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Creative thinking about the CER agenda

By JOSHUA SEIDMAN This week the Institute of Medicine (IOM) released its list of the top 100 topics that should be addressed in comparative effectiveness research (CER) now — thanks to $1.1 billion in the American Recovery & Reinvestment Act…

HELP! This is Unbelievable

By ROGER COLLIER Key members of the Senate Health, Education, Labor, and Pensions Committee announced on Thursday what they claimed were dramatically improved cost and coverage estimates for the latest version of their health care reform bill. Headed by Democratic…

Big Bang Theory for July 4: Leave It to the Professionals

fireworksBefore the Health Blog heads off for the Fourth of July weekend, we offer a reminder about this holiday’s big downside: firework-related injuries. Some 70% of such injuries last year occurred between June 20 and July 20, according to the Consumer Products Safety Commission.

There were nine firework-related deaths and 7,000 injuries in 2008, down from 11 deaths and 9,800 injuries the year before, says that the CPSC. (See here for more history.) Half of these type of injuries are burns, according to the Centers for Disease Control. Hands and fingers are the most vulnerable body parts.

For tips to prevent firework injuries, click the CPSC link or these from the National Council on Firework Safety. Highlights:

  • Avoid buying fireworks that come in brown paper packaging, because it could mean the fireworks were made for professional displays.
  • Don’t try to re-light fireworks that haven’t gone off properly.
  • Light fireworks one at a time and don’t set them off in metal or glass containers.
  • Douse fireworks with water after they’ve gone off to prevent trash fires.

For a walk down memory lane to check out the Health Blog’s other Fourth of July posts, see here and here.

Image: Centers for Disease Control


The Need for New Research to Include Old Patients

elderlyOne thing health-care practitioners know about treating the elderly is that they don’t know enough about treating the elderly.

The point is underscored today by Richard C. Frank, a doctor who writes in a WSJ.com guest column about a 83-year-old patient with heart problems seeking aggressive treatment to fight non-Hodgkin’s lymphoma. The cancer is often curable but there is precious little information about how much an elderly patient with a weak heart — or other serious conditions, for that matter — can handle the normal rigors of anti-cancer treatment. Frank writes:

Clinical trials for cancer treatments usually enroll patients with few if any major health problems besides cancer. And patients in their 70s, 80s and 90s are notoriously underrepresented in trials, even though cancer is much more common in the elderly.

We know that older, sicker people are at higher risk of harmful side effects from cancer treatments, but we don’t know how best to vary those treatments to accommodate the wide range of health problems common in the elderly.

Of course, the fact that the elderly are underrepresented in much research has been well-known for a long time. In a 1997 analysis published in BMJ, researchers looked at a group of published studies and concluded that more than a third excluded elderly people without justification.

A 1999 study in the New England Journal of Medicine found those 65 years and older represented 63% of the population with cancer in the U.S. but they accounted for only 25% of people in cancer-treatment trials. There are some signs of change, however; an NEJM study published earlier this year looked only at women 65 and above who were at risk for a recurrence of breast cancer.

As for Frank’s lymphoma patient, the doctor came up with a treatment plan and the cancer has been in remission for two years. But Frank says of the patient: “Knowing that he received less-than-ideal therapy, I continue to worry about his cancer returning.”

Photo: Associated Press


Medicare May Pay More for Primary Care, Less for Procedures

stethoscopeWe mentioned yesterday that the feds are proposing their annual tweaks to the way Medicare pays doctors. But we were so busy geeking out on a proposed accounting change that we neglected to mention a few other details likely to be of interest: Namely, the feds want to increase Medicare payments to primary-care docs, and decrease payments to some specialists.

This is something that’s been bandied about for awhile, and there have been some small shifts in this direction. Still, specialists argue that they often have to train years longer than primary care doctors, and deserve higher pay. (They will still be paid more if the new Medicare payments take effect, but the gap between specialists and primary care docs might shrink a bit.)

CMS, the agency that runs medicare, is proposing a set of tweaks that would raise the fees Medicare pays for primary care by 6% to 8%, according to this statement. (The physicians included in this bucket are internists, family docs and geriatrics specialists.)

