Posted on 09/25/2009 10:11:59 PM PDT by DesScorp
The Food and Drug Administration's new leaders issued a scathing report about the approval of a knee device last December, saying "extreme" pressure from Democrats on Capitol Hill damaged the integrity of the process.
The FDA said it is reconsidering its decision on ReGen Biologics Inc.'s Menaflex device. A page-one Wall Street Journal article in March first raised questions about the decision and reported that the FDA's then-device chief overruled objections of FDA scientists in clearing Menaflex...
...Four Democrats from New Jersey -- Sens. Frank Lautenberg and Robert Menendez, and Reps. Steve Rothman and Frank Pallone Jr. -- contacted the FDA in 2007 and 2008 to encourage it to speed its review of the ReGen device, according to the report, emails and other records. ReGen is based in New Jersey.
(Excerpt) Read more at online.wsj.com ...
What do you want to bet some big-time campaign contributions were involved?
FDA is typical Govt AGency ... It CANNOT do ANYTHING right.
It’s screws up everything it touches.. .. VIOXX, anyone!!
Vioxx, schmioxx.
Doctors knew about the risks years before the stuff was banned.
**Doctors knew about the risks years before the stuff was banned.**
And the FDA knew it was Deadly before they released it to the Market,, the FIRST TIME..
FDA finally got caught with their hand in the COOKIE JAR.
and OF COURSE it was NEW JERSEY that was holding out the JAR. NJ AND the FDA should be DeCertified and turned into entities with NO POWERS or AUTHORITY.
Smoking is worse than Vioxx. It’s not banned, only taxed out the wazoo.
Smoking takes 40 years .. Vioxx can take two weeks..
BIG EFFING DEAL!!
Vioxx, a COX-2 inhibitor, was used by 84 million people at the height of the lawsuit frenzy and 61 thousand claimed related deaths, not proven - claimed. So that's 0.07 percent. Look at the US, 21 thousand deaths out of over 4 million scripts. Maybe 0.5 percent.
Sounds horrible with the numbers until the big follow-up study of Vioxx vs placebo. Vioxx users 3.5% coronary events, placebo 1.9%.
Wait, people having heart attacks without Vioxx? How can that be?
The population prescribed Vioxx included a huge number of those with osteoporosis and severe degenerative arthritis to relieve their pain. But those people are already at significant risk of heart attacks. Factor out the at risk population and compare Vioxx to placebo and the result becomes statistically even.
Vioxx was released with the warning of "Additionally, rare but serious side effects have been reported in patients receiving Vioxx and/or related medications. These include stomach problems, such as stomach and intestinal bleeding, heart attacks, allergic reactions and skin reactions."
What Merck and physicians should have done is screened patients for high coronary risk first. Then prescribed.
But by then, the lawyer feeding frenzy and grossly ignorant juries had destroyed the drug and took down the company.
When I was in grad school, we discussed the mechanism of estrogen therapy and protective effects on heart health and osteoporosis. The professor brought up the then recent controversy on the inceased risk of breast cancer. He illustrate the media lies this way.
Media - estrogen will double your risk of breast cancer!!
Odds of breast cancer without 1/100000, odds with 2/100000. Yep, double the chance by 1/100000 but better chance winning the lotto.
Odds of heart attack without 1/1000, odds with 1/100000
Do you see the risk/benefit argument?
Vioxx was not a perfect drug but it did not make healthy people suddenly have heart attacks. No smoking gun, no big cover-up. Just out of control court greed and a media loving a scary story.
Will you please stop making sense. Its Saturday and epidemiology is tough with cornflakes.
Four Democrats from New Jersey -- Sens. Frank Lautenberg and Robert Menendez, and Reps. Steve Rothman and Frank Pallone Jr. -- contacted the FDA in 2007 and 2008 to encourage it to speed its review of the ReGen device, according to the report, emails and other records. ReGen is based in New Jersey.Battlescar Corruptica.
That was funny
I took the stuff for several months, in fact. Then a couple years later I had a then-new coronary artery calcium scan being promoted by a health club. The scan score: zero (no lesions at all). Smoking has proven to be the chief grim reaper’s helper in my family; I have never smoked. But my mother died 20 years prematurely from the weed.
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