AAJ's
Keep Our Families Safe: Consumer News For Families
Newspaper Columns
Breast Cancer Awareness
[Column 359, October 17, 2005] | Archived
Columns
By Ken Suggs*
October is National Breast Cancer Awareness Month. All the pink,
looped ribbons you see throughout the year—and especially this
month—are out there for a reason: In 2005, an estimated 212,000
new cases of invasive breast cancer and 58,000 cases of non-invasive
(non-spreading) breast cancer will be diagnosed. And, this year 40,000
women will likely die from this disease.
There are many factors that contribute to whether a woman will develop
breast cancer, such as her age or whether there is a history of the
disease in her family. For other women, breast cancer may have been
triggered by other causes such as the use of hormone-replacement therapy
(HRT) during menopause.
Specifically, these are women who took a combination of manufactured
estrogen and progestin in a pill called Prempro. Many women now want
to know why the drug manufacturer, Wyeth, did not do a long-term,
randomized study to test for cancerous side effects before putting
the drug on the market.
"The drug makers knew back in the 1970s that women on estrogen
alone had higher risk of uterine cancer," says James Ronca, a
Pennsylvania lawyer who represents women in their cases against Wyeth.
Researchers found a way to prevent uterine cancers by giving women
estrogen plus progestin, says Ronca, but, when Wyeth combined the
two hormones into one pill -- Prempro -- and put it on the market
in 1995, the company "never tested the long-term effects to show
if the drug combination would also be a risk."
There had been earlier studies that suggested risks and benefits
of hormone therapy, but, no long-term study of combination HRT until
the Women's Health Initiative (WHI, funded by the National Institutes
of Health) started tracking the effects of Prempro in the late 1990s.
In July 2002, the study was halted prematurely after researchers
noticed that far more women who took Prempro developed breast cancer
than the women who took a placebo (inactive pill). The cancers found
in women on HRT were "larger and had spread more throughout the
body than those in the placebo group," according to the WHI.
Overall, there was a 24% increase in the risk for breast cancer due
to combination HRT.
"Much less was known about progestin or the estrogen plus progestin
combination," said principal WHI investigator Marcia L. Stefanick,
Ph.D., at the press conference announcing the study's end. "The
bottom line is that none of these earlier studies was able to provide
the definitive answers about the overall balance of risks and benefits
that we now have in the WHI study."
The study also found that women on combined HRT were more likely
to have abnormal mammograms. Of Prempro users, 9.4 percent had an
abnormal mammogram after one year, compared with 5.4 percent of women
on placebo. Risk of abnormal mammograms went up as Prempro use continued,
from about 1 in 25 women after one years use, to about 1 in 10 women
after 5.5 years of use.
WHI investigators also determined that combination HRT caused a significant
increase in the risk of heart attacks (29%), blood clots (100%), and
cardiovascular disease (22%).
HRT studies were halted in 2003 in the United Kingdom and in 2004
in Sweden, also due to concerns of increased risk of breast cancer.
The attorneys who represent injured people say they see a repeating
pattern, whether its Prempro, Vioxx, Bextra or other products: not
enough testing to make sure a drug is safe before it hits the market.
"There should be more emphasis on safety and less emphasis on
speed of [drug] approval," says Pennsylvania attorney Michael
Monheit. "I have no problem with expediting approval for drugs
for cancer and other deadly diseases. Menopause is not a disease."
Monheit would like to see the U.S. Federal Drug Administration (FDA)
make some changes so that the approval process is completely separate
from the monitoring process. Other wishes on Monheit's and Ronca's
list include: drug promotion solely for the FDA's specified and approved
use; full disclosure to the public if drug companies provide money
to sponsor medical education seminars or studies; and design and approval
of all studies by an independent organization.
Says Ronca, "Independence is the key when it comes to people's
health."
Prempro is still on the market. The FDA has approved lower doses
of the drug and now requires all estrogen and estrogen plus progestin
products to include "black box" labels to warn of the products'
risks that were uncovered in the WHI study.
For more information on National Breast Cancer Awareness Month please
see:
www.nbcam.org.
For information about the Women's Health Initiative, see http://www.whi.org.
For HRT information from the FDA, see: http://www.fda.gov/bbs/topics/NEWS/2004/NEW01022.html
*Ken Suggs, president of the American Association for Justice, is a partner in the Columbia, SC, law firm of Janet, Jenner
& Suggs.
|
