By John LaMattina, Contributor
Source: Forbes
Photo Source: Unsplash, D. O. So, if current events weren’t enough to scare you, now you have to be on the lookout for “malady mongers” – drug companies that sell pills by inventing disease. We have Michael Walsh to thank for bringing this to the public’s attention.
“There’s a substantial body of medical literature dating back to the early ‘90s about the practice known as ‘disease mongering.’ Pharmaceutical companies regularly pathologize everyday experiences, convince doctors that they are serious problems, tell a hypochondriacal public it needs help and offer the cure: a new drug.” Walsh goes on to quote Georgetown Professor Adriane Fugh-Berman on the topic. “Marketing for a drug can start seven to 10 years before they go on the market. Because it is illegal to promote a drug before it goes in the market, what they are promoting is the disease. That’s not illegal to do because there’s no regulation on creating diseases.”
Walsh also shared the thoughts of Jack James, a clinical psychologist at Reykjavik University, who claims that “Studies show that pharmaceutical industry ‘normal’ business is characterized by persistent deceit, ranging from subtle image manipulation to outright and frequent research fraud.” Wow! For the thousands of people working in biopharmaceutical R&D, people supposedly devoted to helping people through hard work and great science, this is pretty damning.
Now, let’s get back to reality. Another quote used by Walsh, this one from Cindy Pearson of the National Women’s Health Network, claims that “Osteopenia is disease-mongering plain and simple.” Osteopenia is a term used to describe bone-thinning and is considered to be the mid-point between healthy bone and osteoporosis. Is osteopenia (bone-thinning) a disease? Absolutely not. However, if you are a petite woman of Asian or Northern European descent, bone-thinning is the first sign of osteoporosis. Should you wait until your bones are brittle or even breaking before seeking treatment? No, because by then it will be too late. This isn’t disease mongering. It’s called preventative medicine.
Another supposed invented disease is “Restless Legs Syndrome (RLS)”. According to Walsh’s article: “Everyone’s legs feel restless now and then, or they feel occasional stinging or burning sensations in their eyes. But far less people have symptoms severe enough to need medical treatment.” It is easy to trivialize RLS. But, when you talk to patients, you find that they don’t share the view that RLS is a creation of the pharmaceutical companies. “I know it won’t kill me, but I wish it would. It’s horrible. It’s torture.” “Imagine dragging a stiff bristled hair brush across the sole of your foot, over and over for 6 – 8 hours.
Now try to imagine the same sensation inside your legs.”
“It’s like having wasps in your leg bones stinging and stinging….People who don’t have it will never, ever, understand the P A I N.”
“It sounds insane to someone without RLS, but I fantasize about death and chopping my legs off. Sounds crazy, I know, but any RLS sufferer will tell you the same thing. I am only 30. I can’t imagine living the next 30 – 40 – 50 years if my life is like this.”
Yes, these may be extreme cases, but RLS can’t possibly be considered an invented disease. Companies do, in fact, seek out drug approval for diseases that are unrecognized. But the steps that a company must take to accomplish such recognition are onerous. 1) Global regulatory agencies must recognize such a condition merits treatment. 2) The drug company must agree to criteria established by regulatory agencies for potential drug approval. 3) Clinical trials must be done to show that the drug is efficacious and safe. 4) Physicians must believe that the condition is serious enough to be willing to prescribe the medicine. 5) Payers must believe the condition is serious enough to warrant reimbursement. 6) Patients must be sufficiently concerned about their illness, pain or discomfort to be willing to seek treatment.
To invent a disease, there would need to be a conspiracy on the part of companies, regulators, patients, doctors and payers. I submit that this is a fantasy.
Let’s apply these criteria to one of Walsh’s examples, female sexual dysfunction (FSD) also known as hypoactive sexual desire disorder (HSDD) and, according to Walsh’s article, “a textbook case of disease mongering.” A small biotech company, Sprout Pharmaceuticals, sought to market a drug, Addyi (flibanserin), for FSD. But, this was already a controversial therapeutic area. Many women’s groups were lobbying the FDA because, just as men had access to erectile dysfunction drugs like Pfizer’s Viagra and Lilly’s Cialis, women should also have the right to female sexual health drugs. Sprout did meet with the FDA which agreed that a safe and effective drug for such an indication could be approved. Was this an invented disease? Not really, as many women complain of such a disorder.
Sprout ran clinical trials to demonstrate the drug’s safety and efficacy. Unfortunately, Addyi’s efficacy was limited and its toxicology profile caused the FDA to slap it with a black box warning on its label. Upon getting this controversial FDA approval, Valeant bought Sprout for a $1 billion. Unfortunately, Addyi proved to be a bust. Doctors didn’t prescribe it, payers were reluctant to reimburse payments for it, and women weren’t interested. Yearly sales barely reached $10 million and Valeant gave the drug back to Sprout. So much for the lucrative world of disease mongering.
But, there are cases when a pharmaceutical company can discover a treatment for a previously unrecognized disease and work with the FDA to bring such a drug to patients in need. Such was the case with Pfizer’s Lyrica for the treatment of fibromyalgia. Descriptions of fibromyalgia appeared in the medical literature over 150 years ago. It is characterized by widespread pain that can be relentless and is accompanied by loss of sleep, stiffness and fatigue. Because of the multiple symptoms present in fibromyalgia, companies struggled to find a single effective treatment for it.
Pfizer’s Lyrica was initially approved by the FDA to treat neuropathic pain due to diabetes and post-herpetic neuralgia. Pfizer scientists believed that Lyrica might help fibromyalgia patients. But given that the FDA had never approved a drug for this condition, the clinical path needed for approval was not defined. Thus, Pfizer met with the FDA and other regulatory agencies to understand what would be needed to get approval for a drug to treat a previously unrecognized disease. With that guidance in hand, Pfizer was able to show that Lyrica was indeed a safe and effective fibromyalgia treatment. Upon gaining approval, Pfizer then launched a direct-to-consumer (DTC) campaign to let potential patients know that there was now a treatment for their painful condition.
Pfizer didn’t “invent” fibromyalgia. But, Pfizer did find a way to treat these patients in need and then worked with the FDA to get a drug approved for this condition. The advertising campaign did bring disease awareness to potential patients. But it is hard to believe that fibromyalgia patients are “hypochondriacal” and that Pfizer “pathologized” their pain. The fact that payers put Lyrica on their formularies also shows the importance and value of Lyrica for use in a previously untreatable condition.
There are great new medicines emanating from the biopharmaceutical industry that are benefiting people around the globe: gene therapy to cure certain forms of blindness; drugs to cure hepatitis C thereby reducing liver cancer and the need for liver transplants; new treatments for all types of cancer; vaccines to prevent pneumonia and other infectious diseases. The biopharmaceutical industry isn’t perfect. But let’s stop with the nonsense that the industry invents diseases. It’s not true.
(The author is the former president of Pfizer Global R&D)
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