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Why are Drug Companies Suddenly Agreeing to More Regulations?

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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.

Reports the Guardian:

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.

Reports the New York Times:

“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.

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52 comments

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8:30PM PDT on Aug 3, 2013

The medical industrial complex sees the writing on the wall. The good times are almost over. We cannot afford to continue paying ever increasing prices for drugs, doctors, hospitals, devices and procedures. The pharmaceutical companies are just joining doctors and hospitals who are facing reality, cutting prices, opening their books for comparisons of costs and effectiveness. The drug companies know they are distrusted by everyone, even doctors, so they are trying to deal with it. The alternative, which is just around the corner, is that governments are going to slash prices on everything and have the FDA and it's European equivalent go back to regulating the hell out of them. Believe it or not, the FDA used to make them wait years to bring a new drug to market after they completed their testing, because they tested it themselves.

Thalidamide, a drug used to treat nausea, was widely prescribed to pregnant women the world over in the 1950s for the treatment of morning sickness, but not in the US, because the FDA was still running animal tests and wouldn't approve it for use in pregnant women. Sure, some doctors prescribed it anyway, but nothing like as often as they did elsewhere. The result? We had far less birth defects than anyone else. We need to go back to a robust, well funded FDA, not one that's been drowned in a bathtub by defunding and lack of authority.

7:06PM PDT on Aug 1, 2013

We'll see!

9:08AM PDT on Aug 1, 2013

Lin M. - generic is the real thing just hasn't got a Pharmaceutical's worldwide known name on it but all licensed as the real thing.

This generic is another reason why Big Pharmacy wanting to play nicer than in the past ... health systems in many countries including UK, Europe, Developing World have caught up with their profiteering. To keep profiteering they started taking drug manufacturers to court because they making and selling medication without big labels - the publicity of such woke up Health professionals to reality.

4:16AM PDT on Aug 1, 2013

Because they want to be compliant with the law.

10:23PM PDT on Jul 31, 2013

You can bet it isn't because Big Pharma CEOs are suddenly taking truth serum. As long as there are obscene profits to be made, they will continue giving us the bitter taste of their own medicine to one extent or another.

6:30PM PDT on Jul 31, 2013

As with most research and insight these days, Europe leads the way. Perhaps because their institutions aren't as bought off as those in this nation. Clearly, their people appear more proactive. What then, is Americans excuse?

4:27PM PDT on Jul 31, 2013

thanks

3:21PM PDT on Jul 31, 2013

Ik ben al 22 jaar invalide,weet genoeg van al hun onderzoeken en pillen .Als ze het niet meer zien zitten moeten we geen pijnstillers of andere pillen nemen of zou op de nieren slaan ,gewoon de pijn verdragen zeggen de artsen nu zijn het allemaal witte producten die zoveel kosten als vroeger de echte.

3:02PM PDT on Jul 31, 2013

Running out of money for lawsuits?

2:20PM PDT on Jul 31, 2013

Just about all my meds. are generic......sad but medicare wont pay for the real thing. If you
are poor or old or both, you are not getting the real thing.

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