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By PharmaCompass
2020-08-27
Impressions: 25464
With US President Donald Trump getting more aggressive at dealing with widespread criticism over how he mishandled the ongoing Covid-19 pandemic, the US Food and Drug Administration (FDA) is increasingly getting embroiled in electoral politics.
On August 22, President Donald Trump slammed the FDA in a tweet: “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!” Trump had tagged FDA Commissioner, Stephen Hahn, in this Twitter post.
Trump also accused government scientists of holding up potential coronavirus treatments for political reasons. “I think there are people in the FDA and actually in [the larger health] department that can see things being held up,” he had said.
According to the White House chief of staff, Mark Meadows, Trump’s remarks were part of a larger effort to put pressure on the FDA and other agencies working on the coronavirus response, to move quickly.
In a move that seemed to placate Trump, FDA issued anemergency use authorization (EUA) for investigational convalescent plasma therapy for the treatment of Covid-19 in hospitalized patients. The EUA came a day after Trump had slammed the FDA on Twitter.
Convalescent plasma therapy is a treatment in which blood from patients who recovered from Covid-19 is used to treat those who have the disease. Also known as passive immunization, plasma therapy was first tried out against diphtheria in 1892 and later against the 1918 flu pandemic.
The EUA announcement also came on the eve of the Republican National Convention, where Trump was to be nominated to lead his party.
‘Convalescent plasma, a safe approach’
The FDA said early evidence suggested blood plasma can decrease mortality and improve the health of patients when administered in the first three days of hospitalization.
Until now, most Covid-19 patients in the US who have received plasma have gotten it through an expanded-use program the FDA has set up with the Mayo Clinic.
In June, the Mayo Clinic analyzed the safety of plasma following transfusion in a group of 20,000 Covid-19 patients, finding extremely low rates of side-effects such as heart failure, lung injury, allergic reaction and death.
“We concluded that the use of convalescent plasma was safe,” Scott Wright, who led the study that was published in Mayo Clinic Proceedings, had told AFP.
Scott Gottlieb, former FDA commissioner, in a tweet said the “available data seems to meet the bar for an EUA”.
Some scientists believe that while plasma might be useful right now, in the long-run it might be more advantageous to identify the best antibodies to Covid-19 and then synthesize them in labs.
EUA came despite objections from scientists
Several US government scientists have held that evidence for plasma therapy’s effectiveness is thin.
The FDA has also said that more rigorous study is needed to prove whether the treatment would be effective. FDA distanced itself from a full endorsement of plasma because patients have largely received it outside of randomized, controlled clinical trials.
Janet Woodcock, the head of FDA’s drug division, told Politico magazine that plasma has not been “proven as an effective treatment.” The Infectious Diseases Society of America has said that though plasma treatment shows “some powerful signals”, there is still not enough data to understand its effectiveness for Covid-19.
This had prompted Trump to accuse the FDA of slow-walking the therapy to harm his chances of a reelection in November.
Hahn’s erroneous data readout
The decision to grant an EUA to plasma therapy while controversial, became even more circumspect with FDA commissioner Stephen Hahn’s incorrect interpretation of the benefits of the therapy.
Hahn said: “A 35 percent improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — 100 people who are sick with Covid-19, 35 would have been saved because of the administration of plasma.”
Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered at this statistic and wondered where Hahn got it from. Trump and his health officials cited the same statistic. Trump called it a “tremendous” number.
“For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy,” said Walid Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
What Hahn actually meant was that there was a “relative” reduction in mortality of 35 percent which in “absolute” terms translated to between 3 to 5 percentage points.
It is worthwhile to note that the study lacked a comparison group so everyone received the convalescent plasma with the only difference being that some people, during the course of treatment, received it earlier than others.
The study, to compare efficacy, compared the results of patients who received the treatment within the first three days of hospitalization with the results of patients who received it later. When mortality rates were compared after seven days, the group which got convalescent plasma early was about 9 percent, compared with a 12 percent mortality rate among the patients who got it later. After 30 days, the early-treatment group mortality was at 22 percent versus 27 percent for the later-treatment group.
In an interview with Bloomberg, Hahn admitted that he had overstated the benefits of convalescent plasma.
“I was trying to do what I do with patients, because patients often understand things in absolute terms versus relative terms. And I should've been more careful…,” he said.
He also said he worries about the wide availability of blood plasma to patients making it more difficult to get patients as volunteers for Covid-19 vaccines. “We aren't going to be able to twist doctor's arms to enroll their patients,” Hahn said.
Vaccine and poll agenda
Trump is looking to boost his lagging poll numbers during the Republican National Convention this week. Progress in treatments or an effective vaccine to gain control of the virus definitely would help his chances of a re-election later this year.
In an article published in Stat News, journalist Ed Silverman says the next 73 days are going to be very difficult for Hahn. As the November 3 election nears, Hahn can expect intensifying pressure from Trump to approve a vaccine or a drug to combat Covid-19.
For Hahn, this creates a different kind of challenge — he has to work harder to ensure the FDA remains independent.
Our view
In March, FDA had issued an EUA to hydroxychloroquine (HCQ), a decades-old malaria tablet that Trump was touting as a cure for Covid-19. The EUA was revoked in June when trials revealed that HCQ was not effective in treating Covid-19.
In a tweet, House Speaker Nancy Pelosi said: “The President’s dangerous attempt to inject himself into the scientific decisions of [the FDA] jeopardizes the health & well-being of all Americans.”
The FDA is a deeply respected agency both in the US and abroad. It needs to uphold this image in these times of a global crisis.
The challenge for Hahn is to push back and not sign off on any vaccine or drug unless there is credible evidence that it meets the criteria the agency uses to assess safety and effectiveness.
Asked what he would do if he had to rubber-stamp a vaccine, Hahn had told Bloomberg that he would “not participate in any decision that was made on anything other than the science.”
We hope Hahn lives up to his words.
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Image Credit : Donald Trump by Matt Johnson is licensed under CC BY 2.0 // Modification: text was added to the original image
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
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