Although the Czech State Institute for Drug Control (SÚKL) has authorized for the use of ivermectin targeting COVID-19 off label, it is subject to a prescription authorization for its therapeutic use and is only valid for hospital facilities and outpatient clinics. Of course, any paid advertisements are a no-no, and recently the SÚKL started an investigation into a media publication called Pravo, claiming they are supporting advertisements concerning ivermectin. There’s just one problem: according to the publication’s editor, the content of concern is actually news articles, showcasing that the anti-parasitic drug product is used in various countries, in clinical trials,, etc. According to the publisher Zdenek Porybny, the effort feels like an intimidation campaign. After all, he notes that other press are writing about the potential benefits of investigational products and face no wrath by the government. Is the Czech Republic government picking on publishers authoring stories about ivermectin? Is this yet another form of censorship we have seen surface or does the SUKL here have legitimate claims?
While the Czech Republic experienced its first big wave of pandemic infections later than most of Europe, during October, 2020 two subsequent spikes occurred, one in January and another in March. The rate of daily infecitons now wants and hopefully the situation becomes more contained. With just under 11 million people the country has been hit hard with about 1.6 million recorded cases and over 28,000 deaths. Hence the push to accept ivermectin is undoubtedly a sense of desperation permeating the society. According to Reuters the Czech Republic has administered about 2.5 million doses of COVID-19 vaccines thus far. Assuming that each resident there needs two (2) doses this translates to about 12.1% of the current population has been vaccinated.
TrialSite’s network extends around the world and some community members brought to our attention this growing issue in the Czech Republic. The SÚKL of course has allowed the use of the anti-parasite drug via prescription by licensed physician in a hospital or outpatient setting. TrialSite reported on major hospitals, did a fact check, and found that the drug was available by prescription in a sort of off-label scheme but that there was no formal or permanent authorization for the COVID-19 indication. But SÚKL did authorize that it could be used off label again via prescription in specific settings.
The issue here involves Pravo’s writing of ivermectin articles. Of course, if these pieces are just about the facts of research and of various activities that have in fact occurred—e.g. the government allowing use via proper procedure then this is perfectly legitimate journalism.
But now the publisher believes there is an intimidation agenda much like was experienced during the communist days. Where the government via the food and drug regulator is compelling the publisher to provide information about data and associated information about an article as though it was a paid advertisement. If the publisher doesn’t respond with the goods, they face a fine of nearly 20,000 Euros! But the publisher, Zdenek Porybny, has gone on the record that these are just articles and that there are no advertisements and that rather this is a pure intimidation campaign, writes Eva Struharnanska for the Standard in Czech Republic.
Paid Advertising & Promotion a No-No
Of course, in a jurisdiction such as Czech Republic, the rules are much like other developed nation rules—the information about a drug is tightly regulated. Pursuant to the Advertising-Act of the Czech Republic, actual promotion or advertising of medicinal products that aren’t registered in the Slovak Republic or whose expenditure is subject to a medical prescription or a veterinary medical prescription is prohibited. Ivermectin, of course, meets these conditions and hence there are statutory rules governing what and how information about the drug can be communicated. It’s the same in the U.S., the rest of Europe, etc.
But What about Information & Articles?
Now with the regulatory agency pursuing this publisher, this really comes down to what has been declared in the article. But based on discussions there and translation of news, the regulatory body appears to be treating the article itself as an advertisement. And now compels the publisher to provide information about the advertiser, amount paid, other data about the content. But again the publisher declares that’s impossible, there is no payment—its just a journalistic article.
Mrs. Struharnanska shared recently that there are some “information portals” in this Eastern European nation that have surfaced that may violate the law by offering space to writers touting the drug as a “miracle cure.” There may be critics that lambast the pharmaceutical lobby’s recalcitrance to the accumulation of positive data in trials, or even perhaps “regulatory capture.” There’s a line that cannot be crossed. Legitimate journalism covers the facts and offers as unbiased a stance as possible, offering different points of view.
It’s not clear if Zdenek Porybny is getting censored or not but if he is only writing about the facts and this is classified as “misleading information” then based on what we have seen unfolding in Europe and the USA via social networks, this crosses the line. However, if ivermectin is promoted as some kind of miracle cure and there’s a business angle, then this is wrong and crosses what are legal lines.