TECHNOLOGY: And you thought drugs got on the market too quickly and easily?

I’ll be at the HIT West conference later today hopefully with a little live blogging if things go well.  But meanwhile two articles over the weekend persuaded me that plus ca change plus c’est la meme chose in the wacky world of American health care.

15 years ago I wrote a thesis on the spread of laproscopic cholestectomy (gall bladder removal), which replaced both the conventional surgical method and a sound wave machines called a lithotripter to blast the gallstone. Lithotripsy didn’t actually work in that the gallstones tended to reform later.  Lap choles did work, and were self-evidently better than laparoptomy (surgical dissection and removal).  But in the case of a new surgical technique or procedure, there is no clinical trial required before it hits the market. Lap chole was popularized by a Tennessee surgeon called Eddie Jo Rickett.  In his heyday in the late 1980s, he was teaching other surgeons how to do it 50 week for a couple of grand a time.  He made so much money that (if I recall rightly) he quit surgery and became a country and western singer. Of course everyone had converted over to lap choles without any big clinical trial, just as lots of hospitals had bought million dollar lithotripters who’s main use a couple of years later was as a doorstop. Meanwhile the quick spread of lap choles also produced some real horror stories.

A decade further on not much has changed.  Today’s trendiest surgery is bariatric bypass (or stomach shrinking).  You might think this is pretty rare but there were over 150,000 done last year in the US including weather man Al Roker. However, just like lap choles and anything else that’s spreading fast, there’s not really any good trial data that shows it’s an effective treatment in the real world.  This fascinating and long article in the St Louis Post-Dispatch shows that like lap-chole and laser eye surgery, bariatric surgery has become a cash cow for some hospitals, and a stampede of surgeons learning the technique has massively increased its use.  Of course the backlash is starting and patients including former proponents of the surgery are starting to come forward with a litany of complaints, and many professionals and facilities are either getting out of the business or are starting to offer repairs on the shoddy work that’s being done. The article starts with this grim story:

She dropped from 302 pounds to 126 after her gastric bypass surgery in 2001. Since then, she’s become a strong advocate for other patients,
providing encouragement and advice to hundreds who have had weight-loss
operations. She arranges visits to the hospital rooms of people just
undergoing the surgery. From her home in Cincinnati, she runs a support
group called "Midwest Losers." Her work was honored with an award last
October at a national surgery trade show. But she’s paid a price to be thin: Five surgeries in four years for
related problems, including two hernias and three small bowel
obstructions. She was just diagnosed with a crippling vitamin
deficiency.She’s 41 now. She wonders how much more her body can take. "I’m second-guessing everything right now," Pierce said recently. "Is this what I have to look forward to the rest of my life?"

The point is of course that these surgeries spread in an uncontrolled fashion.  While there’s been plenty of criticism of the FDA, there just is no equivalent body demanding a clinical trial of surgical procedures, and any government agency that even dares to suggest such a thing needs to be wary of the fate of the AHCPR which fell foul of some Texas back surgeons in the mid 1990s and damn nearly was killed off by the surgeons’ friends in the newly Republican Congress.

The only time that surgery tends to get a clinical trial is if Medicare does one (which is rare) or if it involves a medical device regulated by the FDA. That’s just happened in the case of the drug eluting stents (DES).  A new study shows that the DES (Taxus from Boston Scientific and Cypher from J&J’s Cordis unit) both are much more effective than bare metal stents. (Incidentally both stents worked equally well and a new one from Medtronic coming on the market next year did just as well too. In any other industry you might expect a price war, but here don’t hold your breath)!
So at least there’s some good news that the trial proves these things are helpful.  But let’s consider two things.

1)  Virtually anyone who needed a stent was already getting a DES. Even despite the manufacturing problems both major stents have had and an entire recall of the Taxus stent last year, their use has been growing like crazy and they are the dominant treatment of choice for early stage heart blockages.  All this happened well before any clinical trial results came out. So what was the point of the trial? I guess it was like phase IV post market surveillance in the drug world.  But if the results had been bad, would it really have stopped Taxus and Cypher in their tracks? I doubt it.  Why? See reason number two.

2) Because the trial is comparing DES to a treatment that is known to be pretty useless.  The Bare Metal Stents have a high degree of re-occlusion. In other words the arteries they are placed in clog up again anyway. In late 2003 a Stanford study showed that that stents were less cost-effective than traditional by-passes. So the real challenge for the DES is to prove that over time they are more cost-effective than CABGs.  Do you expect to see that clinical trial any time soon? Nope, neither do I.

So 15 years on from the lap chole and lithotripsy story, we still don’t have anything like the clinical controls over new types of surgery that the FDA imposes over drugs.  And you may have noticed that some grumpy people have been complaining that the clinical trial and surveillance system for drugs is too lax!


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4 replies »

  1. The US has a fee based system, money is the name of the game and patients are liabilities. Everyone one wants to jump on the latest trend especially if it’s a money maker. I am so disgusted when I assist in surgery and the surgeon complains he is not being paid enough. America wake up & smell the coffee. Personally when it’s my time to go I’m going, don’t extend my life, don’t touch me find another patient to gas your cigarette boat doc because I’m no masochist. I had had respect for the medical profession prior to becoming a part of it, now i am looking for a way out (other means of support)I am totally disgusted and if the general public knew what was actually occuring in the Operating rooms with the so-called professionals their would be outrage. Yes there are good people in medicine its is just unfortunate that their efforts are often thwarted by those who are less good willed in their intentions

  2. “My point is that the DES spread fast without any final data suggesting that they were better than the bare metal ones.”
    … only lots and lots of promotion and a clear means to additional revenue for those using them…

  3. Quiet Storm may well be right. My point is that the DES spread fast without any final data suggesting that they were better than the bare metal ones.

  4. I think you ( along with the Ny Times and alot of cardiologists) are jumping the gun with these drug-eluting stents (DES). The DES have lower rates of restenosis but what really matters are clinical endpoints, i.e. heart attacks, strokes or deaths. A recent metaanalysis in the Lancet (obviously prior to the conference from which NY Times is reporting) showed no benefit of DES over bare stents with respect to these functional criteria. Because restenotic lesions are at low risk of plaque rupture ( heart attack) alot of this supposed benefit is of little value to patients.