Diagnosis Without Treatment: The Perils of New Tests for Early Alzheimer’s Disease

 In April, an independent panel established by the National
Institutes of Health came to the disheartening conclusion that currently, there
is nothing to prevent or delay the progress of Alzheimer’s disease in those of
us who are destined to join the 5 million Americans currently suffering from
this dreaded ailment.

The panel 
found that: “Although numerous interventions have been suggested to
delay Alzheimer’s disease, the evidence is inadequate to conclude that any are
effective.” Members rejected scientific evidence supporting the influence of
nutritional supplements, herbal products, dietary factors, pharmaceuticals,
medical conditions or even environmental exposures on the risk of contracting Alzheimer’s.

Now, just three months later, it turns out that there are
big developments in the Alzheimer’s field—just not in new treatments. At a conference
in Honolulu sponsored earlier this month by the National Institute on Aging and
the Alzheimer’s Disease Association, researchers from three working groups announced
that by using new imaging technologies, genetic testing, and tests of blood and cerebrospinal fluid, it will soon be far easier to diagnose
Alzheimer’s— in some cases decades before symptoms have even appeared. These
new tests are able to identify so-called biomarkers—amyloid plaques in the
brain, genetic variants, proteins and other substances in body fluids—that signal
a newly defined "pre-clinical" stage of Alzheimer's, when an individual has no symptoms but has positive
biomarkers for the disease.  

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Obama’s National AIDS Plan Is Short on Funding For Most Vulnerable

This week the White House unveiled its new national plan to cut HIV infections and curb the AIDS epidemic. The plan, the first ever since AIDS emerged on the scene some 30 years ago, has the goal of  "intensifying HIV prevention efforts in communities where HIV is most concentrated;” specifically in the gay and African-American communities who are disproportionately affected by the disease. It also aims to increase access to treatment and mount "a more coordinated national response to the HIV epidemic."

Some specific goals from the National AIDS Plan include:

  • Reduce new infection rates by 25 percent by 2015.
  • Devote $30 million from the health care reform law to reducing infection rates.
  • Link 85 percent of those who are HIV-positive to care within three months of being diagnosed.
  • Provide $25 million in funding to help states pay for drugs to treat HIV

This plan, which took 15 months to draw up and included input from 14 community forums around the country, is a good start and helps put the fight against AIDS back on the national radar. Some 1.1 million Americans are currently infected with HIV and infection rates haven’t budged since the mid-1990s. After hitting a peak of 130,000 new infections a year in the 1980’s, the rate dropped to 49,000 a year in the early 1990’s, according to the Centers for Disease Control. But in the past decade this number has increased and remains at 56,000 new infections each year. Meanwhile, in 1995, 44% of Americans indicated that HIV/AIDS was the most urgent health problem facing the country; in March 2009 that number had plummeted to only 6%.

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Illicit Drugs on Campus Are Increasingly the Rx Variety

Here’s something that frankly, disturbed me. My daughter, who just finished her freshman year in college, recently told me, “I can’t believe how many kids at school take prescription drugs on a regular basis. They take Adderall to help them study, Ambien to get to sleep and Xanax to calm down.” It surprised me that at 18 she even knew all the names of these drugs. Had she said that her fellow students were using marijuana or even ecstasy I wouldn’t have been as shocked. Those are the kinds of drugs you expect to find–along with copious amounts of alcohol–on college campuses.

But this sounded like prescription pills were freely available—prescribed to students with attention-deficit diagnoses or some other mental health problem, (or swiped from parent’s medicine cabinet or obtained on-line) and then traded around like loose cigarettes at a frat party.

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A Permanent “Doc-Fix” Remains Elusive

For now, all those physicians who threatened to make a mass exodus from Medicare can take a breather. Last week, the House voted to once again delay the mandated 21% cut in physician fees by another six months; thereby ensuring that the fight over the sustainable growth rate (SGR) will be resurrected sometime around Thanksgiving.

So far, Congress has kicked the SGR can down the road 10 times since 2003—four times just this year alone. The targets have long been considered unobtainable and the mandated physician payment cuts are opposed in Congress by Democrats as well as Republicans and supported by nearly no one. The level of anxiety among doctors continues to escalate every time the issue is raised—even though the cuts have never gone into effect for more than a couple of weeks. Why not get rid of this devilishly frustrating formula once and for all?

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Are Doctors Really Boycotting Medicare?

As Congress once again wrestles with “the doctor fix”—yet another postponement of the 21% cut in Medicare reimbursement that went into effect this month—the media has been swirling with stories warning of a mass exodus of doctors out of the federal program. The reason: In 2008 Medicare paid doctors 78% of what they get from private insurers; with the 21% cut they fear that their income will drop even lower.

The reports hit their peak late last week—USA Today wrote that “[t]he number of doctors refusing new Medicare patients because of low government payment rates is setting a new high,” while the American Medical Association announced that 31% of primary care doctors are restricting the number of Medicare patients they take. In a recent survey, the American Academy of Family Physicians found that 13% of respondents didn't participate in Medicare last year, up from 8% in 2008 and 6% in 2004. Chic Older, executive director of the Arizona Medical Association told the Seattle Times ; "If the 21 percent cut goes into effect, we're going to have a very severe problem in the state of Arizona."

The question is: Will Medicare beneficiaries really face a shortage of providers and restrictions on their access to care? Or is this a scare tactic being used for political reasons?

