One of the goofier moments in The Fugitive is when the Evil Doctor*, addressing a heart specialists’ convention, declares that the new heart drug he helped develop (Provasic) has no side effects whatsoever. This was goofy in that the audience didn’t break out in groans, boos and laughter - seeing that every drug every invented has had side effects - and this applies especially to powerfully effective drugs.
So there was a bizarre deja vu in reading an editorial in today’s Wall St. Journal condemning attempts to control drug prices as “The Assault On Drug Innovation”. In the course of this editorial, the Journal declared that new PCSK9 inhibitors "lower bad LDL cholesterol to levels that statins can’t achieve, with no side effects" (italics added).
Wow! But pathetically untrue.
“All medications have the potential for side effects. Adverse events were reported in 69 percent of people taking evolocumab in the clinical trials. Injection-site swelling or rash, limb pain, and fatigue were some of the reported side effects. Less than 1 percent reported mental confusion, difficulty focusing, or other neurocognitive issues. In the alirocumab trials, adverse events were reported in 81 percent of participants taking the drug. These included injection-site reactions, muscle pain, and eye-related events. Slightly more than 1 percent of participants reported neurocognitive adverse events. These included memory impairment and confusion. Long-term side effects and risks are not yet known.”
Not exactly “no side effects”. And it’s a truism that significant side effects frequently don’t become fully known until a drug has been in clinical use for awhile.
Now, maybe these new drugs (which have to be injected every few weeks and are quite expensive) will have a significant role in preventing cardiovascular disease, especially for those who can’t tolerate statins. Exaggerating their safety profile won’t help instill confidence in them or the companies producing them. And it’s a crappy argument against perceptions that some companies are gouging patients/insurers/the government with outrageously high prices for some new drugs.
At least none of the new PCSK9 inhibitors have been named “Provasic”.
*who was (sorry to say) a pathologist. But at least he was a snappy dresser (adding another note of unreality to the movie).
I want to see one of those drug ads o TV, which list side effects ad nauseam*, to throw in some fake ones, just to see if anybody is paying attention:
'…may cause lycanthropy in some patients – check with your allergist…"
“…not available in Tennessee…”
“…can cause dreams of insomnia…”
*warning: listening to list of side effects may cause nausea in sensitive persons.
“Do not drive or operate heavy machinery until you know how homeopathic water will affect you.”
Now that there is an “Aspartame Withdrawal Syndrome” (see related thread), I’m wondering how long until there’s a “Homeopathy Withdrawal Syndrome”. And will the cure be increasing concentrations of the homeopathic drug?
It doesn’t help that the new PCSK9 inhibitors are biologics which may never (or at least may take a very long time) before generic equivalents are approved (thus costs stay high for a lot longer), all while I was taught that LDL cholesterol should at best serve as one of several factors in calculating overall cardiovascular risk. But don’t worry, Kevin Nealon, some Nascar Driver, and a pro-golfer will soon be pimping this stuff on TV as God/Pharma’s greatest gift to man. Lipitor/Crestor/Healthy Diet/Exercise? Bleep that
