Merck & Co., Inc.
My Problem With Dr. Topel

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By emiller8988
December 6, 2004

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As a physician, I rely on people like Dr Topol for UNBIASED advice. In this instance, while his advice may have been good, there is no way for me to tell how "good" it is/was. I have to wonder if and how much his opinion was colored by his private activity.

I'd heard Dr Topol speak before and came away sure that he had some sort of personal agenda against MRK. I thought, and actually still do, it was simply that Dr Topol had noticed the CV effect early on, published about it and MRK/Vioxx had just become his bete noire. I've seen this over and over with academic MD's and sometimes they end up right, but usually they end up wrong.

Consider these three items about Vioxx.
1-The CV effect was noticed in a study to see if Vioxx was able to prevent or reduce the incidence of colon cancer... Lord help us if it does and we've now lost years on figuring that out
2-it appears that one little baby aspirin a day eliminates the CV problem with Vioxx.
3- if you line up 100K old people and give 1/2 Vioxx and 1/2 a regular arthritis medicine like Naproxyn... more people in the Naproxyn group die of side effects than in the Vioxx group. In other words, Vioxx is a safer medicine than other arthritis pills that remain available.
4- the CV effect of Vioxx was completely predictable and I always suggested people take a baby aspirin with the Vioxx... boom, problem solved.

Back in the mid 80's there was a Dr Burton Sobel who chaired the advisory committee to the FDA that considered the approval of Activase, the clot busting medicine that made Genentech. There was a great concern that Activase had an inordinately high risk of fatal brain hemorrhage associated with its use. I don't remember the exact numbers but as I recall, the committee voted 5-4 to require DNA to provide more data on Activase and recommended against approval. Dr Sobel disbanded the committee (his right as chairman) and 2-3 months later he re-formed the committee with new members. The committee immediately took up the Activase issue and, based on NO NEW INFORMATION, they recommended its approval. As the FDA basically always listens to it "experts".... it shortly approved the medicine... and the rest is history. There was, at the time, a second clot busting medicine available called Streptokinase. It seemed to work just as well...better?... and may well have been safer... to this day the jury is out. It also cost 1/10 of what Activase cost. Genentech was then able, to my astonishment, to convince Medicare/Health and Human Services to pay for Activase as a separate part of treatment for heart attacks.... this was a major deal and the first medicine to be reimbursed in such a fashion. It allowed Genentech to price Activase at a then astronomical $3000 a shot. Since then many other medicines have been given this status at massive cost to the US health care system. In fact, this reimbursement event was the opening of the floodgates for the medicines that cost thousands of dollars per treatment.... Activase was the first one... and it was a groundbreaking tidal change in reimbursement methods for Medicare and the government.

Want a blast from the past... just for fun...

read the third paragraph.... then realize this. At the time Dr Sobel disbanded the committee that voted against approval and reformed the advisory committee that approved Activase (with NO new information!).... he quietly held over 150K stock options in Genentech.

The rest is history. Was Dr Sobel unbiased? Which drug is safer, Activase or Streptokinase? Which drug is more effective? Was it necessary for Medicare to create a completely new reimbursement pattern for Activase when there was a drug available at 1/10 the cost?

We tend to view academic MD's as a cut above somehow... there are many reasons why a fellow chooses academic medicine... not all of them good and a few reasons are actually really bad. Many academic MD's simply could not make it in private practice because they're not really very good "bedside" doctors. They are subject to the same vices and vicissitudes anyone else is. They are, however, in a unique position to "turn the heads" of many, many prescribing MD's. More importantly, bureaucrats are most easily swayed by these fellows. Problem is there are always agendas and issues. We as a public just have to be able to trust that advice that comes from places like the New England Journal of Medicine is as close to "above reproach" as possible.

Over an over, through the years... I've seen situations where it turns out an academic MD had private issues that could be coloring his opinions. Sobel was the first one... for me. It was like finding out your minister is a pimp on Fridays.

So... Topol's stuff is just one more in a long, long line for me. I've learned to view the opinions from on high very a very, very jaundiced eye

That's the problem... as I see it

It may very well be that Vioxx needed to be taken off the market. All I now know is this... we sure can't rely on Dr Topol for an unbiased opinion on the safety of Vioxx. I hope Vioxx DOES NOT reduce the risk of colon cancer... such that Vioxx plus a baby aspirin significantly improves our life expectancy. Who knows


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