What Does this Change Mean for Patients and the Pharmaceutical Industry?
In short, not very much.
It is important to point out this voluntary change would appear to be an attempt to forestall the industry being forced into more stringent measures.
This is not to minimize the changes the new principles could create, but to put them in context: the industry seems to be attempting to retain its freedom by self regulating more closely.
Also, this announcement appears to be part of a carefully coordinated exercise in resisting the more stringent EU regulations.
The Guardian this week alleged PhRMA and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have engaged with patient groups to try to drum up resistance against the EMA forcing a wider release of data.
This came to light after the Guardian saw communications from Richard Bergstrom, director general of EFPIA, that went to directors and legal counsel at drug companies at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and several smaller companies.
The email describes a four-pronged campaign that starts with “mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data”. Translated, that means patient groups go into bat [sic] for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare.
A source in the European parliament, who is close to the negotiations over the clinical trials directive, said he had experienced intense lobbying from patient groups. “We’ve witnessed this sort of activity in recent months, and it’s a concern if the pharmaceutical industry is behind some of it. They are trying to weaken some of the transparency proposals and that’s clear from the amount of lobbying we’ve had,” he said.
Concerns have previously been raised about how the pharmaceutical industry has courted patient groups, using their assumed status as representing wider patient concerns to lobby for the so-called Big Pharma causes.
Seen through this lens, PhRMA and EFPIA’s new principles may ring rather hollow now that it appears while they have been trumpeting their move toward openness, they have also been making a concerted effort to raise spurious concerns about wider transparency; EU regulators have made several assurances that any patient confidentiality concerns could be handled.
All that said, those in the medical community have said the principles, if acted upon, could be significant.
“What they are doing would have been thought to be inconceivable even a short time ago,”¯ said Dr. Harlan M. Krumholz, a cardiologist at Yale who recently oversaw an outside review of a treatment by the device maker Medtronic. “If these companies truly fulfill these promises, then they will have made an important contribution to science and the common good.”¯ But he said their efforts would need to be monitored.
So what does this mean for us, the patients?
It seems the principles outlined above add up to very little right now.
If adhered to, however, they really could represent a large step in the right direction to ensuring more openness and greater oversight.
This should be a first among many steps, though, and not an end goal.
Image credit: Thinkstock.
Disclaimer: The views expressed above are solely those of the author and may
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