The Human Face Of Pharma
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June 19, 2006
Making Partnerships Work For Pharma
Pharmaceutical consultant helped the return to market of a useful drug that many had feared
Linda R. Raber
PHOTO BY EVA THALMAN, MARK KRUEGER & ASSOCIATES |
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Mark Krueger |
Mark Krueger & Associates is a consulting firm in New York City and London that describes itself on its website as "dedicated to getting life-saving and life-enhancing therapies and products to patients as quickly as possible." Its clients are exclusively pharma and biotech companies and diagnostic or therapeutic device manufacturers. The firm, founded by Mark Krueger in 1995, prides itself on its ability to "accelerate regulatory approval and increase public awareness and appropriate use of health care products."
"Professional associations increasingly determine guidelines and activities that impact drug, device, and diagnostic development," Krueger says. Among his firm's staff are former executive directors of professional associations who know the ins and outs of the business.
"We form partnerships and resolve differences among pharma companies and patient groups and associations and, if necessary, implement programs for our clients," he says.
"For example, when Celgene wanted to return thalidomide to the market, we worked with AIDS advocates, women's health experts, and other health groups to finally get Food & Drug Administration approval," he says. There were strong indications, beginning in the early 1990s, that thalidomide could have important applications in treating AIDS-related complications like Kaposi's sarcoma. Thalidomide had been shown to inhibit a cytokine called tumor necrosis factor-alpha (TNF-alpha), which has been linked to disease progression in various conditions, including the progression of HIV disease into AIDS.
Thalidomide had been banned in the U.S. since the early 1960s, when researchers determined that it caused deformed limbs in the children of women who ingested the drug early in their pregnancies to alleviate nausea (C&EN, June 20, 2005, page 122). Some people think it is too dangerous to ever return to the market.
In 1998, however, FDA approved the use of thalidomide to treat erythema nodosum leprosum, a painful skin condition associated with leprosy. Now that thalidomide is back on the market, doctors prescribe it for many off-label uses, especially multiple myeloma, myelodysplastic syndrome, and other blood-borne cancers, reflecting a growing body of peer-reviewed studies, Krueger says. He adds that thalidomide "has the potential to be effective for any number of conditions" and is proud that his firm helped bring it back to market.
Krueger also believes that patients' needs must be built into regulatory risk analysis. "The U.S. as a whole is going through a debate about drug safety. Some patients believe that FDA hasn't done enough to protect patients; others believe it's overly protective. I think that in the next 10 to 15 years, we will have to learn how to balance the risk-benefit ratios," Krueger says. "Someone living with late-stage cancer is willing to accept a different risk-benefit ratio from a drug than someone with, say, chronic allergic bronchitis.
"Patients are customers, and that's the most important thing to think about over the next several years," Krueger says. "If I see one key trend, it is that customers' voices will be heard."
