Questions Raised by “TB Andy”

Posted on: July 30, 2007  |   Author: Catriona
Filed Under: Public Health Policy   |   Leave a Comment

Almost two months have passed since the world’s most famous tuberculosis patient, Andrew Speaker, and the acronym “XDR-TB” were headline news. As it turns out, Mr. Speaker does not have XDR-TB, but rather a less severe form of drug-resistant tuberculosis. He has since undergone surgery to remove part of his lung and has been released from the hospital.

It began with a modern day man hunt. In May, Andrew Speaker, a young attorney in Atlanta, received a preliminary diagnosis of drug-resistant tuberculosis. Despite warnings not to travel, Mr. Speaker proceeded with his scheduled wedding and honeymoon in Greece and Italy. When updated test results showed XDR-TB, the Centers for Disease Control and Prevention (CDC) contacted Mr. Speaker in Italy, directed him not to travel, and advised him to turn himself in to Italian authorities. The newlyweds evaded authorities by flying into Canada and driving a rented car across the border. Once in New York, Mr. Speaker voluntarily checked himself into a hospital and was placed under the first federal quarantine order issued since 1963.

The media craze was further amplified when the drama took a turn from a science fiction plot. Mr. Speaker’s new father-in-law works for the CDC as a microbiologist and conducts research on tuberculosis bacteria. The CDC made an official statement that Mr. Speaker did not contract the drug-resistant tuberculosis from the CDC laboratories. Meanwhile, the timeline, the government’s response, and Mr. Speaker’s actions were the subject of two Congressional hearings.

In the dust that has settled since the initial media frenzy, the incident raises several issues and questions concerning the direction and authority of public health officials, communication and cooperation between government departments, drug-resistant tuberculosis, and the resulting media coverage.

First, there are conflicting versions of what was said in the meeting before Mr. Speaker departed for his wedding. Nonetheless, it appears the local health officials and CDC experts should have communicated the risks and options more clearly to Mr. Speaker. While the local health department in Fulton County, Georgia, knew of Mr. Speaker’s travel plans, it did not notify the airlines about the potential threat to public health.

One of the more concerning statements made by the local health department was that it had no authority to isolate or quarantine Mr. Speaker. This begs the question: How prepared is your state to issue and enforce an order of isolation or quarantine? Have state legislators given the public health departments and the police the right tools to respond to public health threats in a timely and efficient manner? The mechanisms that should have been in place to prevent Mr. Speaker from traveling are the same that will be utilized in an act of bioterrorism or natural disaster.

Second, the Speaker debacle also illustrates that there is much room for improvement in communication and cooperation between health and security departments. When the newlywed Speakers arrived at the Canadian-United States border, an official simply dismissed the alert on Mr. Speaker’s passport because “he didn’t look sick.” Obviously, holds on an individual’s passport should not be a matter of personal discretion.

Third, while the media effectively reported the commercial flights that Mr. Speaker boarded, the incessant coverage sensationalized the incident. For example, in the midst of the Speaker incident, headlines read “Are You at Risk for XDR-TB?” Such headlines only serve to instill panic and increase public fear. The CDC reports that in the United State, 49 cases of XDR-TB have been reported since 1993. XDR-TB is more common in people who do not take their tuberculosis medicine regularly, who do not finish their tuberculosis medicine, who develop active tuberculosis after being treated for it in the past, who come from or visit areas of the world with XDR-TB is common, or who have spent considerable time with someone known to have XDR-TB.

Lastly, protecting Americans against drug-resistant tuberculosis is unlikely to be effective even with secure border control, stronger cooperation between departments, and clearer orders from public health officials. Drug-resistant tuberculosis remains the underlying problem. Although curable and once thought to be under control, many, including the World Health Organization (WHO), warn that tuberculosis is spreading in the world’s poorest countries. Moreover, tuberculosis is mutating so that it is resistant to the first and even second line drugs usually prescribed by doctors. Specifically, WHO estimates that one-third of the world’s population is infected with the tuberculosis bacillus. Meanwhile, tuberculosis patients in the United States continue to make headlines. For example, earlier this month, an isolated tuberculosis patient in Arkansas broke a hospital window and fled. He was found two weeks later and returned to isolation.

