Sunshine gets support from CBO, and other holiday tidbits
Well, we’re back on the Reader wagon just in time for the holidays. So if you’re still in front of your monitor like us, here are a few things that caught our eye.
First, the Physician Payments Sunshine Act won major support this week when a Congressional Budget Office (CBO) report released Thursday supported industry disclosure of relationships with physicians in a volume of health-related budget options.
CBO made a very positive assessment of the Sunshine provision, saying it “believes that, over time, disclosure has the potential to reduce spending.” Among its considerations:
- Hospitals and health plans can use this information to safeguard the integrity of formulary decisions
- Disclosure might encourage physicians to monitor or modify their behavior
- The data collected could help inform further regulations to reduce cost
- CMS could use the data in combination with claims data to better understand trends in physician practices and utilization of drugs, and
- Medicare beneficiaries could be informed to a greater degree when selecting a doctor.
The FDA has found that the quality of prescription drug safety and use pamphlets wanting, according to a new evaluation conducted by the agency. As reported by the Wall Street Journal, a quarter of the leaflets, called consumer medication information or CMI, failed to meet minimum standards set by the agency, including two-thirds that “lacked general dosing information” and two-fifths that “failed to give dosing instructions specific to the patient.”
Stiglitz writes on drug safety, efficacy
And the WSJ’s quicker, freer sidekick, the Healthblog looks a Health Affairs piece by Nobel Laureate Joseph Stiglitz that says one way to better drug safety and efficacy is to use comparative effectiveness tools that would require drugs to be tested in ‘head-to-head’ clinical trials, and to conduct those trials with public funding and public transparency, which Stiglitz argues would unclog the pipeline of endless me-too drugs.
Unlike pretty much all of the economy, Sen. Grassley’s conflict of interest charge hasn’t slowed. This week, he called out Emory University’s semantic defense of Nemeroff’s jillions being non-disclosable because they were for ‘CME-like’ activities.
In a letter sent to Emory’s president, Grassley wrote: “Neither anyone on my staff, nor any medical expert that they have contacted, have ever heard of the term ‘CME-like…It appears to be a new term created at Emory University.” Then he attached the laws pertaining to false statements made before Congress.
Grassley’s investigators have also revealed evidence that Wyeth engaged in extensive ghost-writing around hormone replacement therapy beginning in the late 1990s.
For all you ever wanted to know and more, check out the Health Care Renewal blog.
Florida changes Medicaid rule, allows reimbursement for some off-label prescribing in kids
Pharmalot reports this week that Florida Medicaid department has reversed a rule that prohibited reimbursement for prescriptions to children under a certain age. Pharmalot’s Ed Silverman points out that that this includes atypical antipsychotics, which are not approved for use in children under 10 – in other words, Florida prescribers can now be reimbursed for off-label use of psych drugs in kids, a combination that Silverman says has been shown to have some worrisome side effects in recent studies.
Who’s it gonna be?
And the bets are still rolling in on who will be the next FDA commissioner, though the speculative field is narrowing, according to the New York Times and Wall Street Journal. This week, we found out it won’t be Andrew Von Eschenbach again.
Happy holidays, peace, and travel.