Whoops, I meant someone that couldn't give two shits about you. Yup, that is your FDA speaking. Could you believe AGAIN, that just today, FDA "finally" approves--after much debate--another killer drug, Effient, into the market. According to the NYTimes "The approval makes Lilly’s Effient the first real competition to the blood thinner Plavix, which is made by Sanofi-Aventis and Bristol-Myers Squibb and is the world’s second-best selling medication behind the cholesterol pill Lipitor."
Here, allow me to highlight a two very important words for you: competition; best-selling. If that doesn't put the word "motivation" in blinking lights, I don't know what does. Sadly, this does not come as any new news to those aware of the situation. It just a reiteration of faults made. Redundant ones at that.
Effient, now available, is a new and "upcoming" blood thinner, part of a class of medications known as anticoagulants. Preventing the ability of blood clots, fewer blood vessels are blocked, and thus individuals experience lighter chances of heart attack and stroke. Blood thinners do not actually thin your blood, nor do they remove existing blood clots, fyi. While all that sound nice, Effient comes with a nice little warning: significant and sometimes fatal bleeding. Oh yes, they mean death.
“The F.D.A. has been a lot more liberal with black box warnings than it was in the past, and in a way the black box has lost some of the meaning it had when it was rare,” Mr. Funtleyder said. “But it still has the ability to somewhat limit sales.” Company studies showed 7 percent of patients taking Effient had nonfatal heart attacks, compared with 9.1 percent of patients taking Plavix. Despite lower rates of certain heart attacks, the actual rates of death for the drugs were similar."Wow. Wow. WHAT THE HECK. First of all, these black box warnings are only becoming insignificant, because a strong percentage of available and approved pharmaceuticals contain them. With that said, an approved drug does not mean a safe drug. It means a drug that isn't beyond the tipping point of "harmful" where it still can bring in billions of dollars in profits. The FDA isn't trying to protect you, they are trying to protect themselves. Effient is expected to bring over $1billion in sales (along with internal bleeding) and is considered an important breakthrough for the company because "patents protecting its four best-selling drugs expire by 2013." I cannot understand how the FDA can actually approve a drug that is shockingly harmful. And by shockingly harmful, 1/10 people suffer.
Hats off to FDA's senior drug safety officer, Dr David Graham, whom many of us know as one the few most honest men in the organization. Maybe that's why the FDA has threatened to dispose of him as many times as they did. Just to fill you in, Graham, testified before senate committee recently about the FDA approved arthritis drug "Vioxx", which caused as many as 140,000 individuals to suffer from heart attacks, from which 40% of them suffered fatal attacks. Graham claimed that the people in charge new well about the impending disaster, as it was being approved. The FDA only removed this drug 4 YEARS AFTER IT WAS CLEAR that Vioxx was dangerous.
"Dr. Graham, the federal drug-safety reviewer, continues to seek to publish his study demonstrating the dangers of Vioxx, but he has been delayed and demeaned by top officials at the Food and Drug Administration. At the Senate hearing, Dr. Graham said that the FDA "as currently configured is incapable of protecting America against another Vioxx," because of ties between agency reviewers and the pharmaceutical industry. Graham says that as a result of his testimony, his bosses have threatened to toss him out of the FDA's drug safety unit. At the Senate hearing, Graham said that at least five medications currently on the market pose such risks that their sale ought to be limited or stopped."How can our country rest our faith, health, and lives in an organization which seems so fiscally absorbed? Maybe you all remember the famous case regarding the GlaxoSmithKline pharmaceutical company involving Paxil and SSRI products. Dr. Mosholder, part of the FDA office for Drug Safety, was prevented, BY FDA OFFICIALS, to present harmful findings of suicide in clinical trials related to usage in children to the FDA advisory panel. Hopefully the following proves a point, while giving you more reason to research products you consume.
"Indeed, according to an investigation by Sen. Charles Grassley (see item 2) the FDA actually tried to get Mosholder to present data that deceptively underrepresented the risk of suicidality."
http://www.alternet.org/story/21088/
- shilpa gogna
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