Medical Progress Today
  Volume 2, Number 4
  January 28, 2005


In the Spotlight

Simple, but Effective

David Gratzer, Wall Street Journal, 1-25-05

The health care agenda of the second Bush term is immense, and the administration can begin by pushing a simple idea that won't cost a penny from the treasury: Allow interstate sales of health insurance.

Continue reading . . .


Featured News:
New Medicare Drug Rules Balance Access and Costs
The New York Times, 1-22-05
Featured Commentary:
Call 'Negotiated' Drug Prices What They Really Are: Price Controls
Benjamin Zycher, Ph.D., Los Angeles Times, 1-21-05
Featured Research:
More Evidence on Cardiovascular Risks of COX-2 Inhibitors, Other NSAIDs
Medscape , 1-26-05

News

The Informed Patient: Are Treatment Guidelines Reliable?
Wall Street Journal, 1-26-05

A relatively recent study from the RAND institute found that “Americans receive only about 55% of recommended care for a variety of common [health] conditions, and data from experts at Dartmouth show that medical care is often overused, underused, or misused.”

As a correction to this problem, some experts advise greater use of clinical guidelines, or so called evidence-based medicine: “Medical societies, state health groups and academic medical centers are scrambling to churn out new guidelines for everything from asthma to depression based on the latest medical studies, as are a number of for-profit companies that package guidelines to sell to insurers and employers.”

Doctors, however, have proved to be notoriously resistant to guidelines from on high, and patients tend to trust their doctors. Also, there is some concern that cost-cutting bureaucrats will tout treatment standards that are good for budgets, not patients.

What can be done to ensure better patient care? Put the patient in control. Consumer driven health care, linked to information initiatives that compare health provider performance, will force physicians to compete on quality.

If patients can spend their hard-earned dollars on medical care as they see fit, they will become savvy medical purchasers, much the way that consumers now shop for houses, or cars. Will every patient become an expert? They don’t have to. Studies have shown that quality improvements in industries generally follow when the savviest buyers set trends that the rest follow.

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Merck Plans to Start Phase II Of AIDS-Vaccine Human Trials -- Scientists to Test Prototype Deemed Most Promising For Safety, Effectiveness
Wall Street Journal, 1-25-05

Merck’s new vaccine, called MRKAd5, uses a harmless virus loaded with copies of three key HIV genes to prime the human immune system to attack the virus. “Researchers hope that these three genes will spark killer cells, known as cytotoxic T-cells, to destroy human cells infected by HIV, the human immune-deficiency virus that causes AIDS.”

Merck is testing its AIDS vaccine in 1,500 volunteers in North America, Latin America, Australia and the Caribbean. These trials are called “Phase II” trials, and are primarily designed to gauge safety outcomes and establish baseline effectiveness. “The study will compare the response of volunteers given three injections of the vaccine over six months against a [placebo group]. The study is expected to last at least 4 ½ years, and will examine infection rates, as well as severity of disease in the two groups.”

Researchers aren’t expecting this vaccine to be a magic bullet – different versions of the AIDS virus have different gene copies, meaning that a vaccine effective in North America might not work in Africa - but if the vaccine elicits an effective antibody response against the virus it will be a very important step forward.

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Study by Vioxx Critic Links Drug to Extra Coronary Cases
Wall Street Journal, 1-25-05

Let’s assume, for a moment, that estimates by FDA official David Graham that Vioxx may have caused 140,000 excess cases of heart disease before it was withdrawn from the U.S. last September are correct, and that Vioxx users “had a 34% higher chance of coronary heart disease when compared with people who used other anti-inflammatory drugs.”

Still, this is 140,000 cases out of the estimated 20 million Americans who took Vioxx at one time or another – meaning that the overall risk for any individual Vioxx user was roughly .007%. Further more, this risk was probably correlated with other genetic or environmental factors that we could identify and perhaps weed out through careful prescribing patterns.

Should Vioxx have been prescribed to 20 million people? Almost certainly not, although the blame doesn’t entirely lay with Merck (insurers and doctors should also shoulder some of the blame.) However, some of the 19,960,000 people who took Vioxx truly needed it and got real benefit from the drug.

For those people, the removal of Vioxx from the market did more harm than good.

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Few seniors use Web for health info; Many of those 65 and older are missing out on discounts and online resources, a study finds.
Los Angeles Times, 1-24-05

Many of the complaints regarding the temporary Medicare drug benefit card program have focused on its complexity. Now we know why: new research seems to show that many seniors over 65 aren’t computer literate, and this hampers their ability to navigate the program effectively.

