The Supreme Court and the Future of Obesity Policies

February 5th, 2013 1 comment »

Obesity issues rarely get to the Supreme Court. Obesity advocates spend little time discussing the legality of proposed strategies, at the federal or state level. But two recent Supreme Court decisions, one well known, the other less so, may set the parameters of public policy approaches to the obesity epidemic.

The constitutionality of the Affordable Care Act’s (ACA) requirement that individuals purchase health insurance was challenged in National Federation of Independent Businesses v. Sebelius. The Supreme Court, in a narrow 5-4 decision upheld the law on June 28, 2012. (See NFIB v. Sebelius 567 US __(2012) 132 S.Ct. 2566.)

Why the Court upheld the ACA is important. The US Constitution gives Congress specified “powers.” Congress does have “police powers,” which the states have. Police powers are very broad, while Congress’s authority must be based on enumerated powers.

Chief Justice John Roberts, writing for the majority found that the ACA individual mandate was constitutional based on the taxation power of Congress. The majority of the Supreme Court found that the individual mandate was not within Congress’s power to regulate interstate commerce nor was it authorized under the Necessary and Proper Clause.

Chief Justice John Roberts addressed how far Congress can go in regulating individual behavior and used obesity as a metaphor:

The individual mandate (to purchase health insurance), however, does not regulate existing commercial activity. It instead compels individ­uals to become active in commerce by purchasing a product, on the ground that their failure to do so affects interstate commerce. Construing the Commerce Clause to permit Con­gress to regulate individuals precisely because they are doing nothing would open a new and potentially vast do­main to congressional authority. Every day individuals do not do an infinite number of things. In some cases they decide not to do something; in others they simply fail to do it. Allowing Congress to justify federal regulation by  pointing to the effect of inaction on commerce would bring countless decisions an individual could potentially make within the scope of federal regulation, and—under the Government’s theory – empower to do it.

Allowing Congress to justify federal regulation by pointing to the effect of inaction on commerce would bring countless decisions an individual could potentially make within the scope of federal regulation, and—under the Government’s theory—empower Congress to make those decisions for him. …

Indeed, the Government’s logic would justify a manda­tory purchase to solve almost any problem. (Citation omitted). To consider a different example in the health care market, many Americans do not eat a balanced diet. That group makes up a larger percentage of the total population than those without health insurance. See, e.g., Dept. of Agriculture and Dept. of Health and Human Services, Dietary Guide­lines for Americans 1 (2010). The failure of that group to have a healthy diet increases health care costs, to a greater extent than the failure of the uninsured to pur­chase insurance. See, e.g., Finkelstein, Trogdon, Cohen, & Dietz, Annual Medical Spending Attributable to Obesity: Payer- and Service-Specific Estimates, 28 Health Affairs w822 (2009) (detailing the “undeniable link between ris­ing rates of obesity and rising medical spending,” and esti­mating that “the annual medical burden of obesity has risen to almost 10 percent of all medical spending and could amount to $147 billion per year in 2008”). Those in­creased costs are borne in part by other Americans who must pay more, just as the uninsured shift costs to the insured. See Center for Applied Ethics, Voluntary Health Risks: Who Should Pay?, 6 Issues in Ethics 6 (1993) (not­ing “overwhelming evidence that individuals with un­healthy habits pay only a fraction of the costs associated with their behaviors; most of the expense is borne by the rest of society in the form of higher insurance premiums, government expenditures for health care, and disability benefits”). Congress addressed the insurance problem by ordering everyone to buy insurance. Under the Government’s theory, Congress could address the diet problem by ordering everyone to buy vegetables. See Dietary Guidelines, supra, at 19 (“Improved nutrition, appropriate eating behaviors, and increased physical activity have tremendous potential to . . . reduce health care costs”).

People, for reasons of their own, often fail to do things that would be good for them or good for society. Those failures—joined with the similar failures of others—can readily have a substantial effect on interstate commerce. Under the Government’s logic, that authorizes Congress to use its commerce power to compel citizens to act as the Government would have them act.  That is not the country the Framers of our Constitution envisioned.

The Framers gave Congress the power to regulate com­merce, not to compel it, and for over 200 years both our decisions and Congress’s actions have reflected this un­derstanding. There is no reason to depart from that un­derstanding now.

Clearly, it would be unconstitutional for Congress to require individuals to reach specific biometric targets or spend time in specific activities, like nutrition classes, or purchasing specific foods pursuant to a dietary intervention program or spending time in non-voluntary physical exercise under substantial penalty for non-compliance. (I addressed whether the proposed HIPAA regulations on employer mandated wellness programs whether Congress can incentivize employers to do indirectly what it cannot do directly.)

The second, less well known case is Brown v. Entertainment Merchants Association, (131 St.C. 2729, 2011, 564 U.S. 08-1448). In this case, a California law was challenged which restricted the sale or rental of violent video games to minors. The Court found that video games were protected by the First Amendment’s Freedom of Speech clause and permanently enjoined the statute. The case was decided on a vote of 7 to 2. Justice Scalia wrote the opinion for the majority.

The Court said that there were narrow exceptions to the First Amendment’s protections, such as obscenity, incitement and fighting words. It said that the state, no matter how concerned about a problem, could not create a new exception and then punish it. They found the claim that watching violent video games can lead to violent behavior “unpersuasive.” The majority said that the law has to pass “strict scrutiny,” i.e. California must demonstrate a compelling state interest and that law is “narrowly drawn” to service that interest. In other words, the law must not be under-inclusive or over-inclusive.

The Court did not find California had a compelling state interest because it had not established “a direct causal link between violent games  and harm to minors”. Instead, California had argued that the state legislature can make a “predictive judgment that such a link exists based on competing psychological studies”. The studies in question only produced correlations and had significant flaws in methodology. Even if the effects of the games on minors were shown, the opinion states, “those effects are both small and indistinguishable from effects produced by other media. Here, the Court found the California law suffered from “under-inclusiveness” because it disfavored distributors of video games “at least when compared to booksellers, cartoonists, and movie producers – and has given no persuasive reasons why.”

