Kelani blog

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.

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Dice-K donates $1 mn to quake aid

Boston pitcher Daisuke Matsuzaka is donating $1 million to the Red Sox' official charity for victims of the earthquake and tsunami in his native Japan.

The Red Sox said Friday that his gift to the Red Sox Foundation will be sent to the Japanese Red Cross Society to aid response to the March 11 disaster, which also spawned an atomic crisis thanks to damage to the Fukushima nuclear plant.

Boston's other Japanese hurlers, Hideki Okajima, Junichi Tazawa and Itsuki Shoda, have also made personal donations and joined Matsuzaka, team captain Jason Varitek and others in collecting donations from fans at two spring training games in Florida.

The death toll from Japan's worst post-war disaster had topped 10,000 by Friday, and there was scant hope for 17,500 others still missing.

Matsuzaka, a native of Tokyo, was already a star in Japan when he joined the Red Sox in December 2006, inking a 52 million-dollar, six-year contract.

He became the first Japanese pitcher to start a World Series game as Boston won the Fall Classic in his first Major League season.

"Our efforts on the field are dedicated to all who are suffering from this catastrophe," Matsuzaka said in a videotaped message released by the Red Sox earlier this month. "We are in this together, so we must overcome tragedy together."

U.S. experts: significant water contamination in Japan

Groundwater, reservoirs and sea water around Japan's earthquake damaged nuclear plant face "significant contamination" from the high levels of radiation leaking from the plant, a worrying development that heightens potential health risks in the region.

Nuclear and environmental scientists in the United States darkened their assessment of the risks markedly on Monday after operators at the Fukushima Daiichi power plant said that highly radioactive water has entered underground concrete tunnels extending beyond the reactor.

Sea water and fresh water used to cool the reactors, critically damaged by Japan's March 11 earthquake and tsunami, and spent fuel pools at the plant have been put in storage tanks there. But reports indicate these tanks are full or over-flowing with tainted water, experts said.

"It's just hard to see how this won't result in significant contamination of, certainly, sea water," said Edwin Lyman, a physicist and expert on nuclear plant design at the U.S.-based Union of Concerned Scientists.

"There will be dilution, some of that will be reconcentrated, but I don't think this can be sugar-coated at this point."

The experts said they need more information from Japanese authorities before accurately assessing the exact environmental and health impact. They did not say whether the latest developments can explain low levels of radiation in Tokyo's water supply.

But their remarks were gloomier than a few days earlier when scientists said the vast ocean would dilute radiation and it did not appear to pose a health risk.

Surface and sea water used to cool the damaged plant is tainted with radiation and could contaminate the adjacent ocean, surface reservoirs and groundwater, Lyman said. In addition, water is leaking inside various parts of different reactors and beyond, posing a threat.

"There's already been an enormous amount of radioactivity released from this plant into the air, and that will deposit on sea water and surface water supplies," said Lyman in a telephone briefing on Monday. "It's hard to imagine that there won't be some significant contamination that will have to be dealt with."

Reports that plant workers were exposed to radiation 100,000 times normal in water inside reactor No. 2 at the weekend could suggest a breach in some parts of the reactor buildings, where tainted water is pooling and getting into tunnels.

"Pathways for that (radioactive) material to get out are numerous," said David Lochbaum, a nuclear engineer and direct of the union's Nuclear Safety Project.

Lochbaum noted that the reactor buildings for units 1, 3 and 4 at the Fukushima plant are no longer intact and therefore not acting as barriers to nuclear contamination. This contaminated water "may leave as it evaporates from puddles on the floor," he said.

Contaminated water can also be discharged in liquid form, Lochbaum said.

BIG OCEAN

Sea contamination is a concern for the Japanese, who consume about 9 million tons of seafood a year, second behind China. The Kuroshio Current lies along Japan's east coast, where the $2 billion annual catch includes various kinds of tuna, mackerel, other flat fishes, squid and crabs, according to the Sea Around Us project, a collaboration of the Pew Environment Group and the University of British Columbia.

Radioactive material can get into water from steam or smoke which is carried by wind, rain or other precipitation onto land, surface reservoirs or the ocean. It could also be discharged directly into the ocean or leak onto land and eventually seep into groundwater.

Two materials are of concern -- cesium 137 and iodine 131.

Iodine 131, which can cause thyroid cancer, decays quickly, with a half-life of eight days, meaning its potency falls by a half in that time. The amount of this radioactive isotope of iodine is a tiny fraction of the amount of normal iodine in ocean water, said Timothy Kenna, an expert on the ocean and radiation at Columbia University's Lamont-Doherty Earth Observatory in New York.

