Connections : Join the Conversation - The blog of Biomet CEO Jeffrey R. Binder

Balance and Imbalance

A few months back, Biomet received a call from John Fauber of the Milwaukee Journal-Sentinel. Mr. Fauber writes a regular feature that attempts to expose the supposed evils resulting from the collaboration of surgeons and medical technology companies.

Mr. Fauber posed several questions to Biomet relating to its temporomandibular joint (TMJ) replacement products. The TMJ allows the lower jaw to move. In the U.S. alone, it's estimated that ten million individuals suffer from TMJ disorders.¹ Of those, a very small percentage, who generally have no good treatment options available to them, receive a TMJ replacement device.

It was clear from the questions Mr. Fauber asked that he intended to spin a tale of negligence and corruption involving surgeons, manufacturers, and the U.S. Food and Drug Administration (the FDA). The theme of the story, which can be found here, is that the FDA allowed dangerous products on the market despite warning signs.

The facts are quite different. The FDA did what it does every day: weigh the available evidence and balance risk and benefit. Apparently Mr. Fauber believes the FDA's job is simply to eliminate risk, with no consideration of the risk of treatment denied.

Conflicted studies?

A second underlying current in this story-and in virtually all stories Fauber writes-is that doctors who are compensated for participating in clinical trials, or are paid royalties for designing the products they are studying, are predisposed to generating biased data, tainting the legitimacy of the clinical results.

As we have pointed out in earlier blogs, there is scant evidence that financial relationships with medical technology companies lead to systemic research bias.²

Compensating doctors for participating in clinical trials is appropriate, legal, common, and necessary. Medical device clinical trials require a significant amount of time and effort to complete, and the surgeons involved deserve to be compensated for their time. It's safe to say that doctors would be much better off financially if they spent more time seeing patients and less time conducting clinical research.

A more convincing argument can be made that royalties create a powerful financial incentive for investigators to do everything possible to achieve rapid clearance or approval of a product. However, the FDA reviews all possible conflicts, then weighs the available evidence to determine whether the benefits of product clearance/approval outweigh the risk. This is the appropriate way to evaluate evidence-by noting the potential financial conflicts, scrutinizing the data and science on its own merits, and determining whether the greater risk lies in the potential conflict, or in denying patients access to new technologies.

A pre-written article

Mr. Fauber asked us the following questions, which indicate how he intended to slant the story:

1. The clinical study that you submitted to the FDA to gain approval to market your TMJ product appears to have many patients who were lost to follow-up. Doesn't that bias the clinical results? The answer is that the FDA accepted the study data and approved the product. Since then, we have continually provided data to the FDA and now have follow-up data on 80% of patients enrolled in the study.³
2. It appears that there were a small number of patients in the clinical trial. Doesn't that bias the clinical results? The answer, again, is that the FDA accepted the data and approved the study. We now have data on nearly 300 patients.
3. Two doctors performed the vast majority of surgeries for the clinical study. Doesn't that bias the clinical results? The answer, as discussed below, is: not necessarily.
4. The two doctors mentioned above both have a financial conflict of interest because they receive remuneration from Biomet for the work with the TMJ product. Doesn't that bias the clinical results? The answer is that there is no evidence that compensating surgeons at fair market value for clinical trial work creates systemic bias.²
5. How much did the doctors get paid and for how long? We left it up to the doctors to provide this information to Mr. Fauber.

What he didn't ask, but should have if he was trying to write a story that was balanced and ultimately helpful to patients, was:

1. Can you describe how well your device works in patients? The answer is that they have performed very well; 99% of patients are satisfied with the procedure and would have it done again.³
2. What alternative treatment options are available to patients who receive TMJ implants? The answer is that patients who receive TMJ replacement have severe problems, and joint replacement surgery is the treatment of last resort. Think about not being able to work your jaw properly and suffering from constant pain as a result of damage to the joint. Many of these patients have no good options other than TMJ replacement surgery.
3. Among the many patients with good results from TMJ replacement surgery, how has the treatment improved their function and quality of life? As stated above, patient satisfaction is very high with Biomet's TMJ product. Surely an investigator of Mr. Fauber's tenacity could have found happy patients to interview, had he been interested. Happy patients, however, did not fit into his predetermined narrative.

We appreciated Mr. Fauber's providing Biomet with the opportunity to comment. In fact, he included some of our comments-in paragraph 92 of a 109-paragraph story-long after many readers would have moved on, having absorbed the many unsubstantiated insinuations earlier in the story.

It was clear from what Mr. Fauber asked-and didn't ask -that he had determined the story's content and tone before he contacted us.

Distortions and insinuations

Mr. Fauber's TMJ story creates real and justifiable sympathy for its protagonist, a woman who has suffered as a result of unsuccessful TMJ surgeries (none of which involved Biomet implants). The patient's story deserves to be told: anybody considering TMJ replacement surgery needs to understand the risks. But they also need to understand the benefits in order to make a rational decision on their treatment. At the very least, patients deserve an accurate and complete accounting of the facts, and here Mr. Fauber fails his readers.

