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June 17, 2008

Drug Industry Innovations and the FDA

There was an interesting story on page B3 of the Wall Street Journal [of Medicine] today.  It explained GlaxoSmithKline’s strategy to extend its brand drug patent protection through the use of “RL” and “CR” extended release versions.  Drug modifications like this have enabled GSK to keep sales rising despite difficulty bringing brand-new drugs to market. 

One pharmaceutical analyst was quoted as saying, “The whole industry is finding it difficult to get through the FDA with line extensions because the FDA is understaffed and focusing on things they think are more innovative and important.”  We can only hope this is true. 

An FDA spokesperson said, “The law does not allow the FDA to discriminate against any new drug application based on what else is already on the market.”  Well, here is to hoping the FDA manages its resources well without running afoul of the law, and drug manufacturers respond with real innovations instead of line extensions.

June 16, 2008

Government Trimming Waistlines

Health and productivity management (HPM) is becoming a big priority for many employers.  This has been prompted by a tremendous increase in preventable conditions such as obesity, diabetes, high blood pressure, and asthma.  As the boomers age, their lack of physical activity and poor nutritional habits are catching up and costing employers money.

Health clinics, fitness centers, wellness programs, preventive screenings, food service, and health plan design changes are being reshaped (no pun intended) to encourage healthy employees, great productivity and lower health plan costs.  Some employers are adopting aggressive measures to impact employee health.  Most are more gradually encouraging health risk appraisals and screenings, adding preventive benefits to their plans and hosting wellness fairs, lunch and learns, etc.

So, how do our efforts compare to others across the globe?  The New York Times reported last week on one country that is taking a particularly aggressive stance – Japan. With nationalized healthcare, the Japanese government is on the hook instead of employers, and it has decided to get aggressive.  A new Japanese law took effect two months ago that requires employers and local governments to measure the waistlines of people between the ages of 40 and 74 as part of their annual checkups. Those who fail to meet the applicable standard, are required to participate in education and behavior change programs. 

“To reach its goals of shrinking the overweight population by 10 percent over the next four years and 25 percent over the next seven years, the government will impose financial penalties on companies and local governments that fail to meet specific targets.”  http://www.nytimes.com/2008/06/13/world/asia/13fat.html?pagewanted=1&ei=5070&en=7ba4c425e5d62707&ex=1214020800&emc=eta1

The Japanese have even renamed “overweight” as “metabo” which is short for metabolic syndrome, the condition of heightened risk of developing vascular disease and diabetes (abdominal obesity, high blood pressure, and high levels of blood glucose and cholesterol).

Do we need government to take aggressive action to improve the health of our workforce?  Would our government and society ever be willing to take such action?  Why is a country not known for its overweight people willing to undertake such action and be out front on this issue?

June 02, 2008

Genetic Testing

A couple weeks ago, the president signed legislation to reduce the potential for gene-testing results to be used against people. The new law forbids employers and insurance companies from denying employment, promotions, or health coverage to people when genetic tests show they have a predisposition to cancer, heart disease or other ailments.  This is all good.

My question is “who is going to protect people from unnecessary treatment once a genetic test shows any level of predisposition?” The healthcare delivery system has demonstrated a great ability to not only treat medical conditions, but also to treat the potential for medical conditions. Americans have also shown a predisposition to try to reduce risks through diagnostic testing and medication. Hopefully, some day they will also have a predisposition to improve their diets and exercise levels to reduce these same risks.  

So, will genetic testing lead to a growth in treatment of potential conditions? And, what “prophylactic treatments” will benefit plans be responsible for? I expect genetic testing will lead to more medical treatment – including a rise in the use of bioengineered drugs.  This will undoubtedly be good for some, but bad for many others.  I expect it will go too far, because our culture (and third-party payment model) generally looks at “more” as “better.”

In the meantime, there is one tool available for employers to use – A Purchaser's Guide to Clinical Preventive Services: Moving Science into Coverage which is currently available through the National Business Group on Health at this site: http://www.businessgrouphealth.org/benefitstopics/topics/purchasers/index.cfm.  This guide was developed in conjunction with the Centers for Disease Control and Prevention (CDC) and it leverages the work of the U.S. Preventive Services Task Force.