Health

U.K. Proposal on Alzheimer Drugs – Removal From Formulary

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Internal Medicine News has this story about Alzheimer Drug rationing in the United Kingdom:

A British proposal to remove four antidementia drugs from the National Health System formulary is unlikely to affect Medicare coverage of these agents, but some experts in the United States worry that it could influence private payers here.

The National Institute for Clinical Excellence (NICE), the independent body that recommends which medical therapies the National Health System (NHS) should provide in England and Wales, has proposed that donepezil, rivastigmine, galantamine, and memantine no longer be used to treat Alzheimer’s disease. Although acknowledging that the drugs provide moderate, short-term cognitive and behavioral benefit for some Alzheimer’s patients, NICE’s proposal holds that the drugs fail to delay time to institutional placement and thus are not cost effective.

The proposal appears to be a wholly economic one, according to the draft document and experts in both the United Kingdom and the United States. Although the drugs aren’t prohibitively expensive on an individual basis—annual therapy runs about $2,000 per patient—they cost the NHS the equivalent of $92 million in 2004. As in the United States, the United Kingdom has projected steadily increasing Alzheimer’s drug expenditures, saying spending could exceed $134 million by 2006. The total NHS 2004 budget was about $151 billion.

Withdrawing the drugs from the NHS could save $29 million the first year and $115 million by the third year, the document said.

The U.K. proposal would have no effect on national policy this side of the Atlantic, said Peter Ashkenaz, spokesman for the Centers for Medicare and Medicaid Services. The federal government has already committed to offering at least two cholinesterase inhibitors as part of the Medicare Prescription Drug Improvement and Modernization Act of 2003. The new coverage will begin in January 2006. Mr. Ashkenaz did not know which two in the class would be covered.

“As long as these drugs are approved by the Food and Drug Administration for Alzheimer’s, they will be covered under the new prescription drug benefit,” he told this newspaper.

But should the proposal pass, some U.S. dementia experts are concerned about spillover into the policies of private payers and managed care systems. “Insurance companies worldwide are always looking to minimize their expenses,” said Samuel Gandy, M.D., professor of psychiatry, neurology, and gerontology at Philadelphia University and director of the Farber Institute for Neurosciences, Philadelphia. “I would predict that the U.S. insurance companies are watching this very closely.”

This country’s private health care system is a “patchwork” of different companies that make decisions based on both economic and clinical factors, Lon S. Schneider, M.D., said in an interview. A national dictum condemning a class of drugs as not cost effective will get plenty of notice, he predicted.

“Private payers are really this country’s prescription benefits managers, and they are constantly assessing whether the drugs on their formularies are working and are cost effective,” said Dr. Schneider, professor of psychiatry, neurology, and gerontology at the University of Southern California, Los Angeles. “They are very interested in the NICE decision and analyses, which may have implications into how these companies manage their pharmacies.”

If the recommendation is accepted, no new prescriptions for antidementia drugs will be written through the NHS, although the drugs will not be withdrawn from patients already taking them.

Physicians, advocacy groups, and families in the United Kingdom have bitterly criticized the proposal, announced on March 1. Protesters contend that the drugs’ true value can’t be measured by a single outcome and have complained that the public comment period of only 3 weeks was far too short. They also said the decision would contribute to health care disparity in the country, since patients could still obtain the drugs through a full-price private prescription.

Britain’s health minister, Stephen Ladyman, said his department will ask NICE to reconsider its cost analysis, taking into account the economic and social benefits the drugs provide to caregivers, as well as to patients. But the minister also said he wouldn’t interfere with NICE’s decision-making process.

NICE is expected to render its final recommendation in July.

Damn! And the U.K calls itself a civilized society?

How could you possibly equate the rationing of Alzheimer’s disease care with cost?

I suggest that Tony Blair and his Labour Party get off their arses, privitize a few industries and use the resulting mega-increase in tax revenues to support their own citizens.

Indeed!

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Health

Stem Cell Therapy – An ALS Treatment?

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The Associated Press has the following story about the use of Stem Cells to possibly treat ALS – Lou Gehrig’s Disease:

A University of Wisconsin-Madison researcher said he would ask federal regulators Friday to approve the first clinical trial injecting special stem cells into the spinal cords of people with the degenerative nerve ailment called Lou Gehrig’s disease.

The trial would test whether a technique anatomy professor Clive Svendsen has pioneered on rats afflicted with the disease is safe to use on people. If successful, Svendsen said a much larger clinical trial aimed at treating the disease could be under way in two or three years.

About 30,000 Americans currently have the disease, which gradually kills brain cells that control muscle movement. The disease, formally known as amyotrophic lateral sclerosis, or ALS, typically can lead to death in a few years and has virtually no treatment.

