Years into America’s opioid epidemic, as the death toll climbed into the hundreds of thousands, the US Food and Drug Administration (FDA) held a hearing to consider a drug company application to approve a new high-strength painkiller.
The FDA assembles advisory committees of doctors and scientists to weigh the arguments for and against new drugs. In 2012, an opioid 10 times more powerful than regular painkillers, Zohydro ER, was on the agenda. By then, no one was in any doubt about the ravages of the worst drug epidemic in US history. So far, it has claimed at least 350,000 lives. Around 150 people a day are dying in a crisis with roots in the push for the mass prescribing of opioid painkillers that took off two decades ago.
The toll was very much on the minds of the doctors on the committee. They peppered the drug maker’s experts with questions about why another pill was needed when the market was flooded with opioids. An anaesthetist wondered if the relatively small number who would benefit from Zohydro was worth the “huge risk” of unleashing another powerful and highly addictive drug. The doctors asked if the pills would end up ruining more lives than they improved.
The senior FDA representative on the committee told the doctors they had no business asking such questions. He admonished the committee, saying that there had to be “a level playing field for industry”. In other words, if one company was making money from a dangerous drug then others were entitled to too, even if it was killing people. Some of the doctors were incredulous. One exclaimed that “the primary thing has to be the public health”, not profits. The committee voted 11-2 against approving Zohydro. A majority of members also said it was not safe even for those it was prescribed to. But the FDA decided it didn’t like the committee’s advice and approved the drug for sale on the grounds that it would benefit a narrow set of patients.
How did it come to this, at a federal agency that built a global reputation in the early 1960s for exacting standards by withholding approval for thalidomide, even as the morning sickness drug was deforming the unborn babies of women across Europe? How did the FDA and other federal agencies fail in their singular purpose of protecting the US public, as the opioid epidemic grew for two decades? The answer carries a warning to the NHS about the risk that creeping privatisation and tangled financial relationships between public health services and big business poses, by opening the door to unwarranted corporate influence over medical policies, practices and standards.
The former head of the FDA, Margaret Hamburg, used the federal agency to run a massive conspiracy of racketeering and fraud in order to generate millions of dollars in drug company profits for her husband's hedge fund firm, alleges a damning lawsuit filed in the United States District Court for the District of Columbia. The lawsuit alleges that while acting as FDA commissioner, Margaret Hamburg engaged in a wide-ranging conspiracy to approve an extremely dangerous drug known to cause severe (and even deadly) side effects, in order to financially benefit her husband's hedge fund which held very large financial positions in Johnson & Johnson, makers of the drug. "Defendants, each and every one of them, operated a criminal conspiracy at least between the years 2009 to 2015 to fraudulently suppress warnings about the devastating effects of Levaquin," says the complaint.
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