Denmark recently became the first EU country to approve a new COVID-19 drug from the US pharmaceutical company Merck. The decision is met with difficulties, however, as Danish general practitioners refuse to prescribe the preparation because they do not know enough about how it works and describe it as ineffective and possibly even harmful.
The Danish Society of General Practitioners (DSAM), the professional association of general practitioners, has criticized the National Health Agency for its recommendations on COVID-19 treatment.
The Danish Health and Medicines Authority had previously approved the anti-COVID drug molnupiravir from the US drug manufacturer Merck, which is also known as Lagevrio, as the first EU country to treat high-risk patients with symptoms. So far 50,000 pills have been bought.
Anders Beich, COVID-19 spokesman for DSAM, justified the reluctance to administer the drug with the poor documentation of the drug.
We believe that the documentation base is very, very poor. We fear that we have to use an agent that is ineffective in the best case and in the worst case endangers the treatment of people, ”he told the Danish radio.
In his opinion, patients may receive adequate treatment too late.
There is a tendency to believe that once you’ve received treatment, you’re fine. Both the doctor and the patient may feel that the patient is now being treated. But when treatment is ineffective, time is wasted and there is a risk that the disease could worsen without action, Beich pointed out.
This criticism was also voiced by the Danish Medicines Agency, an independent body that gives recommendations to the regions on the use of various medicines.
“We already have treatments that work for the patient population the pill is intended for. Treatments that work much better and are better documented than this pill, ”said chairman Steen Werner Hansen. “So in the worst case scenario, this would deter some patients from receiving relevant treatment,” he concluded.
According to Jan Gerstoft, professor of infectious diseases at Rigshospitalet Clinic, the problem with Merck’s drug COVID-19 is that the treatment looked promising in the first studies, but that picture later changed.
Gerstoft explained that the positive effect was mainly observed in South America, where specific strains of COVID-19 are widespread. In the USA and Europe, on the other hand, “practically no effect” was observed, he said.
Previously, in its weekly newspaper, the Danish Society for Infectious Diseases urged the Danish Health and Medicines Agency to reconsider both the purchase and use of the tablets. This has happened in France, where the French health authority decided against the introduction.
The European Medicines Agency (EMA) has not yet approved the drug either. However, the EMA has indicated that countries may well decide to approve the tablets themselves if necessary.
The Danish Parliament has approved the purchase of anti-COVID tablets worth a total of 450 million DKK (69 million dollars). This package not only includes tablets from Merck, but also tablets from Pfizer that are still under development.
A recent analysis by the U.S. Food and Drug Administration (FDA) found that Merck’s antiviral pill for COVID-19, molnupiravir, is far less effective than initial clinical trial results suggested. The trial pill only reduced the risk of hospitalization or death from COVID-19 by about 30 percent compared to a placebo and showed no benefits for people with antibodies to COVID-19 from previous infections.