It's coming!!!!! FDA considering changing the label on Plavix

Did you hear? The Food and Drug Administration is in discussions with BMS and Sanofi Aventis to change the label in Plavix.....But here's the rub...

What do they say? The studies definitely show patients are at risk. The question is how many???

With Plavix being the second most prescribed drug in the nation this has left cardiologists jaws agape!

"life just got very confused and much more complex" for cardiologists and patients, said James Calvin, director of cardiology at Rush University Medical Center in Chicago. He added, "We have to start to become very, very aware of how big an issue this is."

This from an article in CNN/Money today!

"Once you know the answer what do you do?" said Douglas Weaver, head of the department of cardiology at Henry Ford Hospital in Detroit and president of the American College of Cardiology. He said there aren't any alternatives to Plavix approved in the U.S. A potential alternative, ticlopidine, is rarely used because it has been associated with serious blood disorders.

Oh, Doctor Weaver, if you only would read the Sherpa, I recently gave you 4 options of things you could do......just because we don't have rock solid evidence behind it doesn't mean we can't do these things....and when the FDA label changes, you better get ready for the trial lawyers!!

"Clearly I think just the blind administration of these drugs is rapidly coming to an end," said Paul Gurbel of Baltimore's Sinai Hospital

That's music to my ears!!!!

To quote my very first post:

Ok,

So I have no idea where to begin. Which is why I will just start with the Stats.......

• Only 17% of patients with familial colon cancer risk were referred to appropriate genetic counseling according to a study at Harvard.


• Prenatal counseling is not offered 9 of 10 women who meet indications!
  


• Only 37% of MDs know that BRCA genes can be passed by the father!

We have a lot to cover and I look forward to sharing my solution to this huge problem. How in the world can we expect to implement Personalized Medicine in all its glory without having some Genome Savvy physicians? Oh....Those geneticists? Too bad almost 90 percent are pediatricians and have no clue what ischemic heart failure is. (Or Plavix)

The Sherpa Says: I see that lawsuit creeping closer and closer......We need some educators and damn fast! The durg-drug interaction with PPIs has been a possibilty for years, the gene-drug interaction too....now what about the gene-drug-drug????

God Bless Michael Crichton, Here Comes Google.

I want to take today and Sunday to reflect on the vision of a fantastic writer a true futurist and a wonderful physician. His Name is Michael Crichton MD. Yes true, he did write some fantastic books....but in each of them a true moral being told......


Just because we can do something, doesn't mean we should.....Even more importantly his stories revolved around those who make great discoveries and how they become corrupted by fame and avarice.


His words are most important in an age when everything is "Science" I actually see Michael reminding us of how we can't let, false science be pushed forward as truth. Never more is this evident than in the "Best Invention of 2008"


Today the Wall Street Journal agrees with my point.


You see, I have mentioned Dr Crichton several times in the past.....a Graduate of Harvard Medical School and a lover of science and medicine, he is quite a role model. From the WSJ...


A medical doctor by training, Crichton knew better than to treat scientists and technologists as a priestly class, immune from temptations of fame, profit or power........As a result, Crichton was sometimes accused of being a Luddite. In fact, he was a champion of good science, and never more so than in a 2003 lecture at Caltech, hilariously titled "Aliens Cause Global Warming."


I too have heard those words about my blog and my ideas. It is the unreasonable man who challenges "conventional wisdom" upon whom the world depends for change. Bad Science is no replacement for Lack of Truth....we must be very careful as we push forward advancing healthcare with technology and "science" We must be very sure that if we are to put something forward for patients that the benefits clearly outweigh the risks......And if we are to have no chance of healing we at least Do No Harm....


That was Dr Crichton's message. I am so very sad to see him pass......his 26 novels and numerous screenplays will be a forever reminder of how


"As the 20th century drew to a close," he warned, "the connection between hard scientific fact and public policy became increasingly elastic. In part this was possible because of the complacency of the scientific profession; in part because of the lack of good science education among the public; in part because of the rise of specialized advocacy groups which have been enormously effective in getting publicity and shaping policy; and in great part because of the decline of the media as an independent assessor of fact."



This is why I formed HelixGene with Drew Y, This is why we started Helix Health of Connecticut, This is why we volunteer to teach Genetics to High School Students, This is why we always have to remember that "Bad Science is no replacement for absence of evidence"


I see the storm clouds rising, people looking to make healthcare efficient, people who didn't study the biological sciences....instead they chose computer science.....I just hope and pray we can demonstrate that science can be just as bad as poor programming.......


Need further proof they are coming? From the WSJ....Bret Swanson


On health care, let's face facts. We are not going to "solve" the entitlements crisis by gouging American producers to pay for the current Medicare/Medicaid abomination. Much better to transcend the issue with medical innovations and an entrepreneurial, consumer-driven market where more physicians go into medical technology, more nurses replace doctors, more technologies replace doctor visits, and, with properly-aligned incentives and real prices, more citizens take better care of their own health and thus their pocket books. The only way to escape current predictions of scarcity is the unforeseen abundance that entrepreneurship can bring


The Sherpa Says: Technology is not Science...it is not even bad science......it just is....and when you pair that with Bad Science....well, then you have some problems.......Oh Michael we need you now more than ever......