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The type of drug treatment used to prevent organ rejection in kidney transplant patients doesn’t affect cancer risk, a new study finds.

Kidney transplant patients are at increased risk for cancer, likely because of patients’ long-term use of immunosuppressive drugs to prevent organ rejection. In this study, Australian researchers examined the incidence of cancer in 481 kidney transplant patients.

The patients had received one of three treatment regimens: azathioprine and prednisolone; cyclosporine monotherapy; or cyclesoporine monotherapy followed by a switch to azathioprine and prednisolone after three months.

In the 20 years after transplant, 226 patients developed at least one cancer, including 48 percent who developed skin cancer and 27 percent who developed non-skin cancer. None of the anti-rejection treatments had a greater effect than another on cancer timing or incidence.

The findings indicate that “any differences in cancer risk from these different treatments are unlikely to be clinically significant,” said study author Martin Gallagher, of the George Institute for International Health in Australia.

He and his colleagues also found that kidney transplant recipients’ increased risk of cancer is significantly influenced by certain characteristics at the time of transplant. For example, non-skin cancer is associated with increasing age and previous smoking history, while skin cancer is associated with increasing age, non-brown eye color, fairer skin, and a functioning transplant.

High-risk patients need to be monitored more closely and use preventive measures to protect against cancer, the researchers said.

The study appears in the issue of the Journal of the American Society of Nephrology.

Women who are overweight or obese appear to have an increased risk of developing the chronic pain syndrome known as fibromyalgia, a new study suggests.

If they are also sedentary, the risk is even greater, said lead researcher Paul Mork, of Norwegian University of Science and Technology in Trondheim, Norway.

The study is published in the May issue of Arthritis Care & Research.

Fibromyalgia is marked by widespread pain lasting more than three months. The pain strikes so-called “tender points” in the neck, shoulders, back, hips, arms and legs.

The condition is also marked by fatigue without apparent cause, mood disturbances, sleep problems and headaches. More women than men have it, and experts don’t thoroughly understand its cause.

The condition may be due to dysfunction in the nervous system and other problems, and it is thought to be affected by genetic susceptibility.

In the new study, Mork and his colleagues turned to a data base of nearly 16,000 women in Norway who had responded to health surveys. Among the participants were 380 who developed fibromyalgia during the 11-year follow-up.

Mork’s team compared the data from patients with the healthy respondents, including body-mass index (BMI) and exercise habits.

Exercise and a healthy body weight were found to be protective.

“According to previous findings reported in the literature, we expected that regular leisure-time physical exercise would have a protective effect on future development of fibromyalgia [FM],” Mork said. “However, we only found a weak association between development of FM and exercise. However, it should be noted that we were not able to differ between different types of exercise, and it might be possible that some exercise types are more beneficial than others in protecting against future development of FM,” he added.

“Women who reported exercising four times per week [or more] had a 29 percent lower risk of fibromyalgia compared with inactive women,” Mork said in a news release about the study.

Those who exercised two to three times a week were about 11 percent less likely to get fibromyalgia.

Being overweight — with a BMI of 25 or higher — was a strong independent risk factor, with the heavier women having a 60 percent to 70 percent higher risk of developing the condition compared to the healthy weight women.

The overweight women who exercised an hour or more a week, however, were less likely to get the condition than were overweight women who were inactive.

Mork’s advice: Regular exercise, which can help maintain weight, may serve as a “buffer” against the symptoms that eventually lead to fibromyalgia.

The results are entirely plausible, said Dr. Patrick Wood, senior medical adviser for the National Fibromyalgia Association, who cares for many fibromyalgia patients.

But with the condition, there are often the chicken-egg questions, he added, such as whether the pain leads to the inactivity or weight gain or vice versa. “It’s difficult with any level of assurance to know what’s driving what,” Wood said. There could be underlying factors driving both excess weight and pain sensitivity, he noted.

The inflammation that is associated with obesity may heighten pain sensitivity, Wood added.

More study is needed, Wood said. Until more is known, however, he would advise people who want to avoid the condition to maintain a healthy weight and exercise regularly. That’s especially wise for those with a family history of fibromyalgia, he stressed, because he has found that it does tend to run in families.

For those already diagnosed with the condition, Wood said, “some data show if you exercise and keep your weight down you may have less pain.”

