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Margaret Mueller, Leo J. Shapiro & Associates
The industry needs credibility with consumers to make a spoonful of risk go down. So how does pharma speak to top concerns?
When it comes to prescription medications, particularly new ones, the general public has two seemingly contradictory desires. First and foremost, they want the new drugs to work better than the old ones. Second, they want to enjoy the benefit of a new drug while incurring as little risk as possible. Most people know it's impossible to eliminate all risk factors in new medications and treatments, but they want reassurances that the risks have been minimized, and they expect both drug companies and FDA to inform them (or at the very least, their doctors) of any risks or side effects they should be aware of so that they can make an informed decision about treatment.
Margaret Mueller, PhD
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.
It 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.
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.
Among middle-aged and older consumers, where medication use increases, skepticism about FDA's credibility is even more entrenched. This isn't surprising since the more prescription medications one takes, the greater the chances are that one will experience a negative side effect. But the aging Baby Boomer/AARP generation tends to be a savvy and medically aware group, so their collective attitude toward both pharma and FDA is extremely important. Information and credibility matter a great deal to these consumers, and if they don't feel they are getting what they want, they are fully capable of voicing their displeasure in ways that can seriously impact a pharmaceutical company's bottom line.
The public's concern about side effects, coupled with its ambivalence toward FDA, is particularly significant when it comes to potentially lifesaving drugs that may have serious or potentially dangerous side effects. Should FDA deny approval of such a drug to keep it from the public? Again, public opinion is divided. It stands to reason that those with a good deal of trust in FDA are likely to support its decision whether or not to make such a potent drug available or not. However, while 54 percent polled said they would take such a drug if necessary, or recommend that a loved one do so, 46 percent said they would not take such a medication, even if it were approved by FDA.
Remember that when asked whether pharmaceutical companies should be able to sell a beneficial drug with potentially serious side effects, the public resoundingly answered yes, demonstrating a much higher level of trust in pharma than in the government's regulatory process. Though public trust in the pharmaceutical industry isn't as high as it could be, the fact that the industry has a larger share of hearts and minds than its government overseers indicates that the public already believes the industry is in a leadership position on these issues.
In view of these findings, it's clear that an opportunity exists for industry to assume an even greater leadership role in addressing public concerns over drug side effects—and in the process gain more of the public's precious trust.
For starters, greater public trust in the pharmaceutical business can be secured by improving industry efforts to inform people about the side effects and dangers of prescription drugs. Transparency and openness are crucial to this effort. People want new drugs, but if they don't feel adequately informed about the risks, and bad things do happen, they feel duped. And once the public's trust has been violated, it is exponentially more difficult to regain.
Pharma companies should also give serious consideration to their relationship with FDA—and how the public perceives that relationship. Our research consistently shows that the more people know about the process of bringing lifesaving drugs to market—from R&D and clinical trials to the relationship between drug companies, doctors, and patients—the more comfortable they are with the risks involved in developing medicines and treatments. Where the public is concerned, information and trust go hand-in hand.
Margaret Mueller, PhD, is a senior analyst at Leo J. Shapiro & Associates. She can be reached at firstname.lastname@example.org