Proposed CMS Sanctions Threaten Theranos’ Future

By Katherine Kwong

The news for blood testing company Theranos has gotten even worse since this blog’s last discussion of the company’s woes. Despite the company’s statements at the end of March that it would correct all of the issues CMS had found, new reports have emerged that Theranos’ California lab may see its federal license revoked. Additionally, Theranos’ founder, Elizabeth Holmes, and Theranos’ president, Sunny Balwani, may be banned from owning or operating any testing laboratories for two years. These potential sanctions have been proposed after regulators concluded Theranos has failed to adequately address concerns raised about its tests by the Centers for Medicare and Medicaid Services (CMS).

How did Theranos get to this point? Continue reading

Additional Troubles for Theranos

By Katherine Kwong

The onslaught of bad news for Theranos, the start-up laboratory services company plagued with troubles since last October, continued this week with a new round of reports and press coverage. First, on March 28, the Journal of Clinical Investigation published an article that found that Theranos’ tests tended to produce more irregular results than those of two other laboratory services companies. Then, on March 31, an inspection report by the Centers for Medicare and Medicaid Services was released, revealing numerous problems at Theranos that led to quality control problems, possibly leading to inaccurate test results for patients. The article and report both raise additional questions about Theranos’ claims and long-term viability – a steep letdown from early hype about the company, which promised to revolutionize the laboratory testing industry. The story of Theranos’ troubles highlights how scientific flaws and regulatory mishaps can lead to serious problems for companies seeking to innovate in the health sciences space.

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Data Mining and Pregnancy Prediction

By Katherine Kwong

Our private health decisions may not be as private as we’d like to think. A recent article in the Wall Street Journal revealed a potentially uncomfortable situation: employers using health care analytics companies to mine employees’ health data to determine which employees may be about to make certain health decisions.

While this type of data analytics can be used to predict a variety of health conditions (ranging from an increased risk of diabetes to back surgery to pregnancy), the most attention-grabbing example discussed was pregnancy. By obtaining permission to analyze employees’ medical information, companies such as Castlight are able to look at factors such as search queries and whether employees have been filling their birth control prescriptions to predict pregnancies. Some commentators expressed concerns that this type of information could be used by companies in improper ways. Continue reading

Studies Find ACA Did Not Lead to Substantial Increases in Part-Time Employment

By Katherine Kwong

Analysts from all over the political spectrum have long suggested that the Affordable Care Act’s provisions could lead to a reduction in employment numbers. New research suggests that contrary to these expectations, the available data do not support claims that the ACA would lead to a substantial shift from full-time workers to part-time workers. The current evidence also does not support claims that there would be substantially more part-time workers and people leaving the workforce due to the ACA’s provisions expanding Medicaid eligibility.

Many politicians have specifically expressed concern that the ACA’s requirement that companies with 100 or more employees provide health insurance to employees working 30 or more hours per week would lead to companies shifting employees from full-time work to part-time. Republican presidential candidates including Ted Cruz and Donald Trump have stated that they believe Obamacare makes more workers part-time instead of full-time. While campaigning in Iowa, even Hilary Clinton said she believes the ACA created “some unfortunate disincentives that discourage full-time employment.” Continue reading

The Ongoing Push for E-Cigarette Regulations

By Katherine Kwong

Last week, the American Academy of Pediatrics publicly joined the group of advocates for federal regulations on e-cigarettes. The AAP urged the government to ban the sale of e-cigarettes to everyone under age 21 and prohibit advertising to minors, and advocated for high taxes on e-cigarette products similar to those on other tobacco products. In its announcement, the AAP cited developing brains’ vulnerability to nicotine and the potential harms to long-term health as reasons for its recommendations to keep e-cigarettes away from youths. It also recommended that smoke-free laws governing secondhand smoke explicitly include e-cigarettes, saying, “[t]he aerosol emitted from e-cigarettes is not harmless; it contains a variety of toxic chemicals, including some carcinogens and significant amounts of nicotine.”

