Indie Film Describes “Certain Adverse Events” from Antibiotic Use
This past weekend, Joe and I volunteered at the Landlocked Film Festival in Iowa City. We were delighted to view a few of the independent films shown during the four-day — mostly free — event. Because of their content, two of the films we watched were particularly suited to discussion here on BPGL. Today’s post is focused on one of them. — Julia Wasson, Publisher
“If you were to look at how prescription drugs are developed and marketed, you might never take a prescription drug again.” So begins the film Certain Adverse Events. Reading the statement on the screen, I felt the first twinge of alarm that I was about to learn more than I might really want to know. And that’s just what happened. The film showed how vulnerable we health consumers are when we take a prescription medicine. We can’t know what the side effects will be — because even the FDA and the drug companies often don’t know. A scary thought, indeed.
Here’s some of what I learned from the film:
- The FDA grants approval for a drug based on data and test results provided by the drug company.
- The FDA does not do its own research on either the effectiveness or the safety of a new drug.
- Two-thirds of the money that supports the work of the FDA comes from the drug companies. (And many officials leave the FDA for jobs at the various drug companies. Hmmm…)
Much of the film focuses on the findings of Public Citizen, a consumer advocacy group that works to protect the public interest in matters of “health, safety, and democracy.” Through the group’s attorneys, viewers learn the perilous position we are in, as consumers, if we experience side effects from a prescription drug.
Once a drug has FDA approval, a rule called pre-emption “freezes the regulatory process on the day the drug is approved,” says Dr. Sidney Wolfe of Public Citizen’s Health Research Group. “But the way the science works, we’re conducting a huge clinical experiment on the American people [after the drug is released].” By this last remark, Dr. Wolfe means that doctors and other researchers continue to learn more about the effects of a drug as it is used in the population. “About half of all changes to drug labels come four to six months after product release,” we learn. Sometimes, the FDA gets so much negative input that they actually pull the drug from the marketplace; but that’s extremely rare.
When adverse reactions are reported by physicians and — increasingly — by patients, the FDA notes the information. If the agency deems the action appropriate, it will require a “black box warning” to be placed in the Physicians Desk Reference (PDR). The PDR is the guide to all prescription drugs, their indications, contraindications, and possible side effects. The fact that there are black box warnings at all is a tribute to the work of Public Citizen, which sued the FDA in order to get this information added to the PDR. But doctors don’t all keep up with the PDR changes. And, though the PDR is readily available on Amazon and in many bookstores, most consumers have never read it.
Once a drug is approved, its place in the pharmacy is pretty much assured. But doctors don’t usually know about a new drug until pharmacy reps (called “detail people” in the business) arrive to sell them on the benefits. As one doctor interviewed in the film said, doctors realize that “drug reps are salespeople,” and don’t necessarily believe every claim they hear. Often, the only way a doctor will learn about a black box warning is when one drug company representative promotes their own product by saying, “The other product has a black box warning; but we don’t.”
For most physicians and residents, “the main input is propaganda from the industry,” said pharmacist Brian Sanderoff, on his radio show at WCBM in Baltimore. Sanderoff and fellow pharmacist Raymond Hinish appear in the film while taping their show, “Your Prescription for Health.” Sanderoff also says that hospitals make a choice to use certain drugs in their formulary (meaning they have these particular drugs in their pharmacy to be used for patients). In some cases, they may have a choice between two or more drugs in the same class, because they can’t stock everything. Yet a given drug may be harmful to some people, whereas its counterpart in the same drug family is not. “Patients have no choice,” Sanderoff says. “It’s a financial decision” by the hospital.
Here’s another problem with prescription drugs that consumers may not realize: Doctors often prescribe uses that are “off label.” In other words, a drug intended for acute diverticulitis might be prescribed for sinus infections, even though the drug company never recommended that use. Or, a drug intended for adults only is prescribed for pediatric use. The latter is especially dangerous, as children’s bodies do not metabolize drugs in the same way that adults’ bodies do.
Because of pre-emption, consumers cannot sue in federal court for damages from a prescription drug’s use “even though we learn more.” This protection, we’re told by Dr. Wolfe, gives “no incentive for creating the best product or to remove bad products.” Only state law provides compensation to victims of drug-related reactions. (And, the film reminds us, we Americans have no national health or accident insurance. In addition, some 45 million of us are uninsured.)
So why is all of this important?
The film introduces several people who were given Levaquin, a prescription drug in the fluoroquinolone family, which can cause extremely nasty — and dangerous — side effects. Yet none of the people interviewed had realized that such side effects could happen with even a single dose of the drug. One young man, a talented modern dancer, tore his Achilles tendon after taking the medicine. Another man had severe muscle tears and persistent insomnia for years. A teenage girl ended up in a wheelchair for six years due to the medicine. A United Airlines pilot has not flown since taking Levaquin a few years before the video was shot. And on and on…
The point of the film, from a consumer’s perspective, is to take charge of your own health. Don’t accept a prescription without carefully considering the risks vs. benefits. The film advises that consumers take no meds at all, if there are other ways to improve your health. If not, then take the least potent drug that you can. Save the “heavy hitters,” such as the fluoroquinolones, as a “drug of last resort,” when they are absolutely necessary — and the only alternative — to save your health or your life.
To learn more about the prescription drugs you take, visit Public Citizen’s Worst Pills, Best Pills website. There, you can look up any pill to find out whether there are recalls, warnings, or side effects that you should be aware of.