Sometimes the whole is not greater than the sum of the parts, just more expensive.
Last week, we reported on GlaxoSmithKline's newly-approved combination drug for migraines, Treximet. ('GlaxoSmithKline sets out to dupe migraine sufferers with Treximet smoke and mirrors") Treximet simply combines Imitrex, a migraine medication that is going generic later this year, with naproxen sodium, better known as over-the-counter Aleve.
"Combination pills" have long been a tactic for brand-name drug companies to try to squeeze a little more profit out of drugs that are going generic -- in fact, Schering-Plough and Merck are famous for another little joint venture combo drug, Vytorin (Zocor/simvastatin and Zetia/ezetimibe), which has been much in the news lately for its lackluster effectiveness.
Lately it seems like big pharma is just insulting our intelligence, repackaging drugs that have been around for a while into combo pills and trying to pass them off as "innovations" onto an unsuspecting public. That certainly seems to be the case with Schering-Plough's (NYSE:SGP) and Merck's (NYSE:MRK) latest proposed joint venture - a combination pill of Singulair and Claritin, two drugs approved for treatment of "allergic rhinitis," aka allergies (Singulair is also approved to treat asthma). The two companies gleefully report that the FDA has accepted a New Drug Application for the combination.
Claritin has been available over-the-counter for several years, at an average monthly cost of $6-18, according to Consumer Reports Best Buy Drugs. Singulair is prescription-only, with its patent set to expire in 2012. Last year, Merck added new information to Singulair's label to report new "adverse events" that were noted in people taking Singulair, including depression and suicidality (suicidal thinking and behavior).
Tellingly, the press release doesn't claim that the combination works better than simply taking Singulair and Claritin together but in separate pills. It says "In clinical trials supporting the NDA, the combination product provided a consistent and clinically relevant effect on congestion that was not demonstrated with the individual components." Which, as we pointed out in our entry on Treximet, is like saying that a chocolate cake tastes better than the ingredients (flour, eggs, sugar) eaten separately.
Combination drugs like these are intended to serve one purpose: to increase the manufacturers' market share, particularly in the face of impending generic competition. Schering-Plough has been down a road like this already with Claritin -- when Claritin was set to go generic, they introduced Clarinex. Clarinex (desloratidine) is simply a metabolite of Claritin (loratidine) -- in a nutshell, Clarinex is what Claritin becomes in your liver. As one blogger put it, "if you've taken Claritin, you've taken Clarinex." Thankfully, doctors and patients weren't really fooled, and sales of Clarinex were never very impressive. I stand corrected! According to this item on Pharmalot, 2007 sales of Clarinex were $799 million! (See "Clarinex Patent Fight Nothing To Sneeze At")
Today I'm seeking to introduce a term for combination drugs that the world doesn't need into the pharamceutical vernacular.
"Goober Grape" Drugs
What's a Goober Grape Drug?
Goober Grape, for the (fortunately) uninitiated, is a appalling combination of peanut butter and jelly in a single jar.
Until Goober Grape came along, millions of parents were forced to endure the mind-numbing routine of spreading peanut butter first, and then jelly. Until this breakthrough miraculously cut that spreading time in half, freeing generations of parents for loftier pursuits.
So henceforth, a "Goober Grape Drug" refers to any combination drug that offers no additional clinical advantage and only the most ridiculously minimal increase in patient convenience. There are certainly conditions in which combination pills are important, in that reducing the number of pills to be taken increases patient compliance, but allergies sure as heck ain't one of 'em.
If and when this Claritin/Singulair combination is approved by the FDA, we at Prescription Access Litigation will most likely give it one of our coveted Bitter Pill Awards. Till then, we'll content ourselves with giving it our first ever designation as a Goober Grape Drug.
Will the FDA approve? Who knows! Probably, since to be approved by the FDA, a drug only has to show that it is better than a placebo (aka a sugar pill aka nothing at all). And since Singulair and Claritin have already each separately cleared that hurdle, a combination of them likely will as well. Hopefully, if it is approved, doctors, patients and insurers will give it the cold shoulder. But, to paraphrase an old saying, "No one ever went broke trying to overestimate the willingness of the American health care system to pay for drugs of questionable value."
Update: Apparently, the FDA issued a "non-approvable" letter for this combination yesterday. (See Schering-Plough's press release on the letter). A "non-approvable," despite what it sounds like, does not mean that the FDA has conclusively rejected a new drug. Rather, it means the application is not approvable in its current form. Drug companies frequently amend or add to their applications upon receiving such a letter, and at times later get approval.
Readers, we invite your nominations/suggestions of other Goober Grape Drugs -- please post in the comments.