Drug development can be hazardous. Recently, a California court held that product users could sue the drug manufacturer, Gilead, for negligence in failing to commercialize a product different from the one they used. Two conditions are yet to be proven to sustain their claim: that Gilead had actual knowledge the new product was safer and that the decision was solely financially driven. But, even if those facts are proven, they are still not enough to sustain a lawsuit.
Gilead
Last week, a California court issued a ruling construed as being anti-industry. The decision defines a company's legal duty to its consumers when a competing and allegedly safer drug is in the development pipeline. Astonishingly, the judicial opinion also insinuates itself into corporate product-development strategies. But does this case really establish the broad anti-industry precedent that some fear?
Another clinical trial of remdesivir – this time with hospitalized patients having moderate COVID-19 – yielded disappointing and strange results. The first randomized trial showed a modest benefit in patients with severe COVID, so theoretically the drug should have worked better in patients who weren't as sick. But, it didn't.
Remdesivir arrived with great hope and even greater expectations. Would this drug finally awake us from the 2-plus-month long nightmare that has the U.S. tossing and turning in its sleep? As things stand now that answer is no. Here's why.
Remdesivir appears to be our first promising treatment for COVID-19. It is certainly neither a cure nor a preventative. But it seems to reduce the length of hospital stays, and thus, increases the health systems’ capacity by about a third. So if you were in charge of selling this drug, what price would you set?
The first data from the SIMPLE trial of remdesivir has been released by Gilead. Even though this is the first complete trial of the drug, it doesn't answer many questions. That's because there was no control group – something that would have been unethical for the trial participants since they had severe disease. We're just getting started.
As the coronavirus continues to terrorize the world, people are pinning their hopes on companies that are doing vaccine and drug research to -- maybe -- get us out of this mess. Yet, many of the companies doing the work, especially Gilead Science, are "the bad guys." Except when we need them. Gilead's drug, remdesivir, is now in clinical trials in China so they're OK for now. Hypocrisy at its finest.
In 2012, the hepatitis C universe changed forever when Gilead's Sovaldi was approved. Finally, there was an excellent drug that could eliminate the infection almost all the time. But some strains of HCV are tougher than others to treat. But now, Gilead strikes again.
With the issue of drug pricing currently in the news, The New York Times ran an editorial decrying prices that are "too high," while failing to truly address the real issues. Instead, the paper took the easy way out by linking Turing's price gouging to pricing methods of established pharmaceutical makers.
Catch the latest news on concerns regarding Gilead's $84,000 hepatitis C treatment drug Sovaldi, the declining sales of traditional cigarettes, and why prior authorization could be hurting the health care system
If there is a better example of the law of unintended consequences we have never seen it.
The incredibly successful battle against HIV/AIDS has saved many lives, and will no doubt continue to save many more. Once HAART (highly active antiretroviral therapy) drugs, aka cocktails, became available in 1995, there was a steep drop in the number of AIDS deaths in the US.
Get the latest news on the costly Hepatitis C drug, why C-sections have skyrocketed in numbers, and the real reason behind the lack of research on antibiotic research