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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?
Posted by Alex Tabarrok on November 19, 2007 at 07:27 AM in Medicine | Permalink
Comments
Triple exclamation marks? Wow, the gloves are obviously off in the battle of the pop econ bloggers.
Posted by: chris at Nov 19, 2007 7:44:05 AM
"Writing on their blog (they or their publicist) say this:"
Their publicist??? I don't understand this remark.
Posted by: Chris Masse at Nov 19, 2007 8:02:47 AM
Very nice Alex. And, just to belabor the obvious, the answer is drugs should be regulated less.
Posted by: angus at Nov 19, 2007 8:30:24 AM
"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."
It's the wrong measure of risk. The real question is: How many of these patients are alive 1, 5 or 10 years from now and how many survivors are there among those who took the drugs and how many survivors are in the control group, that got no treatment whatsoever?
Even if that turns out against surgery, you have to look at the quality of life for the patients.
Every form of surgery bears a risk of death. Always. It is up to the patient to decide, with guidance from his physician, whether that risk is worth the potential reward.
Oh and drugs should be regulated less.
Cheers!
Chris
Posted by: Chris at Nov 19, 2007 8:42:54 AM
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?
Posted by: Ned at Nov 19, 2007 8:52:54 AM
I think the 1% mortality rate is an average. The younger patients have a nearly zero mortality rate, and the older patients have a much higher rate. By younger, I refer to the 20-30 year olds who have the surgery (there are more than you might think), and by older, I refer to the 50-60 year olds.
Posted by: Craig at Nov 19, 2007 8:52:56 AM
An exstudent of mine died after the third operation of this type ,in a year!!!.She was 22
Posted by: juancarlos at Nov 19, 2007 9:10:26 AM
> It is up to the patient to decide, with guidance from his physician, whether that risk is worth the potential reward.
Indeed...And this same standard should be applied to drugs.
Posted by: Christopher Monnier at Nov 19, 2007 9:51:17 AM
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.
Posted by: save_the_rustbelt at Nov 19, 2007 9:54:21 AM
Alex is deploying the same kind of insight he did in his classic Independent Review article on on- versus off-label. See:
http://www.independent.org/pdf/tir/tir_05_1_tabarrok.pdf
Posted by: Daniel Klein at Nov 19, 2007 9:56:11 AM
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.
Posted by: happyjuggler0 at Nov 19, 2007 11:41:10 AM
If you can ban surgeries for riskiness, why can't you ban the morbidly obese from owning cars (or hiring taxis, etc)? That would make the lose the weight right quick. I don't understand the presumption against freedoms that involve chemicals, but not ones that involve machines.
Posted by: yoyo at Nov 19, 2007 12:40:50 PM
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.
Posted by: Jim Lamb at Nov 19, 2007 2:58:55 PM
How about the argument that it's difficult to tell how much drugs are actually regulated because the pharmaceutical lobby is so powerful? It might be that for every Rezulin there are a bunch more other things that are worse.
It might also be that the effects of surgery are better known and predictable, whereas many of the side effects of drugs are difficult to monitor.
i'm not saying we're at the optimum, but rather that if we were, what would be the explanation for it?
Posted by: Adam Bee at Nov 19, 2007 3:12:26 PM
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?
Posted by: Allan Friedman at Nov 19, 2007 3:41:48 PM
This is a stunning statement:
with a mortality rate of around one percent, it isn’t terribly risky...”
are they kidding?
And it is worse that according to this study.
Results There were 440 deaths after 16 683 operations (2.6%). Age-specific death rates were much higher in men than in women and increased with age. Age- and sex-specific death rates after bariatric surgery were substantially higher than comparable rates for the age- and sex-matched Pennsylvania population. The 1-year case fatality rate was approximately 1% and nearly 6% at 5 years. Less than 1% of deaths occurred within the first 30 days. Fatality increased substantially with age (especially among those > 65 years), with little evidence of change over time. Coronary heart disease was the leading cause of death overall, being cited as the cause of death in 76 patients (19.2%). Therapeutic complications accounted for 38 of 150 natural deaths within the first 30 days, including pulmonary embolism in 31 (20.7%), coronary heart disease in 26 (17.3%), and sepsis in 17 (11.3%).
That says nearly 6% at 5 years! Some would have died anyway but 6% at 5 years!!!!
Posted by: Floccina at Nov 19, 2007 3:42:57 PM
PS
Another link:
http://junkfoodscience.blogspot.com/2007/10/jfs-special-latest-research-on-actual.html
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?
Posted by: Floccina at Nov 19, 2007 3:51:51 PM
I would like to add a few things from the perspective of a clinician.
1) bariatric surgery is usually a last resort option. the risk must be looked at from the perspective that all other options have already failed. the risk of bariatric surgery must be compared to the risks of obesity and the host of complications that come with it. from this comparison, the risk of bariatric surgery is more favorable.
2) obesity increases the risk of morbidity and mortality for any surgical procedure, so it should not be surprising that the risk of bariatric surgery which is performed almost exclusively on obese people is relative high.
3) with respect to drugs, there are usually many options so it makes sense to have a low risk tolerance with them. for diseases that don't have many drug options or for disease that have a very high risk of morbidity, the risk tolerance is much higher. for example, chemotherapeutic drugs have significant rates of side effects.
