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The Consequences Of The 2008 Change In PSA Screening Recommendations

September 19th, 2011 by KennyLinMD in Health Policy, True Stories
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Flashback to summer of 2008. I’m looking forward to August 5–the day that I’ll no longer be a faceless bureaucrat. The day that the US Preventive Services Task Force (USPSTF) will issue its new recommendations on screening for prostate cancer–recommendations I’ve labored on as a federal employee for the past year and a half.

For much of 2007 I combed the medical literature for every study I could find on the benefits and harms of prostate cancer screening. In November of that year I presented my findings to the USPSTF, a widely respected, independent panel of primary care experts. They discussed and debated what the evidence showed and then voted unanimously to draft new recommendations. I didn’t get to vote, but it has been my job in 2008 to shepherd the draft statement and literature review through an intensive vetting process and to finalize both.

As August 5 approaches, my colleagues in public relations warn me that the last time the USPSTF said anything about prostate cancer screening, the phones started ringing off the hook. I’m not so secretly hoping that the same will happen this time.

And I’m not disappointed! After we release the statement, Read more »

*This blog post was originally published at Common Sense Family Doctor*

Meta-Analyses And A Capricious Drug Approval Process: The Actos And Avandia Stories

July 13th, 2011 by admin in Opinion
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Both Germany and France have now suspended the marketing of Actos (pioglitazone) due to concerns of a link between Actos and bladder cancer. Though we have known about bladder cancer concerns for some time, these recent concerns about the bladder cancer link stem from a recent report analyzing the FDA’s Adverse Event Reporting System (AERS), which found that 93 cases of cancer were recorded between 2004 and 2009 in patients treated with antidiabetic drugs, of which 31 patients were treated with pioglitazone, representing a statistically significant increased risk of bladder cancer (ROR 4.30, 95% confidence interval, 2.82-6.52; P less than 0.0001).

Interestingly, the FDA announced that it was going to look into the link between Actos and bladder cancer only a few days before it made its final decision on what to do with Avandia (as if they didn’t know about the Actos cancer risk before the July 2010 advisory board).

Despite the many things you have heard about Avandia, back in July 2010, the FDA decided to severely restrict the use of Avandia for three reasons: Read more »

*This blog post was originally published at ACP Internist*