The Court also found the statute to be gravely “under-inclusive” because the law allows the video games in the hands of children as long as one parent (or relative) approves and there is no system to verify the parent-child relationship. The Court noted that there existed a voluntary rating system to help parental control.

The Court goes on to describe the law as “overinclusive”. The opinion states, “Not all of the children who are forbidden to purchase video games on their own have parents who care whether they purchase violent video games. While some of the legislation’s effect may indeed be in support of what some parents of the restricted actually want, its entire effect is only in support of what the State thinks parent ought to want…And, as a means of assisting concerned parents it is seriously overinclusive because it abridges the First Amendment rights of young people whose parents (and aunts and uncles) think violent video games are a harmless pastime. And the overbreadth in achieving one goal is not cured by the underbreath in achieving the other.”

In his dissent, Justice Stephen Breyer argued that there were conflicting studies on the effect of violent video games on children, “I, like most judges, lack the social science expertise to say who definitively who is right associations of public health professionals who do possess that expertise that expertise have reviewed many of these studies and found a significant risk that violent video games, when compared with more passive media, are particularly likely to cause children harm.” He went on to cite positions of the American Academy of Pediatrics, the American Academy of Child and Adolescent psychiatry, the American Psychological Association, the American Medical Association, etc. No other justice joined in Justice Breyer’s dissent.

Now, this is not a law journal article or a brief in a court case. But there are a number of public policies under discussion which need to be rigorously evaluated by the decisions discussed above.

For example, the pursuit of regulation of food advertising directed at children has direct relevance to the Brown decision. The Breyer dissent is eerily prescient on the type of evidence that might be presented in a case involving obesity. Advocates of restricting food advertising to children need to critically weigh how policy proposals can escape being overturned on First Amendment grounds.

Or take the recently enacted ban on the sale of sugar-sweetened beverages in cups of 16 ounces or more in New York City. Now, some will argue that the sale of beverages is not a Freedom of Speech case. I won’t disagree with that. However, I do think that clever lawyers may find a way around this. For example, the New York City regulation only applies to restaurants, fast-food franchises, movie theaters, stadiums and street carts. Excluded are grocery stores, convenience stores, 7-Eleven stores, and corner markets, and gas stations. This may set up a kind of ‘reverse First Amendment’ case (I just made that up) where a fast-food franchise is under the restriction but the 7-Eleven next door can freely advertise it sells the banned combination of beverage and cup size.  I think a number of lawyers and citizens who follow these cases were surprised that the Supreme Court pulled violent video games into the same category with books, plays, and other forms of speech. A future case could give the Supreme Court the opportunity to extend the protection of commercial speech to restrictions on the sale (and advertising thereof) of a combination of legal products, namely, cup sizes and one category of beverage.

Even if the New York City ban on sugar-sweetened beverages in particular cup sizes were not considered a First Amendment case, the law would still have to meet the test that under the Equal Protection clause, laws must be reasonable and not arbitrary or capricious. So, under the New York City regulation some commercial outlets are under the ban. A fast-food outlet cannot stock cups of the prohibited size, but the 7-Eleven across the street can. Pizzas, candy, chips, cookies and numerous other high-calorie, low-nutritional-value can be sold in the regulated sites. High calorie beverages such as alcoholic beverages, beer, milkshakes, lattes, and frappuccinos can be sold. Refills of 12-ounce sugar sweetened beverage can be provided free of charge, even in regulated outlets. Outlets under the ban which have self-service counters cannot stock cups over 16 ounces, even if the consumer were using it for water or non-caloric beverages. While these seem like comprises, a court could well find them arbitrary and capricious, indicated a lack of commitment by the City to reducing obesity, the purported purpose of the regulation. The regulation affects all consumers, those who are overweight or obese but who will not develop serious, adverse health effects. It regulates one source of calories, and not others.

The decision in NFIB v. Sebelius is likely to have long-term impact on future obesity-related federal legislation and regulation. There are several federal statutes which may have difficulty meeting the test in the Robert’s decision. Lawyers will consider what Roberts said about obesity as ‘dicta’. ‘Dicta’ means that the comment was not necessary for the decision and not necessarily a precedent for future cases. Nevertheless, reliance on the taxation power of Congress can seriously constrain the range of Congressional action.

Bottom line: A majority of the Supreme Court are very diligent in scrutinizing federal and state laws affecting behavioral changes in the population. While this may change with future appointments to the Court, it should be noted that the Brown case was a 7-2 decision and not a single justice joined in Breyer’s dissent.

Future public policies relating to obesity need to be developed in recognition of this heightened degree of constitutional scrutiny.

 

1 comment »

Posted in DAILY DOWNEY, Featured, Federal Government

Tags:

Comments Sought on Medicare Screening Proposal

December 14th, 2012 No comments »

The Centers for Medicare & Medicaid Services (CMS) has contracted with Mathematica Policy Research (Mathematica) to develop new measures for potential use by eligible professionals (EPs) in the EHR Incentive Program. Mathematica and its subcontractor, the National Committee for Quality Assurance (NCQA), have developed the measures under consideration based on literature reviews of the evidence and reviews by a technical expert panel that includes clinicians, quality experts, EHR vendors, consumers, and other stakeholders.

This measure involves adult obesity screening and counseling as part of the annual wellness visit for Medicare beneficiaries under the Affordable Care Act.  Comments must be received by December 17, 2012.

Click here for the proposal.

