The drug is designed for patients with metastatic prostate cancer who stop responding to hormonal therapy. The drug triggers the immune system to recognize a particular protein that is found on about 95 percent of all prostate cancer cells. When the immune system identifies the protein, it attacks the cancer cells.

The drug has shown in two previous trials that it increases survival in patients that have prostate cancer that has spread to other parts of the body.

The potentially harmful drugs, sold under than brand names Procrit, Epogen, and Aranesp, are genetically engineered versions of a natural protein, called erythropoietin that increases the number of red blood cells. The drugs, with combined 2006 U.S. sales of $10 billion, are commonly used for patients with certain forms of kidney disease and for those receiving chemotherapy for cancer.

The FDA is adding warnings to the drugs’ labels that will strongly instruct doctors to use the lowest possible dose needed to help patients avoid blood transfusions.

The FDA will also take a close look at how the drugs are marketed, including claims the drugs can improve the quality of life.

A meeting of FDA officials to further discuss this issue, believed to stem from drug overuse by dialysis centers and oncologists who make more money by using more of the drugs. is scheduled for May 10. Recommendations could lead to additional revisions of the drugs’ labels.

It was effective in treating Candida albicans an infection prevalent in HIV/AIDS and cancer patients receiving chemotherapy, and can cause symptoms ranging from cough to brain damage. Research funding for this project was provided by the Canadian Institutes of Health Research, Canada’s major agency responsible for funding health research. Composed of 13 Institutes, CIHR provides leadership and support to more than 10,000 health researchers and trainees across Canada.

The public outcry that caused Merck to announce its stop order on Tuesday stems from the fact that the vaccine protects against the sexually transmitted human papilloma virus (HPV), which causes cervical cancer. School-mandated vaccines are typically for diseases spread through casual contact, such as measles and mumps.

Merck’s medical director for vaccines, Dr. Richard M. Haupt says, “We’re concerned that our role in supporting school requirements is a distraction from that goal, and as such have suspended our lobbying efforts,” adding that the company will continue providing information about the vaccine upon request.

Gardasil, launched in June and the first vaccine to prevent cervical cancer, has inspired controversy since day one. There’s the cost — $360 for three required shots — and all sorts of insurance concerns and conservative groups who worry the vaccine encourages premarital sex and interferes with parental rights. Even those in support of the vaccine — like the American Academy of Pediatrics and the American Academy of Family Practitioners — question Merck’s quick push to market this drug, especially in light of the company’s withdrawn painkiller Vioxx.

“I believe that their timing was a little bit premature so soon after (Gardasil’s) release, before we have a picture of whether there are going to be any untoward side effects,” says Dr. Anne Francis, who chairs an American Academy of Pediatrics committee.

Legislatures in 20 states have taken steps to mandate the vaccine for young girls. And with the exception of Texas governor Rick Perry’s February 2 executive order requiring Texas girls entering the sixth grade in 2008 get vaccinated, nothing has been made official so far.

The researchers tested the effectiveness of Avastin in conjunction with a standard chemotherapy agent in patients with recurrent cancerous brain tumors called gliomas. They found that the two drugs together halted tumor growth up to twice as long as comparative therapies. Though gliomas remain incurable in nearly all cases, the combined drug therapy may buy precious time and preserve physical and mental function longer for patients facing this grim diagnosis, the researchers said.

“These results are exciting because of the possible implications for a patient population that currently has the poorest possible prognosis going into treatment, those with malignant brain tumors that have recurred after initial treatment,” said James Vredenburgh, M.D., a brain cancer specialist at Duke’s Preston Robert Tisch Brain Tumor Center and lead researcher on the study.

The findings will appear in the Feb. 20, 2007, issue of the journal Clinical Cancer Research. The study was funded by the National Institutes of Health, the Preston Robert Tisch Brain Tumor Research Fund, the Bryan Cless Research Fund and Genentech, the maker of Avastin.

Duke currently is participating in a large, multi-institutional study of Avastin to corroborate the results of this initial study, Vredenburgh said.

Kate Carr, president and chief executive officer of Accelerate Brain Cancer Cure, a not-for-profit organization that supports research to hasten a cure for brain cancer, said, “The results of this initial study are very encouraging and we are now excited to learn the findings of the larger study, that, it is hoped, will lead to an approved therapy for patients with brain cancer.”

In the pilot study, the researchers found that dual therapy with Avastin and the chemotherapy drug irinotecan either shrank the tumors or restricted their growth in nearly all cases for up to three months longer than comparative therapies. Three months is a significant advance when dealing with these aggressive tumors, Vredenburgh said; common current treatment normally offers only six to 12 weeks of halted growth before the tumor grows and spreads, ultimately destroying cognitive and physical function and leading to death.

Approximately 18,000 people are diagnosed with gliomas in the United States each year, making them the most common and most deadly malignant tumors of the central nervous system. Gliomas are difficult to treat because they grow quickly and occur behind the blood-brain barrier, a natural protective layer around the brain that prevents materials carried in the bloodstream — including medicines — from reaching the brain and spinal cord.

Avastin, a relatively new type of drug that shrinks cancerous tumors by cutting off their blood supply, can slow the growth of the most common and deadly form of brain cancer, a pilot study conducted at Duke University Medical Center has found.

