By MICHELLE HOLMES and WENDY CHEN |MAY 19, 2014
WE believe that it might be possible to treat breast cancer — the
leading cause of female cancer death — with a drug that can already be found in
nearly every medicine cabinet in the world: Aspirin.
In 2010, we published an observational study in The Journal of Clinical
Oncology showing that women with breast cancer who took aspirin at least once a
week for various reasons were 50 percent less likely to die of breast cancer.
In 2012, British researchers, by combining results from clinical trials that
looked at using aspirin to prevent heart disease, found that aspirin was also
associated with a significantly lower risk of breast cancer death.
And yet, until now, there have been no randomized trials (the gold
standard of research) of aspirin use among women with breast cancer.
It’s not hard to see why: Clinical trials are typically conducted on
drugs developed by labs seeking huge profits. No one stands to make money off
aspirin, which has been a generic drug since the Treaty of Versailles in 1919,
and which costs less than $6 for a year’s supply.
Thankfully, the first randomized clinical trial is now going on in
Britain, made possible by funding from a nonprofit group, Cancer Research UK.
But the British study is looking at four cancers, and won’t be done until 2025.
If we in the United States had funding to do a similar trial, we could combine
our data and get answers much faster. If the United States is to maintain its
role as the global leader in biomedical research, it must fund its own trial of
aspirin in breast cancer.
Aspirin was originally derived from willow bark, which has been used as
a painkiller since the time of Hippocrates. We don’t know exactly why it
appears to work in fighting cancer. Aspirin reduces inflammation, and that may
play a role in inhibiting the growth of tumors — perhaps by slowing the
development of new blood vessels that nourish them, or by fighting old cells
that keep growing when they should be dying off. It may also inhibit estrogen
production, and we know that estrogen fuels the growth of most (but not all)
breast cancers.
If we could prove that aspirin was an effective treatment in a clinical
trial, it would have major implications, especially for low-income patients.
Modern hormonal treatments, used after surgery to try to prevent cancer from
recurring, last a standard five years and can cost between $1,200 and $2,300 a
year. But not everyone who needs them is actually taking them. Higher co-pays
reduce the number of women who fill their prescriptions, according to a 2011
study.
And that is just in the United States. Africa, Asia and Central and
South America already account for more than 60 percent of the world’s cancer
cases and about 70 percent of cancer deaths, according to the World Health
Organization. The majority of the impact of the disease will be felt in those
areas in the coming decades. Aspirin’s minimal cost would make it available in
every country on earth, and for millions of women it could mean the difference
between some treatment and none.
It may also offer an alternative treatment to women who cannot tolerate
widely used cancer drugs because of debilitating side effects. For example,
Columbia University researchers found that half of breast cancer patients
taking hormonal treatments (specifically, tamoxifen and aromatase inhibitors)
were unable to take the drugs for the recommended five years. A survey by the
advocacy group Breast Cancer Action found that the predominant reason was joint
pain. The most serious possible side effects of taking aspirin are
gastrointestinal bleeding and stroke, but they are rare.
If aspirin truly works, we estimate that we could save 10,000 lives per
year in the United States, and 75,000 in the developing world.
It won’t take much to find out. A randomized study of approximately
3,000 women with Stage 2 and 3 breast cancer, lasting five years, would cost
around $10 million. (We wouldn’t study women with Stage 1 disease because they
have such a high survival rate already, nor women with Stage 4 cancer, because
there is not enough evidence that aspirin would help when the disease has
advanced that far.)
Although $10 million is a relatively small amount for a large
pharmaceutical company, it is too big for most federal grant mechanisms and
nonprofit foundations. Our repeated attempts since 2010 to seek funding through
federal grant mechanisms have been rejected.
Yet even as government funding for research is slashed, the government is
still willing to test new cancer drugs pushed by pharmaceutical companies,
despite very high failure rates for those drugs. Federal grant review panels
have no direct financial interest in the studies they approve for funding, but
inevitably they are seduced by the more novel treatments — the scientific
equivalent of the latest smartphone. And generic drugs, particularly ones as
old and familiar as aspirin, just aren’t sexy.
There’s a saying attributed to Hippocrates that extreme remedies are
appropriate for extreme diseases. But in the case of breast cancer, the most
simple of drugs may be the next great weapon.
Michelle Holmes and Wendy Chen are physicians and faculty members at
Harvard Medical School.
Source: http://www.nytimes.com/2014/05/20/opinion/a-cancer-treatment-in-your-medicine-cabinet.html?contentCollection=opinion&action=click&module=NextInCollection®ion=Footer&pgtype=article
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