The world last week: Promoting science and responsibility

The reign of unscrupulousness

The Covid-19 pandemic is still raging across the United States - the country most heavily affected with the highest number of infections and deaths in the world. However, as the demand for antibody testing increases to serve the reopening of the US, a series of unqualified distributors and brokers in the antibody testing business have entered this market. The consequences are huge, the biggest risk being that poor quality test kits are sold, giving false results, leading to the possibility of sending people back into the community, while not knowing that they have endangered themselves and others.

The FDA says test kit manufacturers must submit quality assurance data within 10 days. Photo: AP

The FDA tightened its rules this week to ensure the quality of antibody tests, requiring test developers to undergo regulatory review. The agency also acknowledged that its previous policy had created opportunities for fraud.

The FDA's unprecedented rule has opened the door to questionable suppliers.

The FDA’s lax regulation, which was put in place on March 16, allows antibody test makers to sell their products without having to share data with the agency for approval of accuracy and licensing. According to Reuters, this has created a loophole for non-medical businesses to “dip” into this “hot” market to aggressively advertise, find buyers, and increase production. The unprecedented FDA regulation has “opened the door” for questionable suppliers.

The FDA’s move comes after a report by more than 50 scientists found that only three of the 14 antibody tests on the market were reliable, with the rest showing significant differences in quality. Antibody tests are expected by U.S. government and health officials to be a key tool for widespread testing that will help determine when restrictions can be lifted, people can return to normal life, and the economy can reopen.

Medical staff use rapid antibody testing kits at a stadium in California. Photo: Reuters

“Every step the FDA takes in the fight against Covid-19 is a balance of risks and benefits.”

Dr. Stephen Hahn, Commissioner of the FDA

Oversight of the development of the tests was disrupted early on when President Donald Trump called on the FDA to relax its rules. The agency was criticized in late February for moving too slowly to approve private companies to bring diagnostic tests to market. Now, the FDA faces regulatory scrutiny for allowing manufacturers to distribute antibody tests too quickly without quality control. “Every step the FDA takes in the fight against Covid-19 is a balancing act of risk and benefit,” said FDA Commissioner Stephen Hahn, M.D.

In a recent statement, the FDA said its original policy gave test manufacturers the flexibility to self-certify their quality, but “does not mean that fraud can be tolerated.” “We have seen unscrupulous practices, fraudulent test kits, and attempts to exploit the concerns of the American people,” the FDA said, adding that it has taken action to stop companies from marketing illegal test kits by seizing and rejecting test kits within U.S. borders.

Under the FDA’s new policy, commercial test manufacturers must submit data and apply for an emergency use authorization (EUA) within 10 days. The FDA said it will share the information on its website with potential test purchasers, such as states and hospitals. The FDA is working with the National Institutes of Health and the Centers for Disease Control and Prevention to develop specific evaluation criteria for testing kits that are about to be released to the market, as well as those that are already in circulation.

US Food and Drug Administration.

Leadership by science

On May 6, German Chancellor Angela Merkel announced plans to partially lift the lockdown imposed to contain the spread of Covid-19, but remained cautious and closely monitored the situation to ensure that things did not get out of hand. Germany’s response to the pandemic has been praised globally, despite having imposed some of the lightest restrictions in Europe. The reported numbers have proven the government’s success.

While most other countries struggle, Germany has become a model for Covid-19 testing capabilities.

Germany is the 7th most affected country in the world with more than 169,000 cases, but the death toll is just over 7,300, much lower than other epidemic areas in the continent and the world. The number of new infections per day has also decreased since the beginning of April. Germany's health system is so good that hospitals can accept patients from neighboring countries. While most other countries are struggling, Germany has become a model for Covid-19 testing capabilities.

Germany has conducted more than 2 million tests, a rate of testing per population nearly double that of the United States. The German government is pushing to increase testing from nearly 900,000 to 4.5 million per week by mobilizing veterinary laboratories. Germany also has a dense network of hospitals and clinical laboratories. There are about 34 intensive care beds per 100,000 people, twice as many as in France and three times as many as in the United Kingdom and Italy. In addition, with a federal political system, the states in Germany have a lot of power to design their own containment measures, while the government plays a coordinating role.

Chancellor Angela Merkel speaks on national television about the Covid-19 epidemic. Photo: DW

Comparisons between Germany and other countries in the fight against the pandemic have also led to a surge in Chancellor Angela Merkel's approval ratings, overshadowing all the other faces in the coalition government. Ivana Kottasova, a commentator for CNN, commented: "Merkel's legacy seems to have been saved. She is amazing. Every time there is a crisis, Merkel performs at her best."

Throughout the Covid-19 response, Chancellor Merkel has relied on expertise from well-funded scientific research organizations, including public health agencies such as the Robert Koch Institute and the network of public universities. These organizations are working closely to establish a nationwide research system. The federal government, led by Merkel, plays a convening role. The government recently brought together the medical faculties of universities across the country into a Covid-19 task force.

Honesty plays an important role in convincing Germans to continue to follow the rules and stay calm amid the confusing information flow.

Chancellor Merkel has relied heavily on the expertise of a handful of experts, a honesty that has been crucial in convincing Germans to continue to follow the rules and remain calm amid the chaos of information. Gero Neugebauer, a prominent German political scientist, said Merkel’s scientific background has shaped her response to the crisis and helped boost her credibility.

Medical staff take samples for testing in Berlin in April. Photo: AFP

Germany's fight against Covid-19 has been considered a success under the leadership of the female chancellor with 30 years of political experience, who comes from the scientific community. Although it is not clear what challenges lie ahead, as Ms. Merkel said: "The first phase of the epidemic is behind us, but we are still at the beginning and it will haunt us for a long time"; but observers believe that Chancellor Merkel will be remembered as a "chief scientist" - a leader based on science and leading the country out of the crisis.