Top 2020 Biopharma Scandals and Outrages
Over the course of 2020, the biopharmaceutical industry came together to rapidly address the global COVID-19 crisis. Despite that spirit of comradery and partnership, there were still a few incidents that caused some arched eyebrows, gasps of astonishment and even fits of anger.
BioSpace looked back at some of these moments. The incidents in question revolve around the COVID-19 pandemic, at the point where science intersects with electoral politics, and scandals outside of the political realm as well.
Hacking – While pharmaceutical companies raced to develop vaccines, hackers furiously worked to steal intellectual property. In December, the European Medicines Agency revealed that documents related to the COVID-19 vaccine developed by Pfizer and BioNTech maintained on the agency’s servers were illegally accessed. The EMA was in the process of reviewing the mRNA vaccine for emergency authorization when the cyberattack occurred. Cyberattacks are becoming an increasingly serious problem for the pharmaceutical industry, particularly for those companies developing vaccines and therapies for COVID-19. Just last week, AstraZeneca was attacked by hackers who attempted to gain COVID-19 research. A North Korean hacking collective known as Kimsuky was thought to be behind the attack. In addition to COVID-19 research, Kimsuky has also attempted to steal national security data.
Hydroxychloroquine – In the early days of the pandemic, it was thought the malaria drug hydroxychloroquine was an effective treatment against the coronavirus, and some anecdotal evidence suggested this was so. Without waiting for solid clinical evidence, the Trump administration began touting the antiviral as a “miracle cure” for the virus. Despite the claims from the Trump camp, multiple trials indicated that hydroxychloroquine was not effective. The safety concerns regarding hydroxychloroquine in COVID-19 patients raised in the Lancet study are not the first time these issues have been noted. A study in China showed that not only did hydroxychloroquine not help patients clear the virus better than standard care, the drug was also likely to cause serious harm. A trial in Brazil was also halted due to safety concerns. Another study conducted in New York raised questions not about the safety of hydroxychloroquine, but the efficacy in COVID-19. That research, published in The New England Journal of Medicine, showed that although the drug was widely administered to COVID-19 patients, the results did not show “robust evidence” to warrant continued use.
Opioid Responsibility – In November, Purdue Pharma pled guilty to three criminal charges related to its role in perpetuating the opioid crisis that gripped the nation for years. Purdue pleaded guilty to one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute. Purdue accepted responsibility for its actions and agreed to a settlement that includes a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture. Despite the guilty plea, the Sackler family, which controlled the company, laid the blame at the feet of company management during a December hearing held by the U.S. House Oversight and Reform Committee.
Convalescent Plasma -- Convalescent plasma, which has been used in other incidents, is collected from patients who have recovered from a virus such as the novel coronavirus that causes COVID-19. The idea is that the plasma, which contains antibodies against the virus, will be administered into patients who are critically ill. In March, the FDA created a pathway with strict guidelines for physicians to use convalescent plasma on seriously ill COVID-19 patients. Emergency Use Authorization was granted by the U.S. Food and Drug Administration in August, but only after President Donald Trump accused the FDA of being part of a conspiracy to withhold approval of treatments for the coronavirus in order to politically hurt his re-election bid. When the EUA was finally authorized, the Secretary of Health Alex Azar incorrectly cited claims from a Mayo Clinic study and his department was forced to retract the claim due to Azar’s overstatement of the benefits of convalescent plasma. Not only did HHS have to restate the claims, FDA Commissioner Stephen Hahn was forced to walk back some statements he made about the benefits of the treatment.
Vaccine EUA Guidance – Heading into the Nov. 3 election, there were concerns that President Trump may try to force the FDA to rush through EUA for a COVID-19 vaccine in order to gain a boost at the polls. To stymie that, the FDA submitted a more stringent guidance for EUA of a vaccine to the White House in September. Trump condemned the proposals, calling it a “political ploy.” One day after hinting the White House would reject the guidance, which was within its power, the administration reversed course and approved the new vaccine guidance. Even after the guidance was approved, Trump took to twitter to condemn the EUA calling it “just another political hit job.” While the president showed his displeasure at the new guidelines, the pharmaceutical industry largely supported the move due to declining perceptions on the safety and efficacy of a vaccine hurried through clinical trials because of politics.
Downplaying the Virus – Throughout the pandemic, the White House attempted to put a positive spin on the pandemic, especially in the months leading up to the election. This fall, veteran Washington Post reporter Bob Woodward revealed that Trump knew of the seriousness of the coronavirus in the early part of 2020 but chose to minimize and even dismiss those concerns in public in order to not cause panic. Not only did Trump downplay the severity of the virus, his political lieutenants in HHS, Paul Alexander and Michael Caputo, have been accused of manipulating messaging coming from that department and the Centers for Disease Control. Alexander interfered with language used in the CDC’s Morbidity and Mortality Weekly Reports, and attempted to downplay the spread of COVID-19 at a Georgia summer camp. Alexander was also proponent of mass infections in order to develop herd immunity. Caputo is also under scrutiny for threats made against CDC communications personnel who arranged interviews with the media.
Smuggling – The Chinese government arrested Fangliang “Frank” Zhang, chief executive officer of Legend Biotech on allegations of smuggling. Zhang’s arrest was for “the suspected offense of smuggling goods prohibited by the import and export regulations under the laws of the PRC (People’s Republic of China).” The charges were related to an investigation of “special inspections of the management of human genetic sources – organs, tissues and cells.”