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Monday, September 5th 2011

Marketing Pharmacuticals

Pharmaceutical companies can’t win in the media. We currently face a relatively unprecedented shortage of vital generic drugs,

The Food and Drug Administration says that some 180 medically important drugs have been in short supply, many of which are older, cheaper generic drugs administered by injection that have to be kept sterile from contamination.

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Although there is limited data on how many patients have been harmed, a survey of 1,800 health care practitioners last year by the Institute for Safe Medication Practices found that a third of the physicians and a fifth of the pharmacists knew of adverse patient outcomes because of shortages, including some deaths from microbes resistant to the backup drugs. Cancer patients receiving less effective drugs may well face increased risks in the future.

Nobody is sure just what is causing the shortages because drug manufacturers are not required to report any reasons to the F.D.A. But several factors are likely to be involved…[including] reluctance to invest in production-line improvement for low-profit generics when high-priced brand-name drugs bring in far higher profits. Sweeping consolidation in the generic drug industry means that fewer companies are left in that market to make up for a shortage.

Certainly my primary training facilities have experienced impressive shortages, everything from steroids to sedatives to paralytics to electrolyte replacement solutions and likely a host of others I’m not privy to. And at least partly the focus is on the profit margins afforded some of these drugs as compared to others. It certainly seems, by anecdote, that the vast majority of the shortages involve relatively cheap generic pharmaceuticals. Which makes the pharmaceutical companies current villains in some eyes as they focus on drug development, and more importantly production, for biotech and other “profit” drugs.

The industry is pouring money into clinical trials for cancer drugs (see chart).

This is part of a shift in how big drug firms do business. For years they have relied on blockbusters that treat many people. Now they are investing in more personalised medicine: biotech drugs that treat small groups of patients more effectively.

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The snag, from society’s point of view, is that all these drugs are horribly expensive. Last year biotech drugs accounted for 70% of the increase in pharmaceutical costs in America, according to Medco, a drug-plan manager. This trend will continue as drug firms develop new ways to treat, for example, multiple sclerosis and rheumatoid arthritis.

Indeed, spending on pharmaceuticals in total, and as a percentage of all therapies actually, continues to rise well past inflation even as we struggle currently to supply effective, very necessary generic drugs in enough quantity. That wouldn’t be so remarkable if we were making remarkable advancements in treating patients but that doesn’t appear to be borne out on large scale. What it takes to get a drug to market and then push physicians to use it is remarkably skimpy on evidence. PLoS Medicine’s most downloaded paper ever is titled, “Why Most Published Research Findings Are False.” In profiling the author of that paper The Atlantic points out something I agree with,

Doctors may notice that their patients don’t seem to fare as well with certain treatments as the literature would lead them to expect, but the field is appropriately conditioned to subjugate such anecdotal evidence to study findings. Yet much, perhaps even most, of what doctors do has never been formally put to the test in credible studies, given that the need to do so became obvious to the field only in the 1990s, leaving it playing catch-up with a century or more of non-evidence-based medicine, and contributing to Ioannidis’s shockingly high estimate of the degree to which medical knowledge is flawed. That we’re not routinely made seriously ill by this shortfall, he argues, is due largely to the fact that most medical interventions and advice don’t address life-and-death situations, but rather aim to leave us marginally healthier or less unhealthy, so we usually neither gain nor risk all that much.

Such may be especially true when it comes to drug therapies. Even ignoring the baseline flaws in the vast majority of medical research, research on therapies and drugs in particular face unique problems,

[O]f all the 197 new drugs approved in the past decade, only 70% had data to show they were better than other treatments (and that’s after you ignore drugs for conditions where there was no current treatment).

But the problems go beyond just using the wrong comparator: most of the trials we rely on to make real-world decisions also study drugs on highly unrepresentative, freakishly ideal patients. These patients are younger, with perfect single diagnoses, fewer other health problems, and so on.

This can stretch to absurd extremes. Earlier this year, some researchers from Finland took every patient who’d ever had a hip fracture and worked out if they would have been eligible for the trials that have been done on fracture-preventing bisphosphonate drugs, which are in wide use.

Starting with all 7,411 fractures, 2,134 patients get excluded straight off, because they’re men, and the trials have been done on women. Then, from the 5,277 remaining, 3,596 get excluded again, because they’re the wrong age: patients in trials had to be between 65 and 79. Then, finally, 609 more fracture patients get excluded, because they’ve not got osteoporosis.

This leaves 1,072 patients. So the data from the trials on these fracture-preventing drugs are only strictly applicable to about one of every seven patients with a fracture: they might still work in those who’ve been excluded, though that’s not a judgment call you should have to make; and one problem, in particular, is that the size of the benefit might be different in different people.

Perhaps an even bigger problem in pharmaceutical publishing is ghostwriting and the use of scientific literature as a marketing tool.

Dr Leemon McHenry, a medical ethicist at California State University, says nothing has changed. “They’ve just found more clever ways of concealing their activities. There’s a whole army of hidden scribes. It’s an epistemological morass where you can’t trust anything.”

Alastair Matheson is a British medical writer who has worked extensively for medical communication agencies.

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“The whole thing is a big lie. They are promoting a product.”

Matheson expects an article he wrote about a new cancer treatment to appear in print later this year, with an oncologist considered a “key opinion leader” (KOL) by planners listed as the author in his stead. “You’d do the same thing if you were selling cornflakes,” Matheson told me. “It’s no different.”

In reviewing a book for the New York Review of Books the former editor-in-chief of the highly respected medical journal The Lancet had this to say about the current state of medical publishing,

[J]ournals have devolved into information laundering operations for the pharmaceutical industry.

When the pharmaceutical companies can’t supply the drugs in part because they’re peddling much higher margin drugs on flimsy evidence, packaged as solid, then perhaps such criticism is fair enough.

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