Ray Moynihan is an award-winning health journalist and researcher, and co-author of the bestselling book Selling Sickness: How the World’s Biggest Drug Companies Are Turning Us All Into Patients, which was published in 2006. His latest book, Sex, Lies, and Pharmaceuticals: How Drug Companies Plan to Profit From Female Sexual Dysfunction, written with Dr. Barbara Mintzes, will be released this October. The book builds on his past work and explores how pharmaceutical companies are helping to define and construct women’s sexual difficulties as symptoms of a new disorder. In August, medical anthropologist S.D. Gottlieb interviewed Ray Moynihan for Corporations and Health Watch about the role of the pharmaceutical industry in defining pathology and his new book. What follows is an edited version of that interview.
CHW: Can you explain to the readers of Corporations and Health Watch what it means for pharmaceutical companies to be creating diseases and disorder?
RM: I don’t normally say that companies create diseases. What the evidence suggests is that companies have helped to sponsor the creation of diseases, to create the scientific building blocks of disorders. This can happen in a range of ways. The boundaries that define conditions can slowly be widened. We’ve seen this happen with depression, with Attention Deficit Disorder, we’re seeing it now with female sexual dysfunction. Some of the ordinary ups and downs of life become blurred with the symptoms of medical conditions. This has become one of the elements of contemporary pharmaceutical company marketing because the more people who can be labeled as requiring a pill, the bigger the markets for the drugs. It’s often a subtle process. You’ve got to follow the money to look at the relationships between the companies and the medical profession. When you do that what we see is a merging of marketing and medical science. In the United States particularly, pharmaceutical marketing is off the leash. A key aspect of that marketing is telling as many people as possible that they need not just one drug but a range of drugs. The marketing is insidiously trying to make us feel as if the ups and downs of life are the symptoms of conditions that require drugs. Anyone living in the United States with a television will recognize these: overactive bladder, stomach problems, mild depression, or a bit of unusual busyness in children. Now we have adult ADD as well. This insidious process is largely unregulated because the regulators focus on drugs, not on the science that defines the conditions.
CHW: That’s a great point. Can you speak more about the problem of the difference between regulation and actual oversight of how pharmaceutical companies develop these notions of pathology?
RM: When you look at the specific panels of doctors who sit down and define illnesses, conditions, and the boundaries of high cholesterol, higher blood pressure, type 2 diabetes, or depression—the doctors actually sit down around a table and decide who is sick and who is healthy—you’ll find that many of those doctors are extremely close financially to the drug companies, and will clearly profit if those boundaries are set as widely as possible. Now this is a crude analysis because it comes out of investigative journalism, not a long history of academic research. Certainly there’s been wider debate about medicalization for a long time, but what I’m trying to do is throw the spotlight on the process by which conditions, diseases, dysfunctions, and disorders are being generated and promoted, The closer you look at that process, the more that it smells.
CHW: So to probe a little deeper, you have a book coming out about the idea of female sexual dysfunction. Can you tell us about this category—how is it constructed and what does it mean?
RM: Female sexual dysfunction does have a technical definition in the pages of the Diagnostic and Statistical Manual of Mental Disorders, but I won’t bore your readers with those details. But there are technical definitions. DSM-4 defines four sub-disorders: disorders of desire, arousal, pain and intercourse, and orgasm.
CHW: And do they all have to be present in order to diagnose FSD?
RM: No, they don’t. They are four separate sub-disorders. But that formal definition is constantly in play and is extremely controversial. For the last decade, there has been a cogent, well organized, and small but effective campaign to criticize those formal definitions and promote an alternative view. That’s an incredibly important part of this story. But back to the definitions themselves. For the last decade or so, there’s been an attempt to portray female sexual dysfunction as being a widespread and treatable medical condition that could affect up to 43% of women. That figure sounds absurd, but it is still widely used by people within the medical profession. It comes from a 1999 article in the Journal of the American Medical Association. It somehow has a degree of scientific credibility, despite the fact that many people have criticized the figure and now that figure has largely been discredited. So the simplistic narrative that has been promoted is that 43% of women have this condition, that it can be severe, under-diagnosed, and it can respond to treatment. And anyone who questions this narrative must be trying to disrespect or delegitimize the genuine suffering of women.
