Medical Progress Today
  Volume 1, Number 7
  August 26, 2004


In the Spotlight

Prescription Against Medical Terror
Robert Goldberg, Ph.D., 8-26-04

Acting Food and Drug Administration Commissioner Lester Crawford has recently expressed concern that terrorists might attack the nation's medicine supply. He's right to alert Americans to this possibility, but his warning merely reinforces the difficulty of ensuring the safety of drugs purchased over the Internet. Before Congress considers drug importation legislation, it should enact stringent measures to protect America's most vulnerable targets – sick children and seniors – from this possible threat.

continue reading . . .

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Featured News:

Discounted drugs urged for uninsured Californians; Official rejects Canadian medications as illegal
The San Diego Union-Tribune, 8-20-04

Featured Commentary:

Commentary: How to Heal Health Care
Hillary Clinton, Bill Frist, Washington Post, 8-25-04

Featured Research:

Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial
The Lancet, August 2004


News

Bookshelf: Fighting Disease Is Only Half the Battle
Wall Street Journal, 8-25-04

This is a very well written and lucid dissection of Marcia Angell's new book, The Truth About the Drug Companies, which seems, by all accounts, much less about truth and more about eviscerating the role of market incentives in medicine.

As Miller acknolwedges, there are many pharmaceutical industry practices that could be changed for the better but, in "large part these strategies are the result of the industry's being the victim of government policies, not the beneficiary." When it comes to regulation, incentives are everything, and big pharma reacts exactly as you would expect it to given the regulatory incentives it labors under. Angell's prescription, a fatal one for medical innovation, is not to reform the regulations, but to turn the industry into a quasi-governmental entity. This would be the worse of all possible worlds, and we should avoid it as such.

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15 Illnesses Drive Up Costs Conditions Linked to 56% of Increase in Health Care Bills
Washington Post, 8-25-04

In a new study published in Health Affairs, Emory University health economist Kenneth E. Thorpe revealed that 15 conditions accounted for over half (56 percent) of the $200 billion increase in U.S. health care spending from 1987-2000. Five conditions (heart disease, pulmonary conditions, mental disorders, cancer, and hypertension) accounted for one-third of the increase.

However, Thorpe was careful to note that some increased expenses, for instance on prescription drugs and angioplasty for hearth disease, decreased overall costs. "Higher spending on heart attacks, low-birth weight babies, cataracts, and depression has benefits that out weigh the costs", Thorpe noted. Thorpe's prescription? "[A] stronger emphasis on prevention and following 'best practices' guidelines" that would reduce total costs and improve patient health.

The problem America faces now is that health care is reactive, rather than preventive or "proactive" because of the way financial incentives for third party payors are structured. If you are sick, providers get paid for every test and treatment, regardless of their true effectiveness. If you never get sick, insurers get to keep the premium. The answer: put consumers in charge of their own health care through HSAs. That would give consumers better incentives to improve their own health (through exercise and diet) and put pressure on providers and insurers to offer improved care.

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IN BRIEF
Washington Post, 8-25-04

Human Genome Sciences (Rockville, Maryland) has begun phase 1 clinical trials (which test safety and establish dose-tolerability) of a new anticancer drug, HGS-TR2J. HGS-TR2J is a monoclonal antibody that is designed to bind to the TRAIL (tumor necrosis factor apoptosis inducing ligand) 2 receptor in solid malignancies.

In layman's terms, the drug is a targeted antibody that will, hopefully, cause cancer cells to self-destruct. "Numerous nonclinical studies have shown that cell lines derived from a broad array of solid and hematological human tumors, including lung, colon, breast, multiple myeloma, prostate and pancreas, are sensitive to killing by apoptosis (programmed cell death) induced by native TRAIL or by agonistic antibodies to TRAIL Receptors." HGS-TR2J, and a wide range of other chemotherapy drugs in development are designed to attack cancers without affecting healthy tissues. More information on the clinical trial is available at http://www.hgsi.com/news/press/04-08-24_HGS-TR2J.htm.

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FDA Will Seek To Revise Labels For Antidepressants
Wall Street Journal, 8-20-04

Actual suicide rates among adolescents have been declining since the mid-1990s, which roughly correlates with a surge in anti-depressant prescriptions for pediatric use. However, recent data analysis by some anti-depressant makers and FDA researchers has called into question the risk-benefit profile for these drugs. Some studies indicate that there may an increased risk of suicidal thoughts and tendencies among teens on anti-depressants, and that some anti-depressants don't perform as well as placebos in pediatric patients.

