"Health and Wellness Channel"--PhRMATV

Think deeply for a minute. What are the major holes in your life right now? What are you missing that is preventing true happiness and fulfillment?

If you ponder this, I am sure you will agree on the answer--that you don't have a TV channel to watch that is controlled by one of the large drug companies. Instead of seeing their wonderful "ask your doctor if" ads merely several times every hour that you watch network TV, you could be letting the industry teach you stuff 24/7.

Well, do we have good news:

http://www.fora.tv/health_and_wellness

FORA.tv, based in San Francisco, is pleased to announce its new partnership with Pfizer to launch the Health & Wellness Channel.

If that doesn't make you feel Healthy and Well, you're hopeless.

FDA Compromise Bill Passes: Adding Up the Score

The House passed by a 405-7 vote on Wednesday, 9/19 a compromise measure to extend the FDA's Prescription Drug User Fee Act (PDUFA) by another 5 years. The Senate followed suit the next day and it was anticipated that the bill would quickly be signed by the President, in time to prevent the FDA from having to issue pink slips to 2000 employees as time runs out on the old PDUFA arrangement.

The compromise bill contains several important measures, and some provisions that remind us about the adage of not wanting to watch either sausage or legislation being made. Here's a quick run-down from my point of view:

Good News

• The FDA has increased authority to require companies to do post-marketing safety studies, and impose fines on companies that do not comply. In the past, the vast majority of these requested safety studies were never completed, and the FDA had only the blunt instrument of withdrawing the drug from the market as a method of enforcement.
• The FDA will for the first time have a computerized safety monitoring system utilizing insurance and pharmacy claims data. The existing system depends solely on voluntary reporting of side effects and drug reactions and is estimated to miss 90% of such events.
• The House eliminated some Senate provisions that would have protected drug companies from liability suits. Under the compromise version it is harder for a drug company to argue in court that since the FDA approved the drug and its labeling, the company has no liability if the drug ends up killing people.
• The FDA can actually force companies to alter labels rather than always having to ask nicely.
• Companies are required to post results of all clinical trials of approved drugs on a public, searchable website.
• The FDA gains some new powers to better police deceptive advertising.

Bad News

• The basic PDUFA mechanism remains in place. The industry, not the U.S. public, provides the lion's share of the funds that the FDA uses for the drug approval and safety monitoring process. This perpetuates the basic flaw that FDA critics argue has been the result of PDUFA--that the FDA inevitably sees the industry as its client, rather than seeing its overriding duty as protecting the public health.
• Conflict of interest waivers, allowing scientists with financial ties to the industry to participate in FDA advisory panels despite the rules that supposedly ban such participation, was a particular political football. The Senate version wanted no limits on waivers; the House wanted only one waiver per meeting. (I would vote for none.) The compromise result is delightfully Byzantine. The FDA should count how many waivers it granted in the 2007 fiscal year and reduce the number granted by 5% per year in each of the following 5 years. Congress--ya gotta love 'em.
• The pediatric trials scam continues. For initially excellent motives, Congress agreed that if a company tested its drugs in kids, they would get a 6 month patent extension in exchange. It turned out in practice that the cost of the research in kids was substantially less than the profits made from the 6 month extension, leading to major abuses where drugs that would never be used in kids were tested in kids anyway just to get the extension. The Senate had reasonably wanted to reduce this extension to 3 months; but the compromise version keeps it at 6 months.
• Stronger powers to regulate drug ads, especially a moratorium on direct-to-consumer ads for new drugs, were beaten down by intense lobbying by the media and advertising industries, which clearly don't want to see the DTC-ad cash cow dry up.

Harris G. House passes bill giving more power to the F.D.A. New York Times, Sept. 20, 2007.

Kaiser Daily Health Policy Report. House approves prescription drug user fee act reauthorization. http://www.kaisernetwork.org/daily_reports/rep_hpolicy_recent_rep.cfm?dr_cat=3&show=yes&dr_DateTime=20-Sep-07#47641

Wilde Mathews A, Kang S. Media industry helped drug firms fight ad restraints. Wall Street Journal, Sept. 21, 2007; page B1.

Med Student Activism Pays Off

Thanks to the Prescription Project weekly update(see links) for this item: Medical student activism at the University of Missouri-Kansas City school has had two important outcomes. First, a local medical center, Truman Medical Center-Lakewood, was voted by its staff to go pharm-free. Many of the faculty first thought that the only way to train the medical students there for the "real world" was to allow interactions with drug reps and then teach them the skills to critique what they heard; but the faculty came to realize that the information was so biased that it was better simply to teach the students to forgo the contact completely.

Second, the activities of the students and staff came to the attention of Sen. Claire McCaskill, who is a member of the Senate Select Committee on Aging. Its chair, Sen. Herb Kohl, is championing a national bill that would require that all payments from drug companies to physicians be reported. Sen. McCaskill is actively supporting this bill and expressed her pride in the UMKC students who had taken the initiative on this issue.

