Friday, May 6, 2011

One in 8 UK women will get breast cancer

 Breast cancer rates in Britain increased over the last decade, with one in eight women now expected to develop the disease at some point in their life, figures released by a cancer charity showed Friday.

The number of women diagnosed with the disease in 2008 was 47,700, up from 42,400 cases in 1999, according to Cancer Research UK data.

The figures, released on World Cancer Day, revealed that there were 124 cases diagnosed per 100,000 British women in 2008, compared with 120 in 1999, representing a rise from one in nine women to one in eight.

Experts pinpointed lifestyle factors including alcohol consumption, obesity and the fall in birth rate as contributing factors.

The biggest jump occurred among women aged between 50 and 69, where cases rose by six per cent. Rates among women aged between 25 and 49 fell by 0.5 per cent.

However, the number of women surviving the disease increased with more than 75 per cent of women now living for more than 10 years after developing the cancer.

Almost 65 per cent of women with breast cancer now live for 20 years beyond diagnosis.

British women over 50 qualify for a screening every three years, and around 1.5 million women are screened in the country every year.

Sara Hiom, Cancer Research UK's director of health information, said: "Women cannot change their genes but small changes in everyday habits can help to reduce cancer risk.

"Cutting back on alcohol by keeping within Government recommended limits of no more than 14 units a week (a small drink a day) helps.

"Taking more exercise and eating a diet high in fibre but low in saturated fat can help maintain a healthy weight — which in turn reduces breast cancer risk.

"Women should also discuss hormone replacement therapy with their doctor as long-term use can raise breast cancer risk."

Early balding linked to risk of prostate cancer

A study showing that men who start to go bald at 20 may be more likely to develop prostate cancer in later life suggests they might benefit from early screening or preventative therapy, scientists said on Tuesday.

French researchers compared 388 men being treated for prostate cancer with 281 healthy men and found that those with the disease were twice as likely as the healthy men to have started losing their hair when they were 20.

If the men only started going bald when they were 30 or 40, there was no difference in their risk of developing prostate cancer compared to the healthy group.

"At present there is no hard evidence to show any benefit from screening the general population for prostate cancer. We need a way of identifying those men who are at high risk," said Philippe Giraud of Paris Descartes University, who led the study.

"Balding at the age of 20 may be one of these easily identifiable risk factors and more work needs to be done now to confirm this," he said in a statement.

Giraud, whose findings were published in the cancer journal Annals of Oncology, said men identified as at higher risk of prostate cancer could be selected for earlier screening, or for chemo-prevention therapy using so-called anti-androgenic drugs like Merck's Proscar, or finasteride.

Finasteride is used to treat both prostate enlargement symptoms and baldness. It blocks the conversion of testosterone to an androgen hormone called dihydrotestosterone, which is thought to cause hair loss.

GlaxoSmithKline has a drug in the same class called Avodart, or dutasteride, and is currently seeking approval from the United States Food and Drug Administration (FDA) for a license for use in men at higher risk of developing prostate cancer. But an FDA panel advised last month that GSK's application should be rejected.

Prostate cancer is the second most common cancer in men after lung cancer and kills an estimated 255,000 men each year.

Androgenic alopecia, also known as male pattern baldness, affects around 50 per cent of men in their lifetime.

Previous studies have established a link between baldness and androgenic hormones, and androgens also play a role in the development and growth of prostate cancer.

Giraud and Michael Yassa of the University of Montreal in Canada, who also worked on the study, asked men to fill in a questionnaire about their history of prostate cancer, if any, and to indicate any hair loss they had at ages 20, 30 and 40 using pictures graded from stage I (no hair loss), to stage IV (receding hairline and balding from the top of the head).

The men's doctors also provided patients' medical histories, including any diagnosis of prostate cancer, age at diagnosis, stage of the disease and treatment. The study ran for 28 months.

"The data revealed that any balding at stages II-IV was associated with double the risk of prostate cancer later in life. This trend was lost at ages 30 and 40," said Yassa.

