Human drug trial industry booming despite fears

Government pitch for drug company investment loosens standards and compromises ethics

By: Colleen Fuller

  Anyone who's lived in Canada for more than six months has heard this familiar refrain: "Canada's greatest resource is its people". But these days when the federal government mouths that maxim, they aren't talking about our productivity or genial dispositions. They're talking about our guinea pig potential.
  The Department of Foreign Affairs and International Trade (DFAIT) wants to attract investments from the booming human drug trial industry, and they're making sure the regulatory environment is biotech- and pharmaceutical-friendly. Health minister Alan Rock helped out in January when he proposed changes to how clinical drug trials will be regulated.
 

New regulations mean that, instead of 60 days, regulators soon will have only 48 hours to determine whether human lives might be endangered in clinical drug trials

  Rock's first act of the new millennium was to reduce the length of time regulators can take to review volumes of company data about new drugs before giving the green light for so-called Phase I clinical trials. Instead of 60 days, regulators soon will have only 48 hours to decide whether peoples' lives might be endangered if they participate in drug trials. If the drug experiments involve animal organ transplants, gene therapy or new vaccines, the review period will be reduced to 30 days.
  While Ottawa says the proposed changes will help Canada lure drug company investments in research, it sent shock waves through the community of academics, patient advocates, researchers and policy analysts who watch these things. Dr. Michele Brill-Edwards, formerly one of Health Canada's top pharmaceutical specialists, recently remarked that "This government can't return phone calls in 48 hours," let alone plough through the increasingly complex information about a proposed new drug.
  But beyond these fears that unsafe drugs will be tested on human subjects, there's the even more chilling question of whether the pharmaceutical industry is fully living up to obligations to ensure the informed and voluntary consent of its research subjects.
  This question of consent is no trifling matter. After the Nazis used concentration camp prisoners in gruesome drug experiments during World War II, consent became one of the most important medical ethics questions of the twentieth century. The first "sacred principle" of the Nuremberg Code, written by the judges who presided over the Nazi war crimes trials, states that "the voluntary consent of the human subject is essential".
  Today questions remain about when consent is voluntary, and when it has been secured through some kind of coercion. For instance, when low-income people are paid to take experimental drugs, are they doing it voluntarily, or simply because they have no other economic options?
 

Fernando says its depressing to go to a clinical drug trial. "There's an element of shame associated with it."

  The Ottawa-based National Council on Ethics in Human Research has a clear answer to that question. Its "informed consent" standards state that "Payments and other inappropriate incentives offered for the purpose of inducing participation on the part of those who would not otherwise participate in a protocol unduly affect freedom of choice and are unacceptable."
  Unacceptable, but not prohibited. So the multinational drug testers play both sides of the fence. While referring to Phase I drug test participants as "volunteers," they pay them anywhere between $800 and $2,000 for their time and bodies.
  Fernando Oliviera, a 30-year old Torontonian who began participating in clinical trials at the age of 18, agrees with the National Council's concern about how payment for drug trails erodes the concept of voluntary consent.
  Most of the tests Oliviera was involved in compared one drug with another, for example a new aspirin compared with an existing aspirin. The money he got - between $600 and $2000 depending on the duration - helped put him through university in an era of rising tuition and other costs. He was joined by a wide swath of people, he says, poor and middle-income, illicit drug users and lots and lots of students.
  "It's a depressing environment," Oliviera says. "You're there… because you need a lump sum of cash," he said, adding "there's an element of shame associated with it". Some people, he said, "just get into the cycle" to support themselves or, in the case of drug addicts, their addictions. "It's depressing to see people who've been going there over and over and over again," he explains. "I've met people… who are convinced they'll need this lump sum to start their lives, and then find themselves back in there three or four months later."
  There is a screening process, Oliviera says, but it sounds as loose as the emerging regulatory regime in Ottawa. It begins, he says, with a very short interview with a doctor ploughing volunteers through at a rate of 40 per hour. They ask whether you smoke (a probable disqualifier), whether you're on any other drugs, they take your weight, height and blood and pass you along. Oliviera says most of the volunteers he met were smokers who would sneak into the bathroom during the trial period for a few puffs.
  Oliviera's experiences are probably not uncommon. But, while Ottawa is pushing for more drug research money to be invested in Canada, it does very little of its own investigating to ensure that clinical drug trials are meeting standards the public would find acceptable.

Vancouverite Colleen Fuller is an independent health researcher, a member of the board of directors the Council of Canadians, and a research associate with the Canadian Centre for Policy Alternatives (CCPA). She is also author of "Caring for Profit, How Corporations Are Taking Over Canada's Health Care System" (New Star Books/CCPA).

Drugging for dollars Getting in on the ground floor of the human guinea pig business can lead to a gravy train as the drugs make their way to market For full story, click here

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