhaps even regular. Another example: there was a time not very long ago when someone like Neal Parker of AbbVie [a deal-breaker?…, a window…, who was that guy?…] could get away with making his assertions without much challenge. If you watched his video performance, that’s not at all what happened at the Brussels meeting.
It would be nice, but I’m not sure the current system, where RCTs are considered the gold standard of research, will have the flexibility to allow baring pharma from evaluating their own products, as they are (almost) the only people who can afford it. I’m not sure that our culture, which valorizes authority based interactions, will accommodate a doctor/patient/research relationship what is based on humility. It seems like we want the reassurance of a glossy authority, shored up by large studies and hard science, and we might need to address that addiction first.
We (the U.S./government) need to start paying for research again.
If you have enough money, you can pay for a change in the weather.
3 great on-point comments all. Thanks.
Especially appreciated since those are not always my own forte. 🙂
Pure research doesn’t make a profit, and it’s been a long time since brute forcing molecules could produce anything worthwhile.
The only solution I can see is to finally slap a felony conviction on the companies themsleves instead of their subsidiaries. Strip off that ‘Fig leaf’ protection and allow the conviction to take away federal program reimbursement of drug sales. Goodbye Pharama, hello modern biotech companies that still own the majority of their stock and can make long term investments in research, unlike the old pharma companies.
I wish we could lobby for a judge to show some guts.
Federal regulation of ….souls? The SUPPORT study:
http://impactethics.ca/2013/09/11/judging-souls-versus-acts-in-bioethics/