Medicare payments to cardiologists would be cut by 11% overall, with certain procedures (echocardiograms, cardiac catheterizations) facing steeper cuts, the WSJ says. Radiologists would see a cut of about 20% for doing high-tech scans such as CTs and MRIs.

If you want to dig into the details, you can read the entire proposal in the Federal Register.

Photo: iStockphoto


Multaq Approval Marks Comeback for Sanofi’s Heart Drug

heartMultaq, Sanofi-Aventis’s treatment for heart-rhythm disorders, has made a comeback. Rejected by the FDA in 2006 because of safety concerns, the agency has approved Multaq, the company announced today.

The drug approval is the French drug maker’s first major U.S. approval in seven years, according to Bloomberg. Late last year, Sanofi decided to discontinue development of obesity drug Acomplia, which was once thought to have much promise. Lately, the company has faced questions lately about whether its diabetes drug, Lantus, is linked to cancer.

Sanofi has predicted that Multaq, which treats atrial fibrillation and atrial flutter, eventually will bring in annual sales of more than $1 billion, notes Dow Jones Newswires.

The FDA rejected Sanofi’s initial attempt for approval because a study showed that patients on Multaq were more likely to die than those who received a placebo. The company has since conducted more research looking at patients at a less-advanced stage of heart disease.

Sanofi will also implement a risk evaluation and mitigation strategy to help “ensure the safe use of Multaq” and help health-care workers identify patients appropriate for the treatment, according to the company.

“The drug is now approved, ending Sanofi’s streak of pipeline futility,” UBS analyst Gbola Amusa told Dow Jones.

Image courtesy of Columbia University Medical Center


J&J Antes Up $1 Billion for Alzheimer’s Push With Elan

brainHealth-care giant J&J is making a $1 billion bet for a stake in Irish drug maker Elan and will invest an additional $500 million in Elan’s closely watched experimental bapineuzumab that is in late-stage studies to treat Alzheimer’s, the companies announced this morning.

With the deal, Elan essentially turns over to J&J the development rights of bapineuzumab, which Elan has been developing in partnership with Wyeth (soon to be bought by Pfizer). But the compound isn’t as promising as it initially appeared to be, which resulted in severe punishment of Elan’s stock price last year. Elan has also been sharply criticized by shareholders for its botched marketing of multiple sclerosis drug Tysabri and executive perks.

In January, Elan announced that it would conduct a strategic review process to examine options for the future of the company. More than 30 companies expressed interest in talking with the company since then, Elan CEO Kelly Martin told analysts on a call today.

Under the deal, J&J will become Elan’s largest shareholder with a 18.4% stake in Elan. J&J will also form a new subsidiary company with assets from Elan’s Alzheimer’s drug-development program, in which Elan will hold a 49.9% stake. Elan will share in the profits of bapineuzumab.

The proceeds will allow cash-strapped Elan to reduce its debt to $400 million from about $1.8 billion, said Elan’s chief financial offier, Shane Cooke, on the call. The company will continue to develop other compounds in its pipeline for treatment of multiple sclerosis and Parkinson’s disease. See the WSJ story for more on the deal.

Martin called the deal an “exciting new chapter in our history” and with J&J as a partner, hopes to build the “leading neuroscience immunology company in the world.”

Photo: Associated Press


J&J Antes Up $1 Billion for Alzheimer’s Push With Elan

brainHealth-care giant J&J is making a $1 billion bet for a stake in Irish drug maker Elan and will invest an additional $500 million in Elan’s closely watched experimental bapineuzumab that is in late-stage studies to treat Alzheimer’s, the companies announced this morning.

With the deal, Elan essentially turns over to J&J the development rights of bapineuzumab, which Elan has been developing in partnership with Wyeth (soon to be bought by Pfizer). But the compound isn’t as promising as it initially appeared to be, which resulted in severe punishment of Elan’s stock price last year. Elan has also been sharply criticized by shareholders for its botched marketing of multiple sclerosis drug Tysabri and executive perks.

In January, Elan announced that it would conduct a strategic review process to examine options for the future of the company. More than 30 companies expressed interest in talking with the company since then, Elan CEO Kelly Martin told analysts on a call today.

