On Friday, while Rick Bright was in the process of filing what promises to be a damning whistleblower complaint to the Inspector General of the Department of Health and Human Services, President Donald Trump announced that he was firing the inspector general, Christi Grimm, and nominating a handpicked replacement.
Two weeks ago, Bright, who, as deputy assistant secretary for preparedness and response for HHS, oversaw the government’s purchase and funding of vaccines, treatments, and tests for the coronavirus, said he had been forced out of his job because he refused to cave to pressure to adopt scientifically unproven treatments for Covid-19.
“I believe this transfer was in response to my insistence that the government invest the billions of dollars allocated by Congress to address the COVID-19 pandemic into safe and scientifically vetted solutions, and not in drugs, vaccines and other technologies that lack scientific merit,” wrote in a statement released by his lawyers, as The Intercept reported at the time.
Grimm became inspector general in January and came under attack from Trump after her office published a report pointing out severe shortages of testing supplies and personal protective equipment. In a tweet, Trump called the report, which was based on interviews with hospital administrators from 323 hospitals in 46 states, the District of Columbia, and Puerto Rico, “another Fake Dossier” because Grimm had worked for the Obama administration. In fact, while she did serve under Barack Obama, Grimm, who been in the IG’s office since 1999, has also worked for the administrations of Bill Clinton and George W. Bush. Trump’s nominee to replace Grimm is attorney Jason Weida.
The highly anticipated whistleblower report from Bright is expected to focus on hydroxychloroquine, a drug that Trump hyped as a “game changer.”
The highly anticipated whistleblower report from Bright is expected to focus on hydroxychloroquine, a drug that Trump hyped as a “game changer” but that was found in a Veterans Affairs study to be of no clinical benefit to coronavirus patients, and actually increased their chances of death. While Trump’s enthusiasm, which sent online demand for the drug surging 1,000 percent, has since fizzled, he has now put his faith in another drug: Gilead Pharmaceutical’s remdesivir. On Friday, Trump met with Gilead CEO Dan O’Day to announce that the Food and Drug Administration would be giving the drug emergency use authorization as a treatment for Covid-19.
“We’re going to be having some really incredible results,” Trump predicted.
While incredible results usually precede FDA authorization, with remdesivir, that has changed. The decision was made based on a single study, the results of which have yet to be made public in their entirety but are said to show that Covid-19 patients who received the drug tended to recover more quickly. While the study showed a benefit, it was modest and only about the amount of time it took patients to recover; those who took the drug recovered in 11 days as opposed to 15 for those who didn’t take the drug. There was no significant improvement in survival rates, as some virologists have pointed out: Eight percent of patients on the drug died, compared to 11.6 percent of patients who didn’t take it. And while several other trials of the drug have yet to be made public, a recent Chinese study found that there was no benefit either in terms of mortality or the length of time it took for patient to recover. In the Chinese study, 12 percent of patients who were taking remdesivir had to stop because of adverse reactions to the drug, some of which were life-threatening.
The approval comes as Gilead, which paid out $874 million in cash dividends to shareholders and made $1.3 billion in stock buybacks in the first quarter of this year, has sharply increased its lobbying. The company, whose former top lobbyist, Joe Grogan, is a member of the White House coronavirus task force, spent $2.45 million on lobbying in the first quarter of 2020, up from $1.86 million in the first quarter of last year.
In March, Gilead sought and was granted orphan drug status for remdesivir, a designation reserved for treatments of rare diseases that would have given several benefits, including the ability to profit exclusively from the product for seven years. The company later reversed course. On Friday, Gilead announced that it would be donating 1.5 million doses of the drug to the government. According to tax law, tax deductions for such charitable donations are generally capped at 10 percent of a corporation’s income. Gilead did not respond to an inquiry about whether it would seek a deduction for its contribution.
Now that remdesivir has emergency approval, questions have turned to its pricing. While the cost of producing a 10-day course of the drug is estimated at $9.32, according to the Institute for Clinical and Economic Review, it could be priced at $4,500 or more.
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