FDA Scientists complain of corruption to Obama | Arthritis Information

 

I'm posting this by itself for those not interested in the discussion under the "miranda" thread.

Pip!2009-01-15 12:32:31We'll see if anything gets changed.I don't think it's possible without dismantling the FDA and starting from scratch. Pip, I also posted this, but some people who have the opinion the FDA can do no wrong were oddly silent.Gimpy-a-gogo2009-01-15 12:39:19I know somebody posted this...sorry...thought it was me.  LOL Melody Peterson in Our Daily Meds talks about Pharma's influence on the FDA.  She talks about it alot.all levels of government need to be rattled... every division ... every politician needs to look at himself in the mirror and see if he sees himself or someone he doesn't like.. more often than not. he doesn't see himself.

Yeah, well, me too.

There was some Rep/Sen that swore off Pharma money.  I'd bet the farm he hasn't really done that.  Just no way of checking, is there?

Pip

[QUOTE=Pip!]

Yeah, well, me too.

There was some Rep/Sen that swore off Pharma money.  I'd bet the farm he hasn't really done that.  Just no way of checking, is there?

Pip

[/QUOTE] You know, that's all I want (plus a minimum understanding of stats).  I just want to be sure somebody isn't benefitting from hiding stuff.  KWIM? Below is another AP article on the subject, published today:

High risk medical devices escaped close review

By RICARDO ALONSO-ZALDIVAR – 2 hours ago

WASHINGTON (AP) — Some medical devices for sensitive uses, from certain hip joints to a type of defibrillator, have won government approval without a close scientific review, congressional investigators said Thursday.

Although Congress ordered the Food and Drug Administration years ago to resolve the issue, the agency approved 228 medical devices without a full scale review from 2003-2007, the Government Accountability Office said in a report.

Some devices approved under the less rigorous process have been recalled because of malfunctions and other problems, according to the consumer group Public Citizen. One device was an external defibrillator to assist heart attack victims.

The report comes as the FDA's Center for Devices and Radiological Health is the subject of allegations that scientists were pressured to approve medical machinery against their professional judgment. Nine FDA scientists wrote the Obama transition team last week complaining that a "corrupted" review process is putting public health at risk.

(for complete article see link below)

Hmmm, I had two hip replacements two years ago.

With this news, I'm now concerned about the quality of my two hip replacement devices, and also disturbed that while, at the same time, many devices may have been approved by the FDA without adequate review -- in 2008, the Supreme Court in Riegel vs. Medtronic, ruled in favor of medical device makers protecting them from personal injury lawsuits.

Now I'm not a sue happy person,  but if you're gonna put a possibly faulty device in my body, do not take away my right for my day in court.

http://www.google.com/hostednews/ap/article/ALeqM5gPQRtHKDaBN703dxMlU84zFBeOXAD95NSIGG0

Wow - and yeah, I'm right behind you about the day in court thing. 
I guess I'll call my ortho surgeon's office, and ask what kind of hip joint they put into me, and then see if its on the list of those 228 medical devices that did not have adequate medical review and if there have been reported problems.

This is causing me a bit of anxiety, cuz revision surgery, surgery to repair or replace an artificial joint is more complicated and difficult.  Add to that I have RA and also osteoporosis, so its not a simple matter to repair/replace an artificial joint.

 
Joie, that is a smart thing to do if, for no other reason, to get it off your mind.  I sure hope yours are not on that list.  This goes back to where they were manufactured and, really, what choice do we have in that???
Call your doc, Joie.
[QUOTE=Pip!]Wow - and yeah, I'm right behind you about the day in court thing. 

Jan 17, 2008 | Parker Waichman Alonso LLP

"Stryker Corp., a maker of hip and other joint replacement components, has received a second warning from the Food & Drug Administration (FDA) to correct bacterial contamination issues and other problems at its New Jersey manufacturing facility.  In a warning letter dated November 28, 2007, the FDA said that deficiencies at the plant had led to the manufacture of defective hip replacement components and other medical devices.   Those problems had resulted in injuries to patients who had received the faulty components, and in some cases forced them to undergo additional surgeries.

According to the FDA warning letter, Stryker has been receiving complaints about components made at the New Jersey factory, including hip joints that did not fit properly, since 2005.  Patients had been complaining about a range of problems, including pain, difficulty walking and "squeaky" joints, and some have had pieces of implant parts break off or wear down unevenly."


Well, since my two hip replacements in 2006, I haven't had any problems, so hopefully I don't have a "Stryker" hip joint.  But reading further down in the article, I came across yet another example of conflict of interest in medicine:

"The recent FDA warnings have not been Stryker’s only brush with federal regulators this year.  According to the Associated Press, Stryker was among five companies that make joint replacements in the US that agreed in September to pay a 0 million fine and accept federal monitors to settle allegations they gave doctors kickbacks to use their products."

Geez, no wonder medical students choose not to become primary physicians, but choose specialties like orthopaedic surgery -- much more lucrative.

To view complete article referenced see:
http://www.yourlawyer.com/articles/read/13696



   Great!  Parts breaking off and 310M in fines.  What do the people with broken parts get?
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