“About 30% of people aged 65 and older have gone online, compared with 70% of those age 50 to 64, according to the Kaiser Family Foundation study, released earlier this month.”

Computer literacy is the key to finding the best prices for medicines, and also for collecting important information on medical treatments that is often just a key-stroke away. Of course, this problem will be alleviated when the Medicare drug benefit comes online next year.

However, it also bodes well that folks under 65 – and certainly their children and grandchildren – are internet savvy, and can navigate the Web as easily as their parents could walk down to the neighborhood drugstore. Better access to information leads to smarter consumers, and smarter consumers will demand that health care is as cheap and effective as possible.

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New Medicare Drug Rules Balance Access and Costs
The New York Times, 1-22-05

The Centers for Medicare and Medicaid Services have released new compliance rules for private insurers who will be managing the Medicare drug benefit when it takes effect in 2006. The rules appear designed to ensure all the parties with a stake in the program – pharmaceutical companies, patients, insurers – will find something to like about the program.

Since it is relatively fair, it will also draw plenty of criticism.

“On many issues, the rules strike a balance between competing interests. On the one hand, the rules say that every prescription drug plan must provide ‘adequate coverage of the types of drugs most commonly needed’ by Medicare beneficiaries….On the other hand, the rules say that a plan can establish a list of preferred drugs and can refuse to pay for other medicines.” The final word, however goes to doctors, who can prescribe any medicine they wish provided they certify that it is “medically necessary for a patient.”

Still, these rules are only a small first step in a long reform process that Dr. Mark McClellan (the Medicare Administrator) has embarked on to ensure that Medicare dollars are spent as effectively as possible. The agency is also collecting reams of information on patient outcomes for many common health conditions and treatments that will be used to set up “best practices” guidelines for Medicare providers. In the long run, better spending through information management will drive down overall costs and ensure that seniors are getting the best health care possible.

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Pfizer Delays Cox-2 Polyp Drug Amid Safety Review in Europe
Wall Street Journal, 1-21-05

The European Medical Agency is delaying the introduction of a COX-2 drug in Europe (Onsenal) that prevents colon polyps, precancerous growths that may eventually become life-threatening colon cancer. The EMA is concerned that Onsenal (basically a higher dosage of the painkiller Celebrex) may cause excess heart attacks in some patients. This is certainly a fair enough question to ask on its face, although the data on Celebrex and heart attacks is mixed.

However, if the EMA removes Onsenal from the market altogether it would turn out to be a very troubling development. After all, shouldn’t patients at high risk of developing colon cancer decide for themselves if the relative trade-offs are worth it? Shouldn’t they be able to consult with their doctors, rather than be forced to accept the diktat of a Brussels bureaucrat?

Put another way, why is it that Europeans can smoke, eat red meat to their heart’s content, and drive absurdly fast on the Autobahn but the EMA may still prevent them from buying a life-saving drug in consultation with their own physicians?

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Cancer Passes Heart Disease as Top Killer
The New York Times, 1-20-05

Despite the article’s alarming title, mortality rates for both cancer and heart disease have been falling thanks to the ever growing ability of doctors to treat and detect both diseases before they become fatal. Cancer may now be America’s leading killer, but only because we’ve made more progress treating heart disease than cancer.

Still, “cancer rates have declined about 1 percent each year since 1999,” and we’ve made tremendous advances in treatments for specific diseases like breast cancer and leukemia.

We also stand to gain enormously in the next few years as researchers refine new technologies that can pinpoint the specific genes and proteins involved in the development of cancer and devise powerful new targeted treatments that can annihilate cancer cells with minimal side-effects for healthy tissues.

The fly in the ointment is the FDA itself, which approves new cancer treatments. As Scott Gottlieb at the American Enterprise Institute has pointed out recently, there is growing evidence that the FDA is reacting to widespread criticism by raising the bar for cancer treatments up for accelerated approval. If this happens, the end result will be that new cancer treatments will take longer to reach market and more patients will die waiting.

All of our vaunted cancer-killing technologies will come to naught if the FDA becomes more serious about avoiding criticism than it is about curing disease.

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Commentary

The Gates Vaccinations
Washington Post, 1-25-05

The Post points out that aid from rich nations to poor nations is subject to many confounding factors; for instance, money to buy school textbooks is useless if there are no teachers to teach, or if parents send their children to work in the fields instead of going to class.