The Speaker incident should serve as a wake-up call to all parties involved. The questions and issues raised must be addressed, especially at the state and local level, so that our public health system is prepared to respond quickly and accurately to the next threat.

Low Income, Non-Citizens: Insurance and the Struggle to Access Care

Posted on: July 30, 2007  |   Author: Deepa
Filed Under: Access to Care   |   Leave a Comment

With the upcoming presidential elections (or at least the primaries) and the release of Michael Moore’s latest film, Sicko, a lot of attention has once again shifted to access to care in this country. In June of this year, the Kaiser Commission on Medicaid and the Uninsured issued a policy brief addressing the problem of access to care for low-income, non-citizen adults. Often it seems that when access to care is discussed, the focus is primarily on the elderly, single mothers and children. Karyn Schwartz and Samantha Artiga, however, tackle the issue as it relates to non-citizen adults.

In their brief, Schwartz and Artiga state that low-income non-citizen adults have generally poor access to care, which is due primarily to the fact that these individuals are less likely to have insurance.[1] It’s not that these individuals don’t come from working families- in fact, 71 percent of low-income non-citizen adults are from families in which there is at least one full-time worker.[2] The problem is that they have little access to employer-based insurance. Many times, these individuals work at jobs and within industries which have low rates of employer sponsored health insurance.[3]

Additionally, low-income non-citizen adults have limited access to Medicaid coverage as well.[4] Low-income adults have a hard time becoming eligible for Medicaid as it is, and low-income non-citizen adults have an even harder time.  There are additional restrictions on non-citizen adults who apply for Medicaid- legal immigrants, for the most part, are ineligible for Medicaid coverage for the first five years they are in the United States.[5]  There are Emergency Medicaid services available for those individuals (including undocumented immigrants) who quality for Medicaid, except for the immigrant restrictions, but these services do not include any sort of preventative or routine care.[6]

The authors spend some time in the brief discussing the fact that access to health insurance can considerably improve access to health care, leading to better health outcomes.  Research has proven that there is a distinct relationship between health insurance (or lack thereof) and health outcomes.[7]  Individuals who don’t have health insurance are less likely to be able to access much needed health care services, often resulting in poorer health outcomes.[8]  Schwartz and Artiga note that low-income non-citizen adults who had insurance were more likely to have a steady source of health care, more likely to receive preventive care and more likely to have seen some health care provider within the past two years.[9]  They also note some other interesting patterns of health services use by low-income non-citizens.  They note that low-income non-citizen adults are actually less likely to use emergency room services than citizens, relying instead on clinics or community health centers.[10]

In addition to the issue of insurance for low-income non-citizen adults, the authors point out that there are other barriers to accessing care that these individuals face, including both cultural and language barriers.[11]  There are serious access-to-care issues which low-income non-citizen adults must face.  Hopefully, as more attention is given to expanding health care coverage in general, the needs of this group of individuals will also be addressed.

Import Drugs: Are United States Food and Drug Laws Keeping Us Safe?

Posted on: July 25, 2007  |   Author: Amanda
Filed Under: Drug & Device   |   Leave a Comment

The recent execution of Zheng Xiaoyu, the former head of the State Food and Drug Administration in China from 1998 until 2005, has raised questions regarding the safety of food and drug products internationally. During his reign of the SFDA, Zheng took more than $850,000 in bribes to allow companies to slip past food and drug regulations. The administration approved six medications that turned out to be fake, causing dozens of Chinese citizens’ death from the fake or bad drugs and food. (For more information see, “Chinese Applaud Ex-Official’s Excecution” and “China Calls Official’s Execution a Warning Siren” in the LA Times and Reuters respectively). As the execution dominated both television and print news, questions loomed with regard to U.S. Food and Drug laws: Could unsafe or fake drugs enter U.S. interstate commerce?

