The pensive woman sits with her eyes downcast. A child's arms suddenly encircle her neck, the chubby hands clutching a bouquet of wildflowers. The camera angle widens and the halcyon meadow, in which the mother and child frolic, is fully revealed. A lyrical voice suggests that, by asking your family doctor about Clarinex - which is better than Claritin - you too could enjoy the utopian pleasure once freed of allergy symptoms.

At the bottom of the screen the drug logo and a toll-free number appear and the narrator mentions, very quickly, possible side effects.

Drug marketing, once plied in doctors' lounges and offices with free pens, food, and samples or at conferences sponsored by the companies, has changed. The newest campaigns have targeted the consumer by direct advertising under the guise of fulfilling the public's right to know about new medications. An informed patient, as every healthcare professional will attest, is an advocate for his own course of treatment. Dynamic self-interest in the process of therapy creates a valuable partnership between the medical establishment and the afflicted.

But are the therapies new or more effective? If not, why advertise the formulation changes or promote the product as improved?

Money.

Pharmaceuticals, on average, cost significantly more within this nation than in other countries for the exact same product. For years, senior citizens groups have organized 'Drug Excursions' to our northern neighbor where they can fill their prescriptions at a considerable savings. Canada, who shares many of the same rigorous standards for drug purity and safety as the US, has a single-payer system of healthcare and negotiates lower prices very effectively with the major drug companies. These companies have sought to pass laws preventing Americans from crossing the border for these purposes but have only partially succeeded by blocking distributors from placing their orders through Canadian wholesalers. Legislation is continually introduced to reverse this law but, so far, the lobbyists have prevailed.

The pharmaceutical manufacturers cite expensive research and development costs of a new medicine to justify the price. During the patent period, they claim, these costs must be passed on or the innovation of new and better medications would stagnate. When presented with this argument, most people reluctantly grant the point, especially when every company donates large amounts of their product to programs supplying the needs of the indigent or uninsured.

At the end of the patent period, other companies can formulate their own versions of the active compound without the stringent and expensive procedure of initial FDA phase approval. These generics, frequently much cheaper, are touted to be as safe and effective as the original on which they were based.

Warfarin, an anticoagulant used for many circulatory problems, is the Barr generic of the Dupont drug Coumadin. Dupont has several judgments pending, deciding whether the generic is or is not the equivalent and if pharmacies or insurance providers should be able to substitute without specific physician approval. Anticoagulation therapy is huge business and Coumadin is Dupont's blockbuster. Studies have indicated that not all patients respond identically to Warfarin as to Coumadin but are the suits a humanitarian action or a self-serving one?

Drug companies employ other methods of conserving their cash cows besides litigation and price fixing. One is reformulation.

Prozac is a widely used antidepressant. Eli Lilly lost the patent and experienced an immediate 20% drop in revenue as the generic hit the shelves. In spite of the claim that high prices are the result of R&D, this drug company reformulated the same old medication and, with an extensive marketing campaign, convinced consumers to switch back. The revolutionary change was a 'once-a-week' dosage, which averages out to the same cost as seven-day supply of the old name brand daily pill. Convenient? Yes. Better or improved? Questionable.

Many of the companies that manufacture a popular treatment are pursuing similar revenue saving tactics. Once a day dosing, more easily swallowed tablets, more varied milligrams, and new applications are among these strategies. Sufferers of premenstrual dysphoric disorder (PMDD formerly PMS) can now seek relief in a pill, Sarafem. That Sarafem is Prozac in different packaging is an open secret. Less obvious is the knowledge that Eli Lilly can re-patent the compound under the new name for the new purpose and, because the generics are specifically for Prozac, the generic version cannot be substituted. Prozac is not safe for women who are pregnant, which in the early stages can mimic PMDD, yet Sarafem might be prescribed if the primary diagnosis is faulty. Again, is this new and improved or simply clever - and perhaps dangerous - marketing to extend the revenues of a no longer exclusive formula?

Glucophage, the big gun of diabetes treatment made by Bristol-Myers Squibb, is reaching the end of its golden period. The company has introduced Glucovance, an improved version with a brand new patent.

AstraZeneca has spruced up Prilosec, no longer patent protected in several European countries, with the next generation but chemically identical Nexium... Under a new patent.

Patents are the way pharmaceutical companies protect their revenues and, thus, encourage additional investment. Without the additional investments via stock purchases and partnerships with other manufacturers, the development of new medications might indeed be compromised. But, in these times of increased scrutiny of accounting methods and upper-management shenanigans, shouldn't this protection be extended only to true innovations and not minor tweaks to an existing drug?

As you are sitting in the middle of that blossom filled meadow, enjoying the freedom of suppressed hayfever, ponder the issues.

Remember plain old Claritin, soon available in generic or over the counter form? After spending an hour or so inside your blood stream it is naturally converted to a slightly different but more chemically active form.

Clarinex.

References:

1. Generic Drugs - Texas State Board of Pharmacy
2. Dressed Up Drug - ABC News.com
3. A Bitter Pill
4. New Tricks for Old - CNNMoney
5. Prozac Profit Ploy - Ed Silverman
6. Warfarin vs. Coumadin
7. Bill to restrict substitution of NTI drugs loses a round - Fred Gebhart


*Clarinex/Claritin are trademarks of Schering-Plough
*Coumadin is a trademark of Dupont
*Prozac/Sarfem are trademarks of Eli Lilly
*Glucophage/Glucovance are trademarks of Bristol-Myers Squibb
*Prilosec/Nexium are trademark of AstraZeneca

      Lisa Binkley works within the medical industry and is the popular author of this health series in the Kudzu Monthly. She serves as the fiction editor of this ezine and also edits for the online science fiction magazine Distant Worlds.
      Lisa maintains a website for her own original fiction and poetry called Jolie Howard Fiction.

      As Lisa phrases it, "Woman, wife, worker, writer. We all wear many faces and fill our niches as best we can."

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