When litigation chokes a supply line
Forbes is running a rather refreshing article on the state of the vaccine market in the United States. As someone who has spent quite a bit of time on Internet message boards over the years, and been in any number of various and sundry debates ranging from creation/evolution to economic policy, I can tell you that there's a widespread feeling among the lay public that big drug companies don't want to create vaccines because cures put them out of business, and this is why there's no cure or working vaccine for AIDS. Naturally, this is complete and utter bologna. A financial windfall the likes of which has never been seen in Big Pharma awaits the first company to complete such a treatment. (And we're making progress day-by-day.)
Nevertheless, this is a widely-held opinion, even by otherwise educated, intelligent people. We know argumentum ad populum doesn't make truth, but it also doesn't stop people from believing hogwash, either.
The article starts off with what is arguably the greatest vaccination effort in the history of medicine: polio. It quickly runs over the history of the March of Dimes, and how privatization spurred the development of innovative ways of killing the virus, and scaling up the manufacturing of the vaccine to produce millions of doses.
One might consider that the Golden Age of vaccine development. It was all downhill after that when the litigation started:
Generic Plavix on its way
At long last, generic clopidogrel is on its way to consumers. Apotex has finally cleared the last hurdles (read: legally outfoxed two huge pharmaceutical companies), which means generic Plavix should be available… today.
Some patients will likely to be able to purchase the generic version of blood thinner Plavix beginning on Wednesday. Rite Aid Corp. spokeswoman Jody Cook said the company expects to have the drug "at most, if not all" its 3,300 stores by then.
So clopidogrel should be available today, but the games aren't quite over yet. There's a legal mess over the timing of the release. BMS and SA assert that the generic version shouldn't be allowed until 2011.
The Canadian generic company is taking a major risk in launching the drug now. Bristol-Myers and Sanofi-Aventis sued Apotex over plans to launch a generic version before agreeing to the deal, which is now under federal criminal investigation.
Apotex reiterated in a statement Tuesday that its version of Plavix doesn't infringe on the drug patent because the patent is invalid. But if a court finds there is infringement, Apotex will have to pay damages to Bristol-Myers and Sanofi-Aventis.
BMS's CEO, Peter Dolan, has been subpoenaed in the criminal investigation of the Apotex deal. (Wherein BMS and SA paid Apotex $40 million to hold off launching generic Plavix until 2011.) Nonetheless, BMS and SA are seeking a restraining order on the new generic, but most analysts think there's less than a 50% chance of it being successful. (And some have downgraded BMS's stock as a result.)
Plavix represents a HUGE portion of BMS's annual revenue, as it's the second best selliing drug in the world behind Lipitor, and unlike Pfizer, they don't have more than one blockbuster still under patent protection now that Pravachol is also generic.
Looks like BMS will need another Fred Hassan to settle things down.
[tags]Medicine, pharmacy, BMS, Sanofi-Aventis, big pharma, ethics[/tags]
Merck's Vioxx litigation strategy is paying off
Merck hasn't settled any of the eight lawsuits brought against them in the wake of the Vioxx controversy. They've done the math, and it's cheaper to fight all of the suits than it is to settle out-of-court for one lump sum. So far, Merck's winning: 5 cases to 3, the most recent victory being in a Los Angeles courtroom.
PharmaGossip points out that Merck's stock is now back within 10% of its pre-Vioxx withdrawal price.
There's still some 14,100 cases to be tried, but Merck is banking (quite literally) on the fact that juries will find in their favor when they really delve into the science that's involved. I tend to agree with them — I've long thought that the benefits of Vioxx (and Bextra, for that matter) outweighed the potential consequences of using the medication, and I've spoken to patients who share my sentiments. The law blog at the WSJ has some commentary on the pattern of verdicts:
Nerves "frayed" at Forest? Um… why?
Nothing like a little fear-mongering to make a mountain out of a molehill. Forest has had its patent on Lexapro challenged by Teva in court, in an effort to open it up to generic competition sooner. This practice is pretty common because the windfall from even a single successful patent-challenge could be huge for the company with the 6-month monopoly on generic sales. In the case of a successful patent-challenge, Big Pharma probably wouldn't have had time to cut a deal with a generic drugmaker to create a competing "authorized" generic, which means true market exclusivity for at least a few of those six months.
It is unlikely that Teva's Lexapro challenge will be successful; the odds are statistically in Forest's favor. A decision is expected this summer, possibly even this month.
There's plenty of nervousness because Lexapro's impact on Forest is far greater than what, for example, the cholesterol drug Lipitor provides to Pfizer or the antipsychotic Zyprexa contributes to Eli Lilly.