When this story first emerged, the FDA asked Columbia University researchers to review the results of nine clinical trials and sort out the conflicting evidence. The Columbia researchers have concluded that, overall, trial participants on anti-depressants "were 1.78 times more likely to have suicidal thoughts or actions if they were taking the drugs, compared to those taking placebo pills." It should be noted, however, that rates varied by the anti-depressant prescribed and that no teenagers actually committed suicide during the course of any of the trials.

The only consensus that seems to emerging is that Prozac is probably the best first line treatment for pediatric depression. To date, Prozac is also "the only major antidepressant that won an FDA-approved label for treating depression in young people." An FDA advisory meeting on the study’s findings and possible labeling changes for antidepressants is scheduled for September 13-14, 2004.

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Statins Cut Diabetics' Risk of Heart Attacks, Study Finds
Washington Post, 8-20-04

A new study released in the British medical journal Lancet, sponsored primarily by the British government and the British counterpart of the American Diabetes Association, found that patients with type-2 diabetes and normal cholesterol levels could still substantially reduce their risk for heart disease and stroke through statin therapy. After 4 years, patients on the statin drug were 36 percent less likely to have a heart attack; 48 percent less likely to have a stroke; and 37 percent less likely to have any serious adverse cardiovascular event. The study supports earlier research showing that many diabetics could benefit from the drugs even if their cholesterol levels were not considered elevated before treatment. Given the enormous costs of treating heart disease and diabetes, statin drugs are turning out to be medications worth their weight in gold.

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Discounted drugs urged for uninsured Californians; Official rejects Canadian medications as illegal
The San Diego Union-Tribune, 8-20-04

Never having been known as much of a lemming, California Gov. Arnold Schwarzenegger is bucking the national trend of governors rushing to endorse Canadian drug importation through state sponsored programs. Instead, his administration is proposing a sweeping new program that would offer uninsured, low-income Californians access to already established "free drug programs sponsored by pharmaceutical companies and [would] renew efforts by the state to use its leverage to negotiate discounts." Bravo to the governor, who is once again thinking outside the box.

An official spokesman for the governor hit the nail on the head: passing drug importation legislation in California "would at best be a symbolic gesture that would never be implemented and never bring relief to Californians who desperately need assistance." California is home to many of the nation's leading biotech firms and Gov. Schwarzenegger knows that importing Canadian price controls into his state isn't going to do the industry any favors. The bottom line is that policymakers have to change the fact that Americans single-handedly finance the bulk of the world’s drug R&D. Until that happens, the governor's plan should offer the state's low-income uninsured residents real access at an affordable price.

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Medicare Proposal May Aid Insurers - Preliminary List of Drugs For New Benefits Could Be A Blow to Manufacturers
Wall Street Journal, 8-19-04

Health care in America is largely what the ancient Greeks would refer to as gigantomachia – a battle of the titans between government, insurers, and pharmaceutical companies where the mere mortals (that is, consumers) are, for the most part, relegated to the sidelines.

Under the new Medicare law, the U.S. Pharmacopeial Convention Inc. has the task of devising a blueprint for which therapeutic classes of prescription drugs will be covered by Medicare starting in 2006. The law mandates that insurers must cover at least two drugs in each class; hence, the larger the number of therapeutic classes, the larger number of drugs that insurers have to cover for Medicare beneficiaries.

A larger number of narrowly defined classes benefits the pharmaceutical industry. Fewer classes and broader classes, that lump together older generic drugs with newer medications, would tend to benefit insurers by keeping down prescription drug costs. Drug companies want about 200 classes; insurers and pharmacy benefit managers want about 50 to 90.

The USP's first draft appears to split the difference (with about 146 classes), and the Centers for Medicare and Medicaid Services may tinker with the final list even more. Still, the final draft will no doubt provide plenty of fodder for critics from every corner.

