The FDA is holding a public hearing on the “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” There is a tremendous amount of buzz on Twitter and blogs about this meeting which will hear 60 speakers, some more than once. As ABC News Business division reports this morning “Drug Industry Presses FDA to Allow More Online Ads.” Funny they would try that on the same week we learn that close to 1/3 of all published articles about clinical trials do not mention certain side effects known to the principal investigators! Of course the ads are only a portion of what will be discussed at the FDA hearing. There are 5 questions that will be discussed:

• For what online communications are manufacturers, packers, or distributors accountable?
• How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?
• What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
• When is the use of links appropriate?
• Questions specific to Internet adverse event reporting

To start and  to put you in the right mood, you should know that this official meeting about social media will take place in an office without any cell or internet access! Unlike any of the conferences that people attend every day, there will be no real-time reporting, no tweeting from within the room. As my old buddy John Mack wrote recently

This reminds me of the Cary Grant movie His Girl Friday where reporters in fedoras rushed out of the courtroom and ran to the press room to call in their stories. There is a press room just outside the hearing room at the NTSB Center, but I haven’t been able to determine who can use this, what facilities it has, and why I would want to be holed up in there when all the action is happening up front in the court of public opinion!”

In the age of Web 2.0, Health 2.0 and user-generated content, the Federal agency in charge of the regulation of the entire medical and pharmaceutical  industry will hold this historical meeting about social media and therefore user-generated content with one individual consumer representative (Kim Witczak, whose husband committed suicide after taking Zoloft for five weeks). You heard me right. Most of the 58 other presenters have commercial interests that could suffer irreparable consequences from the effects of future FDA regulations of medically related social media resources. They range from representatives of pharma companies and PR firms to pharma communication consultants and newsletter publishers. There are many representatives of Health 2.0 commercial companies. So, as happens almost every time in Washington, there will be no direct representation of the voice of the patient. In other words, the voice of the patient will be marginalized, as always seem to happen in the Capital city.

The voice that should represent millions of people who have learned over the last 15 years how to use the Internet and grassroot medical online communities will be silent. Just like we have witnessed over the last 6 months in the painful Health Care reform drama taking place in the single-industry town known as DC your future will be decided without asking for your direct input. FDA, way to go in the age of transparency and public involvement! Patient is not a third-person word! It is high time for everybody in DC to learn this simple fact and start to act accordingly!

Just look at what has been published about the meeting and you’ll understand my frustration. Take this video:

So Pfizer will speak at the meeting, and will “get engaged in the conversation” (that sounds like a sentence generated automatically by the BS generator )  and will have representatives seated in the audience about the future of social media, on the same day the New England Journal of Medicine publishes a damning article about reporting practices by Pfizer and Parke-Davis entitled “Outcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-Label Use“. (Note: the drug brand name is Neurontin)

Let me just reproduce the one-line conclusion:

“We identified selective outcome reporting for trials of off-label use of gabapentin. This practice threatens the validity of evidence for the effectiveness of off-label interventions.”

Dr. Sidney Wolfe, head of health research at consumer group Public Citizen, calls the article the first comprehensive look “at studies in which a company and people working for it so maliciously manipulated the data to make a drug look more effective than it actually was. In every instance, the published article made the drug look better than it would have,” said Wolfe, a member of the Food and Drug Administration’s drug safety advisory committee. “This results in harm.” Not surprisingly Pfizer, who pleaded guilty to criminal charges for off-label promotion of Neurontin in 2004, and agreed to pay the largest criminal fine ever levied against any drug company in the world ($1.3 billion in criminal fines and revenue forfeiture, part of a $2.3 billion settlement) disputes the report’s conclusions, and issued a statement saying that it never ”attempted to mislead the medical community about the effectiveness” of the drug for certain uses. The company added that “we believe the review suffers from significant bias, insufficient data, poor methodology and cannot pass the threshold of credible scientific research.”

The same old story, as far as informed patients are concerned. We have reported multiple instances of peer-reviewed-publication manipulations by principal investigators receiving money from pharmaceutical firms. (See Dr. Reuben deeply regrets that this happened!, I Am “A Nobody & A Nothing” & I’m Proud Of It!, FDA Gives Light Scrutiny to Investigators’ Financial Ties, No *other* conflict of interest, huh? for a sample of why it would be so important for the FDA to hear the unbiased voice of some leaders of well established grassroots, non-commercial online communities.)

A couple of examples show what these online communities can do better than any FDA regulated, pharma or PR-generated Internet resource.

