Category: Blog

A Few Ways the Shutdown Jeopardized Your Health

Now that the budget impasse that stagnating swaths of the federal government appears to have ended (Washington Post), it is worth considering what lessons might be learned from the shutdown—in particular, the shutdown’s effect on the health of Americans.

The enforcement of food safety was diminished. The FDA conceded at the beginning of the shutdown that it would “be unable to support the majority of its food safety, nutrition, and cosmetics activities…[and] safety activities such as routine establishment inspections,…some compliance and enforcement activities, [and] monitoring of imports” (HHS Contingency Staffing Plan). Inspections of any single inspection sight are infrequent, occurring only once every few years, but that only underscores the importance of maintaining the already meager inspection regime. The USDA continued to inspect meat, poultry and egg products during the shutdown (USDA Operations Plan for Absence of Appropriations), yet inspecting the majority of food, including all imports, is the FDA’s responsibility.

Congressional wrangling (over, inter alia, a tax on medical devices) also jeopardized likely health legislation. In late September the Senate HELP committee appeared poised to pass legislation increasing regulation of compounding pharmacies (HELP), following the passage of a similar bill by the House (CBS). One year has passed since the deadly fungal meningitis outbreak that has been blamed on contaminated drugs processed by the New England Compounding Center. NECC recalled drugs because of contamination but not, as suits filed in federal court allege, in time to prevent the drugs from being administered. In Tennessee, which has a one-year statute of limitations on product and health-care liability suits, several suits have been filed. 16 of the 64 killed were treated in Tennessee (Tennessean). The outbreak injured hundreds more and publicly illuminated the lack of FDA oversight of compounding pharmacies (New York Times). The Drug Quality and Security Act would create a new class of compounders called “outsourcing facilities” and places the class under FDA’s jurisdiction (MedPage Today). Though critics characterize the impending legislation as insufficient, a distracted Congress means a delay in progress, however minimal.

Also affected by the federal slowdown was the CDC, which monitors foodborne disease. The CDC furloughed 8,754 employees even though, as CDC Director Tom Frieden tweeted, “Microbes…didn’t shut down” (Twitter). In particular, 78 of the 80 foodborne pathogen analysts at CDC were furloughed (New York Daily News). Thirty of those analysts have since been recalled to cope with an outbreak of antibiotic-resistant salmonella that has reached 18 states and sickened more than 278 people. USDA’s Food Safety and Inspection Service announced that it would not shut down a processing plant to which much of the tainted poultry was traced, citing the processor’s timely submission and implementation of improved processing practices (Food Safety News). How much more quickly a fully-operational contamination-detection mechanism would have coped with the outbreak is unclear. But the shutdown has demonstrated the urgency of health preparedness missing since October 1.

While CDC was able to recall the 30 analysts to address the salmonella outbreak and generally retains the authority to recall its furloughed employees in case of emergency, its response was still slowed. The danger may not lie in CDC’s reactive capabilities, but in its proactive capabilities. The shutdown hampered CDC’s role as a hub for nationwide health crisis management. Without employees to field calls from state health agencies, the CDC would have been unable to coordinate state and interstate crises and attack growing epidemics. As flu season approaches, CDC leaders worried they would not be able to react timely to an outbreak. Similarly, they also worried about whether U.S. Muslims, 11,000 of whom will travel to Mecca for the annual Hajj pilgrimage, would be exposed to the MERS virus there, and whether the CDC would be able to respond in time if Americans carried the virus home (USA Today). Moreover, CDC had been forced to cut its quarantine staff at airports around the nation by 80 percent (Time).

In addition to preventing outbreaks of foodborne illness and communicable disease, individuals who are already sick faced barriers to new treatments. Two hundred new patients arrive at the National Institutes of Health each week to begin clinical trial programs with new drugs (CNN). For some, these new drugs may promise hope after all other treatment options have been exhausted. Ongoing trials have not been terminated but new enrollees were turned away. The week the government shut down, 30 of the patients beginning treatment programs would have been children—a third of them pediatric cancer patients.