SOURCES: Patrick Wood, M.D., senior medical advisor, National Fibromyalgia Association, and family medicine physician, Renton, Wash.; Paul Mork, D.Phil., Norwegian University of Science and Technology, Trondheim, Norway;

The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.

Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.

“The availability of Provenge provides a new treatment option for men with advanced prostate cancer, who currently have limited effective therapies available,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Provenge is an autologous cellular immunotherapy, designed to stimulate a patient’s own immune system to respond against the cancer. Each dose of Provenge is manufactured by obtaining a patient’s immune cells from the blood, using a machine in a process known as leukapheresis. To enhance their response against the cancer, the immune cells are then exposed to a protein that is found in most prostate cancers, linked to an immune stimulating substance. After this process, the patient’s own cells are returned to the patient to treat the prostate cancer. Provenge is administered intravenously in a three-dose schedule given at about two-week intervals.

The effectiveness of Provenge was studied in 512 patients with metastatic hormone treatment refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial, which showed an increase in overall survival of 4.1 months. The median survival for patients receiving Provenge treatments was 25.8 months, as compared to 21.7 months for those who did not receive the treatment.

Almost all of the patients who received Provenge had some type of adverse reaction. Common adverse reactions reported included chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions, reported in approximately one quarter of the patients receiving Provenge, included some acute infusion reactions and stroke. Cerebrovascular events, including hemorrhagic and ischemic strokes, were observed in 3.5 percent of patients in the Provenge group compared with 2.6 percent of patients in the control group.

Provenge is manufactured by Seattle-based Dendreon Corp.

If you walk into an emergency room complaining of chest pains, the odds are high that you will end up having cardiac catheterization, where a thin wire is snaked into your heart to determine whether a blood vessel is totally or partially blocked.

But if you do have the invasive procedure, the odds are even higher — nearly two to one — that it will show no significant blockage, a new study finds.

“To me, what this says is that we need to re-evaluate how we work these patients up from start to finish,” said Dr. Manesh Patel, assistant professor of medicine at Duke University, and lead author of a report in the March 11 issue of the New England Journal of Medicine.

More than 10 million Americans each year experience chest pains that can lead to cardiac catheterization, Patel estimated.

He and his colleagues looked at data on nearly 400,000 people with no known heart disease who had cardiac catheterization at 663 U.S. hospitals between January 2004 and April 2008. Of those, just 37.6 percent had obstructed coronary arteries — slightly less than the 39.2 percent in whom no significant artery blockage was found.

Catheterization is called an invasive procedure because it requires that something be inserted into the body, which always carries a degree of risk. So doctors usually want to do a less risky noninvasive procedure, such as a stress test, to decide whether catheterization is advisable.

But while five of every six people in the study — 83.9 percent — did have a noninvasive test before catheterization, those tests did not have an enormous predictive value. Artery blockage was found in 41 percent of those who had noninvasive testing before catheterization and 35 percent of those who didn’t.

“We don’t know that this finding substantiated the kind of noninvasive test we should be using,” Patel said. “We don’t know what the patterns are, and we need more research.”

It’s not enough to simply say that cardiac catheterization is overused, he said. “What we want to do is use it more efficiently,” Patel said, “to determine the features that indicate catheterization is necessary.”

The study “points out a problem, but is not suggesting a solution,” he said. A national data bank on catheterization may provide information pointing toward a solution, as may some randomized trials that are now underway, Patel noted.

One of those trials, in which Patel is participating, is comparing the results of routine stress testing with computerized tomography angiography, which gives a three-dimensional view of the heart arteries, in 10,000 people.

The cardiac catheterization study results are not surprising, said Dr. Andrew Einstein, an assistant professor of clinical medicine at Columbia University Medical Center, whose specialty is cardiac imaging. An old rule of thumb is that one-third of cardiac catheterizations will show no artery blockage, he noted.

“This study does provide stronger data than we have ever had in the past,” Einstein said. “The important takeaway message is that better risk stratification is needed to inform decisions about catheterization. If we have a good strategy, people will not be referred as often for these invasive procedures.”

And cost is an inevitable issue in making those decisions, he added. “The cost of a diagnostic catheterization at our hospital is $2,600,” Einstein said.

