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The drawbacks of a miracle drug Add to ...

Nathalie Le Prohon was president of Nokia Canada, leading a team of senior executives in 2004, when a tumour the size of a quail egg was found in her breast. When it seemed the news couldn't could get any worse, it did: The cancer had invaded 10 out of 14 lymph nodes.

“My prognosis was a 40 per cent chance of survival for five years,” says the Montreal resident. Her son and daughter were aged 10 and 5 at the time.

A warrior in the executive suite, Ms. Le Prohon soon became one in the cancer ward, too. She pushed for quicker mammograms and more timely chemotherapy. And when she couldn't obtain the latest wonder drug, Herceptin, in Canada, she also pushed to get that funded.

Herceptin had been found, when used with chemotherapy, to halve rates of recurrence within four years of diagnosis for women who have HER-2 (human epidermal growth factor receptor type 2) breast cancer, which affects 20 to 25 per cent of patients. But it came with a not-so-wonderful price tag – roughly $40,000 for a year's worth of treatment.

At the time Ms. Le Prohon needed it, in late spring 2005, only those dying of cancer – not those who potentially could be cured of it – could receive the drug. (Cancer drugs are always tried in metastatic patients first. If the treatment improves survival, it's opened up to those who can be cured.) When she and women like her told their stories, it helped pressure provincial governments to fast-track approval, which came later that year.

Estimates show that since Herceptin was approved for those with potentially curable cancer, hundreds of Canadian women – and thousands across North American – have avoided recurrences each year.

But now, five years later, the researcher who developed this revolutionary drug is suggesting that the way it's currently used in Canada may be doing more harm than good.

California researcher Dennis Slamon developed Herceptin after more than a dozen years pursuing why the HER-2 mutation of breast cancer was particularly difficult to treat. Unlike chemotherapy, which destroys both good and bad cells, Herceptin, a monoclonal antibody, specifically targets the receptor of HER-2 and stops or slows the growth of those cells. A book and movie have depicted his quest.

Today the intense but affable Dr. Slamon is trying to change the behaviour of his fellow oncologists. He says that heart problems detected in some patients during the drug trial, which were expected to fade, turn out to persist when Herceptin is used with a particular kind of chemotherapy.

“It's very controversial,” says the director of clinical and translational research at the Jonsson Comprehensive Cancer Center in Los Angeles. “But I am convinced that we're right and the data support what we say.”

Dr. Slamon says breast-cancer patients are risking heart problems when prescribed a combination of Herceptin and anthracycline chemotherapy – and that they need not be. In his study, one out of 50 patients on that regimen developed congestive heart failure, as compared to one out of 250 when Herceptin was used with non-anthracycline drugs. (Anthracyclines are a type of antibiotic that kills cancer cells by damaging their DNA.)

He says he stopped using the more toxic remedy two-and-a-half years ago and switched to approaches that offer just as good a chance of disease-free survival, but with fewer side effects.

The U.S. Food and Drug Administration seem to agree with his approach. It approved two non-anthracycline treatment plans to be used with Herceptin. Today, an estimated 60 per cent of new patients in the U.S. with potentially curable HER-2 breast cancer (that is, cancer that has not spread) are provided with the new, less-toxic treatment.

In Canada, it's a different story. Many patients may not be given the option. That's because not all oncologists are convinced they should scrap the use of anthracyclines with Herceptin: Some still believe it provides a survival benefit.

In general, doctors are hesitant to switch away from effective treatments until research to the contrary has been printed in peer-reviewed journals. Dr. Slamon has presented his findings to conferences but not yet published.

“Although Dr. Slamon may feel that the issue is clear, the majority of academic oncologists in the world do not agree,” says Karen Gelmon, co-chair of the Breast Site Committee of the NCIC (formerly National Cancer Institute of Canada) Clinical Trials Group. “There are options for treatment which include anthracyclines and options that do not.”

British Columbia has one of the most forward-looking approaches, allowing for either regimen to be used, depending on the patient's tumour and risk factors.

“Personalized medicine is in its infancy,” says Dr. Gelmon, “but we are trying to do what we can and prescribe according to the individual, what appears to be optimal for that individual.”

Behind the pink ribbon

Herceptin isn't an isolated case. As cancer has transformed in many cases from a killer to a chronic disease, long-term side effects are being noted for many drugs – simply because patients live long enough to describe them.