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Medication and Kids: A Growth Industry

Children have become the new growth industry for
prescription drug makers. A study released last month by the pharmacy benefit
manager Medco found that 26% of kids under 19—almost
30% of those aged 10 to 19—are now taking prescription medications for a
chronic condition. Meanwhile, spending on prescription drugs for children
increased by almost 11% last year, the largest increase experienced by all
segments of the market, including the elderly. Although asthma drugs are the
still the most commonly prescribed therapeutics, kids are increasingly being
prescribed drugs that are decidedly uncommon for such young patients: atypical
anti-psychotics, diabetes drugs, anti-hypertensives, cholesterol medications
and heartburn drugs—expensive therapeutics that in the past were rarely used
outside of adult populations.

The Medco figures are alarming first of all because
intuitively it just feels wrong that so many children are downing prescription
pills along with their morning multivitamin and orange juice. Kids are supposed
to be healthy, full of energy, free spirited. But increasingly, this is not the
case. More than 17% of adolescents (10-19 year olds) are now classified as
obese: in fact, a whopping one out of three kids is considered overweight or
obese. And obesity brings with it a raft of formerly adult chronic
conditions.  According to a fact
sheet
provided by the Institute of Medicine, in one population-based sample some 60% of obese children aged 5 to 10 years
had at least one cardiovascular disease risk factor—including high levels of
total cholesterol, triglycerides, insulin, or high blood pressure—and 25
percent had two or more of these risk factors.

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Shining a Light on Conflict of Interest in Biomedical Research

Last week Francis Collins, the director of the National Institutes of Health proposed important new rule changes for federally-funded investigators that are designed to increase transparency and remove many of the conflicts of interest that abound in biomedical research.

The proposed NIH rules, which are open for comment and expected to go into effect before the end of the year, represent the first time financial reporting requirements have been overhauled since 1995. The rules require investigators to disclose to their institutions all payments they receive from industry above $5,000, as well as any equity position they hold in a company. Research funding, speaking fees, paid authorship and travel expenses all must be part of this accounting. The previous limit was $10,000. The new regulations, which are aimed at reducing or removing industry bias from academic research, also require the academic medical centers to come up with a plan to manage investigator’s conflicts of interest—for example, university officials might insist that an investigator sell stock he owns in a company that helps pay for his research. Institutions will also be required to post all relevant payments (along with names of individual investigators) on a public website.

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“Better Safe Than Sorry”: Taking Precautionary Action on Environmental Toxins

Last week I wrote about the President’s Cancer Panel Report which highlighted the “grievous harm” caused by environmental carcinogens and urged action that included removing the toxins from our food, water, and air that “devastate American lives.”

Achieving this is will be no easy task for a nation whose primary tool for regulating chemicals, the Toxic Substances Control Act (TSCA), was added last year to a list of government programs at “high risk” of failure by the Government Accounting Office. The Cancer Panel authors write that TSCA, passed in 1976, is a weak law that doesn’t provide the Environmental Protection Agency with enough authority and “may be the most egregious example of ineffective regulation of environmental contaminants.”

When the Act was passed, some 62,000 chemicals already on the market were declared “safe”, even though there was little or no data to support this policy. Every year another 1,000 chemicals are introduced onto the market—usually with little toxicity testing. The net result: Only 2% of the 80,000 to 100,000 chemicals currently in use have been tested for carcinogenicity and other toxicity.

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Cancer Panel Focuses on the “Grievous Harm” from Environmental Toxins

The recent report from the President’s Cancer Panel, entitled “Reducing Environmental Cancer Risk,”  took the bold step of focusing on environmental toxins and their role in causing cancer. In it, the authors charge that “the grievous harm from this group of carcinogens has not been addressed adequately by the National Cancer Program” and they urge the President “to use the power of your office to remove the carcinogens and other toxins from our food, water, and air that needlessly increase healthcare costs, cripple our nation's productivity, and devastate American lives.”

Much of the media chose to highlight the “personal responsibility” aspects of the panel’s recommendations for reducing cancer risk: Eating organic foods, avoiding toxic cleaning products, buying phthalate-free toys, filtering drinking water and avoiding unneeded medical scans, among other suggestions that are practical mostly for an upper-middle-class, educated audience–the media's target group.

But the Panel’s welcome—if surprising—endorsement of “green” living is not what makes the 200-plus page report so groundbreaking. What the authors have dared to do is call for a fundamental shift in direction for cancer research and prevention; away from the relentless pursuit of chemotherapy drugs and other treatments that provide incremental benefits—weeks or months of survival for a limited group at enormous cost—and toward an approach that focuses on taking meaningful steps toward reducing risk and preventing disease in the first place. They write:

“Environmental exposures that increase the national cancer burden do not represent a new front in the ongoing war on cancer. However, the grievous harm from this group of carcinogens has not been addressed adequately by the National Cancer Program. The American people—even before they are born—are bombarded continually with myriad combinations of these dangerous exposures.”

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Worn Carpets and Peeling Walls: The Trials of A Fox News Medical Contributor

Pity poor Marc Siegel, a hard-working, primary care doctor who is facing hard times. “As the months drag on, and my office expenses continue to increase, my patients will find that I am barely able to continue to keep my office open. Many will grow more disappointed as my carpeting grows worn and my wallpaper begins to peel,” he writes in a commentary this week for Forbes.

Struggling to survive on dwindling reimbursement from Medicare, routinely having to tell patients that insurance won’t cover their name-brand prescription drugs and batteries of diagnostic tests, Siegel, who is based in Manhattan, says he can’t even think about accepting Medicaid patients.

For him, health care reform offers no salvo for this sad state of affairs; he might have to close up shop. In fact, in Siegel’s view, health reform is not only an unmitigated disaster, it’s something more sinister as well; “the government is plotting to spread expensive insurance to pay for low-tech care for the entire population.” Government plots, low-tech care for the entire population? Hmm, who is this Marc Siegel after all?

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