Can Aspirin treat breast cancer? Why aren't we trying to find out?
With no lucrative patent to be had, drug companies are reluctant to fund costly trials
When something belongs to everyone, like the sun, or the air, it has no market value. This is also true for the bark of the willow tree.
If no one owns it, then no one can sell it. And if no one can sell it, then who will invest the money to find out if it can treat breast cancer and save thousands of lives?
This is the dilemma confronting Dr. Michelle Holmes, a Harvard University researcher who believes that she has observed a chemical from the willow tree that looks to be doubling the survival rate from breast cancer.
The chemical is salicylic acid, modified into acetylsalicylic acid, pressed into a familiar white tablet and sold for more than a century as Aspirin.
Of course, some companies, notably Bayer, did make a fortune from the sale of Aspirin over the decades.
But its patent has long expired, which means its coffer-filling, block-buster days are over. And that's a problem for researchers who believe this humble drug might be harbouring unrecognized cancer-fighting properties.
Using data from the long-running Nurses' Health Study, Dr. Holmes identified more than 4,000 women with breast cancer, who had already undergone normal treatment, including surgery, chemotherapy and radiation.
She compared the death rate with the amount of Aspirin they had taken for other reasons — such as for pain, or the prevention of heart disease — and found that women who reported taking Aspirin were 50 per cent less likely to die from their cancer than the women who did not take Aspirin or its generic form, ASA.
It was a stunning result, and Dr. Holmes was both amazed and skeptical. There are dozens of possible confounding factors that might be clouding the truth in a study like hers.
The only way to conclusively answer the compelling question — can one Aspirin a day keep breast cancer away? — is through a proper randomized controlled clinical trial, comparing Aspirin with a placebo.
The cost of asking
But that kind of study would cost at least $10 million, and so far Dr. Holmes has been turned down four times by the U.S. federal funding agencies.
More disheartening, because there is no patent any longer on the willow tree or its compounds, and thus no opportunity to make a serious profit, no big drug company will take on that kind of investment themselves.
So, Dr. Holmes wrote an op-ed column in the New York Times, telling the world what it might be missing: a low-cost cancer drug that could save thousands of lives every year, especially in developing countries where women don't have access to the expensive new therapies.
Her column prompted a response to the New York Times from John LaMattina, the former head of research and development for Pfizer, one of the world's largest pharmaceutical companies. LaMattina also wrote a blog about the issue for Forbes Magazine.
LaMattina was irritated that Holmes, like others, seemed to be blaming the drug companies for these kinds of roadblocks, when governments could fund this research.
Although he admits that no drug company would invest in an Aspirin trial because it just wouldn't make good business sense.
I asked him if he could think of some way to make Aspirin profitable again, and he just shook his head.
Aspirin is not the only fading medical wallflower that might have secret anti-cancer superpowers.
Open the medicine cabinet, and there are a series of common generic drugs that show tantalizing cancer-fighting properties, including beta blockers, statins and anti-diabetic medications.
And Dr. Holmes is not the only scientist to get caught in the vacuum of how to test these theories. Here in Canada, for example, it took 10 years to cobble together the money to test the breast cancer-fighting ability of a common diabetes drug.
At Toronto's Mount Sinai Hospital, Dr. Pam Goodwin noticed that women with breast cancer as well as high insulin levels had poorer outcomes. She knew the drug, metformin, could lower insulin levels, and she wanted to see if that, in turn, could improve breast cancer outcomes.
In the beginning, one drug company almost came through with the money, she told me. But when it realized its remaining patent would expire before Dr. Goodwin had her answers, and with it the opportunity for profit, it pulled out.
That started her on a 10-year search for money to do the trial. She was turned down flat by the Canadian Institutes for Health Research, the federal medical science funding agency, though she has received some research money from the U.S. government, the Canadian Cancer Society and some U.S. cancer charities.
In her case, she feels lucky to have found a generic drug maker to donate the individual pills and the look-alike placebos. But she has had to find additional funding to cover the costs of shipping the pills, and moving blood and tissue samples from the research sites back to her lab.
In all, it's been an exhausting $30-million fund-raising effort that has only been made possible, she says, by the overwhelming pile of evidence that has been built up for metformin's anti-cancer effects.
That evidence has come from animal models and cell studies, and from scientists working in the corridors of basic science. Dr. Goodwin says the role of Aspirin in cancer prevention still lacks that degree of scientific backing, but she feels the evidence is growing.
A shrinking pie
Still, the question is who will fund the basic science that in turn will provide the volume of evidence to put the Aspirin question at the top of the list for limited public money. Especially when the researchers who do the basic science are fighting their own battle for that same limited pile of money.
It's a problem, Dr. Goodwin said, because of the decreasing federal commitment to scientific research.
"The funding for biologic questions has diminished greatly," she said. "It's a travesty."
For John LaMattina, on the other hand, all of that missed opportunity is just a fact of life. As head of a major R & D department, he has had a long career of turning down good ideas. You can't fund everything, he says.
Besides, he argues, the system is working, pointing to a British trial just getting underway, funded by a non-profit group in the U.K.
It will be the first randomized trial of Aspirin and cancer, but it is looking at four cancers and will take 10 years to conclude.
If she could find the money, Dr. Holmes believes she would know whether Aspirin can prevent deaths from breast cancer in about half that time. But that's if she can find the money.