Health
A major federal study led by the Department of Veterans Affairs found no difference in survival between men with early-stage prostate cancer who had their prostate surgically removed and those who were simply watched by their doctors, with treatment only as needed to address symptoms if they occurred.
“The study results have significant implications for a great number of Veterans in our care,” said Secretary of Veterans Affairs Eric K. Shinseki. “This study is a prime example of how VA’s research program is advancing medical knowledge in areas that are top priorities for Veterans.”
The findings appeared in the July 19 issue of the New England Journal of Medicine.
“Our data show that observation provides equivalent length of life, with no difference in death from prostate cancer, and avoids the harms of early surgical treatment,” said lead author Dr. Timothy Wilt.
Wilt is with the Center for Chronic Disease Outcomes Research at the Minneapolis VA Medical Center, and the University of Minnesota.
The randomized trial involved 731 men and took place at 44 VA sites and eight academic medical centers nationwide.
Eligible trial participants voluntarily agreed beforehand that to take part in the study they would be randomly assigned to one treatment or the other.
Known as the Prostate Cancer Intervention Versus Observation Trial, or PIVOT, the study was conducted and funded by VA’s Cooperative Studies Program, with additional funding from the National Cancer Institute and the Agency for Healthcare Research and Quality.
The first trial group had a radical prostatectomy – surgical removal of the walnut-sized prostate.
Surgery is generally performed in the belief it can lower the risk of prostate cancer spreading and causing death.
Evidence had been lacking as to the treatment’s effectiveness, especially for men whose cancer was initially detected only on the basis of a blood test – the prostate specific antigen (PSA) test.
In most cases, these tumors are not large enough to be felt during a doctor’s exam and do not cause any symptoms.
The second trial group was the “observation group.”
In this approach, physicians generally do not provide immediate surgical or radiation therapy. Rather, they carefully follow men and provide treatments aimed at relieving symptoms, such as painful or difficult urination, if and when the cancer progresses and causes bothersome health problems.
The trial followed patients between eight and 15 years.
When Wilt and colleagues analyzed the results, they found no difference in death rates between the two groups, either from any cause whatsoever or specifically from prostate cancer.
In terms of quality of life for men in the study, the surgery group experienced nearly double the rate of erectile dysfunction – 81 percent versus 44 percent – and roughly three times the rate of urinary incontinence – 17 percent versus 6 percent. Bowel dysfunction was similar between the groups, 12 percent versus 11 percent.
Dr. Robert A. Petzel, Under Secretary for Health, said the trial “provides crucial information that will help physicians and patients make informed decisions on how best to treat prostate cancer, which affects so many Veterans who rely on VA health care.”
Dr. Joel Kupersmith, VA’s Chief Research and Development Officer, added: “This trial, the largest ever comparing these two treatments, provides definitive evidence on a subject that affects millions of Veterans and all men above a certain age.”
While PIVOT found no difference in overall mortality or prostate cancer deaths between the two groups for men who had cancers with a PSA value of 10 or less, the authors say there may be a survival benefit to surgery for men with PSA scores above 10, or other clinical results indicating more aggressive, higher-risk tumors.
Only about one in five men in PIVOT had tumors classified as high-risk. Wilt said this proportion is representative of U.S. men with an early-stage prostate cancer diagnosis based on PSA testing and follow-up biopsy.
Prostate cancer is usually slow-growing, and most men with PSA-detected prostate cancer do not die from the disease or develop health problems related to it, even if it is not treated with surgery or radiation.
For more information on the Cooperative Studies Program and VA research overall, visit www.research.va.gov .
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Forty-seven million women are getting greater control over their health care and access to eight new prevention-related health care services without paying more out of their own pocket beginning Aug. 1, 2012, Health and Human Services (HHS) Secretary Kathleen Sebelius announced.
Previously some insurance companies did not cover these preventive services for women at all under their health plans, while some women had to pay deductibles or copays for the care they needed to stay healthy.
The new rules in the health care law requiring coverage of these services take effect at the next renewal date – on or after Aug. 1, 2012—for most health insurance plans.
For the first time ever, women will have access to even more life-saving preventive care free of charge.
According to a new HHS report also released today, approximately 47 million women are in health plans that must cover these new preventive services at no charge.
Women, not insurance companies, can now make health decisions that will keep them healthy, catch potentially serious conditions at an earlier state, and protect them and their families from crushing medical bills.
“President Obama is moving our country forward by giving women control over their health care,” Secretary Sebelius said. “This law puts women and their doctors, not insurance companies or the government, in charge of health care decisions.”
The eight new prevention-related services are:
- Well-woman visits.
- Gestational diabetes screening that helps protect pregnant women from one of the most serious pregnancy-related diseases.
- Domestic and interpersonal violence screening and counseling.
- FDA-approved contraceptive methods, and contraceptive education and counseling.
- Breastfeeding support, supplies, and counseling.
- HPV DNA testing, for women 30 or older.
- Sexually transmitted infections counseling for sexually-active women.
- HIV screening and counseling for sexually-active women.
The health care law has already helped women in private plans and Medicare for the first time gain access to potentially life-saving tests and services, such as mammograms, cholesterol screenings, and flu shots without coinsurance or deductibles.
The announcement builds on these benefits, generally requiring insurance companies to offer, with no copay, additional vital screenings and tests to help keep women healthy throughout their lives.
These services are based on recommendations from the Institute of Medicine, which relied on independent physicians, nurses, scientists, and other experts as well as evidence-based research to develop its recommendations.
These preventive services will be offered without cost sharing beginning today in all new health plans.
Group health plans and issuers that have maintained grandfathered status are not required to cover these services.
In addition, certain nonprofit religious organizations, such as churches and schools, are not required to cover these services.
The Obama administration will continue to work with all employers to give them the flexibility and resources they need to implement the health care law in a way that protects women’s health while making common-sense accommodations for values like religious liberty.
For women who are pregnant or nursing, the new preventive services include gestational diabetes screening as well as breast-feeding support, counseling and supplies.
Health services already provided under the health care law include folic acid supplements for women who may become pregnant, Hepatitis B screening for pregnant women, and anemia screening for pregnant women.
Women Medicare beneficiaries may already receive such preventive services as annual wellness visits, mammograms, and bone mass measurement for those at risk of osteoporosis and diabetes screening. Approximately 24.7 million women with Medicare used at least one free preventive service in 2011, including the new annual wellness visit.
Men and children are also able to take advantage of preventive services at no extra charge under the health care law. These services include flu shots and other immunizations, screenings for cancers, high blood pressure and cholesterol, and depression.
To learn more about the health care services you may be eligible for at no extra charge under the Affordable Care Act, go to http://www.healthcare.gov/prevention .
For information about the U.S. Department of Health and Human Services report on the number of adult and adolescent women eligible for the preventive services at no charge after Aug. 1, 2012, see http://aspe.hhs.gov/health/reports/2012/womensPreventiveServicesACA/ib.shtml .
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