Monthly Archives: June 2010

NexGen CR-Flex Knee Device Criticized by Former Zimmer Consultant

Dr. Richard A. Berger, former orthopedic consultant for Zimmer Holdings, has had a public falling out with the medical device company. For years, Berger was a star consultant who’d been paid more than $8 million for his expertise concerning artificial hips and knee devices.
Berger’s relationship with Zimmer was severed after Dr. Berger complained that the NexGen CR-Flex knee was failing at an unacceptable rate. Zimmer officials blamed Berger’s surgical technique for the failure rate. That’s when Zimmer decided to terminate its relationship with the surgeon.
According to Berger, the NexGen CR-Flex artificial knee was designed to provide more flexibility and range of motion than the previous model, the NexGen. Berger told the NY Times that he had given 125 patients the new NexGen CR-Flex since 2005. The new knee was supposed to last 15 years. However, by early 2006, x-rays were showing that the device was loose and had not fused properly to the bone. Berger’s patients were reporting pain while walking and complained to him about the knee implant. Berger reported the complaints to Zimmer officials who dismissed Berger’s claims. The NexGen CR-Flex uncemented knee had no test data because the FDA had not required testing prior to selling the new knee.
Since at the time no other surgeons complained about the knee, Zimmer executives told Berger that the problem had to concern his surgical technique.
By 2007, Berger had stopped using the Zimmer knee device and had decided to perform his own study of the NexGen CR-Flex with another surgeon. The surgeons found that the knee failed in 9% of the cases and that the knee showed signs of looseness in about half of all Zimmer knee patients.
Zimmer continues to dispute Berger’s claims as well as his test results. This leaves patients with a problem-who do they trust?

Medical School Says No to Health Industry Funding for Continuing Ed.

The University of Michigan has become the first medical school in the country to halt the funding of its continuing medical education classes by companies with pharmaceutical and medical device industry ties. The move, approved in a vote by university officials, comes amid widespread criticism in academic and professional circles that the relationship between doctors and these industries is too close and the relationship often blurs the line of professional ethics.
In announcing the school’s decision, Dr. James O. Woolliscroft, dean of the medical school, noted that the school wanted “wanted education to be free from bias, to be based on the best evidence and a balanced view of the topic under discussion.”
However, this decision is not without its own controversy. Many doctors believe such a move cuts them off from access to important scientific knowledge. The heads of the National Institutes of Health and the American Heart Association have decried the move.
The issue has become controversial partly because its a multi-billion dollar industry. Continuing medical education garnered $2.5 billion in 2007 with 700 accredited providers of the education vying for position and access to doctors.
The NY Times interviewed experts on both sides of the issue, one in particular caught my attention because he’s a physician who has also studied how medical education is part of an overall marketing strategy for the pharmaceutical and medical device industry. Dr. Steinman, associate professor of medicine at the San Francisco VA medical Center noted, “The course providers have a subtle and probably unconscious incentive to put on courses that are favorable to industry because they know where their bread is buttered.”

For-Profit Colleges Come Under Congressinal Scrutiny

One US Senate witness referred to them as “marketing machines masquerading as universities” while US Senator Tom Harkin (D-IA) expressed concern that the federal government knows very little about the lucrative world of for-profit colleges. “We don’t know how many students graduate, how many get jobs, how school that are not publicly traded spend their Title IV dollars, and how many for-profit students default over the long term,” said Harkin as he opened an oversight hearing on the burgeoning industry.
Many questions may linger about the for-profit colleges but one thing is for sure-they attract large numbers of students. According to a report released yesterday, the 14 publicly traded colleges enroll a combined 1.4 million students in schools such as DeVry University, Sanford-Brown Institute, the University of Phoenix, and Argosy University, just to name a few.
Some of these schools are not properly accredited so it makes it even tougher to find a job after graduating from one of these for-profit schools. A NY Times article noted the plight of one young single mother who had enrolled for classes at Sanford-Brown Institute in order to be an ultrasound technician. Once she completed the program she discovered Sanford-Brown wasn’t properly accredited so she couldn’t find a job. Yet she was still saddled with $21,000 in student loans that can’t be discharged in bankruptcy.
During the oversight hearings chaired by Senator Tom Harkin, the committee heard from Kathleen Tighe, the inspector general of the federal Department of Education who told the committee that while the for-profit colleges account for only 10% of the nation’s college students, the for-profit colleges account for 70% of the department’s criminal investigations concerning federal student aid fraud. Another alarming statistic concerns the inordinate amount of federal student aid the for-colleges receive-a whopping 25% of all student aid awarded in Pell grants and Stafford loans.
It’s high time the federal government began investigating these for-profit colleges. Too many students are drowning in college loan debt already.