"Further work should be done, both at the molecular level and with larger groups of men, to find the missing link between androgens, early balding and prostate cancer."

Medicare to pay for $93,000 prostate cancer drug

Medicare officials said Wednesday that the program will pay the $93,000 cost of prostate cancer drug Provenge, an innovative therapy that typically gives men suffering from an incurable stage of the disease an extra four months to live.

The Centers for Medicare and Medicaid said the biotech drug made by Dendreon Corp. is a "reasonable and necessary" medicine. The decision ensures that millions of men would be able to afford the drug through the government-backed health care coverage. With government reimbursement, analysts estimate Provenge could rack up $1 billion in sales next year. The decision, which will be finalized by June 30, is important for Dendreon because most prostate cancer patients are 65 or older.

Medicare is legally prohibited from considering price when deciding whether to pay for a new treatment. The Food and Drug Administration approved Provenge last April and in most cases Medicare automatically covers drugs cleared by the agency. But Medicare's decision to review Provenge last year prompted outrage from some patients and doctors who said the government was looking for a reason to avoid reimbursing for the pricey drug.

The infused drug is a first-of-a-kind treatment in that each dose is customized to work with a patient's immune system. Seattle-based Dendreon says Provenge's price reflects the more than $1 billion spent researching and developing the drug. And prostate cancer patients point out that the median survival time with Provenge is double that of chemotherapy, which is about two months and is marked by significant side effects.

"It's impossible to put a dollar figure on a human life, especially when you're talking about a drug that has such mild side effects," said Jim Kiefert, a prostate cancer patient and advocate who was part of the Provenge study. "Of all the treatments I've had -- with surgery, radiation and hormone treatment -- Provenge had fewer side effects than any of them."

But bioethicists who study health care decisions say Medicare's ruling on Provenge mirrors the bias of the overall U.S. health system, which emphasizes expensive treatments over basic medical care. Health care costs account for nearly one fifth of the U.S. economy, more than any other country.

"We tend to put our health care dollars into very high-tech interventions that produce very marginal improvements," said Dr. Steven Miles, a professor at the University of Minnesota's Center for Bioethics. "The problem is that we have created a health care system that is uniquely inadequate in terms of access to primary health care, which is where you get the most bang for your buck."

A growing number of biologically engineered cancer drugs are being priced in the $100,000 range, including therapies from Roche and Eli Lilly & Co. Last week, Bristol-Myers Squibb Co. received approval for a new melanoma drug that will be priced at roughly $120,000 per patient.

Provenge is the first FDA-approved cancer drug that uses the body's own immune system to fight the disease, offering an alternative to chemotherapy drugs that attack cancerous and healthy cells at the same time. The treatment is intended for men whose prostate cancer has spread elsewhere in the body and is not responding to hormone therapy or radiation.

Each regimen of Provenge must be tailored to the immune system of the patient using a time-consuming formulation process. Doctors collect special blood cells from each patient that help the immune system recognize cancer as a threat. The cells are mixed with a protein found on most prostate cancer cells and another substance to rev up the immune system, and then given back to the patient as three infusions two weeks apart.

Industry observers say much of the scrutiny of Provenge stems from the current political climate, as voters push lawmakers to cut the deficit and rein in government spending. At the same time, the new health care reform law has stoked debate about how much say the government should have in approving coverage of medical treatments. Republicans have accused the acting chief of Medicare, Dr. Donald Berwick, of advocating health care rationing, based on statements he made as a professor at Harvard University. President Obama appointed Berwick to the post last year, but Senate Republicans have opposed his confirmation and have urged Obama to nominate someone else.

Dr. Sean Tunis, a former Medicare official, called Wednesday's decision a case of "the dog that didn't bark."

"You could almost guess that this would be outcome before they even started. So why raise all the anxiety and subject yourself to all the criticism of rationing?" said Tunis, who is director of the Center for Medical Technology Policy in Baltimore.

