One of DrRich’s most dearly held theories, which he has expounded upon at length, is that the American health insurance industry supported Obamacare from the very beginning (and continues to do so) because the President’s plan offers them a graceful exit strategy from their now-defunct business model. Without Obamacare, the health insurance industry was headed toward sure oblivion. With Obamacare, they are headed toward – something else.
The remarkable and sustained actions the insurance industry took in support of Obamacare, DrRich continues to submit, is all the evidence that one should need to conclude that a deal has been struck. But even DrRich has had to admit that it has never been entirely clear what, exactly, the deal was. What were the health insurance companies promised in exchange for their support?
One obvious benefit for the insurance industry is the one last windfall they will enjoy when the individual mandate kicks in, and a few tens of millions of mostly-healthy Americans are coerced into purchasing health insurance for the first time. This windfall should not only temporarily boost the insurers’ bottom lines and their stock prices, but will likely push out for a few years the timing of the industry’s ultimate demise. So that part of the “deal” is pretty clear.
The remaining question is what will happen when that “last windfall” runs its course. Here, DrRich has speculated on two possible outcomes. Perhaps the health insurance industry will declare, at the appropriate moment (after profits have been made, stock options exercised, golden parachutes deployed, &c.), that they just can’t make a go of it anymore. This, obviously, will leave the government (whether it is controlled at that particular moment by Democrats or Republicans) with no choice but to step in and take over, lock, stock and barrel. DrRich has called this single-payer end-game the Amtrak Model.
On the other hand, the end-game could follow the Public Utilities Model. Here, the health insurance companies will be converted, either all at once or gradually, into public utilities. Public utilities operate as private companies, but the rates they can charge, the profits they can make, and the products they can offer, are all determined by the government. Such an outcome would be only a quasi-single-payer healthcare system, and so might be easier to justify to a Tea-Partied-up American public.
Either option would provide a graceful exit strategy to our health insurance industry, and either would be far more attractive to them than the ignominious oblivion they would have faced without Obamacare.
Last week, we were informed that what Obamacare has in mind for the insurance industry is the Public Utilities Model. That evidence came in the form of the Medical Loss Ratio (MLR) rule that was formally issued by the HHS, in accordance with a provision of Obamacare.
Under Section 10101 of the Affordable Care Act (Obamacare), beginning in January, 2011, insurers are required report to HHS each year what percentage of their revenues from premiums they spend on a) clinical services for enrollees, b) “activities that improve health care quality,” and c) all other costs. Depending on the size of the group market (and a few other factors), insurers must spend either 80% or 85% of premiums revenue on actual health care. (This amount, in health insurance parlance, is called the “medical loss.”) So only 15% or 20% can be spent on administrative costs, marketing, profit, and other non-clinical expenditures.
Behind the scenes, there was a great amount of jockeying over the past six months to convince the National Association of Insurance Commissioners (NAIC, the organization designated to propose the MLR rule to HHS) as to what constituted clinical and quality-improvement activities and which did not.
The health insurance industry tends to insist that every activity it undertakes is aimed at improving healthcare quality, whereas congresspersons and policymakers and consumer advocates insist that very little of what health insurers do has anything to do with anything except profit and greed. So, for instance, insurers claimed that the “healthcare hotlines” they have set up for subscribers are a quality measure, and should be included under medical loss; whereas opponents of the insurance industry claim it is purely an administrative function.
(DrRich does not know whether opponents remembered to advise the NAIC how certain insurers have utilized such hotlines in the past. For instance, in 2002 Kaiser Permanente paid workers at three northern California call centers bonuses for limiting the number of doctors appointments they set up, and for limiting the duration of patients’ phone calls. Kaiser admitted that workers at the hotlines received between 2 and 4% of their salaries as bonuses if certain criteria were met. In order to receive their bonuses, the hotline workers were expected to make appointments for less than 35% of the callers, to spend an average of less than 3 minutes and 45 seconds per call, and to escalate less than 50% of their calls for further evaluation.)
In any case, the NAIC finally made its recommendation on the MLR rule, and on November 22 HHS accepted the proposed rule in its entirety.
