Health-Medical-Fitness-Diet-zv: septembrie 2012

duminică, 2 septembrie 2012

Can drug coverage erase the income gap in diabetes?

Researchers found that much of the income gap in heart risks among diabetic adults disappeared after the age of 65 - the age at which universal drug coverage kicks in for Canadians.

Canada has universal healthcare, but when it comes to medications, people younger than 65 either pay out-of-pocket or have private drug coverage through work - similar to Americans their age.

In the new study of more than 600,000 Ontario residents with diabetes, researchers found that lower-income people had higher risks of heart attack, stroke and death. But the disparity largely disappeared after age 65.

The findings, reported in the journal Diabetes Care, do not prove that universal drug coverage erased the income gap.

But there is no other obvious factor that would explain the "sudden shift" at age 65, said lead researcher Dr. Gillian L. Booth, of the University of Toronto and St. Michael's Hospital in Ontario.

"This also fits in with what's been seen in other studies," Booth said in an interview.

Research has shown that a growing number of people with diabetes cannot afford their medications - which include not only drugs to control blood sugar, but also those for high blood pressure, high cholesterol and other problems that commonly go hand-in-hand with diabetes.

Another study in Ontario also found a widening gap in death rates between the rich and poor with diabetes - but the trend is mainly among people younger than 65.

"I feel confident that expanding drug coverage could help save some lives," Booth said.

Her team's findings are based on health records for 606,051 Ontario adults who were followed over six years. During that time, over 48,000 of those people were hospitalized for a heart attack or stroke, and just over 111,000 died of any cause.

Booth's team found that among people younger than 65, those in the bottom 20 percent for income had a higher rate of heart attack, stroke and death: just over two percent per year, versus 1.4 percent among the wealthiest 20 percent.

Even when the researchers considered certain other factors - like people's history of heart problems before the study - low income was still linked to a 51 percent higher risk.

But when the researchers looked at older adults, the gap between the rich and poor was much smaller: the lowest-income group had a 12-percent higher risk of heart attack, stroke or death than the most affluent group.

Even though Booth thinks universal drug coverage helps explains the findings, she said it is not the sole reason for the gap between the rich and poor.

"It's more complicated than that," Booth said. Diabetes is a complex condition that requires people to keep up a healthy lifestyle, and tackle daily tasks like measuring blood sugar.

So differences in diet, exercise, smoking and general "health literacy" - a person's ability to read and understand information about a health condition - are all important, according to Booth.

"Drug coverage is one piece," she said. "We think it's an important piece, but it's not the only one."

Booth also said she thinks her findings are relevant to other countries, including the U.S., where the Medicare program for older Americans has covered the cost of prescriptions since 2006.

Studies have shown that since that benefit started, Medicare recipients' adherence to their medications has generally improved. That includes the poorest and sickest beneficiaries.

Those studies have also found that "non-drug" spending - mostly for hospitalizations - has declined among Medicare recipients who previously had only limited drug coverage.

Medicare drug coverage is subject to coverage gaps, in which seniors have to pay full price for their prescriptions. Recent studies have found that participants often drop their medications when they hit that so-called "donut hole" in coverage, but have not documented any health consequences from that choice. (See Reuters Health stories of July 2, 2012 and August 17, 2012.

Still, Booth said the overall evidence argues for better drug coverage for younger people as well. "More and more people are being diagnosed with diabetes at younger ages," she noted.

Older age is a major risk factor for type 2 diabetes, by far the most common form of diabetes. But so is obesity. And in the U.S., about 36 percent of all adults are now obese.

An estimated 26 million Americans have diabetes, including 14 percent of all people between the ages of 45 and 64, according to the Centers for Disease Control and Prevention.

SOURCE: http://bit.ly/RLDmqT Diabetes Care, online August 13, 2012.

FDA approves Medivation prostate cancer drug

Approval of the pill, to be sold under the brand name Xtandi, comes three months ahead of the agency's late-November decision deadline and sent shares of Medivation up 7.6 percent.

Wall Street analysts, on average, have forecast Medivation's sales of the drug at $1.2 billion by 2017, according to Thomson Pharma.

Xtandi, or enzalutamide, is one of a new class of drugs known as androgen inhibitors, designed to interfere with the ability of testosterone to bind to prostate cancer cells. Testosterone is the male hormone that fuels prostate cancer cell growth.

Medivation said it would begin selling the drug in the United States in mid-September at a wholesale price of $7,450 for a 30-day supply. Trial patients, on average, used the drug for eight months, the company said.

Medivation and Astellas, which have also filed for European approval, reported in November that a pivotal study of the drug had been stopped early after it became clear that it improved median overall survival by 4.8 months compared with a placebo.

The pill is also being tested in men with earlier stage prostate cancer, but Medivation has not said when those results are expected.

"The real opportunity for Xtandi is in pre-chemotherapy," Sanford Bernstein analyst Geoffrey Porges said in a research note.

He estimated that 18,000 to 20,000 U.S. prostate cancer patients receive chemotherapy every year and 4,000 to 5,000 eventually progress to other treatments.

"I am confident that this is only the beginning of success stories with this agent and that it will be used in earlier stages of prostate cancer in the near future," Dr. E. David Crawford, head of the urologic oncology department at the University of Colorado Health Sciences Center and chairman of the Prostate Conditions Education Council, said in a statement.

The FDA last year approved Johnson & Johnson's Zytiga, which is designed to work inside cancer cells to block testosterone production.

