New Ideas on Attacking Alzheimer’s

June 11, 2010
11:19 am

Over the last decade, medical science has made tremendous strides in conquering disease.  Deaths from stroke, HIV, heart disease, prostate cancer and several other diseases have dropped significantly thanks to investments in research and strides in developing new treatments.

Alzheimer’s Disease, however, has been an illness that has, to date, defeated the best that modern medicine has thrown at it.  From 2000 to 2006, deaths from Alzheimer’s actually increased by over 46 percent, making it the nation’s seventh leading cause of death.

There’s encouraging news, though, in a new approach that many of the nation’s drugmakers are taking toward this challenge.

Johnson & Johnson, AstraZeneca, Sanofi-Aventis, Abbott Laboratories and GlaxoSmithKline are going to take the unusual step of pooling the data from the clinical trials they have performed in their respective efforts to find an effective treatment for Alzheimer’s.  This means information from over 4,000 patients will now be in a single database accessible to all of the participating pharmaceutical companies as well as outside researchers.

The significance?  Such a large database may shed more light on how Alzheimer’s progresses in patients and potentially enable the development of new studies.  As Food and Drug Administration Deputy Commissioner Joshua Sharfstein said, this is the “kind of collaboration that does represent a major shift in thinking about how to accelerate drug development.”

Kudos to the involved pharmaceutical companies for taking a creative step that may bring us closer to treatment for a disease that is affecting millions of individuals and families.

The “Brave New World” of Health Insurance Markets

June 10, 2010
2:04 pm

One of the best overviews I’ve seen of the issues facing health insurers – and, for that matter, health providers – as we move forward toward health reform implementation comes in this month’s issue of Health Affairs.  It’s an article written by Healthcare Leadership Council member Troyen Brennan, executive vice president of CVS Caremark, and University of Melbourne professor David Studdert.  For those speculating on the coverage-and-cost obstacles, as well as opportunities in the new health reform law, this piece is well worth reading.

Among the key points made by Brennan and Studdert:

•     Under the Patient Protection and Affordable Care Act, medical underwriting will be virtually eliminated.  The authors write that insurers should still be able to construct reasonable risk pools, but many insurers fear that the new insurance mandates will fall short of compelling compliance.  This is a worry we’ve expressed frequently in this space.

•     When Massachusetts launched its own health reforms, all stakeholders in the state wanted the reforms to work.  This is not the case with the federal version, as exemplified by 20 states suing  to overturn the new law.  The smart money, they write, is on the suits failing and insurers would be prudent to plan for the new exchanges in 2014 rather than waiting for the Supreme Court to rule.

•     Various players in the new exchanges will face difficult cross-pressures.  Insurers will be under pressure to keep health coverage affordable, even though the legislation “does not do enough to change the fundamental cost drivers in health care.”  That places state insurance commissioners in the undesirable position of trying to hold the line on consumer costs while also maintaining the solvency of insurance carriers.

•     There still exists a critical lack of details on important issues such how insurance products can be sold across state lines (a door opened by the new law), the amount of transparency required, and how the costs of disease prevention factors into the new medical loss ratio requirements.

Brennan and Studdert write that, through new care models and payment reforms, the new law does provide opportunities to reduce care costs without compromising quality, but that success will rest upon the ability of providers, regulators and insurers to productively cooperate.

The Value Of Breaking Away From The Beltway

June 04, 2010
1:43 pm

Whenever I speak to members of Congress or high-ranking officials from federal departments and agencies, I always encourage them to escape from the confines of Washington, DC and gather their own eyewitness accounts of what’s happening in American healthcare.  While policy may be written in the nation’s capital, healthcare innovation is taking place every day in hospitals and clinics as well as facilities where lifesaving medicines and medical devices are being created.  It’s important for policymakers to be aware of the new breakthroughs happening in healthcare as they are drafting new laws and regulations.

That’s why I applaud Health and Human Services Secretary Kathleen Sebelius for taking the time from her busy schedule to travel to Rochester, Minnesota and visit the Mayo Clinic this week.  As you see from the video on this post, Secretary Sebelius received a comprehensive tour of the Clinic from Mayo CEO John Noseworthy and many of the facility’s outstanding physicians. 

Mayo is one of the healthcare providers in the U.S. that is constantly staking out new ground on our nation’s most important healthcare priority, how to strengthen the quality of healthcare while increasing cost-efficiency as well.  Kudos to Secretary Sebelius for seeking out real world demonstrations on how patients are benefiting from American medical innovation.

On Drug Importation, Listen to John Dingell

June 02, 2010
11:03 am

It’s so ironic that it could almost pass for satire.  Some in Congress want to use a food safety bill currently making its way through the legislative process as a vehicle to press for prescription drug importation.  Using a measure to protect the safety of what we eat as a means to make ourselves more vulnerable to dangerous counterfeit medications?  To say the least, it defies logic.

Congressman John Dingell (D-MI) doesn’t find it the least bit amusing.  He’s the sponsor of the House food safety bill and, according to an article in The Hill newspaper, he is extremely concerned that a drug importation amendment being pushed by some of his counterparts in the Senate could derail the whole measure.

Not only that, but Congressman Dingell believes, correctly, that drug importation is simply a bad idea.

“It will allow this country to be flooded with unsafe, counterfeit drugs, drugs that will not do what they should, drugs that are unsafe, drugs that will kill the American people,”  he said, during a 2003 debate on the issue, according to The Hill article.

Senator Byron Dorgan (D-ND), one of the most ardent proponents of importation, argues that the food safety bill may present the last opportunity in this Congress to enact wholesale drug importation into law. 

The real question, though, is why do it at all?

Importation proponents argue that it will bring Americans cheaper drugs.  And yet, the nation’s wholesale distribution companies have testified before Congress that the storage, relabeling, transportation, inspection and liability protection costs involved in bringing prescription medicines into the country would wipe out any savings.  So, with incidences of counterfeit drugs on the rise globally, we would be incurring greater risk without reaping any meaningful benefits.

Instead of clamoring to import other countries’ price controls into the U.S., wouldn’t it make more sense to make this an international trade issue and push price-controlling nations to pay their fair share for American pharmaceutical innovation?

Congress would do well to listen to John Dingell on this issue.