For the purposes of this post, the details of the new MLR rule are not particularly relevant. What is relevant is that such a rule was made at all.
The MLR rule sets a federally mandated, one-size-fits all limit on how much of its revenue an insurance company can use for administration and profit. That is, the MLR rule is explicitly the very kind of control that government agencies always impose on public utilities.
For public consumption, proponents of Obamacare have always claimed that insurance expenses – including profits – will be controlled through the competition that will be provided by the new “health insurance exchanges.” If market-like competition were actually simulated through these exchanges, then it is true that the MLR ratio would be driven toward the optimal value.
But the MLR rule establishes, among other things, that market forces are actually not going to be allowed to function in this arena. Rather, the optimal value for MLR will be determined by governmental regulators.
And so, dear readers, it appears that the deal, which proponents of Obamacare struck with the health insurance industry, is beginning to take definite shape. What we’ve got here, increasingly clearly, is the Public Utilities Model – a truly graceful exit strategy by anybody’s reckoning.
Regular readers will know that DrRich is not enamored with Obamacare. Further, they will recall that DrRich’s chief objection to Obamacare is that it codifies into law the final destruction of the classic doctor-patient relationship.
Under Obamacare, the physician is not only released from her fiduciary obligation to her individual patient (i.e., the obligation to place the interests of the patient above all other considerations), but is strictly forbidden from acting in accordance with it. Indeed, elaborate mechanisms are established to assure that physicians will follow the directives which are to be handed down from omnipotent and immutable government panels, directives which will be explicitly aimed at optimizing collective rather than individual outcomes. And whereas physicians have long been discouraged from making healthcare decisions based on individual considerations and needs, Obamacare makes doing so a felony.
Combine that fact with inevitable future provisions that will prevent doctors from opting out of the system, and patients from spending their own money on their own healthcare, and you’ve got a prescription for a healthcare system (and a society) that are somewhat less friendly to individual needs, and somewhat more tyrannical, than supporters of Obamacare have promised us.
So, as a matter of principle, DrRich is sympathetic toward the newly-elected (and newly-reformed) Republicans who promise they will introduce and vote on a bill to repeal Obamacare.
But let’s be realistic. Even the most zealous Republicans understand that any repeal bill that passes in the House will stall in the Senate, and if it does not, the President will veto it. Indeed, it is this comforting assurance, DrRich thinks, that will induce many Progressively-oriented Republicans to go along with a repeal vote in the first place. By voting to repeal Obamacare, frightened and disoriented Republicans can mollify the Tea Party, without risking an actual abolition of the new reforms. Because if Obamacare were somehow repealed – well, where would the Republicans be then?
The health insurance industry, however, is taking no chances.
DrRich will remind his readers that Obamacare never would have become law in the first place if not for the solid and unrelenting support of the health insurance industry. The industry’s support for Mr. Obama’s effort was unfaltering. And during the long and perilous process that finally brought Obamacare to the President’s desk, whenever the cause faltered and appeared to be lost, representatives of the insurance industry would rise up and take whatever strong and difficult action was needed to get it back on track.
DrRich will further remind his readers that the insurance industry did not support Obamacare out of any principle, or compassion, or any sense of what was moral or right. They did it as a matter of life and death – theirs. For the health insurance industry had run out its string, shot its wad, blown up its business plan, and had nowhere else to turn. It was Obamacare – and its soothing “promise” to allow the industry to survive in diminished form, as a government-controlled utility – that offered insurers their only visible path away from oblivion.
The insurance industry is not about to go back. Furthermore, unlike Nancy Pelosi, Harry Reid and even President Obama, the insurance industry is not satisfied to let the political realities of the day block the Republicans’ efforts at repeal. For all they know, nervous Democrats in the Senate who want to be re-elected in 2012 will allow the repeal bill to go to the President’s desk. Worse, unused to seeing Presidents willing to sacrifice themselves on the alter of principle, the health insurers, in their existential panic, must wonder whether even Obama might finally change his mind and decide that he wants to be re-elected badly enough to sign a repeal bill. These possibilities seem pretty far-fetched to DrRich, of course, but to DrRich the prospect of repeal does not spell Armageddon.
