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.

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

The AAOS Responds to 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.

The American Academy of Orthopedic Surgeons and the American Association of Orthopedic Surgeons (AAOS) have responded, first with a letter by President James H. Beaty MD. Dr Beaty's main points were:

• Disclosure is important, up to a point. "AAOS supports appropriate financial disclosures to patients regarding relationships between orthopedic surgeons and implant manufacturers."
• There are good aspects to relationships between doctors and device manufacturers. "Many of our AAOS colleagues choose to work in partnership with implant manufacturers to provide consulting advice, conduct research, and educate orthopaedic surgeons and the public. A number of AAOS members are engaged in developing new medical devices to better serve patient needs."
• It is not necessarily bad for physicians to receive money from commercial firms. "The appearance of a physician's name on any disclosure filing referenced above indicates only that he or she has received compensation from the implant manufacturer."
• More detailed disclosure might be good. "Financial disclosures that display only the name of the physician and the aggregate dollar amount received without any explanation of the nature of the relationship and without educational context may be confusing and misleading to the public and patients."
• In the future, AAOS members should better understand these issues. The letter alluded to a "webinair" on the subject to be conducted in November. It also alluded to a new patient discussion guide (found here). (I may discuss that guide further in another post.)

In my humble opinion, the letter was most remarkable for what it did not say.

Although it sought to justify why orthopedic surgeons should work with manufacturers, it did not explain why these relationships should include payments by the manufacturers to the physicians.

It did not discuss whether disclosures of these financial relationships were made in the time up to the release of the lists by the companies. It did not discuss disclosure to learners in the context of teaching, to readers of articles or attendees of talks, or to subjects in research trials. It did not criticize surgeons who had not disclosed prior to release of the lists.

Although the letter suggested that more detailed disclosure might be better than that which has taken place so far, it did not suggest that doctors who have received money should make such detailed disclosure, or criticize doctors who have not made such detailed disclosure in the past.

Finally, the letter did not advocate that doctors who receive payments from device manufacturers or other commercial firms actively disclose these payments going forward.

All in all, Dr Beaty's letter seemed to avoid more issues than it addressed. It was not exactly a ringing call for greater transparency, much less a condemnation of the opacity of past practices.

I could not help but notice that the letter was written on AAOS letterhead which listed current officers and board members. Ironically, several of these people appeared on the companies' payment disclosure lists. These include:

• Dr Joseph Zuckerman, Second Vice-President, who was listed as the "individual provider" for the Musculoskeletal Research Center, which received $1-25,000 from Smith & Nephew (see list here.)
• Dr William L Healy, Treasurer, received $25,001-$50,000 from DePuy (see here)
• Dr Richard F Kyle, Past President, received $25,001-50,000 from Smith & Nephew (here) and $715,163 from Zimmer (here)
• Dr Joseph C McCarthy, Chair, Board of Specialty Societies, received $475,000-500,000 from Stryker (here)
• Dr William Robb III, Secretary, Board of Specialty Societies, received $75,000-100,000 from Smith & Nephew (here)
• Dr Kevin J Bozic, Member at Large, received $2750 from Zimmer (here)
• Dr Christopher D Harner, who was listed as rendering services for the University of Pittsburgh Department of Orthopedic Surgery, which received $100,000-124,999 from Biomet (here)

As we have noted before, " people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult."

That is yet another argument for avoidance of the sorts of conflicts copiously disclosed in the lists of payments made by device manufacturers.

Post Title → The AAOS Responds to Disclosure of Payments to Orthopedic Surgeons