Domain: fiercepharma.com
Stories and comments across the archive that link to fiercepharma.com.
Comments · 7
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Re:There's no money to be made in health.
https://www.washingtonpost.com... https://www.fiercepharma.com/s... Most of pharma's "R&D" is spent on marketing.
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Re: Pfizer and Amphastar the only option?
I suspect that may be the answer. Lots of chemicals sold by international companies specializing in chemicals (e.g., Fisher, Baker) have switched their raw suppliers from Western sources to China. As we all know, you have to ride herd constantly on Chinese suppliers because they will take any shortcut they can to save money.
It wouldn't surprise me if the latest batches failed QC testing here in the States even after supposedly passing QA at their source. Even more fun, if FDA inspectors found problems anywhere in the supply chain it may take a while to remedy. With only two end product suppliers problems at one can cause a shortage very fast.
Hospira (a Pfizer company), which is the one that has the shortage, has had a recent history with quality control issue (problems with cardboard particulates in injectable vancomycin).
FWIW, in an email, a spokesman said the shortage is due to issues with a third-party supplier but not the API supplier. (API means active pharmaceutical ingredient), so it isn't likely to be the actual soda ash / bicarbonate supplier that is the issue per se, but perhaps some other company that supplies testing materials, or perhaps some packaging supplier. As I mentioned the USA is one of the largest suppliers of sodium bicarbonate, it seems unlikely that there is a simply sourcing problem with the basic ingredient and not something fixed by going to China.
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Re: in the pastIn the past, long before the vaccinations were started, hygienic, medical and nutritional conditions were improving and the incidence of the diseases you are talking about was already in a long decline. Maybe that's why they are not dying of the disease 'that we now vaccinate against'? There is zero proof that the further decline can be contributed to vaccinations instead of a further improvement in social, hygienic, medical, environmental and nutritional conditions. Zero.
I also have no idea what you mean by a guy who was (and still is) trying to promote his own vaccination method.
It could be that you are hinting at Dr. Andrew Wakefield who publicly suggested separating the measles vaccination from the MMR vaccin and giving it 6 months later in order to decrease the amount of autism cases.
I'm also totally at a loss why that would be such a bad advice.
And where, by the way, is the randomly controlled double blind trial in an epidemiologically relevant part of society that shows both the efficacy and the safety of the MMR vaccin?
After carefully profiling your character I decided to come up with a link out of a New York Times article that you might accept as genuine:Like many vaccines, Prevnar requires multiple jabs. Each shot is priced at $136, and most states require children to get four doses before entering day care or preschool. Pfizer, the sole manufacturer, had revenues of nearly $4 billion from its Prevnar vaccine line last year...
Further I think that there must be something wrong with your be-ing rather than with my e key, which was a mere typo.
There is no provenly safe jab. And therefore parents should have the right to decide, and also healthcare professionals should have the right to vent their opinions. -
Re:It's not innovative
Or, it could be not malice, but mere stupidity.
It seems there's been a series of unfortunate events affecting Mylan's competitors:
Will anyone ever give Mylan’s ($MYL) blockbuster epinephrine injection, EpiPen, a run for its money?
That’s the question now that another potential competitor is out of the running. The FDA stiff-armed Adamis' ($ADMP) prefilled epinephrine syringe, asking for more data. Regulators want the San Diego-based company to expand a patient usability study and product stress testing studies included in the original application.
The way Evercore ISI analyst Umer Raffat sees it, Adamis’ product wouldn’t have been “a large competitor” for EpiPen, given the difference between its prefilled syringe and Mylan’s more convenient injection pen device. But “Adamis could have added to managed care pressures,” through its stated strategy of acting as a discounted product.
Instead, Mylan is home free--a status it must be getting used to, given the failures that have repeatedly befallen its competitors. Back in November, Sanofi's ($SNY) Auvi-Q hit a wall, when an injector fault triggered a hefty recall. Ultimately, the pharma giant yanked Auvi-Q from the market, and then bailed on its marketing partnership with developer PDL BioPharma ($PDLI), putting the med’s future up in the air. It was EpiPen's first real challenger in years.
More recently, the FDA handed generics giant Teva ($TEVA) a rejection for its generic version of EpiPen, flagging “certain major deficiencies” in its letter to the Israeli pharma. With serious issues to work through, Teva said earlier this year that it expects its product to be "significantly delayed"--meaning it doesn’t expect a rollout before 2017.
The FDA wouldn't have anything to do with the recall, and a request for more information isn't really a particularly effective use of corrupt power. Requests for more data happen all the time, so they're usually turned around pretty quickly. My money's on a perfect storm of chance events, and Mylan's taking the opportunity to capitalize on it.
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Re:Federal Analog Act?
I hardly suspect drug companies of goodwill toward men, as a rule; but there are a couple of factors that probably make legal blugeoning tricky at best and useless at worst (for any compound with a history in medicine that isn't told purely as a 'horror stories from the old days' anecdote).
If you shove something to Schedule I, nobody inside the law gets to make a penny on it (barring possible tiny-batch stuff for the occasional research project that somehow fills out all the paperwork the DEA throws at them). If something remains Schedule II or lower, access gets substantially more difficult for people too poor to have a doctor write them a prescription; and less convenient for everyone; but the barriers to entry, and prices, of off-patent generics, especially common and relatively simple ones, are low, and as long as the assorted bottom feeders don't really piss off the FDA through shoddy manufacturing practices or outright falsification of test data, you can't schedule drugs differently by brand. Even for the company with the original brand name, logo, and coloration, margins suffer; but anybody who isn't actually losing money at least gets to move product.
Further, if it remains at Schedule II or lower, mostly-law-abiding drug companies can sometimes get a cut (probably at lower margins than they would really prefer; but above zero, and check out that volume!) of the action that would otherwise go to dealers of chemically similar Schedule I compounds. Perhaps most notably, Purdue Pharma(and, amazingly, even a few of their individual executives!) actually ran into a nasty little bit of legal trouble for their effort to downplay the addictiveness and abuse rates of Oxycontin in an effort to continue selling as much of the stuff as possible. Especially in the heyday of the Florida pill-mill scene, the legality of Oxycontin and some other all-fancy-and-medical opiates allowed the legal players to take a sizeable bite of a market that would otherwise be left to heroin pushers.
I do suspect that they'd prefer people stop self-medicating with booze and weed, and face their problems like healthy, functional, adults, with the prescription drugs recommended by TV commercials, preferably choosing patented or name-brand formulations wherever possible; but as a more general strategy, I'm not sure that prohibition, as currently implemented, offers enough flexibility to be a truly good tool for profit maximization. -
Re:Optimisim
The money is not in a cure for the disease, the money is in the treatment for the disease. If the big pharmas were in it for the good of mankind, they would be non-profits and their CEOs wouldn't make the money they do.
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Re:Is there anyone not terminal?
Tied to a chair with bedsores, sedated to keep you from becoming troublesome, and spoon fed whirled peas. Be careful what you wish for.
Deaths can be prevented, but when you see the term "preventable deaths" in the press they're never using it correctly. You prevent deaths with condoms, birth control pills, and poor oral hygiene - by preventing the lives from starting.