During the long and painful process that saw Obamacare become law, the health insurers clearly demonstrated just how far they were willing to go to keep that process alive. DrRich is certain they will be happy to go at least that far to block repeal.
So it came as no surprise when, just last week, the insurers sent Republicans their first, gentle reminders that they will not countenance any such thing. At the Reuter’s Health Summit in New York, David Cordani, the CEO of Cigna, warned Republicans, “I don’t think it’s in our society’s best interest to expend energy in repealing the law. Our country expended over a year of sweat equity around the formation of it.” And Mark Bertolini, president of Aetna, said that any attempt to repeal Obamacare, or even an attempt to hold up funding for it, would be “problematic.” “We can’t go back,” said Bertolini, “We need to keep moving, and we need to improve upon what we have.”
These seemingly mild-mannered statements should send a chill up the spines of Congressional Republicans. Any repeal of Obamacare necessarily and utterly relies on the acquiescence of the insurers, on their desire (or at least willingness) to continue with their current business model (possibly with some tinkering around the edges). Republicans, bless their innocent hearts, assume that’s what the insurers want.
But the truth is that the insurers know that their current business model is completely defunct, and far beyond any salvation. They see Obamacare as their only visible lifeline, and any serious threat to Obamacare as a threat to their survival.
The health insurers simply will not countenance a repeal of Obamacare. They will do whatever is necessary to demonstrate this fact to the Republicans. Their initial foray is suitably gentle. But once the repeal effort gets revved up, watch out. The insurers have already graphically demonstrated just how ungentle they can be.
If the Republicans really want to get rid of Obamacare, they’re going to have to propose an alternate solution that, among other things, provides the health insurance industry with a new and viable business model, one that seems at least as good to them as the rather paltry one Obamacare has promised. (If the Republicans want such an alternate solution, they have only to ask DrRich.)
DrRich does not think the Republicans have any idea of what may be coming their way, and from the very industry, no less, they consider to be their chief ally in the healthcare wars.
They should pay more attention.
Q. What’s the difference between a public health expert and an incompetent doctor?
A. An incompetent doctor tends to kill only one person at a time.
The deep recession and jobless “recovery” which we have enjoyed in the U.S. for going on three years now was triggered by the bursting of the housing bubble. The housing bubble was created by lending practices that awarded “subprime” mortgages to people with bad credit ratings, and offered to people with good credit ratings adjustable-rate mortgages (ARMs) that enticed them to purchase more expensive homes than they could afford.
Traditionally, banks were always reluctant to award mortgages, of any flavor, to people who obviously could not afford them, since doing so would wreck their businesses. The reason the banks began making bad loans in the 1990s is that new government policies, chiefly the Community Reinvestment Act, strongly “encouraged” them to.
The banks, being businesses, reacted logically to the new regulatory climate, to threats by ACORN and other activist groups, and to the escape hatch opened for them by the government which allowed them to turn over their toxic mortgages immediately to Fanny and Freddie. Banks quickly began turning out as many questionable mortgages as they could write, to as many uncreditworthy individuals as they could find.
Fannie and Freddie, in turn, securitized all those bad loans into complex investment instruments, which they released into the general worldwide marketplace. Investors around the world were happy to take these questionable new instruments since Fannie and Freddie, tacitly at least, were backed by the United States government.
And so, when the unqualified homeowners, who never had any prayer of making long-term payments on their mortgages to begin with, proceeded (at the very first and gentlest whiff of a recession) to default on their loans, the whole structure rapidly collapsed, nearly causing a global financial Armageddon.
Thank goodness us U.S taxpayers “volunteered” to clean up the whole mess with our taxes and those of our children and grandchildren.
There’s plenty of blame to go around for causing the mortgage crisis. We can blame all those people agreeing to mortgages they could not afford, the banks pushing mortgage deals on people who clearly did not understand what they were getting into, and Fannie and Freddie infecting the worldwide investment structure with toxic instruments. But the root cause was bad government policy.
