Archive for June 5th, 2006
Washington.– A vaccine that blocks viruses that cause most cervical cancer is safe and effective and should be approved, a federal panel recommended Thursday.
The drug maker said the vaccine could slash global deaths from the No. 2 cancer in women by more than two-thirds.
A Food and Drug Administration advisory committee voted 13-0 on five separate times to endorse Merck and Co.’s Gardasil. The anticipated cost of the vaccine, administered in three shots over six months, is $300 to $500 — a possible impediment to widespread vaccination campaigns.
The drug protects against the two types of human papillomavirus (HPV) believed responsible for about 70 percent of cervical cancer cases. The vaccine also protects against two other virus types that cause 90 percent of genital wart cases. All four virus types are sexually transmitted.
The FDA is not required to follow the recommendations of its outside panels of experts, but usually does. An agency decision is expected by June 8.
HPV is the most common sexually transmitted disease. It affects more than 50 percent of sexually active adults. The cervical cancer it can cause kills each year about 290,000 women worldwide, including 3,500 women in the United States, where regular pap smears often detect precancerous lesions and early cancer.
“This is certainly a wonderful, good step in addition to our screening processes” in helping eradicate cervical cancer, said Dr. Monica Farley, who heads the advisory panel. She is a bacterial infectious disease expert at the Emory University School of Medicine.
Making their case for approval, Merck officials suggested that development could make Gardasil the biggest advance in preventing cervical cancer since the pap test.
“Gardasil has the potential to meet an unmet medical need as the first vaccine to prevent cervical cancer,” Merck’s Dr. Patrick Brill-Edwards told the Vaccine and Related Biological Products advisory committee.
Several speakers said the vaccine should not replace screening. Merck said the drug is not intended to do that.
“We would like to see the FDA mandate some sort of labeling or other mechanism to communicate to health care providers and patients the continued need for regular cervical screening,” said Amy Allina, program director of the National Women’s Health Network.
Merck said the vaccine could be used in females age 9 to 26, but would work best when given to girls before they begin having sex.
Pending action by the FDA, the national Advisory Committee on Immunization Practices will decide in June whether to endorse routine vaccination with the vaccine.
The committee’s HPV vaccine group is recommending giving the vaccine to girls 11 and 12. The 15-member committee of experts who advise the government will consider recommendations for females 13 to 26.
The committee’s HPV vaccine workgroup is recommending the vaccine be given to girls 11 and 12, and the committee will consider recommendations for females 13 to 26.
Early opposition to Gardasil was based on concerns it could encourage sexual activity in the young. But that largely faded away because of vaccine’s potential for reducing cancer.
FDA reviewers said Gardasil appears safe and effective, according to agency documents. One agency reviewer, Dr. Nancy Miller, told the advisory committee that Merck submitted data to support the use of the vaccine in females 9 to 26.
Miller said Gardasil does not necessarily protect against one or more of the four viruses in people already infected before they get the vaccine, and can increase their risk for precursors to cervical cancer.
Also, the drug does not protect against infection from the many other virus strains not included in the vaccine. In addition, the FDA staff highlighted five cases where children with birth defects were born to women who received the vaccine around the time of conception. Merck, based in Whitehouse Station, N.J., developed the vaccine and tested it in more than 27,000 females and males.
Thursday’s discussion focused on its use in preventing HPV-related disease in girls and women, including those as young as 9. But only 250 9-year-old girls and boys received Gardasil in trials.
June 5th, 2006
Toronto.–
Many survivors of childhood cancer are not getting the optimal follow-up care recommended for detecting the long-term consequences of cancer treatment, according to a study of Canadian patients.
Though the majority of children and teenagers with cancer can be cured, they still face a risk of long-term, or “late,” effects from the drugs and radiation used to fight the cancer.
These effects vary widely and depend on a number of factors, such as the type of cancer and the type and duration of treatment. But they can include anything from problems with memory, attention or intellectual ability to damage to the heart, lungs or other organs. Treatments for certain cancers may harm hearing or vision, while some can affect future fertility.
Childhood cancer survivors are also at greater-than-average risk of developing a second cancer later in life.
