1. We re often your doctor s biggest source of information.
It s comforting to imagine your physician sitting behind his desk after hours, carefully perusing reports on the latest drugs. While some still do their research the old-fashioned way, many doctors today get the bulk of their information from drug reps who are pushing specific medicines. To make sure physicians are paying attention, pharmaceutical companies spend more than $50 billion a year on promotional activities, according to a 2008 report, the most recent available.
Typically, says Allen F. Shaughnessy, doctor of pharmacology and professor of family medicine at Tufts University, a drug rep gives a 90-second spiel that hits three or four salient points, followed by the classic sales pitch. And often doctors will bite. Reps are very effective in changing physician behavior, says Shaughnessy. That interaction is necessary says a spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), an industry group, because the companies have the most knowledge about the treatments that took them years to develop.
To gauge how seriously your physician relies on drug reps, Shaughnessy suggests that you press for details: Ask why you are taking the drug he is prescribing, and make sure you understand what they explain. This approach will either get you the information you need, or else you ll see a physician who blusters and carries on about why you are questioning him, says Shaughnessy. The latter scenario will show you that they don t have a clue.
2. Hype is our favorite medicine.
Choosing a medication shouldn t be like choosing Pepsi over Coke. But that s very much what s happening, thanks to the drug companies and their ad agencies. With famous faces like Sally Field, NBA star Alonzo Mourning and Lance Armstrong all playing spokesperson for various brands of medication, the companies marketing prescription drugs have learned to harness celebrity star power to help boost their brands.
Blame it on the Food and Drug Administration. In the late 1990s, the agency s decision to liberalize drug advertising allowed direct-to-consumer, or DTC, campaigns, and pharmaceutical ad budgets skyrocketed. From 1996 to 2005, spending on DTC campaigns increased 330 percent, according to a 2007 study by The New England Journal of Medicine, the most recent study available.
It s horrendous, says Brian L. Strom, M.D., chairman of biostatistics and epidemiology at the University of Pennsylvania. It s directly in conflict with proper therapeutics. But the manufacturers use patients as arms of their marketing departments. It can be dangerous, too. When Olympian Dorothy Hamill appeared promoting Vioxx for her arthritis pain, prescriptions were filled before the drug s heart risks became known. Strom says the drugs advertised are exactly the ones patients should not use. If you needed them, I would have given them to you already, he says.
3. There s no such thing as a free sample.
Patients love getting free trial-size medications from their doctors, doctors like giving them away, and drug companies rely on samples to filter new treatments into the pharmaceutical mainstream. In pushing free samples, drug companies hope that physicians will continue to prescribe the new and often pricier medication long after the honeymoon period is over. If the sample drug works and is tolerated, the physician will often continue to prescribe it instead of alternatives. The small outlay for free samples will eventually be compensated by large profits when physicians start prescribing the drug at full price, says Allan S. Brett, a professor of medicine and director of the Division of General Internal Medicine at the University of South Carolina.
While some believe that free samples are an important source of medication for uninsured patients who can t afford to pay, studies have shown that most free samples are actually given to insured, says Brett. A bigger issue is safety, says Joel Lexchin, an emergency medicine doctor and professor at the School of Health Policy and Management at York University in Toronto. What is being sampled is usually the newest product that has less known about its overall safety profile, says Lexchin.
In a recent statement about free samples, PhRMA said: Clearly, the most important components of a prescribing decision are the physician s clinical knowledge and the patient s unique situation. Free samples can provide a useful tool in the prescribing decision.
4. Your doctor is our bounty hunter.
Facing mounting pressure to bring new medicines to market, drug companies often pay doctors who refer patients for their studies. And depending on the drug being tested, the payments will often be in thousands of dollars per patient. It should be noted, these aren t payments for referring a patient. The physician is receiving payment to enroll a patient in a study, but he or she is involved in the research as well, says Daniel Carlat, a psychiatrist in Newburyport, Mass., who writes about the pharmaceutical industry on his blog.
