According to an AP story I saw this morning, “the new class of sleep aids promises an advertising war. Some industry watchers say the coming ad blitz for the emerging class of longer-term sleep aids such as Sepracor’s Lunesta could rival the ad campaign associated with erectile dysfunction drugs.” I certainly hope that there have been some lessons learned. While ads for sleep aids won’t offend people the way some ED promotions have, there is still the very real threat that an orgy of advertising will further stoke the anti-DTC fire. I hope that long-term thinking is not in short supply and that these new commercials will lean more towards a disease-awareness creative strategy. Otherwise we’ll have a new definition of “D’s, “Dems,” and … “Doze.”

After too much bloviating and posturing and delay, all I can say is —IT’S ABOUT TIME that Dr. Crawford has been confirmed as FDA Commissioner. Sid Wolfe has already said that Les will be “the worst Commissioner ever,” making Les Dr. Wolfe’s most recent “worst Commissioner ever.” And that bodes well, because Sid’s last worst was Mark McClellan. The most exciting thing about last evening’s debate was how Senators Kennedy, Hatch, and Enzi triple-teamed Senator Grassley and set the man from Iowa straight on what authorities FDA has and doesn’t have — as well as what committee has authority over the agency. Well done gentlemen. Lester, excelsior.

The Canadian Minister of Health, Ujjal Dosanjh just announced that he’s introducing legislation that will, for all intents and purposes, end the charade of “Canada-only” drug importation. Now those who want to import will have to turn elsewhere — and where they’re looking is to Europe. Well, I’ve just returned from Europe and they’ve got a lot of problems over there. One of them is that profiteers masquerading as pharmacists are selling unsafe, unregulated, mislabeled, repacked, and co-mingled drugs to unsuspecting consumers. In Europe the cause of this malaise is known as parallel trade. Here at home we know it as drug re-importation. Unfortunately, the consequences of this “drug shuffle” are inconvenient for some American politicians and so they parse the truth. That’s bad medicine.

Senators Byron Dorgan (D, ND) and David Vitter (R, LA) have both introduced bills that would allow for drug importation from certain nations within the European Union. But they’re confused. They don’t seem to understand (or they choose not to admit) that you can’t cherry-pick drugs from just one or two of the 25 European Union nations. Senators Dorgan and Vitter may only want drugs from Great Britain or France, but that’s impossible — because that’s the law. According to the Treaty of Rome, parallel trade is completely legal and Articles 30 and 36 prohibit manufacturers from managing their European supply chains in their own or patients’ interests. Sorry Senators, the truth is inconvenient.

Last year 140 million individual drug packages were parallel imported throughout the European Union — and a wholesaler repackaged each and every one. This means that, literally, parallel traders open 140 million packets of drugs, remove their contents and repackage them. But these parallel profiteers are in the moneymaking business, not the safety business. And mistakes happen. For example, new labels incorrectly state the dosage strength; the new label says the box contains tablets, but inside are capsules; the expiration date and batch numbers on the medicine boxes don’t match the actual batch and dates of expiration of the medicines inside; and patient information materials are often in the wrong language or are out of date. Oops.

This means that drugs purchased from a British pharmacy to an unknowing American consumer (or a blissfully ignorant United States Senator) could come from European Union nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia. In fact, parallel traded medicines account for about 20% (one in five) of all prescriptions filled by British pharmacies, the same pharmacies so highly touted by Senators Dorgan and Vitter and Governors Pawlenty (MN), Blagojevich (IL) and Doyle (WI). In the EU there is no requirement to record the batch numbers of parallel imported medicines, so if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Indianapolis) is impossible. Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.

There is evidence linking parallel importation with the growing threat of counterfeits. In August 2004 counterfeit medicines were found in the legitimate British supply chain after a patient complained of a crumbling tablet. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued an immediate alert. Only days later, the MHRA had to issue another alert after a different counterfeit medicine was found in Great Britain’s legitimate supply chain. Pharmaceutish Weekblad, a respected pharmacy journal in the Netherlands, recently reported that counterfeit medicines found in the Netherlands at the end of last year entered the legitimate supply chain through parallel importers. Stubborn facts.

The World Health Organization (WHO) estimates that 8-10% of the global medicine supply chain is counterfeit — rising to 25% or higher in some countries. The largest counterfeit market with close proximity to the EU free trade zone is Russia, where the generally accepted estimate is that 12% of drugs are counterfeit. Now that the Baltic nations of Latvia, Lithuania, and Estonia have joined the European Union, WHO has warned that an increase in the risks of counterfeits entering the EU supply chain is “obvious.” Facts are stubborn things.

According to Sue Mitchell, editor of the British journal Epilepsy Today, “The parallel trade in medication is damaging people’s health and, at worse, putting lives at risk. Strong words, but when the discussion of the parallel importing of medication seems to revolve primarily around money, the reality of patient experience goes unheard all too often.” Senator Dorgan, Senator Vitter â my 18-year old son has epilepsy. Please pay attention to the facts.

The issue of more and ever more black box warnings, beyond any individual therapy or class, is whether the pendulum has swung too far — and it seems as though that’s a real possibility. It’s crucial for FDA — and for those who are irresponsibly calling for “100% safety” — to realize that pronouncements made in the heat of political debate have serious and deliterious impact on not only the scientific debate, but also on the lives of real people outside the Beltway. Further, as labels become increasingly muddled with more and more warnings, fewer and fewer physicians and patients will pay them any heed. Label fatigue is a real threat to the public health.

Check out Alex Berenson’s article in today’s (7/12) New York Times. It is trying to make the argument that a few additional weeks/months of life aren’t worth the cost. When OMB makes similar remarks they are excoriated by the Gray Lady and others in very aggressive tones.