Advanced Therapies For The Diabetic Foot: Are We Getting Our Money’s Worth?

In a recent issue of Diabetes Care, Kahn and Anderson examine the issue of diabetes care as a model for healthcare reform.1 The authors point out that the prevention of diabetes and the prevention of complications associated with diabetes are seldom cost-saving. This is contrary to many arguments that suggest preventive care is ultimately cost-effective and reduces expenses associated with the management of diabetes.

While no one would argue that the prevention of diabetic foot complications is certainly “cost effective” with regard to human suffering, such as the prevention of amputation in a patient with diabetes, the question of financial realities surrounding the prevention of amputation is a different matter altogether.

In regard to the issue of comparative effectiveness of various interventions, I would like to specifically address an analysis of technology associated with the evaluation and management of diabetic foot pathology.

Podiatric CME meetings are heavily dependent upon corporate sponsorship. It is not a coincidence that corporations listed as platinum, gold or silver sponsors at these meetings provide speakers who endorse various products, many of which are quite expensive.

In some instances, entire programs appear to be industry supported and the lecture content of these programs seem to be substantially or entirely controlled by corporate sponsorship. As a result, various products are promoted and endorsed, and they come to be accepted by those in attendance as the “standard of care.”

As noted by Kahn and Anderson, some technology “has gained widespread adoption without much evidence that it is cost-effective for all persons with diabetes.” I would like to explore this concept with readers this month.

Raising Questions About The Cost And Long-Term Benefits Of Advanced Modalities

Examples of technology, which have been accepted, would include the use of bioengineered products for ulcer management or the utilization of external fixation for reconstruction of Charcot's joint disease. We frequently do not hear much regarding alternative methods of treatment for ulcers because there is no corporate sponsorship for non-weightbearing and casting in the management of Charcot's joint disease. Instead, corporations are more than happy to provide speakers to endorse the utilization of large external fixation, orthobiologic materials, bone stimulators and other technologies that physicians can employ for the treatment of Charcot's joint disease.

The question, however, is whether such technologies provide any clear advantage to the treatment of these problems over alternative methods that do not involve the application of expensive advanced technologies. Traditional management may take longer to achieve a result but is the expedited effect of advanced technology worth the cost?

Many of us who treat patients with significant pathology, such as Charcot's joint disease, have patients who have refused surgical intervention. I would argue that the outcome in such patients has been essentially no different than those who have undergone surgical intervention.

Granted, surgical intervention offers the opportunity to reconstruct anatomy and provide the patient with a more normal looking foot than the patient who declines surgical intervention. However, it is also true that surgical intervention in the patient with Charcot's joint disease is associated with a variety of possible surgical complications. This is not to suggest that advanced technology is not useful in the management of Charcot's joint disease. However, there are no clear studies that indicate a distinct long-term advantage to the treatment of Charcot's joint disease with a variety of expensive technologies in comparison to more traditional, minimally invasive, limited surgical or non-operative treatment of the same problem.

The examination of advanced technology in the treatment of the diabetic foot must also include bioengineered products. All of these products are quite expensive and, in my opinion, are frequently utilized at the urging of corporate representatives rather than patient need.

Somehow, over the years, I had been able to heal the majority of patients with diabetic wounds in my practice without the need for hyperbaric oxygen or advanced wound care products. However, the corporations producing such products as growth factors and various skin equivalents dominate the educational sessions at meetings where wound care is discussed. As is the case with Charcot's joint disease, the alternative viewpoint is not discussed because there is simply no potential profit to any corporation in discussing more traditional approaches to wound care.

Somehow, I have had great success in the healing of venous ulcerations by utilizing in-office debridement, appropriate topical agents and old-time Unna’s boots. Of course, I will utilize advanced wound technologies when necessary. However, I do not believe that the majority of patients that I have cared for required such technologies.