"The need for additional treatment options for advanced prostate cancer continues to be important for patients," Richard Pazdur, director of hematology and oncology products at the FDA's drug evaluation and research center, said in a statement. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient's life."

Xtandi "should have comparable or higher sales than Zytiga because it appears to have superior efficacy and had no serious adverse events in clinical trials," said ThinkEquity analyst Kimberly Lee.

Zytiga's worldwide sales rose about $32 million to $232 million in the second quarter from the first quarter.

Prostate cancer kills about 250,000 men a year globally and is the second most common cause of cancer death in men in the United States, after lung cancer.

The most common side effects seen with Xtandi were weakness, fatigue and back pain. The FDA said seizures occurred in about 1 percent of patients and they were taken off the therapy.

The FDA required that Medivation conduct a post-marketing study to further determine the seizure risk of Xtandi.

Medivation said the FDA approval and European regulatory filing trigger milestone payments from Astellas of $35 million, 10 percent of which it is obligated to pay to the University of California, Los Angeles under a licensing agreement.

Shares of Medivation gained $7.44, or 7.6 percent, to $104.86 on Nasdaq.

Shares of Japan-based Astellas closed down less than a percentage point at 3,820 yen in Tokyo, ahead of the announcement.

(Additional reporting by Ransdell Pierson and Michele Gershberg; Editing by Leslie Gevirtz, Tim Dobbyn and Dan Grebler)

German drug firm makes first apology for thalidomide

Gruenenthal Group's chief executive said the company wanted to apologize to mothers who took the drug during the 1950s and 1960s and to their children who suffered congenital birth defects as a result.

"We ask for forgiveness that for nearly 50 years we didn't find a way of reaching out to you from human being to human being," Harald Stock said. "We ask that you regard our long silence as a sign of the shock that your fate caused in us."

Stock spoke in the west German city of Stolberg, where the company is based, during the unveiling of a bronze statue symbolizing a child born without limbs because of thalidomide. The statue is called "the sick child" — a name German victims group object to since all the victims are now adults. In German, the name also implies cure.

The drug is a powerful sedative and was sold under the brand name Contergan in Germany. It was given to pregnant women mostly to combat morning sickness, but led to a wave of birth defects in Europe, Australia, Canada and Japan. Thalidomide was yanked from the market in 1961 and was also found to cause defects in the eyes, ears, heart, genitals and internal organs of developing babies.

Thalidomide was never approved for use in pregnant women in the United States.

Freddie Astbury, of Liverpool, England, was born without arms or legs after his mother took thalidomide. The 52-year-old said the apology was years long overdue.

"It's a disgrace that it's taken them 50 years to apologize," said Astbury, of the Thalidomide U.K. agency, an advocacy group for survivors. "I'm gobsmacked (astounded)," he said. "For years, (Gruenenthal) have insisted they never did anything wrong and refused to talk to us."

Astbury said the drug maker should apologize not just to the people affected, but to their families. He also said the company should offer compensation. "It's time to put their money where their mouth is," he said. "For me to drive costs about 50,000 pounds ($79,000) for a car with all the adaptations," he said. "A lot of us depend on specialist care and that runs into the millions."

Astbury said he and other U.K. survivors have received some money over the years from a trust set up by thalidomide's British distributor but that Gruenenthal has never agreed to settle.

"We invite them to sit around the table with us to see how far their apology will go," he said. "I don't think they've ever realized the impact they've had on peoples' lives."

Gruenenthal settled a lawsuit in Germany in 1972 — 11 years after stopping sales of the drug — and voiced its regret to the victims. But for decades, the company refused to admit liability, saying it had conducted all necessary clinical trial required at the time.

Stock reiterated that position Friday, insisting that "the suffering that occurred with Contergan 50 years ago happened in a world that is completely different from today" and the pharmaceutical industry had learned a valuable lesson from the incident.

"When it developed Contergan Gruenenthal acted on the basis of the available scientific knowledge at the time and met all the industry standards for the testing of new drugs that were known in the 1950s and 1960s," he said.

A German victims group rejected the company's apology as too little, too late.

"The apology as such doesn't help us deal with our everyday life," said Ilonka Stebritz, a spokeswoman for the Association of Contergan Victims. "What we need are other things."

Stebritz said that the 1970 settlement in Germany led to the creation of a €150 million fund for some 3,000 German victims, but that with a normal life expectancy of 85 years the money wasn't enough. In many other countries, victims are still waiting for compensation from Gruenenthal or its local distributors.

In July, an Australian woman born without arms and legs after her mother took thalidomide reached a multimillion dollar settlement with the drug's British distributor. Gruenenthal refused to settle. The lawsuit was part of a class action and more than 100 other survivors expect to have their claims heard in the next year.

Attorneys for Lynette Rowe said in a statement released Saturday that Grunenthal's apology rang hollow.

"To suggest that its long silence before today ought to be put down to 'silent shock' on its part is insulting nonsense," the statement reads. "For 50 years Grunenthal has been engaged in a calculated corporate strategy to avoid the moral, legal and financial consequences of its reckless and negligent actions of the 1950s and 1960s."

Thalidomide is still sold today, but as a treatment for multiple myeloma, a bone marrow cancer and leprosy. It is also being studied to see if it might be useful for other conditions including AIDS, arthritis and other cancers.

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Associated Press writers Maria Cheng in London and Kristen Gelineau in Sydney contributed to this report.