FDA knew since 2005 that Needle Factory sold contaminated syringes

[WillYourVoteBCounted]

In 2005, the North Carolina manufacturer of needles was cited for falsifying sterility records on pre-filled heparin and saline syringes that sickened more than 100. Then in 2007, the company
(AM2PAT) moved their operations to a former motorcycle factory in Angier,North Carolina. Shortly after that, complaints were made to the FDA about sediments in some of the saline syringes. If the FDA knew that there were dangerous violations, such that deaths would (and did occur), then why no action?
At least 100 patients receiving chemotherapy, kidney dialysis and other intravenous treatments were sickened by the outbreak. Many people suffered severe injury, and at least five deaths are associated with the infection.

FDA knew of syringe firm's laxity

Agency cited 'serious underlying problems' at AM2PAT's old Wake plant
Sarah Avery - Staff Writer Raleigh News and Observer Thu, Feb. 26, 2009

RALEIGH -- The operators of a company that shipped bacteria-tainted syringes linked to at least five deaths had been warned by the U.S. Food and Drug Administration about serious problems at a previous plant.

The Aug. 11, 2005, warning letter, provided by the FDA on Wednesday, foreshadowed the legal problems now facing AM2PAT Inc. and its officials, who have been charged with falsifying sterility records on pre-filled heparin and saline syringes that sickened more than 100.

The violations, which arose while AM2PAT operated its plant south of Raleigh on Ransdell Road, were "symptomatic of serious underlying problems" in the company's quality control system, the FDA's warning letter stated.

...By December 2007, syringes infected with the Serratia bacteria were traced to the Angier plant. At least 100 patients receiving chemotherapy, kidney dialysis and other intravenous treatments were sickened by the outbreak. Many people suffered severe injury, and at least five deaths are associated with the infection.

...more at the link

"Earlier this week, two of the company's former plant operators pleaded guilty in U.S. District Court for falsifying documents to make it appear that the syringes underwent sterility testing." Government agencies have supressed a lot of embarrassing information about risks to public health from pharmaceuticals and other medical services the past 8 years.

The FDA is horribly compromised with internal conflicts of internest with agency staff profiting through their ties to Big Pharma. That means that Big Pharma is helping to regulate itself by controlling the FDA. And anyone who thinks a business or industry will regulate themselves, needs their head examined. After all, the CEOS need those big multi million $ bonuses each year and there's pressure to cut costs and maximize profits from their shareholders.

Sheesh, this is kind of like that tv show, Damages where the theme is "Trust no one!"

[MikeE]

1. More bush legacy crimes surfacing

Hopefully, since Pres. Obama supports more oversight and regulation, we will beging to see an end to this kind of behavior.

[indepat]

2. Proud to kick this expose of cruel criminality and malfeasance to the greatest page

:D

[newfie11]

3. Sound like the quality control in China

except in China these idiots would be dead by now!

[Why Syzygy]

4. Meanwhile, the FDA had time to harrass cherry growers.

http://www.mi-cherries.com/fda1.htm

On October 17, 2005, letters went out from the Food and Drug Administration warning tart cherry purveyors that they had better quit telling people that tart cherries have health benefits or dire things are going to happen. The lucky recipients were warned that it's illegal to say things like, "The same chemicals that give tart cherries their color may relieve pain better than aspirin and ibuprofen." Testimonials such as, "I no longer take any drugs!" had better cease - or else. Although most of the 29 letters were aimed at Michigan tart cherry growers, some were fired off to growers of other berries in other states. What prompted the berry attack is still at large. Inquiries to the office of Judith Putz, compliance office for the FDA's Detroit district office, didn't yield answers beyond that the FDA had become aware that people were "making claims." The action is not unprecedented, however. Back in 2001, somebody at Food and Drug got bugged about a different berry - the cranberry.
...
Unlike the cranberry situation, however, the recent attack on tart cherries is aimed at statements made on websites not linked to labels. Since the FDA has no authority to dictate website content - which is regulated by the Federal Trade Commission - we asked the agency by what authority it was threatening to seize property and stop people from selling tart cherry products. The agency responded that websites are part of the legal definition of "label." A reading of the legal definition, however, reveals that a label is, well, a label - something stuck to a product or its package. The definition also allows Food and Drug to regulate things that come with the product, such as a package insert. But no mention is made of websites.

What The Supreme Court Says
Not surprisingly, some in the cherry industry are talking about their First Amendment Rights. "Tart is Smart," according to King Orchards, and it's not rolling over. Neither, apparently, is the Supreme Court. In sharply worded opinions, the Court has repeatedly rebuked the FDA's "highly paternalistic approach" to keeping information from people for their own good. When the FDA tried to keep compounding pharmacies from advertising, the Court warned the agency that whether a person wants alternative choices is not the government's decision to make. The searing verdict: Bans against truthful, non-misleading commercial speech... usually rest solely on the offensive assumption that the public will respond "irrationally" to the truth. The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. The Court further admonished the agency to quit trying to protect favored markets by suppressing information. According to these and other Court opinions, the FDA appears to have more bureaucratic bark than legal bite.
*empahsis

[Warpy]

6. The way to keep the FDA out of the sour cherry business

is to avoid making health claims on the label. The generic "Tart is Smart" label shouldn't have been a problem since it is smarter to eat foods in their sour original form than to add loads of sugar to make them more palatable to childish palates.

However, telling people they can substitute it for anti inflammatory pain medicine has not been verified by double blind testing, only anecdote, so that claim on a label was irresponsible.

[Why Syzygy]

7. It wasn't on the label.

There were lab studies. The Supreme Court doesn't appear to agree with your assertion.

[flyingobject]

9. Since Big Pharma and Gov are in bed together, Pharma gets away with MURDER

think about Merck and Vioxx, which Merck knew would kill thousands but covered up
the test results.

[wellstone dem]

5. And the recipients of this disaster were people already sick.

[flyingobject]

10. These corporations know its easier to screw over the sick and weak

or the poor.

[Why Syzygy]

8. Hey, WYVBC ..

I want to apologize for worming the cherry story into your thread. I thought it made a good contrast.
As a visual designer, I expect *everyone* to have the same ability to see contrast and hue that I do. I need to be more mindful of the linear thinkers among us, at least some of the time.

I'm glad they caught those bastids, and hope they meet with the full extent of consequences for their negligence.
And may the FDA get what's coming to them as well.