Establishing policies that compelled banks to award mortgages to people who could not afford them (in order to advance the noble goal of creating a nation of homeowners) may seem like a compassionate thing to do. But the laws of economics are like the laws of nature. You can’t change them by government fiat. All you can do by fiat is to get people to behave in new and possibly unpredictable ways. And when those irreducible economic laws finally come around to assert themselves, you will be surprised, and likely dismayed, by the result.
As it turns out, setting health policy can have much the same kind of result. If you fail to pay sufficient attention to certain irreducible laws of nature – such as the laws of human behavior, and the laws of human physiology – you may not get the effect you are looking for (or, at least, not the effect you say you are looking for).
And this brings us to the obesity crisis.
Whether or not you agree that obesity is a “crisis” in the U.S., or even that mild to moderate obesity is the medical disaster it’s often painted to be, you’ve got to admit that Americans have gotten substantially fatter over the past few decades. And whether or not our increased corpulence is a grave threat to life and limb, it is creating an opportunity for the government to seize control over our individual freedoms – so it is, in fact, an important phenomenon.
DrRich is not the first to suggest that the public health policies of that very government substantially contributed to our obesity crisis. But as we enter a new era of Progressive healthcare, in which medicine is going to be practiced by policy fiats instead of by individual decision-making, it serves us to remind ourselves just how much the obesity crisis is tied to the great push, instigated by government policies dating back to the 1970s, for everyone to eat low-fat diets.
An association between dietary fats and coronary artery disease was first noted in the 1950s. In 1957, the American Heart Association (AHA) published its first, tentative recommendations for limiting the consumption of saturated fat. The recommendations were specifically aimed only at people who had strong genetic predisposition to heart attacks or strokes, or who already had heart disease. An accompanying editorial by Herbert Pollack, in the August, 1957 issue of Circulation, specifically warned against the widespread application of the recommendation to avoid saturated fat:
“Altering the dietary habits of a large population group is fraught with a great many dangers. Our knowledge of nutrition is not sufficient at this time to anticipate what ultimate results would happen if the public were encouraged to alter radically their basic dietary patterns.”
The AHA’s recommendations regarding saturated fat in the diet received sparse attention for 20 years. Then in 1977 (during arguably the second most Progressive administration in our history), the Senate’s Select Committee on Nutrition and Human Needs, chaired by George McGovern, nationalized the question of fat avoidance. After holding a series of hearings which tied fat consumption to heart disease, the Committee published the first “Dietary Goals in the United States,” advising all Americans to cut back on fat consumption. With this report, the US government officially supported low-fat diets for everyone. (The public then was judged to be just as stupid as we are judged to be today, so any real effort to distinguish between unhealthy fats and healthy fats was quickly set aside. “Fat is bad” is a message you can sell even to gun-toting Bible-thumpers.)
The anti-fat boulder got a great big push down the hill in 1983, when the Framingham study published a landmark paper tagging obesity as an important risk factor for cardiac disease. Because eating a diet high in fat obviously caused obesity, it seemed self-evident that low-fat diets would prevent heart disease both directly, and indirectly (by preventing obesity).
Accordingly, in 1984 the NIH issued a Consensus Statement entitled “Lowering Blood Cholesterol to Prevent Heart Disease,” which amounted to an all-out attack on dietary fat. Many scientists pointed out that there really was a lack of convincing evidence demonstrating that low-fat diets would be healthful. But the majority, seeing an epidemic of heart disease which must surely be due to fatty diets, outnumbered the reticent ones, and the Consensus Statement was voted into publication. Then, when the AHA abandoned its earlier caution and endorsed this Consensus Statement, the scientific backing for the government’s public policy encouraging low-fat diets for everyone was fully in place.
This action finally ignited the great low-fat diet era. Spurred on by government policy, prestigious medical organizations and others began a campaign of public service announcements and media blitzes. Influential magazines (that is, magazines read by women) began a prolonged onslaught of low-fat diet tips, articles, and human interest stories emphasizing the deadly nature of dietary fat. The food industry, which was at first very skeptical (like the banks when subprime mortgages were initially foisted upon them), finally jumped in with both feet. A massive new product line of low-fat and no-fat snack foods were invented which were just packed with carbohydrates, and often with supposedly “healthy” man-made trans fats. (This major shift in food production has been referred to as the “Snackwell phenomenon.”) The AHA found a lucrative new revenue source officially certifying such low-fat, high-carb products (including Frosted Flakes and Pop-Tarts) as being “Heart Healthy.”
