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Risky Business – How Buying a Ford Explorer is Like Taking Zometa

Last week, Peggy Stevens, a woman in Missoula, Montana who developed osteonecrosis of the jaw (ONJ) while being treated for lymphoma, was awarded $3.2 million. The settlement was based on Ms. Stevens’claim that Novartis did not disclose risks associated with the bisphosphonate, Zometa (zoledronic acid).

Imagine this scenario.

You walk into your local Ford dealership intending to buy a Ford Explorer for your daughter’s 17th birthday. The salesman says he’s happy to help. With this scenario in mind, which of the following questions do you think the salesman is least likely to ask?

  • How much do you want to spend?
  • What options are you looking for?
  • Did you know that Ford Explorers are notorious for overturning at low speeds, that SUV rollovers account for 33% of passenger vehicle fatalities and that close to 10,000 people died in SUV rollover crashes in 2002 alone?

Dollars to doughnuts, you answered C. How do I know that? Because it is obvious that a Ford Explorer car salesman is not going to bring up the subject of rollover fatalities with someone about to buy an SUV for their teenage daughter.

Unlike car salesman, however, drug companies are FDA mandated to communicate safety risk information regarding the drugs they market. Unfortunately, like the car salesman, the drug company has a financial stake in framing information about their products in the most appealing way possible. And in a profit-driven health care industry, who can blame them?

This tendency to present safety risk information in a favorable light, however, does come with a price tag. It means that companies downplay the risks of the drugs that we take. This tendency to minimize concerns about drug safety is typical of pharmaceutical advertising and promotion, as well as industry-supported CME (continuing medical education). Medical communication firms and ad agencies do not go out of their way to bite the hand that feeds them, so pharmaceutical copywriters and medical writers are well versed at presenting efficacy and safety information about prescription drugs in ways that minimize the negative and accentuate the positive.

An industry-sponsored online CME program on bisphosphonates illustrates this point. Below is the introductory paragraph to a CME program “Advances in Treating Metastatic Bone Cancer” sponsored by InforMEDical Communications, Inc and funded by Novartis Pharmaceuticals, Amgen, Inc. and Merck & Co., Inc. The original version mentions ONJ in the middle of the introductory paragraph to the program. In my rewrite below, I present the same information. However, in my revision, I reorder and reframe statements, and also use formatting and subheads, to bring the physicians attention to ONJ, rather than burying it in the middle of the paragraph.

Original

Bisphosphonate therapy, the current standard of care for metastatic bone cancer, has been shown to decrease SREs by up to 50% and also to slow the rate of development of SREs. While this therapeutic advance is significant, bisphosphonate therapy does not completely block the process of bone metastasis; despite treatment with bisphosphonates, approximately 20% of patients with bone metastasis still have elevated bone resorption markers.In addition, bisphosphonate therapy is associated with renal toxicity and the emerging problem of osteonecrosis of the jaw (ONJ), which is causing deep concern among patients and dental care professionals who fear development of ONJ following dental procedures or even basic dental cleaning. Addressing these issues and finding treatments that more effectively prevent and suppress the bone metastatic process are needed.

Suggested Revise
Risks of Bisphosphonates Administered to Patients With Metastatic Bone Cancer

  • There have been a number of published studies that highlight the incidence of osteonecrosis of the jaw (ONJ) in cancer patients receiving bisphosphonate therapy for metastatic bone cancer.
  • While bisphosphonates have been shown to decrease SREs by up to 50%, approximately 20% of patients still have elevated bone resorption markers.
  • Because of bisphosphonates association with ONJ, it is critical to consider this adverse event, and communicate the risk of ONJ to patients, before initiating therapy.

Whether you are Republican or Democrat, for single-payer health care or against it, support private health insurance options or prefer a government run system, it all comes down to this. In a market-drive health care system, drug companies make money by selling drugs and insurance companies make money by restricting care. Is that good? Is that bad? I am not always sure. I do know, however, it is an inescapable fact of life in the good ole USA.

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