Showing posts with label transparency. Show all posts
Showing posts with label transparency. Show all posts

EU's EMA Plans to Open Up Proprietary Drug Trial Data to Outside Investigators

European Medicines Agency (EMA) -- the European drug regulator -- "is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information," according to Reuters news (here).

This is big news depending on how EMA makes these large data sets available to outside investigators and which investigators are granted access. Reuters reports that the agency will host a conference in November to determine who has access to what and how fast. As I always said of the FDA, if an agency wants to delay something, its best bet is to hold a meeting to discuss it or sponsor research to study it.

The drug industry has long argued that the clinical data it presents to the FDA and other regulators as part of the drug approval process is proprietary -- ie, closely guarded trade secrets. But critics contend that important safety data about drugs is hidden from outside investigators and the data is critical for maintaining public health.

"It will make a huge difference to public health," said Peter Gotzsche, director of the nonprofit Nordic Cochrane Centre in Denmark, which carries out systematic healthcare reviews. "The pharmaceutical industry routinely exaggerates the benefits of its drugs and plays down the harms or hides them. By getting access to material held by drug regulators we may discover that many drugs are less effective than we thought they were and also more harmful."

In 2011, Gotzsche wrote paper titled "Why we need easy access to all data from all clinical trials and how to accomplish it." In it, he said "Calls for data sharing have mostly been restricted to publicly-funded research, but I argue that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests" (find the full text here: "Call for Easy Access to ALL Clinical Trial Data").

A case in point is Vioxx, whose harmful side effects once were secrets known only to Merck and the FDA.

"Europe used to be behind the FDA in terms of openness and transparency but now Europe is ahead," Gotzsche said. Will the FDA ever follow EMA's lead?

I doubt it. FDA has been very gun shy of the pharmaceutical industry, which pays over 60% of the agency's budget for approving drugs. Also, the drug industry has no qualms about taking the FDA to court to defend itself. Usually, the FDA is sued by pharma for limiting the industry's First Amendment right to free and open speech. In this case, however, the industry would argue that FDA has no right itself to "speak" freely about clinical data provided to it by drug companies.

UPDATE (7/16/2012): While the EU plans to provide access to "confidential" clinical trial data, the FDA is prohibited by LAW to do so. The Wall Street Journal reports that the FDA is monitoring some of its own employees who are suspected of leaking confidential medical device data to the press (read about this here).

A Call for Pharma Social Media Transparency Guidelines for Patient Bloggers

"Political strategists agree that the acrimony that has tinged many of the attacks on the news media this year feels different," according to a story in today's New York Times (see "Politicians Are Fighting Mad, at the News Media"). “Everyone has always bashed the media,” said Dana Perino, a Republican consultant who was a White House press secretary under Mr. Bush, “but I do think there’s something larger going on.”

What's going on is this: "the eagerness of many candidates to bypass the mainstream news media in favor of social networking or media outlets that they perceive to be embracing of their political platforms."

I believe the pharmaceutical industry has the same "eagerness" to bypass mainstream news media in favor of social networking. This is evident by the growth in Twitter use by pharma companies to push out news that it used to do via press releases distributed through channels cherished by reporters (eg, prnewswire).

Pharma PR and corporate communications professionals have been courting bloggers with dinner meetings and invites to events that previously only mainstream media journalists were privy to. Johnson & Johnson and Pfizer have lead the way ("Bloggers Dining at Pharma's Table", "Thank You Johnson & Johnson for Dinner", and "Chantix 'Roundtable' Apparently Not Round and Not a Table"). Of course, as a blogger, I have encouraged this.

But influential patients and physicians are becoming more important to pharmaceutical companies than industry bloggers like me. Patient bloggers, for example, are high up on pharma's list of people they'd like to influence. At least some influential patient bloggers have put out the PHARMA WELCOME mat (see "Some Social Media Patient Opinion Leaders Want to be Paid Pharma Professionals").

Many patient bloggers claim that it is important for pharmaceutical companies to "join the discussion." But pharma marketers and PR people -- who control the communications budgets within pharma -- want to "influence the discussion" and not merely "join the discussion" on social networks frequented by patients and physicians.

