With hundreds of new drugs entering the market every year, where can you turn for reliable information?
In 2006, the FDA approved 436 new medications - nearly two per business day.
Although three-quarters are “me, too” drugs (generic forms of branded medications), more than 100 are newcomers, making them potential additions to your therapeutic repertory. But it takes time to properly assess them, time you don’t really have after devoting more than 50 hours every week to direct patient care and administrative issues. So what’s the best - and most time-efficient - way of sorting the copycats from the cutting edge?
A number of low-tech and high-tech sources can help you stay current. Here’s what’s out there and what you need to know about each.
Finding information is certainly not the problem: There are pharmaceutical ad campaigns, medical journals, CME courses, newsletters, online and software applications, or your second cousin Cosmo, the family know-it-all.
All of these sources have merit of varying degree and usefulness - well, maybe not cousin Cosmo. Knowing the best places to look for fast, comprehensive, unbiased feedback will keep you up to date and your patients happy with the care you give.
Some sources should be scrutinized with a little skepticism. Ranking No. 1 in this category: Pharmaceutical companies hawking their cures with billion-dollar ad campaigns. While nobody is likely to know more about a drug than its maker, pharmaceutical companies usually de-emphasize the negative in marketing materials. “You should understand that if it’s an ad, it’s there to increase the sales of that medication,” says Rick Kellerman, president of the American Academy of Family Physicians and chairman of the University of Kansas School of Medicine’s department of family and community medicine.
Drawing information from pharmaceutical companies tends to be a personal choice. “There are some physicians who readily welcome drug reps and others who won’t allow any,” he says. The fact that pharmaceutical companies do everything they can to ensure the success of their new drugs in such a competitive market does not automatically negate the usefulness of the information they provide. “It’s not bad; it’s not good. It’s the American way, and should be factored in,” says Kellerman.
David Durham, an internist from Roanoke, Va., agrees. “[Drug companies] do a tremendous amount of good discovering new drugs. You take away drug companies, and you’re in a Third World country.”
Better living through chemistry
Clinical trial results can offer a wealth of new information and might seem to be the perfect source for getting the facts and only the facts. But tread carefully here. Before accepting the reported outcomes of a clinical trial, find out who sponsored the trial. Often the answer is a pharmaceutical company that stands to benefit directly from favorable results. Trials funded by a neutral party are much more likely to be truly evidence-based. This means “an objective, well-designed study in a controlled setting that shows that something works or it doesn’t,” explains Durham.
Carefully consider the risk factors and potential benefit predictors inherent in each clinical study. For example, a certain drug may lower one’s chance of having a heart attack by 30 percent (an impressive figure hailed by the pharmaceutical company), but closer inspection reveals that this is true only if the patient has high cholesterol, too. Otherwise, the drug’s usefulness falls to less than 3 percent.
CME courses also can help you assimilate new drug therapies. But once again, be sure to examine the source carefully. Is the course backed by a pharmaceutical company with a vested interest? Yes? Be wary. “It doesn’t mean a physician shouldn’t go to a particular meeting,” says Kellerman. “But where does it fit in the armamentarium?”
Read all about it
Of course, print and online drug reference materials abound. Medical journals that accept no advertising and use no one with a conflict of interest to review a new medication are terrific sources. Put every journal to the test: Open it up and look for ads, especially pharmaceutical promos. If you find some, relegate it to the “possibly biased” pile.
Even reputable journals can fall victim to conflicts of interest. In 1996, on behalf of the New England Journal of Medicine, two obesity experts wrote a very favorable editorial on Interneuron Pharmaceutical’s antiobesity drug Redux. An endorsement in this prestigious journal caused a monumental jump in sales, with Interneuron’s stock rising 13 percent in one day. Then evidence surfaced that these experts had financial ties to Interneuron, and the journal’s credibility suffered. (Redux was pulled from the market for its bad habit of causing fatal primary pulmonary hypertension and heart disease.)
Meanwhile, medical newsletters published without advertising offer another fine source of objective information. Kellerman subscribes to multiple newsletters and contrasts the reports. “It’s one thing to find out something that’s new and another to compare it with other [reports],” he says. Some excellent, bias-free newsletters to consider are The Medical Letter, The Cochrane Review, andPrescriber’s Letter. All come in both print and online versions.