Svendsen and his colleagues are asking the U.S. Food and Drug Administration for approval to bypass testing the technique on primates, typically the next step after rats, and to go straight to humans. The trial would involve five ALS patients treated by neurosurgeons at the Cleveland Clinic.

The trial would build on research Svendsen published this week in the journal Human Gene Therapy, which found that injecting certain types of stem cells into the spinal cords of rats could help stave off the disease and potentially prolong their lives.

Svendsen and his colleagues said the study was the first to show that the stem cells carrying a protein that fights ALS could flourish after being injected into their bodies.

The ALS Association, which is spending millions of dollars to fund Svendsen and other researchers rushing to find a cure, called the research encouraging.

“It is so exciting to see how rapidly ideas are moving from the laboratory into potential clinical applications through strong collaborations with leading investigators,” the association’s science director, Lucie Bruijn, said in a statement Thursday.

While noting the promise of his research, Svendsen sought to play down expectations, saying a cure of the debilitating disease was still years away.

“We’re not going to cure ALS in the first clinical trial,” Svendsen said Thursday at a forum on bioethics in Madison. “We’re going to tell the patients that as well.”

The research does not involve human embryonic stem cells, the blank-slate cells derived from human embryos that can be molded into any type of tissue cell in the body.

Researchers are instead using neural progenitor cells in fetal brain tissue, which are in the early stages of brain development. Those cells – derived from miscarried fetuses – are obtained through the National Institutes of Health.

Svendsen’s research team first created stem cells that pumped the disease-fighting protein, and then had to find the exact location in the rat’s spinal cord to inject them to fight ALS. The latter step took months of trial and error but may help surgeons deliver the treatment to humans.

Svendsen acknowledged the clinical trial proposal was risky. If the research on humans fails or is deemed unsafe, it could set back the field for years.

But he said waiting to unleash a potential cure for the lethal disease was unacceptable and the research has been safe so far.

“We’re hoping the FDA doesn’t require a lot more animal work,” he said.

Having seen this devastating disease ravage at least three men I have known, I can only pray that these trials will be successful.

Note: this treatment invovles Stem-Cells but not Embryonic Stem-Cells from Aborted fetuses.

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Canada

Prime Minister Paul Martin Offers to Call Election Within 30 Days of Gomery Report

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The Globe and Mail has the following on the Adscam Scandel:

Prime Minister Paul Martin offered to call an election within 30 days of the final report from the Gomery commission, in an extraordinary prime-time address to Canadians Thursday night.

He made the speech in an effort to stem the damage the sponsorship scandal has caused the Liberal party and to appeal directly to Canadians.
“I commit to you tonight that I will call a general election within 30 days of the publication of the commission’s final report and recommendations. Let [Mr. Justice John] Gomery do his work. Let the facts come out. And then the people of Canada will have their say,” Mr. Martin said from the desk in his office, in a taped televised address in both French and English.
Mr. Martin said he takes responsibility for the actions of his party and is prepared to let Canadians judge his response to this test of his leadership.

“I will be politically accountable. But I believe that before there is an election, you are entitled to answers — to the answers that [Mr. Justice John] Gomery is working toward,” he said.

The final report from Mr. Justice John Gomery is expected to be released in mid-December.
Mr. Martin said he recognizes that the choice to hold an election may not be his, as the opposition parties could bring forward a no-confidence motion and bring down the government.

“If the opposition forces an election before then, that is their choice. But I believe we can do better. I believe we can — and we should — use the coming months to pursue the public’s business,” he said.
Opposition Leader Stephen Harper did not respond positively to Mr. Martin’s plea to wait until December to hold an election.

In a speech in the foyer of the House of Commons immediately following Mr. Martin’s speech, Mr. Harper said Mr. Martin is the leader who called an election last year, before the Gomery commission had heard a single witness.

“We have all just witnessed a sad spectacle — a Prime Minister so burdened with corruption in his own party t
hat he is unable to do his job and lead the country, a party leader playing for time, begging for another chance,” Mr. Harper said.

Bloc Québécois Leader Gilles Duceppe said Mr. Martin’s words did nothing to change the opinion of the Bloc on Liberal corruption. He said his party still plans to vote against the Liberal budget implementation bill when it comes to a vote.

NDP Leader Jack Layton, however, offered an olive branch to the Prime Minister, saying his party would consider supporting the Liberals on the budget bill if they were willing to make some changes.
The minority Liberals are outnumbered in the House of Commons and would need the support of the NDP to pass the bill.

In his speech, the Prime Minister also went over a number of steps that he took, beginning when he became Liberal Leader in late 2003, including firing former public works minister Alfonso Gagliano, setting up the sponsorship inquiry, cancelling the sponsorship program and launched lawsuits to try to recover some of the money that went missing.

He said the Liberal Party takes full responsibility for the sponsorship scandal.

Ok, he takes responsibility….. how about resigning?

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