September 21, 2005--New York, New York. The public, press, and regulators alike are not well-equipped to weigh pharmaceutical benefits against pharmaceutical risks, leading to an unnecessary climate of fear. So says a new report from the American Council on Science and Health (ACSH), a non-profit health education group.
All drugs involve some degree of risk or side effects, notes the ACSH report, Weighing Benefits and Risks in Pharmaceutical Use: A Consumer's Guide. To abandon medication that may provide relief from illness or pain to millions because of a very small risk to a small number of consumers may result in a net loss for public health, warns the report.
Vioxx, for example, was withdrawn from the market due to a very small increased risk of heart problems, even though it provided life-altering relief from arthritis pain for millions of users. The ACSH report notes that the eagerness of lawyers, regulators, and even manufacturers to suspend the use of such drugs springs from a "zero-risk" view of health problems and interventions -- that is, the notion that no risk is acceptable, even if the status quo is far more dangerous than the new risk being contemplated.
There is a widespread and growing perception in the media and among the public that unacceptably "risky" drugs are rushed to market by pharmaceutical companies and rubber-stamped by the Food and Drug Administration (FDA); in fact, notes the ACSH report, the FDA carefully weighs known benefits and likely risks, in a process that typically takes years, before allowing drugs to go on the market.
The "zero-risk" standard is at odds with the nature of science, which is never final and must continually consider new data, with which regulatory agencies and physicians revise the advice given to patients about what benefits and risks different available medications offer.
By contrast, the press, with the urging of attention-seeking consumer activist groups, often reports each new scientific finding as if it is revolutionary -- and as if it represents the last word on whether a drug is completely beneficial or terribly dangerous. Science, by contrast, is a gradual process, and it examines the risks of disease and the risks of not using drugs, not simply the risk of drug side effects.
"Looking at risk without examining benefits, and vice versa, is like hearing one side of a phone conversation and expecting to understand the entire conversation," said ACSH medical director, Dr. Gilbert Ross. "The information is inherently incomplete."
The report Weighing Benefits and Risks in Pharmaceutical Use: A Consumer's Guide examines benefits and risks in context and concludes that the zero-risk standard "is too high a price to pay to ensure a margin of safety that no product could ever possibly achieve."
Contact:
ACSH President Dr. Elizabeth Whelan
at 212-362-7044 x237 (Whelan[at]acsh.org)
or
ACSH Executive and Medical Director Dr. Gilbert Ross
at 212-362-7044 x242 (Ross[at]acsh.org)