November 2, 2012
Regulation of New Smokeless Nicotine Delivery Systems
Three days at the American Public Health Association’s annual meeting has provided me with enough information/inspiration for dozens of posts. But the most interesting thing I learned, and would like to share, is the very complicated dance now being performed by the FDA’s new Center for Tobacco Products’ efforts to regulate in the face of the Tobacco’s industry ingenious efforts at evading regulation by developing a range of new products attractive to children which are either “not cigarettes” or “not smoked” but do not necessarily pose different health risks than those already identified from smoking cigarettes. It’s highly likely that many of our students have a product like “Snus” in their mouth during class. Here’s a recent 60 Minutes Report describing the phenomena
As the CDC reported recently, “Although total cigarette consumption continued an 11-year downward trend with a 2.5 percent decline from 2010 to 2011, dramatic increases in use of non-cigarette smoked tobacco products have slowed the long decline in overall consumption of smoked tobacco products.”
The CTP is doing its best to keep children from being addicted to tobacco. But it is a new operation operating under many restrictions. As many of you may know, on June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act. Before that, the FDA was prohibited from regulating tobacco at all. However, the political compromises that led to the FSPTCA being passed has made for some very odd restrictions on its ability to directly address the marketing of tobacco to children. For example, one of the things the FSPTCA did was ban flavored tobacco because of its appeal to children. But since cigars are exempt from regulation, imagine the wholesome images of new dads handing out cigars, the industry has developed “mini” cigars that not only look and feel like cigarettes but also have the kinds of appealing to kids. As the Washington Post reports:
“[t]hey come in ice cream flavors such as strawberry, watermelon, vanilla and chocolate. They are packaged in colorful wrappers. “Little cigars” are finding a niche among teens, who like the price — about a dollar — and the taste.
Young smokers say these cigarette-size little cigars and cigarillos — slimmer versions of big cigars — look better and can be bought one at a time instead of spending more than $5 for a pack of cigarettes. Many teens also think that they are less addictive.”
JSBIt’s also legal to make claims like “lite” on these “non-cigarette” tobacco products even though the FDA has managed to prohibit these claims on traditional products. How this possible? Because a “cigar” is wrapped with a tobacco product (often a leaf from “shade tobacco” grown in my native Connecticut River Valley) while a “cigarette” is wrapped in paper. So what looks like a cigarette but isn’t—a mini cigar with a paper wrapping that contains tobacco.
What made the panel so interesting was the “dance part” because it included representatives from the CTP and lawyers from the Public Health Law Center at William Mitchell School of Law who were not at all restrained in their ability to criticize the industry.
While I don’t have the slides from the presentation, here is similar information from the PHLC’s website.
PHLC is working on all fronts to ban these products—including closing tax loopholes in many states which exempt these “non-cigarette” products either directly or simply through old definitions which do not apply to these new products.
If you know someone using tobacco products under the delusion that they are less dangerous in any way, talk to them about quitting. But it’s a hard sell. I often ask my students who smoke why they don’t use a nicotine patch or chew the gum—and the answer I get is usually some variation on “it’s too expensive” or “I’m not trying to quit” or “I just don’t like the gum.”
One thing this has sparked in me is an interest to find out more about pure nicotine delivery systems. Given all the dangers of tobacco, would it be so bad for people to take in nicotine the way we do coffee? Could Starbucks or Pinkberry put a shot of nicotine in a latte or smoothie? A recent report from the UK considers the issue—and makes some interesting conclusions. So reports from Sweden about a reduction in cancer rates from use of an oral product, Snus, which is available in the US, and which delivers nicotine without the tar and other carcinogens. But it too is controversial. As explained by Michael Thun, M.D., vice president emeritus of epidemiology and surveillance research at the American Cancer Society “The last time companies introduced smokeless products in the U.S., there was a big epidemic among teenage boys. There is no way the FDA is going to encourage young people to start with snus in the hope that this will prevent them from starting with cigarettes.”
Worth Reading This Week
- Christopher J. Phillips et al, Moneyball and Medicine, N Engl J Med
- Marc Rodwin, Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform, SSRN/JLME
- Aaron S. Kesselheim et al, A Randomized Study of How Physicians Interpret Research Funding Disclosures, N Engl J Med
- Katie Keith et al, Implementing the Affordable Care Act: State Action on Early Market Reforms, SSRN/Commonwealth Fund
November 1, 2012
Seventh Circuit on Medicaid and More
In what may be the first case to apply both of the Medicaid decisions from last Term, the Seventh Circuit issued a preliminary injunction last week against Indiana's new law preventing Planned Parenthood from receiving either federal or state funding.