 

No comments »

Posted in DAILY DOWNEY, Federal Government

Tags:

Look AHEAD Crashes

October 22nd, 2012 No comments »

 

Behind Look Ahead

The National Institutes of Health (NIH) has announced that the Look AHEAD trial has been stopped in its 11th year, two years short of completion. The extensive trial, involving over 5,000 patients at 16 centers, was intended to find out if there was increased mortality from intentional weight loss and to see if intentional weight loss among obese patients with type 2 diabetes would result in fewer cardiovascular (CV) events. At the end of the trial, there was no difference between the study group, which received intensive behavioral counseling and the control group which received standard diabetes education and occasional support group meetings.  The NIH press release indicates that both arms had lower CV rates that reported for patients with diabetes in previous studies. NIHNEWS: Weight Loss Not Reduce CV events in Type 2 diabetes

While this is news is something of a shock, many folks saw it coming. Two years into the trial, which began in 2001, the monitoring board noticed that the event rate in the control arm was much lower than expected. The expected CVD event rate in the control arm was 3.125% per year; in fact it was 0.7%. A committee was formed and made changes to the original study protocol designed to capture more events. These changes went into effect in 2008. There appeared to be three reasons for the lower event rate. First, while cardiovascular disease (CVD) is still the major cause of death in the United States, mortality has gone down, resulting from better control of dyslipidemia and high blood pressure and improved care of chronic and acute coronary syndromes. (See NCHS Data Brief, NCHS DataBrief: Prevalence of Uncontrolled Risk Factors for CVD)  Second, study participants who choose to involve themselves in a long clinical trial may well be healthier than a community sample and more motivated to follow the diet and exercise and participation requirements. Finally, the Look AHEAD trial employed the Graded Exercise Test which excluded participants most likely to develop CVD. Because of the low event rate, an additional primary endpoint was added (hospitalized angina) and the trial was extended for 2 years. (See PubMed: Brancati_Midcourse Correction to clinical trial whe the event rate is underestimated: the Look Ahead Study) Readers may recall that the SCOUT trial of sibutramine also had to revise its protocol midway through the study for the same reason, resulting in a population which was older and sicker than typical clinical population. In both cases, revising the protocol did not favor the intervention.

The stopping of Look AHEAD raises a host of questions. Was the study protocol correct? Did it end up studying healthy obese diabetics? Do long-term studies produce more noise than insight? Are we really studying the aging process when we cannot control for changes in health status, drug utilization (including drugs which can increase weight) and changes in energy intake, fitness levels, etc.? What is the picture for sub-groups, such as the 60-74 age group which had good weight loss in the DPP and 4 year results of Look AHEAD? Were there specific improvements, such as reductions in medications usage, fewer hospitalizations or shorter length of stays, improvements in quality of life? Did the presence of any the alleles associated with success in bariatric surgery affect outcomes? PubMed: High allelic burden of four obesity SNPs associated with poorer wt loss.  Should future efforts be devoted to cases where the disease process is already well-established or where high-risk populations can be identified and appropriate interventions evaluated? In future trials, should comorbid management be left to the local standards of care or defined in the study protocol?

Looking Ahead of Look Ahead

Whither behavioral lifestyle interventions?

The lifestyle interventions in the DPP and Look AHEAD were regarded as the ‘gold standard.’ They involved recruiting and training health professionals who provided not only the intervention but provided a supportive environment and a community spirit. Extensive communication with the patient was maintained. PUBMED: Look AHEAD: Description of the Lifestyle Intervention. Look AHEAD  participants even received an honoraria of $100 at each annual visit to improve adherence. (FDA EMDAC Hearing, March 28, 2012, Dr. Rena Wing, transcript, p. 169).

Recently the CDC and the NIH were looking at ways to take the DPP/Look AHEAD model to a more replicable model. The CDC’s National DPP program awarded $6.75 million in grants to develop lifestyle interventions program among people at high risk. One involves using the YMCA to provide lifestyle counseling. http://www.ymca.net/diabetes-prevention/ Questions will certainly be asked if highly trained professionals with incentives for participants did not produce better results will a down-scale program do better?

Whither diabetes prevention?

Look AHEAD was designed following the Diabetes Prevention Program (DPP). The DPP established that both lifestyle changes and metformin could reduce the incidence of type 2 diabetes, through weight loss, although lifestyle was superior to metformin alone. Look AHEAD was taking this important finding one step further asking whether weight loss among type 2 diabetics would reduce the incidence of cardiovascular events.

Even though the DPP has been promoted as a model for preventing the development of type 2 diabetes through weight loss, there were problems.

Dr. William Knowler of the National Institute on Diabetes, Digestive, and Kidney Disease (NIDDK) told the FDA Advisory Committee earlier this year,that, after three years of the DPP,

“the rates (of development of type 2 diabetes) have tended to flatten out and become parallel among all three groups. The rate of new development of diabetes has actually slowed down in the placebo and metformin groups, compared to what it was in the first three years. And the lifestyle group has flattened out a little bit at the end, but the difference that was attained has been largely maintained over time.  Notice, though, that over 10 years, although there still are remarkable treatment effects, if you look at things in an absolute sense, we can’t say that we still know how to prevent diabetes because, still, close to half of the people who enrolled in the trial developed diabetes over a 10-year period. But at least it’s been substantially delayed in those who have had the interventions.” ( FDA Endocrinologic and Metabolic Drug Advisory Committee Hearing on assessing cardiovascular safety of obesity drugs, March 28, 2012, Transcript, p 131-2).


(Figure: Diabetes Prevention Program Outcomes Study, Lancet (2009) 374; 1677-1686)

Is ‘delaying’ diabetes onset as powerful as ‘preventing’ diabetes from occurring in the competitive race for health care dollars and public attention?

Furthermore, a study earlier this year indicate poor outcomes in drug treatment of adolescents with type 2 diabetes with barely half showing glycemic control with metformin. PubMed: Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes

Will the Look AHEAD experience affect FDA approval of drugs and devices to treat obesity?

