Gene therapies have the potential to dramatically improve the lives of millions of Americans living with life-threatening diseases. Watch the video to learn how policy obstacles are standing in the way of making gene therapies a reality for millions. [vc_video link="https://www.youtube.com/watch?v=eCW-E9i_jP8"]...
Congress could soon vote on legislation that would gut America’s intellectual property laws. The bill isn’t just bad news for big pharmaceutical companies that hold lucrative patents. It’s terrible news for patients — medical research spending would dry up without strong patent protections. Americans could lose out on cures for cancer, heart disease, and other deadly chronic conditions. The proposed law would target patented drugs sold through Medicare’s Part D prescription drug program. Right now, private insurance companies design Part D plans...
By Mia Zaharna, MD and Henry I. Miller, M.S., M.D. Insomnia is a common and often frustrating sleep disorder that can make it hard to fall asleep, to stay asleep, or cause you to wake up too early and not be able to get back to sleep. It can adversely affect your health, work performance, and quality of life. It can also be hard to treat, even by experts — but help, in the form of technology, is on the way. Although...
Despite the constant barrage of negative news, this is an exciting time for patients. Truly innovative medicines and gene therapies are under development. New gene therapies are particularly exciting because these therapies do not just treat diseases – they often cure them by fixing underlying genetic defects, frequently with only one dose. There is great optimism that these fundamentally new therapies will, ultimately, cure diseases like hemophilia and sickle cell disease, and even many ultra-rare diseases that were previously untreatable. Take...
Government solutions often come with a price. For the America Invents Act (AIA), this price was an unintended impediment to medical innovation. Proposed legislation known as the Hatch-Waxman Integrity Act can reduce these costs, if Congress takes advantage of the opportunity. The problem of patent trolls plaguing Silicon Valley was a well-documented, and troubling, problem. Patent trolls are entities that obtain patents, often obscure patents, for the sole purpose of filing lawsuits in court. The troll then uses the threat of...
Sen. Bernie Sanders, I-Vt., and Rep. Ro Khanna, D-Calif., recently proposed bills that would impose price controls on prescription drugs. The legislation would require pharmaceutical companies to sell their medicines in the United States for no more than the median price charged in five countries – Canada, the United Kingdom, France, Germany, and Japan. If companies refuse to cut prices in the United States, the federal government could revoke existing patents or market exclusivities and allow generic drug manufacturers to sell knockoff copies...
Animal products used in or on humans have been an invaluable part of medical practice for almost a century. Examples include animal insulins to treat diabetes and pig heart valves transplanted into humans. A related medical breakthrough was just published on Dec. 5 in the journal "Nature": Genetically modified pig hearts transplanted into baboons can function long-term, a major step towards the clinical use of pig donor hearts in human patients. But suppose bioethicists objected, on the grounds that such mixing of...
Seasonal outbreaks of the flu cause thousands of deaths even in a good year, and the last flu season, 2017-2018, was a terrible one. It killed 80,000 Americans and sent 900,000 to the hospital, making it the worst influenza season in decades. Data from the Centers for Disease Control and Prevention (CDC), show how much of an outlier it was: Previously, seasonal outbreaks since 2010, had killed between 12,000 and 56,000 and caused between 140,000 and 710,000 hospitalizations. Statistics like that can seem impersonal,...
Patients could save time and money if federal law is reformed to allow pharmacists to administer all CDC recommended vaccines. Right now, pharmacists are subject to a patchwork of laws in each state that are effectively barriers to vaccines being administered at neighborhood pharmacies. This access barrier exists even though pharmacists receive vaccination training in their pharmacy school education....
Striking the right regulatory balance for pharmaceuticals is no easy task. On the one hand, policy should promote drug affordability by encouraging robust competition. On the other hand, policy should encourage future innovations by granting these drugs temporary market exclusivity. While these goals appear contradictory, the federal government’s drug approval process has reasonably balanced these competing interests for many years. This approval process is based on legislation passed in 1984 colloquially known as the Hatch-Waxman Act. One of the primary goals of...
Disincentives plague the U.S. health care system, driving costs higher and the quality of care lower. Improving health outcomes requires reforms that remove these disincentives. With respect to health insurers, this means returning payers to their proper role of providing effective risk management services to patients. In contrast to other insurance markets, health insurers degrade their ability to cover medical emergencies because they cover the costs of routine expenditures that are not risks in the true sense of the word. If other...
The deaths of two patients at the Ronald Reagan UCLA Medical Center in early 2015 were blamed in part on a drug-resistant superbug. Two years earlier, the Centers for Disease Control and Prevention predicted that a “nightmare” was coming in the form of the killer bacteria carbapenem-resistant Enterobacteriaceae, also known as CRE. The bad dream was a grave reality for those patients who had gone to the hospital to merely undergo endoscopies and were likely infected by CRE from equipment...
Between 2006 and 2015 the S&P 500 grew 7.25% per year on average–if you had invested $100 in the stock market in the beginning of 2006 it would be worth nearly $188 by the end of 2015. Sounds great. But, any investor during that period would surely feel less confident. After all, following the 36% decline in stock prices in 2008, a nervous investor might inaccurately conclude that the future is grim and that stock prices will never grow again. Alternatively, following the...
Innovations in the pharmaceutical industry have significantly improved health outcomes for patients and have made important contributions to the U.S. economy. Provisions in the 21st Century Cures bill would help address these problems by accelerating the approval process for innovative pharmaceutical drugs and as a result, extend the effective patent lives for new pharmaceutical innovations....