WASHINGTON (AP) — Dr. Vinay Prasad, a well-known critic of the pharmaceutical industry and COVID-19 policies, has been appointed to lead the U.S. Food and Drug Administration’s (FDA) program for vaccines and biotech drugs.

FDA Commissioner Dr. Marty Makary made the announcement on Tuesday, acknowledging Prasad’s “long and distinguished history in medicine.” This move marks a significant shift in leadership, as Prasad is stepping into a role traditionally held by a career scientist at the FDA, raising questions about how this might impact vaccine approval processes.

Prasad, who has long been vocal in his opposition to various pharmaceutical industry practices, is the latest figure from the medical and political fringes to join the federal government under President Donald Trump. His appointment, however, has sparked concerns over whether new therapies will face heightened scrutiny, potentially slowing down approval processes for vaccines and other critical treatments.

Prasad takes over from Dr. Peter Marks, the FDA’s previous vaccine chief, who resigned in March following disagreements with Health Secretary Robert F. Kennedy Jr. over vaccine safety issues. In a social media post, Prasad sharply criticized Marks, calling him “a bobblehead doll that just stamps approval.”

In interviews, Prasad has made his views on the FDA clear, suggesting that the agency’s current form may not be beneficial. Last year, during a podcast with former Republican presidential candidate Vivek Ramaswamy, Prasad boldly stated that Americans might be “better off” without the FDA as it stands.

Prasad, a professor at the University of California San Francisco, has a medical background in cancer and blood disorders. He first gained recognition in academic circles for scrutinizing cancer therapies, showing that many fast-tracked cancer drugs approved by the FDA had never been proven to improve patient outcomes. These drugs were often approved based on measures like tumor shrinkage, which is thought to be a predictive sign of long-term survival but does not guarantee actual improvements in patients’ lives.

The FDA has consistently defended this approach as a way to expedite the approval of medications for patients with serious or terminal conditions.

During the COVID-19 pandemic, Prasad gained wider attention for his criticisms of vaccine mandates, mask mandates, lockdowns, and the accelerated approval of booster shots from Pfizer and Moderna. His stance echoed that of other Trump appointees like Makary and National Institutes of Health (NIH) Director Jay Bhattacharya.

In 2022, Prasad and Makary co-authored a paper criticizing the recommendation for booster shots in teens and young adults, particularly males, due to concerns about the risk of myocarditis (a rare heart condition). The paper argued that mandating boosters for this group could cause more harm than good, though it was met with resistance from experts who noted that none of the authors were specialists in infectious diseases or vaccine reactions.

Angela Rasmussen, a virus expert at the University of Saskatchewan, expressed concern about Prasad’s appointment, predicting that it could harm vaccine access in the U.S. and hinder transparency in vaccine approvals. Rasmussen warned that Prasad’s leadership could lead to fewer approvals and a decrease in the public’s access to vaccines.

In recent years, Prasad has become a prominent voice in podcasts aligned with the “Make America Healthy Again” movement, which often criticizes the FDA for being too closely tied to the pharmaceutical industry.

Prasad’s appointment is sure to cause unease among drug and vaccine manufacturers, as they rely on the predictability and stability of the FDA’s standards to guide their lengthy and costly drug development processes.

Prasad’s leadership at the FDA will likely be a point of contention in the coming months, as debates over vaccine safety and pharmaceutical industry influence continue to shape public health discussions.

Source: AP News – Critic of drug industry and COVID-19 measures to lead FDA vaccine program

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A Breakthrough in Pain Relief

The U.S. Food and Drug Administration (FDA) has approved suzetrigine, the first new type of pain reliever in over two decades. This non-opioid medication, developed by Vertex Pharmaceuticals, provides an alternative for managing acute pain without the risk of addiction.

Marketed under the brand name Journavx, suzetrigine is a 50-milligram prescription pill taken every 12 hours after an initial larger dose.

Why This Approval Matters

Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, emphasized the importance of this approval:

“A new non-opioid analgesic for acute pain offers an opportunity to mitigate certain risks associated with using opioids and provides patients with another treatment option.”

This move aligns with the FDA’s efforts to combat the opioid crisis by promoting safer pain management alternatives.

How Suzetrigine Works

Unlike opioids, which dull pain by acting on the brain, suzetrigine targets pain at its source by blocking pain-signaling nerves before they can transmit pain messages to the brain.

Dr. Sergio Bergese, an anesthesiologist at Stony Brook University, explained:

“This drug interrupts the pain pathway so that even though the tissue injury exists, the brain doesn’t recognize it as pain.”

Crucially, suzetrigine does not produce euphoria or a “high,” reducing the risk of dependence and addiction.

Inspired by a Rare Genetic Mutation

The breakthrough behind suzetrigine stemmed from a Pakistani family with a rare genetic condition. Members of this family could walk on hot coals without experiencing pain due to a mutation in their sodium channels—the same channels responsible for transmitting pain signals.

This discovery led researchers to develop suzetrigine, which works by blocking a specific sodium channel that only carries pain signals, leaving other sensations like heat and touch unaffected.

Dr. Stephen Waxman of Yale University described it as a major advancement:

“This provides proof of concept that a sodium-channel blocker can reduce pain in humans, opening the door for even more effective medications in the future.”

How Effective Is Suzetrigine?

Suzetrigine has been tested in multiple clinical trials, including:

1. Post-Surgical Pain Relief
   • In two studies with 600 participants, suzetrigine reduced pain as effectively as Vicodin (a combination of acetaminophen and the opioid hydrocodone).
   • Participants reported about a 50% reduction in pain levels.
2. Chronic Pain & Sciatica
   • A smaller study on sciatica patients showed mixed results, with pain reduction similar to a placebo.
   • Vertex Pharmaceuticals insists ongoing research suggests the drug may work for other types of chronic pain, including diabetic neuropathy.

Dr. Kimberley Mauer, an anesthesiologist at Oregon Health & Science University, highlighted the significance:

“The more options we have, the better we’re able to treat each and every patient.”

Availability & Cost

• Pricing: $15.50 per 50-mg pill
• Insurance Coverage: Still uncertain; patient assistance programs will be available

Dr. Mauer cautioned that insurance coverage could impact access:

“It might limit some patients from getting it. We’ll have to wait and see how it plays out in the market.”

The Future of Pain Management

Suzetrigine represents a significant step toward safer pain relief options, particularly as the medical community seeks alternatives to opioids.

With this approval, researchers hope to develop even better non-opioid painkillers, offering relief without the risks of addiction.

Source

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