Wednesday, September 04, 2013

Will Social Media Make it Harder for Pharma to "Hide" Drug Side Effects?

John LaMattina, former Pfizer president of Research and Development, suggests that FDA regulations make it virtually impossible for the pharmaceutical industry to "hide" drug side effects. "Most people don’t have a clue as to the vigorous requirements put on pharma by the FDA for reporting a drug’s side effects," says LaMittina. "Actually, specific regulations exist as to how the industry must handle and report adverse events" (see "Can Pharma Hide Side Effects Of Marketed Drugs In The U.S.?").

LaMattina laments that he "often get[s] attacked that I am defending an evil empire." Some might say a "criminal organization" (see "GSK, GSK, GSK: TSK, TSK, TSK!").

I don't want to "attack" LaMattina, but I will point out one or two things that bother me about his post.

First, he insults the intelligence of "most people" who he claims "do not have a clue" about the constraints under which the drug industry operates and which REQUIRE that drug companies report adverse events. The tone, IMHO, is a bit paternalistic and echoes the attitude I've heard expressed by other current or former drug industry executives. See, for example, "Bayer's CEO Accuses Patients of Being Ungrateful B*stards! We Cured Cancer, Dammit!"

Up until now, the main way that healthcare professionals and consumers report drug adverse events (AEs) is through the voluntary Medwatch program, which LaMattina himself says is "not perfect." That's an understatement. In 2011, the Tufts Center for the Study of Drug Development gathered and analyzed 10.2 million adverse event reports filed with the MedWatch system. "Patient information was generally complete and accurate. Suspect product information, on the other hand, showed high levels of incomplete and inaccurate data" (see "Evaluating the Completeness and Accuracy of MedWatch Data").

Also according to PatientsLikeMe (PLM) CEO James Allen Heywood, MedWatch collects only a small percentage of total AEs. He also said: “MedWatch is hostile ... and written in a language that patients don’t understand.”

Yes, most people have not heard of MedWatch. Even if they did, however, the system would not capture most adverse events.

So, there really is no need for drug companies to actively "hide" adverse events -- they just need to keep the status quo and the system will do it for them.

But social media threatens to upset the status quo as far as adverse event reporting goes. PLM found that 7% of 500 randomly selected posts from the 364,000 posts contributed by patients within the PatientsLikeMe Forum during 2009 incorporated all four elements required for reporting an adverse event (an identifiable patient, a specific medication, an identifiable reporter and a reaction). (See "PatientsLikeMe Reports High Rate of Adverse Event Reporting Among Its Members".)

Recently, I interviewed Pharma Social Media Pioneer Alex Butler who pointed out that pharma may face an adverse event crisis amplified by social media. “We will see very quickly if people are responding badly to medication,” said Alex. “There is bound to be at some point a crisis situation which now in the social world that we live in will be amplified beyond people’s imagination and the impact it will have, possibly with some drug withdrawal, some situation that’s mismanaged” (listen to a snippet from my interview here).

If the drug industry is REALLY interested in NOT hiding the side effects of drugs, then I suggest it follow the advice I gave back in September, 2009 (here); i.e., each website should include an AE reporting widget as in this mockup:

The widget would include patient education about adverse events and how to use the Medwatch system to report events, using easy-to-understand language and an online Medwatch form that pipes reports directly to the FDA.

If the industry has nothing to hide, it should use technology to help patients report adverse events. Or the industry can maintain the status quo until Butler's worst case future AE scenario unfolds.

1 comment:

  1. Actually, it's already happening not just in the realm this article focuses. Pediatric vaccine uptake continues to drop year after year as more an more parents exercise religious and philosophical belief exemptions. Recent estimates are that 15% of Marin County children entering kindergarten have some sort of "mandatory" vaccine exemption (causing much angst among public health officials). I choose Marin as it's affluent and well-educated. Why would otherwise responsible parents choose not to protect their children against these various disease? The answer is increased knowledge of adverse reactions.

    Social media has allowed concerned parents to network and share first hand experience of the adverse reactions they observed. Despite a pediatrician claiming it's fine to inject a toddler with seven or more vaccine doses in a single visit, more an more parents are saying no. They vaccinate selectively against diseases that they think are worth the risk and taking a pass on low risk diseases like chicken pox and flu. Instead of getting every single booster as mandated by the schedule, they are first measuring antibody titers to see if the shot is really needed. They are spacing doses apart and skipping some altogether. They are taking charge of their children's medical care and the medical establishment/pharma don't like it one bit and are throwing a collective hissy fit.

    Why was Gardasil a flop? It flopped because girls told each other via social media that they felt like $#^& after getting the shot. Not only is uptake in general low but the percentage of girls who get one shot and don't finish the three dose series is astronomical. Social media is killing Gardasil. People won't put up with feeling terrible for some theoretical protection thirty years down the road against something that may never happen to them anyways. Parents won't watch children suffer for the same reason. When they thought their child's adverse reaction was the proverbial "one in a million", they put up with it. Once they began to network (and read the package inserts) and realized how common these adverse reactions really were, parents started saying no. More an more say no every year.

    Pharma can't put the genie back in the bottle. They once controlled the flow of information as the mainstream media wouldn't jeopardize their pharma advertising revenue with critical stories. Blogs, facebook, twitter, etc. have broken the gatekeepers stranglehold on information. It's already happened with vaccines, and it will also happen with traditional drugs. The only reason it hasn't fully happened yet is that the primary market (senior citizens) aren't as plugged into social media as younger consumers. That's changing and it won't be good for pharma.


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