See, students-- you can make a difference! Keep up the good work.

Houx K. Medical groups, state senator seek drug company disclosures. Kansas City Community News, Sept. 5, 2007;
http://www.kccommunitynews.com/articles/2007/09/05/wednesday_sun/news/c-ws-news-medical.groups.txt

Schizophrenia, According to Websites--Depends on Who's Buying

John Read in New Zealand has done a nice little study of the way that schizophrenia is portrayed on websites. He looked at 50 websites that purported to provide patient and public education about the disease; somewhat over half acknowledged funding from pharmaceutical companies. Those getting such funding were more likely to portray schizophrenia as a biological disease with genetic determinants and to gloss over any psychosocial contributing factors, to stress the debilitating and chronic nature of the disease, and to warn about possible violence if one stops taking one's medications.

Read in passing mentions a nice quote from a thoughtful column by the 2005 President of the American Psychiatric Association, Steven S. Sharfstein: "As we address these Big Pharma issues, we must examine the fact that as a profession, we have allowed the biopsychosocial model to become the bio-bio-bio model."

Read J. Schizophrenia, drug companies, and the internet. Soc Sci Med (2007), doi:10.1016/j.socscimed.2007.07.027. http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6VBF-4PMJB40-1&_user=10&_coverDate=09%2F10%2F2007&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=34628b8624b0b7362b79d3343c456822

Sharfstein SS. Big Pharma and American psychiatry: the good, the bad, and the ugly. Psychiatric News 40(16):3-4, 2005; http://pn.psychiatryonline.org/cgi/content/full/40/16/3

Why Visits with Reps Cannot Be Education

Sarah Taylor, one of the drug reps cited in my August 29 post, is as noted the author of a handbook for reps. The handbook offers a number of interesting observations, but what particularly struck me was the most definitive example, to date, as to why a visit between a physician and a drug rep cannot be "education." Indeed, if the rep tried to be an educator, she'd be fired, indicted, or both.

Taylor advises reps who want to rise to the top of their business (that is, to win a coveted award for most sales) to go to the medical library and read all the articles they can find about the drug they detail and its competitors. But--here's the rub--the reps cannot mention the content of these articles during a detail, unless the article is part of the standard package supplied to the rep by the firm. If, for example, the article mentions any off-label uses of the drug, both the company and the rep could be prosecuted by the Feds for mentioning it.

Let's suppose that the rep goes to the library and reads an article (not in the company packet)that shows that the competitor drug may have fewer side effects than the company drug, but the rep also notes several methodological flaws in that study design. The next day the rep is detailing Dr. Smith, who likes to argue, and Dr. Smith mentions that same article as evidence that he should use the competitor drug instead.

What is the rep to do? Taylor suggests a script like: "Yes, I did read that article and understand your concern, but if you look here at our product circular, our Phase Three study with over 3000 patients showed..." (p. 32) In other words--impress the doc with your keeping up to date on all the latest science, then change the subject. But the rep cannot get into an actual discussion with the physician of the pros and cons of the methods of that article--which is precisely what a truly educational encounter would focus on.

Now, one might object here--whose fault is this? The fault lies with the drug industry's favorite bogeyman, the FDA. They are the ones that impose these crazy rules that muzzle the reps, especially that bit about off-label marketing (which I admit is a very fragile basis on which to distinguish good from bad uses of a drug). And this objection might indeed have some validity. But notice what the industry's mantra is. It is not: "We would love to have our reps be educational when they see physicians, but unfortunately this is not allowed by current FDA regulations." Rather, the mantra is, "When our reps see docs, it's education, not marketing." It's the industry itself that claims that these visits are educational, under the current regulatory regime.

While we are on the subject, a few more tidbits from Taylor:

• Yet more evidence of the fallacy of "education" (as if more were needed--what is the rep to do when he is having trouble getting up enthuisiasm to keep detailing the same old drug, when there are no new data, nothing really new to say at all? Taylor's answer--read a lot of motivational literature!
• Just because you visit the office, Taylor warns, don't be misled into thinking that you have achieved a "detail." She advises: "Poor reps count signatures [for leaving samples] as details; mediocre reps count 'something accomplished' [like maybe educating the physician?] as a detail; successful reps count 'something sold' as a detail." (p. 16)
• As an example of how 'something accomplished' like informing the doc does not equal 'something sold,' Taylor is a great believer in the absolute need of the rep to "close." She argues that if you work at it, you'll find a way to phrase the closing so that it does not sound heavy-handed. Example: "Something like, 'Have I shown you today that Product X is a great choice for elderly patients with high blood pressure?' does not go far enough. You must ask directly for the business. To that last sentence add, 'Great! Then will you please prescribe Product X for those elderly patients we discussed today?'" (pp. 57-8)

Taylor S. Secrets of successful pharmaceutical salespeople. Gig Harbor, WA: Taylor Presentations, 2004; available for $14.95 at www.TaylorPresentations.com