STAT记者Adam Feuerstein发长文科普药企为何在临床数据发表前先发新闻稿，未披露任何新的公司层面事实

Why do drug makers (biotech, pharma) issue press releases on the outcomes of clinical trials before publication and without including substantive data?

This is a question — more often a complaint — I see a lot. Merck and Moderna with the mRNA cancer “vaccine” and Novartis with the lp(a) study are recent examples. Let me try to explain:

1. These are publicly traded companies, regulated by the SEC. As such, they are required to promptly disclose information to shareholders and the public that is “material” to the business. Bottom line: “Oh shit” news — good and bad — that affects the company and the stock price needs to be publicly disclosed quickly. Management cant sit on it. (And yes, there are exceptions to all rules.)

2. The amount of information about study outcomes disclosed in press releases varies. It’s frustrating when a company says, “Drug X achieved the primary endpoint” without disclosing numbers. Why is this done? Often, it’s to preserve data for presentation at a medical meeting.

Cardiology meetings like ACC and ESC, for instance, have strict rules. If you announce data in a press release, you can’t present at their meetings. Cancer meetings like ASCO are also strict. Once upon a time, even a bland press release would violate medical meetings disclosure rules. It took awhile before they understood drug makers have SEC regulations that must be followed.

3. Study papers in journals take time to compile, write, submit, go through peer review and the get published, etc. Do you really want to wait that long to know how a drug study turned out?

4. Thankfully, the dissemination of study results, like life, is ruled by compromise. In my experience, a majority of press releases announcing material study results contain some top-line data, enough to quantify the outcome. We may have to wait for a medical meeting months later for important details, but the press release gives us enough data to answer basic questions.

5. Who decides which data to disclose promptly and which to withhold for later? The lawyers, of course. Always the lawyers. But also, company scientists and management. It depends on type of study, the indication, potential competition and the venue (medical meetings) where data will be later presented. At a minimum, you like to see data on the primary endpoint, maybe a key secondary endpoint(s) and safety. Rules vary. The rules work and they can also be abused. Some companies are transparent and honest, others not so much. Like life.

5A. I would prefer even a tiny sliver of data in a press release over no data at all. I think we all would. But when the latter happens, there are usually legit reasons for it that go beyond, “[Drug company] is hiding or misleading…”

6. It’s not a perfect system, but in my experience it works well enough to satisfy investors and scientists.

7. If you’ve read all the way down here, thank you! I now welcome all your comments about why I’m an idiot and wrong. 😑