Forcibly Medicating Mentally Ill Death Row Inmates

First year law students are taught the basic theories of punishment in their Criminal Law classes within the first week — deterrence, rehabilitation, isolation, education, and retribution.  These relatively straightforward concepts seem simple enough until they are complicated by obstacles that exist solely outside of textbooks and in the real world like mental illness and the death penalty.

On September 11, 2013, the Texas Court of Criminal Appeals held that a court may not order the forcible medication of a mentally ill death row inmate to render him competent to be executed.  (see Staley v. Texas ; Chattanooga Times Free Press; Death Penalty Information Center)  This decision is one of a number of cases across the country, including state supreme courts in Louisiana and South Carolina, that have had the same essential ruling — that an inmate on death row cannot be forcibly medicated to stand trial or be executed.  (Star-Telegram)

In the cases dealing with forcibly medicating mentally ill death row inmates, the court is faced with the task of considering a host of difficult questions in addition to keeping the delicate balance, including issues of public health, policy, state law, and the specific facts of each case.  Still, regardless of the appreciation for the challenge of the task at hand, many critics of decisions such as the one that the Texas court handed down believe that the American court system is not a strong enough institution because of its apparent inability to protect the collective security of the public.  Those in favor the decision believe that the court intelligently practiced judicial restraint in remaining faithful to the text of the state’s constitution.   (John Katz, PC; Penn State Law Review)

Interestingly, both the American Psychiatric Association (APA) and American Medical Association (AMA) have publicly denounced the practice of forcible medication, calling it ethically unacceptable.  (see  The APA is specifically concerned that when a court is making life-altering decisions and writing about psychiatric illness and treatments, judges have an accurate set of facts to work from.  Furthermore, the APA is concerned that that the authorities who have custody of a defendant to make decisions regarding forcible medication can do so in a timely and efficient manner.  (Death Penalty Information Center)

Considering the gravity of any decision involving forcible medication and the potential it has for serious health law and policy consequences, it is surely an issue that will be highly scrutinized and debated for years to come.


USDA Certified: Born And Raised in_______?

Do you want to know where your food came from? Well, Congress made this really COOL law in 2002 that gives you all the information you want right at your fingertips. COOL (Country of Origin Labeling) was signed into law as part of the 2002 Farm Security and Rural Investment Act (known as the 2002 Farm Bill) and amended by the 2008 Food, Conservation, and Energy Act. (House Agriculture Committee) This law requires retailers to provide country-of-origin labeling for foods including fresh fruit and vegetables, fish, shellfish, peanuts, pecans, macadamia nuts, ginseng, and ground and muscle cuts of beef, pork lamb, chicken and goat. The authorization and implementation of this mandatory federal labeling program has been controversial, especially surrounding the meat products.

How exactly do these USDA regulations work? For example, roasts from cattle raised in Mexico for slaughter in the US would say, “Born and raised in Mexico, slaughtered in the United States.” Imported meat would be tagged as “Product of” of the originating country. These regulations would not apply to processed food or food purchased in restaurants. Those that advocated against mandatory COOL said that it would provide U.S. products with a competitive advantage over foreign products. If offered a clear choice, U.S. consumers prefer fresh foods of domestic origin, thereby strengthening demand and prices for locally grown food. Many countries and parts of the meat industry fought against this law, arguing that it violated the World Trade Organization’s (WTO) regulations preventing barriers to free trade. In order to comply with WTO regulations, Congress amended the law. COOL was approved by the WTO in 2013. (World Trade Organization)

