Harry & Louise 2.0

07/27/2009 12:11 PM |

Remember Harry & Louise?  Well welcome Harry & Louise 2.0.  And this time they’re for healthcare reform.

As Ad Age reports:

Harry and Louise's job description is dramatically different today than it was in the 1990s. During the Clinton administration, all they had to do was poke holes in a complex government plan -- something TV advertising lends itself to. This time around, the characters must use the medium to build support for a complex government plan.

Former FDA Associate Commissioner Peter Pitts, now the president for the Center for Medicine in the Public Interest, said he doesn't think the ads are going to do much to help Mr. Obama's cause.

"What's important to remember is that nobody -- not insurance companies, not drugmakers, not doctors, not patients, not politicians -- disagrees that reform is needed," Mr. Pitts said. "That said, 2009 is very different from the initial iteration of Harry and Louise. The average television viewer and YouTube viewer is much more sophisticated and much more aware that these are two paid actors. They were paid 16 years ago to be against health-care reform, and now they're being paid this year to be for health-care reform. If they were paid tomorrow to be New York Yankees fans, you would see a commercial for that."

The complete article can be found here.

And, speaking of the NY Yankees -- Happy Birthday to A-Rod.

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Filling the Donut Hole of Healthcare Costs

07/24/2009 04:55 PM |

Following Obama's press conference claim that reimbursing for nutrition might be more cost effective than treating disease,  Psycho Donuts will be reimbursed at the government rate under the public plan as a provider of mental health services.... 









http://www.psycho-donuts.com/home/

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Deadbeat Dutch

07/24/2009 03:18 PM |

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Magic's Hook

07/24/2009 03:10 PM |

Will DDMAC’s July 14^th warning letter to Abbott  send shivers down the spines of MLRers, reinforcing the notion that the FDA doesn’t approve of the use of celebrities?

Let’s look at the facts:

DDMAC cites Abbott’s promotional DVD, titled "I Know What's Important," for clumping the risk information in a dull section of at the end of the video and suggesting that Kaletra (lopinavir/ritonavir) has broader utility in treatment-experienced patients than the label supports.  The “I” is non other than Ervin “Magic” Johnson.

In the Kaletra DVD, the first 111/2 minutes are devoted to an "engaging and lively" discussion with Johnson about the benefits he has experienced from the drug. "In contrast," DDMAC writes, "the presentation of serious risks associated with Kaletra is relegated to the end of DVD after the interview is over, where it is unlikely to draw the viewer's attention, and is displayed as a running telescript."

The only risk information included during the interview is a brief acknowledgement by Johnson that he experiences "fatigue sometimes" and disclosures in SUPERs that Kaletra "is not a cure for HIV infection," that "the most commonly reported side effects of moderate severity that are thought to be drug-related are: abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, headache, and nausea, " and that "children taking KALETRA may sometimes get a skin rash."

DDMAC argues that while Johnson's claims may be an accurate reflection of his own experience, "inclusion of the SUPER stating 'Individual results may vary' ... does not mitigate the misleading impression created by the promotional DVD that all or most treatment-experienced patients taking Kaletra can expect to survive and be healthy for at least five years."

"FDA is not aware of substantial evidence or substantial clinical experience to support effectiveness for five or more years of treatment with Kaletra in treatment-experienced adults," DDMAC wrote, and the "personal experience of a Kaletra patient such as Magic Johnson does not constitute such evidence."

"These claims misleadingly overstate the efficacy of Kaletra by suggesting that the usual outcome of treatment with Kaletra is the preservation and continuance of a 'normal life,' including activities of daily living, work productivity, and social, emotional, and physical functioning," DDMAC wrote.

Note: No claims were made to infer that use of  Kaletra helps to enhance one’s baby sky hook.

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Yes I Hate Medicaid

07/24/2009 01:32 AM |

Watch the unraveling of the liberal mind. Yes, they can't believe there are individuals who do not systematically confuse expanding entitlements with concern with individual health or in the case of Igor, who equates forcing poor people to stay in Medicaid with "access" or keeping the healthcare or doctor you have.

