Dr. Charles Rosen

WHAT’S WRONG WITH THE CHARITE ARTIFICIAL DISC?

Essentially the problems with the Charite Artificial Disc are, in my opinion, two fold. The Disc it self has mechanical problems and the FDA study used to approve its use was flawed.

The human spine is designed to be the framework for your body and the disc are the shock absorbers of the body. This artificial disc is supposed to be a replica of what you already have in your spine. However the Charite Artificial Disc does not replicate a natural disc. The Charite is two hard pieces of metal and polyethylene, where as the human disc is made of soft material that acts as a shock absorber for your spine. Two hard pieces of metal hitting each other don’t provide the necessary absorption needed.

Secondly, the motion of the Charite disc appears to have an excessive amount of what we call “bad motion” which is sliding back and forth, not the natural up and down of a shock absorber. An unnaturally large amount of sliding motion causes numerous problems, including speeding up the arthritic process. Another problem is that the center of rotation of the Charite disc also does not replicate that of a natural spinal disc.

In my opinion the FDA study, which was used to approve this disc was seriously flawed on several levels. First, when the study was designed the FDA allowed for 26% of the results from first group of patients – not to be released. I’ve never reviewed one FDA study in the past 15 years that didn’t release the details of all of the complications. In fact, I had the last 5 years of all volumes of “Spine” reviewed for any studies at all where this was done, and none could be found.

It’s important for doctors to have the complication information of all the patients in a study, because this is how a doctor learns about the procedure. When I requested the information from the FDA, I was told it would not be released because it was a “trade secret,” and that they were considering the first 26% of the patients as the doctors in the study getting their “feet wet.” Not to provide the information does no one any good, neither the doctor nor the patient. I’m personally affronted as a doctor by this attitude and believe the “training “ patients and their families would be too, if they knew how they were categorized.

Next, the Charite disc operation in the FDA approved study was compared to a failed procedure that was considered by most surgeons a failure at the time the study was implemented. However, it wasn’t considered a failed procedure when the study was designed. So, instead of revising the protocol to eliminate this large fault, and slow down time to market, the study just went ahead anyway with this inherent, known, bias.

WHAT’S YOUR GREATEST CONCERN ABOUT THE DISC?

My greatest fear in all this is that thousands of people will have horrible outcomes that will result in chronic severe pain that they didn’t have before and the only solution at the moment is a surgery that risks death or loss of the use of their legs to walk.

WHAT NEEDS TO BE DONE ABOUT THIS PROBLEM?

I believe the FDA should immediately recall the Charite disc and put it back into a redesigned study. That study should release all the patient complications and provide at least five years worth of data. What’s really going on here is that the FDA process needs to be refined, so this type of study does not provide the basis for an approval.

WHAT OTHER PROBLEMS ARE THERE BESIDES THE FDA PROCESS?

I believe one of the single most potentially damaging problems facing medicine today is the ability of big business to recruit doctor’s practices as “distributorships” for their products. Which translates into doctors being paid salesmen for big business.

For example, a distributorship may be owned by a number of doctors. It makes the implants such as screws or rods or whatever, that are implanted in their patients which is essentially selling them to the insurance co, or in some cases to the hospital directly. Since the distributorship buy or makes the items at a substantial discount, it becomes very profitable , particularly if that’s the only product line all the surgeons in the distributorship use. The effort to use the best equipment out there vs. the most profitable is no longer present. The patient rarely if ever knows about this either.

Or the arrangement can be for a “consulting” agreement. Here some symbolic work done by the doctor gives the company an excuse to pay him a lot of money. However, the real consideration received is that the doctor tacitly agrees to only use that co.’s implants which can be from $5,000 – $20,000 per case .

Or the doctor can own stock options or stock itself in the smaller companies that may even be start- ups, where success or failure will make a big difference in the stock’s value.

HOW DID YOU BECOME INVOLVED IN THIS CONTROVERSEY?

When the FDA first approved the Charite Disc, I was intrigued and wanted to find out more about it. I believe it’s the responsibility of the individual doctor to review case studies and FDA approvals before implementing a new procedure or device. After my review of the Charite disc, I became concerned and began asking some very difficult questions to the FDA and DePuy. The more questions I asked the more concerned I became.

DID YOU HAVE MANY PROBLEMS IN FINDING THE ANSWERS TO YOUR QUESTIONS ABOUT THE DISC?

I’ve had many problems finding simple answers to questions. The FDA demanded that I fill out a Freedom of Information Act for access to the complications data in the study. To date, after numerous letters and phone calls, I’ve only received partial information and certainly not what I would need to review the study

DID YOU CONTACT THE COMPANY AND ASK FOR INFORMATION?

I have had several phone conversations and few letters from the company. Neither produced the information that I needed. In fact, all I received in the end from DePuy was an invitation to attend one of their courses on how to implant the device and some very vague overviews on the complications, which of course were of no help.