"What Just Happened?": a view from the State House (and other musings)

Who says? (More about swine flu)

September 13, 2009

Tags: swine flu

The New York Times reported on Fri., Sept.11, 2009, on the good news that a new swine flu vaccine only requires one shot instead of two. "This is definitely a big deal," says a doc who's a "vaccine expert" at the Univ. of Rochester.

Wait, wait. What's the vaccine? What's in it? How safe is it? How has it been tested? Has it been tested on children? Have there been any independent reviews of the tests?

The NYT story is based on a report in the New England Journal of Medicine, Sept. 10, available on line. The latter makes for interesting, if dry, reading.

The report is "preliminary." The vaccine is made by an Australian company called CSL Limited, whose CEO came from GlaxoSmithKline in 2009. (GlaxoSmithKline, maker of the antidepressant Paxil, was sued by NY's Attorney General in 2004 for fraud; the company withheld studies that showed Paxil was not only not helpful for children but actually made their depression worse.) Finally, there are ten authors of the Sept. 10 NEJM study; all are paid by CSL, and eight of the ten hold equity interests (stock) in CSL. These are independent researchers without a stake in the outcome?

In answer to the above questions: You can't tell what's in it (for example squalene). It has not been tested on children. It has not been independently reviewed. And we can't tell how safe it is. "Data regarding unsolicited adverse events are being collected but are unavailable for this preliminary report."

I suspect CLS Limited's stock has gone up, but I'm not buying any.

Comments

  1. September 21, 2009 9:07 AM EDT
    Thank you so much for pulling this info together. There really has been so little press about the downsides of these vaccines. My family really appreciates your efforts.
    - Michael Royer
  2. September 21, 2009 9:07 AM EDT
    I share your worries - the companies that make our health care products have been remarkably untrustworthy, and the New England Journal article was written by company insiders who stand to gain from the success of their product, the vaccine. This is largely true for any new medical drug, device, procedure or test. And, there have been some very bad consequences as a result, including deaths. So, the system of assessing new products definitely needs an overhaul, starting with the FDA.

    However, because the virus mutates so rapidly, we need a new flu vaccine every year. That means there is rarely time to test it thoroughly. However, most of the vaccine is similar to previous vaccines - it is not a completely novel product. And, even though the authors of the article were not independent, it was reviewed by a panel of outside reviewers and editors at the journal. And, both the CDC and the FDA (for what it's worth) have been keeping close tabs on the manufacturers.

    Influenza is a veryy nasty disease, with lots of illness, lost time from work, school and play, many hospitalizations, and no small death toll in the US every year. Although this year's batch may be different, over the last 20 years, flu shots have been well studied and proven to be just about the safest and best health bargain we have.

    So, taking everything into consideration, vaccination is still the right way to go for almost everybody. I will take my shot at the first opportunity and advise my family and patients to do the same.

    I will also join you in agitating for more transparency in medical product assessment and regulation.

    Thanks for your good work!

    Benjamin Littenberg, MD
    Professor of Medicine
    Director of General Internal Medicine
    University of Vermont

    - Benjamin Littenberg
  3. September 21, 2009 10:22 AM EDT
    The vaccine shouldn't be trusted because the Australian company's director once worked for GSK? So what?

    Do you have any evidence at all that this vaccine is unsafe?

    After taking just a short look at your blog, I must conclude that your understanding of the issues involving vaccination safety is far different than scientific consensus. I would suggest you do some reading here, a webblog by a real MD who writes specifically about these issues:

    http://scienceblogs.com/insolence/.

    Here you will discover that the claims that vaccines are unsafe are based originally on falsified research results by a cult figure of the anti vaccination movement, that large well-controlled studies show no association, let alone cause and effect, between vaccines, mercury and autism or serious health problems, and that the anti vaccine movement is doing real harm to the community immunity rates for serious diseases around the world. Yes - kids are dying needlessly because their fearful parents are not vaccinating them. Your blog appears to be abetting such fears.

    If you want to discuss this with me, my phone is 863-9787.
    - Roger Lambert - Ledgemere Street
  4. October 12, 2009 1:48 PM EDT
    Here are the answers to many of the questions you raise. I must say that I was disapointed to see an elected official spreading baseless fears that could limit use of the vaccine. Flu epidemics are not something to be taken lightly:

    http://www.nytimes.com/2009/10/12/opinion/12offit.html
    - Dale Azaria, S. Prospect St..

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