The FDA has viewed obesity as a cosmetic issue and only recently acknowledged it as a disease, worthy of attention as other cardiovascular risk factors. They (meaning the FDA Endocrinologic and Metabolic Drug Advisory Committee and FDA staff) have started, just barely, to view obesity as a cardiovascular disease risk factor, like hypertension. They have also opined, from time to time, that if folks only ate less and exercised more, they would not need drugs. So how does this decision play into these views? On one hand, they may be convinced that obesity is not so easy to treat as they thought by diet and exercise. On the other hand, they may think that there is less need for anti-obesity medications because other treatments, e.g. statins, lipid-lowering drugs, anti-hypertensives, are doing their job in reducing CV risk factors. So, this view may raise the bar for approval of new anti-obesity medications. On the other (the third?) hand, we may need a re-definition of obesity which tones down its “diabetes-metabolic syndrome-mortality” axis and raises its “disability-mobility-quality of life” axis. (Running out of hands here, I would not underestimate the potential for greater evidence of obesity’s role in the development of various cancers).

The recent trend in thinking at the FDA Endocrinologic and Metabolic Drug Advisory Committee (EMDAC) has been to view anti-obesity medications narrowly as cardiovascular disease treatments. The EMDAC met on March 28th and 29th,2012  and discussed how to assess the cardiovascular benefits and safety of anti-obesity medications. At the end of March 28, Dr. Rasmussen, who is the Industry Representative on the committee had the following exchange with Dr. Eric Coleman of the FDA.

Dr. Rasmussen: In your (Dr. Colman’s) presentation, you showed that there are different            populations pre-approval and in post-approval studies. ..Are we compromising the risk-            benefit evaluation if we impose more risk-based patients pre-approval?

Dr. Colman: I’m not sure I understood your question. Could you rephrase it?

Dr. Rasmussen: Maybe I’m preempting some of the discussion that we’ll be having                        tomorrow, whether we should require more high-risk CV patients pre-approval to rule out        a upper bound of the 95 percent confidence interval. But by doing so, we will likely be                including older patients with established cardiovascular risk disease. And I’m wondering          whether including more of those types of patients will compromise the benefits side of                doing the benefit-risk evaluation.

Dr. Coleman: Yes. And it might be that if the program had the resources to do this, that              that would just be one component of the program, and that there would be other be other,        smaller, shorter-term studies where they could study lower-risk individuals, younger                   individuals for shorter periods of time.

Dr. Rasmussen: But my concern was based on the fact that the SCOUT study didn’t really – I      mean, it looks like it wouldn’t be actually be able to be approved if it was submitted pre-            approval. ..(FDA EMDAC, March 28, 2012, transcript at p. 334-5)

On the second day of the hearing, Dr. Rasmussen returned to the topic.

Dr. Rasmussen: So I would just like to add a little bit of perspective on what “enrichment”          (Editor: “enrichment” is the term used here by the FDA referring to adding persons at high        risk of CVD to the pool of subjects in obesity drug trials) in this context will mean. I mean, I      did a little bit of “back-of-the-envelope” calculation, and maybe we’ll have that confirmed        after lunch. But, I mean, current programs, approximately 3,000 patient-years of                        exposure generate 15 MACE events or so. Even if we were to double that patient-year                  exposure with a population of a 3-percent annual event rate coming to additional 60                    events, we would still only be able to exclude a doubling of the hazard ratio. So, I mean,              what we’re talking about here is actually completely shifting the population that we’re                going to study in obesity programs to establish cardiovascular disease and not necessarily        the population that we know actually seek treatment in the real world. So, I think that’s              worth keeping in mind, that enrichment may sound appealing because it sounds like we will       add a fraction of sick patients, but in reality, this will be a complete shift of the population.        (FDA, EMDAC, March 29, 2012, at p. 169)

(Dr. Rasmussen’s calculations appear correction. The cardiovascular safety trial the FDA asked Orexigen Therapeutics to undertake surpassed its original goal of 7,000 patients in process of enrolling 9,000 patients to find 87 major CV events earlier than expected. Orexigen: Press Release Contrave CV study.)

A bit later, Dr. Rena Wing was asked about the influence of statins on the Look AHEAD trial. She responded:

Number one, that more and more people are being treated with statins. There’s better                blood sugar control. There’s better hypertension control. So you’re going to have to look          at what’s going to happen to the event rates in these studies. I was very surprised that your      event rates that you’re showing me in many of these trials looked so high compared to the        event rates we’re seeing in Look AHEAD. Now, some of that is because we did do GXTs.                (Editor: Graded Exercise Tests.) We did select healthier patients. But I also think that if you      are doing trials, in the United States especially, and with diabetics where there’s more and        more emphasis on increasing the use of lipids, increasing their blood pressure control, that      you’re going to be driving down your risk factors, and you’re going to have more and more      confounds with medication. (FDA, EMDAC, March 29, 2012 transcript, at p. 346)

At the Cleveland Clinic’s Obesity Summit earlier this month, I asked cardiologist Steve Nissen about the FDA’s pushing companies to undertake clinical trials to rule out a CVD risk. He responded that one of the challenges of cardiovascular outcome studies of obesity drugs is that in order to get enough cv events you have to study patients with existing heart disease or at very high risk of a cv event . This pushes the trial into populations which are considerably sicker than the population likely to take the obesity drug. He suggested that FDA should look at absolute risk rather than the relative risk of the drug. If one looks at the absolute risk, you can study any reasonable population likely to take the drug. This change in the statistical approach allows one to study more typical populations.

 

In any event, it will be sometime before we know how the newer anti-obesity medications, like Contrave if approved), Belviq™ and Qysemia™ will impact cardiovascular disease risk factors.

Bariatric Surgery: Last Man Standing?

