IOM Report - US Cancer Clinical Trials Network Has Broken

The latest news from the Institute of Medicine is a report about the dysfunctional NCI Clinical Trials Cooperative Group in the US, a topic breast cancer activists have been discussing for a while.

Below is the text of IOM's press release

Overhaul of NCI Cooperative Group Program Needed to Ensure

It Can Continue to Conduct Important Cancer Clinical Research

WASHINGTON -- Because a robust national clinical trials network is essential to achieving advances in cancer treatment and prevention, the National Cancer Institute (NCI) should preserve and strengthen the capabilities of the Clinical Trials Cooperative Group Program through an overhaul of its organization, management, and funding, says a new report of the Institute of Medicine. The program has been instrumental in establishing many therapies routinely used to treat cancer patients, said the committee that wrote the report. But it faces many difficulties at present that undermine its ability to facilitate the multi-institutional collaborations necessary to conduct large, late-stage trials that answer important research questions single institutions and the private sector cannot or do not tackle.


Inefficient processes for developing trials, complicated government oversight, and a lack of sufficient resources hinder the program's ability to efficiently and effectively design and conduct trials, the committee concluded. To reduce waste and streamline the program, the report calls for consolidating redundant administrative and support functions that are handled separately by each of the 10 cooperative research groups that comprise the program. It recommends strategies to more effectively incorporate scien­tific advances into clinical trials and a boost in funding and other incentives to encourage and support health professionals' participation in studies. And it urges public and private health plans to fully cover the nonexperimental costs of study participants' health care during trials to eliminate financial disincentives that lead patients to decline enrollment or to drop out.


"Cooperative group studies have steadily improved the care of cancer patients for more than 50 years, but the program is at a breaking point," said committee chair John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center in Houston. "Its effectiveness is being undermined at a time when the opportunity for improving cancer care has never been greater because of rapid advances in biomedical research. A few isolated or partial measures won't suffice. The program urgently needs changes across the board if it is going to continue producing the kind of studies necessary to answer crucial and fundamental questions about how to successfully treat and prevent cancer, which can't be answered through other means."


The Cooperative Group Program involves more than 3,100 institutions and 14,000 investigators who enroll more than 25,000 patients in clinical trials each year. Research by the cooperative groups has contributed to the introduction of treatments and drug indications that have led to improved survival for cancer patients.


Successful trials depend on sufficient involvement by physicians and other health professionals. Cancer care providers devote significant amounts of time and effort to recruit patients into trials and manage their care during the studies. Inadequate reimbursement and recognition for their efforts are increasingly deterring their willingness to initiate or participate in trials, the report concludes.


The committee called on NCI to increase the amount it reimburses clinicians for the costs of managing each of their patients in trials, and to pay for their time and effort spent on designing and carrying out clinical trials. Medical centers should take into account health professionals' participation in clinical trials during their consideration for tenure and promotions. NCI should establish a centralized credentialing system for investigators and sites that wish to participate in a national trials system to increase consistency across sites and eliminate the burden of recredentialing with different cooperative groups. This system also would provide a way to eliminate research sites with low levels of recruitment or inadequate data management capability.


Insurance providers' variable and uncertain coverage of patients' care during studies and overly restrictive eligibility criteria deter patient involvement in clinical trials. The committee called on public and private health plans to cover all nonexperimental costs of participation in clinical studies. Patient eligibility criteria should allow the broadest participation possible to facilitate more rapid recruitment and allow broader generalizations about study results to be made. Greater involvement by patient advocates could help facilitate this change, the committee added. Advocates can provide valuable input to study design and procedures, safety and confidentiality issues, and other factors important to potential research participants.


Funding for the Cooperative Group Program is lower now in inflation-adjusted dollars than it was in 1999, and constitutes less than 3 percent of NCI's total budget. Current funding is insufficient to support the number of trials the groups undertake, especially as trials are becoming more complex with a new focus on developing therapies tailored to the molecular and genetic characteristics of individual patients' cancers. NCI should allocate a larger portion of its research portfolio to the program, and if adequate funding is not available, cooperative groups should reduce the number of NCI-funded trials undertaken to a quantity that can be fully supported.


The report was sponsored by the U.S. Centers for Disease Control and Prevention, Food and Drug Administration, National Cancer Institute, American Society of Clinical Oncology, Association of American Cancer Institutes, and C-Change. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. A committee roster follows.

Link to Nature.com news story

Link to IOM Press Release


Link to IOM Report

Scholarships Available for National Breast Cancer Coalition Advocacy Conference May 22-25

NBCC and NOBCCF have scholarships available for area breast cancer activists who wish to attend NBCC's Annual Advocacy Training Conference in Washington DC.

