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Update: Klobuchar’s breast-cancer bill: a misguided effort?

Despite criticism from leading cancer scientists, Sen. Amy Klobuchar, D-Minn., appears to be continuing to work with Rep.

Despite criticism from leading cancer scientists, Sen. Amy Klobuchar, D-Minn., appears to be continuing to work with Rep. Debbie Wasserman Schultz, D-Fla., to move a controversial breast cancer bill through Congress.

Announced in March, the Education and Awareness Requires Learning Young (EARLY) Act would allocate $45 million to the Centers for Disease Control and Prevention to implement a national education campaign to increase breast-cancer awareness among young women.

Breast cancer is the leading cause of cancer deaths in women under the age of 40. More than 10,000 women in this age category are diagnosed with breast cancer in the United States annually (compared with 192,000 cases diagnosed among all age groups). This year, about 40,000 American women — 1,000 in the under-40 age group — will die from the disease.

First, do no harm
With so many women developing this potentially deadly disease, what could possibly be wrong with a breast cancer educational effort aimed at young women?

A great deal, say some experts. Here’s what Leslie Bernstein, a breast-cancer epidemiologist and director for cancer etiology at City of Hope, a National Cancer Institute-designated comprehensive cancer center in Duarte, Calif., wrote in an April 7 letter to Klobuchar:

This proposed bill does too much HARM! It sounds wonderful on the surface, but cannot help reduce the burden of breast cancer in young women or in women of intermediate ages. It takes for granted that risk factors for breast cancer in young women are firmly defined and are modifiable. I have spent nearly 30 years working to define novel breast cancer risk factors. What we know cannot be translated into appropriate action on the part of young women. Those risk factors which apparently affect young women (whom the bill defines as ages 15-39 years) are not modifiable. We cannot change them.

And here’s what The National Breast Cancer Coalition, a nationwide breast-cancer advocacy group, wrote in their analysis of the proposed legislation:

It is laudable that Congress continues to care deeply about breast cancer and strives to address it. However, it is vital that Congressional action is the right action that helps and does not harm the public and is a responsible use of federal funding and outreach. Unfortunately, the bill at issue is based on several false premises, contains incorrect information, and will not achieve these goals. The bill is addressed to a population of women in whom breast cancer is exceedingly rare, and presumes we know what to tell these women about prevention, risk reduction and early detection. We do not.

Otis Brawley, chief medical officer of the American Cancer Society (ACS), has also tried to dissuade Klobuchar and Wasserman Shultz from sponsoring the EARLY Act. In a letter to ACS volunteers he explained his position on the bill:

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If implemented as written, [the EARLY Act] can actually cause harm. If implemented, a number of women will seek genetic testing and find out that they have “mutations of unknown significance.” Some of these women will seek a bilateral mastectomy. Many of these women will in reality have mutations of no significance, but our science cannot determine most of these yet. There are already scientific data to show that many women getting these messages will suffer significant emotional and mental harms.

Donald Berry, chairman of the Department of Biostatistics and Applied Mathematics at the M.D. Anderson Cancer Center in Houston, Texas, and a breast-cancer prevention expert, told Paul Goldberg, editor of The Cancer Letter, last April, “Much of this bill is misguided. I leave politics to the politicians. Why can’t they leave science to the scientists?”

A personal testimonial
Goldberg seems to have been the lone reporter covering scientific opposition to this bill. In an article published last Friday (hat tip, Gary Schwitzer at Schwitzer Health News Blog), Goldberg described a June 16 teleconference call organized by one of the bill’s primary advocates, the United Jewish Communities/Jewish Federations of North America. Both Klobuchar and Wasserman Schultz, who underwent a double mastectomy last year after being diagnosed with breast cancer, participated in the call, which was intended to build a groundswell of support for the legislation, particularly within the Jewish community. Breast cancer is of special concern to women of Ashkenazi Jewish heritage because of their increased risk of carrying a gene mutation for the disease.

Wrote Goldberg:

At the telephone conference, Wasserman-Schultz credited breast self-examination with saving her life….”I didn’t find my tumor early because of luck,” she said. “I found my tumor early because of knowledge and awareness. I knew that I should perform breast self-exams. I was aware of what my body was supposed to feel like.”

But, as Goldberg points out – and the experts concur – no evidence supports the effectiveness of breast self exams.

Here’s what NBCC wrote in its analysis:

There is no known effective method of detecting breast cancer in a healthy population of women under 40. Breast self examinations have been shown to be ineffective and potentially harmful [due to the fact that they trigger unnecessary breast biopsies]. … Spreading the message to the public that early detection is important in this age group would result in an extraordinary waste of funds, and unnecessary exposure to the health risks associated with the additional interventions.

An EARLY passage?

According to Goldberg, the EARLY Act has garnered 360 co-sponsors in the House of Representatives, more than enough to pass the bill once it reaches the floor. Co-sponsors have been more difficult for Klobuchar to amass in the Senate. So far, the Senate version has 14 co-sponsors, and, says Goldberg, “it’s by no means certain that the measure would get through committees now that skeptics have made their case increasingy public.”

I sought comment from Sen. Klobuchar and received this statement from Rose Baumann, health legislative aide:

The Senator supports this legislation and is working with the Senate committee and Congresswoman Wasserman Schultz to push this through the legislative process. We have met with individuals regarding their input on this legislation and will continue to work to address their concerns. The EARLY Act is supported by Susan G. Komen, breast cancer advocacy groups and has bipartisan support in Congress. We believe this bill will help provide women access to the best information and the best support possible to protect themselves against breast cancer. The bill now has 362 authors in the House and 15 authors in the Senate. We believe this bill should and will pass.