The oil that keeps this whole machine running is trust in pharma and FDA to act responsibly on the public's behalf. Unfortunately, the public's trust in drug companies and the agency that oversees them is not nearly as high as it should or could be, and this represents a very real risk factor for the entire industry. The US House of Representatives recently approved a bill 403 to 16 giving FDA $400 million (paid by drug companies through extra fees) to study side effects of drugs once they are on the market. The bill also requires drug companies to study drug safety more closely, which is essentially a vote of no confidence in the industry's current efforts.
Patients Seek Side Effect InfoIt is not difficult to understand why trust is such a volatile issue. According to the Journal of the American Medical Association (Vol. 279, No. 15, April 1998), more than 106,000 people die each year from the side effects of prescription drugs, and close to 2 million people suffer severe side effects every year from medications given in hospitals. High-profile cases of drugs that FDA has pulled off the market after approving them, such as Vioxx, focus a disproportionate amount of attention on unfortunate outcomes.
Still, consumers have a high level of trust in their physicians and continue to take the drugs their doctors prescribe. Patients show a high degree of caution when drug treatments are recommended, however, and often ask physicians and pharmacists about the potential side effects of these drugs. Our firm, Leo J. Shapiro & Associates (LJS), recently conducted an online poll of 863 US households and found that the public has several ongoing concerns regarding prescription drugs, pharmaceutical companies, and FDA. Public interest in and efforts to learn about side effects are high. In fact, a great majority of people (75 percent) discuss side effects with their physicians; one-third raise the issue themselves and don't wait for the physician to point out side effects.
Half also discuss side effects with their pharmacist when filling a new prescription, evenly divided between those who broach the topic first and those with whom the pharmacist initiates the discussion. Pharmacies will be glad to know that 86 percent (72 percent usually, 14 percent occasionally) of their customers take the time to read the patient information leaflets distributed with the medication. Patients really want—and need—to know about the drugs they're relying upon to help make them well.
These findings suggest that efforts to increase awareness and educate the public about the issue of side effects have been successful. Unfortunately, our LJS survey determined that the public is divided over the issue of how well the pharmaceutical industry manages its efforts to inform the public about side effects: The majority feels that drug companies' efforts are sufficient, but nearly 40 percent feel that pharma needs to do more.
Patients Are Wary of FDA
Despite this divide in opinion, the public has substantial regard for the industry's credibility about side effects and actually trusts the industry far more than FDA. When asked whether pharmaceutical companies should be allowed to sell any drugs with serious side effects, as long as they provide full disclosure about the side effects, 73 percent answered yes. Contrast these feelings with the public stance on FDA: Only 20 percent of those polled have complete confidence in FDA. More than half of the respondents find fault with FDA requirements, with 39 percent feeling that FDA's standards for new drugs entering the market are too lenient, and 17 percent saying the requirements are too stringent.