DrRich has expended a fair amount of effort explaining to his readers why it is so critically important for Obamacare (and for the Progressive program in general) to conduct a vigorous war against the obese. For the benefit of readers who may be new to DrRich’s thinking on this subject, please note the proper emphasis: This is not a war against obesity, but against the obese.
A central tenet of this war is the assertion (sometimes overt, sometimes tacit) that the obese are fat by choice, that is, as a matter of willfulness and recalcitrance. Their unsightly adiposity is a condition of their own choosing, a direct result of their having settled upon gluttony and sloth as central life-principles. It is because of their self-indulgence that the obese have allowed themselves to become a threat to humanity, and most especially, a threat to the fiscal stability of our healthcare system and therefore our nation. They have, by their own volition, made themselves fair game for whatever actions our Central Authority may deem necessary to protect the legitimate interests of the collective against their corrosive corpulence.
When we who are thinner (and purer) go along with, and even encourage, official actions against the freedoms of fat people, we will have allowed an important precedent to become established. It will be a precedent under which our ever-wise leaders may legitimately restrict, control and tax virtually any human behavior they can claim may lead to an increased risk of healthcare expenditures.
DrRich’s hypothesis is that the real point of this war is to set this very precedent. And hence, the actual war is against the obese, and not obesity.
Any hypothesis, of course, is useful only if it helps to explain certain interesting phenomena that otherwise would be difficult to explain. And this hypothesis (as do all of DrRich’s hypotheses) does just that.
For instance, consider several recent decisions the U.S. Food and Drug Administration has made removing from the market, or preventing from entering the market, certain drugs aimed at treating obesity.
Pharmaceutical companies, in recent years, have steered hundreds of millions of dollars toward the development of drugs for the treatment of obesity. They made these investments in confident reliance on a particular premise, a premise that has been explicitly and passionately expressed in a thousand ways by physicians, government agencies, beloved public figures, the popular media, academics, public health experts, and (chances are) yo’ mama.
The Obesity Premise
This, of course, is the Obesity Premise. According to the Obesity Premise we are now engaged in a great war against obesity. Obesity, this premise holds, is perhaps the greatest threat to the health of our nation. Obesity imparts tremendous risk to the individual by causing vascular dysfunction, hypertension and insulin resistance, leading to heart attacks, strokes, peripheral vascular disease, aortic aneurysms, kidney failure, arthritis, depression, disability, and death.
It has been asserted that it would be better to receive a diagnosis of many types of cancer than it would to be obese. It has been asserted, in well-organized public service campaigns that allowing oneself to become obese is the equivalent of committing suicide (again, emphasizing the central tenet that obesity is voluntary). Because the scourge of obesity is such a grave threat to individuals and to our society, the Obesity Premise concludes, extraordinary measures are justified in fighting it.
Accordingly, our drug companies have invested many years and vast amounts of money (time and money they could have invested in banishing wrinkles, say, or creating fine and durable erections upon demand), to develop drugs for treating obesity. They have invested in this way completely assured that their efforts, if reasonably successful, would be richly rewarded in the marketplace. Thus has been the promise of the Obesity Premise.
But today, drug company executives, if they are at all astute, must surely agree with DrRich that the great premise upon which their massive efforts have relied is, in fact, not actually operational. Not even close.
Consider what has befallen drug companies just in recent weeks when they relied on the Obesity Premise:
Item 1. The August 14, 2010 issue of Lancet published the obituary for the once-sure-blockbuster anti-obesity drug rimonabant (Sanofi-Aventis). Through years and years of development efforts, and through several clinical trials, rimonabant looked very promising. It proved effective not only in producing significant weight loss, but also in significantly aiding in smoking cessation, and in improving blood lipids. It won marketing approval in Europe, and was on the verge of being approved by the FDA. But in the end, the FDA declined to approve the drug – and in 2008 the Europeans withdrew it from the market – because of strong “signals” seen in clinical trials, indicating an excess of significant depression and even suicide* among patients taking rimonabant. As a result, Sanofi-Aventis abandoned all further development efforts for rimonabant.
* The relationship between obesity and suicide is surprising and intriguing, but has received relatively little public attention. Because this relationship could possibly be useful to the Progressives in their war against the obese, DrRich may soon write a post to help them along in their efforts.
The recent Lancet article on rimonabant describes the results of the once-anxiously-awaited CRESCENDO study, a study designed to evaluate rimonabant’s effect on long-term mortality and morbidity. The study was ended prematurely (when rimonabant was withdrawn from the market), so only 14 months of follow-up were able to be reported. Out of over 9000 patients randomized to rimonabant, there were 4 suicides, as compared to 1 suicide in the 9000 patients receiving placebo. An accompanying editorial laments that investigators were compelled to stop the study early, since the potential cardiovascular benefit that might have been realized from the impressive reduction in risk factors among patients taking rimonabant, given another year or two of follow-up, might well have outweighed the small (and statistically non-significant) increase in suicides. The editoralists go on to observe, “However, any mortality associated with cardiovascular preventive therapy is generally viewed as unacceptable. The preventive approach is fundamentally different from curative therapy for a potentially lethal illness.”
Item 2. In October, 2010, the FDA withdrew the weight-loss drug sibutramine (Meridia, Abbott) from the market, when the post-marketing SCOUT study showed a 16% increase in serious cardiovascular events in patients taking the drug. The FDA advisory panel was split as to whether the drug should be withdrawn, but the FDA concluded that the drug was too unsafe to remain on the market. (It was originally approved in 1997.)
