From the Chicago Tribune:
Given the option of living with pain or an increased heart attack risk, some Baby Boomers are assuming the risk and going back to a drug still considered potentially dangerous by the government. Two years after Vioxx and other powerful arthritis pain fighters were linked to cardiovascular trouble, there is a big comeback under way for those types of drugs known as Cox-2 inhibitors.
One of them, Pfizer Inc.’s Celebrex, saw its sales jump 18 percent last year, even though it must now be sold with a “black box” label warning of the risk to the heart.
Now Merck & Co., which pulled Vioxx from the market in 2004 and is fighting billions of dollars in court damage claims, is trying again with another Cox-2 drug. It is seeking U.S. approval to introduce Arcoxia, while the Swiss drug giant Novartis AG is doing a large clinical safety trial of its own Cox-2, Prexige. Later this year, Novartis will ask U.S. regulators for permission to market it.
There is no doubt that seniors are in desperate need of pain relief, but hopefully this time Merck and the FDA will exercise more caution than they did with Vioxx.
From The Washington Post:
Texas lawmakers are fighting to block the governor’s order requiring that sixth-grade girls be vaccinated against the virus that causes cervical cancer, with the House giving key approval to a bill to make the shots strictly voluntary.
Gov. Rick Perry’s executive order has inflamed conservatives who say it contradicts Texas’ abstinence-only sexual education policies and intrudes into family lives. Some critics also have questioned whether the vaccine has been proven safe.
This bill clearly will pass both houses with enough votes to override a Perry veto. In other words, the Gardasil mandate is dead in the water.
I have mixed feelings about this one — because if the mandate is overturned, it will be overturned for the wrong reasons.
For those who believe in democracy and oppose political corruption, the real issue shouldn’t be that the mandate runs counter to conservative views on abstinence. The real issue is that Perry issued an executive order that would provide significant financial benefits to a specific company, Merck – and he did this despite the fact that it would run counter to the views of his political supporters.
Are we REALLY supposed to believe that Perry’s actions were the product of political courage? If you think this deal was about courage and not Big Pharma money, I’ve got a bridge to sell you in Brooklyn.
The Kaiser Family Foundation has an update on other HPV vaccine proposals in California and Washington.
Bloomberg reported last week that Merck & Co. will stop lobbying state officials to require girls receive the Gardasil vaccine:
Merck made the decision after groups including the American Academy of Pediatrics said there wasn’t enough state funding to pay for the $360 vaccine or public acceptance … Texas this month became the first state, among about 20 considering legislation, to require school-aged girls to get the shot. Merck began its campaign for the vaccine among state lawmakers even before it was approved in June 2006.
Merck’s management, along with Wall Street, are banking on Gardasil to be the savior of the company’s depleted pipelines. The drug recorded $155 million in revenues in the fourth quarter of 2006, and is projected to bring up to $3 billion annually into Merck’s coffers.
Unfortunately for Merck, the public finally may be getting tired of Big Pharma’s arrogant power plays.
Although some states are making the HPV vaccination Gardasil mandatory for young girls, those who seek the vaccine in states where it is not provided by the government may have a difficult time finding it at all.
According to howstuffworks, the medical reinbursement system currently in use is failing. Normally doctors purchase a vaccine themselves, then charge the patient’s insurance company for the cost of the medication plus an additional 10 to 17 percent over retail (to cover costs from stocking and administering the medicine). Gardasil, however, is so expensive that some insurance companies are refusing to pay the $171.50 per dose.
Howstuffworks states:
So doctors — pediatricians in particular, who tend to stock the most vaccines of all medical specialists — and insurance companies appear to be in a deadlock. Pediatricians claim they simply can’t afford to stock Gardasil since they’re not getting reimbursed for all of their expenses. For some, stocking the drug would mean operating at a loss or barely breaking even. And most insurance companies, who have been trying to change the biologics-reimbursement situation for years now, are standing their ground at $132 per dose (called “ASP+6,” or “average selling price plus 6 percent”), saying that doctors are demanding over-reimbursement. And in the meantime, many people who can’t afford to shell out up to $400 to get their daughter(s) vaccinated are left running from pediatrician’s office to public health clinic to gynecologist’s office and back again trying to find someone who has Gardasil.
This in the wake of Texas Gov. Rick Perry melodramatically claiming that he “can’t look a young woman in the eye” who contracted cervical cancer because she didn’t have access to Gardasil. If that’s really the case, get off your duff and start fixing our broken healthcare system instead of settling for self-serving photo ops.
I refuse to look a young woman in the eye who suffers from this form of cancer and tell her that we could have stopped it but we didn’t. Others may focus on the cause of this cancer. I stay focused on the cure.
These are the words of Texas Gov. Rick Perry, defending his executive order making Gardasil a mandatory vaccination for young girls going into the sixth grade. Gardasil, produced by Merck, prevents women from contracting HPV, the leading cause of cervical cancer, through sexual contact. Perry’s right-wing base has slammed the governor for requiring the vaccination, because it allegedly strays from Texas’ abstinence-only sex education policy. This — coupled with a $120 per-shot price tag — has many questioning Perry’s motives.
