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September 27, 2007

Ads Infinitum

by Peter Pitts

Two cheers for the American Cancer Society's efforts to focus attention and its advertising dollars on the nation's health access problem -- specifically the uninsured. I'm holding the third cheer in reserve because of our concern that policymakers will interpret these commercials as an endorsement of a single-payer, "universal" healthcare system. We're also not 100% convinced that this is the best way for the ACS to spend its money -- but that's their business.

The ACS says that is has "no position" on what kind of health system should be in place in the U.S. Here's a suggestion -- how about one that delivers the highest rate of cancer survival in the world.

According to a recent study in the respected Lancet Oncology -- the most comprehensive ever conducted -- America's cancer-survival rate is the highest in the world among both men and women. By contrast, Britain -- despite its reputation as a utopia of "free" healthcare -- has some of the lowest survival rates in the western world.

Improved access is an worthy goal -- but a single-payer system is not the answer -- especially for cancer patients.

And the American Cancer Society should be brave enough to say so.

Posted by peterpitts at 01:59 PM
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September 19, 2007

AHRQ Diocese

by Peter Pitts

Comparative effectiveness? Well since you mentioned it ...

CBO’s Estimate of the Budgetary Impact of Section 904

(Sec. 904. Comparative effectiveness research. Establishes within the Agency of Healthcare Research and Quality a Center for Comparative Effectiveness Research to conduct research on the outcomes, effectiveness, and appropriateness of health care services.Also establishes an independent Comparative Effectiveness Research Commission to set priorities and ensure credibility for the Center’s work. It also establishes a Comparative Effectiveness Research Trust Fund, initially funded through the Medicare trust fund, to support the work of the Center and the Commission.)

* CBO estimates that Section 904 of the CHAMP act (H.R. 3162) would increase Federal spending (Medicare, Medicaid, and FEHBP) by $600 million between 2008 to 2012, and $2.4 billion from 2008-2017.

* While the agency estimates that the bill could reduce public and private health spending by up to $6 billion, direct Federal spending would only be reduced by $100 million over the 2008-2012 period and $1.3 billion between 2008 and 2017. (Those amounts would constitute a very small fraction of overall federal outlays for those programs.)

* Thus, enacting section 904 would increase federal direct spending by $0.5 billion over five years and $1.1 billion over 10 years.

* CBO assumes that the provision would result in better information about which health care services and procedures are ineffective and some changes in coverage rules that can be implemented under current law.

Well that's certainly reassuring.

Posted by peterpitts at 05:11 PM
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September 06, 2007

in PDUFA veritas

by Peter Pitts

Drug Industry Daily

PDUFA Provisions Could Harm FDA and Industry, Expert Say

Some of the provisions in the FDA Revitalization Act, S. 1082 and H.R. 2900, would be ineffective, could cripple the FDA and would put unnecessary burdens on pharmaceutical companies, Center for Medicine in the Public Interest President Peter Pitts said at the Third Annual FDA Regulatory and Compliance Symposium at Harvard University. “Political battles are trumping public health,” he added.

The most important part of the bill is a provision funding the Reagan-Udall Institute and the agency’s Critical Path Initiative, according to Pitts. “This is the single most important advance and change in FDA legislation, possibly ever,” he said. “It really sets the FDA on the path to a 21st century perspective in terms of both protecting the public health and advancing the public health.”

The FDA’s recent label change for Coumadin (warfarin) to add information about genetic tests was “such an important advance,” Pitts said, adding that the agency should continue doing more with the Critical Path Initiative (DID, Aug. 17).

However, Pitts said some provisions in the legislation will be ineffective and could harm the FDA. He criticized a provision that would ban members with more than $50,000 in financial conflicts of interest from voting on advisory committees. The FDA recently issued a draft guidance of a proposed rule that would do the same thing (DID, March 22).

“All this will succeed in doing is allow the agency to recruit the second best and the almost brightest for advisory committees, and that is not acceptable,” Pitts said. He added that $50,000 is an arbitrary limit.

Pitts also criticized the bill’s Risk Evaluation and Mitigation Strategies (REMS) requirements. He noted that early drafts of the bill contained language that would have made it mandatory for each new drug application to contain an REMS. “That’s like saying every new product is equally risky,” Pitts said.

Giving the FDA the authority to require an REMS as part of a new drug application could encourage the agency to call for them more, even when they are unnecessary, he said.

However, the enhanced focus on safety and postmarketing surveillance is the industry’s fault for not living up to its commitments to conduct postmarketing studies, Pitts said. “Now they are reaping what they sowed,” he added. Companies should use the opportunity to conduct postmarketing studies for public health purposes, he said.

Pitts also criticized the provisions in the bill that would add a user fee for a voluntary review of direct-to-consumer advertisements. The FDA’s Division of Drug Marketing, Advertising and Communications has no predictability and will send companies warning letters even if they incorporated all of the agency’s suggestions in their advertisements, according to Pitts. “If the FDA wants to have an impact in quality and safety and appropriateness, they can’t change their minds after the fact, fee or no fee.” — Emily Ethridge

Posted by peterpitts at 10:35 AM
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September 04, 2007

Meet me at the corner of Information and Engagement

by Peter Pitts

If you decided to use MapQuest for directions to better drug safety ideas, it might very well direct you to the intersection of Information and Engagement.

Nowhere is this made more clear than with a new program called iGuard. According to their website (http://www.iguard.org):

"iGuard is the fastest and easiest way for you to get personalized alerts and updates on the safety of your medicines.

We are the catalyst for the new conversation among patients, physicians, pharmacists, drug researchers and the government. Launched in 2007 as a startup venture funded by Quintiles Transnational, "iGuard puts the power of drug safety in the hands of each American, right where it should be," states Dr. Hugo Stephenson, founder and president of iGuard.

We facilitate the virtual flow of communication among patients, physicians, and researchers according to two guiding principles:

With iGuard, patients can feel safer because they will be sent the drug safety information they need, when they need it.

The more people that join iGuard, the faster we can help researchers identify safety problems - and communicate this information back to patients, caregivers, and their providers."

It's worth a look -- because it provides a hopeful glimpse into the future of drug safety.

I have seen the future -- and it is collaborative.

Posted by peterpitts at 04:21 PM
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