Surgery vs. Drugs

Levitt and Dubner discuss bariatric surgery in their most recent NYTimes column.  Writing on their blog (they or their publicist) say this:

Bariatric surgery is often the most effective treatment for the morbidly obese,
and with a mortality rate of around one percent, it isn’t terribly risky…

Not terribly risky!!!  I consider a 1% chance of death to be very risky, perhaps worthwhile for some morbidly obese people but when 1 in every 100 patients doesn’t make it off the table that is not good odds.

What I find most interesting, however, is that I don’t think that any drug, even one with net benefits, could pass FDA trials with a mortality risk of 1%.  Recall that Rezulin was pulled from the market when 63 out of 750,000 people developed liver problems (the actual number may have been higher of course but the numbers aren’t even close.)   

It doesn’t make sense to regulate one source of risk at much higher rates than another source, given equal benefits.  It’s quite possible, for example, that patients denied risky weight loss drugs turn to even riskier bariatric surgery.   (I am not arguing this point here, I am explaining why efficiency requires that equal risks be regulated equally).

So if it doesn’t make sense to regulate one source of risk at much higher rates than another source, should surgery be regulated more or drugs less? 


Triple exclamation marks? Wow, the gloves are obviously off in the battle of the pop econ bloggers.

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Very nice Alex. And, just to belabor the obvious, the answer is drugs should be regulated less.

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You point out an interesting conundrum - drugs and devices are carefully regulated by the FDA, while surgical procedures are not. Years ago, when I was a medical student, I spent some time with a general surgeon who was famous for his bariatric operations. He performed these procedures on patients who were massively obese - usually over 300 lb. The results were often dramatic - most of the patients lost lots of weight, diabetes, hypercholesterolemia and hypertension disappeared or were greatly improved, etc. Unfortunately, over the years, it became apparent that many of these patients developed liver disease or other complications that were sometimes fatal. Eventually the surgeon just stopped doing these procedures. Is this right? Who knows? If you want to bring a new drug or device to market, you have to spend millions of dollars doing trials and gathering data in an attempt to satisfy the FDA. Sometimes you spend the money and still can't get approval. If a surgeon wants to hook your esophagus up to your rectum to help you lose weight, the FDA could care less, but if the same surgeon wants to implant a device to do it, that's a different matter. OK?

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An exstudent of mine died after the third operation of this type ,in a year!!!.She was 22

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The morbidly obese are already in a much higher risk category than
the general population.

Having said that, I have major concerns about some of the surgeons
doing these procedures and the long run impacts even if the procedures are
done properly.

In legitimate hospitals and surgery centers safety concerns are paramount.
In centers where revenue generation is paramount, safety may be a secondary
concern. It is almost impossible for patients to know going in.

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We should pass a regulation that bans all regulations for adults (not just in medicine), leaving them only, if we must, for minors.

Adults are not children, and governments ought not to be implementing one size fits all policies that can't possibly be best for many, if not most, people.

The government would rather risk banning a drug that could save millions of lives if the cost is tens of thousands of lives killed via side effects. They do this because the 10,000+ would be agonizingly obvious for eveyone to see, while under a ban the 1,000,000+ would be next to impossible for everyone to see. This is so hideously immoral it is staggering that we allow our individual freedom (and lives)to be trampled upon in this matter.

Medicine is too important to allow government meddling.

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One reason to regulate drugs more tightly than surgery is that people have a very instinctive fear of being cut open that helps them to regulate themselves. The risks from drugs aren't as obvious. Not that 1% doesn't sound awfully high.

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I'm not an expert on these things, but it seems that surgeons have their own incentives to minimize risk to patients from a professional perspective. A risky surgery leading to complications/mortality would make the surgeon look bad compared to simply saying "too risky". Is there a similar set of incentives and precautions for prescribing drugs?

From the patient perspective, it is clear that being cut open can lead to death, but we may not truly understand that popping pills can not only fail to make us better, but it can outright kill us. First, do no harm and all that. I'm not saying this is rational, but having dealt with enough of the healthcare system on a personal level, pills aren't intuitively risky.

How would we change public perception of risk of drugs (as opposed to surgery)? What would the equilibrium be if people were as scared of drugs as they are of surgery?

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Another link:

During the first 30 days, about 1% of all of the bariatric patients had died. The highest post-op deaths were among those over age 55, with those over age 65 having more than a three-fold increased risk.

Thereafter, among the average age patients, annual death rates were about 1.31% for the women and 4.09% for the men. Confirming other studies, men, older people and blacks had higher mortality rates.