CHW: Isn’t that a slippery slope, to be critical of this diagnosis because it could suggest a lack of recognition of the plight of women?
RM: Absolutely. Almost everyone who is critical of the way in which this condition has been promoted acknowledges that sexual difficulties are widespread and that sometimes those difficulties are so debilitating that a medical angle and a medication may be the best strategy. I don’t think there’s any denying that. The controversy is about the extent of those treatable medical problems. And I think that estimates like 43% are clearly such vast exaggerations that they themselves have sparked a backlash of rationality. When you drill behind that 43% figure and look at the surveys from which it comes, you realize that it in no way represents the proportion of women with treatable medical problems. It represents the proportion of women who say yes to having experienced very common ups and downs in their sex lives. People who have had lack of interest in sex for a few months, people who have had problems with pain, people who have had problems with orgasm. Very common aspects of sexuality that have been categorized as the symptoms of a treatable medical condition.
CHW: Can you clarify why you think these experiences might not require medical intervention?
RM: Sure. In 2000, the New View Campaign was co-created by a New York psychologist called Dr. Leonore Tiefer. This is a global campaign that has a totally different way of framing sexual difficulties. They talk about sexual problems and why women might suffer sexual difficulties. In their view, a passing lack of interest in sex is not something that should be pathologized, not something that should be seen as a symptom of a disorder called Hypoactive Sexual Desire Disorder. It’s an aspect of ordinary life that sometimes is so serious and severe that professional help may be necessary and valuable, but in many cases is not.
CHW: To bring it back to the production of the disorder, a lot of readers probably know about the successful—and profitable—male sexual dysfunction drugs on the market, the most familiar version of which is Viagra. In your view, how has the development and marketing of female sexual dysfunction drugs differed from or paralleled the drug for erectile dysfunction?
RM: The biggest difference is that despite ten years or more of trying a whole range of different drug therapies, nothing has yet been successful in terms of female drugs, whereas my understanding is that the trials of Viagra showed fairly good evidence of effects. But when it’s come to trials of drugs for female sexual dysfunction, so far the FDA has approved nothing. To date, there have been three main waves of potential drugs to treat this condition. First, there was Viagra. The trials of that showed that for women it didn’t work any differently from a placebo. Secondly, there was testosterone, and that failed at the FDA because of fairly negligible benefits but serious risks of harm. And then thirdly we’ve just had this drug called flibanserin which affects the neurotransmitters in the brain, and that just recently failed as well. So I think in all these trials we have seen the power of the placebo.
What is similar is that as the drug companies approach the FDA approval for these drugs, they put a lot of energy into what’s called preparing the market, trying to cultivate the market so that as soon as their drug is approved, a lot of doctors are ready to prescribe. And we saw this most beautifully this year, 2010, when the German drug company Boehringer Inglheim were seeking approval for their drug flibanserin in June. For the last couple of years, behind the scenes, very quietly, Boehringer has been developing links with senior researchers within the world of sexual research. It’s been holding forums, it’s been starting to prepare the market, it’s been funding medical education, things like that. In May 2010, they sponsored a very aggressive media assault that rolled out across the United States and the world, trying to frame sexual difficulties in women as a problem in the brain. They claimed that their drug, which was about to go up for approval, could then be the white knight that rode in on a horse to fix the problem. Things didn’t go according to plan. The FDA rejected the drug. So in a sense there are very similar marketing strategies at play here, but one of the big differences is there’s been no drug approved yet in the United States.
CHW: My understanding of Viagra’s history is that it was more or less coincidence that its indication for erectile dysfunction was discovered. From what you’re saying, it sounds like the female sexual dysfunction pill has been much more directed in its intentions than the discovery of Viagra.
RM: You’re right. Viagra was being tested for something else and this was discovered as a serendipitous side effect and that then became the main indication. And I think that the discovery of Viagra’s sexual benefits for men in the 1990s immediately sparked enormous interest on the part of Pfizer and other companies in the possibility of a market among women. So a lot of energy is going into trying to find a drug that may get approval here. And of course testosterone is used in men and so it was a natural idea to try it in women. The German drug company that has brought us flibanserin also has a similar narrative to the Viagra narrative. Boehringer Inglheim says that flibanserin’s sexual benefits were only discovered accidentally, because the drug was originally tested as an antidepressant. And as it happened, it failed as an antidepressant and now it looks like it may have failed as a sexual dysfunction drug as well.