A month ago, I presented at the IOM workshop “A Foundation for Evidence-Driven Practice: A Rapid-Learning System for Cancer” the story of the Zometa study done by Mike Katz, a long term Multiple Myeloma survivor, long term board member of the International Myeloma Foundation (IMF), former chair of the NCI Director’s Consumer Liaison Group and manager of the ACOR MYELOMA list since 1995. That study was done just months after the initial FDA approval of Zometa , with an infusion time of 15 minutes (changed from 5 minutes to avoid renal failure in a small number of patients). Within 3 months of the drug approval, the MYELOMA online community had received enough individual reports of both of these problems to convince Mike that something needed to be done fast. He asked expert advice from the expert clinicians at the IMF and rapidly communicated back to the membership of the MYELOMA list that they had to insist with their doctors to change the Zometa injection to a 30- minute schedule. From that moment the community no longer received reports of renal failure. That was years before “Lost in Transmission — FDA Drug Information That Never Reaches Clinicians” (NEJM, Oct 2009) where you can read:

“Sometimes what gets lost is data on harms. For example, in 2001, Zometa (zoledronic acid, Novartis) was approved for use in patients with hypercalcemia of malignancy. Approval was based on the results of two trials, in which 287 patients with cancer were randomly assigned to receive either 4-mg or 8-mg doses of Zometa or Aredia (pamidronate), the standard of care. According to the label, 8 mg of Zometa was no more effective than 4 mg in reducing calcium levels but had greater renal toxicity (see box on Zometa data). The numbers quantifying the renal-toxicity data for the 8-mg dose did not appear in the label, as they did for the 4-mg dose. But they did appear in the 98 pages of FDA medical and statistical reviews. Surprisingly, the reviews also noted that the 8-mg dose was associated with a higher rate of death from any cause than the 4-mg dose (P=0.03). These mortality data also did not appear in the label. Nor did they appear in the journal article reporting on these studies, which actually recommended the 8-mg dose for refractory cases. In 2008, the FDA approved an updated Zometa label with an explicit warning statement: “Renal toxicity may be greater in patients with renal impairment. Do not use doses greater than 4 mg.” Yet the mortality data are still missing from the label.

Another study done by Mike Katz and using a variety of medical online communities (for myeloma and breast cancer patients) showed a significant number of adverse events (AE) related to the resulting osteonecrosis of the jaw following treatment with Zometa. That study, “Osteonecrosis of the Jaw and Biphosphanates” was published in the New England Journal of Medicine in 2005. Would any of the reports made through online communities be enough to generate an AE report? As @jonmrich wrote “You need four things:

• an identifiable patient,
• an identifiable reporter,
• a specific drug or biologic involved in the event, and
• an adverse event or fatal outcome.

If you don’t have all four, don’t bother submitting it because the FDA won’t accept it. In their words, “[Without these four pieces] a report on the incident should not be submitted to the FDA because reports without such information make interpretation of their significance difficult, at best, and impossible, in most instances.” [ital. added]. I am not clear that all these reports have the four elements since we don’t really know who the reporters should/could be. It would be so easy for the FDA to embrace Web 2.0 technology and enter the Health 2.0 universe by creating a public-oriented website to get user generated adverse event reporting!

This evening I was told of another survey organized on the OVARIAN community years ago and published in JAMA in 2004. This survey was done to explore whether there were early symptoms of ovarian cancer, once called the “silent killer.”  The ovarian list participated heavily in this study.  As a result, there is now an official list of early warning signs of ovarian cancer that is approved by the gynecologic oncologists.  As Deborah Bell told me “We hope that doctors never again are taught that there are no early symptoms of this deadly cancer.”

Deborah added

Let me give you a little background on the survey: The study was started by Cindy Melancon, a (now deceased) listmember who ran an ovarian cancer newsletter, done with Dr. Barbara Goff (gyn oncologist), to see if there were symptoms of ovarian cancer before diagnosis.  We all suspected that there were, due to discussion on the Ovarian list and in other groups.  The survey was the first of its kind, and was aided significantly by the women on the Ovarian list.  We were encouraged to make copies and send them to everyone we knew who had ovarian cancer.  This is possibly the only survey with a greater than 100% response rate.  The outcome of this made serious news – and yes, there are symptoms.  Prior to this survey, everyone called it the “silent killer,” with no symptoms until it manifested in a very advanced stage.  This is what doctors were taught in medical school:  no early symptoms.  There is now an official list of early warning signs on every serious ovarian cancer website.”

Don’t you think these people should be the ones telling the FDA how social media is working and how pharma communication via social media should be regulated/managed/moderated? They have nothing to win or lose by speaking about the reality of the internet medical communities, of the ad blindness, of their personal interactions with drug manufacturers and any other topic that relates to today’s hearing. But their voice won’t be heard. Because as health care tweeter @eyeonfda wrote in  “What If FDA Threw a Party and No One Came? BioPharma Participation in the Part 15 Social Media Meeting,” the real stakeholders are not represented at the meeting. It’s just that we disagree on who are the real stakeholders! We, of course, consider the patients and general population the first and most important stakeholders in any conversation related to health and health care. @eyeonfda, who represents pharma interest sees it differently: “The bulk of the presentations are tertiary stakeholders perhaps sensing a vehicle for free self-promotion such as advertising and public relations firms and bloggers, but they aren’t the real stakeholders in this issue.  The real stakeholders are those who are referred to in the meeting notice — the medical products industry.  Not their vendors or observers.”