Cesium 137, also a carcinogen, takes much longer. It has a half-life of 30 years. There are still traces of this radioactive isotope lingering from nuclear weapons tests in the Pacific in the 1950s and 1960s, Kenna said. So far, it has not been a threat to marine life, he said by telephone.

Both chemicals would likely stay in the upper 100 yards (meters) of the ocean if they were deposited on the surface by emissions from the Fukushima plant, he said. The ocean has an average depth of 4,000 yards, meaning it has a far large volume to allow for dilution compared with rivers or lakes.

Global nuclear weapons tests showed that marine wildlife tends to absorb less radioactive material than organisms in lakes or rivers, said F. Ward Whicker, an emeritus professor at Colorado State University and one of the founders of the field of radioecology, which addresses the affects of radioactivity on the environment.

Additionally, when there is plenty of potassium and calcium in the ocean, marine life will absorb those nutrients before taking in radioactive materials, lessening the danger of seafood contamination, experts said.

(Additional reporting by Charles Abbott; Editing by Stella Dawson)

Nets owner has not changed his mind on Anthony

NEWARK, N.J. – New Jersey Nets owner Mikhail Prokhorov has not changed his mind about the franchise's pursuit of Carmelo Anthony.

The Russian told team executives last month to end drawn-out trade talks for the Denver Nuggets All-Star forward and nothing has changed with the NBA trading deadline a week away, his spokeswoman said Thursday.

There were reports on Wednesday that the Nets and Nuggets had renewed talks about a deal for Anthony. However, Prokhorov spokeswoman Ellen Pinchuk said in an e-mail that the billionaire maintains his stance, despite the reports.

"Mikhail has not changed his mind," Pinchuk wrote.

When asked if that meant Prokhorov does not want the Nets to reopen talks with Denver at this point, the spokeswoman said:

"What I said is what I said," she insisted. "Not what you said."

Prokhorov stunned NBA followers last month during a visit to New Jersey when he told the team to end trade talks for Anthony just a day before he was to have a sitdown with the player. At the time Prokhorov said the much ballyhooed, 15-player, three-team deal that also involved the Detroit Pistons had become too become too expensive. The negotiations had also become too public and the constant rumors were hurting his team.

Prokhorov also said at the time there was no chance the talks would be resurrected.

A league official with knowledge of the Nets told The Associated Press on Thursday that Denver recently contacted New Jersey to see if there would be any interest in acquiring Anthony, who can become a free agent at the end of the season. The official asked not to be identified because he was not authorized to speak for the Nets.

The Nets and Knicks have been mentioned as the most likely future home for Anthony, should he be traded. And Anthony has been quoted several times that he would love to play for the Knicks.

But the Nets might have more to offer the Nuggets. Rookie power forward Derrick Favors, the No. 3 pick in the draft, has tremendous upside as a 19-year-old. His first season has not been overly impressive because of foul problems and a general learning curve. New Jersey also has five first-round draft picks over the next two years to offer.

Prokhorov and Nets general manager Billy King are expected to be in Los Angeles for the All-Star game this weekend, and Prokhorov might get a chance to say hello this time to Anthony. Of course, any trade to New Jersey would be contingent on Anthony signing a $65 million contract extension that's been on the table since June.

Anthony also would have to know that coming to New Jersey probably would end his playoff hopes. The Nets have a 17-40 mark entering the break and are 8 1/2 games out of a playoff berth with 25 left.

The Nuggets (32-25), meanwhile, have the seventh best record in the West.

2.4 million in Somalia face drought: UN

UNITED NATIONS (AFP) – Somalia, home to one of the world's largest population of displaced people, is teetering on a crisis with drought now threatening some 2.4 million people, a UN official said Thursday.

"Somalia... is on the brink of a much larger disaster due to the threat of a country-wide drought," said UN under secretary general for humanitarian affairs, Valerie Amos.

"Malnutrition has increased in the last six months in Southern Somalia and 2.4 million, 32 percent of the population, remain in crisis," she told a press conference, after returning from a trip to Somalia and Kenya.

"Families are set to start selling their assets, including their houses and land to get by."

Some of the people at risk are in areas controlled by armed groups of Islamist insurgents, who are complicating the situation, Amos warned.

"I cannot stress enough the importance in Somalia of finding a political solution. Only that would enable people to live in peace and dignity."

Somalia has lacked an effective central government since the ouster of president Mohamed Siad Barre 20 years ago unleashed bloody violence there.