Envisioning 2.0

- Is Telephone Telepathy Real?: Earlier this month, Robert Sheldrake, director of the Perrott-Warrick project for research on unexplained human abilities, suggested that there is plenty of scientific evidence for telepathy, but it is widely ignored. His column and the trial he cited, a research study indicating that 45 percent of people were able to identify a randomly-selected caller before they picked up the phone, has caused quite a stir.

Commentary: I have experienced “telephone telepathy” quite a few times in my life. However, since reading this article, I’ve learned that there are problems with Sheldrake’s research methodology. Whether Sheldrake’s study holds water there is something going on. However, I’m not ready to call it telepathy. In addition, the reporting on this study reinforces the fact that people have to take research with a grain of salt and reporters should dig deeply into the methodology and validity of studies before writing about them.

- Doctor Does Not Mind Pharma Marketing: Earlier this week, I reported on a new Stanford University policy that bans, among other things, small gifts, free lunches and other marketing activities by pharmaceutical companies. Now FierceHealthcare reports that at least one physician is not very happy with efforts to curb drug firm marketing activities. Mike Wei, M.D argues:

“In a perfect world the [Stanford] policy made sense, but in the real world, this is another policy that some bio-ethicist who has nothing better to do dreamt up in his office . . . The Society of Critical Care dropped pharmaceutical industry support for providing lunch at their annual meeting in order to avoid any possibility of being improperly influenced. The net result is the exhibit hall is like a ghost town during lunch hours whereas in the years before this policy was adopted the hall was usually full. I am equally helpless in telling you who was paying for lunch boxes in the prior years. This type of overly-cautious policy is detrimental to everyone. Pharma companies are not willing to pay high fees to rent exhibit hall space if no physician is around to talk to them. And we as physicians are missing the chance to be exposed to some genuinely new products at these meeting.”

Commentary: From my experience, I understand that some physicians rely on sales representatives and drug firm-sponsored continuing medical education (CME) courses to learn about new drugs. They find the information provided by pharma useful. This physician’s remarks remind us that although the pharmaceutical industry is routinely criticized its marketing activities, they do serve a purpose. There are many new drugs being approved and it is difficult for doctors keep up. Some physicians believe that CME and lunches provide a service and do not overly influence their decision-making.

- FDA “Drugged” By Pharma Industry?: In a new documentary, Money Talks, critics of the Food and Drug Administration contend that the agency is beholden to the interests of the pharmaceutical industry.

In a press release issued earlier this month about the film, they point to the fact that the FDA receives money from drug firms to review new products coming to market. Kathleen Slattery-Moschkau, who made the movie, said, “I think the most shocking information to come out of this documentary was the direct level of financial dependence the FDA has on the pharmaceutical industry. Agency jobs and funding are sustained by the monetary success of new or existing drugs. This conflict of interest significantly jeopardizes public safety.”

Commentary: I have not yet seen this movie, but based on what I have read thus far, it is filled with the usual criticisms of the FDA. From my interaction with FDA officials and attendance at FDA advisory board meetings, I know that many people in the agency are very hard working and honest – even if they are unwilling to admit their mistakes and aggressively counter their critics.

Slattery-Moschkau said that she was “surprised” that the FDA takes money from drug firms to review medications. She is referring to the Prescription Drug User Fee Act (PDUFA). This legislation was passed after pharmaceutical industry and consumer advocates complained that the FDA did not have the resources to review drugs quickly. They said that needed medications were not getting to market and that innovation was being threatened because the agency was not approving products quickly enough. Today, more than half of the FDA’s budget is comprised of monies generated by user fees.

The question remains: Does the PDUFA compromise the FDA’s integrity? There certainly needs to be more transparency in the process the agency uses to negotiate fees with the industry. However, as Mark Senak, author of Eye on FDA notes, “we either have to accept the premise that this funding leaves the agency impartial or move to have the federal government subsidize truly expanded activities for the agency.”

With new evidence that members of Congress are once again holding up the confirmation of a new FDA commissioner for political reasons, there is waning hope that the agency will have the leadership in place to aggressively tackle its many problems and proactively address its future. If critics really want to reform the agency, they should focus on getting leadership in place so that the FDA will have the power to better shape its future.