Is this the best way of funneling prescription drugs to patients? Probably not. Drug quality and value, after all, should be determined by patients, not the pharma companies or the insurers. However, because patients don't pay for their own care, decisions about coverage inevitably become political firefights. Health Savings Accounts would solve this problem by having consumers pay for routine prescriptions, with catastrophic costs covered by insurance. Patients would then have powerful incentives to choose the most cost-effective medications available, not necessarily the cheapest or the newest.

Until consumer driven health care becomes a reality, the gigantomachia will go on, with patients caught in the middle.

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A Test Predicts Breast-Cancer Survival - Inexpensive Blood Screen May Emerge as Key Tool In Choosing Treatments
Wall Street Journal, 8-19-04

Immunicon Corp., a Pennsylvania company, has developed a blood test that can measure the number of tumor cells circulating in the blood stream of patients with metastatic breast cancer. The test should be available for patients as early as this fall.

The number of circulating tumor cells is a remarkably accurate biomarker for the aggressiveness of metastatic cancers; "women with five or more tumor cells in a small test tube of blood died in an average of 10 months. That compares with more than 18 months for those with fewer than five tumor cells in their blood."

Doctors hope that this test will help physicians determine more quickly – in a matter of weeks as opposed to months – if a given treatment is working. The test is also significantly cheaper than imaging tests like PET scans. Biomarkers like this one are at the forefront "personalized medicine": fine-tuning treatments to respond to a patients individual disease or genetic profile. The pharmaceutical industry is rushing to find dozens of other biomarkers that will help determine at an early stage whether potential drug compounds are worth further research. Private sector investment in biomarker research is helping to save lives, drive down costs, and expand the frontiers of human biology.

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Irish officials: prescription drug import plan "unusual"
Associated Press Newswires, 8-19-04

Illinois Gov. Rod Blagojevich's program to import prescription drugs from Canada, Ireland and the U.K. is running into more problems every day. The latest misstep by the program was revealed when it was discovered that, in point of fact, mail order sales of prescription drugs is illegal in Ireland. The governor's office apparently had not contacted the Irish Medicines Board to notify them of its plan in advance of putting it into operation. Blagojevich's office said that the Illinois program would circumvent Irish laws by buying from wholesalers instead of pharmacies. "The drugs would then be funneled through pharmacies in the U.K., where such sales are legal."

Legal niceties aside, the governor's plan is having the ironic effect of showing exactly how impractical drug importation really is. A representative from Ireland's biggest pharmaceutical trade association called the governor's plan "unworkable and impractical" because it would force Irish consumers to compete with American buyers, potentially causing drug shortages and driving up Irish drug prices. Anne Nolan, chief executive of the Irish Pharmaceutical Healthcare association said that the governor’s program, if successful, "would cause enormous problems for us to meet our local obligations here."

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EUROPE'S gag reflex - Drug companies in Europe fight to take their message to the masses
The Star-Ledger, 8-18-04

Direct-to-consumer prescription drug advertising is illegal in the European Union, except for information inserted directly into prescription drug packaging. The ostensible reason advanced by European regulators is that drug advertising in the U.S. creates irrational prescribing patterns by physicians. The truth is that member states in the E.U. ration their prescription drug budgets, often introducing newer, more effective drugs years after they have been approved by regulators. The result: cancer drugs like Taxol and Gleevec may take years longer to reach consumers than in the U.S., where drugs reach market quickly after being approved by the FDA. If the Europeans were to allow drug companies to pass information on effectiveness directly to patients, they would be forced to admit that cost, not patient care, was the driving force behind drug coverage decisions in the E.U. And that is the last thing they want to happen.

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Catching The Bad Bug
Forbes, 8-16-04

Critics of the pharmaceutical industry like to tout the ability of government researchers to drive biomedical innovation to the extent that private invest comes across as superfluous. If this is true, why is there such a dearth of vaccines and medicines to treat bioterror weapons like anthrax? Isn't this one area of research, riddled by true market failures, where government researchers ought to be radically outperforming industry?

Alas, they are not – and policymakers recognize that government has to create market incentives for private industry to commit wholeheartedly to biodefense innovation. Project Bioshield, signed into law by President Bush in January, has created a ten-year $5.6 billion fund to stockpile treatments for smallpox, botulism, and anthrax. Still, large pharmaceutical companies are holding back on biodefense research projects because the government, during the 2001 anthrax attacks, forced Bayer to slash the price of one of the few truly effective anthrax treatments, Cipro. This sent a signal to the market that the government wouldn’t let industry recoup its biodefense research costs if there was an actual attack.

