When the modern biotech company announced the positive results of a small preliminary trial of its coronavirus vaccine early Monday, May 18, the company's medical director referred to the news as a "victorious day for us".
Moderna's share price rose as much as 30 percent. This announcement helped the stock market rise and had extensive media coverage, including The New York Times.
Nine hours after its initial publication - and after the market had closed - The company announced a public tender offer for its shares to raise more than $ 1 billion to help finance the development of the vaccine. That offer had not been mentioned that morning at its investor and journalist briefings, and the Moderna president later said that decision had been made in the afternoon.
On Tuesday there was already an adverse reaction. The company had not released any more information, so scientists were unable to assess its claims. The government agency leading the trial, the National Institute for Allergy and Infectious Diseases, had not commented on the results. And the sale of the shares raised questions about whether the company had tried to increase its share price with that news.
What happened with Moderna is an example of how the coronavirus pandemic and the desperate search for treatments and vaccines are altering financial markets. and how researchers, regulators, pharmaceutical companies, biotech investors, and journalists work.
A new and more general audience suddenly accuses pharmaceutical companies, accustomed to publishing initial information to attract investors and comply with regulators, of disclosing too much, or not enough. We could reprimand journalists for exaggerating the initial findings, as well as blaming those who dismiss inaccurate information for missing the news.
Scientists, who take time to collect and analyze information for publication in popular journals, are criticized for withholding life-saving information. Upstart websites compete against magazines and break the usual rules by publishing unconfirmed studies, some of dubious quality. President Donald Trump also uses his rostrum to promote treatments that have not yet been tested.
"We see these sudden swings based on incomplete information," said David Maris, managing director of Phalanx Investment Partners and an analyst who has long covered the pharmaceutical industry. "It is a delusional speculative environment because the pandemic has made people want to believe that there will be a miracle cure in a miraculous span of time."
Moderna President Noubar Afeyan defended the decision to put his shares up for sale a few hours after publishing that limited information. He said the company's board of directors had been considering launching a takeover bid before Monday's announcement, but made the decision until later that day.
At the same time, a torrent of information is emerging both from medical journals and from corporate and university publications. Unlike articles published in well-known medical and scientific journals, articles on studies that have not been peer-reviewed are published on so-called prepublication websites. Clinicaltrials.gov, which elaborates A list of medical studies showed that, as of May 23, 1,673 studies were underway on COVID-19, the disease caused by the coronavirus.
The news media rushes to keep up to date with new findings and provides material to a public hungry for any information about advances in possible treatments or vaccine candidates that offer something promising against this highly contagious virus. Some media outlets would prefer to continue working as they always have and not consider the initial results of medical studies to wait for fellow experts to evaluate the information, but they also have to report on the latest studies.
However, Doubts arise about the quality of the information that is published quickly and the motivations behind the ads.
The publication of scarce information is not uncommon in the world of biotechnology, in which companies often submit initial trial results months before they are published in magazines. Publicly-traded companies are required to disclose relevant information that may cause investors to buy or sell their shares. The company said federal investigators running the trial would be responsible for evaluating the information for publication.
Maris said she would let regulators decide whether the company had acted improperly by not announcing the sale of the shares earlier, adding that investors should have been given advance notice that the company was planning to sell shares.
"Something is wrong here," he said.
Modern, based in Cambridge, Massachusetts, went public on the stock exchange in 2018 and has been a favorite of biotech investors. Because it focuses on new areas of immuno-oncology and because it has a partnership with companies like Merck and AstraZeneca and with the Vaccine Research Center of the National Institute for Allergy and Infectious Diseases.
Its technology, based on genetic material called messenger RNA, or mRNA, is considered very promising.
"Messenger RNA is one of the new platforms in vogue," Anthony Fauci said in an interview Thursday, director of the Institute of Infectious Diseases, adding that it can be quickly adapted to produce new vaccines and that it can be easily expanded.
Despite the fact that Moderna has other vaccines in process, none have been released, and the viability of its platform to develop mRNA vaccines - the company's base - is at risk. It is one of the favorites to make the coronavirus vaccine and its actions have increased more than 250 percent since the beginning of the year. On Friday afternoon, its shares closed at $ 69, 26 percent less than its peak of $ 87 on Monday.
Moderna is not the only company that has not published detailed scientific information. Not much has been known about remdesivir, another product that is closely followed as an experimental treatment for COVID-19 developed by the pharmaceutical company Gilead.
On April 29, Gilead announced that he was "aware of optimistic information" about remdesivir's behavior in a federal trial. A few hours later, from the Oval Office, Fauci said the drug could slightly speed up the recovery of patients. Although he said the drug was not "forceful," Fauci - whose body also conducted that trial - noted that it could become the standard treatment.
A few days later, the Food and Drug Administration granted an emergency authorization to use remdesivir in the treatment of COVID-19.
Despite the fact that doctors were already administering the drug with little information to guide them, for a few weeks there was no detailed data on the clinical trials that were being published.
"It was a confusing statement from a deservedly well-respected scientist," said Gary Schwitzer, editor of HealthNewsReview.org, a surveillance publication that advocates for more accurate science journalism. "So that makes us wonder again: What should we believe Who do we believe? ”
Fauci claimed that he and his research team decided to report some results when the study was stopped after an independent safety council found that treated patients were recovering faster than those receiving placebos. For ethical reasons, the drug had to be offered to all patients.
The information was likely leaked, especially since two weeks earlier the information from another trial with remdesivir had been released to the STAT news website, driving up Gilead's stock price.
Fauci announced that the remdesivir-treated patients recovered in eleven days, unlike the fifteen days it took for those who received placebos to recover.
"It was all the information we had," he said.
The full results were published Friday in The New England Journal of Medicine.
The accelerated pace of the investigations has caught many media outlets and has made them analyze each case with very limited time to decide whether to cover scientific news - and how - even though the quality of the studies at another time would not have met. its parameters.
In general, the evaluation process of scientific articles by expert colleagues takes several months. But now, many articles are published on pre-publication websites, where scientists are publishing their research before any journal accepts it. The medRxiv website, founded in June, had 10 million visits in April and has published nearly 3,100 COVID-19 related articles since January. A similar site, bioRxiv, has published nearly 760 articles on the virus.
"People recognized that there was an urgent need to spread the information"said Harlan Krumholz, a cardiologist and health care researcher at Yale University and co-founder of medRxiv, which is pronounced "med archive." "People know that even weeks are important at this time when we don't know much."
When questioned about criticism that sites like medRxiv encourage hasty publication of poor-quality science, Krumholz said these discussions were good, noting that there could also be errors in articles reviewed by expert colleagues. Proposals go through basic scrutiny to ensure the research is legitimate.
"Get to see if it's good quality science or not," he said. "Let's assume the consequences of this."
(c) 2020 | The New York Times