Because of all these potential health threats, experts advise patients to regularly see a specialist trained in the long-term care of childhood cancer survivors.
Of the more than 2,000 survivors in the new study, the majority said they’d seen a general practitioner in the past year, but only 29 percent had been to a cancer specialist.
This suggests that the “large majority of survivors may not be receiving optimal care,” the study authors, led by Amanda K. Shaw of the Public Health Agency of Canada, report in the journal Cancer.
The reasons for the lapse are not clear. But, the researchers note, the findings are “strikingly similar” to what’s been seen in the U.S., despite Canada’s universal healthcare coverage.
The study included 2,152 childhood cancer survivors who ranged in age from 6 to 37, and a comparison group of healthy individuals matched to patients by age and sex. The groups were similar in the percentage who’d seen a general practitioner in the past year, at about 70 percent.
Among cancer survivors, less than one-third said they’d seen an oncologist during the previous year, with the likelihood diminishing as patients grew older — at exactly the time, Shaw and her colleagues write, that the risk of health problems and death go up.
Other studies, the researchers note, have found that cancer survivors are often unaware of the details of their treatment and the potential long-term health risks.
June 5th, 2006
Los Angeles.– A rare germ that killed four California women who took the abortion pill RU-486 has been implicated in the deaths of even more women following childbirth or miscarriage, broadening the debate beyond abortion on the eve of a meeting to examine the bacterial mystery.
While the abortion link has grabbed the most attention, Clostridium sordellii has killed at least 11 other women, women’s health experts said in interviews.
That’s more than twice as many as have died of infection after taking the abortion pill, also called Mifeprex or mifepristone.
The numbers suggest the bacterium’s threat, while still limited, could be broader than previously thought.
“That’s a critical question: Is this association between use of Mifeprex and infection with C. sordellii … or is it something more general?” asked Susan Wood, the former top women’s health official at the Food and Drug Administration. She thinks it’s the latter.
Scientists from the Centers for Disease Control and Prevention, National Institutes of Health and FDA are meeting Thursday in Atlanta to decide what research is needed to better understand the emerging threat posed by C. sordellii and a second bacterium, Clostridium difficile. The second germ is not linked to the abortion pill but is growing in prevalence in hospitals and nursing homes, and is increasingly resistant to antibiotics.
C. sordellii has been linked to four abortion pill deaths; a fifth is being investigated.
Opponents of the abortion pill have seized on those deaths — along with hundreds more complications after pill-induced abortions — to call for pulling Mifeprex from the market. A congressional hearing is set for next week, where Monty Patterson, a California man whose 18-year-old daughter died in 2003 after taking the abortion pill, is expected to renew his call for a ban. Also expected to testify is a doctor from the American Association of Pro Life Obstetricians and Gynecologists.
“We’ll let the scientists talk about the science but we already see the drug is killing women and causing a lot of adverse events,” said Michelle Gress, counsel to the subcommittee holding the hearing. A Senate bill proposes suspending sales of RU-486 while the Government Accountability Office reviews how the FDA approved the pill.
The drug’s manufacturer, Danco Laboratories, has repeatedly said the pill is safe.
The risk posed by C. sordellii remains murky. In studies and letters published in the New England Journal of Medicine in December and April, researchers detail eight other women who died of C. sordellii infection after giving birth, vaginally or by Caesarean section. Also counted are two additional deaths following miscarriages and a final death linked to infection during the woman’s menstrual period.
“That’s 11 other cases that have nothing to do with abortion — they’re other obstetric events,” said Dr. Beverly Winikoff, a women’s health advocate who worked to bring the abortion pill to the United States.
The abortion pill might suppress the immune system, which would increase susceptibility to bacteria already present in the vaginal canal, according to a study published last year by Dr. Ralph Miech of Brown University.
However, pregnancy naturally suppresses the immune system, too. Dilation of the cervix, whether because of abortion, childbirth or miscarriage, also may let bacteria penetrate deeper into the body, Miech and others have proposed.
Various species of Clostridium bacteria are found naturally in the vaginas of an estimated 4 percent to 10 percent of all women. C. sordellii in particular accounts for perhaps just 1 percent of those bacteria, meaning that roughly one in 1,000 women may harbor the bug.