Food and drug laws in the U.S. were designed to protect consumers from adulterated foods and drugs. With regard to the importation of drugs, the Food and Drug Administration (FDA) works with U.S. Customs to prevent a product from entering interstate commerce if it appears to be misbranded, adulterated or otherwise in violation of the Food, Drug and Cosmetic Act (FDCA). If FDA takes enforcement action against an imported drug that appears to be in violation of the FDCA, the effects of the enforcement on the company and the foreign economy are great. FDA may refuse entry into interstate commerce, which can have a significant impact if the product is perishable or has a short shelf life. FDA may also block importation of all products that meet certain criteria, such as a chemical from a certain country that has been shown to be contaminated on a regular basis. See A Practical Guide to Food and Drug Law and Regulation (Kenneth R. Pina & Wayne L. Pines eds., FDLI 2002) for a more in-depth discussion of U.S. food and drug laws.

However, the FDA only chooses to examine approximately five percent of the imported FDA-regulated products, a small portion of the one to two million FDA-regulated products imported yearly. Therefore, some FDA-regulated products that are misbranded, adulterated or otherwise in violation of the FDCA enter into interstate commerce despite FDA’s enforcement power. These products that fall through the FDA/U.S. Custom’s examination process could potentially harm the public. One such incident occurred recently when toothpaste containing traces of a highly toxic liquid (an ingredient in brake fluid) originating in China was found in stores in New York, New Jersey, Pennsylvania and Maryland. Although no deaths were reported in the United States, Panama saw dozens of deaths after medicine that contained the same liquid was ingested.

As most Americans believe that the government has a significant role to play in protecting public health, FDA should examine alternative methods to ensure that food and drug imports do not violate the FDCA. (A Practical Guide to Food and Drug Law and Regulation (Kenneth R. Pina & Wayne L. Pines eds., FDLI 2002)). Almost ever industrialized nation maintains a regulatory structure similar or comparable to the FDA, although not all countries systems are modeled after the FDA. In most countries, enforcement, product approval, and policymaking are divided among different departments. In recent years, however, FDA has borrowed ideas regarding food and drug laws from other countries and there has been pressure from industry and Congress to look to the more advanced regulatory systems, such as the European Union (EU), Canada, and Japan for guidance. (A Practical Guide to Food and Drug Law and Regulation (Kenneth R. Pina & Wayne L. Pines eds., FDLI 2002)).

In the past, FDA has been reluctant to enter mutual recognition agreements with foreign countries. Although information exchange and other cooperative efforts exists, FDA has chosen to enter into only mutual agreements for inspections and product standards with foreign regulatory agencies that are narrowly confined to certain industry sectors or certain regulations. (A Practical Guide to Food and Drug Law and Regulation (Kenneth R. Pina & Wayne L. Pines eds., FDLI 2002)).

However, a mutual agreement with foreign nations with regards to the inspection process and product standards for food and drugs is an additional step to protect public health and ensure imported products do not violate the FDCA. For example, in 1997 a mutual agreement signed by the U.S. and the EU covers conformity assessments of quality systems for devices and inspections for pharmaceuticals.The agreement allows the EU conformity assessment body (CAB) and the U.S. CAB to monitor food, drugs, and medical devices based on joint requirements and to determine if a lack of equivalent inspection systems exist. In addition, the countries will notify each other if there is a danger to public health or of any reports, corrective actions or recalls. A complete text of the EU/US Mutual Recognition Agreement: The Medical Device Annex is available at http://www.fda.gov/cdrh/mra/introduction.html (last visited July 17, 2007).

A mutual agreement between the U.S. and other foreign countries, like the agreement with the EU, would allow the U.S. to further examine the other country’s food and drug regulatory scheme and therefore, allow additional controls as to what products enter into the U.S. If the country lacks a comparable inspection system, the food or drug product would be banned from entering U.S. commerce. As well, the agreement could establish a system between the countries to communicate food and drug threats to public health, recalls, and corrective actions.

Although mutual agreements may not stop misbranded or adulterated food and drugs from entering the U.S. market, they would indeed add an extra level of protection over the 95 percent of products and drugs that escape examination.

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