BIG PHARMA'S DEADLY EXPERIMENTS

[Guest guest]

Big Pharma's Deadly Experiments

By Kelly Hearn, AlterNet

Posted on June 9, 2006, Printed on June 22, 2006

http://www.alternet.org/story/37024/

A newly surfaced report alleges that in 1996, drug monolith Pfizer

gave an unproven drug to Nigerian children and infants suffering from

meningitis -- without the authorization of the Nigerian government.

Completed five years ago and coming to light in a May 7 Washington

Post investigation, the confidential report, written by a panel of

Nigerian health experts, concluded that administering the drug Trovan

to 100 patients suffering a deadly strain of meningitis was " an

illegal trial of an unregistered drug. " The drug was ultimately shown

to be ineffective. A lawsuit against Pfizer claims some of the

children in the trial died and others suffered brain damage.

 

The report surfaces as more and more clinical research relocates to

the Global South in order to escape burdensome regulation schemes in

the United States and Western Europe. AlterNet has obtained an early

look at a book to be published later this year -- The Body Hunters:

How the Drug Industry Tests Its Products On the World's Poorest

Patients (New Press), by investigative journalist Sonia Shah -- that

raises the curtain on a trend that's harming patients and health care

systems while eroding the developing world's trust in conventional

medicine.

 

Researchers needing patients and freer working conditions have for

years found a honey pot in the world's slums and shantytowns. The

fact that poor, desperate patients are willing to try anything, means

companies like GlaxoSmithKline, Merck and Wyeth currently conduct 30

percent to 50 percent of their experiments outside Western Europe and

the United States, and plan to boost foreign trials by 67 percent

this year, according to USA Today. Their urgency is understandable;

Shah's book notes that to get a single drug to market, drug companies

are forced " to convince more than 4,000 patients to undergo 141

medical procedures each in more than 65 separate trials. "

 

Clinical investigators and the companies backing them argue that

overseas trials get drugs to a lucky few and lead to faster cures for

us all. But Shah, the author of Crude: The Story of Oil, deftly takes

that Big Pharma myth to task, tracing how drug trial exports ruin

third-world health care systems, steer attention away from public

health needs like clean water and sanitation, and ignore the health

safety of subjects.

 

From the history of placebo controls to a modern map of how loophole-

prone laws in the 1980s paved Big Pharma's easy way, Shah shows

that " the main business of clinical research is not enhancing or

saving lives but acquiring stuff: data " -- making it an industry

instead of a social service, as it would have the world believe. As

an industry, she argues, they should be denied the regulatory winks

and nods reserved for a public health entity.

 

Hearn: What struck you as the worst case of excess or neglect you

found while researching this book?

 

Shah: It was probably the trial I covered in Zambia [involving a drug

to combat cryptosporidium, a diarrhea-causing infection]. It was

stark, children dying, little kids dying. But from what I can tell if

these kids had received antiretroviral therapy they could have

survived. But they were put into a trial for a drug that never

benefited them or their families or siblings because the drug was so

completely targeted for other populations, almost a luxury drug for

fighting an infection that in Western children means a day of

diarrhea. It is so mild in kids who are healthy that lots of people

don't even notice it.

 

So for such a minor condition they tested the drug on people who were

so, so sick. And in the end, 12 kids died.

 

Kelly Hearn: You write that by the late 1990s, pharmaceutical

companies had grown frustrated with the pace of academic hospitals

and research centers, and changed the contracting focus to " contract

research organizations, " private companies that promise to get drug

trials done quickly. What role do these companies play in the scheme

of drug trials, and to what degree are they responsible for the

growth in overseas trials?

 

Sonia Shah: There are two things, a push and a pull, that force

trials overseas. The push is a patient recruitment bottleneck. Most

trials don't meet recruitment deadlines, whether it's because

Americans aren't interested or their profiles are wrong. Often the

right kind of patients don't exist in enough quantity in the U.S., or

if they do they drop out of trials.

 

The big pull is the contract research organizations (CROs). If anyone

is a body hunter, it's the CRO industry, an industry that has largely

escaped public notice, perhaps because of the weird, vague sounding

moniker, CRO. Public Citizen called them, more accurately, " human

experiment corporations. " They are, though, just a business, and are

not any more venal than other actors involved.

