How The FDA Supercharged the Opioid Epidemic by Approving Battlefield Painkiller Dsuvia

Executive Summary

• The opioid epidemic has ravaged the US, but the FDA still thinks stronger opioids are needed.

Introduction

It is incredible to see what drugs FDA decided to approve. The article “How Effective Are the Covid 19 Vaccines” covered that the covid vaccines should never have been approved. The FDA has also been continually enlarging the availability of opioids. One of these recent approvals is for the battlefield opioid called Dsuvia.

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The FDA States There is a Need for Stronger Opioids?

The FDA approved a new opioid 10x stronger than the present opioids. But again, the approval is not for the drug, but the submitter is a pharmaceutical company called AcelRX Pharmaceuticals, which checked the FDA’s boxes. It is doubtful that the FDA even read this study or that the side effects were hidden entirely from it. The Pentagon developed this drug for battlefield injuries, which the FDA believes is appropriate for civilian use. 

This is further explained in the following quotation.

The FDA has approved a new sublingual formulation of sufentanil, Dsuvia, for the management of acute pain in adults in medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. The drug is supplied in a 30 microgram tablet in a single-dose, prefilled applicator for administration by a healthcare professional, and it will not be available in retail pharmacies or for outpatient use.

The drug was developed in collaboration with the Department of Defense with the military population in mind. AcelRx Pharmaceticals, maker of the drug, explains that, in many care settings—including battlefield settings—patients may not have readily available access to intravenous (IV) treatments for pain, and intramuscular injections (currently the standard of care for battlefield patients) are not as effective as IV options at providing timely relief, and may not be effective in cases of severe trauma that involves hypovolemic shock.

The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment. – AJMC

This is almost amusing — the idea that a drug provided more pain alleviation than no drug at all.

Naturally, the drug’s approval was ludicrous, but it needed to be defended. And this was done by Pharmacy Times, a shill for pharmaceutical companies.

The outcry occurred almost immediately. Politicians and other critics could not believe that the FDA would approve such a potent opioid, given the addiction and overdose crisis.

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” Sidney Wolfe, MD, cofounder of and senior advisor to nonprofit Public Citizen’s Health Research Group, said in a statement. – Pharmacy Times

Notice that pharmacy times assumes that the drug will never find its way out of these supervised settings, even though previous opioid prescriptions have been routinely overprescribed by “pill mills.” As pharma companies pay Pharmacy Times, they don’t point out the history of opioid prescribing practices. This author, Cmdr John Burke, addresses this issue and then lies about it.

The RADARS system is a program that I have been a part of for many years with the Science Advisory Board. The RADARS system will put the new drug into a group that is monitored by several surveys, one of which is the drug diversion survey. This survey is compiled by several hundred law enforcement agencies across the country that report to the system quarterly. If Dsuvia shows up in the hands of law enforcement, it will be easily and quickly identified. I do not expect that to happen, but it is one example of the safeguards that will accompany the drug. – Pharmacy Times

Of course, he won’t say anything against RADARS, as he is on the board. However, Cmdr John Burke does not seem interested in discussing how the US has such a massive opioid problem if the systems are so good.

Constant Lies by The Head of the FDA for Justifying Approval of Dsuvia.

This is expressed by Public Citizen, which is one of the best public interest groups covering the areas of drugs. Public Citizen is one of the few watchdog groups with enough knowledge of pharmaceuticals to challenge Big Pharma.

In a statement issued on the day the agency approved the medication, Gottlieb cited nonexistent benefits for Dsuvia and omitted known risks. Gottlieb said that Dsuvia could help treat soldiers “on the battlefield”; however, the use of Dsuvia in any setting of severe trauma-induced pain and shock, as encountered in the battlefield, has never been studied. Clinical trials of the medication have been conducted only on patients who had undergone minor surgical procedures. But Dsuvia can take up to an hour to achieve clinically meaningful pain relief, unlike intravenous pain relief provided by other medications, suggesting the pill would not meet either the needs of seriously injured soldiers or even post-operative patients in hospitals. – Public Citizen