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

 

We're All Patients Now

 

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

 

 

The authors of 'Selling Sickness' explain how pharmaceutical companies

make everyday life into an illness. Now the backlash against Big

Pharma has begun.

 

Last month, the state of California sued 39 drug companies for price

gouging. A week earlier, a jury hit Merck & Co. with a $253 million

verdict over its painkiller Vioxx, which was linked to patient deaths.

 

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 recommend Marcia 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.

 

Kelly Hearn is a former UPI staff writer who lives in Montana and

Latin America. His work has appeared in the Christian Science Monitor,

American Prospect, and other publications.

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