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Cancer patient Darcy Doherty. (Kevin Van Paassen/The Globe and Mail)
Cancer patient Darcy Doherty. (Kevin Van Paassen/The Globe and Mail)

Drug trials on trial: Is it really greed versus good? Add to ...

They tried for months. Petitions, e-mails, phone calls, videos, personal pleas, all with a simple message aimed at drug giant Bristol-Myers Squibb: “Help Save Darcy.”

Darcy Doherty was a 48-year-old Toronto businessman and father of three who was dying of melanoma, a type of skin cancer. Bristol-Myers had actually kept Mr. Doherty alive for a good part of the past four years: It included him in a trial for a new drug it was developing in 2007, just after doctors discovered that his cancer had spread and he had only a few months to live.

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The drug, now on the market as Yervoy, proved effective and Mr. Doherty thrived. But he stopped responding at the end of 2011.

Still, there was still hope. Bristol-Myers had started early testing of a new version of Yervoy called BMS-936558, and it also looked promising. If Mr. Doherty could get into those trials, maybe he would get a few more years. But he was medically disqualified because the cancer had spread to his brain, and companies prefer not to enroll test subjects who may become gravely ill or die before the study is complete.

Mr. Doherty’s family asked Bristol-Myers: Give him the drug anyway. We’ll take our chances. We’ll sign off on all liability. We’ll try anything. The company said no. It was too early in development. Too risky, even for someone who was dying.

So Mr. Doherty’s wife, Rebecca Cumming, went public. She organized petitions, sent e-mails, contacted journalists and posted videos online. The company had an ethical obligation to help Mr. Doherty, she argued. The message resonated and within weeks nearly 200,000 people signed an online petition. E-mails flooded inboxes at Bristol-Myers. Mr. Doherty’s story was featured in newspapers and on television across the country.

Bristol-Myers held firm. While the drug had shown potential in early testing, “we believe there is not enough information on its use in humans at any given dose to allow use outside of a well-controlled clinical trial at this time,” company spokeswoman Monica Flores said.

Mr. Doherty died on Tuesday.

“We always remained hopeful that [Bristol-Myers] would change its mind and Darcy would have another miracle,” Ms. Cumming said in a statement. “Sadly, that did not happen.”

The sad case has given new urgency to a long-standing, gut-wrenching debate: What obligation, if any, do drug companies have to terminally ill people? Should they help very sick individuals even if that could jeopardize clinical trials and delay the introduction of a drug? What about the testing process over all? Why does it take more than a decade and as much as $1-billion to bring a new drug to market? And should these questions be left in the hands of drug companies in the first place?

This case “is sort of illustrative of the tension that arises during drug development,” said David Hogg, an oncologist at Toronto’s Princess Margaret Hospital specializing in melanoma, who treated Mr. Doherty. “We all want things to go really fast and we all want things to be very safe.” But sometimes you can’t do both.

“I don’t think it’s an issue that’s ever going to be resolved completely,” Dr. Hogg said, “because the objectives of pharmaceutical companies and the objectives of an individual patient are not congruent.”

It’s an age-old problem – how to balance the rigour and rationality of scientific advancement with the all-too-human emotion of compassion. Must we look beyond saving one life now for the greater good of society in the future? Scientists, drug companies, advocates, governments and ethicists have been seeking that balance for more than a century, to the earliest attempts to control the proliferation of new drugs.

Some of the first drug-control measures were adopted by British officials in the mid-1800s after a series of deaths caused by questionable pills and potions. In one case, a drug maker accidentally substituted arsenic for sulphate of lime in peppermint lozenges, killing 400 people. Canada and the United States followed suit in the early 1900s, also in response to deadly outbreaks of contaminated food and medicine.

Even then, though, there was no formal approval process for new drugs. That came in the late 1930s after S.E. Massengill Co., a Tennessee-based drug maker, created a new liquid version of a popular medicine for strep throat. The company used diethylene glycol as a solvent, not understanding it was toxic. When it hit the market in 1937, 108 people died. The chemist who came up with the lethal formula used the medicine as well – to kill himself.

After that, U.S. and Canadian officials began requiring drug companies to seek government approval for new products. Even bigger changes came in the 1960s, after another tragedy – thalidomide. What looked like a safe, effective medication for morning sickness in pregnancy proved, as it took researchers years to discover, to cause severe birth defects. The public outcry led to an overhaul of the drug-testing process around the world and created a regulatory system that is still used today in most developed countries.

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