FDA Spanks 23andMe, Grants Breakthrough Status To Factor Xa Inhibitor, and Approves Promus Premier Stent Reply

It was a busy morning at the FDA. Three new FDA actions may be of considerable interest in the cardiology universe:

FDA Halts 23andMe Personal Genome Test– The FDA sent a scathing letter to 23andMe ordering the company to stop selling its Personal Genome Service (PGS) test.   The FDA highlighted two cardiology-related uses of PGS as “particularly concerning,” including drug responses involving warfarin sensitivity and clopidogrel response.

FDA Grants Breakthrough Status To Factor Xa Inhibitor Antidote–

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FDA Approves Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System–

Click here to read the full story on Forbes.

 

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No, Dean Ornish And Elizabeth Blackburn Have Not Discovered The Fountain Of Youth Reply

A very small pilot study offers early evidence that a program of comprehensive lifestyle changes increases telomere length. Telomeres, which have been compared to the plastic caps that prevent shoelaces from unravelling, help protect chromosomes. Telomere length is closely correlated to cellular aging: as we age the telomeres in our cells grow shorter. The new study, published online in Lancet Oncology, is one of the first studies to test whether the Nobel-prize winning research into telomeres has a role to play in assessing the health of humans in typical clinical situations.

The first author of the new paper is Dean Ornish, whose career has been devoted to demonstrating the benefits of a comprehensive lifestyle program consisting of radical changes in diet and exercise, accompanied by stress management and social support. The senior author of the paper is Elizabeth Blackburn, who won the Nobel Prize for her discovery of telomeres and their significance. In the paper Ornish and colleagues report on a long-term followup study in a small group of people with low-risk prostate cancer who agreed to follow Ornish’s rigorous program.

After 5 years telomere length increased in this group and decreased in a group of matched controls. Adherence to the lifestyle program varied among the participants, and some members of the control group made lifestyle changes on their own. The investigators reported that change in telomere length was significantly related to the degree of lifestyle change regardless of the study group. Further, as expected, telomere shortening was independently predicted by age, but the effect of the lifestyle program was independent of age and worked in the opposite direction.

Click here to read the entire story on Forbes.

 

 

Dean Ornish

 

Study Casts Doubt On Value Of Genetic Testing For Familial Hypercholesterolemia 3

new study published online in the Lancet suggests that one of the main screening plans that relies on genetic tests will fail to identify a substantial portion of people with familial hypercholesterolemia.

Investigators from the UK and Belgium analyzed DNA from several cohorts of FH and non-FH patients. Their chief finding was that a large percentage of FH patients did not have one of the single genetic mutations known to cause FH. Instead, these patients, termed “polygenic,” were found to have variants in multiple genes, each of which had a small LDL-raising effect, but when combined resulted in LDL levels similar to those in people with known FH mutations.

According to one cholesterol expert: 

The take home is that genetic screening is not a panacea and that screening based on fasting ipids makes most sense. Indeed, I never understood genetic screening for this disease anyway, since the phenotype (hypercholesterolemia) is what kills people, not the genotype, the phenotype is readily available with a blood test, the disease is not immediately fatal (It takes years to develop), and treatment is based on the numbers. It is like asking for a gene test fro sickle cell anemia. You can look at blood and make the diagnosis.

Click here to read the complete story on Forbes.