SOURCES: Manesh Patel, M.D., assistant professor, medicine, Duke University, Durham, N.C.; Andrew Einstein, M.D., Ph.D., assistant professor, clinical medicine, Columbia University Medical Center, New York City; 2010, New England Journal of Medicine

Children inherit fewer gene mutations from their parents than was previously thought, say U.S. researchers who are the first to sequence the entire genome of a family.

The analysis of the four family members — the parents, daughter and son — revealed that each parent passes about 30 mutations to their children. It had long been believed that each parent passes 75 gene mutations to their children.

“That’s the kind of power you get from looking at the whole genome. The mutation rate was less than half of what we’d thought,” Lynn B. Jorde, professor and chairwoman of the department of human genetics at the University of Utah School of Medicine, said in a news release from the school.

Most gene mutations passed from parents have no effect on children’s health. But it’s important to know the number of parent-to-child gene mutations.

“The mutation rate is our clock, and every time it ticks we have a new genetic variant. We need to know how fast the clock ticks,” Jorde said.

The actual rate of gene mutations each parent gives a child will vary depending on the age of the parents (particularly the father) when a child is conceived.

The study was led by the scientists at the Seattle-based Institute for Systems Biology and also included researchers from the University of Utah and the University of Washington.

The findings appear in the issue of Science Express.

Over 5 million Americans are living with Alzheimer’s disease, and blacks and Hispanics are at highest risk of developing the disease, a new report finds.

The report, 2010 Alzheimer’s Disease Facts and Figures, from the Alzheimer’s Association, finds that black Americans are about two times more likely to develop Alzheimer’s disease than whites, and Hispanics face about 1.5 times the risk.

“Alzheimer’s is continuing to be on the rise,” said Maria Carrillo, the association’s senior director of medical and scientific relations. “So many people are affected by it across the country, but we are rallying to highlight the disparities that exist in populations,” she said.

Much of the increase in Alzheimer’s is because of increasing high blood pressure and diabetes, which increase the odds of developing Alzheimer’s in all populations.

“African-Americans and Hispanics are particularly vulnerable, because the proportion of these two risk factors is higher even still,” Carrillo said. “We can actually do something about this increased risk with better management of the conditions.”

This year, 500,000 new cases of Alzheimer’s will be diagnosed, with a greater number of new cases expected in the years to come, the report found. By 2050, the report estimates that almost a million new cases of Alzheimer’s will be diagnosed annually.

In 2006, Alzheimer’s was the seventh leading cause of death in the United States and the fifth leading cause of death among those 65 and older.

From 2000 to 2006, death rates declined for most major diseases, including heart disease, breast cancer, prostate cancer, stroke and HIV/AIDS. However, deaths from Alzheimer’s rose more than 46 percent during that time period, according to the report.

Not only are there more cases of Alzheimer’s, but more families are shouldering the burden of the disease, Carrillo said. This is particularly true for minority families who may have less access to outside care.

“There are 5.3 million Americans with Alzheimer’s,” noted Robert J. Egge, vice president of public policy and advocacy. “And for each of those people there are many others whose lives are consumed with caring for those Alzheimer’s patients,” he said.

That totals some 11 million Americans, Egge said.

In 2009, these unpaid caregivers provided 12.5 billion hours of care “valued at $144 billion, more than the federal government spends on Medicare and Medicaid combined for people with Alzheimer’s and other dementias,” according to the report.

Part of the problem is that Alzheimer’s isn’t recognized until it is in a late stage, Egge said. “So there isn’t adequate care planning and other kind of support structures, especially in communities with socioeconomic disadvantages,” he said.

Another reason behind Alzheimer’s grim rise is that people are living longer — escaping illnesses such as heart disease and cancer that might have killed them before Alzheimer’s arose.

“We are managing many diseases that do allow us to live longer,” Carrillo said. “With age being the greatest risk factor, we are just skewing our population towards the Alzheimer’s arena.”

Another expert agreed.

“We have some pretty effective solutions for a lifetime of cardiovascular disease risk, but your bypass and stent may just give you time to dement,” said Greg M. Cole, a neuroscientist at the Greater Los Angeles VA Healthcare System and associate director of the Alzheimer’s Disease Research Center at UCLA David Geffen School of Medicine.

Often, it all adds up to many years of needed care. And since it often takes a long time to die from Alzheimer’s, “you may have lost touch with your loved ones for 10 years, sometimes even 20,” Carrillo said.

Research dollars remain key to turning the numbers around, she said. “We really need to focus on Alzheimer’s,” she said. “We need more of an investment in Alzheimer’s disease.”

