©Moira Dolan, MD May 8, 2020
The timeline of the news about Gilead Science’s drug remdesivir portrays an unprecedented rush to endorse an unproven drug.
The statistics for benefit are frail indeed, and the potential for adverse drug effects are high.
April 16, 2020: Stat news reported early promising results from a trial of remdesivir in CoVID patients in Chicago.
A surge in Gilead stock in after-hours trading on that day was followed by the information that none of the Chicago patients were so ill as to need a ventilator, so they were expected to recover anyway.
April 23, 2020: The World Health Organization (WHO) accidentally posted results indicating that testing of remdesivir in China was a flop.
This was picked up and reported on by the Financial Times and by Stat. The Financial Times report has been removed, but as of 5/8/2020 the Stat site still shows the WHO screenshot reporting the failed trial.
Gilead stock dropped 4%
This non-physician banking advisor broadcast his opinion that the drug was started too late in the course of illness to show effectiveness.
Raffat had given Gilead stock an “outperform rating”, meaning it would be recommended that investors buy the stock.
Gilead medical director Merdad Parsey chimed in with his own theory – he thought the Chinese stopped the trial early because they could not find enough patients sick with CoVID to enroll in the study.
4/29/2020: The medical journal Lancet published the China study.
This was a double-blinded, placebo-controlled study, meaning neither the patients nor the doctors know who was getting the real drug, and represents a gold standard for drug testing, as it minimizes the chance of bias entering into the evaluation of the results.
158 patients were treated and compared to 79 not on the drug.
The treated patients failed to improve. The drug did not reduce the viral count in their blood.
14% of the 158 patients treated with remdesivir died 28 days after treatment, compared to 13% of the 79 who were on placebo.
In addition, remdesivir was stopped due to side effects in 18 patients versus in just 4 who received placebo.
4/29/2020: Joe Grogan announced his resignation as the top White House policy advisor. Grogan had been an advisor to the FDA and lobbyist for Gilead.
4/29/2020: Anthony Fauci announced preliminary findings from a US government sponsored study on hospitalized CoVID patients with lung involvement. Those taking remdesivir recovered within an average of 11 days, compared to 15 days to recovery for those not on the drug.
However, the death rates were the same in both groups. Those not on the drug were likely to recover anyway, since death occurred at the same rate regardless of who was treated.
4/30/2020: Gilead announced preliminary results from an unpublished, non-blinded, study that compared 5 days of remdesivir to 10 days of remdesivir, finding that the shorter course was as effective as the longer treatment.
This study only compared lengths of treatment, and did not compare to patients who were on no treatment.
The researchers and patients knew who was getting the drugs, and there was no comparison to placebo.
A Gilead press release said, “The most common adverse events occurring in more than 10 percent of patients in either group were nausea and acute respiratory failure.” In addition, 7.3 percent of patients had liver toxicity.
Gilead stocks took off like a rocket at this press release.
5/1/2020: FDA approved emergency use of remdesivir in severely ill hospitalized patients with CoVID.
In summary, with one well-conducted study showing no benefit from the drug, and one unpublished, non-blinded study not compared to placebo, and one study showing a shorter course of illness but no difference in death by CoVID, Anthony Fauci endorsed remdesivir as becoming a standard of care.
In order to guide the government on what to accept for pricing of remdesivir, the Institute for Clinical and Economic Review (ICER) estimated it costs the company $9.32 to make enough to treat one patient for 10 days, and only $5 for a 5-day course of treatment.
They project the drug will sell at $4,500 for a course of treatment.
This assumption of fair value drug pricing takes into the account the cost savings to insurance plans of not having a patient in the ICU on a ventilator, despite the facts that:
- remdesivir has not been shown to reduce viral load in the bloodstream of CoVID patients;
- remdesivir has not been shown to reduce the progression of CoVID illness to needing a ventilator;
- remdesivir has not been shown to reduce death rates from CoVID.
Gilead is likely to try to get that number well above $4,500, as it says it expects to spend $1 billion on “developing” the drug this year. This is not a new drug. It was developed 10 years ago to treat hepatitis C, but the company has since made billions in successful drugs for hepatitis and is estimated to have long since recovered their research costs sunk into remdesivir.
Meanwhile Gilead stock is up 20% since the beginning of the year.
Tip for the smart health care consumer: Beware of rushing to be the first one on the block to champion a new and unproven drug.
Here’s other interesting news on the coronapocalypse:
‘Open Texas’ continues!
Light therapy can be effective for bioterrorism and pandemics.