Each story of buried evidence, bogus research, physician kickbacks and other dubious marketing ploys ticks up public outrage. Feeling pressure, the Federal Drug Administration, harshly criticized as a minion of the $500 billion pharmaceutical industry, may now raise standards for new drug approvals. In September, at least four major drugs -- each potentially worth $1 billion in annual sales -- will go before FDA's expert panels, and observers say they could take a tougher line than ever before. What's more, having spent billions of dollars marketing minor variants of hot-selling drugs instead of developing novel ones, Big Pharma is short on innovative drugs as lucrative patents near their end.
Now a new book, Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients, examines how the drug industry makes new markets by creating and expanding the definition of disease, from depression to attention deficit disorder, social anxiety to high cholesterol. Alan Cassels, a Canadian science writer, co-authored the book with Ray Moynihan, a medical writer for the Milbank Memorial Fund in New York and a contributor to the British Medical Journal. Cassels spoke to AlterNet from his home.
You use the term "the worried well." Can you describe that in the context of your book's thesis?
I think we would define the worried well as people who are relative healthy but have had the seed of concern or anxiety planted, whether it's over cholesterol level, density of bones or whether they have problems paying attention, that sort of thing. You're taking something perhaps that wasn't worried about in the past and ramping it up and doing it in a number of ways. It is a kind of fear-mongering to create a sense of worry.
Can you talk about some of those ways?
One simple way is for companies to feature celebrities on television or being interviewed talking about a type of test he or she might have undergone. They say this or that saved their life and everyone should be getting it.
Books like yours help confirm many people's suspicions that the pharmaceutical industry pathologizes much of the unpleasant parts of the human experience in order to sell more medicines --
Well, also it's just pathologizing what's normal or what in the past was considered normal. Years ago, for example, a child who behaved a certain way would be considered boisterous. Today, those kinds of kids are being diagnosed with ADD and prescribed stimulants to calm them down.
The pharmaceutical industry has obviously done well at selling sickness. With so much money at stake, is there any hope for reform, for stopping or at least tempering this trend?
Yes, I think the seeds are planted. People are more skeptical and there's a backlash to the massive increase in direct-to-consumer marketing, that in your face marketing barrage. The political and legislative climate may be turning on direct marking. This is the post-Vioxx world. Vioxx is as big of an event as the thalidomide disaster was 40 years ago and now the FDA is using a bit of teeth.
Recently, for example, drugs for female sex dysfunction were refused by the U.S. FDA. They said, we are not going to approve this because we are not sure it is even a disease. They were concerned about not having any long-term safety data on treating with testosterone. Why are they doing it? They are probably feeling stung by previous regulatory failures.
Speaking of advertising, many complain that the FDA does not get to approve an advertisement before it goes on television. By the time a misleading or inappropriate ad becomes the subject of enforcement, the damage is already done, right?
Exactly, and punishments are small. Nobody goes to jail for a misleading ad or for getting thousands to take a drug they don't need or a drug that they could be harmed by. The regulatory agencies need to be able to mete out punishments with real consequences.
Patent laws often allow extended monopolies for so-called me-too drugs, which are minor variants of existing drugs that have few if any new advantages. The laws also extend patents when a drug is used to treat a new condition, even if that condition is not generally agreed to be a real disease. What would you recommend to a reformist politician?
Probably I would recommendMarcia Angell's book. Just in simple terms, we should be rethinking whether we want to be automatically giving 20 year monopolies on something that already exists. The whole idea of me-too categories is troublesome. If there is a newer and demonstrably better drug, there is a reason to reward that manufacturer with monopoly sales. But society should not be hoodwinked to pay extortionist prices for me-too drugs. What advice for reformists? We have to look what the value added is of any new product and price it accordingly.
You've suggested a publicly funded institution should review all scientific studies, published and unpublished, on a particular treatment. Given the extent of financial collusion between leading researchers and pharmaceutical companies, do you think it would be hard, if not impossible, to find experts for the job who were not already touched in some way by Big Pharma's influence?
Luckily we already have them out there. One is the Cochrane Collaboration where volunteers from around the world do systematic reviews of clinical trials and they don't take money from pharmaceutical companies. They try to answer important scientific questions. That is one of many kinds of groups already doing it. Probably most of clinical research is going to be done by the pharmaceutical companies themselves, which means the public can get biased information. If I'm a drug company, I do eight studies, five are negative so I bury and never publish those. That's how the public and prescribers get a skewed impression.
Given then that drug companies have the option of burying unfavorable studies or tweaking the intent of a study to match the findings, do you support the creation of a national drug trial registry where companies register the intent of all trials beforehand?
Yes, and it's not just me. Lots of experts, including editors of major medical journals, have called for a registry. The industry has embraced the idea but they are not registering their trials.
What is the media's role, both in terms of culpability and potential for correcting the problem?
The media has done a lot of good covering major scandals such as Vioxx. Some of your colleagues, such as David Willman at the L.A. Times, have done fabulous work in exposing conflicts of interest and problems in regulation. So I think in many cases journalists have done a great job. The problem is that oftentimes much of journalism looks like marketing when journalists write about newest wonder drug or miracle pill. That's not really journalism.
Tue, 09/13/2005 - 21:00