4) surgery in general is only tried after drugs have failed. the risks associated with surgery need to be compared to the risks associated with doing nothing, not with the risks of the drugs used to treat the disorder.
Posted by: Key at Nov 19, 2007 4:06:26 PM
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
Posted by: MS at Nov 19, 2007 4:31:22 PM
I'd be willing to be that some chemotherapy drugs have a mortality rate greater than 1%. Not that this fact, if true, justifies the risk of bariatric surgery. I'm just saying.
Posted by: Cardinal Fang at Nov 19, 2007 4:42:40 PM
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.
Posted by: Key at Nov 19, 2007 5:15:19 PM
REGULATING DRUGS BUT NOT PROCEDURES
Historically, surgeons were not separable from the treatment while drugs were. A quack surgeon didn't last long, but snake oil could be sold by many, repeat quacks while surgeons could not get away with such "hit and run" competition.
Surgeons came to regulate themselves more while drugs remained risky and required supply chain custody to insure at least knowledge of source if not efficacy.
In modern times, safety regulations designed to reduce quackery and counterfeit drugs was taken over by Big Pharma as a "gold standard" designed to suppress and avoid competition.
While individual surgical procedures are not regulated similarly, general license and board requirements coupled with medical school restrictions have similar anti-competitive effects, but perhaps not as strong.
It seems not many surgical procedures are reasonable substitutes for drugs anyway, at least directly. True, a statin drug may reduce clogged arteries which may avoid angioplasty which may avoid a heart attack.
But it's a one-way trip up the decision ladder, heavily associated with income and lifestyle choices. Some would assert the rich experience moral hazard since all the options are available while others rely on an aspirin a day.
Also, if drugs were deregulated in terms of being more available despite known risks, they may still be rejected irrationally based on the data for a "less risky" surgeon. More generally, surgery is less of a "credence" medical good (with unknown outcomes) than are most drugs.
Posted by: barry payne - economist at Nov 19, 2007 5:18:10 PM
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.
Posted by: bb8343 at Nov 19, 2007 5:30:26 PM
A speculation:
Person dies of drugs = Person was poisoned.
Person died of surgery = Someone tried to save person, but failed.
I am aware of no research whatsoever to back this up.
Posted by: LemmusLemmus at Nov 19, 2007 6:04:35 PM
I agree, this suggests a large inconsistency between the regulation of surgery and drugs.
Posted by: Robin Hanson at Nov 19, 2007 6:14:02 PM
Just to put this in context -- I can not think of any other surgery that someone who is 20-40 would get that has a mortality of 1%. When this operation goes bad, it can go very bad. Some of the complications (forgetting mortality) can be awful enough that you might as well be dead (i.e. no longer being able to eat at all, slowly wasting away, etc.).
I dont know what the serious morbidity + mortality rate is, thats what you should want to know when undertaking this surgery.
In terms of health benefits, there was a recent observational study in NEJM showing some mortality benefit for obese people who underwent the surgery -- however I'm not sure if I believe it. The results (at least to me) are somewhat counterintuitive in that most of the benefit was a decrease in cancer deaths, and there was not that large a decrease in cardiac deaths.
Posted by: Jor at Nov 19, 2007 6:54:59 PM
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.
Posted by: wcu1291 at Nov 19, 2007 9:04:12 PM
Alex>> The relevant data is the marginal risk increase, no? E.g. it may be that the overall risk is 8/1,000 and with the operation it is 10/1,000, but the benefit of the operation (if not leading to mortality) is very high. Then the benefits should be compared to a risk increase of 0.2/100?
Posted by: Mike at Nov 20, 2007 3:00:56 AM
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.
Posted by: Brutus at Nov 20, 2007 8:01:37 AM
I believe drugs should be less regulated. If the numbers are accurate that just shows you that certain drugs are not as dangerous. I do not believe however, surgery at all should be regulated. If it is a fatal surgery that can be life or death consequence then the person, getting the surgery should be able to decide or if they cannot then the closest relation to the individual should be able to decide for them. Going back to regulation of drugs, we take for instance pro-hormone supplements such as M1T, which was recently banned. I think things like this should not be as regulated because just like alcohol and cigarettes these supplements will kill you. That is why it says on the back warning! People know what they are doing when they take these drugs even if they will kill you. They have been warned. Any kind of drug that will help save a life should not be regulated on especially when statistics like this are given.
Posted by: Derek Keener at Nov 20, 2007 11:30:05 AM
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.
Posted by: ww5009 at Nov 20, 2007 12:46:16 PM
Good luck, ww5009. Phen-fen, Vioxx and our surfeit of lawyers have sentenced many to unnecessary death.
In all the discussion of weight control drugs, and surgical procedures, what gets lost (and only brought up once here-maybe people on this site are bright enough) is the fact that people using these things are HIGH RISK!
I have a friend with such acute arthritis that it forced him out of his profession into a new gig riding a chair. He took Vioxx since its introduction, and would gladly take it again if it were available to him.
Posted by: Brutus at Nov 20, 2007 3:23:56 PM
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...
Posted by: Thomas Purves at Nov 20, 2007 4:01:31 PM
No mystery at all here. The risk of not going to the hospital when needed is high indeed. The risk of not taking a drug is likely quite low. Focusing more on hospital safety may increase benefits substantially for a few, while focusing on drug safety may increase benefits marginally for many. Any other comparison of risk is meaningless.
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