News Hounds points out some of the ties that Perry has with Merck:
Two of Perry’s former chiefs of staff currently work for Merck, and the mother of one of them is involved in lobbying for this … Has Perry just caved in for Merck? … His former c-o-s is being paid $250,000 by Merck to lobby for this, a Texas state legislator (Diane White Delisi) is pushing for it and working with Merck, and her daughter-in-law is the current chief of staff.
I believe that the vaccine is helpful and that girls should receive it. However, Perry’s unilateral approach suggests that he may be pushing a personal agenda. Texas politicos — Republicans and Democrats alike — are urging him to recall the mandate. Republican state senator Kevin Eltife expressed the same thoughts that I have on the matter when he said,
I am not opposed to the state providing funding for those who want the vaccine, but to mandate the vaccine is government interference at its best. This is an issue that should be taken up by the Legislature and fully debated with input from the public. The issue in no way warrants an executive order.
Perry can’t “look a young woman in the eye,” but he can sign an executive order to mandate an unproven medication that’s been on the market for less than a year? His words say he wants what is best for young girls, but his actions say he wants what is best for him.
Although the FDA approved the production of a generic version of Zocor in June 2006 by both Teva Pharmaceutical and Ranbaxy Laboratories, prices for the drug have dropped less than 10 percent since then. The recent approval of six more companies to sell generic Zocor should change that.
Analysts expect prices to drop as much as 70 percent with the new competition. According to the New York Times:
As the first companies to file for approval of generic versions of Zocor  known as simvastatin  Teva and Ranbaxy won six months of exclusivity under an American law aimed at offering an incentive to generic drug makers. That enabled them to keep prices close to what Merck charges.
The QDIS Blog adds:
This could have an impact on other brand name statin drugs particularly Lipitor from Pfizer, the best selling of all the statin class of drugs. Many health insurance companies are certainly going to recommend that their patients ask their doctor about switching to simvastatin as a means for not only controlling cholesterol but also controlling cost. It will be interesting to see how much of an impact it does have on the sales of LIpitor
As the QDIS Blog points out, I hope that this has an impact on the price of other statins on the market — but I doubt we will see that happen. This is where all that money that Pfizer has poured into direct-to-consumer marketing comes into play.
Damian Trouse of the Houston Chronicle writes:
Licensing deals between pharmaceutical and biotechnology companies is the norm for the industry, giving development stage companies the money to continue developing products, while larger companies get a chance to bolster their product pipelines.
But with more large companies facing pipeline holes, biotech companies are seeing more money being thrown their way for innovative products, and the deals could lead to future acquisitions.
“That’s going to continue to heat up and pick up,” said Jason Napadano, senior biotechnology analyst at Zach’s Investment Research. “The reason it’s happening is that you have these large pharmaceutical companies with an unprecedented number of products going off patent.”
That could amount to billions of dollars in losses for some of the major pharmaceutical companies.
He goes on to say:
In October, Merck & Co. said it would buy small biotechnology outfit Sirna Therapeutics Inc. for $1.1 billion. Abbott Laboratories is in the process of buying Kos Pharmaceuticals for $3.7 billion.
“Big pharma could start knocking on the door of biotech with market caps of $5 billion,” said Morningstar analyst Karen Andersen.
“If you’re a pharmaceutical company and you want these products and need these products, biotech can continue to demand these types of big prices,” Zack’s Napadano said.
By most estimates, the market for licensing deals and pricier acquisitions will continue into 2007. News last week that Pfizer Inc. ended a late-stage program on its experimental heart drug highlighted the company’s pipeline problems, with many analysts predicting it will acquire another company, possibly within the next year.
I hardly think drug companies buying out small biotech firms in order to procure new drugs is the same thing as in-house development. It speaks poorly of Big Pharma’s R&D efforts. The sports analogy would be a team that has to bring in big-name free agents because it doesn’t have a good farm system or doesn’t draft well.
Which raises the question: Doesn’t the government gives Big Pharma the monopoly on the American drug market in order to promote new and innovative drugs? And if that’s not happening, why are American consumers suffering in order to boost Big Pharma’s profits?
From Pharma Times:
Head of research at Merck, Peter Kim, made special mention of the Phase II drug MK-859, which raised levels of ‘good’ HDL cholesterol by more than 50% in clinical trials, without raising blood pressure or causing serious cardiovascular side effects.
PharmaGossip notes:
MK-859 is a member of the same class of medicines as torcetrapib, Pfizer’s high-profile experimental medicine that was discontinued earlier this month after it was linked to elevated blood pressure and a worrisome number of deaths.
Merck definitely would have a head start in the market due to the halt of testing and production of Pfizer’s drug torcetraphib. As Alan Milstein points out, torcetraphib was sure to be the “Mother of all Blockbusters”, and the door is certainly wide open for Merck and its new drug MK-859 to step right in and reap the benefits.
Despite a recent downturn in Merck’s sales, cost-cutting has offset the effects of slowing revenues from Merck’s blockbuster drug Vioxx and recent growth in the generic market. Merck posted a five percent rise in profits and met the expected $0.81 a share.
Merck has reportedly cut back on television ads and focused on more targeted media like online Internet communities. Merck follows Pfizer’s announcement that it is reducing its sales force. Layoffs as well as expiring patents, an increase in the amount of recalls, and inflated sales predictions have all played a role in forcing Merck’s recent downsizing.
You reap what you sow. Big Pharma’s lack of focus on R&D and overemphasis on advertising and gaming the system to extend patent life is finally catching up with them.
