Thursday, November 15, 2007

The AAOS "Patient Discussion Guide" Regarding Disclosure of Payments to Orthopedic Surgeons

We have previously posted ( here, here, and here) about the payments, often huge, that five manufacturers of prosthetic joints ((Biomet, DePuy Orthopaedics (a unit of Johnson & Johnson), Stryker Orthopedics,a unit of Stryker Inc, Zimmer Holdings, and Smith & Nephew) just revealed they made to orthopedic surgeons and various academic and other organizations. The lists are here: Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer.

We analyzed a letter by President James H. Beaty MD of the American Academy of Orthopedic Surgeons and the American Association of Orthopedic Surgeons (AAOS), and suggested that it was more remarkable for what it did not say than what it did say. We noted that the presence among the leadership of AAOS of many individuals who had received payments, some large, from artificial joint manufacturers may have lead to its lack of clarity.

The AAOS also produced a "Patient Discussion Guide" which was "intended to provide you [orthopedic surgeons] with important facts and information to facilitate discussions with your patients, and to help you answer any questions that you may receive from your patients concerning a settlement announced by the Department of Justice with five medical device manufacturers of artificial hips and knees."

In my humble opinion, the guide, designed in an "FAQ" format, was equally unclear, but did seem to try to minimize the effects of disclosures of payments made to physicians. Let me go through it, question by question.

First, it posed the question, "why is this financial information posted on the websites of these five companies." After giving some dry facts about the settlement, this appeared in bold type,

It’s important to remember that the appearance of a physician’s name on any disclosure filing referenced above indicates only that he or she has received compensation from the manufacturer. It is not an indication that any doctor on the list has broken the law or violated professional standards.

It then asked, "why would a doctor ever take money from implant manufacturers?" The answer included,

The relationships between physicians and device manufacturers have led to many significant developments that have benefited millions of patients.

This was followed by a listing of some examples of such "significant developments." The answer did not contemplate the possibility that there could be a down-side to an orthopedic surgeon being paid by the manufacturer of artificial joints.

Then, "what different kinds of financial relationships do doctors have with implant manufacturers?" The answer in full was,

First, it’s important to understand that not all physicians have financial relationships with implant manufacturers. In fact, we believe that a majority of orthopaedic surgeons do not.

For those doctors who have relationships with implant manufacturers, there are a number of different types of relationships with implant manufacturers that result in compensation, including providing consulting advice, conducting research, developing new products and educating fellow orthopaedic surgeons and the public.

These arrangements have led to a number of important breakthroughs and developments that have helped millions of patients.

Again, the guide included more words about the limited prevalence of the payments and their possible good effects than about the question itself.

The next question was "If these relationships are commonplace, what did these implant manufacturers do that was wrong and that led to the settlements?" The guide noted,

The U.S. Attorney that led the investigation was concerned that some of the payments made by the implant manufacturers to a limited number of physicians were improper.

However, it never really answered the question, and certainly did not suggest that anyone or any organization, manufacturers, orthopedic surgeons, or others, did anything wrong.

The guide did assert that the AAOS just adopted, that is, in 2007, new "Standards of Professionalism on Orthopaedist-Industry Conflicts of Interest that require orthopaedic surgeon members to identify and disclose potential conflicts of interest to their patients, the public, and colleagues." However, it neglected to note that these standards are not yet in effect.

Finally, the guide got to the crucial question, "have you personally taken money from implant manufacturers," but then refused to answer it directly,

Recognizing that the facts, circumstances and contractual provisions governing the relationships between certain member-physicians and medical device manufacturers, are unique and confidential, the AAOS cannot provide members with individualized counsel on how to respond....

It then just advised doctors "to be truthful and factually accurate," and cite the need, according to the new Standards of Professionalism, to disclose conflicts.

So, to be charitable, the Guide, like the letter written by the President of the AAOS, was more notable for what it did not say than what it did say. In particular, it failed to say anything negative about artificial hip manufacturing companies paying orthopedic surgeons, but did defend "relationships" among doctors and these corporations, while trying to minimize their prevalence. The Guide avoided any discussion of how financial relationships among orthopedic surgeons and device manufacturers could have any negative effect on patients. The Guide failed to discuss any effects these relationships could have on orthopedic surgeons' teaching, research, or health care policy.

As we noted before, some of this lack of clarity might have to do with the relationships between individual leaders of the AAOS and the artificial joint manufacturers.

After an opportunity to further peruse the lists of payments made by the five manufacturers, (Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer), I found that the AAOS itself has been paid quite handsomely itself (so far in 2007) by:
  • DePuy, $225,000-250,000
  • Smith & Nephew, $25,001 - 50,000
  • Stryker, $150,000 - 175,000
  • Zimmer, $434,480

Thus, the AAOS received from $834,481 to $909,480 from four artificial joint manufacturers so far in 2007.

Also, note that the related American Orthopedic Association received payments by:

  • Biomet, $25,000-49,999
  • DePuy, $50,000-75,000
  • Zimmer, $200,000

Furthermore, the related Orthopedic Research and Education Foundation received payments by:

  • DePuy, $375,000-400,000
  • Stryker, $25,000-50,000
  • Smith & Nephew, $75,001 - $100,000

So it is not surprising that the AAOS collective response to the release of the lists of payments lacked clarity and failed to address most of the major issues. Not only are some of the top leaders of the organization recipients of payments from the same companies whose disclosures created the controversy in the first place, but also the organization, and some related organizations, get substantial funding from these same companies.

This illustrates the pervasiveness of conflicts of interest affecting medical organizations and their leadership. The fear is that such organizations, rather than being a bulwark of physicians' professionalism, have become just more cogs in the medical - academic - industrial complex.


Anonymous said...

Is it possible to get full disclosure for previous years? Am particularly interested in Stryker.


Anonymous said...

How can I find out how much compensation the companies are paying the patients for knee replacement failures?