Why are Drug Companies Suddenly Agreeing to More Regulations?

Drug companies in the U.S. and Europe, facing the prospect of EU officials forcing them toward more transparency, have nowagreed to share some clinical research data. Does this mean a new era of openness or is this just lip service?

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the U.S.’s Pharmaceutical Research and Manufacturers of America (PhRMA) released a joint set of principles last week outlining a plan to allow greater access to clinical drug trial data so that qualified scientists could, in theory, analyse the results and confirm or refute the drug companies’ claims.

It is believed that less than half of research trial data is currently published, with critics saying the data is withheld so that pharmaceutical companies can overstate the effectiveness of their drugs, downplay side effects and maintain a competitive edge over each other — all at the expense of patients.

So strong are the concerns that the European Medicines Agency (EMA) has begun to formulate regulations that would force the companies to publish such data. Many have resisted such interference, as had PhRMA and EFPIA , with PhRMA on record as late as this January formally opposing any wider changes to data publishing.

However, with the publishing of a new set of transparency principles, both companies appear to be at least offering tacit agreement with the EMA initiative. So what are the principles, and what is going on here?

The New Principles PhRMA and EFPIA Have Agreed On

Due to be implemented in January 2014, thePrinciples for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers outline that data requests will be allowed under certain conditions.

All such requests will first be referred to review boards established by each company. Those boards may include independent scientists and health care professionals, as well as company officials, to offer a balanced assessment of data requests. However, the individual makeup of each review panel will be set by the companies and there will be no mandate that companies have to include outside reviewers.

Researchers will at the same time have to demonstrate that they have the qualifications to handle the data and that their use of the data will fulfill a legitimate research question, though exactly how that is defined appears quite nebulous at this stage.

Other commitments outlined in the document include an agreement for companies to work more openly with regulators to provide a detailed summary of relevant information for patients who participate in clinical trials.Moreover, companies will also agree to make available to the public summaries of clinical study reports when new medicines are approved by Europe and U.S. regulators.

The principles encourage publication of positiveand negative results from what are known as all “phase III” trials, where a prospective treatment is given to large groups of people to confirm its effectiveness and monitor side effects — this even if those results do not provide evidence for the effectiveness of a given drug or show signs of above acceptable side effects.

The principles explicitly state, however, that no data will be shared that could compromise pharmaceutical industry competitiveness. The principles also reserve far reaching powers to protect data that companies deem could compromise patient confidentiality.

Given the wider pharmaceutical industry has resisted attempts to force more transparency in data publishing, why have PhARMA and EFPIA suddenly changed course? And is this really all it seems?

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.

Image credit: Thinkstock.

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Cathleen K.
Cathleen K.2 years ago

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.

Jacqueline S.
Jacqueline S.2 years ago

We'll see!

Sarah Mumford
S M.2 years ago

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.

Laura Saxon
.2 years ago

Because they want to be compliant with the law.

Ron B.
Ron B.2 years ago

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.

Doug G.
Doug G.2 years ago

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?

Natalie V.
Natalie V.2 years ago


Walter Botteldoorne

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.

Marie W.
Marie W.2 years ago

Running out of money for lawsuits?

Lin M
Lin M2 years ago

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.