Medicare officials have said the agency's review of Provenge was aimed at clearing up bureaucratic confusion among Medicare carriers across the country, some of whom already pay for Provenge. Medicare on Wednesday called its online memo a "proposed decision," but it essentially amounts to agreeing to cover the drug for millions of seniors enrolled in its program.

The news sent Dendreon shares up 66 cents to $36.20 in after-hours trading. The stock closed the regular session down 34 cents at $35.54 before the announcement.

Sex can be heart attack trigger for couch potatoes

Sex and exercise can trigger heart attacks in older people who don't get much of either, a new analysis finds. The risk is low, but it's a good reminder that slackers should change their exercise habits gradually, especially in middle age.

People who exercise regularly have a much smaller risk of having a heart attack immediately after sexual or physical activity, said lead author Dr. Issa Dahabreh of Tufts Medical Center in Boston.

"It would be really bad if someone thought our paper means people should not exercise," Dahabreh said. "If anything, it's the opposite."

The analysis, appearing in Wednesday's Journal of the American Medical Association, combined results from 14 studies involving more than 6,000 patients.

The studies involved only people who had had heart attacks or had died suddenly from a heart problem. The studies looked at what the people were doing during the hour or two before their heart attacks and compared that to the same people's activity on normal days with no major heart problems.

That study design is used to try to answer the question, "Why did the heart attack occur now?"

Physical activity and sex increased the risk of heart attack by a factor of about three, according to the analysis of the pooled results. Exercise increased the risk of sudden cardiac death by nearly five times. The researchers didn't find a triggering relationship between sex and sudden cardiac death, that is, a sudden death from a heart problem.

The risk for any one person is extremely low.

"If you were to follow 10,000 people for a year and if they all decided to increase their physical activity by an hour a week, you could expect to see two to three more heart attacks," Dahabreh said.

That risk is offset for most people by the benefits of exercise. The more frequently people exercise, in general, the less risk they have of exercise or sex triggering a heart attack.

Most of the patients in the studies were in their late 50s and early 60s, but the findings are a cautionary tale for people in any age group who are slowing down.

Exercise might even be considered cross-training for sex, said Mercedes Carnethon, a heart disease researcher at Northwestern University's Feinberg School of Medicine, who wasn't involved in the research.

"Engaging in regular physical activity is a requirement for maintaining a long, safe, healthy sex life," Carnethon said.

"If this isn't more motivation for people to maintain some degree of physical activity, I'm not sure what is," Carnethon said. "Get out and walk. Do something."

FDA finds no heart attack risk with HIV drug

The Food and Drug Administration reviewed data on abacavir after studies showed conflicting information about a possible link to heart attacks.

Abacavir is an ingredient in HIV drugs Ziagen, Trizivir and Epzicom sold by ViiV Healthcare, a joint venture between GlaxoSmithKline Plc and Pfizer Inc. Glaxo is the majority partner.

The FDA said doctors should continue to prescribe abacavir as directed. The agency had disclosed it was reviewing the heart attack data in 2008.

Chrissie Fletcher, Director and Head of Biostatistics of Amgen International, in collaboration with Pharma IQ presents the path to health technology assessment

Chrissie Fletcher discusses Pharma IQ of health technology assessment (HTA​​, Health Technology Assessment). In this podcast he explained in his comprehensive  vision of  the future  in relation  to the interaction between economists and statesmen in the health field, has identified the reason why so much emphasis  is placed on the preparation  of reports for reimbursement  and has indicated its outlook  on trend in the coming  years  by pharmaceutical companies to test more frequently to perform this task internally.

According to Mrs. Fletcher, the preparation of reports for reimbursements is playing an increasingly important role, because it represents the basis for all programs of clinical trials, the evidence that will attempt to demonstrate the clinical efficacy of the products and their safety, in addition to their economic advantage.

The original text of this announcement in the language of departure is the official version prevails. The translations are provided solely for the convenience of the reader and must return to the original text, which is the only legally valid.