Posted on 11/09/2014 11:28:36 AM PST by Nachum
Unauthorized and potentially counterfeit, dangerous surgical devices and medical supplies have flowed unchecked into the Department of Veterans Affairs supply chain and into VA operating rooms, according to internal agency correspondence from a major supplier who blamed new procurement rules.
The bogus supplies gained a foothold when the department started using reverse auctions to fulfill some contracts, according to both department officials and a 2012 memo from Johnson & Johnson, the world’s largest medical device business.
In the memo, the company told the VA it was getting surgical supplies bought from unauthorized distributors through the so-called “gray market,” and said those supplies raised serious questions about patient safety, according to emails obtained through the Freedom of Information Act.
Read more: http://www.washingtontimes.com/news/2014/nov/6/va-surgeons-risk-danger-by-using-unauthorized-pote/#!#ixzz3IbLHsApG Follow us: @washtimes on Twitter
(Excerpt) Read more at washingtontimes.com ...
But don't worry soldier... there's good news! I saved 15% with GEICO!
The list, Ping
Let me know if you would like to be on or off the ping list
Coming soon to the rest of us via ObamaCare.
We have a stellar VA Hospital here in Madistan, WI. My ‘Bestie’ of 30+ years ran the Psych Ward there and did a LOT for returning Vets that were really, REALLY messed up, mentally. Lots of drug & alcohol abuse, anger issues, psychosis of every stripe, homelessness. I don’t know how she made it through a DAY, let alone a DECADE doing that, God Bless Her!
That said, I hope I never need to use my VA benefits.
Glad to hear it.
One of the news crew this morning wondered why doctors and surgeons didn’t blow the whistle...might be why so many VA doctors are foreign...they may not know supplies are inferior or just not care...
Y’all come! People drive all day from all parts of our state just to use it.
Outrageous! I would expect no less from our current administration and lifetime government workers however.
Well if you take generic drugs here in US sold at all drug stores, you may be getting bogus ingredients, too. I looked up my blood pressure meds and if it is not Brand Name or made by Parr corporation, it is bogus.
My thyroid med was always Brand, Synthroid. I noticed they were giving me a generic, and it is NOT the same active ingredient. Is it “similar”
Drugs made in India are inferior and many drug making companies there have been shut down. But there are not enough inspectors.
I called the 800 number for CVS and the person talking to me admitted that Generic drugs for the most part are inferior and made only for people who are hypochondriacs and they just want to take the pills. Most generics are no better than SUGAR PILLS....
I had a prescription filled from a nationwide drug store chain.
It did not work at all. So I had it refilled at Wal-Mart, and that immediately brought my blood pressure down to normal. That does not prove the first was fake, but I have become much more suspicious now.
http://online.wsj.com/articles/SB10001424052702303874504579374841914031168
U.S., India Clash Over Generic Drugs
FDA Takes Aim at Pharmaceutical Makers Including Ranbaxy
(JUST ONE OF THE STORIES)
Generic drugs account for nearly 85 percent of medicines prescribed in the United States and the government is relying on them to help rein in healthcare costs.
“We are losing control over what people are swallowing,” said Dr. Harry Lever, a cardiologist at the Cleveland Clinic who is trying raise awareness of the matter among U.S. lawmakers. “Now, when a patient comes in who is not doing well, the first thing I do is look at their drugs and find out who makes it.”
Increasingly, Lever said, he is recommending patients seek out generic drugs from specific manufacturers outside India.
“I’m tending to stay away from India,” he said. “There’s something wrong. Too many things are happening.”
Unease grows among U.S. doctors over Indian drug quality
http://in.reuters.com/article/2014/03/18/usa-india-genericdrugs-idINDEEA2H03120140318
NEW DELHI—A regulatory culture clash between the U.S. Food and Drug Administration and Indian pharmaceutical makers is sparking friction between Washington and New Delhi over generic-medicine production.
Since last year, the FDA has blocked shipments to the U.S. from a series of plants operated by Indian generics makers Ranbaxy Laboratories Ltd. and Wockhardt Ltd. , culminating in a ban ordered last month against Ranbaxy’s main ingredient factory.