The report found that payments for health and long-term care services for people with Alzheimer’s will total $172 billion this year.

In addition, Medicare costs for Alzheimer’s patients are almost three times higher than for other older people, and Medicaid costs are almost nine times higher, the report found.

Many people with Alzheimer’s also have one or more other medical conditions, such as diabetes or coronary heart disease, making their care even more expensive.

Yet far less is spent on Alzheimer’s research than on other diseases.

In fact, “for every $25,000 the government spends on care for people with Alzheimer’s and dementia, it spends only $100 for Alzheimer research,” the report said.

According to Cole, “this new report details how the long predicted ‘epidemic’ rise in Alzheimer’s disease and other dementia is already upon us.”

The report also sounds the alarm that the situation may get worse before it gets better.

“We hope to have better treatments, but cures are unlikely,” Cole said. “The only cost-effective answer we can realistically try to achieve is an effective prevention program,” he said.

SOURCES: Maria Carrillo, Ph.D., senior director, medical and scientific relations; Robert J. Egge, vice president, public policy and advocacy, both of the Alzheimer’s Association; Greg M. Cole, Ph.D., neuroscientist, Greater Los Angeles VA Healthcare System, and associate director, Alzheimer’s Disease Research Center, UCLA David Geffen School of Medicine, Los Angeles; Alzheimer’s Association report, 2010 Alzheimer’s Disease Facts and Figures

U.S. regulators said on Wednesday they have found no link between oral bisphosphonate osteoporosis medications such as Merck & Co Inc’s Fosamax and certain thigh bone fractures.

The U.S. Food and Drug Administration issued its statement following the publication of case reports of atypical subtrochanteric femur fractures - or fractures in the bone just below the hip joint - in women with osteoporosis using oral bisphosphonates.

Bisphosphonates are a class of drug aimed at preventing bone fractures and offsetting bone loss associated with menopause.

They include Fosamax, Roche Holding AG’s Boniva, Novartis AG’s Reclast and Procter and Gamble Co’s Actonel.

In June 2008, the FDA requested information from all bisphosphonate drug makers related to these type of fractures. The agency said a review of the data did not show an increased risk for women using the medications.

The FDA said that, although its review of the data did not show a clear connection between bisphosphonates and atypical subtrochanteric femur fractures, the agency is working closely with outside experts to gain more insight into the issue.

Bisphosphonates, which have been on the market for roughly a decade, have raised safety concerns in the past, including heart risks.

But in 2008, the FDA said the drugs showed no overall risk of heart problems. The agency’s review followed reports of serious atrial fibrillation, a type of abnormal heartbeat, in the New England Journal of Medicine.

In January, a Manhattan federal judge refused to dismiss a lawsuit alleging that Fosamax caused jaw damage to a woman during the nearly eight years she took the pill.

Merck faces a slew of lawsuits involving almost 900 cases by patients who say Fosamax caused osteonecrosis of the jaw, or death of jaw bone tissue.

The FDA recommended patients keep taking their medication unless told not to by their doctor. It also recommended that healthcare professionals be aware of a “possible risk” of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.

The sound of two languages spoken regularly during pregnancy might encourage babies to tune in to both tongues soon after birth, a new study finds.

A team of psychological scientists at the University of British Columbia, Canada, and the Organization for Economic Cooperation and Development in France, watched the sucking reflexes of newborns born to either monolingual English-speaking women, or women who spoke both English and Tagalog, a language native to the Philippines.

The researchers explained that increased sucking behavior indicates newborns’ interest in a particular stimulus, including spoken language.

The team found that babies born to monolingual mothers exhibited increased sucking behaviors when they heard English, but not Tagalog, while infants born to the bilingual mothers showed interest, regardless of which of the two languages was being spoken.

A separate experiment suggested that infants could tell when a speaker switched from one language to the other. That’s important, the team said, because it shows that from the very start babies born to bilingual mothers do not confuse the two languages.

“Monolingual newborns’ preference for their single native language directs listening attention to that language,” the researchers wrote. “Bilingual newborns’ interest in both languages helps ensure attention to, and hence further learning about, each of their languages.”

The study findings were released online in advance of publication in an upcoming print issue of the journal Psychological Science.

