To be blunt up front – SBM is not apologetic about the pharmaceutical industry. We get zero funding from any company, and have no ties of any kind to “big pharma.” In today’s world I have to spend time making that clear, because despite the reality critics are free to assume and falsely claim that our message is coming straight from the bowels of hell (a.k.a. the pharmaceutical industry).
We promote science-based medicine and criticize pharmaceutical companies along with everyone else when they place other concerns ahead of scientific validity, or promote bad science, for whatever reason.
It has become fashionable, however, to not only criticize the pharmaceutical industry but to demonize them – and the term “big pharma” has come to represent this demonization. Cynicism is a cheap imitation of skepticism – it is the assumption of the worst, without careful thought or any hint of fairness.
A recent article by Martha Rosenberg is an excellent representation of the mindless demonization of the pharmaceutical industry – good for scoring cheap points, but very counterproductive. She essentially accuses big pharma of inventing diseases in order to sell their products.
The premise strikes me as profoundly naive – which diagnostic entities are considered legitimate diseases is actually a complex question that is debated within the medical field. Rosenberg acts as if diseases can be invented out of whole cloth and then imposed upon medicine by a pharmaceutical executive. It is a grand-conspiracy type of thinking which erodes under scrutiny.
After hinting at anti-vaccine leanings, she writes:
Now pharma is back to creating new diseases, patients, risks and “awareness campaigns” faster than you can say thimerosal (the vaccine preservative that started the backlash.)
No – thimerosal did not start the backlash, Andrew Wakefield demonstrably did, with the MMR vaccine that never contained thimerosal. Thimerosal was simply act 2, after the evidence failed to find a link between MMR and autism (and of course there is also no link between thimerosal and autism either). But Rosenberg acts as if the anti-vaccine movement is a justified backlash against the excesses of big pharma – nice historical revisionism.
The sad fact is, Rosenberg might have a kernel of a legitimate point if she did not come across with her anti-scientific conspiracy mongering. That is why such demonization is so counterproductive – it actually backfires and let’s pharmaceutical companies off the hook for their real excesses.
Harriet Hall, for example, wrote an excellent piece on osteopenia – (Osteoporosis Drugs: Good Medicine or Big Pharma Scam?) which takes a properly nuanced and balanced approach to such questions. Do we really need to be treating pre-osteoporosis? The evidence should ultimately guide us. What pharma is guilty of doing is jumping prematurely on the bandwagon of a questionable diagnosis because it is a new market for them.
I think the same is true of the drugs that are now approved for the treatment of fibromyalgia – a controversial diagnosis, to say the least. But here we see more complexity and nuance. The FDA requires that a drug be indicated to treat a disease – not a syndrome or symptom. So there is no drug indicated for treating neuropathic pain as a symptom – drugs have to be indicated for diabetic neuropathy or post-herpetic neuralgia.
This forces pharmaceutical companies to find a disease, even when they have a drug that can potentially alleviate a symptom. Fibromyalgia is the perfect example of this – the very diagnosis itself is mostly used as a garbage pail diagnosis for vague syndromes of muscle pain and tenderness with fatigue and poor sleep. But you cannot get FDA approval to treat vague muscle pain.
Meanwhile, doctors are struggling to understand these syndromes and come up with a proper system of labeling what we find. We don’t want to prematurely use the “disease” label, but we also need to recognize patterns of patient complaints. I prefer terms like “myofascial pain syndrome” because it says what it is without implying a specific disease.
But regulation exists in its own world, and the FDA demands a disease label. So we have drugs, which are likely fine for the symptomatic treatment of myofascial pain, indicated for a dubious diagnosis (at least as it is often applied) like fibromyalgia. But it is doctors that invented the concept of fibromyalgia, and we still debate about it.
Rosenberg, however, cuts through all this nuance and goes for the simplistic and cynical conspiracy theory – pharma “invented” fibromyalgia to sell its drugs. She writes:
Nothing proves pharma’s when-the-medication-is-ready credo better than the legions of people who have fibromyalgia now that Cymbalta, Savella and Lyrica are available to treat it.
This is more historical revisionism. Having lived, and practiced medicine, through the fibromyalgia controversy it is clear that what happened is fibromyalgia became a popular diagnosis for the common vague syndrome I described above. Much after fibromyalgia became a popular diagnosis, some pharmaceutical companies saw it as a potential market. Rosenberg therefore has it backwards.
What we do have to recognize is that, now that there are drugs indicated for fibromyalgia, those pharmaceutical companies that make those drugs are invested in the reality and popularity of the diagnosis. They may therefore seek to distort the debate in that direction.
Rosenberg also embarrasses herself by criticizing the notion that there is an epidemic of sleep disorders in our society – the evidence suggests that there is, and it is under-treated. She further goes after adult ADHD and adult autism. The alternative is that autism and ADHD are childhood diseases only and always spontaneously resolve by adulthood – a scientifically untenable, and even laughable, position.
She further completely distorts the notion of “treatment resistant” conditions. She misinterprets that fact that many drugs are initially approved for adjunctive (add-on) therapy. This is not because the notion of “treatment resistance” was invented by big pharma. It is partly due to the fact that it is easier to do clinical trials where a new treatment is added to an established treatment, rather than to prove equivalence as stand alone therapy. So pharmaceutical companies go after the low-hanging fruit to maximize their return on investment.
Also – some patients are difficult to treat, and when one approach is not adequate it is nice to have more options. Rosenberg somehow turns this into a negative.
Rosenberg’s approach to this complex issue is simplistic, naive, and conspiracy-mongering. She brings no useful insight to the discussion. She also demonstrates nicely the method of “demonizing” a convenient target – re-write history, white wash over all complexity and nuance, and cast everything into a maximally sinister light.
But further Rosenberg shows that taking such an approach is highly counterproductive. The pharmaceutical industry, like every industry, needs an effective watchdog to guard against abuse and excess. I also think they require thoughtful and effective regulation (although this question is difficult to disentangle from political ideology).
Rosenberg and other big pharma conspiracy theorists make ineffective watchdogs and critics, because their criticisms are paper thin and easily countered . By not recognizing the complexity of the issues involved, or making any attempt at fairness, Rosenberg is easily dismissed.
If I were a conspiracy nut I might even suspect that people like Rosenberg are actually fronts for big pharma, used to create a straw man of criticism that they can then easily knock down to show that all criticism is weak and invalid.