Following are some of the most outrageous comments in Mr. Fauber's article:

• "...the [FDA] approved the [TMJ replacement] devices even after a disastrous series of failures and recalls during the 1980s."
  
  The devices from the 1980s Fauber refers to are long gone. In the 1980s, Biomet did not manufacture TMJ replacement products.
  
  Implants of today are very different than those of the 1980s, and biomaterials science has advanced significantly, as have the FDA requirements for granting approval for TMJ devices.⁴ To suggest that the FDA should not approve any TMJ devices based on what happened more than 20 years ago is analogous to suggesting that automobiles should be banned because Ford Pintos occasionally caught fire in the 1970s.
   
• The Journal Sentinel's review…found that the FDA ignored warnings, patient testimony and its own staff recommendations to side with device companies whose research was conducted by doctors with a financial stake in the outcome.
  
  In making this statement Fauber incorrectly generalizes from four separate reviews of four different implants. In fact, the FDA staff and management differed on two of the four device approvals-not all four. And the FDA did not ignore warnings or patient testimony. As stated in the Government Accountability Office (GAO) report on the FDA's review of TMJ devices:
  
  
  The FDA management acknowledged that the concerns raised about the implants were legitimate. However, they ultimately concluded that the benefits provided by these two devices outweighed the concerns and approved both devices to help patients obtain relief from chronic pain.⁴
  
  Far from ignoring the concerns, the FDA weighed the evidence and "sided" with suffering patients.
  
  Biomet's device was one of the two devices approved with no difference of opinion among the FDA staff and management.
  
  Mr. Fauber apparently thinks that doctors who are compensated for participating in a study qualifies as "having a financial stake in the outcome." In Biomet's case, during the FDA's review of our submission, none of the investigators who conducted the research had a "financial stake" in terms of royalty payments tied to product sales. The physicians involved did get paid for consulting on product design and surgeon education. They were also compensated for participating in the clinical trial, which, as stated before, is appropriate. To Fauber's credit, he does clarify his statement...but not until paragraph 81 of his story.
   
• "There are a few instances in which the benefits outweigh the risks-such as patients with cancer, trauma or severe rheumatoid arthritis in the joint...but those cases make up less than 2% of the implants installed.

The impression left is that, for 98% of patients, the risks outweigh the benefits. Clearly, the FDA disagrees with Mr. Fauber's statement.

In Biomet's case, 196 of the patients in the FDA IDE study completed a patient satisfaction questionnaire at three years postoperation, and 195 patients (99.5%) indicated that they would have the surgery again.³

Since receiving approval of its TMJ device in 2005, 846 Biomet joint constructs have been implanted in the United States. The revision rate reported to Biomet at five years is less than 3%.³

• "When 96% of the surgeries in a clinical trial are done by two doctors, the success of the device can be overstated because it does not reflect real-world results that less experienced surgeons are likely to have...
  
  This comment refers to Biomet's clinical trial, which included a large majority of procedures performed by one surgeon. In this case, Fauber has a point: a high concentration of patients treated by a small number of high-volume surgeons may indeed skew results when compared to those from a broader group of surgeons. But it's hardly certain that the results diverge from what actually happens in the real world. In the real world, a small number of doctors perform most of the surgeries.
  
  In 2002, the FDA advisory panel discussed this very issue extensively and voted unanimously for approval. As a condition of approval, the FDA required that Biomet conduct training for surgeons prior to their use of the product, and to continually monitor our clinical results. We have done both judiciously, and have achieved very good clinical results.

Conclusion: Editorializing disguised as journalism

Mr. Fauber's work is consistently biased against industry-surgeon collaboration, and his latest story on TMJ replacement surgery is no exception. Not surprisingly, his colleagues applaud his work.

Gary Schwitzer, whom we discussed in an earlier blog, has referred to Mr. Fauber's earlier articles as "terrific work." Mr. Schwitzer, the self-styled watchdog of integrity in healthcare journalism, wrote the Statement of Principles for the Association of Health Care Journalists.^5,6 Among the principles:

1. Show respect. Illness, disability and other health challenges facing individuals must not be exploited merely for dramatic effect.
2. Report the complete risks and benefits of any treatment, along with the possible outcomes of alternative approaches, including the choices of "watchful" waiting.
3. Clearly identify and explain the meaning of results that indicate an association, rather than a causal link, between factors in a study.
4. Clearly define and communicate areas of doubt and uncertainty.

As demonstrated above, Mr. Fauber violated Mr. Schwitzer's principles. Despite our disagreements with Mr. Schwitzer on many issues, his code includes sound principles that journalists should follow with greater diligence.