House Bill 1210 prohibits Indiana state agencies from contracting with or making grants to any entity that performs abortions or maintains or operates a facility in which abortions are performed and that receives state or federal funds, even if abortion services are provided with non-government funds. Hospitals and ambulatory surgery centers are not subject to the law, but all other healthcare providers are limited by this restriction, which prevents even indirect funding of entities that may perform abortions. Planned Parenthood and Medicaid enrollees made three claims to support their motion for a preliminary injunction to prevent implementation of this law: (1) the funding restriction violates Medicaid's "free choice of provider" provision, 42 U.S.C. 1396a(a)(23), which protects Medicaid enrollees' ability to choose who will provide their services; (2) the restriction is preempted by a federal law providing block grants to states for preventing STDs; and (3) the law operates as an unconstitutional condition on the funds granted by Indiana. The United States supported Planned Parenthood's position on the Medicaid claim (CMS has denied Indiana's request for a State Plan Amendment to exclude abortion providers from any Medicaid funding administered by the state; the determination is being appealed).
This set of claims allowed the 7th Circuit to evaluate the big question of remedies under the Medicaid Act, which the Supreme Court narrowly dodged in Douglas v. Independent Living Center last term. As to the question of private rights of action to enforce the 'free choice of provider' provision, the court determined that even under Gonzaga University v. Doe's restrictive analysis, Medicaid enrollees and Planned Parenthood may proceed under section 1983. Though many provisions in the Medicaid Act have been deemed outside the reach of 1983 rights of action, this particular provision contains individual rights-style language that other circuits have deemed to fit within the Gonzaga requirement for "individually focused terminology." Based on the likely success of this first claim, Judge Sykes granted the request for a preliminary injunction. Interestingly, Indiana appears to have pushed an NFIB-style coercion argument (we could lose all of our funding if we don't comply with 1396a(a)(23), so a private right of action is inappropriate); but, the court rejected that defense because the theory that spending legislation can never create private rights of action seems to be too extreme - even for the circuit that misinterpreted the nature of the states' obligations in Medicaid in Bruggeman v. Blagojevich.
Even though it permitted the 1983 claim to proceed, the court considered the remaining two claims. Evaluating open-ended federal grant for preventing STDs, the court noted that the majority in Douglas did not decide whether private parties may enforce federal spending programs through Supremacy Clause claims. But, relying on the strongly-worded dissent authored by Chief Justice Roberts, Judge Sykes concluded that no private right of action is available to enforce possible preemption of the state's use of the block grant at issue. Although the block grant does not contain the kinds of specific requirements that Medicaid does, the application and adoption of the dissent from Douglas is still notable. The court quickly dismissed the unconstitutional condition claim as being answered by Maher v. Roe and Harris v. McRae, both of which found that funding restrictions are not an undue burden on access to abortion. Though this is the correct interpretation of these cases, I maintain that the cases are wrongly decided.
I suspect we will see additional fighting in Indiana, but for now, the 7th Circuit has given us a small window into what will undoubtedly be a new line of cases attempting to limit Medicaid enforcement mechanisms. This set of considerations will only become more prominent as we approach the Medicaid expansion in 2014.
October 31, 2012
Dying in the US--still problematic
Today is Halloween, all Hallows Eve, the eve of All Saints Day. And last night, my father-in-law died peacefully at the age of 96. So I thought, amidst all the turmoil of death panels, that it might be useful to call attention to the continuing evidence that hospice is underutilized in the US, that changes in the hospice benefit found in the Affordable Care Act may not help, and that the controversy over physician-assisted suicide continues.
One of the persistent problems with hospice in the US has been its utilization too little and too late. Joan Teno among others has studied the use of hospice extensively. According to one of her most recent papers, "It Is “Too Late” or Is It? Bereaved Family Member Perceptions of Hospice Referral When Their Family Member Was on Hospice for Seven Days or Less" (Teno et al.2012), http://dx.doi.org/10.1016/j.jpainsymman.2011.05.012, of the over 1.4 million patients receiving hospice care each year in the US, 34.4% are enrolled for seven days or less and over half for less than 30 days. In many of these cases, the study found, earlier referral would not have been possible because either the patient refused hospice or the patient's downhill course was quite rapid. But in other cases, the late referral was attributed to poor provider-patient communication or to a failure in prognosis, both long-standing problems in US health care. The study concludes that many patients do not receive the full benefits of hospice services and that there is also need for better end of life services for those patients who receive hospice for only a very short period.