Senators Orrin Hatch and Joseph Lieberman are trying to draw larger companies into the biodefense market by offering better incentives, for instance tax credits, blanket liability protections for bioterror treatments, and even patent extensions for blockbuster drugs (like statins) already on market. Until the government makes it clear that industry profits in this critical sector will be honored, biodefense research will remain agonizingly slow.

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Commentary

Commentary: How to Heal Health Care
Hillary Clinton, Bill Frist, Washington Post, 8-25-04

This op-ed calls for government to lead the way in modernizing health care markets through "federal investment in health information technology and quality standards", including "interoperability standards so systems can communicate with each other, privacy protections, targeted investment and payment systems that reward quality care."

Fair enough, and well said. But if consumers are to become the real drivers of high-quality care – as Senators Frist and Clinton envision – they need market leverage. And that means putting health care purchasing power directly into the hands of every American through universal Health Savings Accounts, along with tax credits for low-income Americans to buy their own health insurance. Until then, technology upgrades and operability standards won't benefit the stakeholders in the current system – the providers and insurers who get paid whether care is good or bad, written in pencil and paper or transmitted via electrons. Until patients have the same power that consumers in every other market have, stakeholders won't have the incentives to provide better quality treatments and services.

Commentary: In search of the next old thing - The copycat culture of America's drug industry
Marcia Angell, The Star-Ledger, 8-22-04

For a more detailed engagement with Marcia Angell's new book, see book review by Henry Miller. But briefly, there are two main points to Angell’s argument.

The first is that truly innovative drugs are largely developed through government funded research, not industry. The second is that the pharmaceutical industry deals in copycat drugs that are minimally, if at all, different from older (and cheaper) drugs already on market. Her solution to both problems: the FDA should force pharma companies to test new drugs and old drugs in head to head clinical trials before allowing new treatments on market. She argues that this would lower the price of drugs and force companies to create truly innovative medications.

If the first was true, why don't we see a blizzard of new drugs for all of the orphan diseases that industry doesn't see a viable market for? After all, nothing prevents government from coming up with innovative treatments for those diseases. Government doesn't do that (and won't) because drug development is tremendously difficult and expensive. Governments know that most of their efforts in these areas would go for naught, and so they don't bother. Taking private industry to task for not doing something that even governments (with their vastly larger resources) don't do is not only unfair, it misses the point.

Drug development is complex, expensive, unpredictable and time consuming—to the tune of about $800 million dollars and 10 years per product that actually reaches the market. If governments had to shoulder those costs global drug development would freeze in its tracks. Solving the problems that Angell complains about when it comes to orphan diseases or anti-infectives, or the sixth statin drug on market, would mean improving the drug discovery process, streamlining regulations, and making it easier for companies to move innovate products through the pipeline – subjects about which Angell has nothing to say.

So, in this immensely difficult financial and regulatory environment imagine going to potential pharmaceutical investors and telling them that from henceforth not only could they waste hundreds of millions of dollars and years of researcher time on a single new product, but, at the end of it, even if they had a workable drug that did benefit patients (thank God!) they would now have to test their candidate against a competitor's drug, or a generic, and that if it wasn't better (Significantly? A little bit? Somewhat?) the FDA would tell them to flush it down the drain.

As an investment vehicle, that doesn’t even pass the laugh test.

Pharmaceutical innovation depends on generating profits on products, and if Marcia Angell wants to kill innovation there is no surer way of doing so than killing profits. Anyone who doubts this point should look at the track record of European based pharma companies, which have become increasingly less innovative as price controls took hold there.

What would patient health look like if you remove the profit motive from pharmaceutical investment? Again, look at Europe. The National Health Service in Britain has price controls on prescription drugs and strictly limits access to new drugs – and has the highest cancer mortality rates in the developed world. Is that the kind of innovation that Angell wants to inflict on American patients?

Editorial: Cover These Treatments
Frank R. Lichtenberg, Washington Post, 8-20-04

When it comes to speed and responsiveness, the federal government is usually about as agile as a Jersey cow knee deep in mud. Sometimes this costs people their lives. According to Frank Lichtenberg, a medical economist at Columbia University, Medicare doesn’t cover some of the latest cancer drugs because they come in oral form, and won’t cover them until Medicare prescription drug coverage takes effect in 2006.

This is a tragic oversight because recent cancer research shows that many breakthrough chemotherapy drugs are available only in oral formulations, or are more effective in oral form. Currently, Medicare only covers cancer drugs given intravenously in a doctor's office. Covering drugs in oral form now would undoubtedly help cut Medicare costs, improve cancer patient care, and lessen the strain on care givers who must transport very sick patients too and from doctor's offices.

The Centers for Medicare and Medicaid Services are in the midst of a sea-change, led by Administrator Mark McClellan, who very much deserves his many accolades. Still, Medicare should find a way to cover these prescription treatments now, rather than in 15 months. Lives depend on it.

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Research

Treatment Of People With Mental Illness: A Decade-Long Perspective
Scott Bilder, David Mechanic,
Health Affairs
August 2004

There has been much made in recent years of a critical shortage of access to mental health services in the U.S. However, this study shows that access to care "has not decreased for people with the most serious conditions where they were more likely to receive specialty mental health care after 2000. Further, once people enter specialty care, the number of visits appears unrelated to need." However, cost pressures – particularly to rein in prescription drug costs – may still pose a threat to patients outside of the most severe categories who require treatment.

Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial
D. John Betteridge, Valentine Charlton-Menys, Helen M. Colhoun, Paul N. Durrington, John H. Fuller, Graham A. Hitman, Shona J. Livingstone, Michael I. Mackness, Andrew W. Neil, Margaret J. Thomason,
The Lancet
August 2004

Patients with type 2 diabetes have a significantly increased risk for cardiovascular disease, but it has been a matter of speculation whether statin treatment would reduce heart attacks or stroke in diabetes patients without high LDL cholesterol. This study's findings in that regard were so significant that it was cut short 2 years ahead of schedule. The results: treatment with statins reduced "acute coronary heart disease by 36%, coronary revascularisations by 31%, and rate of stroke by 48%." Overall, "atorvastatin reduced the death rate by 27%" with "no excess of adverse events."

Recently, guidelines released by U.S. government officials and the American Heart Association recommended that patients at high risk of heart disease consider using statins to lower their cholesterol levels below previous guidelines. These recommendations were attacked by industry critics, who claimed the researchers' findings were tainted by their ties to industry. This study, which seems to support the U.S. findings, was primarily financed by British patient groups and the British government.

Which Medical Conditions Account For The Rise In Health Care Spending?
Curtis S. Florence, Peter Joski, Kenneth E. Thorpe,
Health Affairs
August 2004

A very small number of expensive diseases account for most of the increased growth in health care spending from 1987-2000. In fact, only 5 conditions accounted for 31 percent of the increase. However, despite widespread media concern about increasing health care expenditures, the authors believe that "higher spending on treating heart attacks, low-birthweight babies, cataracts, and depression has benefits that outweigh the increased costs." In other words quality, not cost, ought to be the driving force behind American health care policy.

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

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HOME

SPOTLIGHT

Prescription Against Medical Terror

NEWS

Bookshelf: Fighting Disease Is Only Half the Battle
15 Illnesses Drive Up Costs Conditions Linked to 56% of Increase in Health Care Bills
IN BRIEF
FDA Will Seek To Revise Labels For Antidepressants
Statins Cut Diabetics' Risk of Heart Attacks, Study Finds
Discounted drugs urged for uninsured Californians; Official rejects Canadian medications as illegal
Medicare Proposal May Aid Insurers - Preliminary List of Drugs For New Benefits Could Be A Blow to Manufacturers
A Test Predicts Breast-Cancer Survival - Inexpensive Blood Screen May Emerge as Key Tool In Choosing Treatments
Irish officials: prescription drug import plan "unusual"
EUROPE'S gag reflex - Drug companies in Europe fight to take their message to the masses
Catching The Bad Bug

COMMENTARY

Commentary: How to Heal Health Care
Commentary: In search of the next old thing - The copycat culture of America's drug industry
Editorial: Cover These Treatments

RESEARCH

Treatment Of People With Mental Illness: A Decade-Long Perspective
Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial
Which Medical Conditions Account For The Rise In Health Care Spending?
Center for Medical Progress 
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