Once upon a time, in a faraway land, there was a young law student. She felt lost and alone, realizing that she didn’t want to practice at Big Soulless Law Firm, Inc, but unsure about what else to do.
She did enjoy her course in public health, however, and wondered if there might be a way to combine this interest with her law degree. After a cursory search of the online catalogue, she ventured into a quiet section of the law library. There, on the bottom shelf, she found a book called Public Health Law: Power, Duty, Restraint, by a certain Lawrence O. Gostin. Well, she thought, that’s a thing. Maybe that’s something I can do.
Fast forward ten years, and that student finished her law degree, got a PhD, and came to work for the O’Neill Institute. She also got sick of writing in the third person.
I’ve only had a year at the O’Neill Institute, but what a year it’s been. Working for the Institute was a dream come true – literally. I could talk about my inspiring colleagues, the interesting and challenging work, or the many food trucks just around the corner from Georgetown Law, but rather than bore you with the details, here’s a roundup of ten favorite memories from my time in DC.
Posted in Uncategorized;
“Right to Try” laws have come into fashion with the success of the beautifully crafted and acted Dallas Buyer’s Club. That the movie was simply a movie with significant historical inaccuracies and that demonized the one drug (AZT) in the film that was actually effective at fighting HIV has apparently been lost on policy makers. Several states – some citing to the movie directly – are now pushing forward with legislation to supposedly improve access to investigational new drugs (INDs) for terminally ill patients. These right to try laws have now passed in Colorado, Missouri, and Louisiana and several more states are considering them. Additionally, federal legislation has recently been introduced that would go even further at a federal level.
The basic outline of these laws will be given below, but it’s important to note here that the “right to try” movement has been pushed forward by the Goldwater Institute and it’s model legislation. This is relevant only to the extent that the Goldwater Institute’s understanding of medical science are severely questionable. In their policy report Everyone Deserves the Right to Try: Empowering the Terminally Ill to Take Control of their Treatment, they state the following:
After the enactment of the FDCA, the FDA began to require pre-market testing for drug safety, however pre-market testing for efficacy was not required until the 1960’s with the passage of the Kefauver-Harris Amendments. The Kefauver-Harris Amendments were enacted as a direct result of worldwide Thalidomide-caused birth defects. Although Thalidomide was sold in 46 countries, it was never approved for sale in the United States due to the FDA’s lingering safety concerns. While over 10,000 children worldwide were born with birth defects attributed to Thalidomide, only 17 of those children were born in the United States, where access to the drug was limited to those patients undergoing the FDA safety trial. The Kefauver-Harris Amendments drastically expanded the FDA’s regulatory authority by requiring drug manufacturers to prove efficacy prior to being approved for sale.
This vast new granting of power was unwarranted. Thalidomide presented a safety problem (over which the FDA already had authority) – not an efficacy problem. As a result of the Kefauver-Harris Amendments, no drug could be sold within the United
States until it had been deemed both safe and effective by the FDA.
In response, the FDA designed a clinical trial process which is substantially the same practice still in place today. During the ensuing 50 years, everything in the medical world — from the way diseases are diagnosed and treated to the way medical records are kept — has been modernized, but the FDA continues to adhere to an approval process that is half a century old.
Since my last post on the Ebola virus merely one week ago, the death toll in West Africa has risen from approximately 600 to close to 1,000, it has reached one more African country (Nigeria), and the first European to contract the virus was admitted to a hospital only yesterday. There are currently over 1,700 cases, and if not contained soon, Ebola will spread to even more countries and continents. Only today, the World Health Organization (WHO) declared the outbreak a “public health emergency of international concern” (PHEIC) in order to “[alert] the world to the need of high vigilance for possible cases of Ebola virus disease.”
“There are no nations! There is only humanity.” — Isaac Asimov (in I, Asimov: A Memoir)
In a tragedy born of gang violence in Honduras, Guatemala, and El Salvador, compounded by poverty, tens of thousands of children, many unaccompanied by an adult, are risking the treacherous journey across Mexico and to the United States.
What would our response be if we were to let human rights, including the right to health, be our primary policy guide? (I leave aside the fact that the United States has signed, but not ratified, the main international treaty containing the right to health, the International Covenant on Economic, Social and Cultural Rights.)
Françoise Barré-Sinoussi, co-chair of the recently concluded 20th International AIDS Conference, believes that “[a]nti-gay laws in Russia, Uganda, Nigeria and other countries around the world will have ‘consequences’ for the continued spread of HIV around the world, potentially dashing hopes of eradicating the virus in the early 21st century.”