A study out of the Cleveland Clinic published in the New England Journal of Medicine in April, 2012 followed over 90% of 150 patients for 12 months. The study, a face to face comparison of medical therapy versus surgery in patients with uncontrolled type 2 diabetes, showed a clear superiority for bariatric surgery.  The proportion of patients achieving a hemoglobin A1c level of 6% after 12 months by medical therapy alone was 12%; for those in the medical plus gastric bypass surgical group it was 42% and for the medical plus sleeve-gastrectomy group it was 37%. Weight loss was greater in the gastric bypass group (-24kg) and sleeve gastretcomy group (-25.1kg) than in the medical therapy group (-5.4kg). Use of drugs for glucose control, lipids and blood pressure control decreased in the surgical group but increased in the medical group. PubMed: Bariatric surgery versus intensive medical therapy in obese patients with diabetes

In regard to cardiovascular risk factors, a systematic review of the literature on bariatric surgery analyzed over 60 studies involving 19,543 patients. At baseline, the mean patient was 41.7 years old, female and had a BMI of 47.1. Baseline prevalence of comorbid conditions which increase risk of CVD was hypertension (44.4%), diabetes (24%) and hyperlipidemia (43.6%). After correcting for publication bias, 36% of subjects had improvements in hypertension, 26% for diabetes and 34% for hyperlipidemia. Calculating the changes for mean participants, the authors found that a woman, without baseline CVD, diabetes or smoking, who is taking anti-hypertensive drugs, will move from an 8.6% 10 year global risk for CVD to a 3.9% risk. A man, with no CVD or smoking but whose diabetes and need for anti-hypertensive drugs resolves after surgery, will move from a 10 year global risk of 18.4% to 4.7%. PubMed: Bariatric Surgery and Cardiovascular outcomes: a systematic review

So, where are we? The gold standard of lifestyle change is tarnished. The drug story is muddy at best. Bariatric surgery is clearly producing the superior results. However, access to surgery is, and will remain, a problem. The challenge for the leaders in the field is to find ways to have surgery reach more people and not be a procedure for the 1 percent. Even with greater access to surgery, the obesity-diabetes epidemic will continue to be a major health crisis. It’s time to be humble in the face of this disease and realize a lot more research is going to be needed…and soon.

 

No comments »

Posted in Behavior, Counseling, DAILY DOWNEY, Featured, Federal Government, Treating Obesity

Tags:

Arlen Specter and NIH

October 14th, 2012 No comments »


Today’s news include the passing of Arlen Specter, former Senator from Pennsylvania. Most of the obituaries will focus on his important role in Supreme Court nomination fights, the impeachment of President Clinton, being one of only 3 Republican votes for the Affordable Care Act and for supporting NIH, including stem cell, breast cancer, Alzheimer disease research. All this is true of course. But when it comes to NIH, his contribution is so much greater.

When Specter came to Congress in 1983, the NIH budget was about $3.6 billion. Now, it is about $30 billion. Much of that increase is due to the year-in-year-out work on the Appropriations Committees of which Senator Specter was a leader…for all areas of research. His staff was always open and interested in how basic biomedical research can be expanded. Specter was part of a cadre of Republicans in the 80s and 90s which included Lowell Weicker, Pete Domenici, and, in the House of Representatives, Silvio Conte, who continually worked with Democratic allies like Senator Tom Harkin, Ted Kennedy, Dave Obey and William Natcher to grow NIH. These Members had a huge respect for NIH, often referring to it as the “crown jewel” of the federal government. They understood that biomedical was an engine not only to improve treatments and cure diseases but to support drug and device developers, the biotech industry, hospitals, the health professions and others grow and prosper. Unfortunately, today, we do not have a similar senior cadre with the same commitment to biomedical research. And, as a result, the NIH budget is stagnant. There are great shoes which other Members of Congress can, and should, fill.

 

No comments »

Posted in DAILY DOWNEY, Federal Government, RESEARCH

Tags:

FDA to Liberalize Obesity Drug Process

October 11th, 2012 No comments »

The Food and Drug Administration  (FDA) may have gotten the word. A report on Bloomberg Businessweek indicates the FDA is considering, for obesity and infectious disease treatments, allowing developers to conduct faster clinical trials with a small group of patients than now required. The proposal evidently would look at a pathway to ensure that the drugs were only used in patients where there was an applicable risk-benefit situation. Bloomberg Businessweek: Faster Process for Obesity Drugs

To my mind, this is the kind of policy which could energize drug developer to start (or restart) obesity drug development programs. “High time”, in my view.

No comments »

Posted in DAILY DOWNEY, Featured, Federal Government, POLICY

Tags:

Obesity and the 2012 Elections

October 1st, 2012 No comments »

At this point the election is some 36 days away. How would different outcomes in the races for President, and control of the Senate and House of Representatives affect health care policies relating to prevention or treatment of obesity? What are the issues? What are the candidates saying about them? What policies might or might not change?

THE ISSUES

One of the major issues in the campaign has been the Affordable Care Act (ACA) with Republicans vowing to repeal and/or replace it and Democrats pledging to defend it.

The Affordable Care Act (ACA) is also referred to as “Obamacare.” While Republicans initiated the term ‘Obamacare’ as a derisive term, Democrats, including President Obama, have become more comfortable using it.

This may be because their overall favorability rating in the polls has gone from very unfavorable to 50% favorable. While the reasons for the shift are not clear, it is likely that it is at least in part due to some of the benefits kicking in, such as no pre-existing conditions exclusions for children, coverage of children on their parents plan up to age 26, and state insurance programs for those unable to acquire individual insurance coverage, strengthening of consumer’s hands in appealing insurance denials, covering USPSTF preventive services without charge in new (i.e. not grandfathered) health plans, rebates to consumers of $1.1 billion this spring from health insurers with excessive administrative costs.

For many months, the ACA has been under legal attack as unconstitutional, especially the requirement that all individuals purchase health insurance. However, in June, 2012 the Supreme Court upheld the law’s constitutionality in this respect.