My complaint is we have started to utilize expensive technologies without any firm basis of significant long-term benefit that would justify the cost. I would not argue that the use of certain bioengineered products might expedite the resolution of ulcer but at what cost? I would not argue that the utilization of external fixation might speed the resolution of a Charcot's joint deformity or provide a more normal anatomical presentation of the foot following such surgical intervention but at what cost? Where is the long-term data to suggest that these patients are ultimately better served than those patients who were provided more traditional conservative management?

Are We Getting The Education We Need At These Conferences?

We are now facing healthcare reform. The frequency of diabetes is increasing dramatically in United States and throughout the world. Podiatrists are increasingly providing preventative as well as interventional care for patients who have been diagnosed with diabetes.

The late James Ganley, DPM, once referred to the “technological imperative,” examining the proposition that newer is always better.

Given the strong dependence upon corporate sponsorship, the content of many of these meetings is severely limited and provides the practitioner with only those educational objectives that can be encompassed within corporate sponsorship. When a speaker receives support from a corporation, he or she may be ostensibly “neutral, fair and objective.” However, he or she is not likely to continue as a speaker for a corporation unless a certain message is delivered to those attending that meeting.

The next time you receive a brochure for a “scientific program,” look at the contents and correlate this with the listed corporate sponsors. You then begin to understand why certain advanced technologies have become accepted without any firm evidence of long-term benefit.

Are Unrestricted Educational Grants Truly ‘Unrestricted’?

I am not certain how to change our current corporate influence on CME provision. I constantly hear the argument that without such sponsorship, it would be financially difficult to provide CME programs. However, with such sponsorship, post-graduate education in our profession has become limited to just a few topics such as wound care, bone growth stimulators, external fixation, fixation devices and various pharmaceuticals.

At times, many of these CME programs remind me of the movie Groundhog Day, as it seems we are seeing the same topics over and over and over. There are exceptions such as the annual scientific meeting of the American College Of Foot and Ankle Surgeons (ACFAS). To their credit, the ACFAS provides a lecture program with little corporate sponsorship.

The solution is to make an unrestricted educational grant truly unrestricted. Somehow, when I look at programs “provided by an unrestricted educational grant from … ,” it appears to me the content of these programs is anything but “unrestricted.”

Perhaps we can eventually have forthright discussions regarding the proper place for advanced technology in the treatment of the diabetic foot and determine the true need for, and effectiveness of, such technologies. Until this happens, you will see the same speakers giving the same lectures and discussions of the same limited topics.

I welcome responses to this commentary.

Reference
1. Kahn R, Anderson JE. Improving diabetes care: the model for health care reform. Diabetes Care 2009 Jun;32(6):1115-8.



Anonymoussays: June 24, 2009 at 8:46 pm

Allen,

Dear friend I applaud you, as I always have, for saying what needs to be said without fear of the consequences. You are perhaps THE ONLY PERSON IN PODIATRY who does so!

That said, I would offer this additional information and ask for some information from you:

Some universities around the country currently have created a blind fund into which these unrestricted grants go. They are then doled out to requesting groups. That is one solution but I do worry about where podiatry might fit on the scale.

In 2003 Margolis did a study* predicting whether or not expensive, advanced therapies should be used to treat diabetic neurpathic foot ulcers or if standard of care would do the job. He computed the probability of complete healing based on the percentage of healing at week four. This number was the marker he used to justify bringing out the big guns. I believe it is as valid a marker as there is today.

Lastly, my question. You mention that ACFAS provides a lecture program with little corporate sponsorship. What is their secret? How do they exist without corporate support? I thought their exhibit hall was flush with supporters and last time I saw my many friends who were lecturing there, their names were followed by "supported by XYZ corporation." So I don't fully understand your statement. Please explain.

Kathy Satterfield, DPM

*Margolis DJ, et. Diabetic neuropathic foot ulcers: predicting which ones will not heal. Am J Med. 2003 Dec 1;115(8):627-31.

