(CN) — Less than a week after a study found only harm and no benefit in using hydroxychloroquine to treat Covid-19, the Department of Justice cleared antitrust hurdles to facilitate distribution of the drug Monday.
Pharmaceutical wholesaler AmerisourceBergen had requested the green light as part of the initiative to supply communities ravaged by the novel coronavirus with hydroxychloroquine from the national stockpile.
President Donald Trump has touted the unproven drug as a “game changer” in the pandemic, but a new French study found that administering hydroxychloroquine to hospitalized patients produced no statistically significant difference in the patients’ death rates or in their admission to intensive care units.
More alarmingly, however, researchers found that eight patients had to stop taking the drug because they developed abnormal heart rhythms during treatment. The study has not been peer reviewed but was published Tuesday by MedRxiv.org, a pre-print server founded by Yale University, the journal BMJ and Cold Spring Harbor Laboratory.
According to Monday’s reply from Assistant Attorney General Makan Delrahim, the chief legal officer at AmerisourceBergen wrote to the Justice Department on the same day the study was published for relief from antitrust enforcement procedures.
“The hydroxychloroquine is donated, meaning the U.S. government does not charge AmerisourceBergen or other distributors for it,” the letter states. “Further, AmerisourceBergen does not charge the U.S. government for its distribution services, nor does AmerisourceBergen charge the health care providers for the medicines that they receive. Recognizing the extreme urgency of getting medicines to areas of greatest need, AmerisourceBergen, along with other distributors, are serving as the U.S. government’s distributors while concurrently seeking to memorialize their role in a written agreement.”
Public health crises require collaboration, said Olivia Webb, a policy analyst at the American Economic Liberties Project, but she noted that the medical supply industry is uniquely vulnerable to abuse.
“There's only a few major medical supply distributors in the country, and to me, that seems like an environment that's ripe for anticompetitive abuses, particularly price fixing,” Webb said in a phone interview.
For Webb, the agreement reached between the Justice Department and AmerisourceBergen had few safety values.
“Something that stuck out to me in the letter is that it seems there's not a ton of restrictions beyond the company agreeing not to price-fix, which — because price fixing is illegal — I hope that they already had agreed not to price-fix,” Webb said.
The U.S. contracting database, by press time, did not show any relevant contract this month with AmerisourceBergen, a Fortune 500 pharmaceutical giant based in Conshohocken, Pennsylvania.
Dr. Dena Grayson, a physician who helped research an antiviral drug to combat the deadly Ebola disease, noted that it is not unprecedented for the government to stockpile drugs before they were proven to be effective for a particular illness.
“We’re in emergency-use land, and this is a crisis,” Grayson said in a phone interview, citing the stockpiling of the antiviral drug tecovirimat for biodefense against smallpox as an example.
“The thing that I find very curious as well we see all this activity to stockpile hydroxychloroquine, which objectively has not shown any benefit for Covid-19,” Grayson added. “But we've also seen, of course, treatment-related deaths.”
President Donald Trump has denied at multiple press briefings that there are any dangers associated with the anti-malarial hydroxychloroquine.
“What do you have to lose?” the president has been fond of asking.
American Medical Association President Patrice Harris answered to CNN’s Wolf Blitzer: “You could lose your life,” an assessment repeated on April 8 by the American Heart Association, the American College of Cardiology and Heart Rhythm Society.
For U.S. Attorney General William Barr, the chorus of medical voices urging caution about hydroxychloroquine amounts to a left-wing plot against President Trump.
“As soon as he said something positive about it, the media has been on a jihad to discredit the drug,” Barr told Fox pundit and pandemic-skeptic Laura Ingraham earlier this month. “It's quite strange.”
For Grayson, a former Democratic congressional candidate, Trump’s Justice Department appeared to be the one politicizing the science.
“Again, if the idea here is — ‘Let's stockpile drugs in case it works. We can always stop the stockpiling order’ — OK, but then why isn't there this big push to start stockpiling drugs that look much more promising?” she asked. “The only thing I can come up with is because Trump's on the bully pulpit, and for whatever reason it's become this — I've never seen this. Like, where a treatment has become politicized about whether or not it works. Uh no, that's my how it works. Either it works or it doesn't, based on data and evidence.”
Several Covid-19 treatments are currently in the clinical trial phase, but Delrahim’s letter mentioned hydroxychloroquine only, citing the importance of expediting medication distribution to protect the health and safety of Americans during the pandemic.
“The department understands that other, additional medicines could eventually be added to this distribution initiative,” he added in a footnote.
New York Governor Andrew Cuomo indicated that preliminary data from the state’s use of hydroxychloroquine will be released today, though that information will not mark the culmination of any clinical trial.
The federal government’s $750,000 contract with PPD Development to draw up treatment protocols for hydroxychloroquines use against Covid-19 comes to an end on Tuesday. Some two decades ago, that company oversaw the defrauded clinical trial of the antibiotic Ketek, in a scandal that led to one of the industry’s rare criminal prosecutions.
Before the coronavirus pandemic, Amerisource had been sued hundreds of times as part of the nationwide litigation over the opioid crisis.
Public officials West Virginia, Oklahoma and two Ohio counties are among those who accused Amerisource, along with medical suppliers like McKesson and Cardinal Health, of exacerbating the abuse of those drugs. The Washington Post reported last year that a sweeping investigation found that those three companies controlled 85% of the market.
All three companies announced $215 million settlement last October for a global resolution to the opioid claims in Ohio.
Earlier this month, the Justice Department signed off on a business review letter earlier this month allowing McKesson and Cardinal Health to collaborate on pandemic-response without antitrust concerns.
New York Times reporting says Assistant Attorney General Delrahim has previously asserted that monopolies could be legal until they abuse their power. Upon entering the Justice Department, he was reportedly gifted a “Makan Antitrust Great Again" hat, playing on his name and Trump’s slogan.
Delrahim was previously accused of playing politics with antitrust enforcement when he unsuccessfully tried to block AT&T’s merger with Time Warner — a move that some suspected served to carry out Trump’s vendetta against the telecom’s subsidiary CNN.
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