The ACA has many provisions of importance to persons with obesity. (See http://www.downeyobesityreport.com/category/policy/health-care-reform-policy/page/2/)

In addition to the above mentioned policies, the biggest benefit to persons with obesity is being able to access insurance without their weight being considered a pre-existing condition. This will come into fruition in 2014 when the state health exchanges are operational but state insurance programs are available now until the exchanges are operational. The ACA also established a Prevention Wellness Fund and a National Prevention Council which developed a national prevention strategy. The strategy has been developed and grants have been issued to a number of states.

The ACA did not change Medicare coverage of bariatric surgery; nor did it eliminate the exclusion of drugs for weight loss in Part D. The decision by the Centers for Medicare and Medicaid Services to expand Medicare benefits to include intensive behavioral counseling for obesity in adults, as recommended by the US Preventive Services Task Force, was authorized by prior Congressional statute, not the ACA. Therefore, were the ACA to be repealed, it would not affect this coverage.

Medicaid was greatly expanded by the ACA but the Supreme Court decision in NFIB v. Sebelius has thrown this aspect into some doubt. Medicaid coverage of bariatric surgery, anti-obesity medication and counseling vary widely (See http://www.stopobesityalliance.org/research-and-policy/research-center/gw-research/)

Other provisions of the bill expanded comparative effectiveness research, required employers with over 50 employees to provide private areas for breastfeeding newborns and restaurant chains with 20 or more outlets are required to post calorie information on the menu boards. A controversial provision, offered by Republicans, provides added ‘incentives’ for employer wellness programs in terms of having employees pay more of their health insurance premium costs if they not reach certain specific health metrics, such as BMI. More and more employers have expanded using these ‘incentives’.

The Democrats have no reluctance to pointing to Republican nominee Governor Mitt Romney’s own legislation in Massachusetts as the grandfather of Obamacare, particularly the individual mandate to purchase insurance.

Other policies can affect persons with obesity, outside of the ACA. Balancing the federal budget, reducing the federal debt are also issues in the campaign and can affect funding for the National Institutes of Health and other federal research programs. “Entitlement reform” referring to changes in the Medicare, Medicaid and Social Security programs can also affect both participation in those programs and how benefits of those programs are structured.

The Presidential Race

Recently, the New England Journal of Medicine published editorials by Governor Romney and President Obama on their health care proposals, giving us the most recent and authoritative statements for each camp.

President Obama’s editorial is an strong defense of the ACA. He writes, “Today, 105 million people have seen a lifetime cap on their coverage lifted, so your patients no longer face the tragedy of approaching a lifetime limit in the middle of a round of chemotherapy or an episode in the ICU. Most of your patients can now get preventive care without paying deductibles and copays, care that you know saves lives, from early colon-and breast cancer screenings to cardiovascular tests and flu shots. Because of these new limits on insurance overhead costs, 13 million Americans got more than $1 billion in rebates – and by 2019, economists believe, family premiums will be about $2,000 less.” He goes on to cite saving seniors an average $600 by closing the ‘donut hole’ in Medicare drug coverage, adding 3 million young adults under age 26 to their parent’s insurance coverage, providing that up to 17 million children with preexisting conditions are no longer at risk of being denied coverage. He looks forward to 2014 when 30 million currently uninsured Americans will have health insurance which will stay with them, regardless of employment status. He promises to work on ACA implementation, fix the Medicare physician payment problem and supports medical malpractice reforms without arbitrary “caps”, continue support for the life-sciences research (read NIH) and ensure that the regulatory system (read FDA) helps bring new tools to patients and health care professionals. Finally, he criticizes the Republican ticket for proposing a budget which would eliminate 1,600 NIH grants, make Medicaid into a block grant and cut funding by 1/3 and turn Medicare into a voucher program. NEJM: Perscpective_President Obama

Governor Romney’s editorial criticizes Obamacare and pledges to repeal it and replace it with “not another massive federal bill that purports to solve all our problems from Washington, but with common- sense, patient-centered reforms suited to the challenges we face.”  Under his plan, “families will have the option of keeping their employer-sponsored coverage, but they will also be empowered to enjoy the greater choice, portability, and security of purchasing their own insurance plans.” He argues that this will increase competition, improve quality and lower costs. He would eliminate mandates (presumably state benefit mandates), facilitate purchasing pools and open up an interstate market. Regulation (presumably federal) would prevent insurers from discriminating against people with pre-existing conditions “who maintain continuous coverage.” He pledges better approval of innovations by the FDA and malpractice reforms. He would replace the current Medicare program with one like how Members of Congress choose from among plans, “including today’s traditional fee-for-service option.” The government will provide premium support…more for low income seniors and less for well off seniors…in purchasing their plans. He notes that insurers have said that they would keep coverage for children up to age 26 on their parent’s plans, regardless of Obamacare because they are responding to the market. Finally, he promises to transform Medicaid into a block grant. NEJM: Perspective_ Governor Romney

Three items of interest. First, President Obama nowhere mentions the “public option” which was a major issue within his own party during the legislative process. That idea is clearly off the table. In fact, the Democratic party platform did not mention it, nor does it appear that any Democratic Members of Congress running for re-election who supported the idea are campaigning on it.  Second, Governor Romney did not repeat his promise, made on his website, that on “day one” he would grant waivers from the Obamacare to all fifty states. MittRomney.com:Issues/health care. There is no way of knowing if this omission indicates a change in his position but he may have learned that the ACA does not provide for waivers for states from its mandates. A couple of specific provisions have allowance for waivers. But the key section, regarding the individual mandate, only allows waivers where states offer innovative plans for its citizens which are at least as comprehensive and affordable as the ACA and cover at least as many residents, i.e. Vermont’s single-payer system. Waiver applications from the states have to be reviewed by Department of Health and Human Services and the Internal Revenue Service. Waivers are limited to 5 years but can be renewed. Public hearings are required as well as a 10-year budget plan and periodic evaluation of the program. In any event, waivers are not available until 2017, the year after the next President’s four year term. Of course, Congress could pass legislation to provide waivers by the President on his own volition but if Congress were to do that, why not just repeal the statute altogether? Third, both candidates, but especially President Obama are inexplicitly silent on Medicaid and the Supreme Court’s opinion that Medicaid expansion be “optional.” Medicaid has become even more important in this recession as the health care safety net for millions of Americans who have lost private coverage. Tim Jost Health Blog: behind-the-uninsured-numbers-a-diminishing-sense-of-urgency/ In 2013, the provision of Obamacare which gives a state an additional 1% of the federal share of Medicaid spending in that state if they cover USPSTF recommendations, such as intensive behavioral counseling for adult obesity, is scheduled to go into effect. There is no indication if or how the Supreme Court opinion might affect this provision’s implementation.

