The Pharmaceutical Industry: Angels or Demons?
Over the past several years, journalism and its practitioners have strayed far from its mission, and many “journalists” today do not have much worldly knowledge about or deeper context of the stories they cover. As a result, Michael Kirsch, MD, a gastroenterologist, explained in a recent article that this change in journalism has considerably narrowed the gap between hard news and tabloid sensationalism.
According to his article entitled, “The Pharmaceutical Industry: Angels or Demons?,” which was published in the American Journal of Gastroenterology, Dr. Kirsch is “disappointed by the state of journalism and its practitioners today,” because reporting “now routinely demonizes individuals and institutions.”
While some argue that it is the press’s responsibility to “shine light on the darker corners of society,” why is it never news when a business is functioning in a legal and ethical manner? Instead, the current state of journalism has exposed the public to an imbalance of negative news.
Consequently, Dr. Kirsch explains that with a focus on the negative news only, the public loses a fair and proper context of the issues. “When we repeatedly read about demons and villains, we may not appreciate that there are angels hiding in the story that we cannot see. This is one reason why cynicism has crept into the public’s consciousness. However, just because something has been demonized doesn’t mean that it’s a true demon.”
He noted that media has targeted people and institutions including Wall Street, Oil companies, and the pharmaceutical industry. In looking closer at “Big Pharma,” Dr. Kirsch notes that the press and various pundits immediately identify an institution as nefarious by use of the prefix “Big.” He asserts that this kind of press coverage of the pharmaceutical companies has been unfairly negative for years because the news routinely reports and editorializes about:
- It earns unconscionable profits.
- It is regularly fined for aggressive and illegal marketing to physicians.
- It hires ghostwriters to pad the medical literature with favorable articles.
- It buries research in order to cover up dangerous side effects.
- It tries to silence or disparage industry critics.
- It purchases physician loyalty.
- It schemes to sabotage generic competitors.
- It gouges the public.
- Its priority is profits, not patients.
Dr. Kirsch makes it clear that he is “not defending the drug industry, or suggesting that the points above have no merit.” He acknowledges that he does not work with the industry “and receives nothing of value from them, except for periodic free food for me and my staff.” Instead, Dr. Kirsch argues the press does not give the public the “whole story, a full and fair airing of the facts.”
For example, Dr. Kirsch explains that it is routine press procedure to dig out and publicize negative research results on a drug after adverse effects become known. “Similarly to the typical strategy used by plaintiffs’ attorneys in medical malpractice litigation against physicians, drug company critics comb through years of records, after an adverse reaction is known—pharmaceutical retrospectoscopy—and then claim to have found the smoking document.”
While the press account may suggest a “Big” cover-up, Dr. Kirsch asks, is this really fair? He explains that every “drug, medical device, medical treatment, and diagnostic test has negative research findings in its files.” Medical science proceeds in a zigzag fashion, and conflicting results are expected. Even the safest drugs on the market today have research and opinions that are off the curve. As a result, Dr. Kirsch recognizes that the “only instance when we can be assured that a medical paper has no dissent in the literature is when only one study has been published.”
Next, Dr. Kirsch acknowledges criticisms from news that drug prices are too high. However, “can we expect this industry, or any business, to spend a fortune on research and development, with high risks of product failure at any point in development or afterward, without the promise of many years of high profits? Would you invest a fortune in a business venture that faced similar risks without the hope of a generous return on investment?”
Unfortunately, journalists who create sensational stories about high drug prices often neglect to inform the public that it takes years of study and FDA applications to push a drug through the tortured process toward final approval, and that the majority of drugs under study never reach a pharmacy shelf.
Dr. Kirsch also notes that some industry critics oppose any corporate funding for physician continuing medical education (CME) activities. He explains that whatever “positive influence the drug folks have managed to achieve in physician-education endeavors are still dwarfed by the routine demonization of them in the public square.”
