Pharmaceutical Executive-10-01-2007

A landmark court case in the United Kingdom has left Alzheimer's patients with mild to moderate disease unable to receive any of the three drugs that might help them-Aricept (donepezil), Reminyl (galantamine), and Exelon (rivastigmine). Eisai and Pfizer, which make and market Aricept, had challenged the ruling made last year by the National Institute for Clinical Excellence that the drugs should be prescribed only to patients in the later stages of the disease. They were granted a judicial review-the first time one of NICE's decisions had been challenged in this way-and while the judge upheld one part of the challenge, the other two parts were dismissed and NICE's guidance stands.

The first wealth is health, wrote American thinker Ralph Waldo Emerson. Indeed, history has taught us (even before Emerson) that health and wealth are inextricably linked-the more money one has, the healthier one is likely to be.

These are challenging times for senior operations executives who support sales, marketing, and managed markets. The pipeline shortfall, drug-approval delays, and increasing regulatory complexity have squeezed budgets while raising revenue targets. The Medicare Modernization Act (MMA) has caused some of the most far-reaching changes in the sales and marketing landscape, as government purchasing power creates both new opportunities and greater restrictions. In addition, traditional modes of selling have saturated the market, and the sales model the industry knows and loves is no longer so effective.

There has been a lot of good news about the Medicare drug benefit in recent weeks. Surveys show a substantial increase in coverage, particularly among low-income seniors. Costs are less than expected; employers continue to offer retiree benefits; major insurers are sticking with the program; and product coverage remains fairly broad. Beneficiaries seem generally satisfied with the program, and the much-feared "doughnut hole" appears less lethal than anticipated (see "A Narrow Gap").

Cancer R&D IS booming right now. At a time of poor ratings on both Wall Street and Main Street, pharma can at least point proudly to its oncology pipeline as proof that it still takes big risks to make big advances against big killers-and win. According to a recent IMS report, the cancer pipeline contains 380 compounds, with nearly 100 in Phase III. The long-established standard of care-surgery, radiotherapy, and chemo-is fast giving way to a high-tech array of targeted therapies. These molecules and antibodies are designed to block specific disease pathways, and they are proving both far more effective and far more tolerable than the sledgehammer status quo. Since 1996, the overall survival rate for patients has jumped by 30 percent, from one-half to two-thirds.

David Barlow is the closest thing you can find to a pharma-industry ecologist. He takes companies that deal with technology that Big Pharma won't touch and turns them into drug powerhouses.

We've all experienced it...working with a colleague who takes all the credit for whatever success the department or division achieves. It is frustrating-and not motivating-to be around. It's even worse to have to report to a person like that. Having researched this particular aspect of nonleadership, I've found that these department heads have some traits in common. As a rule, they all have low self-esteem, are fairly insecure, and cannot tolerate pushback from their direct reports. To insulate themselves, they put yes-men and -women in direct-report roles and survive until their superiors wake up one day and realize there's a nonleader in place running a dysfunctional group.

The clinical trials space these days is an alphabet soup of technologies: CTMS (clinical trial management systems); CDM (clinical data management); CDR (clinical data repositories); eCTD (electronic common technical document); and many more. But the technology with the most promise for transforming the way clinical trials are performed (and for driving everyone mad throughout implementation) is EDC-electronic data capture. It's taken more than a decade, but today most big pharma companies-and a fair number of smaller ones-are using some form of EDC in clinical trials. The early adopters might have experienced some growing pains, but the benefits seem to be outweighing the high cost of implementation. Few companies would consider going back to paper-based trials.

Very few drugs live forever. Barring remarkable scientific advances and radical market dynamics, most drugs hit old age-and sharply declining sales-several years before their patent expires. But some drugs go out with a bang, not a whimper.

As I work with pharma companies, I'm often asked "When will we get major reform of the healthcare system?" and "What will the reformed system look like?" And sometimes "How will we get there?" This is not the same as asking "How should we reform the system?" Or "What should a reformed system look like?"

Gotcha, Big Pharma! Sort of.... Not me, a guy named Jeffrey Light. The young founder and head of tiny DC-based nonprofit Patients not Patents hit the wires recently, charging that Abbott Laboratories had edited its entry in Wikipedia, the online everybody-can-play encyclopedia, trying to make itself look better. Using a brand-new online tool called the Wiki Scanner, which allows anyone to track the source of any change entered into any of Wikipedia's 2 million articles, Light discovered that at 4:38 P.M. on July 2, 2007, several edits to the article on Abbott were made from a computer at Abbott's Chicago office.

You have to admit: Mark McClellan, MD, has quite a resumé. But after you've been the commissioner of FDA and the administrator of the Centers for Medicare and Medicaid Services (CMS), what comes next?

If you've been thinking of online video as a toy or, worse yet, as something that's going to happen at some point in the future, let me offer you a picture: Me, a target pharma customer, on the elliptical machine at the gym, watching, no, not CNN or Katie Couric, but "Nephrology Consult 101, Unusual Causes of Renal Failure" and "Internal Jugular Central Line Placement," a pair of free video podcasts I downloaded from the Yale School of Medicine.