Big Pharma guiding doctors on how to discuss side effects
Frontline News recently reported that FDA officials concede that, “no pharmaceutical is a hundred percent safe" and many actually cause the very ailment they are supposed to treat.
The task of informing patients of potential side effects is undertaken by drug manufacturers themselves as well as doctors and pharmacists
Big Pharma writes the patient inserts
Pharma plays a direct role in determining what side effect information is available to patients as the drug manufacturers themselves prepare Patient Package Inserts (PPIs), also known as “Patient Information,” although they sometimes need to adapt their initial draft to obtain FDA approval. According to Peoples Pharmacy, a long list of adverse effects in the inserts may actually not have the effect of discouraging the drugs' use.
We used to think that pharmaceutical companies reluctantly included long lists of side effects because the FDA made them do it. That is no doubt true, but there may be a more self-serving reason.
Telling patients about lots of nasty adverse reactions might provide a legal defense in case of litigation. And people tend to zone out after about the tenth or eleventh side effect anyway.
Big Pharma guides doctors on presenting side effects
Pharma also plays an indirect role in how doctors present the potential for side effects to patients.
The Washington Post published a piece in 2017 detailing the reasons why many doctors fail to warn patients of a drug's adverse effects, casting light on doctors' training in the area both in medical school and afterwards through continuing education seminars:
Doctors often don’t tell you about drug side effects, and that’s a problem
… Doctors learn about drugs in medical school and later during continuing-education programs. But those programs are often funded by drug companies, according to J. Douglas Bremner, a professor of psychiatry and radiology at Emory University School of Medicine in Atlanta.
Bremner said pharmaceutical companies even reach medical students by influencing those who train them.
“They’re not really trained to be scientists, they’re trained to be apprentices,” Bremner said. “That’s what the drug companies know . . . If they can get the person who trains them to change what they’re prescribing, they can get them to.” [Emphases added.]
Slides and all
Professor Bremner wasn't just conjecturing about continuing education instructors — he was one himself. But he was not like the rest. The drug companies wanted him to use their prepared slides in his presentations, but he eventually saw the bias it created and balked, even though it would mean more work for him as he would need to create the slides himself.
In actuality, it meant less work — as he was not longer selected as a presenter, sending a message not just to Bremner but to any of his colleagues who might get the idea of preparing their own slides.
When Bremner taught continuing-education sessions, the pharmaceutical companies that paid him provided the slides. Because the slides seemed to favor those companies’ drugs, he started using his own.
“When I did that several times, they stopped asking me,” Bremner said. [Emphases added.]
'The people in control of prescribing drugs know the least about the drugs'
If researchers are discouraged from doing their own research and preparing their own slides, what of the physicians who attend their lectures? They “prescribe irrationally,” according to a pharmacology professor. By irrationally, she means irrational from a patient perspective, but perfectly rational from a profit incentive, as newer, more expensive but less tested drugs are preferred to older ones with a lot more information about their safety and efficacy:
Adriane Fugh-Berman, a professor in the Department of Pharmacology and Physiology at Georgetown University Medical Center, said doctors often “prescribe irrationally,” pushing branded over generic drugs, new over old, and suggesting medication for diseases invented or exaggerated by drug companies.
“We’re in sort of a bad situation now where the people in control of prescribing drugs know the least about the drugs,” said Fugh-Berman, who directs PharmedOut at Georgetown, which researches drug marketing and educates health-care professionals about its influence …
Patient experts
The result, according to the professor: patients are left with no choice but to do their own research:
Fugh-Berman said patients need to become their own experts, researching drugs on websites — such as the government database MedlinePlus — that are "free of [the pharmaceutical] industry."
Independent research gives patients the confidence to challenge a doctor who immediately dismisses a pharmaceutical, whether a medicine or a vaccine, as the cause of a medical issue. In fact, patients should not only know the potential side effects, but should also demand of their treating physician that they not dismiss the pharmaceutical as the cause of a new problem "until proven otherwise."
Doctors have a responsibility to listen to their patients about side effects, too, she said.
“I tell medical students: If a patient develops a symptom after they’ve gone on their drug, it’s always the drug’s fault until proven otherwise,” said Fugh-Berman.
Amy Thompson, a clinical pharmacist and an associate professor at the University of Michigan’s College of Pharmacy, said doctors have plenty of knowledge about drugs, but there are so many available they don’t know the possible side effects of all of them.
“But they have access to look into it,” she said, referring to online databases, continuing education and pharmacists …
Such foreknowledge empowers parents to be insistent when a doctor asks, “What happened?” the parent responds, “Nothing, except that the child just got a shot,” and the doctor, having learned that the shot is safe, cuts the parent off with, “No, it's not that.”
Cycle of misinformation
The Washington Post adds that the faith that doctors have in Pharma's assertions that drugs are safe leads them to fail to ascribe adverse events to the drugs and they therefore fail to report them. This in turn lowers the reported side effect rate, making drugs appear safer than they are.
Marlene Beggelman, founder and chief executive of Enhanced Medical Decisions, a health information technology company in Cambridge, Mass., said the FDA might be underestimating side effects because doctors often don't report them. Although the FDA collects reports on its Adverse Event Reporting System, the reporting is voluntary and adverse reactions are considered underreported. Beggelman described her own experience with side effects in a blog post on KevinMD.com.
But maybe they meant well:
Beggelman, an internal medicine physician, said doctors mean well even when the care they deliver has negative consequences.
“I think that very often it’s a human quality of not wanting to think that what you’re doing to try to help people is actually causing problems,” she said. [Emphases added.]
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