Winikoff said some doctors speculate that the presence of placental or fetal tissue in the vagina following childbirth, miscarriage or abortion could provide the medium the bug requires to flourish.
June 5th, 2006
Washington.– Smoking history contributes to poor outcomes in the treatment of lung cancer, according to a new study.
Non-small cell lung cancer (NSCLC) lung cancer patients who have never smoked before in their life have better overall survival rates and respond better to chemotherapy than current or former smokers.
Published in the June 1, 2006 issue of CANCER, a peer-reviewed journal of the American Cancer Society, the study also reveals that smoking status during treatment has no affect on clinical outcome.
Cigarette smoking is the most significant risk factor for developing lung cancer, one of most common and aggressive malignancies in the world. In 2005, over 170,000 Americans were diagnosed with lung cancer and over 160,000 patients died.
The five-year survival rate from lung cancer is less than 20 percent at best. NSCLC causes the majority of lung cancers, and if cured, the survivor has up to a 4 percent annual risk of developing another tumor.
Despite the association of lung cancer with cigarettes, diagnosed patients continue to smoke. However, physicians remain unable to tell their patients how that will impact their cancer treatment. Previous studies have failed to agree on whether smoking status impacts the outcome of chemotherapy or chemotherapy and thoracic irradiation.
Led by Anne S. Tsao, M.D. of the University of Texas M. D. Anderson Cancer Center in Houston, researchers reviewed the medical records of 1370 patients with NSCLC who were treated with chemotherapy or chemo-radiation to determine an association between smoking and treatment response and survival.
The researchers found that patients who never smoked had a better response to the chemotherapy; developed less disease progression during therapy; and showed improved survival over former and current smokers.
They say the finding may be due to non-smokers having less genetic damage compared to smokers, being less likely to have other ailments that would affect survival, and having better preserved lung function.
The authors write that “Continued efforts at preventing smoking initiation are a critical public health issue and emphasize the need for chemoprevention for smokers and primary-prevention protocols to prevent smoking.”
June 5th, 2006
Cape Town.– A safe and effective gel allowing women to protect themselves from the AIDS virus may be available by 2010 if current trials involving thousands of women are successful, researchers said Sunday.
Gita Ramjee, director of the HIV prevention research unit at South Africa’s Medical Research Council, said microbe-killing vaginal gels offered huge potential for stemming the epidemic, especially in societies where men are reluctant to use a condom.
Ramjee said that five separate clinical trials were underway involving 12,000 people in South Africa and thousands in other countries. Results should be ready in the next two years, she said.
“We have waited 25 years to address the epidemic, so 2008 is really not too much longer to wait,” she told a press conference before an international conference on microbicides.
She said that if governments fast-tracked the regulatory approval process, the gels might be on the market by 2010 — although she cautioned this was the earliest anticipated date.
The conference co-sponsored by the World Health Organization brings together more than 1,000 scientists and researchers from around the world.
HIV infection is rising more rapidly among women than men in many parts of the world. Half of all adults living with the virus that causes AIDS are female, according to U.N. figures.
In sub-Saharan Africa, home to more than 25 million of the nearly 40 million people infected around the world, women account for nearly 60 percent of infections, with most acquired through heterosexual intercourse. Yet strong taboos still exist on the continent against the use of condoms.
The London School of Hygiene and Tropical Medicine has calculated that a microbicide that is 60 percent effective against HIV and used by only 20 percent of women in 73 developing countries over three years could prevent 2.5 million infections.
Microbicides can take the form of a gel, cream, sponge or ring that releases an ingredient that can kill or deactivate HIV during intercourse.
Coinciding with the start of the conference, South African AIDS activists launched a new campaign to try to prevent 2 million new AIDS infections by 2010.
The Treatment Action Campaign — which until now has focussed on improving access to medication — said it would press the government to provide more condoms and improve sex education.
“There is a crisis of prevention in this country,” said Zackie Achmat, president of the campaign.
“There are 1,400 new infections every day. That must stop,” he told a crowd of about 1,500 activists.
Up to 6 million South Africans are infected with HIV, the highest number of any country. It is projected that 2.5 million more may become infected by 2010.
June 5th, 2006