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chock full o’ nuts: 04.26.11 edition

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Hello readers!

I hope everyone enjoyed their Easter holiday weekend, or at the very least, Earth Day.  It’s been 2 weeks since I last posted but you can expect to find a new entry this week.  In the meantime, here are some link that have caught my attention for your Tuesday morning consumption:

  • Roadblock for HIV prophylaxis?  Last year, the AIDS community was clamoring over the promise of pre-exposure prophylaxis (or PrEP) as a public health measure and as an effective form of intervention.  PrEP is the use of HIV drugs in uninfected but high risk individuals in order to stem the virus at the point of initial contact.  As detailed in an earlier posting of mine, a landmark study published in Nov 2010 showed that PrEP reduced HIV infections by 44% in gay men compared to placebo, and as high as 73% risk reduction for patients compliant with the experimental regimen.  These are truly remarkable results for an intervention in the fight against the global spread of AIDS.  However, the halo of promise from that study may have been dampened by a recent study reported in the Wall Street Journal last week using the same drug combination (Truvada: tenofovir + emtricitabine) which had to be stopped early because a benefit did not seem likely to be shown.  Unlike the previous study, this study population included 2,000 high-risk women in Africa.  Another strange outcome of the study was that women on the drug combo was more likely to get pregnant than those on placebo even though 96% of women in the study were on contraceptives.  Perhaps a drug interaction?  Researchers are wondering whether compliance is a key factor in this study,  but the more intriguing hypothesis is that the oral drug combo does not build a high enough concentration in vaginal tissue compared to rectal tissue.  One reason to buy this explanation is that a study which testing tenofovir in gel form was quite successful in preventing infection.
  • Obama v. Ryan in the vision for Medicare: It was quite a bold gesture when Rep. Paul Ryan from Wisconsin released a Republican plan to cut the deficit by slashing spending and entitlements, including the previously untouchable Medicare.  He proposed that government could no longer afford to manage Medicare and that coverage of seniors should be left to the private sector with means-tested subsidies (about $8,000) to cover the premium costs.  Surely times have changed, and even the NY Times conceded that Medicare will need to change in order to remain solvent for future retirees.  But Obama responded to Ryan’s bold plan by reaffirming the regulatory and negotiating power of government to bring Medicare to fiscal sanity (but yet you have to wonder why they haven’t done so already).  Joe Paduda over at Managed Care Matters discusses the philosophical and practical differences between these two approaches on the table.  While Ryan’s plan may be palatable to deficit hawks and pro-business, small-government pundits, it poses serious challenges around the medical coverage of seniors, in particular, how seniors with pre-existing conditions are supposed to gain access to care.  Additionally, who will be charged with overseeing insurers in the way they deal with this fragile population?  And shifting seniors to the private market does nothing to rein in high medical costs, with Medicare Advantage plans demonstrating the opposite (~14% higher costs than traditional Medicare).  Obama’s plan is a high-minded view of government’s market power but it’s just hard to see that pharma companies and medical care providers are simply going to accept this without a drawn out fight.  I’m not sure what the best answer is, but it seems to be that Medicare should be slotted into that “too big to fail” category.
  • Is doctor-linked prescribing data free speech?  I had worked on the sales operations analytics side in my previous job and encountered physician-level prescribing data first hand.  The data is very robust, and provides detailed visibility into the prescribing behavior of physicians down to the level of drug shares and changes in drug shares over time.  The data is indeed blinded from any patient linkages in compliance with HIPAA.  The way we used this data was to provide aggregate analysis of prescribing trends but also to inform sales rep “call plans” with prescribing information about doctors in their territory.  A sales rep will surely know whether a doctor has prescribed a certain drug or if the doctor is lying to the rep about their prescribing behavior.  Sales reps will also know who are the highest value (or highest “decile”) doctors to focus on.  Yesterday’s New York Times comments on the debate around certain state initiatives to restrict prescribing data from being sold and used by drug companies.  So far, Maine, Vermont and New Hampshire have pushed legislation against this, and data vendors as well as the PhRMA are fighting back in the courts.  The states are arguing that the way the data is being used is driving up drug costs and potentially pushing drugs that may be less effective than their counterparts.  I think it’s very hard to limit marketing practices when they adhere to professional standards, but the more interesting issue is whether there are doctor privacy issues being breached, as some commercial transactions do carry a level of privacy (like movie rentals at a hotel).

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