And even without complications, the extended survival Herceptin makes possible comes with other costs. Cancer does not end when treatment does, yet a public bombarded by inspirational stories has expectations of what a survivor should be.





At age 40, Leslie Cowan was diagnosed with stage-3C cancer – the nearest curable step to the fatal stage 4. The culprit was a tumour roughly the size of an apricot.

Now 46, she sits in her sister's home in Toronto, where she's visiting from Calgary, looking remarkably healthy and fit, a black sweater and pants over her petite frame.

Ms. Cowan has lost a right breast and two ovaries, endured chemotherapy, radiation treatment and a reconstruction. When she, like thousands of others, fell outside the Herceptin treatment gap in the spring of 2005, her daughter Samantha wrote a letter to then-Ontario Health Minister George Smitherman, explaining that her mother needed the drug to live. Ms. Cowan's son, Sean, presented his mother with his piggy-bank money.

At the time, Herceptin was available in the United States for a price. So Ms. Cowan drove to Buffalo and paid out of pocket for two treatments. Later that summer, when Alberta approved the drug for funding, she was invited to the press conference, and became one of the first to receive it.

With her treatment behind her, Ms. Cowan says she no longer looks like a cancer patient – but she still sometimes feels like one. “What I find is when you're bald or you look sick, people are great, they bring you dinner,” she says. “The minute you start to look good, people think, ‘You're fine.' That's when you need the support the most. And there's nowhere to go.”

She became obsessed for a time with making the most of her reprieve from death, perhaps by climbing a mountain or working in an orphanage in a developing country.

“I feel like I failed Cancer 101. I got one shot at it. I didn't climb Kilimanjaro. I haven't written a book,” says Ms. Cowan, who used to work in fundraising and public relations. “There's this pressure to do something spectacular with your life because you have cancer. It didn't result in some greater meaning for me.”

It's hard to escape those expectations. Each October, in Breast Cancer Awareness Month, an avalanche of pink products hits shelves – ribbons, hats, T-shirts and blenders. Inspirational stories fill papers and magazines.

For Ms. Cowan, there was fallout: Her marriage faltered and she sought the help of a psychiatrist.

Last June, lesions were found on the bottom of her lungs and liver. The bumps are too small to biopsy, so a PET scan this spring is expected to provide more information. It could be benign, but as a cancer patient, there is always the worry of the disease returning.

“You hope it's nothing but they don't really know,” she says. “I don't know why I feel I need to give back to something that took so much. I don't care how many people say it made their life better. I don't believe that.”

The icon of the cancer superhero creates stress for patients, and while it may help society feel more comfortable with the disease, Joyce Bichler, deputy director of the San Francisco-based organization Breast Cancer Action, points out: “We don't want to be comfortable with cancer. Cancer sucks.”

There are no guarantees

When Donna Denison needed Herceptin, at age 62 in the spring of 2005, she had to wait for its approval in Ontario, which came just in time that summer. These past five years have brought her two new grandchildren.

Her friend, Sue Cortlett, also received Herceptin in 2005, but was not as lucky. She died in September, 2008, of a recurrence of the disease.

“I can be philosophical – on a good day, we really have such limited control over our affairs,” Ms. Denison says. “But when push comes to shove, what we want is more and not all of us are going to get it.”

For Nathalie Le Prohon, the one lesson she can impart from the Herceptin campaign is that patients must be their own best advocates.

“I truly believe I am alive because of all of this,” said Ms. Le Prohon, 47. “I was always an extremely busy, career woman who gets results. So I attacked the cancer the same way.”

She paid $13,000 (U.S.) to obtain two treatments in Buffalo. And she was one of the first women to get the drug when it was funded in Ontario.

Today, her life is focused on advocacy rather than swinging big business deals: She does charity runs, fundraises for children's schools and is chair of the Quebec Breast Cancer Foundation, and has considered running as a Liberal candidate for parliament.

Though Herceptin helped Ms. Le Prohon make the best of her cancer experience, she says, it was by far the hardest thing she has ever done.

“Every time I go for a new mammogram, the worry creeps in again. You have to live with that all your life. You are never cancer free. You are always thinking: ‘When will the beast return?'”

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