 

Hearn: Like you, many journalists and health experts I have

interviewed almost invariably say the FDA should require new drugs to

outperform existing ones rather than simply work better than a

placebo. Given your sense of the FDA's ruling culture, the growing

public frustration with drug companies, Washington's current

political climate, and so on, is there real hope of this happening in

the next few years?

 

Shah: I think not. But the history of regulation goes in fits and

starts based on scandals, horrible mistakes like thalidomide, and

then regulations change rapidly. And we can't predict disasters,

something that will come into the limelight and expose a controversy,

something that can change headlines. The FDA is vulnerable to

headlines, to politics.

 

Hearn: What are the most dangerous structural impacts overseas trials

can have on developing countries' health systems?

 

Shah: The main thing is misallocation of resources. You're talking

about such a scarcity in terms of clinics, nurses, doctors,

facilities, medicine, tools and time. You have places where all this

is in short supply and in that setting they have this fruit dangled

in front of them -- we'll pay you so many hundreds per patient, we'll

give you new technology, new MRI machines, etc.

 

But what this means is that doctors and nurses there are performing

experiments for treatments for things like diabetes, arthritis,

erectile dysfunction. These things are important in the West but

these people have malaria, cholera, and other infections. In that

sense, the industry sponsored trials are distorting health care.

 

Part of a larger trend, as is happening in places like India that

have and want more foreign trials, is the rise of privatized, two-

tiered health care where high-tech facilities and highly specialized

physicians are available for the wealthy, but the poor just have

basic service that they have to pay for. In India and in South

Africa, they are building hospitals not for people who live there but

for foreigners. Doing trial business is part of the trend toward

creating two-tiered systems in these countries, a private one for the

rich and nothing for the poor.

 

Hearn: You talk about the phrase " due to ethical concerns " appearing

frequently in biomedical conversations. You note that it is

almost " exclusively reserved for biomedical transgressions. " Can you

explain?

 

Shah: It's just that you never hear it outside these circles it

seems. If you're talking about something unethical, you don't

say, " It's not possible due to ethical concerns. " You don't

say, " It's not possible to gas people due to ethical concerns. " You

say, " Such and such happened, and it was wrong, immoral and illegal. "

 

Hearn: Rep. Tom Lantos of California said after the Washington Post's

coverage of the Nigerian report that he will offer a bill making U.S.

researchers give federal regulators details of tests planned in

developing countries. What do you think of that idea, and what are

some of the necessary regulatory changes for reining in the

transgressions you address in the book?

 

Shah: I think it's a baby step in right direction. But most

important, there needs to be restraints and breaks in the exportation

of drug trials. It's not possible to put in enough oversight to

protect these subjects, at the present time. Restraint is necessary.

I was giving a talk at the FDA, and the regulators wanted to know

what they can do to make it better. What about a new rule that says

there should be an ethics committee review in this country and the

country taking the trial? That's already true for NIH trials.

 

That would be good, but we know from NIH trials that lots of things

fall through cracks, and that just requiring the ethics review is not

sufficient. Another thing you could do is require verification of

informed consent and really make sure people understand what's

happening, that they fill out forms or take quizzes to show they

understand.

 

Hearn: You put hope into the rise of the nonprofit drug companies.

What are some of the key ways they can help?

 

Shah: I don't think it's wrong to do trials in developing countries.

It's about what kind of drugs that are being developed. Are the drugs

a public health priority? Those who take on the burden of

experimentation should enjoy the fruits of research rather than

watching the benefits go only to a tiny percentage of white,

overweight bald men.

 

Hearn: Having now written about two of the world's most powerful

interests, Big Oil and Big Pharma, what common themes emerge?

 

Shah: What's interesting to me is they produce commodities that are

public goods. Society needs energy and medicine, but we let private

companies do it for us. And their goals are to enrich shareholders.

We need these things, but we decide the responsibility for providing

it should go to for-profit entities. This develops all kinds of

distortions.

 

Kelly Hearn is a former UPI staff writer who divides his time between

the United States and South America. A correspondent for the

Christian Science Monitor, his work has appeared in The Nation, The

American Prospect and other publications. He is a regular contributor

to AlterNet.

 

© 2006 Independent Media Institute. All rights reserved.

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