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Who Paid for Your Doctor's Opinion?

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It would be nice to think your doctor prescribed you that new drug based only on the science, based only on those dry journal articles they fine-toothed after the children had gone to bed. But according to experts on "publication planning," your doctor also has to contend with sophisticated pharmaceutical industry strategies, careful plans to convince them to choose new and exciting medications. Described as not just ghost writing, but a kind of ghost management, publication planning is part of a growing culture, these experts say, of corporate-led science.

There are academic pharmaceutical researchers still publishing independent, peer-reviewed articles, just as there are still farmers who have small farms with the kinds of smiling animals one sees in children's books. But more and more pharmaceutical research is done factory farm-style, with organized precision and efficiency. It is paid for and driven by companies, coordinated by professional publication planners, and presented by medical journals looking for prestigious articles, better impact factors, and more money.

It may sound like a conspiracy theory, but professors like Sergio Sismondo and insiders like Alastair Matheson reveal how hired teams create careful plans to convince prescribers to tip toward new medications, using onslaughts of peer-reviewed articles, the credibility of respected medical leaders, and a marketing ground game built on the door-to-door combat that pharmaceutical companies have long perfected.

That may still sound like no big deal, but listen to how it all happens. A planning team is brought in right from the beginning to help choose study angles, to craft research most likely to convince prescribers of the value of the drug. This is especially important, one insider says, if there is a "need to create [a] market," or to create an "understanding of an unmet need." The question they ask is: "How are we going to create publications that have the right message, and a memorable message, for prescribers?"

The company then hires the right contract research organization to do the studies for them. The pharmaceutical industry has been sliding from academic researchers to private contract researchers, which Dr. Sismondo suggests, is in part because contract research "can be exploited for marketing purposes more easily than academic research."

The publication schedule is planned out. Not two, or three, or five articles supporting the use of the drug like in the days of the family farm, but as many as 80 or 90, all timed to coordinate with the launch of the medication, "ensuring that medical professionals are familiarized with the product at a commercially optimal time." The studies are designed to create two "narratives," one that maintains there is a medical gap that needs filling, and the other declaring that their drug is just the medicine the job.

Some of the articles will be publications of the drug's clinical trials, with others being further analyses, different angles on those studies or their data. Some articles will be about the disease in question without mentioning the drug, to get it in prescribers' minds, and to remind them there's a problem in need of a fix. The idea is to saturate journals, get everyone thinking about the disease to be treated, and the importance of the new treatment, just as the new drug splashes onto the market.

Company statisticians do the analyses and company or outside hired medical writers do most of the writing of each article. These professional medical writers are experienced at creating solid papers, often better than the average researcher, and better than a marketing department could.

But a paid medical writer can't be the lead author; the articles need to be seen to be written by credible authorities. So publication planners find "key opinion leaders", or KOLs, to put their names on the papers. Usually the KOLs are highly regarded specialists who can "influence other physicians," and who themselves benefit from their name on another paper.

Most journals thankfully won't let you put just anyone's name on an article though; the author has to have made a "substantial contribution." So the KOLs are given the opportunity to at least comment on the manuscript -- though the planning team often tries to make sure the specialist doesn't create too much work or too many headaches. One industry representative advises not to share the data with the author to avoid complications. Another insider estimates that 50% of companies show only the near-final draft to KOLs offering no earlier involvement.

Drug trials are some of the most prestigious publications. And thanks to publication planning and professional medical writers, journal editors can count on quality submissions that make their lives easier. The journals also see these factory-farmed articles as a potential source of revenue. Along with industry articles often comes industry advertising. As well, a company might buy a large number of copies of the articles to hand out to prescribers. Published peer-reviewed studies, after all, are the best advertising money can buy. The copies of those studies end up in the briefcases of drug company salespeople who visit physicians, selling the new drug with their most powerful tool: scientific evidence.

But so what? The move to publication planning makes perfect sense for companies, and with millions of dollars of research and development on the line, one can see why a comprehensive, methodical approach is the best way to ensure a return on their investment. And scientific evidence is scientific evidence, factory-farmed or not, right?

Not really. There is plenty of subjectivity in science, from the framing of the study and the choice of participants to how the data are reported and how they are interpreted. There is a growing stack of papers showing that who sponsors the research matters, that industry-sponsored studies are more likely to show positive results for their products. And that's without any fudging, just the biases that come with having a financial interest in the research.

So what's the concern? The worry is that ghost management, and the rest of the company game plan, medicalizes more problems to create more "unmet needs," expands diagnoses so more people have those needs, and leads to more prescribing of newer, more expensive drugs, one of the fastest rising health care costs.

The existence of a sophisticated commercial machine designed to influence prescribers to embrace new drugs should make us concerned -- concerned about new drug safety, about new drug effectiveness, and about new drug costs. A lot of money is invested in getting your doctor to prescribe companies' new products. What does it cost the rest of us?