Abusing trust, hurting patients, collecting big bucks

Tooth for a tooth

How does Dr. Kenneth Shay live with himself? How does he sleep at night? How does he even dare leave the house?

I really would like to hear what Dr. Shay could possibly have to say in his defense. This is a man who went way over the ethical line and put the neurological health of potentially THOUSANDS of people in jeopardy for a payday.

Even Bernie Madoff would tell you…that’s plain evil.

But let me back up…

Putting in the Fix

You’ve probably heard of “peer review.” Before a major study is published, it’s reviewed by impartial experts in the field. This supposedly ensures that the study design is sound, results are accurate, conclusions are logical, etc.

So the stamp of peer review is a stamp of authenticity. It’s a measure of TRUST.

This is where Dr. Shay comes in. He’s a dentist and an Adjunct Associate Professor at the University of Michigan School of Dentistry–obviously an expert.

Dr. Shay was asked to conduct a peer review of a study I told you about two years ago. Researchers examined four subjects with neurological abnormalities. Each subject used large amounts of denture cream (such as Fixodent and Poligrip) that contained zinc, and each turned out to have very high blood levels of zinc.

When zinc levels are too high, copper levels drop, and the risk of neurological problems increases sharply.

The study was finished in 2006, but wasn’t published until 2009. Why? Well, the authors told ABC News that Dr. Shay’s peer review delayed publication.

Among other things, Dr. Shay claimed the link between neurological symptoms and denture cream use was “little more than speculation.” The authors even admit that Dr. Shay’s recommendations caused them to “water down” the findings.

Then, earlier this month, the first shoe dropped…

ABC reported that Dr. Shay never disclosed that he was a paid consultant for Proctor & Gamble (the maker of Fixodent) at the time of the peer review–an OUTRAGEOUS ethical offense.

And the second shoe…

Dr. Shay sent drafts of the study to P&G–another huge ethical blunder, which he himself acknowledged in an e-mail at the time: “Please be circumspect because, as a reviewer, I’m not supposed to be passing an unpublished manuscript around.”

The worst part of this sorry mess is the delay of publication. Who can say how many denture-wearers experienced further harm while the study was stalled in peer review?

Since publication of the study, Fixodent labels now carry warnings about potential zinc overload from excessive use. The makers of Poligrip went one better and removed zinc from their products last spring.

But all of that is too little too late for Anne Coffman.

The ABC report featured Ms. Coffman, a 48-year-old Maine woman who is one of 35 million Americans who wear dentures. After three years of Fixodent use, she began to feel numbness in her toes. The numbness gradually spread to her feet, and then her legs. Today, Ms. Coffman is wheelchair-bound and so weak she finds it difficult to feed herself.

Dr. Shay’s ethical lapses may have burdened hundreds and maybe thousands of people like Anne Coffman–many with handicaps they’ll live with the rest of their lives.

The final irony: Dr. Shay specializes in geriatric dentistry. He betrayed the very people who trusted him the most.

It’s hard to get much lower than that.

“Fixodent: Can Excessive Use of Popular Denture Cream Cause Nerve Damage?” ABC News, 2/8/11, abcnews.go.com
“Denture Cream–An Unusual Source of Excess Zinc, Leading to Hypocupremia and Neurologic Disease” Neurology, Published online ahead of print 6/4/09, neurology.org

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