Within these online communities are "thought leaders" who feel equal to or superior to institutions such as the press, or government agencies. Pharma is poised to exploit these feelings and is probably doing so now as I write this.

The only issue I have with this is that a lot of it may be happening "behind the curtain" (see "Pharma Social Media Behind the Curtain"). Often, neither the pharma company nor the social media patient leader reveals the relationship. New guidelines from the FDA will NOT address this issue because the FDA is concerned only that pharma commercial speech stick to the approved labeling when discussing brand name drugs. FDA cannot, for example, regulate non-branded, disease information that pharma companies may share with patients and physicians. Furthermore, FDA cannot enforce transparency -- it has no authority over patients who are free to do and say what they like without mentioning any relationship they may have with pharma companies.

That's why I say that pharma companies MUST make known their transparency policy with regard to social media. I'm not talking about their policy for how they expect their employees to behave when engaged in social media discussions. I'm talking about policy about how the corporation will behave in relationships with patients and how they will reveal those relationships.

For example, imagine that a pharmaceutical company has invited several influential patient bloggers and social network leaders to a 2-day "conference" at a resort in Orlando, Florida, all expenses paid. The "conference" is all about diabetes and support for diabetes, but not about specific diabetes treatments. It's all about "opening up a dialogue," that sort of thing.

Like a physician author in a medical journal, should patients who receive such largesse from pharma companies be required to reveal that? If the answer is "yes," who requires it? It can't be the government. It must be what I call the pharma company's "social media transparency policy," which might state something like "We require all patients who receive money or goods in kind such as free lunches and airplane tickets and other travel-related expenses to reveal that to their readers and social media followers in an appropriate fashion."

I have revealed my relationships with pharma companies many times, but not every time I write a blog post. What I have done, however, is to update my profile by adding this statement:
"I am not a paid consultant to the pharmaceutical industry, but I occasionally get invited to speak within pharma companies or at industry conferences. For this I receive reimbursement for travel expenses and ask that any speaker fee be donated to a charity. As a publisher, I do accept paid advertising mostly from agencies that work for the pharmaceutical industry."
I think patient bloggers should have something similar in their profiles (or whatever is appropriate for their relationship with the drug industry). Patients who participate in social networks and are considered "leaders" in the community might include the transparency statement in their profiles and/or signature files as well. And pharma companies should encourage this by publishing social media transparency guidelines for their patient blogger/social media partners.

Eight BloggersP.S.  Recently, GSK invited eight bloggers to visit its manufacturing facility to "tour the facility and learn about the role that vaccination plays in keeping adults and families healthy" (see "Opening Our Doors--Again").

At least two of the bloggers wrote about their experience (see here and here). At the beginning of each blogger's post was a disclosure. Here's what they said:

"My travel, accommodations and food (except for the bagel and an extremely necessary cup of tea) were covered by GlaxoSmithKline. They did not require me to write about the trip at all, nor did they pay me, review this post or dictate what I have to say. Which is a really impressive release of control for these folks." -- Nutgraf

I don't know who "Nutgraf" is -- life's too short to track down a name when it's not mentioned in the "about me" section of the blog -- but he/she states in her/his "A Note on Integrity":

"I review things – including books, products and advice submissions – in my own time and on my own terms. I need your input to make the advice project a success, and you can rely on me to clearly disclose my policies, protect your privacy and generally deal with you and others in an above-board manner. As for products, books, pitches or anything else of that nature, I’m a big fan of disclosure. I disclose early, loudly and often. I am easily skeezed out and want to be proud of what I do here."

Meanwhile, the other blogger (see profile here, which does not include a blanket disclosure statement as above) states at the beginning of her blog post:

"I went on a trip to Philidelphia to tour the GlaxoSmithKline vaccine plant. My flight, hotel, cab fare and meals were covered expenses. The opinions represented in this post are all mine and were not compensated in any way.This is a VERY long post, and yet I feel strongly about it and would really appreciate if you would take the time to read it in it's entirety." -- Scrutiny by the Masses