There’s a report out stating that the amount of money spent on prescription drugs has slowed somewhat in 2005. Good news for employers and employees, and bad news for Big Pharma. The report suggests that the slowdown is due in part to the controversy over the CV complications of COX-2 inhibitors. While Bextra and Vioxx accounted for some $2.6 billion in sales in 2004, I don’t know how accurate this assertion is: Celebrex is still on the market and undoubtedly picked up some of the COX-2 slack.

Overall, sales only increased 5.4% in 2005, down from an 8.5% increase in 2004. This data comes from Medco (the people behind the PAID PBM, one of the largest prescriptions insurers in the country), and their numbers cover a wide cross-section of the market, so they’re probably representative of the industry as a whole. Big jumpers on terms of dollars spent were sleep aids: Lunesta and Ambien leading the pack, probably due in large part to direct-to-consumer advertising.

Curiosity got the better of me, and I did a little research, and here are the drugs that have either come off patent in 2006, or will in the next few months. The numbers in front are where the drugs listed stand on the top 200 list* for US sales:

• #2: Zocor
• #6: Zoloft
• #21: Pravachol
• #35: Allegra
• #44: Flonase
• Total sales: $13 billion

I suspect that we’ll see a continuing downward trend when the numbers are released for next year. These drugs are some of Big Pharma’s biggest hitters in terms of overall sales, and the total revenues for COX-2 inhibitors don’t even compare to what is being lost in 2006. Great news for consumers and employers. Newer medications could pick up some of the slack, but super costly niche drugs like Humira and other monoclonals will never pack the revenue punch that widely-used statins, allergy meds, and SSRIs do.

* All numbers are from 2004, which is the most recent year for which data is available.

[tags]Prescription spending, COX-2 inhibitors, consumer spending, medicine[/tags]

I must confess, I was shocked when I read about this. Imigran going over-the-counter (OTC) is huge for sufferers of migraines in the UK. Sold as Imitrex here in the US, it will be going OTC sometime during the middle of June. This is also big news for GSK, the makers of Imigran/Imitrex. Revenues for the drug in 2004 topped $1.10bn from the US alone, and while I can’t find the numbers for the UK, I wouldn’t be surprised if it was popular over there as well.

In the United States when a drug goes OTC, you typically see a huge price drop because people are unwilling to pay what it actually cost their insurers when a drug is prescription-only. I’ve touched on this briefly in the past — people have no concept of the costs associated with medicine. You see medications go OTC like this when their patent protection is about to run out: mandatory generic substitution robs Big Pharma of revenues if a drug stays behind the counter. In the case of a relatively safe, proven drug like Imigran/Imitrex, making it available OTC can only mean more money for the manufacturer. People know the brand name, not the generic one, so that’s what they seek out. This is the same reason that Tylenol and Motrin outsell their generic counterparts.

Continue reading Sumatriptan (Imitrex/Imigran) approved for OTC use in the UK →

Merck is waiting on approval from the FDA for its new vaccine, Gardasil, which block four types of the human papilloma virus (HPV) which causes genital warts and cervical cancer in women. As the AP article points out Merck could really use a new hit because of the 11,500 upcoming Vioxx lawsuits, and its blockbuster statin Zocor losing its patent protection in June.

Testing shows Gardasil is nearly 100 percent effective and works for at least five years, said Dr. Eliav Barr, Merck’s head of biological clinical research. He said some of the first women and girls who got the vaccine will be followed for years to see if booster shots are needed.

The vaccine targets four of the roughly 40 types of human papilloma virus: HPV 16 and 18, which cause about 70 percent of cervical cancer cases, and HPV 6 and 11, which cause 90 percent of genital warts.

Continue reading A vaccine for cervical cancer and genital warts →

I read the Wall Street Journal just about every day. Today’s Health Mailbox was concerning old medications. A reader wrote in:

What is a safe method for disposing of old pharmaceuticals? I’ve been told they can enter drinking-water sources if they are flushed.

-G.C.

Now, this is actually a pretty good question. I get asked probably once every week to ten days, and I’ve never had an answer that I’ve been satisfied with. Tara Parker-Pope, the Health columnist for the journal, responds explaining the research behind the claims that these old pharmaceuticals can get into drinking water — all undoubtedly true. She then goes on to suggest that patients contact their local community pharmacies for advice, because she doesn’t have a surefire method of disposing them:

The best advice is to ask your local pharmacy if it has a medication disposal program. Your pharmacist could incinerate medicines along with other pharmacy waste products.