Start Date: Saturday, May 22, 2010
End Date:   Tuesday, May 25, 2010

Address:
Renaissance Washington, DC Hotel
999 9th Street, NW
Washington, DC 20001
You can apply for NBCC's scholarship, covering registration and lodging expenses here .
Deadline to apply is April 2010, so hurry!

You can apply for NOBCCF's scholarship, covering travel expenses, etc. by sending an email to info@nobcc.org.  We'll send you an application to apply.  Deadline for NOBCCF's application is May 1, 2010.

Mathematical Theories of Cancer Metastasis

A recent article in Forbes magazine discussed Dr. Larry Norton's theories regarding cancer metastasis and "dose-dense" chemotherapy treatment. Dr. Norton is a leading breast cancer researcher at Memorial Sloan Kettering's cancer center.

A number of scientists continue to work on theories of cancer metastasis that use mathematical modeling in determining the cycle of how tumors "seed" distant metastasis and even "re-seed" the original tumor site.  Dr. Norton and others have used this knowledge to conduct research on the timing and dose of administering chemotherapy for more effective results. 

There's a lot more in the article, its a good read.

More info

FAQ's About New Guidelines for Breast Screening in Women under age 50

I was pleased to give a talk recently to the Wellness Council of greater Cleveland about the new guidelines for breast screening issued by the US Preventive Services Task Force.

Many women were understandably confused by conflicting news reports when the guidelines were issued last fall.  Fortunately, National Breast Cancer Coalition developed an excellent list of  frequently asked questions to help women understand the new guidelines and discuss them with their physician.  Following is a sample of just a few of the questions and answers. You can read the rest at this link.

What does the Task Force say about breast cancer screening?

On November 16, 2009, the Task Force released the following new guidelines for healthcare providers:

•    The Task Force does not recommend that women automatically begin mammography screening at the age of 40.  Instead the Task Force recommends that the decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take into account patient context, including the patient’s values regarding specific benefits and harms.
•    The Task Force recommends every other year screening mammography for women aged 50 to 74 years.
•    The Task Force concludes that there is not enough evidence to determine the harms and benefits of screening mammography in women over 74.
•    The Task Force recommends against healthcare providers teaching breast self-examination.
•    There was not enough evidence for the Task Force to make a recommendation on clinical breast examinations, digital mammography, or MRI

Does this mean that women in their 40s will not be able to get mammograms?

NO.  That is a misrepresentation of what the Task Force said.  The Task Force said that the decision to start regular mammography before age 50 should not be automatic but should be an individual decision and take into account the patient’s values regarding specific benefits and harms. It gives women more control over their health care decisions.

Has breast cancer screening had a significant impact on mortality from breast cancer?

No, over 40,000 women continue to die of breast cancer each year, despite the emphasis on breast cancer screening in our country.  To change this, we must address the facts about breast cancer and not simply accept what we want to believe.  The fact is that all breast cancers are not equal and that we don’t currently have tools for “early detection” that are good enough for the life-threatening breast cancers.

But doesn’t early detection save lives?

Not necessarily. Some breast cancers are slow-growing and have a good prognosis, whenever they are found, whether small or large.  Other breast cancers are aggressive and fast growing, and we don’t have the tools to catch them early enough or treatments that will work.

Why doesn’t mammography work as well for women in their 40s?

Younger women have more dense breast tissue, making mammography less accurate.  Also, mammography is better at detecting slower growing tumors more common in older women, than the fast-growing, aggressive tumors more often found in younger women.  And the balance of benefit vs. harm changes as women get older since the likelihood of breast cancer increases with age.  The disease is relatively rare in younger women.

But shouldn’t a woman in her 40s have a mammogram if she feels a lump?

Certainly. The Task Force recommendations are meant to be guidelines for broad public health policy for healthy women with no symptoms, and an average risk for breast cancer.  These guidelines are not meant for any woman with an increased risk or for any woman who feels a lump or change in her breast.  Women who have any concerns need to visit their doctors and may need diagnostic mammograms.  Mammograms taken to assess a problem are not the kind of mammograms we are talking about with these guidelines.

What’s the harm in trying to detect breast cancer early, even if our methods don’t work that well?

The harms from screening too early or too often include increased false positives, leading to increased imaging and radiation exposure, biopsies and scarring that can affect the accuracy of future mammograms, and anxiety.  There is also the harm of overdiagnosis of breast cancer.  This would involve treatment of cancers that would never be life threatening, and treatment of cancers that may regress, or go away on their own.  The treatments for breast cancer are not aspirin, they are toxic and can be life threatening; the scenario of overdiagnosis should not be taken lightly.

A mammogram/self examination found my breast cancer and I am alive today so these methods clearly work, right?