However, vaccination programs avoid these conundrums: once a vaccination is given, the effect is locked in. Consequently, “vaccinations offer some of the clearest development wins, and [explains] why the Bill and Melinda Gates Foundation is right to devote huge resources to them.” The resources are indeed massive: to date, the Gates Foundation has devoted to about $1.5 billion to providing vaccines for poor nations, a sum so massive it has changed the financial incentives for the vaccine industry. “Before, the industry had little reason to manufacture vaccines for which there might be no market; after, a multimillion-dollar pot of cash hung like a carrot in front of drug companies.”

Thanks to market incentives like these, companies are doing more research on vaccines that disproportionately effect poor nations. The example the Gates Foundation is setting is commendable and effective and other donors should follow their lead.

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HSAs Are A-OK
Andy Laperriere, Wall Street Journal, 1-24-05

Laperriere endorses President Bush’s plan for controlling health care costs by putting patients in control of their own routine health care spending through Health Savings Accounts. Currently, “most patients have no idea how much medical procedures, tests, doctor visits or even prescription drugs actually cost” because someone else inevitably pays the bill.

“The bottom line is this: The biggest beneficiary of consumer-driven health care will be the patient. Not only will consumers benefit from lower health care costs, but HSAs will inevitably shift decision making away from employers and insurance companies to patients, who will have more control over one of the most important aspects of their lives – their own health care.”

TOP^

The Budget Health Shock
Sebastian Mallaby, Washington Post, 1-24-05

A new study has shown that implantable cardioverter-defibrillators can save lives, and the Bush Administration has said that it will implant them in Medicare patients who need them. Cost to taxpayers: $3 billion to $15 billion annually.

Pricey, right? Maybe not. Mallaby cites research from several different sources showing how targeted spending that reduces heart disease turns out to be a real bargain in terms of added health and longevity.

Translation: “spending ever growing billions on health care is likely to be worth it.” The problem Mallaby sees is that we’re not taking in enough taxes to pay for the nation’s expanding medical bills. The villain: the Bush tax cuts.

Not true. Medicare was heading into deeply troubled waters well before the Bush tax cuts took effect because states and the federal government have been spending money on Medicare and Medicaid like it was going out of style.

Currently, Medicare is in the midst of a sea-change in how it pays for care and allocates its dollars by setting better treatment guidelines and only paying for treatments that are cost-effective. More savings can be had by shifting the nation towards consumer-driven health care through Health Savings Accounts, and requiring that every American purchase health insurance. Through these and other market driven policies, we can limit government spending to a true insurance model, i.e. covering costs that individuals can’t.

In other words, taxes won’t solve the Medicare problem – but good policies can.

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The burden of staying alive; It's the drugs you can't get that might kill you
Dr. Scott Gottlieb, Chicago Tribune, 1-21-05

Gottlieb points out (from personal experience) that the FDA is a punching bag for a small army of interests who gain from portraying the agency as a hapless lackey of big pharmaceutical companies.

The result? Every time the FDA is accused of moving too fast, it suddenly shifts into tortoise mode - across the board, including for new cancer treatments. Gottlieb says that a “new policy promulgated by the FDA will effectively raise the bar for approving new cancer drugs, meaning cancer medicines may take many more years to come to market, if they make it at all.”

The lesson learned: while agency critics may applaud a slower FDA, patients will die waiting for it to speed up again.

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Call 'Negotiated' Drug Prices What They Really Are: Price Controls
Benjamin Zycher, Ph.D., Los Angeles Times, 1-21-05

Should the government negotiate with drug manufacturers for better prices for America’s seniors? What could possibly be wrong with negotiation?

Well, try negotiating with an 800 pound gorilla that will roll right over you if you don’t “negotiate” with it. Zycher points out that “under the 1992 Veterans Health Care Act, two price constraints are imposed upon pharmaceutical manufacturers in dealing with the [Department of Veterans Affairs]: There is a minimum 24% discount off the ‘non-federal average manufacturer price.’ And there also is the Federal Supply Schedule, or FSS, requirement that the pharmaceutical producers sell drugs to the VA at the ‘best price’ offered to private sector buyers.”