Florida Lifts Bar on Time Limits regarding Sexual Abuse Victims

On May 11, 2010, Florida Governor Charlie Crist signed into law a bill that lifts the statutes of limitations in both civil and criminal cases for victims of sexual abuse under the age of 16. While this is a step in the right direction, it doesn’t address the thousands of survivors who were abused prior to this bill becoming law. In the version that the Governor signed, there is a clause that states, “This subsection applies to any such action than one which would have been time barred on or before July 1, 2010.” That one sentence excludes all those who were abused when they were minors but could only come forward years later as adults.
This is an important point because anyone who has worked with survivors of sexual abuse realizes that the majority of those abuse as minors were unable to come forward in what the law considers a timely manner. The nature of the crime, the fact that the perpetrator is often well known and/or well-respected, and their own shame over the incident prevented them from coming forward sooner. Unfortunately, the new legislation doesn’t take this important aspect of abuse trauma into due consideration.
It shouldn’t come as any surprise that the Florida Catholic Conference opposed the legislation. In doing so, the Conference issued the following statement: “it would create great uncertainty for any organization.” In my opinion, that’s pretty weak when you consider the permanent harm done to our children.
At the least, Florida’s children will be afforded the law’s protection going forward. There will be no civil or criminal statute of limitations for those coming forward reporting the crime of sexual abuse. That is a good step in the right direction. We need to do more but we’ll take this as a first step.

Zimmer Medical Device Consultant Let Go

After a long and mutually lucrative relationship, Zimmer Holdings and Dr. Richard A. Berger are parting ways, and the parting isn’t all that amicable. Zimmer Holdings manufactures artificial medical devices such as knees and hips. Dr. Berger is a renowned orthopedic surgeon and former consultant for Zimmer. The relationship soured after Berger was critical of one of Zimmer’s artificial knee devices. Berger told the company that the knee’s early failure rate was unacceptable and was due to a design defect. Zimmer officials countered by stating that the problem was not with the medical device itself but Berger’s surgical technique.
Once the accusations began to fly back and forth, the relationship broke down quickly. In detailing the relationship and its demise, the NY Times made an important point when it stated that such disputes have an adverse effect on the patient. There is no way for the ordinary medical device candidate to determine if the doctor or the medical device company is correct. This makes it difficult for the patient facing a knee replacement or a hip replacement to know for certain if the device is defective or the surgeon lacks skill. Either way, it’s not a good situation for the patient.

FDA Warns About Possible Vitamin D Overdose in Children

We’ve all grown up with the good news about Vitamin D and its role in building strong, healthy bones. As children, we were told to drink our milk for this very reason.
The good news is that Vitamin D still plays a vital role in healthy bone development. The bad news-too much of the vitamin may cause serious damage to children. That’s why the FDA has issued a warning to consumers that Vitamin D purchased in liquid form must be carefully administered to avoid overdoses that could cause a wide variety of problems such as nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, fatigue and even serious damage to kidneys.
The FDA issued the following list of recommendations for vitamin D supplements:
- Make sure infants do not receive more than 400 IU of vitamin D a day
- Keep the supplement product with its original package so instructions can be followed to the letter by parents and caregivers.
- Use only the dropper that comes with the product and is manufactured just for the product
- Make sure the vitamin D dropper is clearly marked with units of measurement
- If you don’t know how much is a correct dosage, ask your physician
- If your child takes infant formula, it is best to check with your pediatrician before giving your child vitamin D supplements at all

