Category: Blog

Cancer patients, and patients with a wide range of other ailments, may not be receiving the best possible medicine because the required drugs are in shortage.  The prescription drug market is consistently afflicted with shortages, both minor and major.  Each shortage can affect one particular drug, or a range of drugs within a class.  In 2011, the United States experienced 251 drug shortages. In the same year, 183 (nearly 75%) of these shortages were of sterile injectable drugs, most commonly used for cancer treatments.  (FDA Factsheet)  Doctors do not have the option to prescribe the drugs they believe to work best because they are unavailable.  (The New York Times)

Manufacturing costs are a major contributor to the problem.  Sterile injectable drugs are very costly to make, and thus not many companies are willing to take the risk of setting up facilities to make them.  Further, the facilities that make such medicines are subject to many regulatory rules, including caps on drug prices. This means that, even when there is strong market demand for more product, manufacturers may not be able to afford to produce them, Plainly said, these drugs do not become more expensive when supply is at issue, as they might in an unregulated market, they become scarce. The manufacturing web is so fragile that a certain factory closing can extend a shortage for several months or even years.  (Medscape)

The prescription drug market is “characterized by sporadic shortages of individual drugs and occasional periods during which many drugs in a class are in shortage,” and few legislative or regulatory solutions have made a difference in solving the problem.  (ASPE Brief)  The Food and Drug Administration (FDA) takes measures to prevent and solve these shortages, which include working closely with drug manufacturers to help restore availability and working with other potential manufacturers to encourage them  to increase production to prevent future shortages.  (FDA.gov)  Unfortunately for FDA, its power is limited, and legislative response to this problem has been insufficient.

In 2012, Congress passed the Food and Drug Safety and Innovation Act of 2012 (FDASIA).  Title X of that Act is committed to the issue of drug shortages, and, in part, requires that manufacturers give the FDA prior notification when a shortage is predicted.  Other requirements laid out in Title X include allowances for expedited FDA review of drugs that may help alleviate a shortage, creating an FDA task force dedicated to the issue of shortages, maintaining a drug shortages list, agency analysis of manufacturing quotas (including the ability to change the quotas if a particular drug seems likely to be in shortage), and allowances for hospital repackaging of drugs so that they may be distributed in a more efficient way.  (FDASIA 2012 Summary)

Title X puts forth ideas that could potentially solve part or all of the shortages problem, but some of these measures have flaws that make them potentially useless.  FDASIA undercuts itself often.  For example, section 506D of Title X mandates the creation of a drug shortages taskforce.  The taskforce is to create a strategic plan which should include measures to increase communication between manufacturers and FDA.  The taskforce should also ensure that the Secretary of Health and Human Services considers shortages when executing regulatory actions, considers the implications shortages have on clinical trials, and examines opportunities for more manufacturing partnerships.  Given enough time, these steps could create a useful taskforce, especially if it fosters improved communications between manufacturers and the agency regulating them. But the taskforce is simply not given the time required to become fully ingrained in the market/regulation system.  Section 506(f) is a sunset provision, meaning that the structure and purpose of the taskforce are to end exactly five years after the bill was enacted.  This means that even if it begins to succeed, the taskforce will cease its operations at the end of five years.  It has, essentially, been hobbled with “lame duck” status since the very instant it was created.  Though sunset provisions are not uncommon in legislative acts, one as short as five years does not give the taskforce much time to assert itself before losing its mandate.  Generally, sunset provisions are meant to prevent outdated laws in the far future, but here the sunset provision renders the taskforce useless in a much smaller timeframe.

Despite the other contradictory measures, at least one part of the FDASIA has been proven effective: the early notice requirement.  This requirement forces manufacturers to inform FDA if they anticipate a shortage to be imminent, and has been effective in helping to coordinate efforts to curb existing shortages or even prevent them outright.  The effectiveness of the plan can be seen in the numbers: new shortages are at the lowest they have been since 2006.  (Salon)  It is possible that, given enough time, other sections of the act will prove equally or more effective, and in the future shortages will not be as much of a burden on the medical community as they currently are.  But unless new ideas and initiatives are given more time to become effective and do their jobs, drug shortages will remain a serious problem for the medical community.

HealthCare.gov, the online marketplace for enrolling in the health insurance exchanges implemented by the 2010 PPACA, has left the Obama administration with egg on its face after sputtering to life on October 1, 2013. A series of technical glitches has brought unwanted attention to an already beleaguered initiative and has precipitated calls for the resignation of Kathleen Sebelius, Secretary of the Department of Health and Human Services (USA Today).

In the first five days of operation, 9.5 million unique users visited HealthCare.gov to shop for insurance. Only 36,000 completed the enrollment process (The Hill). This high rate of failure discouraged potential users and traffic on the site dwindled.

The administration has at least been able to blame last weekend’s hiccup on Verizon, the operator of the federal data hub responsible for running the enrollment website (Politico). The hub failed on Sunday, blocking any potential enrollees in the federal exchange and those of 14 states and D.C., but returned to service on Monday morning (Reuters).

This, one of the latest in a string of technological embarrassments, came after a Friday announcement that the administration indicated it does not expect to fully resolve glitches until the end of November (Washington Post). The same announcement revealed that management of HealthCare.gov had been ceded to a private contractor, Quality Software Services Inc. (QSSI), based in Columbia, MD.

Numerous errors have prevented most would-be shoppers in the online marketplace from completing their enrollment. The administration has blamed overloading of the web portal, yet contractors involved in development of the site point to insufficient testing of the site prior to launch (AP).

Firms such as QSSI and CGI Federal also expressed bewilderment that the administration directed designers to prevent HealthCare.gov users from shopping anonymously. This means that, while users of most e-commerce sites are able to shop online and set up accounts only at check out, HealthCare.gov shoppers must create accounts before even viewing available rates. HHS indicated that users are only able to see if they are eligible for tax credits once signed up and thus shopping without an account, or “window shopping,” would prevent users from properly evaluating rates (McClatchey). The outcome was greater site traffic and overloaded servers. Limited window shopping is now available.

The Obama administration has yet to reveal any enrollment figures, though states operating their own exchanges, such as Connecticut, Kentucky, Maryland, and Washington have been forthcoming with enrollment data (ProPublica). Some analysts suspect the administration is embarrassed by modest numbers and is waiting until those improve to publish results. Obama has made no secret of his goals for the exchanges program and is undoubtedly underwhelmed by current progress towards those targets.

For a number of reasons, compiling enrollment statistics is difficult. For example, enrollment for a user is only technically complete once the first month of insurance has been paid for (Atlantic Wire). In the first two weeks of operation for the 14 state-run health care exchanges, CNN discovered that 20,994 users had signed up and paid and another 96,980 had signed up but not yet paid (CNN).

Sebelius faced questioning from the House Energy and Commerce Committee on Wednesday, though her post seems secure for the moment (CNN). She admitted frustration and stated more than once: “I am responsible for the implementation of the Affordable Care Act” (Wall Street Journal). President Obama has expressed support for the under-fire Secretary as well as confidence the problems will be resolved (Politico). Nevertheless, HealthCare.gov crashed during Sebelius’ Congressional testimony (The Hill).

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.

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.

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.