Under the deal, J&J will become Elan’s largest shareholder with a 18.4% stake in Elan. J&J will also form a new subsidiary company with assets from Elan’s Alzheimer’s drug-development program, in which Elan will hold a 49.9% stake. Elan will share in the profits of bapineuzumab.

The proceeds will allow cash-strapped Elan to reduce its debt to $400 million from about $1.8 billion, said Elan’s chief financial offier, Shane Cooke, on the call. The company will continue to develop other compounds in its pipeline for treatment of multiple sclerosis and Parkinson’s disease. See the WSJ story for more on the deal.

Martin called the deal an “exciting new chapter in our history” and with J&J as a partner, hopes to build the “leading neuroscience immunology company in the world.”

Photo: Associated Press


J&J Antes Up $1 Billion for Alzheimer’s Push With Elan

brainHealth-care giant J&J is making a $1 billion bet for a stake in Irish drug maker Elan and will invest an additional $500 million in Elan’s closely watched experimental bapineuzumab that is in late-stage studies to treat Alzheimer’s, the companies announced this morning.

With the deal, Elan essentially turns over to J&J the development rights of bapineuzumab, which Elan has been developing in partnership with Wyeth (soon to be bought by Pfizer). But the compound isn’t as promising as it initially appeared to be, which resulted in severe punishment of Elan’s stock price last year. Elan has also been sharply criticized by shareholders for its botched marketing of multiple sclerosis drug Tysabri and executive perks.

In January, Elan announced that it would conduct a strategic review process to examine options for the future of the company. More than 30 companies expressed interest in talking with the company since then, Elan CEO Kelly Martin told analysts on a call today.

Under the deal, J&J will become Elan’s largest shareholder with a 18.4% stake in Elan. J&J will also form a new subsidiary company with assets from Elan’s Alzheimer’s drug-development program, in which Elan will hold a 49.9% stake. Elan will share in the profits of bapineuzumab.

The proceeds will allow cash-strapped Elan to reduce its debt to $400 million from about $1.8 billion, said Elan’s chief financial offier, Shane Cooke, on the call. The company will continue to develop other compounds in its pipeline for treatment of multiple sclerosis and Parkinson’s disease. See the WSJ story for more on the deal.

Martin called the deal an “exciting new chapter in our history” and with J&J as a partner, hopes to build the “leading neuroscience immunology company in the world.”

Photo: Associated Press


J&J Antes Up $1 Billion for Alzheimer’s Push With Elan

brainHealth-care giant J&J is making a $1 billion bet for a stake in Irish drug maker Elan and will invest an additional $500 million in Elan’s closely watched experimental bapineuzumab that is in late-stage studies to treat Alzheimer’s, the companies announced this morning.

With the deal, Elan essentially turns over to J&J the development rights of bapineuzumab, which Elan has been developing in partnership with Wyeth (soon to be bought by Pfizer). But the compound isn’t as promising as it initially appeared to be, which resulted in severe punishment of Elan’s stock price last year. Elan has also been sharply criticized by shareholders for its botched marketing of multiple sclerosis drug Tysabri and executive perks.

In January, Elan announced that it would conduct a strategic review process to examine options for the future of the company. More than 30 companies expressed interest in talking with the company since then, Elan CEO Kelly Martin told analysts on a call today.

Under the deal, J&J will become Elan’s largest shareholder with a 18.4% stake in Elan. J&J will also form a new subsidiary company with assets from Elan’s Alzheimer’s drug-development program, in which Elan will hold a 49.9% stake. Elan will share in the profits of bapineuzumab.

The proceeds will allow cash-strapped Elan to reduce its debt to $400 million from about $1.8 billion, said Elan’s chief financial offier, Shane Cooke, on the call. The company will continue to develop other compounds in its pipeline for treatment of multiple sclerosis and Parkinson’s disease. See the WSJ story for more on the deal.

Martin called the deal an “exciting new chapter in our history” and with J&J as a partner, hopes to build the “leading neuroscience immunology company in the world.”

Photo: Associated Press


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