Shares of those two companies were rattled when generic-drug companies tried to overturn their U.S. patents, but Big Pharma investors rejoiced when Lilly won a court fight in April 2005 and Pfizer prevailed last December.
Delaying generics through "citizen petitions"
I saw this a few days ago in the WaPo — which is quickly becoming a favorite news site of mine, due to real, original reporting — and it's another straw on the camel's back, so-to-speak. I find myself defending Big Pharma quite a bit; I feel they're given an unfairly bad rap most of the time. Perhaps because they're easy targets, I'm not sure. But then you read stories like this that make you ready to throw in the towel and write the lot of them off as nothing but greedy money-grubbers.
On the one hand, you've got rules that work in your favor for a certain amount of time in the form of patent protection. They protect your intellectual investments so you can recoup costs and make money. I don't know of a single person that would begrudge anyone this. Without the profit incentive, why innovate? It didn't work particularly well in Soviet Russia, and it doesn't work well today, either. Carrots work better than sticks when it comes to creating and innovating.
On the other hand, you wonder why one of the parties has to be a spoil-sport and ruin the party by trying to bend the rules to their further benefit. Given that any single member of the one group has more resources than all the opposition put together*, this often makes for a pretty lobsided game. Especially when one party begins exploiting safeguards put in place by the government to work on behalf of the People.
Swapping Zocor & Vioxx for Gardasil & Januvia?
Is it news if it's obvious? Apparently, yes.
Beleaguered or not, I like Merck more than its competitors; I think they've probably got a deeper pipeline than most of the other big drugmakers, and they're certainly more interesting. They've got their Gardasil vaccine for HPV, and they've got Januvia for diabetes, and Zostavax for shingles. Three completely new therapies, with a mix of evergreening of a few other drugs for good measure.
I think Merck will be the model the model for major pharmaceutical companies from now on. Or perhaps it should be. There's a lot of ruckus made on both sides of the fence when it comes to litigation vs. innovation as a profit vehicle. Not being an insider, I'm not sure what to think, though I think the truth is probably somewhere in the middle (it usually is) — big pharma has gambled too much on DTC advertising and has focused on quarterly profits rather than on long-term health, and it's going to bite them eventually, more than it currently is.
The problem is probably due to two main factors: greed (money now!) and an overall shift in focus on the part of investors from long-term health and viability to quarterly returns. We're seeing this in fields outside healthcare as well, particularly in technology and every other R&D-driven industry. The Warren Buffett school of thought seems terribly lacking in today's investment world, and I think the house of cards is going to come crashing down eventually.
Beat the horses until they're dead, but then what?
[tags]Medicine, pharmacy, big pharma, merck, zostavax, januvia, gardasil[/tags]
"Minimally conscious" man wakes up after 19 years
I wouldn't normally post about something like this, but I think the ramifications of this development are huge from a clinical and financial point of view. While the science behind the occurrence is quite interesting, the science is going to take a backseat in the near-term as debates over patients' rights, etc. are, well, debated.
I'm getting ahead of myself. What has happened is that a man has emerged from what amounts to a coma after 19 years, and his brain has shown some impressive neural rewiring. Stuff that's never been documented in medical literature before.
They found that new axons – the branches that connect neurons together – seemed to have grown, establishing novel working brain circuits.
Surprisingly, the circuits look nothing like normal brain anatomy. A lot of the damage had been to axons that passed from one side of the brain to the other, torn by the force of the accident. But Schiff says that new connections seem to have grown across around the back of the brain, forming structures that do not exist in normal brains.
What effect this will have on medical procedure is unknown. One can easily imagine fiascos like the Terry Schiavo incident persisting longer and more vehemently had these findings been released before her plug was pulled. (Though in her case brain imaging showed nothing but neuronal soup.)
Then there are insurers who foot the bill for extended hospitalizations. Will patients' families push for longer stays and more tests in the hopes that their loved ones will have a similar recovery?
But improvements in the care of patients could be made without putting every patient into a brain scanner, says Schiff. There is currently no system for even a bedside re-examination from 8 weeks after an initial diagnosis, despite the fact that “their whole prognosis might change”, he says.
Wallis was frequently classified as being in a permanent vegetative state. Though his family fought for a re-evaluation after seeing many promising signs that he was trying to communicate, their requests were turned down.
“A careful bedside examination at 6 months [after the accident] would have unequivocally said he was not in a vegetative state,” says Schiff. There is a much greater chance of a late recovery from a minimally conscious state, he adds, although such recoveries are still rare. “The Wallis case will force the issue,” he believes.
I don't have any answers, only more questions. If anyone has any insight, I'm all ears.
[tags]Medicine, coma, neuroscience, neurology, neural rewiring[/tags]