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Anonymoussays: July 9, 2009 at 6:38 pm

With all due respect my learned friend, you correctly recognize the problem with Continuing Medical Education but you apparently don’t understand it.

The problem is that money is the heroin of the CME industry and that industry, and its participants, are addicted in a really big way. And unless and until the industry decides to go “cold turkey” and take money out of the speaker equation, the problem will get worse and not better.

Let me explain.

The sad truth is that professional organizations are businesses. The bigger the organization, the bigger the business. All of them give lip service to the notion that they are non-profit eleemosynary institutions but the truth is that they all have to bring in more money than they spend each year or they go out of existence.

All of these organizations generate their income, in theory, by charging “dues.” In theory, each of the member’s dues pays his or her fair share of the group’s overall operating expenses so that all may benefit from the advantages which membership in the group provides. That’s great in theory but in practice it simply doesn’t work any more. There isn’t a professional organization in the world which can operate and pay its bills using only dues revenues. The name of the game in the association “biz” these days is “non-dues income.” You have to have it because you simply can’t charge your members high enough dues to pay all of your bills.

That’s where CME comes in. Every health care practitioner has to have a certain number of continuing education credits each year or they cease being health care practitioners. Most of them buy those credits from someone and the professional associations long ago recognized that CME was a cash cow waiting to be milked. In fact, every professional organization figured that out and the competition for CME dollars has become fierce. To attract the audience and its CME bucks in this market you have to put on a better CME show than your competitors. Putting on a CME show with enough “sex appeal” to attract a profitable audience means big stars and hot topics and all of that costs money.

The “hot topics” part is, admittedly, mostly a function of human nature. To use your examples, $10,000 worth of gleaming antiseptic stainless steel (ex-fix) is a lot sexier than $1.50 worth of gauze and zinc oxide (Unna’s boot). But you can even sell a lecture on Unna boots if you have Angelina Jolie or Brad Pitt deliver it.

So how do you attract the “big stars?” In today’s market you pay them a big honorarium. And that’s a big factor in the addiction to the heroin of money in the CME business.

The money to cover the expenses of the speakers can drastically reduce the income from the program to the sponsoring organization. Reduce it so far, in fact, that the particular CME presentation in question might, God forbid, not make a profit. Since we obviously cannot allow that to happen, someone came up with the bright idea of sponsored speakers. And the problem with sponsored speakers, as you so brilliantly demonstrate, is that they are almost always there to sell something on behalf of their sponsors. That, after all, is what sponsors do.

The problem you folks are having with the CME business is very much like the problem the government is having with the heroin industry. And you are failing in your efforts to eliminate the problem for the same reason that the government can’t eliminate the drug traffic: You’re attacking from the wrong direction. Instead of trying to eliminate the supply of the money/drug why don’t you eliminate the demand?

I would suggest that the problem could be solved rather simply. The effect would be extreme, at first, but the CME industry would survive and be the better in the long run.

How would I do it? I would require the medical profession to pass a rule making it unlawful for a speaker at a CME program to accept an honorarium for his or her presentation. The speakers could be reimbursed for their expenses, at a fairly Spartan level, but they couldn’t be directly enriched for their efforts. Further, the new rule would require all of the reimbursement for expenses to come from the attendance charges for the presentation and not from corporate sponsors.

That would end the “sponsored speaker” game “cold turkey.”

For what it’s worth that’s what happens, for the most part, in the continuing LEGAL education industry. Few CLE speakers ever receive honoraria and most even pay their own expenses. The CLE programs continue to be excellent. The Bar Associations and other groups who put on the CLE programs continue to make obscene profits from the programs. Better still, lectures tend to be stuff that the average practitioner can actually take home and use without bankrupting himself, the client and the economy as a whole.

I think it might work for the continuing MEDICAL education industry as well.

Richard W. Boone, Sr.
Health Care Attorney

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