At my pharmacy, we do not have such a program, nor do we incinerate pharmacy waste on site. (We do, however, ship PHI off to the home office where I assume it gets incinerated, though for all I know it could be shredded instead.) What we normally do is simply throw old pills in the trash. I guess that makes us bad citizens. The EPA, on the other hand, recommends simply flushing the old drugs down the toilet (PDF).

[tags]Pharmacy, medication disposal, EPA, environment[/tags]

Before I even begin, I should state that Americans, by and large, have absolutely no idea what health care costs. This means doctors’ visits, prescription costs, and anything else you can think of. Insurers have added a layer of abstraction to health care equation that insulates the public from what drugs, in this case, actually cost. (As a result, you’ll find patients complaining about insurance companies far more often than you’ll hear them complain about anything else.) By and large, this insulation is probably a good thing — when one is sick, worrying about what something costs should be the last thing on one’s mind. Many HMOs charge a flat copayment for long hospital stays. Rarely does a patient see an itemized bill.

The downside of this is the “Holy crap!” factor that a patient experiences when a particular treatment is not covered. I see it every day, and I’ve grown immune to it and the string of complaints that usually ensues. (What I do find funny in a sad sort of way is that the patient often blames the wrong entity for their misfortune — for instance complaining about Blue Cross when they should be complaining about Express Scripts.) Every once in a while, the media catches hold of a particular drug or class of drugs and focuses in on how exorbitant the cost is, and how it shouldn’t be that way. Sometimes they’re right, and sometimes they’re wrong.

This time, the media was wrong.

Continue reading The real cost of healthcare →

Those looking to quit smoking have another weapon in their arsenal to kick the habit. Chantix was approved by the FDA yesterday, but whether insurance companies will cover it remains a mystery. Chantix works by “selectively blocking the α₄β₂ nicotinic receptors” (PDF) in the brain.

Chantix joins another smoking-cessation drug that’s not very popular at all: Zyban. Zyban never really made it big because insurance companies refused to pay for it, and there was another drug on the market that had the same active ingredient — the perennially popular Wellbutrin.

For Pfizer’s sake, I hope they find a second clinical use for Chantix before someone else does, otherwise I suspect they will have wasted a boatload of money. Rarely are brand-name medications priced low enough to appeal to the masses who have to pay out-of-pocket.

On a completely unrelated note, I saw Thank You for Smoking yesterday and it was excellent.

[tags]Chantix, Pfizer, smoking cessation, Wellbutrin, Zyban[/tags]

Working in a pharmacy, people bring us all kinds of strange news pieces: pharmacies being robbed in new and creative ways, and studies about X drug causing Y problem. Today someone brought in a piece of news from USA Today — not my favorite newspaper for myriad reasons. One of them is their propensity for building stories around what amounts to hot air. This one is no exception. Provocatively titled “1 of 7 prescriptions are ‘off-label'”, Ms Ruben builds a hype-driven story around a 2001 study which concluded that some 21% of prescriptions are written to treat conditions for which they were not explicitly approved.

I do not doubt the accuracy of the study — truth be told, I’m surprised it’s not closer to 35% — but it is certainly no cause for alarm, or even a mention in a mainstream newspaper. The piece is pure fear-mongering, and the 6 medications that are specifically cited are largely broad-spectrum drugs. These are only available in the print edition of USA Today, but here they are:

Continue reading Bad journalism intersects with medicine and off-label drug usage →

In my last post about Seroquel’s future, I mentioned the Hatch-Waxman Act (PDF), which was passed in 1984. The Act was supposed to speed up the adoption of generic drugs when the patents behind name-brand drugs ran out. This happened at first, but as pharmacy has expanded, the Act has created a bottleneck at the FDA. It is speculated that the bottleneck is Big Pharma itself: creative lobbying seems to have resulted in a reduction in the budget for the Office of Generic Drugs — which in turn has limited its capacity to approve generic drugs to some 400 per year.

Unfortunately, I can’t seem to find which drugs’ patents will expire without a generic equivalent to take its place — I suspect that none of them are massively profitable by themselves — but all told, the market value of these 800 drugs is a whopping $78 billion per year for their manufacturers. For comparison, the entire generic drug industry is only worth just over $22 billion — even though it accounts for over half the prescriptions dispensed each year in the United States. Broken down, that’s almost $100 million per drug, ceteris paribus. Regardless of the specifics of each case, the aggregate dollars involved are huge.

Continue reading 800 drug patents backlogged at the FDA →