CHW: Let’s go back to the ideas of companies framing and structuring the marketplace, instead of creating markets. I’m wondering about the innovation-oriented conferences. I read one of your 2003 articles about female sexual dysfunction and you mention in that article the idea of innovation-oriented conferences where so-called “knowledge and opinion leaders” in the pharmaceutical world are coming together to educate other clinicians, to create a community of experts, and to use clinicians as emissaries to other clinicians.
RM: Yes, that’s exactly right. There really is a very frightening merging of marketing and medical science going on, often behind closed doors at these so-called scientific gatherings. The extent of involvement of drug companies in these so-called scientific gatherings has really gotten out of control. Particularly in the early 2000s when this disorder was being developed as a widespread epidemic, the extent of involvement of Pharma was extreme. So not only did companies fund, sponsor, place their booths, and have their marketing people interact with doctors and researchers at these events, the company representatives were actually inside the educational lecture halls taking part in all of the debates, and these debates were actually defining what is human pathology and what is normal life. So drug companies help to define their own markets. I was at a conference in Paris just last year and to my dismay, the senior drug company marketing staff were not just there flogging their drugs, they were in the mainstream so-called scientific discussions, going on about how to define and treat these conditions.
Let me briefly describe three of the building blocks where this merging of medicine and marketing is happening. One is the studies of prevalence. So when we hear studies that say one in ten women have Hypoactive Sexual Desire Disorder, sometimes these surveys are being designed and executed by drug companies. So if you look closely at the fine print of the journal articles that produce these prevalence estimates, these big surveys, companies are actually explicitly involved in them. The next thing is the measurement tools – the tools that are used to measure whether or not a woman suffers from this so-called condition, and whether or not a drug helps. Drug companies have actually created those measurement tools. They’re not being done independently outside the companies, they’re being specifically created by company staff. The third area, and this is perhaps the most shocking, is the diagnostic questionnaires that are used to determine whether or not someone has Hypoactive Sexual Desire Disorder are actually being created by the staff from the companies who are making the drugs for the same condition. In the book Sex, Lies, and Pharmaceuticals I present this evidence. It’s referenced and fact-checked within an inch of its life.
CHW: How would you say that pharmaceutical companies defend this practice when they’re called to task?
RM: I think that we’ve all slowly slipped into these processes. The closeness between the pharmaceutical industry and the medical profession is at least a century old. Recently, the relationship has gotten closer, and in the last decades of the 20th century, without knowing it, we’ve seen a frightening merging of the profession and the industry. In the first decade of the 21st century, the world is starting to wake up to this and we’re seeing widespread concern about this overly cozy relationship between doctors and drug companies. In America, there are now new laws that will force companies to reveal every single payment to every doctor that they put on the payroll. These are unprecedented levels of transparency, and ultimately they’ll produce a new independence in the relationship between industry and the profession.
What’s flown under the radar in all of this is the way in which this closeness has actually started to affect how we define illness. And direct-to-consumer advertising in America has been the vehicle by which the industry has helped to pathologize vast swaths of the healthy population. So far, industry has not really been called to account for this, because this analysis is still not widely understood. On the rare occasions that the industry does have to answer the criticism that it is widening the boundaries of illness, companies simply say that they are responding to legitimate areas of unmet need, legitimately funding science to help bring an end to suffering and improve the health of people and populations, and that its relationships with professionals are entirely appropriate and legitimate, and legal and acceptable. That is their standard approach.
They can’t really deny any of the evidence that we’re discussing, because all the evidence is there. In this new environment, it will be interesting to watch where there is a genuine push for more independence between health professionals and industry and what effect that will have on the way in which we define illness. If we bring a whole fresh bunch of people, good people, and ask them to put their minds to this problem of how to define an illness without that conversation being in the shadows of the pharmaceutical companies, I think we might come up with some very different sorts of answers. We may not find that diseases and definitions keep being broadened.