(For a detailed non-partisan analysis of the health plans of President Obama and Governor Romney see this report just issued by the Commonwealth Fund: http://www.commonwealthfund.org/Publications/Fund-Reports/2012/Oct/Health-Care-in-the-2012-Presidential-Election.aspx?page=all.

This leads us to the variations in the Congressional elections.

CONGRESS

The Presidents proposes but the Congress disposes is an axiom of American government. Obviously, whatever a President may want, it is up to Congress to decide what he gets to sign into law or veto. So, what are the possible President-Congress combinations, and how would they affect the above policies?

  1. President Obama, Democratic Senate, Republican House

Today, this appears the most likely outcome, identical to the past four years. However, strategies might change. The Senate would block any House legislation to repeal Obamacare. However, it is unclear if the Republican strategy would change or not. For the past four years, the Republican strategy has been to limit President Obama to one term by denying him major legislative accomplishments. With an Obama victory, this strategy no longer has meaning. Depending on the extent of an Obama victory, Republicans may decide not to oppose virtually everything. Winning counts and Republicans may decide to become somewhat more cooperative. The Democrats are likely to be comfortable with staying with the implementation of the ACA and only making legislative changes of narrow scope, much like the changes to Medicare and Medicaid which Congress makes on a pretty regular basis.

2. President Obama, Democratic Senate, Democratic House

It is possible, that with only a change of 25 seats needed, that Democrats could take back control of the House of Representatives. While some very liberal members might bring up the ‘public option,’ in my opinion the White House and Congressional leaders will have little stomach for another health care fight when other pending issues have gone unattended, like immigration reform and the federal deficit. The one factor that can change this is the Supreme Court’s limitation on Medicaid expansion. Making Medicaid expansion optional may mean than more people will remain uninsured than expected. If the numbers bear this out, the Dems may be forced to go back to the drawing board. At this point and given the Supreme Court decision, the public option could be back on the table.  This complete Democratic control is probably the only scenario in which Medicare Part D would be re-opened, providing an opportunity to change the statutory language prohibiting payment for drugs causing weight loss.

3.  President Obama, Republican Senate, Republican House

This is a nightmare scenario for the White House. While President Obama has said he would veto a repeal of the ACA this would be very problematic especially if repeal were included in must-do legislation. Remember Obama agreed to extend the Bush tax cuts which he opposed because he needed Senate votes to approve a treaty extension with Russia and continuation of unemployment benefits. All kinds of legislative games could be played with repeal of the ACA.

4.  President Obama, Republican Senate, Democratic House

It is highly unlikely that both the Senate and House would flip party control but all things are possible. In this scenario, more gridlock is foreseeable.

5.  President Romney, Democratic Senate, Republican House

Gridlock. A Democratic Senate could kill most bills coming from a Republican House. Romney needs the Senate to confirm his Cabinet and other personnel, so Senate Democrats would have a lot of leverage. Democrats would not be expected to announce that they will act to make a President Romney a one-term President, but they will probably act that way. President Romney would have the power to re-open many of the regulations already issued to implement the ACA. The law also provides for a great deal of interpretation by the Secretary of Health and Human Services in its implementation which a Romney Administration could affect. Probably the provision of most importance and undefined at this point is the definition of “essential health benefits” which would be included in plans offered in the federal and state health exchanges. Here, a Romney Administration would have significant latitude.

6.  President Romney, Republican Senate, Democratic House

This is probably the least likely scenario. While Democrats would control one House of Congress, the greater constitutional authority in the Senate would give an edge to enactment of the Republican agenda. However, regarding the ACA, that agenda may be a little murky. In elections in 2014 and then in 2016, when President Romney would run for re-election, 37 Republican Senate seats will also be on the ballot compared to 32 for the Democrats. 2016 will have one of the most un-balanced slates facing the Republicans in some time with 24 Republican seats and only 12 Democratic seats up. It is likely that a number of Republican Senators would not want to see their opponents using repeal of popular ACA provisions against them. So, rather than outright repeal, they might want a more ‘nuanced’ approach which doesn’t leave them politically exposed. Just what that would look like is very unclear. Also, there are a number of provisions of the ACA favored by Republicans including the employer wellness program incentives and the development of Affordable Care Organizations or ACOs.

As long as the Republicans controlled one house of Congress, they could use the “reconciliation” process to avoid a Senate filibuster and enact legislation by majority vote. (Democrats used this at the end of the legislative process to make key changes in the ACA.) However, reconciliation is not for every issue. Under what is known as the “Byrd Rule” a provision excluded from a reconciliation bill if extraneous, i.e., it does not produce a change in federal outlays or revenues; or it produces changes in outlays or revenues that are merely incidental to non-budget components of the provision; or would increase the deficit. So a reconciliation bill could address equalizing the tax treatment of individual and employer purchased health insurance; Medicaid expansion; premium tax credits or the individual mandate. But reconciliation could not be used for changing the insurance reforms, banning use of health status on underwriting or the ban on pre-existing conditions. See Tim Jost Health Blog: dismantling-the-affordable-care-act-what-could-a-president-romney-and-hill-republicans-do/ On the other hand, were a reconciliation bill to repeal the Medicare provisions of the ACA, the federal deficit would actually increase, and so run afoul of the Byrd Rule. (Widely misunderstood, the Byrd Rule is not a Senate Rule but  a federal statute.)

