| 来源类型 | Article |
| 规范类型 | 评论 |
| Bernie blocks the FDA—and shows the folly of single payer | |
| Joel M. Zinberg; Thomas Peter Stossel | |
| 发表日期 | 2016-02-16 |
| 出版年 | 2016 |
| 语种 | 英语 |
| 摘要 | By advocating “Medicare for all,” Sen. Bernie Sanders has rekindled the progressive dream of government-run health care. Yet Washington can’t even manage the health bureaucracy it already controls. Take a look at the sad circus surrounding the doctor nominated to lead the Food and Drug Administration—a qualified man whose confirmation is being blocked for political reasons. Last September the White House nominated Robert Califf, an FDA deputy commissioner since early 2015. Previously a heart specialist at Duke University’s prestigious medical school, Dr. Califf has directed many clinical trials of drugs under evaluation for FDA approval. He has also sat on several FDA advisory committees. It is difficult to imagine a better candidate to lead the FDA through the serious reforms it desperately needs. Yet politics have prevailed over common sense. Dr. Califf’s confirmation is being blocked by a “hold,” a procedural maneuver that allows a single senator to prevent his colleagues from considering a nomination. Who has put a hold on Dr. Califf? None other than Bernie Sanders. “Dr. Califf’s extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies,” Sen. Sanders said last month in a statement. “We need someone who will work to substantially lower drug prices, implement rules to safely import brand-name drugs from Canada and hold companies accountable who defraud our government.” These allegations are misleading. The FDA’s statutory mandate is to review clinical trials submitted by manufacturers and approve drugs for use based on their therapeutic effectiveness and safety. The commissioner has no authority to regulate drug prices. Nor can he, by administrative fiat, alter the laws governing the importation of drugs from abroad. Even if the commissioner had such powers, using them would be a huge mistake. Developing new drugs is tremendously difficult and risky. Since 1950, the number of new drugs approved per billion dollars of research has fallen 80-fold, halving about every nine years, according to a 2012 study in Nature Reviews Drug Discovery. The profound complexity of biology ensures that only about one of every 10 drugs in development will eventually gain approval. Imposing price controls in the U.S.—or allowing importation of cheap drugs from Canada, which controls prices—would greatly decrease the return that manufacturers receive for undertaking risky drug development. Many would scale back new research. Pharmaceutical innovation would slow to a crawl. That said, an FDA commissioner like Dr. Califf could help patients in real ways, contrary to Sen. Sanders’s aspersions. A commissioner with experience in the industry and clinical research could streamline the process and expedite the approval of lifesaving drugs. He would also be equipped to uncover and redress any questionable industry practices. Even the editors of the New England Journal of Medicine, hardly friends of the pharmaceutical industry, have urged the Senate to confirm Dr. Califf “as quickly as possible.” Their extensive investigation of his published studies from industry-sponsored drug trials found no evidence of favoritism. Given his record, the editors wrote, “it is impossible to argue that Califf has a pro-industry bias.” Sen. Sanders isn’t alone in blocking Dr. Califf. Sen. Edward Markey (D, Mass.) has also placed a hold on the nomination. Citing widespread opioid addiction, Mr. Markey demands that the FDA reconsider its 2015 guidelines on the pediatric use of prescription opioids. Abuse of opioids is indeed serious. But Sen. Markey’s maneuver is pure grandstanding: Pediatricians have always been able to prescribe opioids for their patients. All the FDA did was establish recommendations for how to administer OxyContin to teenage patients suffering from severe, otherwise untreatable pain. Sen. Lisa Murkowski (R., Alaska) says she will hold Dr. Califf’s nomination until the FDA agrees to require labeling for genetically modified salmon. She is pandering to her home state’s fishing industry. This mess provides a window into what a completely government-run health-care system would look like. Politicians would have license to micromanage the drugs and services that physicians provide and patients receive. The popular passions of the day would trump science. That isn’t a future anyone should fight for. |
| 主题 | Health Care ; Economics ; Health Economics |
| 标签 | Bernie Sanders ; FDA ; health insurance ; Medicare ; Presidential Election |
| URL | https://www.aei.org/articles/bernie-blocks-the-fda-and-shows-the-folly-of-single-payer/ |
| 来源智库 | American Enterprise Institute (United States) |
| 资源类型 | 智库出版物 |
| 条目标识符 | http://119.78.100.153/handle/2XGU8XDN/260106 |
| 推荐引用方式 GB/T 7714 | Joel M. Zinberg,Thomas Peter Stossel. Bernie blocks the FDA—and shows the folly of single payer. 2016. |
| 条目包含的文件 | 条目无相关文件。 | |||||
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