What's the point of developing new drugs?

This question is not rhetorical. A new treatment to lower harm from a minor respiratory virus in infants instead is associated with MORE baby deaths, clinical trials show. Yet no one seems to care.

Two years after Covid jabs turned into the world’s best-selling pharmaceutical product, Big Pharma is chasing billions from new products for another airborne illness: respiratory syncytial virus, or RSV.

Two European drug companies, AstraZeneca and Sanofi, want the Food and Drug Administration to approve a costly new treatment called nirsevimab for RSV for kids under age 1.

The FDA looks ready to go along. There’s just one catch.

The companies’ own trials show far more deaths in infants who received nirsevimab than those who got either placebo or a competing older treatment.

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(THE STORIES YOU DON’T GET ANYWHERE ELSE)

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In the most important trial, of healthy near-full-term and full-term infants, three out of 994 infants given nirsevimab died within a year. None of the 496 infants who received a placebo shot died.

In all, 12 infants treated with nirsevimab died in the trials, compared to four who were treated with an older antibody or a placebo. Even accounting for the fact that more infants received nirsevimab than placebo or the older antibody, infants given nirsevimab had a nearly 50 percent higher risk of death.

But the deaths did not bother an FDA’s advisory committee on antimicrobial drugs, which unanimously supported the nirsevimab application earlier this month.

The FDA reviewers who examined the companies’ application also downplayed the deaths. They noted that eight of the 12 deaths “were clearly unrelated to study drug” and related the death rate to the global infant mortality rate.

That comparison is so irrelevant as to be misleading. The point of clinical trials is to provide two balanced arms for comparison so that scientists don’t need to guess what reasonable background rates might be.

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(Previously healthy, found dead in crib)

SOURCE

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The imbalance in deaths is particularly troubling because the safety standards for nirsevimab’s approval should be even higher than for most drugs, and not just because it will be given to infants.

Like the mRNA Covid jabs, nirsevimab falls in the grey area between a vaccine and a traditional drug - and its corporate developers hope it will be given to “all infants,” including healthy children, like a vaccine.

Nirsevimab consists of antibodies that attack RSV in much the same way that the body’s natural immune defenses do, preventing the virus from latching to cells.

But the antibodies aren’t given after an infant has been infected, as anti-viral drugs usually are. Instead they are injected in the fall, for protection through the winter, when most RSV cases occur.

Thus, like a vaccine, nirsevimab is offered before infection, in advance of illness. But unlike traditional vaccines, nirsevimab is not meant to stop (nearly) all infections. Instead - like the mRNA Covid shots - the antibodies are supposed to lessen RSV’s severity, saving infants from needing a doctor’s visit or hospitalization.

Sanofi refers nirsevimab as an immunization. But in reality might best be called a “preventative therapeutic” - an awkward name for an awkward category of drug.

Further, RSV is generally mild illness for most healthy infants. In the pivotal clinical trial of healthy infants, only two infants required intensive care for RSV - including one who had received nirsevimab. Most infants who required medical care were treated as outpatients.

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For infants with chronic conditions, RSV can be more dangerous. But an antibody treatment for those kids already exists. And when AstraZeneca and Sanofi tested nirsevimab against that older treatment in a separate trial for infants at high risk from RSV, the results were even more concerning.

Five of 614 infants given nirsevimab died. Just one out of 304 who got an older treatment did. And nirsevimab’s overall side effect profile looked even worse compared to the older treatment after a second year of dosing. Almost 10 percent of infants who received two years of nirsevimab suffered a serious side effect in the second year - none of the infants who received the older drug did.

In other words, for the kids most at risk, nirsevimab appears less safe than the older drug.

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And the companies will likely charge a high price for the treatment, maybe as much as $500-600 per child in the United States, or in the range of $2 billion annually if they succeed in their quest to give nirsevimab to “all infants.”

Even assuming that nirsevimab prevents some hospitalizations, its widespread use would “add marginal effectiveness at very high cost in the general population,” a Michigan professor warned the Centers for Disease Control last week.

But even putting cost aside, anyone looking at the data has to wonder why regulators appear so eager to approve a drug that has at best marginal benefit in the face of serious red flags. Deaths are the ultimate yardstick for whether a drug aimed at healthy people - much less healthy infants - is working as promised.

By that yardstick nirsevimab has failed. That fact alone suggests that regulators should take a very cautious attitude toward its approval - possibly by insisting on another large trial that would focus primarily on safety.

But once again, they seem to have forgotten that their first duty is to protect the public, not Big Pharma’s ability to sell new medicines.