"This morning on MSNBC, Igor Volsky, the Wonk Room’s health care blogger and co-author of Howard Dean’s Prescription for Real Health Care Reform, defended President Obama’s health care proposal. When host Chris Jansing argued that the Congressional Budget Office is predicting that health care reform would “increase long-term costs facing the government,” Igor noted that the CBO released a statement last night stating that the House bill would be deficit-neutral.

Igor debated Robert Goldberg, the president of the industry-funded Center for Medicine in the Public Interest. Towards the end of the segment, Goldberg attacked Igor, saying, “I can’t believe I’m hearing a liberal think tank support systematically restricting minorities from access to quality care.” Igor noted that “no one is restricting minorities, Robert — what are you talking about?” Goldberg revealed that his real problem is that he hates Medicaid:

GOLDBERG: If you’re a Medicaid recipient, you are not allowed to take a voucher and go to a plan that you think is good for you. You are forced to stay into Medicaid. Do you think that’s right or wrong? Yes or no?

IGOR: I think Medicaid provides essential services for many Americans that the private market simply can’t provide, which is why we’re expanding Medicaid. … It’s not putting people into Medicaid against their will."

Right, the "private market" can't provide... maybe because the rules and price controls make it impossible for a private market to exist let alone response to unique patterns of care?  Another reason I hate Medicaid, along with the fact that under Obamacare it will subsidize rich and healthy people...

Igor also noted that the motive behind including a public health insurance option for all Americans is to ensure everyone is given access to a solid benefits plan regardless of their income or class.

Watch it:

I provide the link since the site has so  many intelligent comments that follow the original post...

Read more here

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Health Insurance Fugitives: Compliance with mandates in Germany, Switzerland, and the Netherlands

07/23/2009 03:22 PM |

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Details? We don't need no sticking details.

07/23/2009 05:21 AM |

Sounding more wonky than usual, the President still offered no details on what he thinks healthcare reform should be or how we will pay for it.  But, according to the New York Times coverage of the press conference:

"He praised the pharmaceutical industry for making a hard commitment, but added, We might be able to get $100 billion out of them, or more. Mr. Obama offered no specific plans to increase the companies’ contributions to health care savings."

Folks -- 10% of our national healthcare spend cannot finance the other 90%.

Hullo?
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No Two Atypicals Are Typical

07/21/2009 04:02 PM |

Despite all the verbiage about using CER to find differences in response among subpopulations and to support personalized medicine, the CER industry consists of conducting/reviewing one size fits all trials to conclude that there is no difference between older and newer drugs...

Hence, this in Health Affairs...

Bethesda, MD -- Are drugs known as "second-generation antipsychotics" (SGAs) being overused and misused? What steps can be taken to make sure that medications are used correctly? Those questions are addressed in a trio of articles published today on the Health Affairs Web site.

Read article here

SGAs, also known as "atypical antipsychotics," have largely replaced older, less expensive first-generation (or typical) antipsychotics in the treatment of schizophrenia. SGAs are increasingly being used for a wide range of other clinical conditions as well.

The cost of SGAs is typically from ten to 100 times the cost of "first-generation" antipsychotics, and domestic U.S. sales of SGAs have reached $13 billion a year. However, based on recent research, some experts believe that the overall risk-benefit profiles of SGAs may be no better than those of some of the older and cheaper medications they have displaced, although important questions remain to be addressed through further research, and considerable variation exists in treatment response across individual antipsychotic drugs. While SGAs appear to cause fewer "extrapyramidal" side effects, including serious movement disorders, they bring increased risk of weight gain and blood-lipid abnormalities that may increase the risk of heart disease and diabetes.

 

Other researchers believe that SGAs can offer important new benefits for patients with schizophrenia and other serious mental conditions, but that the broadened use of these drugs for a more clinically diverse population of patients may have outstripped the evidence base for such use.

Examining The Use Of SGAs Among Youth and Elderly. In "Broadened Use of Atypical Antipsychotics: Safety, Effectiveness, and Policy Challenges" Stephen Crystal and coauthors document the increased use of SGAs on the two ends of the age spectrum, the nation’s youth and the elderly in nursing homes. When the researchers examined youth in seven state Medicaid programs, they found that 4.2 percent of enrollees ages 6-17 filled at least one prescription for an antipsychotic medication in 2004, up from 2.7 percent in 2001. Virtually all of the antipsychotics used were SGAs.

Read article here

Clinical indications approved by the Food and Drug Administration for antipsychotics in young people are limited to schizophrenia, behavioral symptoms in autism, Tourette’s disorder, and mixed or manic bipolar episodes. But in 2004, one-third of the youth in the seven Medicaid programs studied were being treated for attention deficit hyperactivity disorder without diagnostic codes for more-serious diagnoses such as schizophrenia, autism or bipolar disorder, according to Crystal, director of the Center for Education and Research on Mental Health Therapeutics in the Center for Pharmacotherapy at Rutgers University, and colleagues. Overall, almost three-quarters of Medicaid youth receiving antipsychotics were being treated only for conditions for which no FDA clinical indication existed. The results were similar among privately insured youth.

 

Likewise, among elderly nursing home residents, most use was for residents without an FDA diagnostic indication, and use increased from 1999 to 2006 despite new safety concerns including FDA warnings of increased mortality associated with use among elderly with dementia. Among nursing home residents in 2006, 27.6 percent were receiving antipsychotics, up from 20.2 percent in 1999.

Increasing Information To Ease Resistance To Practice Changes. In "Developing A Policy For Second-Generation Antipsychotic Drugs," Robert Rosenheck and Michael Sernyak report that many SGAs were prescribed for questionable reasons at one university-affiliated Veterans Affairs health center caring for veterans with serious mental illness. "The most frequent reasons given for prescribing SGAs … were greater efficacy, followed by patient preference and sedation/sleep, none of which is well-supported by current research. In contrast, prevention of neurological side effects – the reason for using SGAs with the strongest research support – was the least frequently cited reason for starting a new SGA," say Rosenheck, codirector of the New England Mental Illness Research, Education, and Clinical Center at the VA Connecticut Health Care System, and Sernyak, chief of the Mental Health Service at the VA Connecticut Health Care System.

Read article here

Rosenheck and Sernyak suggest that the most appropriate policy would be "stepped therapy," in which patients would have to start on first-generation antipsychotics and would only be allowed to try the SGAs with the most risk of side effects if other drugs had failed to help them. However, this policy would be likely to meet resistance, the authors acknowledge. They suggest that "counter-detailing, with its emphasis on individualized education and direct feedback, may be crucial in garnering the understanding and needed support for successful implementation of meaningful practice change."


Notice, no measure of individual response or outcomes..

Whereas David Meltzer and co. note what happens when individual responses to individual drugs are counted...

The Need For More Comparative Effectiveness Research. In "Comparative Effectiveness Research for Antipsychotic Medications: How Much Is Enough?" David Meltzer and coauthors examine a high-profile study funded by the National Institutes of Health that has been used to argue for restricting coverage of SGAs. In 2006, a cost-effectiveness analysis based on this study – known as the Clinical Antipsychotic Trials of Intervention Effectiveness study, or CATIE – found that "treatment with perphenazine [a first-generation antipsychotic] was less costly than treatment with second-generation antipsychotics with no significant differences in measures of effectiveness." 

Read more here

However, there are a number of concerns about CATIE’s design that create "great uncertainty about the extent to which CATIE findings should be used to make coverage policy," write Meltzer, Director of the Center for Health and the Social Sciences at the University of Chicago, and colleagues. The authors present a model that they say indicates that additional comparative effective research involving SGAs would be of immense value – exceeding $300 billion – to those who have schizophrenia today and to those who will develop it over the next 20 years. The model also suggests that it would be worthwhile to perform studies of the effectiveness of SGAs with much larger sample sizes than CATIE, on the order of 8,300 patients in each treatment group as opposed to the 400 patients per group in CATIE. The model indicates that studies of cost-effectiveness should be even larger and would offer the greatest value.

Larger?  I don't think so.  I think spending money developing/testing predictive and biomarker based tools in observational settings would be a lot cheaper.  

What are people thinking? 

After the embargo lifts, you can read the article by Crystal and coauthors at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w770

After the embargo lifts, you can read the article by Rosenheck and Sernyak at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w782

After the embargo lifts, you can read the article by Meltzer and coauthors at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.28.5.w794

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The Three Urban Myths of Healthcare Reform

07/21/2009 12:04 PM |

When it comes to healthcare reform, as Aldous Huxley said, “Facts do not cease to exist because they are ignored.”

Three of the most common “urban myths” of American healthcare are that:

1. The lower life expectancy in the U.S. “proves” the total inadequacy of our system;
2. There are 47 million uninsured Americans — proving the inequity of our system; and
3. We spend “too much” on health care — proving the wastefulness of our system.

For the rest of the story, see this new op-ed, part of the Reuters’s “Great Debate” series on healthcare reform.

As the old saying goes, everything you read in the newspaper is true, except for those things you know about personally. Healthcare reform is too important (and too complicated) to permit reform by sound bite.


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Show me the money ... but how much?

07/21/2009 11:56 AM |

The AP reports that the FDA -- "which has struggled to fulfill its mission of regulating food, drugs, and other consumer goods that make up nearly a quarter of the US economy -- does not have the expertise to forecast its own budget needs," GAO officials say. "While many lawmakers and consumer advocates have long complained that the agency lacks the staff and equipment to accomplish its mission," according to the GAO, the FDA "doesn't even have 'the data to develop a complete and reliable estimate of the resources it needs.'" FDA officials said that "they are working to get a better picture of the agency's spending and how much additional funding it needs." Dr. Joshua Sharfstein, FDA deputy commissioner, said, "We have to be able to talk about the funds we need, and how we're using the money, with more detail than FDA has in the past." He noted that the agency is already "working to keep better track of how the agency uses its funding," saying, "We've actually been working on this since we started here, but it's a big agency and it's going to take some work to get to the level of detail people want."
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Incomplete Headline

07/20/2009 12:29 PM |

Front page, top of fold article in today's edition of the Wall Street Journal Marketplace section.  Headline reads, "Drug Makers Criticized for Co-Pay Subsidies."

Then, when you read the article, you see that those doing the criticizing are ... insurance companies while those doing the praising are ... patients.

Why not a headline that reads, "Patients Praise Drug Makers for Co-Pay Subsidies."

I know -- man bites dog.
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Dean of all Lobbyists?

07/20/2009 11:00 AM |

Steve Usdin reports in BioCentury:

 

“In bending political opinion about biosimilars, BIO benefited from the services of prominent Democrats, most notably former Democratic National Committee chair and former Vermont Gov. Howard Dean, and perennial Democratic presidential campaign manager Joe Trippi, as well as well-placed lobbying firms. Trippi and Dean are not registered as lobbyists. Their activity, which supplemented the efforts of BIO’s in-house and external lobbyists, may not have met the legal criteria for requiring registration, but it was aimed at influencing the views and votes of members of Congress.”

 

“Dean, who represents the progressive, or more liberal, wing of the Democratic Party, surprised many on the political left by writing a commentary on biosimilars that was published in the July 8 issue of The Hill, a newspaper that is widely read on Capitol Hill. Dean repeated BIO’s talking points on biosimilars, contending that a “commonsense and fair approach, similar to the process and timeline currently in place for generic versions of chemical-based medicines, would allow the original developer of the biologic to protect the proprietary data used to develop the medicine for at least 12 years.” Dean, who attacked pharmaceutical company profits during his 2004 presidential campaign, wrote in the commentary that a “shorter exclusivity period would prematurely rob biotech innovators of their intellectual property and destroy incentives to develop new cure.” The Hill identified Dean as a physician, ‘former Vermont governor, Democratic National Committee chairman and presidential candidate,’ but did not mention any relationship with BIO.”

 

"In his e-mail to board members, Greenwood did not fail to include Dean in his praise. ‘Our team at BIO, the D.C. offices of our members, our consultants (now including former Vermont Governor and Democratic National Committee Chairman Howard Dean) did a magnificent job,’ he wrote. Dean told BioCentury last week that he provides ‘long-term and short-term strategic advice to BIO. I do not lobby.’ ”

 

In the same article Usdin also reports:

 

“Speaking at a briefing last week at the Center for Medicine in the Public Interest, Rep. Anna Eshoo (D-Calif.) said she plans to introduce a version of her Pathway for Biosimilars Act (H.R. 1548) as an amendment during Energy and Commerce Committee markup of its draft healthcare reform legislation.

The Eshoo amendment, which hasn’t been publicly released, “embodies the strengths of both H.R. 1548, as well as the recently passed Hatch/Enzi/Hagan Amendment at the HELP Senate Committee,” Greenwood noted in a July 16 letter of support for the Eshoo amendment.”

 

“The Eshoo amendment combines the 12-year exclusivity provisions passed by HELP last week “while also retaining the important provisions in H.R. 1548 aimed at avoiding patient and provider confusion over biosimilar products and ensuring patent disputes will be resolved prior to the expiry of data exclusivity.’ “

 

“Greenwood’s letter stated. H.R. 1548 requires that all biosimilars be assigned a unique international non-proprietary name (INN) rather than adopt the INN for the reference product as is the case for generic drugs. BIO has advocated for unique INNs, while biosimilars manufacturers oppose this as a barrier to interchangeability. Eshoo seems to have lined up enough support in the Energy and Commerce Committee to get the amendment passed — 23 of its 59 members are co-sponsors — if a vote is taken.”

 

CMPI (the public policy home of drugwonks.com) was proud to have sponsored that event (which also included comments by Representative Mike Rogers (R, MI), the Honorable Mike Ferguson, Former Vice-Chairman of the House Health Subcommittee (and a CMPI senior fellow), John F. Crowley, CEO, Amicus Therapeutics, Founder, CrowleyFamily5.com, and Dr. Geno Merli, Senior Vice President & Chief Medical Officer, Thomas Jefferson University, and Director, Jefferson Center for Vascular Diseases.

 

Video of this event will be available shortly on www.cmpi.org

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Beware the Social Media Maginot Line

07/17/2009 04:40 PM |

The Internet is agnostic. It’s a library without a librarian. The Internet is agnostic to truth, accuracy, and spelling. So, when we talk about social media, it’s imperative to view it separate and apart from “the agnostic Internet.” Social media uses the Internet as its delivery mechanism and is anything but agnostic. The Internet is not social media – it is the playing field of social media.

If the Battle of Waterloo was won on the playing-fields of Eton, wither the battle of social media and healthcare? While everyone else is using social media as a healthcare communications blitzkrieg, or “lightening war,” regulated industry is digging in for a sitzkrieg, a “sitting war.”

This is not good news for pharma, physicians, or patients. Social media is driven in real time by facts (often wrong), statistics (regularly misunderstood), snake oil salesmen (wearing white coats), and just plain folks looking for information from a variety of sources – the most important being each other. Social media is the newest arrow in the quiver of social marketing, but it’s a discipline both misunderstood and frightening to those operating in the heavily regulated world of healthcare.

Pharma mustn’t feel safe behind a social media Maginot Line strategy.

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The AMA Pseudo-Endorsement

07/16/2009 11:59 PM |

Democrats are touting the fact that the AMA has signed on to their health care reform effort. But is the AMA really representing the views of its members, or are they playing a Washington game: currying favor with the Democrat majority, in the hopes that when negotiators decide who’ll pay for national health care, they’re not left holding the bill? Here’s one suggestion that the AMA leadership may be getting ahead of its rank and file:

Concerned that the American Medical Association has taken too tepid a position on Democratic healthcare reform plans, a coalition of state medical associations and specialty organizations is breaking from the country’s largest physicians’ group to mount its own push against the inclusion of a public insurance option in any overhaul bill.

Seventeen state medical associations and three specialty physicians’ groups planned a conference call late Wednesday to discuss a draft letter that would go much further than the AMA’s more measured responses to the public option.

The AMA has made clear it is not opposed to a public plan, but would resist a Medicare-like program that mandates physician participation and pays less than their costs..

The draft letter, written by members of the Medical Association of Georgia, says flatly that the physicians’ groups unequivocally oppose a government-administered insurance plan, as well as use of government-funded effectiveness tests, or “comparative effectiveness research,” to dictate which medical procedures should be eligible for coverage…

A Republican aide familiar with the coalition’s concerns said the physicians’ groups especially worry that AMA’s position on public option language in the House’s developing legislation has been “too squishy…”

“Physicians have been offered a seat at the table so long as we sit still with our hands folded in our laps and keep our mouths shut,” wrote John Black president of the South Carolina association, and Gary Delaney, the group’s chairman. “The muzzle that the Feds placed on us must be removed and the decibel level of our voices must be raised so that we are unmistakably heard.”

