The Danish Society for General Practice (DSAM), which is the professional community of general practitioners, has criticised the National Board of Health for its recommendations concerning COVID-19 treatment.
Earlier, the Danish Health and Medicines Authority has approved the US drugmaker Merck's anti-COVID pill molnupiravir, which also goes by the name Lagevrio, to treat at-risk patients with symptoms, making Denmark the first EU country to do so. So far, 50,000 pills have been purchased.
Explaining their reluctance to administer it, DSAM's COVID-19 spokesman Anders Beich cited the drug's poor documentation.
“We think that the documentation basis is really, really flimsy. We are afraid that we will have to use a remedy that is ineffective at best and, at worst, jeopardises people's treatment,” he told Danish Radio.
According to him, patients may receive proper treatment too late.
“There is a tendency to believe that once you have received your treatment, you will do well. It may be that both doctor and patient think that now the patient is in treatment. But if the treatment is ineffective, then you will waste time, and there is a risk that the disease will get worse without action being taken,” Beich mused.
The same criticism was echoed by Danish Medicines Agency, an independent council that makes recommendations to the regions on the use of various drugs.
“We already have treatments that work for the group of patients where the pill is intended for use. Treatments that work much better and are documented much better than this pill,” chairman Steen Werner Hansen said. “So in the worst case, this would prevent some patients from getting a relevant treatment,” he concluded.
According to Jan Gerstoft, professor of infectious diseases at Rigshospitalet Clinic,
the problem with Merck's COVID-19 drug is that the treatment looked promising in the initial studies, but later that picture changed.
Gerstoft explained that the positive effect was observed largely in South America, where special COVID-19 strains abound. By contrast, there was “virtually no effect” in the US and Europe, he said.
Previously, the Danish Society for Infectious Diseases called on the Danish Health and Medicines Authority in its weekly newspaper to reconsider both the purchase and use of the tablets. This has been done in France, where the French health authority has decided against the rollout.
The drug has also not been approved by the European Medicines Agency (EMA) yet. However, the EMA suggested that countries may well decide to approve the pills themselves if needed.
The Danish parliament has approved purchases of anti-COVID pills for a total of DKK 450 million ($69 million). This batch includes not only Merck tablets, but also Pfizer pills still under development.
In recent analysis by the US Food and Drug Administration (FDA), Merck’s antiviral pill for COVID-19, molnupiravir, appeared far less effective than early results from the clinical trial first suggested. The experimental pill only cut the risk of hospitalisation or death from COVID-19 by about 30 percent, compared to a placebo, and showed no benefit whatsoever for people with antibodies against COVID-19 from prior infections.