7.   President Romney, Republican Senate, Republican House

While this sounds like a dream scenario for the Republicans, it is actually fraught with danger. The Republican base will expect the party to deliver on its promises on the ACA, Medicare and Medicaid and on the deficit. How the public will react to seeing the Republican positions move from rhetoric to reality will be fodder for pundits and policy-makers for years. Will the public be comfortable with governmental programs, Medicare, Medicaid, Obamacare, being largely turned over to the private insurance market? Certainly, Republican control of Congress and the White House will allow for the de-funding of ACA implementation, including areas like comparative-effectiveness research and the fund for prevention programs.

8.  President Romney, Democratic Senate, Democratic House

This is Romney’s nightmare scenario. Democrats would be expected to pass legislation almost begging for a veto. Romney would have to demonstrate great skill to show leadership on the national political agenda. Given his signature health care legislation as Governor of Massachusetts, I would not expect a President Romney to pick a fight with a Democratic Congress over repeal of Obamacare.

In the meantime, we should not lose sight that many businesses, health care providers, insurers and others are anticipating that current law, i.e. the ACA, will continue. They are making changes to their businesses accordingly. For example, of the 29 state governments under Republican control, only seven are not developing state health care exchanges, while 22 are.

States setting up their own exchanges are submitting their list of ‘essential health benefits.’ We know that Colorado is including the preventive recommendations of the USPSTF, evidently including the recommendation for intensive behavioral counseling for adult obesity while Oregon has decided not to include bariatric surgery.

Litigation over provisions of the ACA will continue. However, it is unlikely that any future challenge will change the Supreme Court’s interpretation of its constitutionality. Implementation may also present problems in satisfying the law’s requirements. Specific provisions may change and will need to be addressed in remedial legislation.

Looking at specific obesity treatment modalities, for bariatric surgery, it seems as if current Medicare coverage will stand. Indications are not good that it will be part of many states’ essential benefit packages under the ACA. Medicaid coverage is unlikely to change because of the election.

Coverage of drugs to  treat obesity has gradually improved over the past few years. It may be that the newly approved drugs by the Food and Drug Administration will spur additional private sector coverage. However, adding such drugs to Medicare Part D or Medicaid Plans remains a long shot. I have not seen what states may do with drug coverage under essential health benefits for the state health exchanges but I would expect most states will go with what they cover in the Medicaid program.

The recent coverage of intensive behavioral counseling for adults with obesity would continue even if the ACA were repealed. However, the ACA would bring intensive counseling in other programs, such as Medicaid and non-grandfathered health plans. So repeal of the ACA would delay or deny expansion of intensive counseling.

So this election and the subsequent make-up of Congress will have a major impact on obesity.

 

No comments »

Posted in DAILY DOWNEY, Featured, Federal Government, Health Care Reform, Politics, States and Localities

Tags:

Obesity is a Military Readiness Problem

September 28th, 2012 No comments »

Mission: Readiness, a non-profit organization of some 200 former senior military officers, has issued its report, “Still Too Fat to Fight,” an update of its 2010 report.  The report notes that 1 in 4 American adults of military service age are ineligible because of body weight. The report calls for additional efforts to remove junk food from schools. See http://missionreadiness.s3.amazonaws.com/wp-content/uploads/Still-Too-Fat-To-Fight-Report.pdf

Additional ammo for appreciating the gravity of the obesity epidemic for the US military comes from two papers by John Cawley and Johanna Catherine MacLean,  of Cornell University and University of Pennsylvania, respectively.

In their article, “Unfit for Service: the implications of rising obesity for US military recruitment,” the authors document the fraction of age-eligible civilians exceeding the weight and body fat standards for the US Army.  They find that the percentage of military age adults ineligible for enlistment because they are overweight or over-fat more than doubled for men and tripled for women from 1959 to 2008. They further estimate that a rise of just 1% in weight and body fat would further reduce eligibility by over 850,000 men and 1.3 million women, posing a major challenge for defense policy-makers. PubMed: Unfit for Serivce

In another article coming out in December 2012 issue of the journal, Applied Economic Perspectives and Policy, they address the consequences of rising youth obesity for US military academy admissions. They found that the fraction of age-eligible civilians exceeding the standards for admission to the US Military Academy at West Point, the US Naval Academy at Annapolis and the US Air Force Academy in Colorado Springs, CO, has more than doubled for men and quadrupled for women between 1959 and 2010. Among women, it is 13% more likely that African-American will not meet the standards than white women. Further increases of just 1% in the civilian obesity rate will increase ineligibility 16.5% for men and 10.9% for women. Not only do these findings threaten the military’s drive to greater diversity in its officer corps, but they may reduce US military readiness as well.

The obesity problem does not end with military service A recent study by Littman and colleagues at the VA Puget Sound Health Care System, found that weight gain was greatest around the time of discharge from service and in the 3 years prior to discharge. Being younger, less educated, overweight and have combat experience were all associated with clinically significant weight gain. This identifies a window which accounts for higher rates of obesity in veterans. PubMed: Weight Change following US military service

 

No comments »

Posted in DAILY DOWNEY, Federal Government

Tags:

Federal Priorities: Twinkies over Apples

August 31st, 2012 No comments »

A report from the Oregon Student Public Interest Research Group found that, “In the seventeen years between 1995 and 2011, taxpayers spent $18.2 billion subsidizing junk food ingredients; they spent $637 million on subsidies for apples. On average, every year, that’s $1.07 billion for junk food, and $37.4 million for apples.” See OSPIRG: Apples to Twinkies

 

No comments »

Posted in DAILY DOWNEY, Featured, Federal Government

Tags: