Latest Drugwonks' Blog
I bring this up again, because...
New tests may help spot early-stage Alzheimer's
CHICAGO (Reuters) - New tests assessing brain changes and body chemistry are showing promise at diagnosing Alzheimer's disease in its earliest stages, aiding the search for new drugs, researchers said on Tuesday.
In one study, Irish researchers found scans measuring brain volume and a combination of memory tests accurately identified nearly 95 percent of people who had progressed from mild cognitive impairment to early Alzheimer's disease.
In another study, U.S. researchers found that a type of brain scan that measures glucose combined with low scores on memory tests was a strong predictor of disease progression.
The findings, presented at an Alzheimer's Association meeting in Vienna, Austria, are some of the first from a five-year, $60 million study aimed at identifying brain changes that signal the advance of Alzheimer's disease.
"The idea is if there could be biological markers identified that tracked what was going on in the brain, this would give you a better idea of whether a drug was having a biological effect," Neil Buckholtz, who heads the U.S. National Institute on Aging's Alzheimer's Disease Neuroimaging Initiative, or ADNI, said in a telephone interview.
The study, which is funded with U.S. government and industry funds, involves more than 800 people looking at brain structure and biological changes such as in spinal fluids that could signal disease progression.
Despite decades of research, doctors still have few effective treatments for Alzheimer's disease, a mind-robbing form of dementia that affects more than 26 million people globally and is expected to reach 100 million by 2050.
CHEAPER TRIALS
Only an autopsy revealing the disease's hallmark plaques and tangles in the brain can offer a definitive Alzheimer's diagnosis. Short of that, doctors use neurological and memory tests. Because they are subjective, drug companies must run large, costly trials to show their drugs work.
Biomarkers may lead to cheaper trials, Buckholtz said...."
Newer tests. Earlier intervention. More drugs that are targeted.. More costs upfront. People living longer, healthier lives.
Not good in the Orszagian Universe...
BioCentury reports:
“Proponents of six separate bills seeking to create a pathway for approval of biosimilars are trying to line up enough support to prevail in a vote that could come as early as Friday in the Senate Health, Education, Pensions and Labor (HELP) Committee. The bills have been introduced as amendments to healthcare reform legislation.
The Biotechnology Industry Organization is strongly backing an amendment introduced on Thursday by Sens. Kay Hagan (D-N.C.), Michael Enzi (R-Wyo.) and Orrin Hatch (R-Utah) that would provide 12 years of exclusivity for pioneer biologics. BIO is opposing an amendment introduced on Tuesday by committee Chairman Sen. Edward Kennedy (D-Mass.), arguing that the amendment's nine year period of guaranteed exclusivity is too short. BIO also opposes language that seeks to limit exclusivity to a "major new substance" that would exclude many biologics, as well as the amendment's limited exclusivity for products approved before enactment of the legislation.
Sen. Sherrod Brown (D-Ohio) has introduced two biosimilars amendments, which would provide for seven and nine years of exclusivity. Two other pending amendments, filed by Sens. Barbara Mikulski (D-Md.) and John McCain (R-Ariz.), would provide 10 years of basic exclusivity. If the HELP Committee fails to agree on one of the amendments, it may send healthcare reform to the Senate floor without biosimilars provisions. This could put the creation of a biosimilars pathway in the hands of the House of Representatives.”
On a related note, it seems that BIO needs to hire a new publicist for Jim Greenwood. In her Wall Street Journal article, reporter Alicia Mundy refers to him simply as an “industry lobbyist.” I guess the fact that he’s the president of BIO and a former United States Congressman isn’t relevant. It’s also interesting that she describes the Kennedy bill as a “victory” for biotech.
Ms. Mundy should probably put Steve Usdin on speed dial.
What is surprising is how ignorant some physician/representatives are when it comes to existing options for their patients/constituents who are without health insurance. Representative Steve Kagen (D, WI) is upset that a patient cannot afford the medicines he prescribes, but seems ignorant or unwilling to recommend the many patient assistance programs available to those who earn too much to receive government assistance but too little to afford private insurance. Such programs are valuable options, providing free or low cost medicines to millions of Americans. The Partnership for Prescription Assistance (toll-free, 1-888-4PPANOW; www.pparx.org) is a single point of access to the more than 475 patient assistance programs, which include more than 180 programs offered by the pharmaceutical industry.
Dr. Kagen, the other physicians in Congress and every member of Congress should be aware of private sector healthcare access success programs before opting for a government-run public option.
By ERICA WERNER
Associated Press
WASHINGTON -- Conservative Democrats in the House rebelled against their party leaders Thursday, raising concerns about the cost of President Barack Obama's health care overhaul and seeking to put the brakes on legislation. The fiscally conservative Blue Dog Coalition planned to present a letter to House Democratic leaders asking for more time, members of the group told The Associated Press.
Democratic Rep. Mike Ross of Arkansas said that if the Democrats' liberal legislative plan came to the floor as proposed, an "overwhelming majority" of his group would oppose it. The Blue Dogs claim 52 members, so that could endanger the bill.
The move comes just as House Democratic leaders are trying to finalize the proposed legislation and unveil it Friday. Committees plan to vote next week and House leaders want to pass a bill before the August recess.
"We've just got a lot of questions and the top of the list would be how to pay for it," said Rep. Marion Berry, D-Ark.
Pushing to complete a comprehensive health care overhaul plan, House Democrats focused on an income tax surcharge on the highest-paid wage earners to help subsidize insurance for the 50 million people who lack it.
As discussed in the tax-writing House Ways and Means Committee, the surtax would apply to individuals with adjusted gross income of more than $200,000 and couples over $250,000, according to officials involved in the discussion. Most spoke on condition of anonymity because the talks were private.
Rep. Shelley Berkley, D-Nev., a member of the panel, said the panel is looking at a surtax of around 3.5 percent on income above those amounts. Other members suggested it would be closer to 3 percent.
In addition, key lawmakers are expected to call for a tax or fee equal to a percentage of a worker's salary on employers who do not offer health benefits.
Ways and Means Chairman Charles Rangel, D-N.Y., has said his committee needs to come up with $600 billion in new taxes to deliver on Obama's goal of sweeping changes to the nation's health care system to bring down costs and cover the 50 million uninsured. Hundreds of billions of dollars more would come from cuts to Medicare and Medicaid to pay for legislation expected to cost around $1 trillion over 10 years.
Lawmakers cautioned that no final decisions have been made. Smaller tax options remained possibilities, depending on the overall cost of the legislation, including a tax on sugared soft drinks and ending a tax break that drug companies receive for advertising.
In the Senate, Democrats edged away from their goal of passing health care legislation by early August amid heightening partisan controversy over tax increases and a proposed new government role in providing insurance to consumers.
Sen. Chuck Schumer, D-N.Y., told the AP he believes the "ultimate goal" is to have a bill by the end of the year that is signed into law by the president.
Separately, Republicans who met Wednesday with Senate Majority Leader Harry Reid, D-Nev., said he indicated he was willing to allow more time before legislation is brought to the floor.
Failure to meet the August goal would be a setback - but not necessarily a fatal one - for Obama's attempt to achieve comprehensive health care legislation this year. A group of Democratic and Republican senators led by Finance Committee Chairman Max Baucus, D-Mont., is still trying to work out a bipartisan deal.
But the Finance Committee work appeared to have suffered a setback when Reid relayed concerns to Baucus about the compromise taking shape. Finance's proposal was expected to omit a new government insurance option to compete with private insurers - something Republicans oppose but most Democrats favor. A leading contender to pay for the measure was a new tax on employee health benefits, which Obama campaigned against and many Democrats oppose.
Pelosi made clear Thursday that whatever the Senate comes up with, the House bill will have a public plan and will not tax benefits.
"We will not be taxing benefits, health care benefits in any legislation that comes from the House," Pelosi said. "And it will have, coming out of the House, a public option," she said. "The only debate on that is what it will be called: a patient option, public option. Write in your suggestions."
I suppose that goes for hospitals as well -- and doctors.
No laughing matter.
House majority leader Steny Hoyer (D, MD) said Tuesday that the healthcare reform bill now pending in Congress would garner very few votes if lawmakers actually had to read the entire bill before voting on it.
"If every member pledged to not vote for it if they hadn't read it in its entirely, I think we would have very few votes."
In fact, Hoyer found the idea of the pledge humorous, laughing as he responded to the question. “I’m laughing because I don’t know how long this bill is going to be, but it’s going to be a very long bill,” he said.
Cliff Notes. Not acceptable in high school. Not acceptable in Congress. Not acceptable for healthcare reform.
In all the tumult over healthcare reform, we haven’t heard that much about “drugs from
Witness PhRMA panjandrum Billy Tauzin, who, according to a report in today’s edition of the Wall Street Journal told a White House meeting Tuesday that “if the larger health-care bill passes, the cost savings will be big enough to make reimportation unnecessary.”
A White House official confirmed the meeting took place and said, "As a political matter there may be less pressure" to pursue reimportation after a health bill passes.
(Meanwhile, Bernie Sanders -- the Senator from Ben & Jerry's -- disagrees with "any move to drop the importation idea." Yawn.)
Two things.
First, it’s amazing that this issue is even being mentioned. Why? Because, according to the Congressional Budget Office, importing drugs would lower costs by less than 1% -- decimal dust when you compare it to the $80 billion “deal.” And that’s not even factoring in the significant safety questions.
Second, there is no such thing as “reimportation.” The various schemes under discussion (most recently Senator McCain’s amendment that got voted down in committee the other day) call for the importation of drugs from a variety of nations around the globe – including
(It should also be noted that on-patent medicines represent about 8% of our national healthcare expense. The rhetoric may be great for headline-seeking pols, but is trivial when it comes to lowering health care costs.)
There is no such thing as “reimportation” and no financial incentive for importation. But the most important issue of all is safety. And that should be what stops this absurd notion from going even one step forward.
Hamburg's FDA Reorganization Merges Budget And Policy Functions
FDA Commissioner Margaret Hamburg is reorganizing her direct staff reports to streamline the development and tracking of the agency's budget.
As part of the proposed reorganization, the Office of Policy, Planning and Preparedness is being dissolved and a new Office of Policy, Planning and Budget will be created, housing the Office of Policy, the Office of Planning and a newly created office, the Office of Budget. It will be headed by an associate commissioner for budget. Currently, the budget functions are handled in the Office of Operations, which is being trimmed down and re-launched the Office of Administration.
The new structure will be accompanied by new faces at FDA. It may also involve departures: Randall Lutter, the current deputy commissioner for policy, planning and preparedness, and John Dyer, the chief operations officer are absent from the proposed organizational chart included in a memo outlining the proposed changes.
The departure of Lutter and Dyer would noteworthy because they are the last members of senior leadership team tapped by the Bush administration. Former Chief of Staff Susan Winckler departed June 19.
In the memo making the case for the new organization, Hamburg states, "Our program directors have been concerned for some time that we must be more successful in aligning our budget commitments with measurable outcomes."
"I intend to make the development and presentation of the agency's funding needs and performance goals among my highest personal priorities," Hamburg notes.
A focus on planning and budgeting has been one of the requests of congressional appropriators, and FDA's reorganization may help address the concerns of the purse string holders on Capitol Hill.
Appropriations and authorizing committees have expressed willing to provide FDA with more resources, and even as the agency's budget has gone up in recent years, the increases have been accompanied by comments that FDA needs a better plan for spending the funds.
Among the other features of the reorganization is a new deputy commissioner for foods, who will oversee the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. "There is no higher priority than assuring the public that we intend to make the food safety program at FDA successful," Hamburg said.
Former FDA Deputy Commissioner for Policy Michael Taylor is seen as the likely candidate for the post.
He is an experienced former FDA leader and recognized food safety expert. His resume includes posts as the administrator of the Food Safety and Inspection Services at the U.S. Department of Agriculture; vice president for public policy at Monsanto Corp.; and a senior fellow at Resources for the Future, where he focused on food safety. He is currently a research professor at George Washington University's Health Policy Department.
Also as part of the reorganization, the Office of Chief Scientist will be streamlined to focus on innovation and integrity issues, and a new Office of Special Medical Programs will be created. The proposal also adds an Office of External Affairs and elevates the agency's crises management functions.