Then there are reference books that can reinforce physicians’ fundamental understanding of pharmacology, says Durham: “If you understand that, you’ll understand how each drug will relate.” He relies on Goodman and Gillman’s textbook, “The Pharmacological Basis of Therapeutics.” Such a solid foundation will give you better recall on whether a drug is right for your patient. “There are surprises out there,” he says, “but knowing the basics is critical.”
Other good references: the AMA’s “Users’ Guides to the Medical Literature,” the pharmacology chapter of “Harrison’s Principles of Internal Medicine,” and McGraw-Hill’s clinical library.
Durham’s favorite online reference is UpToDate, which requires evidence-based attribution for its reports. He also suggests staying tuned to developments at the National Institutes of Health. “NIH is putting together a comprehensive review of pharmacy Web portals,” he says. Professional associations can also offer help, such as the American Academy of Family Physicians’ monthly drug summary. You can also check the FDA’s Web site - but with caution. The FDA has been accepting more and more funding from pharmaceutical companies.
Finally, of course, there’s the good ol’ “Physicians’ Desk Reference,” the physician’s standard go-to guide for drug information for the past 50 years. The online version is free to medical professionals.
The most basic form of technology is an Internet connection, which just about every physician in the United States has. At the other end of the technological spectrum is an EMR - ideal because your patient’s drug history and current medication are logged into his record, so adding a new drug would automatically flag a dangerous interaction.
The middle step is a PDA. Kellerman says a PDA is faster than manually looking through 2,500 pages of the “Physicians’ Desk Reference.”
Irene Chenowith, an internist at Summa Medical Center in Uniontown, Ohio, uses a drug interaction software product on her PDA called Lexi-Comp, developed by a company of the same name. Lexi-Comp (the product) is a point-of-care computer program specializing in pharmacology, drug interactions, and patient education. You can access a wealth of drug information within this one product, and it’s customizable with add-on specialty databases. “You can go in and out of the various databases without closing one,” says Chenowith. “Like if you read about a drug and want to pull up the diagnostic procedure. But the single thing I like is the purity of it - it’s very unbiased.”
Patients also benefit. “They’re getting better care, safer care, more efficient care,” Chenowith says. And there’s nothing like the power of making a good impression. “When I pull out my PDA, the patients feel like you’re more current and up-to-date.”
Chenowith serves as a physician consultant to Lexi-Comp. “I bring a physician’s perspective,” she says. “[Lexi-Comp Inc.’s] clinical staff is largely pharmacists. As a user, I bring the physician’s perspective on the actual operations.”
Chenowith is forthcoming about Lexi-Comp’s downside as well as the up. “It’s not the easiest to navigate. It’s not as intuitive as I’d like it to be. It’s still largely targeted to institutions rather than the individual.” Read the directions, she advises.
To be sure, Lexi-Comp does not fill this market niche alone; many other PDA-based drug information solutions exist, including the free product Epocrates, PDxMD, InfoRetriever, and others.
Invest in technology if you haven’t already. Drug interaction software and a PDA is a cheap solution compared to a full-blown EMR. Yes, shifting to an electronic reference requires some training, but Chenowith asserts that when adopting the technology “you have to take time to make time.”
Wait and see
Your patients are also possible sources of information, considering the heavy direct-to-consumer marketing common today. They make good targets. A patient may come to an exam championing “that whatcha-ma-call-it drug with the butterfly in the TV ad,” certain it’s the perfect cure for her insomnia. Is it? Maybe, maybe not.
Make sure the medication is truly indicated for her condition. Heed black box warnings. Poll other physicians or medical librarians. For tricky cases, get the skinny from a pharmacist, particularly a clinical pharmacist.
In the end, taking the time to learn about a drug is an important investment for the patient and for you. You’ll almost certainly be faced with this same decision again with a different patient.
Finally, try following Durham’s Rule of Three: Establish three benefits to the patient, three ways it affects a body’s chemistry, three ways it is metabolized, three drug interactions, and three side effects. By using this simple rubric and arming yourself with the facts, you’ll know what to do.
Shirley Grace, senior writer for Physicians Practice, holds an MA in nonfiction writing from The Johns Hopkins University. Her articles have appeared in numerous publications, including The Washington Post and Notre Dame Business magazine. She can be reached at firstname.lastname@example.org.
This article originally appeared in the July/August 2007 issue of Physicians Practice.