Science by Press Release

Commentary

We’ve been subjected to an extraordinary display of the integration of finance and the medical industry that came in the form of a press release. Based on nothing other than this release, the stock of a company worth $54 billion soared by 170 percent. That’s some serious marketing power on a level not available to any other industry.

The company in question is the pharmaceutical maker Moderna, which specializes in mRNA technology, which many have said for decades represents the future of medicine. Its first deployment—and the first product ever produced by Moderna—came with the release of the COVID-19 shot in 2020.

That too was announced in a press release advertising a 95 percent effectiveness rate, a number many people confused with a pledge that 95 percent of the people taking the shot would not get COVID-19. The company never tested for that at all. It was not part of the endpoint of the trials, which only measured symptomatic cases on a short-term basis.

Then in real life—as could be easily predicted—mutations eventually outran the formula and the original shot became ineffective.

One might suppose, then, there would be more financial incredulity toward yet another exuberant press release from the same company coming before anyone outside the company can examine the results objectively. But no: Such efforts are so potentially lucrative that investors are happy to leave their critical minds on the shelf and hope for the best.

The new announcement concerning its seeming cure for melanoma generated a wild frenzy. The stock of the company has not recovered its old highs at the height of the vaccination frenzy, but it seems to have broken free of its low point after the demand for the COVID-19 shot died away following persistent reports of its ineffectiveness.

Watching this unfold made me curious how companies can do this science by press release. Keep in mind that no one has any access to details or data other than the release by Moderna. It featured the key takeaway by the CEO.

“These Phase 3 findings represent a pivotal moment for the field of cancer research. For many years, the idea of creating an mRNA treatment designed specifically for an individual patient’s cancer was aspirational. We are now helping turn that vision into a reality,” said Stéphane Bancel, CEO of Moderna. “Together with Merck, we have started to demonstrate the transformative potential of this technology to address critical unmet needs in the adjuvant melanoma setting. We are deeply grateful to the patients, investigators and study teams whose contributions make this progress possible.”

Notice the very careful and mostly neutral language wrapped in nonspecific exuberance, wholly avoiding hard words such as “cure.” Language such as “transformative potential” and “address critical unmet needs in the adjuvant melanoma setting” is not about a cure. No one really knows what a “pivotal moment” is because it is a metaphor.

But overall the etymological suggestion is rather obvious. It is a buy signal. No question that the company intended to send such a signal. It certainly worked.

To be clear, this kind of “forward-looking statement” of trial results—unverified and unbacked by any details, much less regulatory findings—is not only legal. It is even encouraged as a drive toward transparency to prevent insider trading of the sort that has always vexed the publicly traded pharmaceutical industry. One in five trial results for new drugs is announced in this way, nearly always with celebratory language.

The ending of the press release explains what it can and cannot say. It can use words such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” and “continue,” but it should avoid words that are completely decisive. The proviso in the press release truly matters:

“The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied.”

“Differ materially” sounds perhaps like the results could be the opposite. Indeed. Why, then, did the stock soar to the heavens? It’s not because traders believe Moderna has cured cancer. It’s because they believe that others would believe that others would believe that the stock would go up on the implied news. Of course the news of the 170 percent gain also conveys the impression of investor confidence, rightly or wrongly, and provides resources to the company to undertake its full filings with the regulators.

Some close watchers were not having it. Maryanne Demasi writes:

“If they soon produce data from a large, well-conducted randomised trial showing that intismeran substantially reduces melanoma recurrence on top of an already effective treatment like Keytruda, that would represent real progress. But we need to know how large that additional benefit is, what harms come with it, how many patients discontinue treatment and, ultimately, whether it helps them live longer. I don’t want to dump on progress. But until Moderna and Merck release the Phase III results, their melanoma ‘breakthrough’ remains exactly what it is—science by press release.”

These events caused me to look back more carefully at Moderna’s original trial, which was essentially identical to Pfizer’s with the same results. The Pfizer trial has been examined extremely closely by Yaakov Ophir, six years later, which is enough time to do deep research.

The 95 percent effectiveness number masked the extremely low number of cases they found in either the placebo or vaccinated subjects. Some 43,500 people were in the trial, split down the middle between placebo and vaccine. Results: The vaccine group had eight cases while the placebo group had 162 cases, so we are talking 1 percent versus 0.1 percent.

However, the narrow endpoint did not evaluate asymptomatic infection or transmission, and testing data covered only a small fraction of participants. When the much larger number of suspected but unconfirmed symptomatic cases (3,410 total) is included, the difference shrinks dramatically to roughly 12 percent fewer cases in the vaccine arm. Keep in mind: That’s with the original formula that targeted the then-circulating strain.

The relevant question, then, is whether the costs of the shot were worth the benefit. The trials produced four times the adverse events in the vaccinated versus the unvaccinated group. The number needed to vaccinate to prevent one severe case during the short follow-up was approximately 9,200, many of whom would certainly experience adverse events. And keep in mind that this is for a disease that was long known to have a medically significant fatal risk for only the aged and infirm, who were not even part of the trial.

All of this is very interesting and covers only the trial before the release of the product, which came with a generous indemnification against liability for harm. In real life, the virus mutated, which reduced effectiveness further until the original variant disappeared from the population, thus requiring more and more boosters. The shot is hardly used at all today because the pandemic turned endemic mostly through exposure and resulting immunity, naturally and not artificially.

That’s the first and most famous product produced with mRNA technology. The record is empirically unimpressive and notably dangerous.

There is every reason to be suspicious of wild claims from any company that sound like a cancer cure, especially when it is based on an experimental technology that was approved only on an emergency basis. One suspects, in this case and many others out there, that the desire for profit is overriding medical rationality and objectivity. A higher stock valuation should not be confused with a genuine innovation to improve health and well-being.

Views expressed in this article are the opinions of the author and do not necessarily reflect the views of The Epoch Times.