As women age, they receive fewer benefits from frequent screening for human papillomavirus (HPV) and vaccinations to prevent the virus, new research shows.

While infection with certain types of HPV can lead to cervical cancer, there is a vaccine that can help protect against many of these HPV infections.

However, this study of Costa Rican women, aged 18 to 97, concluded that the benefits of HPV vaccination and screening are low among women over the age of 41. The rate of newly detected cancer-causing HPV infections declined with age, ranging from 35 percent in women aged 18 to 25 to 13.5 percent in women aged 42 and older.

The researchers also said that new HPV infections among women at any age typically do not progress to cervical intraepithelial neoplasia (CIN) grade 2 (CIN 2) or CIN 3, which are precursors for cervical cancer.

“Evidence that newly detected infections in older women do not harbor a higher risk of persistence or CIN 2 [or worse disease] than in younger women, and that older women acquire fewer new infections, indicates that the possible benefit of vaccinating older women is much reduced,” wrote study authors Dr. Ana Cecilia Rodriguez and colleagues of the Proyecto Epidemiologico Guanacaste, Fundacion INCIENSA, in San Jose, Costa Rica.

The study was published online in the Journal of the National Cancer Institute.

Researchers have found a way to analyze the “fingerprint” of a cancer, and then use that fingerprint to track the trajectory of that particular tumor in that particular person.

“[This technique] will allow us to measure the amount of cancer in any clinical specimen as soon as the cancer is identified by biopsy,” said study co-author Dr. Luis Diaz, an assistant professor of oncology at Johns Hopkins University. “This can then be scanned for gene rearrangements, which will then be used as a template to track that particular cancer.”

Diaz is one of a group of researchers from the Ludwig Center for Cancer Genetics and Therapeutics and the Howard Hughes Medical Institute at Johns Hopkins Kimmel Cancer Center that report on the discovery in the Feb. 24 issue of Science Translational Medicine.

This latest finding brings scientists one step closer to personalized cancer treatments, experts say.

“These researchers have determined the entire genomic sequence of several breast and colon cancers with great precision,” said Katrina L. Kelner, the journal’s editor. “They have been able to identify small genomic rearrangements unique to that tumor and, by following them over time, have been able to follow the course of the disease.”

One of the biggest challenges in cancer treatment is being able to see what the cancer is doing after surgery, chemo or radiation and, in so doing, help guide treatment decisions.

“Some cancers can be monitored by CT scans or other imaging modalities, and a few have biomarkers you can follow in the blood but, to date, no universal method of accurate surveillance exists,” Diaz stated.

Almost all human cancers, however, exhibit “rearrangement” of their chromosomes.

“Rearrangements are the most dramatic form of genetic changes that can occur,” study co-author Dr. Victor Velculescu explained, likening these arrangements to the chapters of a book being out of order. This type of mistake is much easier to recognize than a mere typo on one page.

But traditional genome-sequencing technology simply could not read to this level.

Currently available next-generation sequencing methods, by contrast, allow the sequencing of hundreds of millions of very short sequences in parallel, Velculescu explained.

For this study, the researchers used a new, proprietary approach called Personalized Analysis of Rearranged Ends (PARE) to analyze four colorectal and two breast cancer tumors.

First, they analyzed the tumor specimen and identified the rearrangements, then tested two blood samples to verify that the DNA had been shed into the blood, sort of like a tumor’s trail of bread crumbs.

“Every cancer analyzed had these rearrangements and every rearrangement was unique and occurred in a different location of genome,” said Velculescu. “No two patients had the same exact rearrangements and the rearrangements occurred only in tumor samples, not in normal tissue,” he noted.

“This is a potentially highly sensitive and specific tumor marker,” Velculescu added. Levels of the biomarkers also corresponded with the waxing and waning of the tumor.

“When the tumor progresses, the relative amount of the rearrangement increases in the blood and goes down after chemotherapy,” Diaz said. “It tracks very nicely with the clinical history of the tumor.”

The method would not be used for cancer screening and more research needs to be done to make sure PARE doesn’t detect low-level tumors that don’t actually need any treatment.

Although this approach is currently expensive (about $5,000 versus $1,500 for a CT scan), the authors anticipate that the cost will come down dramatically in the near future, making PARE more cost-effective than a CT scan.

Under the terms of a licensing agreement, three of the study authors, including Velculescu, are entitled to a share of royalties on sales of products related to these findings.