It is understandable that many people would think that they are alive today because their breast cancer was discovered through screening. But this makes many assumptions that just can’t be known, such as how life-threatening the cancer would have been, if the cancer may have regressed on its own, and whether the cancer would have been discovered in other ways and would have had the same prognosis. The point is, individual stories are not evidence of effectiveness.  Detection, screening, breast cancer…these are all very complicated issues.

Look at bone marrow transplant for breast cancer.  It seemed to make sense: if chemotherapy works, maybe even more chemotherapy would work better.  Bone marrow transplant is a method of giving patients lethal doses of chemotherapy, then replacing their bone marrow.  It was believed that level of dosing would kill all the cancer.  And in some cancers, usually blood based, it worked.  So women with breast cancer received this incredibly toxic treatment outside of clinical trials.  When the trials were actually performed and we had the scientific evidence, it showed that not only was bone marrow transplant not more effective than standard treatment, but it actually resulted in deaths from the treatment itself.  Health care should always be based on the highest level of scientific evidence or well designed studies to get that evidence.

Isn’t it better to give women a simple public health message?

These issues are complex. We would like it to be a simple message, but we also want it to be truthful. Women deserve the truth and are capable of understanding the facts and making their own decisions.

Aren’t these guidelines really about saving money?

These recommendations are not about saving money or about the current health care debate.  The Task Force began their review of breast cancer screening well over two years ago.  The recommendations and accompanying scientific literature were published in the Nov. 17 issue of Annals of Internal Medicine.  The recommendations were made by scientists and physicians based on a systematic review of the evidence of the benefits and harms and an assessment of the net benefit.  There were no economists involved and the recommendations were not based on considerations of cost. 

The full list of FAQ's is very helpful and informative, so please make sure to read all of them. You can download your own copy at NBCC's site and share it with your friends and family.  Here's the link.

Please also take a moment to review NBCC's detailed analysis of the USPSTF recommendations and learn more about the importance of high quality scientific evidence in  developing health guidelines for breast screening.  Link to NBCC analysis

New Way to Predict Breast Cancer's Response to Anthracyclines

Researchers have discovered a new way to detect which breast cancers will respond to chemotherapy with anthracyclines.   The research was recently presented at the European Breast Cancer Conference.  To date, there has been no reliable means of detecting which kinds of breast cancer would respond to the drug.

Researchers conducted a meta-analysis of four large breast cancer trials that included over 3,000 patients. They found that patients with an abnormality on chromosome 17, or CEP 17, treated with anthracycline therapy were 2/3 more likely to have disease free survival and less likely to have recurrence of disease.

Even more encouraging, the test for CEP17 abnormality can be done with the same test used to detect Her2neu susceptibility - a test most breast cancer patients routinely receive.

Read more

Link to Abstract

Questioning Breast Cancer Marketing

A recent article from Canada expresses the growing concern among breast cancer survivors about the movement of breast cancer from being a serious disease to simply a tool to sell products.

The over-emphasis on using breast cancer to sell products changes the focus on which solutions are best in dealing with the disease

In her book Pink Ribbons Inc, Samantha King points out that "it's unlikely that the battle against breast cancer will be won so long as it is approached as a single-issue problem that is unrelated to other health conditions or to broader social issues. Large, corporate-funded, single-issue foundations have come to dominate health advocacy and, as a result, questions related to universal healthcare, discrimination, or the impact of the environment on disease have been pushed to the margins."

Straight Goods - Think before you pink - Breast cancer is a disease, not a marketing opportunity.

Using pink ribbbon marketing to raise "awareness" and focus only on screening is a simplistic solution that could do more harm than good.

House Passes Health Care Reform Bills

We did it!  Thanks so much to our northern Ohio breast cancer activists for all your help making calls, sending emails and lobbying on Capitol Hill.  Your work was incredibly important in gaining passage of this historic legislation.

We began our work on health care reform in 2001.  At a time when most others didn't understand the need for health care reform, breast cancer activists knew all too well that women were losing the battle against this disease simply because they lacked access to timely, affordable screening and treatment.

Thanks so much to National Breast Cancer Coalition for all their hard work over the years in both policy analysis and development as well as legislative action. Thanks also to key northern Ohio leaders in Congress like Sen. Sherrod Brown, Rep. Dennis Kucinich, Rep. Stephanie Tubbs Jones, Rep. Tim Ryan and Rep. Betty Sutton who didn't need to be persuaded to understand the health care crisis breast cancer survivors faced and the utter futility in "finding a cure" when so many patients had no access to treatment. Like us, they awoke every day thinking of what they could do to solve this problem.

The effort for affordable, quality health care for all isn't complete. The Senate still has legislative fixes to pass and there are many improvements needed to ensure cost control, patient protection and adequate enforcement of regulations.   But we're well on the way to our goal of affordable, quality health care for all.  So let's celebrate!