A worried meatpacking industry, grocers, and livestock producers filed suit in 2013 in a federal court, alleging that the final 2013 COOL rules violate their constitutionally protected rights to freedom of speech, that the labels were not specifically authorized by the Farm Bill, and that COOL labels provide no benefit to consumers. They also stated that COOL would drive up their costs and become a book-keeping nightmare. The meatpackers that have filed this lawsuit include nine trade associations including one Mexican and two Canadian livestock-producer groups as well as six domestic meatpacker or meatpacker-producer groups. (American Meat Institute) Four groups representing farmers, ranchers, rural communities, and consumers have filed court papers to defend COOL. On Wednesday, September 11, 2013 Judge Ketanji Jackson, from U.S. District Court for the District of Columbia denied the meatpacking industry their injunction, refusing to stop mandatory COOL Law from being implemented. Canada and Mexico are bringing the amended law in front of the WTO once again as a U.S. trade barrier. The law is slated to take affect starting in November, 2013. Members of America’s beef and pork industry issued a plea to hold off on enforcement of the new COOL Law requirements until the WTO has an opportunity to hear Canada and Mexico’s challenge to the new regulations. The meatpacking industry is arguing that the new law takes discrimination to a new level by not only requiring labeling, but also preventing comingled packaging. The prevention of mixed-label packaging will likely encourage consumers to buy products born, raised, and slaughtered solely in the U.S. (Ecowatch). If the WTO rules in favor of Canada and Mexico on their appeal, the law will have to be rewritten or the U.S. will risk facing retaliatory tariffs. When consumers prioritize country of origin labeling or the price tag when purchasing their meat. Consumers making an informed decision is COOL.

Telemedicine in Rural Communities

Imagine you live in a small rural community in northern Montana with no more than a thousand residents, each of whom lives miles from the next. Your child becomes ill with a sudden high fever and you don’t know what to do.  Just five years ago, this situation would have necessitated an hour drive to the nearest hospital emergency room, or a call to a volunteer-run ambulatory services center.  Now, patients have the option to receive care via telemedicine instead, improving the level of care and making healthcare accessible to more people in rural areas.

Telemedicine is the use of medical information exchanged from one site to another via electronic communications to improve a patient’s clinical health status.  (ATA)    Sometimes referred to as “telehealth,” telemedicine can be accomplished via email, smart phone, two-way video, and many other forms of communication technology.  It can be as simple as two physicians discussing a case via cell phone, or as complex as using video-conferencing to facilitate a real-time consultation between medical providers in two different countries.  (Medical News)  The main benefits of telemedicine derive from its flexibility—any physician can participate in one of its several different user options.  The practice has been lauded by many in the medical community for increasing care options to patients and cost-effectiveness.  Medicaid guidelines recognize the cost difference between face-to-face consultations or examinations and telemedicine, and incentivize the practice through its coverage levels.  (Medicaid)

Telemedicine has had a widespread effect globally, especially in rural communities that lack a brick-and-mortar healthcare presence.   Rural populations consistently face obstacles to healthcare that urban areas do not encounter.   Challenging issues such as a lack of healthcare professionals, physical distance between providers, and a lack of emergency facilities have created a care gap between the people in these two regions.  (Stanford School of Medicine)  The majority of the problems stem a deficiency of healthcare professionals per patient in rural areas.  According to Stanford University’s Rural Health Factsheet, , about 20% of American’s population resides in rural communities, but less than 10% of physicians practice in rural areas.

Telemedicine helps correct that imbalance by ‘bringing’ physicians into the rural communities in which they are needed via electronic media.  Before telemedicine, a patient may have had to wait two or more days for a physician to travel to his town, or had to travel long distances to the doctor.  Now, the same patient can set see his doctor via Skype when it’s most convenient or most needed.   (Healthcare IT News)  Additionally, because web communication software is relatively inexpensive, the cost to the patient is negligible.

Telemedicine has also led to improvement with in-home monitoring.  Clinical observations or costly hospital stays are avoided when a patient is given a device to monitor his status at home which uploads all relevant information to the monitoring physician.  This allows the patient to be at home, even if his home is far away from the nearest medical facility.  At-home monitoring also helps hospitals reduce readmission rates.  (Time)  Fewer readmissions means less billing to Medicare and Medicaid, which reduces the cost of these programs.

Possibly the biggest boon to rural communities is the increased availability of specialists.  In locations where physicians of any type are scarce, finding available specialized care, even types as basic as emergency pediatric care, can be difficult or near impossible.  (University of California)  Telemedicine allows specialized physicians to consult with other physicians on difficult cases—in some situations, they can even virtually examine the patient via video conference and electronic medical records.  In the case of emergency pediatric care, telemedicine consultations have been proven to greatly improve the quality of care for children treated in rural emergency rooms.  (Kaiser Health News, NTCA)

Threre are ways to even further increase the level of health in rural communities via telemedicine.  A 2011 report from the UnitedHealth Center for Health Reform and Modernization gives eight strategies to improve further the reach and abilities of telemedicine in rural communities.  (UnitedHealth Group)  Among the suggestions made were expanding broadband connectivity, offering education to physicians on how to incorporate telemedicine into their practice, and updating regulations to allow the practice across state lines.