A recently released poll found that a majority of Americans (57%) believe e-cigarettes should be regulated like tobacco products, while less than 25% of respondents felt they should not be. The Food and Drug Administration proposed e-cigarette regulations in 2014, and recently sent the regulations to the Office of Management and Budget for review. While the final form of the regulations is still unknown, the proposal banned the sale of e-cigarettes to minors and required e-cigarette labels include a list of ingredients and a disclosure that they contain nicotine.

There is growing concern about the potential health risks posed by e-cigarettes. Advocates for restrictions on e-cigarettes have long warned that unregulated e-cigarettes frequently expose users to the harmful effects of nicotine, as well as toxic chemicals such as formaldehyde, benzene, and other carcinogens. There have also been warnings about the risk that e-cigarette use may lead to greater social acceptance of smoking and higher rates of tobacco use. (Despite frequent claims that e-cigarettes may help with smoking cessation, longitudinal studies consistently find no evidence that e-cigarette use increases quitting rates.) Anecdotal evidence has linked e-cigarette use to pneumonia and other lung problems. Forty percent of e-cigarette users reported having health concerns about their use.

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23andMe Releases Transparency Report About Law Enforcement Requests for Customers’ Data

By Katherine Kwong

The direct-to-consumer genetic testing company 23andMe was widely discussed in the news recently after it announced it would resume providing health information to customers. Less widely reported was another important announcement: for what appears to be the first time, 23andMe has released a public report about the number of requests it has received from law enforcement seeking its customers’ genetic information. According to the Transparency Report, 23andMe has received four requests for user data from law enforcement, with five different affected users.

Although 23andMe has thus far successfully fought off all of the law enforcement requests for its users’ data, there has long been concern about the potential release of 23andMe’s customers’ information to law enforcement. The 23andMe Privacy Statement states, “23andMe will preserve and disclose any and all information to law enforcement agencies” when it believes it is required to do so. Even though 23andMe has not yet disclosed any of its users’ information, the day may soon come when it is required to do so. That disclosure could have significant impacts for not only users who consented to the use of their data, but for users’ families, who may be implicated through familial DNA searches.

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Artemisinin: Worthy of Nobel Prize, but Growing Concerns About Resistance

Artemisinin, a drug used to treat malaria, has been a recent topic of public discussion after its discovery was recognized with the Nobel Prize in Physiology or Medicine on October 5. The 2015 prize was awarded to three researchers who developed treatments for parasite-caused diseases, with half the award going to Youyou Tu, who is credited with the discovery of artemisinin. Artemisinin has benefited hundreds of millions of people around the world. Yet the recognition for artemisinin’s discovery comes at a time when public health officials are becoming more concerned about its ongoing effectiveness and struggling to implement policies to slow the spread of artemisinin resistance. Continue reading

Presidential Campaigns Focus on Drug Costs

By Katherine Kwong

Drug prices have become a hot topic on the presidential campaign trail following recent stories such as the sudden spike in price from $13.50 to $750 for the parasitic infection treatment Daraprim. This story is the latest example of a growing number of complaints about steep increases and high prices for many drugs, including those used to treat multiple sclerosis and cancer, as well as commonly-used generic drugs used to treat everything from high cholesterol to bacterial infections.

In contrast with the Republican presidential candidates, who have generally not supported additional government regulation of drug pricing, Democratic presidential candidates responded to the Daraprim story by urging greater government action to lower drug costs.

Hillary Clinton cited Daraprim as an example when unveiling a proposal to cap drug costs to $250 per month, require pharmaceutical companies to spend a minimum amount on research and development, and allow Medicare to negotiate drug prices. She would also end tax credits for drug advertising to consumers and allow the importation of drugs from other countries.

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Introducing the 2015-2016 Petrie-Flom Student Fellows

The Petrie-Flom Center is pleased to welcome our new 2015-2016 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research. Continue reading