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An interesting article. Medical device manufacturers just keep on giving. These days it is all about the sale.

“It is alleged that the deal Dr. Burnam, Burnam, and St. Jude struck was that Dr. Burnam would prescribe St. Jude defibrillators for his patients as a quid pro quo for hiring his son. Burnam also would receive commission points with a guaranteed floor of $200,000 per year. As part of the deal, it is alleged that the doctor would receive compensation for engagements and so-called research projects.”

http://www.qmed.com/news/22308/medical-device-company-cardiologist-and-salesman-son-accused-fraud-and-medical-malpractic

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Why have companies behaved so badly this past decade? Was it cost cutting? Was it greed?

DC and the US Chamber are continuing their march to destroying all middle class protections. The next battle is to get generic drugs preempted from state tort laws because the politically controlled, conservatively underfunded FDA has approved the drug. This is the perfect situation that big business loves. They have the power and the influence to squeeze every ounce of profit out of life.

So who is going to protect the middle class? It is not the Democrats/liberals, Republicans/conservatives or libertarians. No one believes in the power of citizens to determine how they want to orient their society.  We have given up on juries in deciding how citizens want to orient their society. We have given up on ourselves. Maybe we really to need a king since we are not smart enough to determine what is important and what is not?

“Food and Drug Administration inspectors found in April that McNeil Consumer Healthcare, which has voluntarily recalled certain lots of its children’s and infants’ Tylenol products, knowingly used bacteria-contaminated materials to make them, a report posted Tuesday by the agency says”

http://www.usatoday.com/news/health/2010-05-04-tylenol-plant_N.htm?csp=34

A warning letter?! It is up to the manufacturer to provide information to the FDA. I also did not hear of any fine against Medtronic. What will force them to cleanup their act or is Medtronic to big of a ship to steer?

“It took almost two years from when the missing propellant was initially identified to conduct a recall.”

“In a statement, Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic said, quoted the Business Journal, “Medtronic remains committed to providing the highest quality products to our customers and is working with FDA to resolve all remaining issues as quickly as possible…”

“FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner,” the warning letter, dated June 1, states. “It took almost two years from when the missing propellant was initially identified to conduct a recall.”

“According to the letter, training records indicated that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.”

http://www.newsinferno.com/archives/13953#more-13953

The Republicans are not on board to pass the Medical Device Safety Act because they say the industry is regulated by the FDA. Allowing people to sue will place 50 requirements on these device manufacturers and yet they will not fund the FDA.

You draw your own conclusions. If I was in charge I would not let this company sell drugs for one year. Of course with caps they can more easily calculate the cost of doing business unethically.

Diabetes Drug Maker Hid Test Data, Files Indicate

“I was first ignored, then pressured to change my scientific opinion, and when I refused to do that, I was intimidated and ultimately terminated,” he said in an interview. “And I’m going to tell the committee exactly that at this meeting.”

http://www.nytimes.com/2010/03/29/health/policy/29fda.html?pagewanted=2&partner=rss&emc=rss

So Senator Hatch why should I trust the FDA? Senator Hatch will you give the FDA the needed funds to do their job?

“In one instance, it took the FDA 11 years to debar a doctor who had been convicted of 53 counts of criminal offense for, among other things, bribing an employee to conceal information about the attempted suicide of a clinical-trial patient and prescribing a drug without a license.

Types of misconduct that can get doctors debarred include submitting false information to the FDA, forging patient consent forms and not reporting when a patient has an adverse reaction to an experimental drug.”
http://online.wsj.com/article/SB125622345164801405.html

“Delfina Hernandez helped to carry out one of the most audacious drug research frauds in American history, but because federal drug regulators sent a legal notice years late and to the wrong address, she can legally continue to conduct research.”
http://www.nytimes.com/2009/10/22/health/policy/22fda.html
October 21, 2009

Given the fact that this has happened what has been put in place to prevent this from happening again?

“The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.”
http://www.nytimes.com/2009/09/25/health/policy/25knee.html?pagewanted=1&_r=1&hp
September 24, 2009

“After the FDA’s second rejection of fast-track status, in September 2007, ReGen asked lawmakers from New Jersey, its home turf, for help. Supporters included Democrats Sen. Robert Menendez; Rep. Frank Pallone, chairman of the Health Subcommittee of the House Energy and Commerce Committee; Rep. Steve Rothman of Hackensack; and Sen. Frank Lautenberg.

Messrs. Menendez, Lautenberg and Rothman signed a letter to the FDA in December 2007 asking for Dr. von Eschenbach, the FDA commissioner, to review the issue personally. Mr. Menendez talked with the commissioner by phone, his office said.

The four lawmakers defend their actions, saying they were simply assisting a constituent tangled up in government bureaucracy. "Our effort to help them was solely to ensure they received a fair and unbiased FDA review," Rep. Rothman said in a statement.

Congressional support helped ReGen land a meeting with Dr. von Eschenbach on Jan. 23, 2008. Two days later, ReGen in a letter called on Dr. von Eschenbach to put the matter in the hands of Dr. Schultz, head of the FDA’s device division.

In the same letter, ReGen also asked that the FDA staffers who previously had opposed Menaflex be excluded from the decision-making process.

Dr. von Eschenbach wrote back, "I believe it is imperative that FDA follow its well-developed procedures."

In subsequent months, ReGen got much of what it wanted. Dr. Schultz confirms that he took personal charge of the decision-making process”

http://online.wsj.com/article/SB123629954783946701-search.html

So what is to prevent this in the future? State tort laws, the right for patients to sue, is the one last recourse that people have over power and money.

“Both GAO and FDA, however, have identified shortcomings in FDA’s postmarket oversight. For example, in 2006 FDA reported that the agency’s ability to understand the risks related to the use of medical devices is limited by the fact that the volume of submitted reports exceeded FDA’s ability to consistently enter or review the reports in a routine manner. In 2008, FDA officials told us that while they have a number of strategies to prioritize their reviews of adverse event reports, they still cannot review all the reports they receive. Finally, GAO has found that FDA has not conducted required inspections of manufacturing establishments, another key FDA responsibility for medical devices marketed in the United States. In 2008, GAO reported that FDA has not met a statutory requirement to inspect certain domestic manufacturing establishments every 2 years. Instead, FDA officials estimated that the agency has inspected domestic establishments every 3 years (for class III devices) or 5 years (for class II devices). There is no comparable requirement to inspect foreign establishments, and FDA officials estimate that they have been inspected every 6 years (for class III devices) or 27 years (for class II devices).”

http://www.gao.gov/products/GAO-09-370T

“Daniel Troy served as chief counsel for the U.S. Food and Drug Administration from 2001 to 2004. Starting September 2, 2008, he will be head counsel for the pharmaceutical company GlaxoSmithKline. Before his stint at the FDA, Troy "fought the agency on behalf of the right to use medical-journal articles to suggest off-label uses for drugs and medical devices."

http://blog.lib.umn.edu/schwitz/healthnews/2008/07/big-pharma-big.html

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more about “Investigators: Detecting The Dangers“, posted with vodpod

So what happened? Was the FDA influenced by politics? Was the Bush administration telling the FDA to back off so that we could have more innovation? So what happens next presidential election if a President gets in that thinks we have to much regulation or the Republicans want to cut government funding?