The agency says it is acting to protect U.S. consumers after its inspectors discovered serious shortcomings. At one Ranbaxy factory, for example, the FDA says workers repeatedly fudged test results. Ranbaxy didn’t respond to a request for comment.
Indian officials and drug makers, however, insist that their drugs are safe and say the FDA is too focused on relatively minor flaws in manufacturing processes. Some Indian officials say they suspect commercial motivations.
On Monday, FDA Commissioner Margaret Hamburg met with Indian Trade Minister Anand Sharma. Among the topics that were discussed, Indian officials said, were drug-production safety standards.
After the meeting, Altaf Lal, the FDA’s representative in India, said, “there is a renewed interest to work together to inform the industry.”
Indian officials say that the drugs produced at factories barred by the FDA are acceptable according to Indian regulators’ tests.
“It looks like a case of damaging the Indian generic-pharma industry,” said a senior Indian official. He said it appeared inspections were being used to keep less-costly medicines out of the U.S. market.
Erica Jefferson, an FDA spokeswoman, said the agency isn’t trying to keep Indian products off U.S. shelves. “The FDA remains confident that most Indian companies understand and manufacture in accordance” with FDA rules, she said.
“However, we also remain vigilant and will take appropriate action if, or when, lapses occur,” Ms. Jefferson said.
The financial implications for Ranbaxy and Wockhardt are certainly stark. Wockhardt, which generated 80% of its revenue from exports before the FDA barred drugs from two plants, is contending with a sharp decline in profit.
Four of Ranbaxy’s five manufacturing facilities are now barred from exporting to the U.S. The company derives about 40% of its revenue from the U.S.
At the root of the problem is a fundamental disconnect between how U.S. and Indian drug regulators approach safety, said Ajaz Hussain, a former FDA deputy director who now works as an industry consultant.
In India, the safety of a particular drug is monitored by collecting and testing samples of the drug. In the U.S., the manufacturing process is strictly regulated and if violations are found, the end product is considered defective.
“It comes down to a difference in risk tolerance,” Mr. Hussain said. For example, he said, it is common in India for propane cylinders to be transported around cities balanced between the legs of someone riding a motor scooter. “If that happened in U.S., they would shut down the highway,” he said.
The stakes in drug regulation are high. In 2008, adulterated supplies of Heparin, an important blood thinner, led to the deaths of 80 people in the U.S. The problem was eventually traced to contaminated supplies from China.
In that case, “the tests in place did not detect the contaminant. If you don’t control the process, other things could come in that your tests will never detect,” Mr. Hussain said.
Critics of the FDA’s approach in India say the agency is continuing to allow imports of Ganciclovir, an antiviral drug, despite manufacturing violations at the facility where it is made, because Ranbaxy is the sole supplier of the drug. Ranbaxy didn’t respond to a request for comment about the matter.
The FDA also often recommends that patients continue to take drugs manufactured by facilities that have been barred from exporting, saying it could be injurious to their health for them to stop.
For U.S. officials, the spate of problems in India is likely evoking memories of a 1980s generic-drug scandal in the U.S., in which U.S. generics makers were found to have falsified test data, said Mr. Hussain, the former FDA official.
India made its name as the preferred location for affordable drugs, Mr. Hussain said. “Now with the erosion of trust, you risk losing that.”
There are SO MANY factories making generic drugs in India and not enough inspectors. they are selling us DEATH...
That’s not very comforting to hear. We’re going to have CVS/Caremark come January. And dealing with Express Scripts/Medco was no day at the beach either.
Ya but just watch all the suits in D.C. who never served a single GD day in the military, get on TV this Veterans Day and tell all how proud they all are of the “troops” as they spend more tax dollars on illegal aliens than they do for U.S. military veterans.
Spit*
Could it be that the lab looks at what my generic drug is supposed to be doing and then enters a fake number into the results?
The VA had been there all these years, and we still got øbolacare.
V A ping.
Obama just heard about this. He’s just as angry as you are, and he’s determined to get to the bottom of this as soon as he finishes his next round of golf.
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