How the NFIB v. Sebelius Ruling Will Increase the Amount of Uninsured under the ACA

In a March 2012 report, the Congressional Budget Office (CBO) estimated that by 2022, the Patient Protection and Affordable Care Act (ACA) would reduce the number of nonelderly people without health insurance by 33 million, leaving another 27 million still uninsured.  A significant part of that 33 million included the 17 million more people the CBO estimated to qualify for Medicaid by 2022 under the ACA.  They had not previously qualified because the ACA increased the eligible income to those making up to 138% of the Federal Poverty Level.  This increase in eligibility would have been implemented by making all federal Medicaid dollars given to the states contingent on states increasing the pool of eligible individuals.

On June 28th, the Supreme Court ruled in National Federation of Independent Business v. Sebelius, however, that the federal government could not withhold current levels of Medicaid funding to force the Medicaid expansion.  Instead, it could only withhold the additional funds it planned to give out, making the Medicaid expansion optional state-by-state.

Based on the Sebelius ruling, the CBO reworked its estimates in a July 2012 report that concluded, because of the Supreme Court ruling, six million fewer people would qualify for Medicaid than previously estimated. Of those six million, however, an additional three million would qualify for the new exchanges.  Therefore, the net loss of insured people thanks to the Supreme Court ruling was three million.  In updating their numbers, the CBO did not attempt to guess which states would or would not expand their Medicaid program, but attempted to “reflect an assessment of the probabilities of different outcomes…and are, in their judgment, in the middle of the distribution of possible outcomes.”

These figures are being discussed again because of a June 2013 study by HealthAffairs, which did attempt to guess state-by-state who would be expanding their Medicaid programs and its affect on the uninsured.  They note that, after the Supreme Court decision, 14 states had announced their intent to opt-out of the expansion, six were undecided, three were leaning against the expansion, and two were leaning toward the expansion.  They found that if all currently undecided states opted in, 29.8 million people would remain uninsured by 2016 (compared to 26 million people uninsured according to the CBO by the same year).  That number would rise to 31 million if all of the undecided states opted out.  They also note that around 80% of those uninsured would be US citizens, and no matter which way the undecided states go, 4.3 million children and 1 million veterans would likely remain uninsured.

As of a September 17, 2013 a report by the Advisory Board Company found that the number of undecided and not participating states had increased. They found 15 (up from 14) states firm in opting out of expansion, seven (three) leaning against expansion, five (six) undecided or exploring an alternative model, four (two) leaning towards expansion, and overall 20 (25) firmly participating.  Therefore, the percentage of states that could be opting out has increased from 34-46% to 44-54% of states.  This will in turn increase the number of uninsured people.  As the merits of the ACA continue to be debated on Capitol Hill in light of the budget debate, and more states become firm in their plans to opt-in or opt-out of the Medicaid expansion, the number of those who are ultimately uninsured could rise and continue to undermine the goal of universal health care.


Plan B May Be Over the Counter Now

A US federal judge ruled on April 5th that Plan B and emergency contraceptives be made available to minors without the need of a prescription.

Prior to the Obama Administration’s 2011 decision to restrict access for anyone under the age of 17, the Food and Drug Administration recommended that Plan B be made available without a prescription for all women of any age. Judge Edward R. Korman determined that there was no reason to restrict access, even to minors, because Plan B is “among the safest drugs sold over the counter.”

Although the decision to restrict access was likely an attempt to avoid angering religious groups who claim the drug is an abortifacient, science shows that the drug prevents implantation on the uterine wall. A woman is not considered pregnant until the fertilized egg has implanted itself in her uterus’ wall.

Women still face the common problems of buying the drug: Pharmacists sometimes lie and claim even adults need a prescription, refuse to sell to men, or refuse to sell at all.

Komen’s decision will appeal to the Second Circuit, which is one of the most liberal in the country.