Apropos to the theme of the conference, activists, researchers, policymakers, donors, and celebrities challenged the rest of the world to “pick up the pace” to combat discrimination, stigma, and sustain momentum – political and financial – to fight HIV. While scientific, technical, infrastructural, and financial capacity were discussed and deliberated, little attention was paid to issue of legal capacity.
For the most part, lawyers are viewed as extraneous to conversations on health; they are relegated to some shadow world of paper, words, and bureaucracy that at turns frustrates and mystifies all others to no end. Yet, in this instance – where legalized discrimination is not just an active barrier, but also perhaps the greatest barrier to positive health outcomes – more science, more activism, and more money are not enough. A cure for AIDS could be found tomorrow, but the laws and policies that discriminate against gays, criminalize sex work, and prohibit harm reduction programs will ensure that the most vulnerable populations, concurrently the most at-risk populations, will never realize the end of AIDS. Read More
West Africa is currently experiencing the worst Ebola outbreak since the disease’s first appearance in humans in 1976. This time around, what began as one outbreak in Guinea in February has spread to 60 outbreak sites to date. Since then, it has already killed over 600 people and infected nearly 1,100 in Guinea, Liberia, and Sierra Leone combined (although the numbers are thought to be higher than what has been reported). Only a couple of days ago, the head doctor in Sierra Leone, who has treated more than 100 people and has been leading the fight against the disease since it first appeared in the country, has contracted the disease and is currently being treated by Doctors Without Borders (MSF). Only a few days earlier, three of the nurses working with him died from the disease.
Ebola does not necessarily pose the type of global threat that H1N1 represented back in 2009. It is simply not as contagious—it is transmitted through extended direct contact with the infected person’s bodily fluids and the person only becomes contagious when she or he begins to exhibit the symptoms). It is highly fatal (90% mortality rate), and it kills the infected (if left untreated) in an average of ten days. Nevertheless, given that the incubation period (period of time that it takes for symptoms to develop since first being exposed to the virus) can range from two to 21 days, it is possible that a person could hop on a plane and get to another corner of the world before developing any symptoms. Read More
This post originally appeared on Out2Enroll. To learn more please visit www.out2enroll.org or contact Katie Keith at email@example.com. Katie is a former Research Fellow at Georgetown University’s Center on Health Insurance Reforms. She is currently Director of Research at Trimpa Group and a Steering Committee Member of Out2Enroll.
Yesterday, Out2Enroll—a nationwide campaign dedicated to connecting LGBT people with their coverage options—released a new report exploring the extent to which this year’s outreach and enrollment efforts met the needs of the lesbian, gay, bisexual, and transgender (LGBT) community. The report, Key Lessons for LGBT Outreach and Enrollment under the Affordable Care Act, reflects Out2Enroll’s experience as well as interviews with key stakeholders such as navigators, state equality organizations, national membership organizations, and marketplace officials in the District of Columbia, New York, and Washington.
The US Centers for Disease Control and Prevention (CDC) has come under fire this past month for a series of biosafety problems reported by the country’s top government labs. Last week, the CDC released a report reviewing an incident that occurred in early June that involved the unintentional exposure of CDC personnel to potentially viable anthrax. Additional biosafety violations were also disclosed, including the discovery of smallpox vials in a Food and Drug Administration lab and a transfer from a CDC lab to a US Department of Agriculture lab of an avian influenza cross-contaminated with a highly dangerous influenza strain, H5N1. As a result of these incidents, the CDC issued a moratorium on the transfer of biological specimens from the agency’s highest-level biosafety labs, the closure of the two labs involved in the recent breaches, and the appointment of a senior scientist to be the single point of responsibility for lab safety going forward. The CDC has also established an external advisory group to review the incidents and make recommendations for strengthening biosafety in its labs. Read More
Posted in Global Health;
In my last post, I discussed seven things individual consumers can do to stop the spread of antibiotic resistant superbugs. I left out one important element: the need to lobby our government’s leaders to make this issue a priority. This summer, combating antibiotic resistance is making headlines on both the national and international level. On June 25-26, the Netherlands hosted an international conference on antibiotic resistance as a follow-up to a World Health Organization (WHO) report on antimicrobial resistance. On July 1, British Prime Minister David Cameron announced the creation of a new review panel to investigate antibiotic overuse and explore why new drugs are not being developed. And here in the states, the President’s Council of Advisors on Science and Technology (PCAST) will meet tomorrow to discuss its work on antibiotic resistance.
Momentum is building. Pressure from constituents will further influence government to give the threat of antibiotic resistance the attention it deserves. The following list provides six things constituents should nudge government officials at the local, national and international level to consider among their top priorities. Read More
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.