Health Business Blog

A novel idea for a post-marketing commitment

I was at a joint Forum for Collaborative HIV Research/FDA meeting in Washington today focused on issues for CCR5 antagonists, a new class of drugs working its way through clinical development. The meeting featured productive panel discussions including representatives from the FDA, National Cancer Institute, European Union, community activists, academic researchers, diagnostics companies, and pharmaceutical companies. (The meeting is available on the web if you want to watch.)

When new drugs are approved, especially in areas like HIV and oncology where fast-track approval is the norm, the FDA often asks for post-launch studies to resolve outstanding issues. Companies don’t do a great job of fulfilling their commitments, as I’ve described before, and the FDA isn’t well equipped to police these commitments.

One member of the audience offered a novel suggestion: rather than the FDA seeking commitments for follow-up studies on the specific CCR5 drug approved, they should ask for a commitment to fund existing patient cohorts to study a broader set of questions than could be addressed by a continuation of trials on the specific drug. There are some specific scientific reasons to recommend such cohort studies in this case, but it would also have the advantage of making it easier to track compliance.

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A different planet

A front-page Wall Street Journal article describes how complex software is causing glitches on modern airliners and the steps manufacturers and airlines are taking to fix the problems. The safety culture and record of the airline industry is sometimes cited by advocates of improved patient safety. But with all the problems, are airplanes really that much safer than hospitals? Absolutely.

Get this:

In North America, there were 1.3 crashes per million departures in the late 1980s. By 2004 and 2005, the average figure was about 0.4, meaning the chance a plane now taking off will crash is less than one in two million.

Can you imagine a safety record like that in health care? Major and minor errors occur all the time, and the equivalent “crash rate” is orders of magnitude higher than one in two million.

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Co-opted by Google Co-op?

Despite (or more accurately because of) my concerns about Google, I received the following email today:

Dear medical colleagues,

[A physician/blogger] suggested I contact you about participating in the Google Co-op health topic. Contributions to Google Co-op by experts such as you help Google users better find the high quality and specific health information they are looking for.

As a contributor you choose websites or pages and apply relevant health topic labels to them. Users can then subscribe to your profile in order to have their Google search results improved by your expertise — pages that you have labeled will appear higher in their search results and will reference you as the labeler. Google Co-op participation provides you with more relevant touch points to your target health audience.

The list of current health labels and related documentation can be found here: http://www.google.com/coop/docs/guide_topics.html.

Please feel free to contact me with any questions and we look forward to your contributions.

best regards,

[Google staff member]

I replied as follows:

Thank you for your message. I am a regular, long-term user of Google and am impressed with the quality of the search results and expanded features. I also advertise my business and blog on Google. The company’Â’s success and ambition are admirable.

I do have some problems with the Co-op concept and with Google’Â’s moves into e-health in general, which I have written about on the Health business blog (powered by Google’Â’s Blogger). I’d welcome your perspective:

• Google Health may need a lot more free consulting
• Is Google a threat to e-health?
• Google Health: Up, down, and moved around

Regards,

David Williams

I’ll let you know what I hear.

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Grand Rounds is up At Kidney Notes

Check out Grand Rounds, the best of the week’s medical blogging, at Kidney Notes.

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Mercury

Respectful Insolence has a good post on the prevalence of mercury in some Chinese herbal medicines, noting the irony that a good number of alternative medicine fans blame the ills of modern society (autism, Alzheimer’s, etc.) on mercury in dental fillings and vaccines.

When I was in the UK earlier this week there was an article about leading physicians asking the NHS not to pay for alternative medicines. They were hoping to counteract Prince Charles’ advocacy of same. Both sides could be right in that one. A spokesman for the Prince noted that he was calling only for coverage of alternative treatments shown to be efficacious, while critics of the physicians noted their ivory tower approach.

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Internet health companies get hot again

The Wall Street Journal reports that internet companies focusing on health care are getting hot. Five start-up companies have raised about $41 million in the last year –not a huge amount but more than has been seen for a while. The companies include:

• Healthline Networks –a search company
• A Place for Mom –an eldercare referral network
• Healthia –a comparison shopping company (not to be confused with Healia, which I’ve reviewed)
• LifeMed Media –an information site for people with diabetes
• Best Doctors –a tool to help patients make decisions about their care

There are plenty more exciting internet health care companies getting started, so look for a continued uptick in funding.

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USA Today focuses in on health care

All three front-page USA Today articles are focused on health care today:

• Retiree benefits grow into ‘monster’ (a very UK-sounding headline) explains that the cost of future government obligations is $500,00 per household. Medicare accounts for more than half of that total; it’s twice as much as Social Security. That’s why I favor the rule that limits Medicare’s claim on general revenues
• Doctors will transplant a face –but whose? describes the Cleveland Clinic’s quest to be the first hospital to do a total transplant (including ears and head). Apparently it’s hard to find the right patient. Not only that, it’s hard to find a donor!
• Psychiatric drugs fare favorably when companies pay for studies tells us something we already knew. But the interesting data point I picked up was that the share of drug company-funded studies in the four most prestigious journals rose from 25% to 57% between 1992 and 2002. That’s a problem

In the days and weeks after September 11, I remember looking forward to the day when at least one of the three front page stories in the Wall St. Journal was about something unrelated to the attacks. It happened eventually. But while health care won’t always occupy all three slots in the USA Today (or the Journal) it’s likely to be a dominant topic for the next 30 years at least.

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I found this funny

From Modern Healthcare

Anthem Blue Cross and Blue Shield of Kentucky is trying to recover possibly millions of dollars in checks mistakenly sent to members because of a processing error in its prescription-management program. Anthem said the checks, worth between 1 cent and $2,000 each, were sent May 15 to about 10,400 state workers. An Anthem spokeswoman said she was unsure of the total value of the checks. The insurer this week began asking recipients to return the checks or repay the money if the checks were cashed.

Can you imagine trying to return one of these checks? I’m sure they have no mechanism for dealing with it and you’d be placed on hold forever and given wrong information if you tried to call to find out how to return money to Anthem.

How much effort do you think they’ll spend trying to recover the 1 cent checks?

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New ideas needed –here are some

From MedPage Today:

When it comes to teaching high school students to avoid risky sexual behavior, a Mexican study appears to support what U.S. studies have already suggested—no current approach works.

“Innovative approaches designed to decrease adolescent risk behavior are urgently needed,” the authors concluded. One such approach, which has not been studied much, is to educate the parents as well as teens, they added.

We already know that virginity pledges are made to be broken. Since education doesn’t work, how about some punitive measures that teens can relate to, such as a sex detector that cuts off the violator’s IM and MySpace accounts when sexual intercourse is observed?

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Somehow this didn’t surprise me

From MedPage Today:

Older patients at some hospitals are being given urinary catheters for support staffers’ convenience rather for any medically necessary indication…

Nearly one in four older hospitalized patients received a urinary catheter without any medical reason for one, and these patients tended to be the ones who would need the most help going to the bathroom if left un-catheterized, said Seth Landefeld, M.D., of the San Francisco Veterans Affairs Medical Center…

I would have been shocked if they found something different. Bring your own nurse or relative when you go to the hospital. If you can’t afford to do so, consider going into debt.

The study was published in the Journal of Patient Safety.

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