CHW: The United States FDA advisory panel recently issued a recommendation against the Boehringer Inglheim oral drug for sexual dysfunction that’s pending FDA approval. Many people don’t recognize that there’s an advisory panel that’s separate from the FDA regulatory panel. In 2000, the FDA issued preliminary guidelines to help companies plan human studies of drugs for female sexual dysfunction complaints. Can you talk about government involvement in promoting companies’ developments of new categories of illness?
RM: The FDA has its hands full trying to understand the risks and benefits of pharmaceuticals and other products. I would argue that it is not qualified to critique and evaluate the science behind the actual conditions. The regulators, like almost everyone else, take on good faith the disease definitions that are handed to them by groups of experts within the medical profession. But we can no longer take those definitions on good faith. We must look closely at them, who has defined them, who has funded them, and at the relationships between the people doing the defining and the drug companies. And really, I think, we need to start again.
Even this year, I don’t think the advisors to the FDA were well enough aware of the deep controversy surrounding this thing called HSDD, Hypoactive Sexual Desire Disorder. You have a bizarre situation occur where the FDA’s advisors and the FDA are assessing a drug for a condition called HSDD, while at the same time, a panel that is rewriting the DSM, the manual of diseases, has proposed abandoning HSDD as a disease entity. So, in fact, HSDD may no longer exist within a couple of years, and yet the FDA is happily and enthusiastically assessing a drug for this condition. This is just one example where I think the FDA regulators generally need to be a lot more rigorous in their analysis of claims about the nature of conditions. The other important thing to say is that the FDA has actually explicitly encouraged companies to design the instruments that measure the success of their drugs. I find that bizarre but I think it flows from something deeper. Increasingly, health care and medicine are not seen just as something that helps prevent disease and augments human health. Rather they are seen as industries, very large industries, and the FDA sees its role as facilitating that industry. Don’t forget that the FDA itself is funded in a very big way by industry.
CHW: And populated with people who have a lot of industry experience as well. It’s self-contained in some way.
RM: That’s right, and there are often debates within the FDA itself about the extent to which it is too close to industry. At least one bill has been proposed to end industry funding for the FDA. I suppose these are deeper and bigger debates for another day, but they’re certainly relevant to this debate about how conditions are constructed and promoted.
CHW: As our final question, I wanted to ask about one of the things that prompted my interest in this most recently, which is the Boehringer Inglheim website called sexbrainbody.com. It’s one of many drug company educational content websites that precede FDA approval. What do you think are the benefits or challenges that websites might provide for patients?
RM: The pharmaceutical industry and their allies are asking us to believe that their promotion and marketing is actually information and education. This is a deep assault on our sense of reason and I really don’t understand how the assertion can even be made. That’s the big picture answer to your question. The smaller answer is that consumers need to be extremely skeptical of any sources of information that are sponsored by the drug companies or other industries with vested interests in the outcome of that information. I think that the sexbrainbody website was a crude attempt by Boehringer to help build the market for its drug. These promotional exercises, even though there may be independent people involved in running them, need to be heavily labeled. There should be laws that mandate that the sponsorship should be front and center on the front page of such websites. The sad thing is that there are not easily, readily accessible websites that offer truly independent information and education. The few sources that are around don’t have the firepower behind them that a drug company hungry for a new market can bring.
This question of who educates consumers about drugs is raging in Europe at the moment, as the drug companies are attempting to introduce direct-to- consumer advertising into Europe under the guise of providing information to people. And we’re living through a very strange epoch where the belief that knowledge can be generated independently of corporate interests is under threat. Somehow we have come to believe that corporate involvement in the generation of information of knowledge or education is acceptable, actually something to encourage. It’s a blurring of categories.
CHW: Thank you so much.
Ray Moynihan was interviewed by S.D. Gottlieb, MHS, PhD, anthropologist and author of the recent dissertation entitled, “Manufactured Uncertainty: the Human Papillomavirus and the Object Multiple.”
For other related CHW posts, see:
- Vaccine Promotion in the Hands of a Corporation: The Missed Opportunity of Merck’s Marketing of Gardasil
- Assessing the Health Implications of the Supreme Court Decision on Corporate Campaign Contributions