Life expectancy after diagnosis of a stage IV glioma — the most aggressive kind of the cancer — is eight to 15 months, Vredenburgh said. Individuals diagnosed with a stage III glioma, which is slightly less aggressive, survive 16 to 24 months on average. When the tumor returns after initial treatment — which usually includes surgery, chemotherapy and radiation — the prognosis is even more grim, with an average life expectancy of three to nine months.

“When the tumor recurs after treatment, there are no standard therapies,” Vredenburgh said. “This study may lead to options where there previously were none.”

Avastin may be effective in treating gliomas because these tumors have a high concentration of vascular endothelial growth factor, a protein that stimulates development of new blood vessels in a process known as angiogenesis. New blood vessels spur a tumor’s growth and ability to spread, so researchers are interested in cutting off angiogenesis to slow tumors down. Avastin is an anti-angiogenesis drug that works by choking off the blood supply to these prolific blood vessels.

“What makes these tumors so deadly might actually be what also makes them susceptible to this exciting new therapy,” Vredenburgh said.

The 32 patients who participated in this study had been diagnosed with stage III or stage IV recurrent gliomas. Sixty-three percent of the patients saw their tumors shrink by at least 50 percent in the first 12 weeks of the study and 38 percent were progression-free at six months, meaning their tumors had not grown, Vredenburgh said.

“Going forward, we will also explore the efficacy of this treatment in newly diagnosed patients,” he said. “Ultimately, our hope is that this will offer a real weapon in what is now a very limited arsenal for treating a very challenging cancer.”

When cancer recurs following treatment with anthracyclines and taxanes, some of the strongest chemotherapies for breast cancer, patients have limited treatment options. Researchers continue to search for different chemotherapy combinations that are effective against recurrent breast cancer.

The researchers concluded that anticancer responses were 36 percent for patients treated with Gemzar/Navelbine and 26 percent for patients treated with Navelbine alone.

HPV is a sexually transmitted virus and requiring 11-year-olds to be vaccinated the same way they get shots for measles and other diseases is jarring. Add to that the political intrigue: It turns out that Mr. Perry’s former chief of staff is a lobbyist for Merck & Co., the only manufacturer of the drug that has been shown to prevent the virus — Gardasil.

Do pre-teen girls to have this vaccine promote premarital sex?

Conservative groups think inoculating little girls against sexually transmitted disease is a tacit acceptance — or encouragement — of immoral behavior. But right-wingers aren’t the only ones concerned.

The jury is still out on this drug’s long-term effectiveness. And there have been some negative reactions reported. Plus, Merck & Co. is spending millions of dollars to market the drug and their political ties run deep in almost every state. Florida, by the way, is not immune. There are efforts to get a mandatory vaccination legislation pitched in Tallahassee.

Obviously, curing cancer in all of its forms ought to be the goal of modern medicine. But is it medical science, or politics and slick marketing, that’s driving this push for HPV vaccinations?

Meanwhile Governor Rick Perry revealed that his call to vaccinate school aged girls against HPV is more personal than political. In a Perry scheduled interview with five reporters, the Texas Governor revealed that prostate cancer runs in his family, and some personal information about his family member’s experiences with cancer. “Every generation of Perry’s, back to the 1850s, has died of prostate cancer. I’m going to get it,” said Perry.

A study of 4,742 post-menopausal women found that switching from the present gold-standard breast cancer treatment tamoxifen to the new drug exemestane after two or three years resulted in a dramatic fall in death rates, The Times newspaper reported on Tuesday.

The new drug, sold under the brand name Aromasin, is recommended by the National Institute for Health and Clinical Excellence as an alternative to tamoxifen after two to three years, according to the report.

The study followed the progress of women treated for a total of five years and monitored for a further three years, and women assigned randomly to a full five years of tamoxifen, or treatment with tamoxifen followed by exemestane.

The researchers said that giving women tamoxifen after surgery already reduced the risk of dying by 33 percent, and after another two to three years of exemestane, and with a further three years of post-treatment follow-up, survival was found to be significantly improved with the risk of dying 50 percent lower than if they had received no drug therapy.

“This is the first time any hormone treatment has been shown to reduce the death rate more than tamoxifen alone. Switching drugs also seems to avoid the side-effects of long-term tamoxifen therapy, such as cancer of the womb and deep vein thrombosis,” Charles Coombes, director of the Cancer Research UK Laboratories and head of cancer medicine at Imperial College, London, was quoted as saying.

The charity Cancer Research UK, whose scientists were involved in the study, said that the treatment would prevent an estimated 1, 300 annual deaths in this country.

Texas is the first state to require that young schoolgirls receive the cervical cancer vaccine, approved for use by the FDA in June and proven to protect against the most common strains of the human papilloma virus (HPV) — the cause of most cervical cases cervical cancers.

Texas governor Rick Perry (R), who just signed an executive order making this mandate official, believes the high cost of treating diseases and ensuring the health and well-being of our population justifies the vaccine requirement.

Gardasil drugmaker Merck stands to make billions if the vaccine is made mandatory across the country. The series of three necessary shots cost $360.

Researchers conducted a small clinical trial that included 38 patients with metastatic breast cancer. Complete disappearance of cancer was achieved in nearly 9 percent of patients. Partial responses were achieved in about 44 percent of patients. Disease stabilization was seen in almost 33 percent of study participants.

Even though the study was a small one, researchers conclude that it appears that treatment with Abraxane and Xeloda may be effective for patients with metastatic breast cancer.