Looking at the cumulative deaths according to the time after surgery, they found that nearly 3% overall had died after the first year and 6.4% of the patients were dead by the end of the fourth year after their surgeries. They also looked at long-term risks, reporting:

We also estimated the long-term mortality for individuals who had undergone surgery many years ago. For the 1995 cohort who had at least 9 years of follow-up, 13.0% had died. From the 1996 cohort with 8 years of follow-up, 15.8% had died, and from the 1997 cohort with 7 years of follow-up, 10.5% had died. For the 1998-1999 cohorts with 5 to 6 years of follow-up, the total mortality was 7.0% to 2004.

Would people be better off taking steroids which often lead to weight in fat people? Does any reader know if taking steroids for weight loss is legal?

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It would be of interest to know what the comprable death rate was for Fen-Phen, the weightloss drug combo that was pulled by the FDA

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Would people be better off taking steroids which often lead to weight in fat people?

probably not. long term steroid use has many complications. among others, it compromises the immune system and can lead to life threatening infections.

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I think the regulation of drugs versus the regulation of surgery may look out of whack at first, but after I think about it, it does make sense. From my point of view, when a person has a medical issue like being morbidly obese, the first form of serious help they should get would be drugs. They shouldn’t just jump right into surgery.

Drugs are easier to get, are available in more places, and are taken pretty frequently I would think. Because of the access people have to drugs, the regulation for them should be higher. It’s not likely for a person to get super nervous or suffer from intense anxiety because they fear taking a pill. Generally, people aren’t afraid of medicine, so therefore it has to have tough regulation otherwise any pill that advertised itself as a miracle worker would be taken.

Surgery on the other hand is often feared, and can make people uneasy and scared. It’s almost as if people have a mental regulation when it comes to surgery. It’s not something they are going to jump into. They take every bit of it serous, or at least I like to think most people do. Also, like someone mentioned before, surgery is usually a last resort. For a morbidly obese person to have bariatric surgery they have most likely tried other forms of treatment without success which has brought them to surgery.

All types of medical treatment, be it drugs, surgery, etc, is a risk versus reward sort of thing. And while it may seem odd for the regulation of drugs to be much higher than the regulation of surgery, to me it’s an access issue. Drugs need to be regulated more because they are easier to get a hold of and more frequently taken. While surgery is harder process to go through and is regulated in additional ways like mentally and through surgeons who make the ultimate decision on whether to perform surgery on a person or not.

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I agree, this suggests a large inconsistency between the regulation of surgery and drugs.

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In this circumstance, I don't think that a 1% mortality rate is a big deal. For a person who is already morbidly obese, they would be dying a more slow and painful one than if they had not taken the surgery. Personally, if I were in that situation, I would see it as a 99% chance of living, a 1% chance of dying, but a 100% chance of suffering less no matter what happened. It boils down to a personal choice. Also, I don't think that drugs should be regulated any less than they are now, even if they have the same mortality rate as a surgery. Surgery has a certain exactness and knowledge behind it which helps it to be more accepted when there is a risk of fatality. To clarify my point, surgeons are working in a physical world with steps and procedures that makes it mostly black and white. Follow these steps, close these arteries, stop the bleeding, remove this, insert that; they are trained to know what to look for and how to approach it. On a base physical level, human bodies are not very different, which is what gives surgery it’s fairly black-and-white appearance. Everybody has a liver, if they do not, they need one. Drugs bring in a grey area, an air of uncertainty. Unlike surgery, where it is easier to tell what should be where, developing pills that are safe for a vast majority of people is a hard thing to accomplish. Also, even though a drug might be safe right now, there might be unforeseen consequences down the road that could endanger people's health. That is why drugs should always be regulated, heavily tested, and potentially restricted much more so than surgery.

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For those of you believing the conventional wisdom about the "many complications" of steroid use, I suggest you Google it and report the results.

Oh, what's that-no real long-term studies?

Speaking of long-term studies and bariatric surgury, you may want to Google that, too. The results amy surprise you.

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I am morbidly obese. Several months ago I started taking rimonabant. I don't know how much I weighed when I started because I was over 350 and off the scales. I presently weigh about 330. The FDA declined to approve Rimonobant several months ago (technically, their expert panel refused to endorse it) even though it had been approved by the European Econmic Union in 2006. I buy it from India over the internet. Years ago, I successfully took Redux until the FDA took it off the market.

I checked with my cardiologist to make sure rimobant was compatible with the heart medicine I take. His nurse was horrified. I had to explain to her that the FDA is not protecting me; they are trying to kill me. My cardiologist said, go for it!

Anyway, it seems to be working.

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Bah, the 1% number sounds like was rounded up. What are the odds that the odds were *exactly* 1%.

probably a measly 0.79% in reality...

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This like saying to a patient: what do you choose sir? steroids or surgery... That is the way things go... The people have the right to make a choice... and it is their to take... The FDA should only be careful for a drug not actually have secondary effects or to kill people...

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