Because there are such large financial incentives to enroll patients in studies, there s the possibility that the patient might be enrolled inappropriately, says Carlat. The problem is that patients who might be better served by getting standard medical treatment might instead be enrolled in a trial and end up getting a placebo or another medication that they shouldn t.
The American Medical Association says it provides guidelines for physicians to manage potential conflicts of interest, and advises doctors to be mindful of the conflicting roles of investigator and clinician and of the financial conflicts of interest that arise from incentives to conduct trials and to recruit subjects.
5. You ll find out about side effects the hard way.
The arthritis painkiller Vioxx, a blockbuster drug after it was introduced in 1999, was taken off the market in 2004 when a study linked the drug to an increased risk of stroke and heart attack. Bextra, another painkiller, was also removed from the market in 2005 after it was found to pose heart risks.
The problem is that after a drug is approved, there s not a real systematic way for identifying side effects, and making sure those are captured and detected in a reliable way, says James G. Stevenson, associate dean for clinical sciences at the University of Michigan Health System s College of Pharmacy. There is a post-marketing surveillance process in the U.S., but it s voluntary. It relies on physicians and health-care providers to report possible problems with a drug to the FDA or the manufacturer. It s their choice to do something with the information, Stevenson says.
Critics point to the drug industry s funding of the FDA through so-called user fees in the range of hundreds of millions of dollars a year. A company pays user fees when it submits the research that the FDA reviews before deciding to approve a reject a new drug. (These fees were legislated in 1992, under the Prescription Drug User Fee Act, with the aim of helping drugs get FDA review quicker.) Groups like Public Citizen, a consumer advocacy organization, say there s an inherent conflict of interest. An agency cannot effectively regulate an industry that pays the salary of so many of its employees, says Dr. Sydney Wolfe, director of Public Citizen s Health Research Group.
Concerns about a conflict of interest are misplaced, according to the PhRMA, which says that the legislation has done much to advance public health and that safety is a big focus of the FDA drug review process.
6. With all these complicated drug names, it s no wonder you re confused!
The FDA reviews over 500 proprietary (or "brand") name drugs a year, through the Office of Surveillance and Epidemiology. Before a drug s final moniker is settled on, it has to pass an expert panel review, handwriting and verbal analyses, a computer analysis, and overall risk evaluation, collectively aimed at minimizing the risk of soundalike and look-a-like names. But problems persist: Medication errors result in more than 7,000 deaths a year, according to the Institute of Medicine. How to avoid getting the wrong medication? Check your pills against those represented in an up-to-date illustrated reference book, such as The Pill Book by Harold Silverman (14th edition is set for release in April).
With so many drug names floating around, it s not surprising that there are mix-ups. Each drug has a brand name and most have a generic name. Names can potentially look or sound similar. There are only have so many letters in the alphabet, says Stevenson of the University of Michigan. PhRMA says it has worked with and continues to work with the FDA and other groups to prevent medication errors.
7. Don t trust anything you read about our drugs online . . .
If you re searching the Internet for information on, say, arthritis, what better place than a site like Arthritis.com, right? Not necessarily. While you will certainly get information there, it will come from Pfizer, maker of arthritis drug Celebrex not exactly an unbiased source. Similarly, if you re looking to read up on depression, you ll find the site Depression.com is run by GlaxoSmithKline, maker of antidepressants Wellbutrin and Paxil. The problem with these drug-sponsored medical-information sites is that they can easily be mistaken for noncommercial information sources.
Even when such affiliations are made clear, the fine line between editorial and advertorial which can be as subtle as the exclusion of seemingly minor details becomes even finer when viewed on a computer screen. Nevertheless, Robert Rosa, professor of medicine and dean of regulatory affairs at Northwestern University s Feinberg School of Medicine, doesn t think it is an issue for most readers of these sites. They are sophisticated enough to realize that the company is sponsoring the information, he says.
