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The Food and Drug Administration may be a science agency, but that does not mean it's always up to medical science. Too often, it makes a bad choice of products that may exacerbate our country's problems, such as the opioid epidemic.
One of us heads the FDA Advisory Committee on Anesthetic and Analgesic Drugs. The other is a former member of the FDA Advisory Committee on Drug Safety. We are concerned about the recent FDA decision to approve another extremely potent opioid.
Two weeks ago, while she was aware that a new version of an opioid, sufentanil, had limited effectiveness and did not present any unique benefits, and that it did not show any benefits. an older version had been misused by health professionals, the agency had approved a new language version of the drug under the brand name Dsuvia. This drug resembles fentanyl, the synthetic opioid that ravages our streets and explodes a lethal overdose – except that Dsuvia is five to ten times more potent.
Why has the agency not fully recognized the dangers of this drug? This can not be due to its effectiveness. In fact, clinical trials have shown that it is much less effective than advertisers claim.
Dsuvia was designed in part to relieve the pain of our soldiers on the battlefield. But the clinical trials of the drug did not reflect the type of medical conditions – such as trauma or massive shock – for which it would be used in a real military context. Instead, Dsuvia has been tested on patients as a result of minor surgical procedures. Dsuvia needed an average of an hour to maintain the clinically significant level of pain relief, suggesting that it would not meet the needs of injured soldiers.
Rejecting Dsuvia should have been obvious. An intravenous version of sufentanil approved by the FDA is used by clinicians only in hospital settings for general anesthesia and epidurals during labor and delivery for over 20 years. But research shows that, with fentanyl, it is one of the two most misused and abused medications by anesthesiologists. One of us (Brown) has witnessed the power of the drug and tried to resuscitate doctors and other health professionals, some successfully, but others not.
Because of its power, the dosage volume, whether in version IV or in the tiny form of pill under the tongue, is quite small. It lends itself to the theft of medical personnel for personal purposes, possibly to sell it. We anticipate that such misappropriation, abuse and death will occur in the first months of its availability on the market.
Still, the process by which the FDA has approved this drug raises serious questions. Two months before the Oct. 12 advisory committee meeting at which Dsuvia was reviewed, the FDA disavowed members of its advisory committee on the safety of drugs that had been invited, with the exception of three D & Cs. Among them, as one of us (Wolfe), a member of the committee, said. favorable vote for the drug more likely due to decreased focus on safety. A spokesperson for the agency said the contribution of drug safety and risk experts was "taken very seriously," even though most members of the drug safety committee were not present.
The army, which has partially funded clinical trials on Dsuvia, does it know that there is no evidence that these tests confirm the unique utility of the drug on a battlefield? Is it comfortable to use a drug that may not be as effective as the available painkillers, such as intravenous morphine? No competent doctor would use a tongue painkiller that takes one hour to achieve significant pain relief if it can, instead, quickly insert an IV line and get pain relief in minutes with more opioids. old.
Dsuvia is going to add to the flow of opioids that feed the epidemic. His approval sends another sign that the FDA does not recognize the risk to public health of encouraging more opioids rather than offering incentives for the creation of new classes of non-painkillers. effective and safe opioids.
Opioids can provide safe relief for acute pain when they are prescribed rationally, but all opioids can cause serious damage. Our experience over the last decade shows that the more opioids available, the greater the risk of harm to patients and the general public.
The FDA too often encourages the pharmaceutical industry to invest in more opioids. When many of these products need to be reviewed, the agency seems to believe that there is no choice but to continue to flood the market. When asked why, the agency deplores the obligation to maintain a level playing field. In too many cases, the product must appear only to gain the approval of an organization that denies its complicity in creating or promoting the opioid fiasco and continues to ask questions about opioid regulation to which many people from the outside have responded. internal experts.
Too often, the agency plays a deadly game to maintain a level playing field for the industry while not guaranteeing the same for the public. It is high time to ask the difficult question: "When will they ever learn?
Brown is Professor of Anesthesiology and Paediatrics at the University of Kentucky and Chair of the Food and Drug Administration's Advisory Committee on Anesthetic and Analgesic Drugs. Wolfe is the founder and senior advisor of the Public Citizen Health Research Group.
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