Publication of medical data by press release
QUICK READ: The news in the era of the coronavirus pandemic feels like a tsunami of bad and false information. Wall Street is “betting the ranch” on Moderna whose stock price shot up 20 percent on questionable information.
Covid-19 is taking an unprecedented physical and psychological toll on the American people and so small bits of potentially good news that should be taken with a grain of salt can end up dominating the headlines. People turn molehills into mountains because we really need and want a game-changer right now. But the truth is the truth regardless of what we want or feel, especially in science and medicine.
First, it should be known that77 percent of vaccines for infectious diseases make it through Phase I, but only 33 percent make it through the entire process overall.
Upon examining Moderna’s non-peer reviewed press release, the actual data on the vaccine’s success is even more flimsy. According to the document, of the 45 patients who received the vaccine, the data on “neutralizing antibody data are available only for the first four participants in each of the 25-microgram and 100-microgram dose level cohorts.” In other words, that means that when it comes to finding out whether the vaccine elicits an antibody response that could potentially fight the coronavirus, they only had data on eight patients. That’s not enough to do any type of statistical analysis and it also brings into question the status of the other 37 patients who also received the vaccine.
Moreover, when it comes to determining whether the “neutralizing antibodies” were clinically effective against the coronavirus, the only data Moderna eluded to were from mice. Not only are there huge differences between mice and men, but history also proves that success in animal models is often not replicated in human studies. This is especially the case for Moderna’s messenger RNA vaccine, which would be the world’s first to ever reach the market if it passes clinical trials.
Faith in medicine and science is based on trust. But today, in the rush to share scientific progress in combating COVID-19, that trust is being undermined.
Private companies, governments, and research institutes are holding news conferences to report potential breakthroughs that cannot be verified. The results are always favorable, but the full data on which the announcements are based are not immediately available for critical review. This is “publication by press release,” and it’s damaging trust in the fundamental methods of science and medicine at a time when we need it most.
The National Institutes of Health announced last month that the drug remdesivir offered a clear benefit to COVID-19 patients with moderate disease, shortening the length of their hospital stay by several days. But did it really? Twenty days after the announcement, the supporting data has still not been published. Without the data, no doctor treating a patient can be sure they are doing the right thing.
While Moderna blitzed the media, it revealed very little information — and most of what it did disclose was words, not data.
STAT News
We need to take a look at the links between Moderna and the Trump administration. For starters, Mohamed Moncef Slaoui has been tapped to head-up Operation Warp-Speed, the Trump administration’s effort to develop a COVID-19 vaccine by the end of the year, a timeline that many scientists believe is unrealistic. Slaoui resigned from the board of Moderna Therapeutics to take on his new assignment. He has had a long career in the pharmaceutical industry working on the development of a number of vaccines. However, it seems that a good portion of his career has been on the business and financial end of the pharmaceuticals, not on research and science. Before joining the board of Moderna, he was at the European venture capital firm Medicxi.
Moderna, under to leadership of CEO Stéphane Bancel, has been described as a highly secretive company. Moderna has never developed a successful vaccine. One former scientist employed by the firm has described the company as an “investment firm” that hopes to maybe develop a successful drug. Sounds just like the kind of company that Donald Trump and Jared Kushner would like to be associated with.
I would like to see a successful vaccine developed quickly as much as anyone. This is a fearful pandemic. But we cannot allow ourselves to be fooled by the con-man in the White House and we can’t let Wall Street’s foolish gambit sway us.
Originally published at https://worldofdtcmarketing.com on May 20, 2020.