With respect to pharmaceutical representatives, Dr. Kirsch believes that sanctions are appropriate when those individuals advocate unapproved drug indications in physicians’ offices, but he feels that “current regulations are overly restrictive in muzzling reps on discussing off-label use, particularly since physicians prescribe drugs off label every day.” In fact, in some cases physicians prescribe medicines exclusively off label.
For example, Dr. Kirsch notes that many gastroenterologists prescribed Xifaxan for hepatic encephalopathy long before it was approved for this use. As a result, he asks whether it helps physicians and patients if reps who came to detail this drug could only discuss the approved indication of treating traveler’s diarrhea? While he acknowledges the potential for abuse if reps can wander off label, he asserts that the “boundary is skewed too far in the wrong direction.”
Gastroenterologists “prescribe prednisone for ulcerative colitis, Asacol for Crohn’s disease, Lialda for collagenous colitis, Flagyl for pseudomembranous colitis, and Protonix for peptic ulcers—all unapproved uses.” Accordingly, Dr. Kirsch said that it seems “silly that we can’t discuss these treatments with reps who may have deep expertise on these agents.” Dr. Kirsch notes that physicians are aware that these are sales folks, not educators. Consequently, he called for “sensible regulations to be devised to promote greater information flow, and still protect against overzealous product promotion.”
To Dr. Kirsch however, FDA’s recently created “Bad Ad Program,” is not very sensible. The program “recruits physicians as its enforcement agents to be on the lookout for false or deceptive drug advertising and promotion.” Physicians can anonymously contact the FDA with allegations of marketing malfeasance. Dr. Kirsch calls this program the “Healers & Squealers.”
Consequently, Dr. Kirsch recognized that the program must “ascertain the accuracy of the claim and the motivation of the complainant.” He asserted that “allegations or slanted press accounts should not be publicized prematurely until they have been properly vetted and the industry has had an opportunity to respond, particularly as these populist stories may be assumed to be fair and factual by ordinary readers and listeners.”
To change the current practices of news coverage and journalism, Dr. Kirsch suggests more balance and context in press coverage of the pharmaceutical industry because “drug companies are the good guys, at least some of the time.” Drug companies “spend enormous sums of money on products that will serve humanity.” For example, industry delivered for us when we needed H1N1 vaccines in a hurry to protect us against a pandemic.
In addition, the pharmaceutical industry designs, manufactures, and improves medicines to treat disease and keep us well.” Moreover, industry has the expertise, experience, and motivation to create new therapies against diseases that resist current treatment strategies.” They face economic and legal risks that most of us would never accept. Most drugs under study never make it to market. Sometimes, adverse reactions unrelated to the medication can lead to market withdrawal, which might occur soon after a drug is released.”
Today, we need cancer vaccines, immunotherapies, and genetically tailored medicines. We need biologic agents that are more effective and less dangerous to combat a variety of chronic inflammatory and debilitating conditions, such as Crohn’s disease. As Dr. Kirsch points out, “are we satisfied with the current state of medicine?”
Drug companies will be a major force that will help to raise medical care and treatment to a higher orbit. If they are motivated to do so for economic gain, then we should recognize that the profit motive can be a force for good. As Dr. Kirsch explains, “if we want this industry to roll the dice on curing or preventing diabetes, arthritis, cancer, stroke, and Alzheimer’s disease, then let’s give them every incentive to make it happen. Take away the promise of financial reward, and drug companies will pull back and churn out lots of “me too” drugs that we don’t really need. We need game changers, not tie breakers.”
In the end, Dr. Kirsch asserts that journalists should take the target off the drug industry’s backs. “The presumption shouldn’t be that this is a diabolical cabal that is nourished by greed. The press needs to demonstrate that they can treat this industry fairly, and we should demand that they do so. They need to restore some of their credibility.”
A good way to restore their credibility is for journalists to start using headlines that read “New Drug Helps Millions,” and not “New Drug Earns Company Millions.”