New data on Gilead's remdesivir, released by accident, show no benefit for coronavirus patients.

[jberryhill]

https://www.statnews.com/2020/04/23/data-on-gileads-remdesivir-released-by-accident-show-no-benefit-for-coronavirus-patients/

The antiviral medicine remdesivir from Gilead Sciences failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a long-awaited clinical trial conducted in China. Gilead, however, said the data suggest a “potential benefit.”

A summary of the study results was inadvertently posted to the website of the World Health Organization and seen by STAT on Thursday, but then removed.

“A draft document was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed. The manuscript is undergoing peer review and we are waiting for a final version before WHO comments,” said WHO spokesperson Tarik Jasarevic.

[C_U_L8R]

1. Thank goodness for 'accidents''

[Newest Reality]

2. Gilead

That sounds like one great company there that you can count on and, oh, pay a king's ransom for whatever they come up with. Great!

That company name reminds me of something, too

Criticism

Several class-action lawsuits have been filed against Gilead over allegations that the company deliberately delayed development of antiretroviral drugs based on tenofovir alafenamide fumarate (TAF) in order to maximize profits from previous-generation medications containing tenofovir disoproxil fumarate (TDF).[63] Plaintiffs allege that Gilead suspended TAF in 2004 despite clear evidence indicating that TAF-based medications were safer than TDF, a compound whose long-term use was associated with adverse side effects such as nephrotoxicity and bone density loss.[64][65] Gilead intentionally withheld results of clinical trials demonstrating TAF's relative safety and efficacy and shelved TAF-based therapies until 2010, when the Food and Drug Administration approved Gilead's application to patent TAF.[66] Gilead's first TAF medication, marketed under the trade name Genvoya, came out in 2015. In the interim period, many HIV patients who continuously took Gilead's older TDF-based drugs suffered permanent, debilitating kidney and bone damage, often developing conditions such as Fanconi syndrome and osteomalacia.[67]

Gilead has come under intense criticism for its high pricing of its patented drug sofosbuvir. In the US, for instance, it was launched at $1,000 per pill or $84,000 for the standard 84-day course.[18][68]

Gilead has also tried to eliminate competition in lucrative markets by entering voluntary licensing agreements (VLA) with companies from developing countries such as India, which mandated the limitation of the latter's operations to less lucrative markets. The company has also been criticized for creating harsh restrictions within countries where they have been denied rights, or are engaged in VLAs. For example, in India, they tried to create an 'anti-diversion' program to determine who could buy the drug, which was considered a coercive and policing move by Médecins Sans Frontières since it could lead to the exclusion of vulnerable groups like refugees and migrants from accessing the medicines.[69]

On January 21 2020, the Wuhan Institute of Virology applied for a Chinese "use patent" on remdesivir, for the novel use of treating COVID-19.[70]

Gilead sought and obtained "orphan drug" status for remdesivir from the US Food and Drug Administration on March 23rd, 2020. This provision is intended to encourage the development of drugs affecting fewer than 200,000 Americans by granting strengthened and extended legal monopoly rights to the manufacturer, along with waivers on taxes and government fees.[71][72] Remdesivir is a candidate for treating COVID-19; at the time the status was granted, fewer than 200,000 Americans had COVID-19, but numbers were climbing rapidly as the COVID-19 pandemic reached the US, and crossing the threshold soon was considered inevitable.[71][72] Remdesivir was developed by Gilead with over $79 million in U.S. government funding.[72] After facing strong reactions, Gilead gave up the "orphan drug" status for remdesivir on March 25th.[73] Gilead retains 20-year remdesivir patents in more than 70 countries.[74]

Gilead has also been accused of price-gouging on other medications developed with public funding, including AIDS PrEP drug Tenofovir and hepatitis C drug Sofosbuvir.[75]

https://en.wikipedia.org/wiki/Gilead_Sciences

[getagrip_already]

3. I don't believe in accvidents like this....

Someone wanted that "info" out there. If accurate, they wanted to hurt the company. If not, they wanted to deflate the price prior to the real data coming out.

Which is it? Who knows, but trump does stuff like this all the time.

[dalton99a]

4. Accident, my ass.

[Loki Liesmith]

5. Let's wait for the study

Forming opinions on drugs during clinical trials is a bad practice.

[jberryhill]

7. No opinion

Just posting the article.

[SoonerPride]

6. All of the hype and hope for a quick fix needs to stop

There is no magic bullet.
This won't be over in a month.
It won't magically go away.

We need to be told the truth, which is hard and sobering.

This is a long slog. This is a marathon not a sprint. We CAN survive this if we work together, not just in the US, but globally. This requires a change in our government because what we have now has no interest in working with others, helping others, or doing the right thing.

But any news reports of some new miracle cure are just more snake oil.

Look for real hope from a clinically tested vaccine in a year to 18 months.

[Ms. Toad]

8. But I thought it was being slow-walked . . . n/t

[jberryhill]

9. (snort)