Covid-19 Vaccine Development by Press Release and Media Interview Undermines Trust in Medical Science

In the conventional pharmaceutical development process, researchers publish results in peer-reviewed scientific journals, complete with detailed supporting data from double-blind clinical trials. As researchers race to develop a vaccine for Covid-19, some organizations have deviated from the proven drug-development methodology and have used an alarming new strategy of announcing test results.

Companies and research labs are issuing press releases, holding news conferences and speaking to the media to announce their results and predict success, without supplying detailed data to support their conclusions.

Breakthroughs without Data

Vaccine development companies, especially smaller ones, have seen their stock prices soar since the start of the outbreak on hopes that they can develop the first Covid-19 vaccine. Some companies have capitalized on those hopes.

In one example, Moderna announced favorable results from its vaccine trials. Its stock price shot up, even though it released underlying data on only eight patients. Amidst stock market optimism for its vaccine development technology, Moderna executives cashed out $89M in shares this year as the stock price soared. While the stock sales were filed as required with the SEC, there was no Moderna press release about the sales.

Executives selling stock in this situation is probably a prudent personal financial decision, said Thomas Lys, a professor of accounting at Northwestern University’s Kellogg School of Management. “There’s always that other possibility — that these guys really know this whole thing is bogus and they’re selling while the selling is good,” Lys said. “But you can’t tell from the data which one it is, and they certainly have plausible deniability.”

In another example, the National Institutes of Health announced that the drug remdesivir benefited some Covid-19 patients but did not publish supporting data. The announcement caused a stampede for the drug. Gilead Sciences, the maker of remdesivir, was more circumspect, not issuing its announcement until after the paper was published.

The paper on the remdesivir trial in a leading medical journal certainly didn’t report any cure or even miracle findings. The paper said that patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving a placebo. Length of hospital stay to improvement was 15 days for the patients receiving a placebo and 10 days for patients receiving remdesivir. The difference was not statistically significant according to the researchers, though a decrease of 33% in length of hospital stay for potentially thousands of patients could produce significant healthcare savings.

Press Releases Replace Peer Review

Medical experts criticize the practice as “publication by press release.” Without supporting data, outsiders don’t know what to think of the Moderna claims without seeing its supporting research, writes William Haseltine, a former Harvard Medical School professor, in a Washington Post editorial. In fact, other research casts doubt on its claim, says Haseltine, chairman and president of the think tank ACCESS Health International.

“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,” he says. Journalists bear some of the responsibility, he adds. It’s not helpful to ask experts to comment about unsubstantiated claims.

Haseltine compared the announcement to a public company announcing favorable earnings without supplying supporting financial data, which the Securities and Exchange Commission would never allow.

Press Release Timing Raises Questions

Modern’s announcement prompted its share prices to spike almost 20%, adding billions of dollars to the company’s value. Two days after the announcement, four top executives sold company stocks, taking in more than $29 million in gains.

The sales were automatic, prescheduled transactions. But the company controlled the timing of the press release, something the Securities and Exchange Commission should examine, says Michael Hiltzik, business columnist at the Los Angeles Times. The timing of the stock sales may also raise suspicions among investors that top executives lack confidence in the company’s prospects, he adds.

Optimistic Predictions

Some say the University of Oxford in England is the most prolific user of the publication by press release tactic, according to CNN. Oxford scientists have frequently told journalists that they will develop the first successful vaccine. For instance, lead researcher Sarah Gilbert told the media that she was “80% confident” that an effective Oxford vaccine will be ready by September. Other researchers criticized the prediction as overly optimistic.

Dr. Adrian Hill, one of the lead Oxford researchers, even disparaged other research teams in a CNN interview, calling their work “noise from the new boys.”

Scientists and other experts say they want Oxford researches to speak to reporters less and provide more data.

“At this point, the Oxford researchers have no idea whether they have something or not,” Dr. Paul Offit, a University of Pennsylvania pediatrician who developed a vaccine for rotavirus, told CNN. “You just get so tired of this ‘science by press release.’ ”

Over the years, corporate public relations departments and agencies have overhyped many products. Hyping medications without detailed supporting data from clinical trials during a health pandemic and raising public hopes seems almost cruel. The vaccine development community needs to return to time-tested methods of validating medicines and vaccines through thoughtfully developed and carefully administered clinical trials and peer-reviewed publications. PR professionals need to push back when company executives push to promote medical products that don’t have detailed supporting evidence from clinical trials in peer-reviewed publications.

Bottom Line: Using PR tactics to publicize progress in vaccine development without releasing complete research data creates a false sense of optimism and undermines trust in medicine. Such publication by press release may ultimately damage reputations of medical institutions. It’s time for research organizations to release research results and predictions only when accompanied with supporting data. Regulators such as the SEC may need to take a hard look at the practice.