New Study Links Avandia to 48,000 Health-Related Problems

An unpublished study has linked GlaxoSmithKline’s diabetes drug Avandia to 48,000 incidents of heart attacks, strokes, and other adverse medical issues in Medicare patients between 1999 and 2009. The study was conducted by an FDA scientist and comes about a month before an FDA panel is set to review the safety concerns of the diabetes drug Avandia.
Dr. David Graham, the FDA scientist who conducted the study, is an outspoken critic of Avandia and has called for its withdrawal from the marketplace due to its safety concerns and its link to an increased risk of heart attacks and strokes in diabetic patients.
According to an article in the Wall St. Journal, the study found that “patients taking Avandia had a 27% greater chance of suffering a stroke, a 25% increased risk of suffering heart failure and a 13% greater chance of dying. Avandia increased the overall risk of experiencing heart attack, stroke, heart failure or death by 17%, the study said.”

BP Under Fire from All Sides

British Petroleum is taking hits from every side, as well it should. A recent Associated Press report has demonstrated how woefully under-prepared the oil company was as it drilled oil in the Gulf of Mexico. According to the AP, the British company underestimated the economic and environmental impact an oil spill would have in the Gulf. It also underestimated its own preparedness in responding to an oil disaster. The only thing that BP seemed prepared to do-garner huge profits from its oil drilling off the shores of the Gulf of Mexico with little regard for the wildlife, eco-system, or economy of the Gulf shores.
Even now, BP offiicials are downplaying the amount of oil spilled, scientific evidence that the plume is under the surface waters of the Gulf (not along the surface as BP has assured everyone). BP CEO Tony Hayward seems more concerned about restoring a sense of “normalcy” to his private life rather than dealing with the economic and environmental disaster he himself created.
Even the BP claims process is coming under fire from those who’ve submitted claims. Complaints are surfacing that BP is slow to pay on claims, bungling the process, and generally slow to respond to pleas for help.
There’s not one area of this tragedy that’s been handled well by BP. Because of them and their blatant disregard for the Gulf of Mexico, we’re living with the worst environmental disaster in our history.

BP Oil Spill Claims Process

If you’ve suffered loss of income or other damages as a result of the BP oil spill, we’ll be happy to help you free of charge with your BP oil spill claim. Completing the BP oil spill claim form is the first required step in recouping losses suffered as a result of the Gulf of Mexico oil spill.
Florida residents should not sign any documents in return for money from BP until they know the extent of the damage sustained. Also, make detailed records of canceled reservations or any other proof of loss of income including documenting the names and addresses of those who’ve canceled reservations as a result of the oil spill.
You should also consider calculating your estimated losses for a six-week period in relation to your business’ previous years. As part of your record keeping, list all assets that may be subject to damage or loss due to the oil spill.
Finally, Florida CFO Alex Sink has announced that the Florida Department of Financial Services has a toll free hot line to assist businesses with questions concerning their claims. They may be reached at 877-693-5236.

Oil Spill Hits Panhandle

The BP oil spill has come ashore on the white sandy beaches of Florida’s Panhandle. Even though the news was expected for some weeks, the event didn’t cushion the blow for northwest Florida’s tourism industry and local businesses who fear the worst from the oil spill. While cleanup efforts are already underway in the Panhandle, the devastating effects to the local economy may force the shuttering of businesses and vacationers to cancel summer trips. The scenario is grim with no real end in site. Oil is still gushing into the Gulf. BP’s latest attempts at stopping the oil have not proven to be completely satisfactory.
An recent editorial in the LA Times opened with the line, “If you’re planning a summer trip to the Florida coastline, you may want to steer clear of Pensacola Beach.” This is bad for all of Florida.

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