NEW FLU DRUG IS THE LATEST FUTURE
FAILURE IN THE WAR ON INFLUENZA
“Roche today announced that the phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study’s primary objective, and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo. Baloxavir marboxil has already demonstrated a clinically significant benefit over placebo in otherwise healthy people in the phase III CAPSTONE-1 study. We are committed to bringing innovation in the field of infectious diseases, including influenza. Tamiflu has made a significant difference both to the treatment of seasonal influenza as well as in the management of recent pandemics, and we are proud to have brought this innovative medicine to patients.” From the July 17, 2018 Media Release from Roche. Follow along as I show you just how bogus this really is.
In a piece that Gary Schwitzer would undoubtedly have a heyday with, just yesterday, Helen Branswell of STAT gave her readers (mostly medical professionals) an article with the heavily hyped title; A Flu Drug — Shown to Reduce the Duration of Symptoms — Could Upend Treatment in U.S. What is it that could make this new drug (Baloxavir Morboxil / Xofluza) the hottest thing since, well, Beanie Babies?
“Next winter, there may be a new drug for people who contract influenza — one that appears to be able to shut down infection quickly and, unlike anything else on the market, can be taken as a single pill. The drug has been shown to reduce the duration of flu symptoms by a little more than a day….”
OK, let me see if I’m getting this straight? Even though the general public clamors for it, doctors know that Tamiflu is a crappy drug because it’s not only associated with a number of common and rather unpleasant side effects, it only shortens the duration of flu by less than 10%. Xofluza is being plugged as a wonder drug because it’s just a wee bit better? What am I missing here? Furthermore, Xofluza doesn’t address the single biggest problem facing any vaccine or treatment for influenza.
The biggest problem with treating flu is the futility of trying to differentiate between actual flu (of which there are thousands of strains) and Flu-Like Illnesses, of which the number of strains is almost unlimited, and which far-and-away causes the most cases of “flu” (HERE). Branswell went on to discuss some of these problems herself.
“Tamiflu and the other drugs in its class never got the market acceptance in the U.S. that their manufacturers hoped and public health authorities expected them to get. The reason: There has been a perception that the benefits — a little less time in bed — don’t justify trying to get a doctor’s appointment, get to the doctor’s office, and then find a pharmacy with drug in stock. Many doctors also are underwhelmed by the drugs, and aren’t inclined to prescribe them.”
So, the old drugs (Tamiflu and Relenza) don’t work well — a fact which most docs are already aware of. The new drug supposedly works slightly better (I say “supposedly” FOR THIS REASON), costs who-knows-how-much, and like the older drugs, must be taken in the early stages of the illness to work at all. What part of this scenario sounds good enough to “upend flu treatment in America“? Best guess is that once the facts become known about this drug, it will end up relegated to the previous link as it goes the way of the BEANIE BABY. And don’t be surprised if you start seeing reports of people developing resistance to the drug.
The only study I could find on Xofluza (Characterization of Influenza Virus Variants Induced by Treatment with the Endonuclease Inhibitor Baloxavir Marboxil from this month’s issue of Scientific Reports) started out by picking on Tamiflu, saying, “another concern for this class of drugs is the emergence of resistance.” The authors went on to describe the testing they went through to make sure that flu viruses will not become resistant to Xofluza. The problem is that resistance is not something that will be seen immediately, but will likely take several years to develop. This fact was verified in Monday’s issue of the European Pharmaceutical Review (Flu’s Response to Xofluza Explored).
“Stephen Cusack’s group… determined crystal structures of the drug bound to the typical polymerase of the virus as well as the mutant polymerase… ‘This apparently minor change leads to reduced contact between the polymerase and the drug, weakening the drug’s effect. However, the virus pays a price for escaping the drug, since we found that the same mutation also lowers the activity of the polymerase, meaning that the mutant virus is less effective at replicating itself. It is therefore uncertain whether this Xofluza-resistant virus would ever spread.’ Before making definite claims about the possibility of resistance developing, Xofluza will need to be used by many people around the world. ‘Only that way can we find out if resistance spreads and becomes a problem. Finding out could take several years…'”
The cold, hard truth is that when it comes to drugs and procedures, there is always a trade off. And this trade off is always bigger than people are led to believe because firstly, there are so many drugs being consumed by the average American (HERE), secondly, these drugs are far more dangerous than the public has been led to believe (HERE, HERE and HERE), and thirdly, we know that side effects are only reported a little more than 1% of the time (HERE), making said medications appear far safer than they really are. And then there’s the whole issue of being able to trust anything coming out of the pharmaceutical industry (HERE and HERE).
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Roche said a phase III trial showed its novel flu drug baloxavir marboxil was superior to placebo, but a close reading of the company’s press release suggested it wasn’t markedly better than oseltamivir (Tamiflu).