What most in the general media failed to report, however, was that the SCOUT study specifically enrolled patients who had preexisting cardiovascular disease, and for whom sibutramine had never been approved in the first place. In other words, it was a study designed to test whether the usage of the drug could be safely expanded to fat patients who already had heart disease. An appropriate conclusion, from the SCOUT data, would have been that usage of the drug should not be expanded to those patients. There was no apparent objective reason to take the drug away from obese patients who had no preexisting cardiac disease, and who had had access to the drug for 13 years.
Item 3. Also in October, the FDA rejected approval for the obesity drug lorcaserin (Arena Pharmaceuticals). They rejected the drug because preclinical studies showed a “signal” for an increase in breast tumors in rats.
Item 4. Again in October (truly a landmark month for anti-obesity drugs), the FDA rejected approval, for the second time, of the anti-obesity drug Qnexa (a combination of phentermine and topiramate, developed by Vivus). The drug was rated as moderately effective for weight loss, but was rejected because of concerns about cognitive disorders, metabolic problems, increased heart rate, and (most especially) birth defects.
While these are truly legitimate concerns, topiramate (the component to which most of the concerns with Qnexa are due) has been widely used for seizures, and especially for migraine headaches. While the FDA expressed special concern over the possibility of birth defects if topiramate were used in obese women of childbearing age, most migraine sufferers who take the drug are women of childbearing age.
What is the best explanation for these recent FDA decisions?
Please understand, Dear Reader, that DrRich is not necessarily saying that the FDA was flat-out wrong in rendering these decisions on any of these four anti-obesity drugs. All of these drugs posed at least the possibility of serious side effects in at least some patients, and none produced more than moderate average weight loss (though, to be sure, individual patients achieved remarkable results with each of these drugs).
Rather, DrRich is saying that the FDA’s decisions in each of these four cases were inconsistent with the Obestiy Premise, and therefore that the Obesity Premise is operationally false. That is, when it comes to actually taking action, the Central Authority entirely discounts the Obesity Premise.
The severely obese, in point of fact, do indeed have a remarkably elevated risk of developing premature, severe, disabling, expensive and lethal medical problems. Many of these individuals, in truth, would indeed be better off having many types of cancer. This aspect of the Obesity Premise is scientifically correct.*
*There is much less evidence that people who are only moderately overweight – the vast majority of Americans said to be in grave danger due to their weight – are at markedly elevated risk because of weight alone. Indeed, DrRich has discussed evidence for the “Obesity Paradox,” whereby those who are moderately overweight appear to have improved survival compared to those of low or normal weight.
So, at least for people who are very obese, a drug that produced weight loss but carried a small risk of potentially dangerous side effects might be justifiable, just as a treatment for cancer or heart disease might be justifiable despite a risk of serious side effects. But this is clearly not how the authorities are treating weight loss drugs. It appears plain that in order for an obesity drug to be approved, that drug will have to display virtually no side effects. Operationally, therefore, obesity is treated as a low-risk medical condition whose treatment does not warrant any measurable risk. Indeed, obese patients are not to be allowed even the option of choosing such a drug, even after being fully informed of the potential risks and benefits.
If the Obesity Premise were operational, the authorities would have permitted studies with rimonabant – by far the most promising anti-obesity drug yet developed – to continue, in order to measure whether the long-term benefits of weight loss, smoking cessation, and lipid control outweighed what now appears to be a very small risk of excess suicide – a risk which could almost certainly be reduced even further with appropriate psychiatric screening.
If the Obesity Premise were operational, the authorities would not have withdrawn sibutramine from healthy obese patients (who had had access to the drug for over a decade) on the basis of a study which evaluated the drug in people with serious pre-existing cardiac conditions, and for whom the drug had never been approved.
If the Obesity Premise were operational, the authorities would not have banned lorcaserin for the sole reason of a tumor signal of uncertain significance seen in rats.
And if the Obesity Premise were operational, the authorities would not have denied topiramate to obese patients, when they allow the widespread use of the same drug in patients with migraines.
Undeniably, the actions of the Central Authority (as opposed to its words) entirely discount the Obesity Premise. Its actions reveal that the Obesity Premise is for public consumption – that is, for propaganda – only, and that its main purpose is to justify extraordinary measures.
The actions of the Central Authority do, on the other hand, comport with DrRich’s hypothesis – that we’re fighting a war against the obese, and not against obesity. In a war against the obese, a cure for obesity would preclude the need for strong central controls, and so would be counterproductive.
Therefore, while it goes about whipping our population into a frenzy about the scourge of obesity, the Central Authority is simultaneously doing whatever it can to stifle novel therapies that begin to attack obesity. True, none of these four drugs “cures” obesity, and none is risk-free. But the cure for any significant medical problem rarely occurs in a single step, or is accomplished without the possibility of side effects.
The Central Authority has sent a very clear message to the pharmaceutical industry: “When it comes to treating obesity, only perfection will be allowed; we insist on remarkable efficacy, and virtually no side effects. Without such a result all your efforts will come to nought.”
DrRich believes that in the last month the drug industry has heard this message loud and clear, and that it will be a very long time indeed before any more investments are made toward developing drugs to treat obesity.
By the same actions, the Central Authority has also sent a very clear message to the obese: “Do not expect any help from medical science, you self-indulgent, lazy, gluttonous budget-busters, you wreckers of society, you fattys. You did this to yourselves, by your own willful actions, and by your own actions have brought the rest of us to the brink. You deserve no more quarter than other sociopaths who undermine civil society – the bank robbers, the child snatchers, the Tea Party marchers. Because your individual choices have brought you to this juncture, prepare to be constrained in your individual choices.”
And so, in just the past few weeks, the war against the obese has seen significant victories, and has advanced ever closer to its ultimate goal.