So what might ACA do? The flip side of the criticism that hospice referrals come too late is that they come too early or for patients who do not qualify because of financial incentives created by the Medicare hospice benefit, as the Medicare Payment Advisory Commission (MedPAC) argued in a report in 2009. Section 3132 of ACA, in response, requires a face-to-face encounter with the patient by either a physician or a nurse practitioner prior to hospice re-certification after 180 days and each subsequent recertification. After delaying implementation of this requirement, CMS announced that it would expect full compliance after the second quarter of 2011, http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HomeHealthPPS/Downloads/f2f_listserv.pdf. A particularly difficult aspect of this requirement is its application to patients who have received earlier hospice services, as admitting hospices must consider the patient's earlier receipt of hospice services and may have difficulty in getting the required information. The Center for Medicare Advocacy raises the concern that this may limit hospice access, albeit possibly improving the quality of care for those who do receive services,http://www.medicareadvocacy.org/2011/01/20/new-hospice-regulations-are-a-mixed-bag-for-beneficiaries-seeking-high-quality-end-of-life-care/ .
In Massachusetts, voters will address a ballot measure allowing physicians to prescribe lethal medication to certain terminally ill patients. If the Death with Dignity measure (Question 2, http://ballotpedia.org/wiki/index.php/Massachusetts_%22Death_with_Dignity%22_Initiative,_Question_2_(2012)) passes, Massachusetts will join Oregon and Washington in permitting the practice. Current polling suggests that the measure is ahead but that support for it is slipping. In a recent New York Times opinion piece, Ezekiel Emanuel argued that the debate is confused and that while it might benefit those with money and the ability to control their lives, it might also put those who are more vulnerable at risk, http://opinionator.blogs.nytimes.com/2012/10/27/four-myths-about-doctor-assisted-suicide/. Whether risks to the vulnerable are merely hypothetical or actual remains controversial, however; see my colleague Margaret Battin's analysis of the evidence from the Netherlands and Oregon, arguing that the risks are largely hypothetical,http://jme.bmj.com/content/33/10/591.abstract; the most recent report from the Netherlands also indicates that use of the practice remains stable with a decrease in the frequency in which life was ended without an explicit patient request, doi:10.1016/S0140-6736(12)61484-6.
To me, it is a shame that careful consideration of how best to support patients and their families in dying as they would wish, including with physician aid, has been caught up in concerns about costs, in political cross-fire, and in ideology. Joan Teno's call for integrated support systems, whether within or outside of hospice, is an important one. Fortunately, even though my father-in-law declined too precipitously for hospice to be a possibility for him, we received a great deal of support from the skilled nursing facility where he was a patient. But the evidence remains compelling that in the US this is too often not the experience of patients and their families at the end of life.
October 29, 2012
Physician Aid in Dying
While It is not surprising to see Ezekiel Emanuel reject physician aid in dying (which he and others describe as physician-assisted suicide), it is surprising to see some of his arguments. For example, he argues that a right to assisted suicide lacks mass appeal because only a fraction of people actually exercise the right in Oregon or other countries where it is legal. But the benefits of a right to aid in dying extend far beyond those who exercise it or seriously consider it during their dying process. For anyone who develops a serious illness and worries that suffering might become intolerable at some point, a right to aid in dying can provide important reassurance.
Emanuel also worries that the poor and poorly educated dying patient will be abused by a right to aid in dying. But the evidence from Oregon after about 15 years of aid in dying does not indicate abuse of vulnerable populations. Indeed, the risk of abuse is far greater from a right to have life-sustaining treatment, which can be exercised by others on behalf of mentally incapacitated patients, than from a right to aid in dying, which must be exercised by competent patients.
October 28, 2012
Physician Assisted Suicide
Instead of attempting to legalize physician-assisted suicide, we should focus our energies on what really matters: improving care for the dying — ensuring that all patients can openly talk with their physicians and families about their wishes and have access to high-quality palliative or hospice care before they suffer needless medical procedures. The appeal of physician-assisted suicide is based on a fantasy. The real goal should be a good death for all dying patients.