Americans, being filled with the milk of human nature, largely ignored the ubiquitous pleas to abandon their burgers, pizza and tacos in favor of broiled, skinless, sauceless, saltless chicken breasts and broccoli. But they did begin scarfing up the new-age low-fat snack foods in massive quantities, having been assured that, as long as the snacks contained no fat, they could eat as much as they wanted.
There are a few physiological facts about dietary carbohydrates that were largely ignored during the low-fat era. First, the body greedily converts dietary carbohydrates into massive stores of adipose tissue, so indeed you can readily become fat by eating carbs. Second, gorging on the refined carbohydrates found in these new “healthy snacks” causes huge spikes in insulin levels (insulin being a key factor in converting excess carbohydrates to fat). When the insulin levels suddenly drop a couple of hours later, that drop produces insatiable hunger. So, two or three hours after enjoying a fat-free Pop-Tart or a Snackwell cupcake, one is ripping the cubboards open to find another carbohydrate fix. By thus inducing a continuous-snacking mode, the new high-carb snack foods increased overall caloric intake far beyond the calories listed on their labels. Third, diets high in refined carbohydrates increase triglyceride levels, reduce HDL cholesterol (“good cholesterol) levels, and in general create lipid profiles that are quite damaging to the arteries.
So, while few people actually stuck to a strict low-fat diet, many, many people became addicted to refined carbohydrates, and as a result became fat.
It has only been in the past five or six years that the low-fat dogma has begun to moderate, largely thanks to the (now mercifully faded) low-carb craze that struck at that time. We now hear somewhat more reasonable advice about good fats and bad fats, and good carbs and bad carbs. But much of the damage has been done, and at least partially because of the major push for low-fat diets, we Americans are fatter and less healthy than we used to be.
By the way, to this day it has never been shown that low-fat diets applied across the population would reduce the incidence of heart disease.
The low-fat diet policy amounted to a massive public health experiment, with the research subjects being us. Our government and our scientific organizations have yet to apologize for subjecting all of us to this travesty. Indeed, like the outcome of the great experiment in subprime mortgages, the outcome of the low-fat experiment is not particularly chastening to our Central Authorities. In fact, it works to their advantage.
To see why, consider the final way in which the obesity crisis is like the mortgage crisis. To prevent another mortgage crisis, our government, in its wisdom, did not promise to avoid promulgating any more counterproductive economic policies that will force businesses and individuals to act in harmful ways. (In fact, government policy continues to coerce lending to unqualified individuals.) Rather, they passed massive new “financial reform” legislation aimed at preventing banks and other financial institutions from behaving logically in response to bad government policies. The cure for bad regulation is more bad regulation. And when the results of its own bad regulations created an opportunity to grab even more control over the marketplace, our government lept at the chance.
Similarly, having (probably inadvertently) made policies that resulted in a fatter, less healthy populace, our government is now poised to take advantage of that opportunity, to turn the purportedly grave danger posed to the nation by the obesity crisis into a mandate for assuming powerful controls over the prerogatives of individual Americans.
And now, having learned that, like bad economic policy, bad public health policy can get them to where they want to go, our Progressive leaders are turning their attention to the next great public health initiative. Far from apologizing to us for the damage they caused with their low-fat experiment, they are plotting the next great experiment in public health which they will perform upon the population.
It appears it will have to do with salt.
It is easy to be puzzled by Progressives. They tend to be so kind, compassionate and well-meaning, and they try so assiduously to make everything turn out so well for everyone – and yet their works turn out to be so destructive. What’s up with that? And why do Progressives so revere Diversity? And why is the utterance of certain words unforgivable, when there is no absolute good or evil? Why is religion anathema, and politics sacred? Why does individual liberty (and therefore the Great American Experiment) have to go? And why does the idea of eugenics keep popping up, like a lock of unruly hair?
If you are perplexed about such things, you have come to the right place. All is explained in DrRich’s Theory of Progressive Thought.
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.