In addition to Georgia and South Carolina, state medical associations from New Jersey, Florida, Arkansas, Virginia and 10 other states and the District of Columbia planned to discuss the letter and consider signing it.

The Triological Society and the American Academy of Facial Plastic and Reconstructive Surgery were also invited to participate in Wednesday’s discussion, said a spokeswoman for the Georgia group.

Seventeen state associations are considering separating themselves from the national AMA to make clear that they oppose a government-run plan. That doesn’t completely devalue the AMA’s position, but it certainly makes you wonder what could have caused such a sudden and dramatic reversal. Given the threats Democrats have been leveling against groups that refuse to cooperate with their agenda, it would be no surprise if the AMA’s leadership simply calculated that it would be more dangerous to fight than to give in.

We’ll know in the next few days how many state associations are willing to buck their leadership and sign on to this letter. I wonder how much attention that will receive.

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Reid: Between the Lines

07/16/2009 08:24 PM |

The Wall Street Journal reports that:

"Top Senate Democrats were critical Thursday of comments made by the director of the nonpartisan Congressional Budget Office that existing reform plans wouldn't curb federal spending on health care. CBO Director Douglas Elmendorf told lawmakers on the Senate Budget Committee earlier Thursday morning that legislation approved this week by a Senate panel wouldn't reduce the federal government's spending on health care. "And on the contrary, the legislation significantly expands the federal responsibility for health care costs," Mr. Elmendorf said. Mr. Elmendorf went on to say that there is widespread support among health analysts for taxing health care benefits as a way to reduce federal outgoings on health care. Taxing individuals' health care benefits is extremely unpopular among many Democratic lawmakers. Asked about the assessment, Senate Majority Leader Harry Reid (D., Nev.), quipped that Mr. Elmendorf should consider running for Congress."

Senator Reid, what do you mean by that remark?

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Trillion Dollar Baby

07/16/2009 11:26 AM |

That healthcare reform bill just released by Democratic House leaders calls for a public insurance option which would negotiate rates directly with providers, including drug firms.

It's in Subtitle B Section 224, which says: "The Secretary also has authority to negotiate prescription drug prices for the public option."

Direct negotiations? For some things to consider, see today’s edition of the Washington Examiner.

"Direct negotiations" means price controls. And price controls = choice controls.

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Don't fix the blame, fix the problem

07/15/2009 02:58 PM |

Pharmaceutical marketers are in a tough spot when it comes to social media. On the one hand, they understand the importance and opportunity of it. On the other, they are restrained and frustrated by a number of barriers, including actual and implied ones from the FDA, and self-imposed ones from the nabobs of “no” (aka MLR – medical legal review). Anti-depressants anyone?

Social media is a social movement, and using the excuse that pharma can’t engage because, “We’re different,” misses the point. Compliance issues are very important, but it’s precisely because of the “special differences” that pharmaceutical companies must engage actively and creatively in social media. And that difference is the responsibility of advancing the public health.

Don’t pin all the blame on MLR. They’re on board. As the head of one large pharma’s MLR department commented to me, “We have to talk to our customers where they are – and they are in social media.”

MLR looks at risk, but is marketing presenting the benefits? And what about the FDA?  The agency is certainly sending mixed messages. Yet, a senior Center for Drug Evaluation and Research (CDER) official said at the Drug Information Association (DIA) meeting last month: “The FDA does not want to stifle the use of social media.” Good news? We’ll see.

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Comparative Dyslexia

07/15/2009 12:49 AM |

This, in the preamble of section about the public plan in the House Dem bill....

"the Secretary’s primary responsibility is to create a low-cost plan without comprimising quality or access to care. "

So, not only do members not have to read the bill (per Mr. Hoyer) -- spelling no longer counts.

Perhaps the IOM should commission a study on the correlation between spelling errors and medical errors.
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Of Cuckoo Clocks and Market Health Care

07/14/2009 02:59 PM |

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Bend This!

07/14/2009 12:24 PM |

Peter Orzsag is more responsible than anyone for peddling the nonsense that comparative effectiveness research can save $700 billion over ten years and asserting that slowing health care costs are key to economic prosperity... 

I bring this up again, because...

New tests may help spot early-stage Alzheimer's

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By Julie Steenhuysen

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...

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