In other words, the government largely tilts the playing field to its advantage; sellers have play ball unless they want to lose a very big chunk of their market share. The VA system has drug price controls – they just call it negotiation. And study after study confirms that price controls reduce R&D, leading to fewer new medicines for future patients. This means that future cancer, Alzheimer’s, and AIDS patients lose out because they aren’t here yet to object to how the government “negotiates” with drug companies.

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Research

More Evidence on Cardiovascular Risks of COX-2 Inhibitors, Other NSAIDs
Medscape , 1-26-05

This article recounts the findings of four studies on COX-2 inhibitors and other NSAIDS (along with an accompanying editorial) in the January 24 issue of the Archives of Internal Medicine.

The first study found that “patients taking warfarin [a blood thinner] concomitantly with selective Cox-2 inhibitors have an increased risk of hospitalization for upper GI hemorrhage,” although the “risk appears similar to that of patients simultaneously taking warfarin and non-selective NSAIDs.”

The second study found that after COX-2 inhibitors were introduced on the market there was a “rapid nationwide shift away from older, inexpensive drugs with better established safety and efficacy to newer, costly drugs with no real history [of safety]…by millions of people with little or nothing to gain from long-term use.” The study found that for doctor’s visits after which a COX-2 inhibitor or NSAID was prescribed, “the frequency of COX-2 inhibitor use increased from 35%” in 1999 to 61% in 2002.

The third study, an observational cohort “looking at the cardiovascular risk of COX-2 inhibitors compared with nonspecific NSAIDs” found that, overall, COX-2 use showed no significant effect on cardiovascular thrombotic events after treatment. “The investigators concluded that COX-2 inhibitors did not increase cardiovascular risk over nonnaproxen NSAIDS in this population.” (The population was “high risk”: 70% female, 50% African American, and 30% older than 50 years.)

The fourth study found that in patients with type 2 diabetes, hypertension, and osteoarthritis, “patients mean systolic blood pressure was increased significantly by rofecoxib…but not by celecoxib…or naproxen. Furthermore, the proportion of patients with controlled hypertension at baseline who developed ambulatory hypertension was significantly greater with rofecoxib (30%) than with celecoxib (16%), but not significantly greater with naproxen (19%).”

The editorial accompanying the studies concluded that “the current [FDA] postmarketing surveillance system does not work…The [FDA] will need to be more effective in requiring specially designed premarketing clinical safety trials when phase II or small phase III trials suggest reasons for specific concerns. Such a system should be rapidly responsive and objective, and safeguards to protect this agenda against industry influence must be put in place.”

TOP^

Imatinib Manipulation Modifies Resistant Leukemia
Medscape , 1-24-05

In the January 1 issue of Cancer, researchers reported that Gleevec resistant cancer cells, which over express the gene BCR-ABL, can be killed when Gleevec treatment is actually halted. “Abrupt withdrawal of the BCR-ABL inhibitor [Gleevec] from resistant leukemia cells leads to apoptosis of these BCR-ABL overexpressing cells.”

Ironically, Gleevec resistant cells were weakened by the discontinuation of Gleevec treatment; researchers theorize that this weakness “could be exploited” to make these cells more vulnerable to other forms of treatment.

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Medical Progress Today is published by the Center for Medical Progress at the Manhattan Institute for Policy Research.

For more information about Medical Progress Today, please contact the managing editor, Paul Howard, at phoward@manhattan-institute.org, or via telephone at 212.599.7000, x319.

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HOME

SPOTLIGHT

Simple, but Effective

NEWS

The Informed Patient: Are Treatment Guidelines Reliable?
Merck Plans to Start Phase II Of AIDS-Vaccine Human Trials -- Scientists to Test Prototype Deemed Most Promising For Safety, Effectiveness
Study by Vioxx Critic Links Drug to Extra Coronary Cases
Few seniors use Web for health info; Many of those 65 and older are missing out on discounts and online resources, a study finds.
New Medicare Drug Rules Balance Access and Costs
Pfizer Delays Cox-2 Polyp Drug Amid Safety Review in Europe
Cancer Passes Heart Disease as Top Killer

COMMENTARY

The Gates Vaccinations
HSAs Are A-OK
The Budget Health Shock
The burden of staying alive; It's the drugs you can't get that might kill you
Call 'Negotiated' Drug Prices What They Really Are: Price Controls

RESEARCH

More Evidence on Cardiovascular Risks of COX-2 Inhibitors, Other NSAIDs
Imatinib Manipulation Modifies Resistant Leukemia
Center for Medical Progress 
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New York, NY 10017
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