The most egregious misinformation online comes from companies peddling non-FDA-regulated products such as vitamins, minerals, and supplements, according to Brooks Edwards, M.D., the founding medical editor-in-chief of MayoClinic.com. The most important thing in evaluating information is knowing where it s coming from, Edwards says. Sometimes you can tell on the Internet, and sometimes you can t.
8. . . . and be extra careful when ordering meds over the Internet.
Given that Americans spent more than $300 billion on prescription drugs in 2009, the temptation to shop around online for the cheapest prices can be alluring, especially for those who value privacy. But like with most things in life, cheaper doesn t necessarily mean better. In fact, when it comes to buying prescription drugs over the Internet, big discounts might mean counterfeit capsules.
The World Health Organization says counterfeit medicines pose huge health risks and that the growth in international trade of pharmaceutical ingredients and medicines adds further complexity to the issue. In over 50% of cases, drugs purchased online from illegal sites that conceal their physical address have been found to be counterfeit, according to the WHO.
Since web site content is unregulated, the FDA s only recourse is to issue warnings to the public about unreliable online purveyors of pharmaceuticals. It recommends that when buying medication online, you do so only from licensed pharmacies located in the United States; also, make sure the site requires a prescription and has a pharmacist available to answer questions by phone. You can find a list of state-licensed pharmacies on the National Association of Boards of Pharmacy web site.
9. We know your medication history because we bought it.
When a prescription is billed to a third party any HMO or pharmacy benefits-management company that third party can sell the data back to the drug manufacturer. This allows drug companies to know in a particular zip code, for example which medications are being prescribed and in what amounts, says Stevenson. And manufacturers can use that information to better target their sales efforts. It s like market research, Stevenson says.
In 2006 the American Medical Association made it an option for doctors to keep their prescribing information inaccessible to reps. As of 2010, about 25,000 had opted out (out of more than 700,000 patient-care physicians).
Such information is extremely valuable to pharmaceutical companies, which use it to gauge the degree to which individual doctors are prescribing one medication over another in the same class. Then, in order to stimulate sales, drug companies offer a range of perks to groups of physicians plucked from the drugstores sales info. Their swag arsenal includes everything from dinners out to trips for medical conferences all of which ultimately contribute to the rocketing costs of medication. Doctors think of themselves as totally rational, says Tufts Allen Shaughnessy. They get offended when I tell them that they are human and cannot be wined and dined without being influenced.
PhRMA says prescription data help companies properly educate doctors about drugs in a targeted manner. And in the event of a drug shortage, a suspected drug counterfeiting or drug recall, the federal system relies on the manufacturer to communicate directly and promptly with prescribing physicians, a PhRMA spokesman said in a statement.
The just-passed health-care reform also has a provision requiring drug and device companies, starting in 2013, to publicly report payments and gifts made to doctors. Some companies already do disclose such payments. However, there s nothing in the provision that actually prevents doctors from giving these paid speeches, notes Allan Coukell, director of the Pew Prescription Project, a drug safety initiative of the Pew Charitable Trusts.
10. We re in cahoots with your insurer.
Stephen Fried was in the midst of writing Bitter Pills, an expos of the pharmaceutical industry, when a doctor suddenly switched his uncle from Procardia XL to a similar high-blood pressure drug called Norvasc. Fried says he found out that drug companies offer substantial discounts [to health care managers] if they put all their [appropriate] patients on a particular drug. Insurers, of course, are trying to cut costs amid a continued rise in health care expenditures, and doctors typically do what the HMO requests. The problem? You can have seizures, heart problems, dementia, Fried says. The only reason to switch drugs should be to enhance your health. But most drug switches are made for dollars and cents.
A drug company providing financial incentive to a pharmacy benefits manager to switch a patient from one drug to another without good reason is obviously problematic, says Carlat, the Newburyport, Mass., psychiatrist. Even when drugs are in the same class and are designed to treat the same symptoms, they are not necessarily identical. One drug may not work as well as the other, and could have a different set of side effects, he says.