Buried evidence, bogus research, physician kickbacks and other dubious marketing ploys

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Buried evidence, bogus research, physician kickbacks andother dubious marketing ploys

 

http://www.alternet.org/envirohealth/25418/

 

 

By Kelly Hearn, AlterNet. Posted September 14, 2005.

 

The authors of 'Selling Sickness' explain how pharmaceutical companiesmake everyday life into an illness. Now the backlash against BigPharma has begun.

 

Last month, the state of California sued 39 drug companies for pricegouging. A week earlier, a jury hit Merck & Co. with a $253 millionverdict over its painkiller Vioxx, which was linked to patient deaths.

 

Each story of buried evidence, bogus research, physician kickbacks andother dubious marketing ploys ticks up public outrage. Feelingpressure, the Federal Drug Administration, harshly criticized as aminion of the $500 billion pharmaceutical industry, may now raisestandards for new drug approvals. In September, at least four majordrugs -- each potentially worth $1 billion in annual sales -- will gobefore FDA's expert panels, and observers say they could take atougher line than ever before. What's more, having spent billions ofdollars marketing minor variants of hot-selling drugs instead ofdeveloping novel ones, Big Pharma is short on innovative drugs aslucrative patents near their end.

 

Now a new book, Selling Sickness: How the World's BiggestPharmaceutical Companies Are Turning Us All Into Patients, examineshow the drug industry makes new markets by creating and expanding thedefinition of disease, from depression to attention deficit disorder,social anxiety to high cholesterol. Alan Cassels, a Canadian sciencewriter, co-authored the book with Ray Moynihan, a medical writer forthe Milbank Memorial Fund in New York and a contributor to the BritishMedical Journal. Cassels spoke to AlterNet from his home.

 

You use the term "the worried well." Can you describe that in thecontext of your book's thesis?

 

I think we would define the worried well as people who are relativehealthy but have had the seed of concern or anxiety planted, whetherit's over cholesterol level, density of bones or whether they haveproblems paying attention, that sort of thing. You're taking somethingperhaps that wasn't worried about in the past and ramping it up anddoing it in a number of ways. It is a kind of fear-mongering to createa sense of worry.

 

Can you talk about some of those ways?

 

One simple way is for companies to feature celebrities on televisionor being interviewed talking about a type of test he or she might haveundergone. They say this or that saved their life and everyone shouldbe getting it.

 

Books like yours help confirm many people's suspicions that thepharmaceutical industry pathologizes much of the unpleasant parts ofthe human experience in order to sell more medicines --

 

Well, also it's just pathologizing what's normal or what in the pastwas considered normal. Years ago, for example, a child who behaved acertain way would be considered boisterous. Today, those kinds of kidsare being diagnosed with ADD and prescribed stimulants to calm them down.

 

The pharmaceutical industry has obviously done well at sellingsickness. 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 andthere's a backlash to the massive increase in direct-to-consumermarketing, that in your face marketing barrage. The political andlegislative climate may be turning on direct marking. This is thepost-Vioxx world. Vioxx is as big of an event as the thalidomidedisaster was 40 years ago and now the FDA is using a bit of teeth.

 

Recently, for example, drugs for female sex dysfunction were refusedby the U.S. FDA. They said, we are not going to approve this becausewe are not sure it is even a disease. They were concerned about nothaving any long-term safety data on treating with testosterone. Whyare they doing it? They are probably feeling stung by previousregulatory failures.

 

Speaking of advertising, many complain that the FDA does not get toapprove an advertisement before it goes on television. By the time amisleading or inappropriate ad becomes the subject of enforcement, thedamage is already done, right?

 

Exactly, and punishments are small. Nobody goes to jail for amisleading ad or for getting thousands to take a drug they don't needor a drug that they could be harmed by. The regulatory agencies needto be able to mete out punishments with real consequences.

 

Patent laws often allow extended monopolies for so-called me-toodrugs, which are minor variants of existing drugs that have few if anynew advantages. The laws also extend patents when a drug is used totreat a new condition, even if that condition is not generally agreedto be a real disease. What would you recommend to a reformist politician?

 

Probably I would recommend Marcia Angell's book. Just in simple terms,we should be rethinking whether we want to be automatically giving 20year monopolies on something that already exists. The whole idea ofme-too categories is troublesome. If there is a newer and demonstrablybetter drug, there is a reason to reward that manufacturer withmonopoly sales. But society should not be hoodwinked to payextortionist prices for me-too drugs. What advice for reformists? Wehave to look what the value added is of any new product and price itaccordingly.

 

You've suggested a publicly funded institution should review allscientific studies, published and unpublished, on a particulartreatment. Given the extent of financial collusion between leadingresearchers and pharmaceutical companies, do you think it would behard, if not impossible, to find experts for the job who were notalready touched in some way by Big Pharma's influence?

 

Luckily we already have them out there. One is the CochraneCollaboration where volunteers from around the world do systematicreviews of clinical trials and they don't take money frompharmaceutical companies. They try to answer important scientificquestions. That is one of many kinds of groups already doing it.Probably most of clinical research is going to be done by thepharmaceutical companies themselves, which means the public can getbiased information. If I'm a drug company, I do eight studies, fiveare negative so I bury and never publish those. That's how the publicand prescribers get a skewed impression.

 

Given then that drug companies have the option of burying unfavorablestudies or tweaking the intent of a study to match the findings, doyou support the creation of a national drug trial registry wherecompanies register the intent of all trials beforehand?

 

Yes, and it's not just me. Lots of experts, including editors of majormedical journals, have called for a registry. The industry hasembraced the idea but they are not registering their trials.

 

What is the media's role, both in terms of culpability and potentialfor correcting the problem?

 

The media has done a lot of good covering major scandals such asVioxx. Some of your colleagues, such as David Willman at the L.A.Times, have done fabulous work in exposing conflicts of interest andproblems in regulation. So I think in many cases journalists have donea great job. The problem is that oftentimes much of journalism lookslike marketing when journalists write about newest wonder drug ormiracle pill. That's not really journalism.

 

Kelly Hearn is a former UPI staff writer who lives in Montana andLatin America. His work has appeared in the Christian Science Monitor,American Prospect, and other publications.