Monday, March 02, 2009

AstraZeneca and FDA - The mockery of science and health

As always this comes from Furious Seasons:

I received the following statement from Tony Jewell, an AZ spokesman:

"AstraZeneca has studied Seroquel extensively and shared all relevant and required data with the FDA -- both before and after the agency approved it as safe and effective. The company has worked diligently with the FDA to ensure that the safety profile of Seroquel is reflected appropriately in the prescribing information that health care professionals use when making treatment decisions.(emphasis mine)

"Seroquel has helped millions of people suffering from schizophrenia and bipolar disorder, which can be serious, debilitating mental illnesses.

"AstraZeneca stands behind Seroquel and its clinical research. AstraZeneca has an internal quality assurance program to ensure that our clinical research complies with good clinical practices and meets the highest ethical standards.

"This litigation is about whether Seroquel caused diabetes in individual plaintiffs. The court in the first two cases in the federal multi-district litigation in Florida granted summary judgment because the judge concluded that plaintiffs did not have sufficient evidence to establish Seroquel was responsible for their alleged injuries. (emphasis mine)

"At this point, there is no trial scheduled in the multi-district litigation because no plaintiff yet has come up with a demonstrated triable claim. AstraZeneca intends to litigate these cases on their individual merits and will defend ourselves vigorously." (emphasis mine)

First I would like to hear from the millions that was helped by Seroquel. Not on a statistic chart or testimonies of key opinion leader patients.
They always claim that there is not enough evidence. I just wanted to know where did this judge got the data and advices to come to the conclusion that there's not enough evidence.
According to the actual scientific method there should be a double-blind test for this specific side effect - diabetes. But they claim they have already done it.
In an ideal world - it's amazing some obvious methods have turned to be "ideal" - these tests should be done by an unbiased institution which unfortunately is not FDA associated to any university.
Of course it would be done by AstraZeneca itself with the support of FDA that for more than a decade is failing to protect American citizens health and is influencing the regulations of numerous nations.
As AstraZeneca said they will defend themselves vigorously and by vigorously they mean no concern with health following the tradition of this Pharma era.They are concerned with money as well as American government, politicians, FDA and all institutions related to health.
You are all making fun of science and medicine at the expenses of people's health.
You have no integrity, no morals, no values... nothing. Physicians should start raising their voices on behalf of their patients.
But it seems they also don't care.
After all who cares for health in US? I wonder when or if Mr. Obama will have enough strength to make the change needed on what drug regulation is concerned.
Mr. Obama, American citizens need a whole reform for their health care and I would like to remind you that US health policy has a global impact. I would also would like to remind you the importance of health for every human being. I guess some people forgot this obvious fact.
I would also like to know how can FDA let a site and others advocate the use off-label of Seroquel for the following diseases:
Restless Legs Syndrome, Insomnia, Headache, Generalized anxiety disorder, Fibromyalgia syndrome, Dementia, Agitation, Anorexia, Asperger's Syndrome, Panic disorder/agoraphobia, Post-Traumatic stress disorder (PTSD), Social Phobia and others.
It's said at this site that FDA has approved Seroquel for depression. I didn't know that.

Cost of Seroquel online:

Seroquel 50 = $1.75 per pill
Seroquel 100= $2.91 per pill
Seroquel 200= $5.40 per pill
Seroquel 300= $7.06 per pill

I wonder how the millions of patients helped by Seroquel will pay for their treatment.
Seroquel generated sales of $4.45 billion in 2008 and is the company's second-biggest seller after the ulcer treatment Nexium.


kim said...

We do have real health care problems here in the U.S. It's something they've been trying to "fix" for years with no luck. But in my opinion, they haven't really been trying.

The FDA is a mess. Millions do not have health insurance. (I'm currently sick and can't even go to the doctor because I lost my health insurance after having it 20 years due to the premiums rising) and millions are losing their insurance. But that's the problem, it's not and should not be health INSURANCE, it should be health CARE. Anytime they (the US government) sits down to fix the problem-insurance companies are always at the table. The problem will never be fixed that way. It's very sad.

Anyway, nice post and you know how much I despise Seroquel.

Ana said...

I always have the feeling that governments don't care about people.
It's worldwide.

MamaC said...

A very dangerous drug.

Ana said...

Yes, very dangerous but over-prescribed.