Medical Progress Today
  Volume 1, Number 21
  December 17, 2004


Featured News:
Chemical Compound Shows Promise Against Tuberculosis; New Medicine Is Best Hope Against Disease in 40 Years
Washington Post, 12-10-04
Featured Commentary:
The High Cost of Cheap Drugs
Jacob Arfwedson, Wall Street Journal Europe, 12-13-04
Featured Research:
Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer
ATAC Trialists' Group, The Lancet , 12-8-04

News

Certain Type of Breast Cancer Drug Shows Better Result in Study
The New York Times, 12-9-04

Research interest continues to build in a novel class of breast cancer drugs called aromatase inhibitors, which block the production of estrogen in body tissues. A new study, published in the medical journal The Lancet, found that “aromatase inhibitors [were] more effective in preventing breast cancer recurrence in women past menopause than was tamoxifen, a medication now prescribed by many doctors.” The study tested the drug Arimidex (made by AstraZeneca) against tamoxifen (available in both brand and generic forms) in more than 9,000 women over five years. The study was financed by AstraZeneca.

Survival rates in the study were basically the same between Arimidex and tamoxifen groups. However, “the group that took Arimidex reduced the chances of their cancer spreading by 14 percent and were 42 percent less likely than women on tamoxifen to develop a tumor in the other breast. They also suffered fewer side effects like blood clots, hot flashes, and endometrial cancer.”

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Genetic Mutation Tied to Depression, Drug Response
Wall Street Journal, 12-10-04

Duke University researchers have identified a gene that “appears to make people more likely to suffer major depression and less likely to respond to treatment with antidepressants. The test could lead to a gene test to identify such individuals, and possibly new ways to treat them.” The gene is called TPH2 and is involved in the brain’s production of serotonin, a neurotransmitter. The mutated version produces “80% less serotonin than normal.”

Of course finding a gene is only the first step; many people may carry the gene without major depression, and others may have major depression and not carry the gene. Even after identifying the gene, the Duke researchers checked 300 people to see if it was linked to symptoms of depression. Out of nearly 90 patients with major depression, only 9 (about 10%) had the gene; out of these, “seven had not responded to antidepressant drugs and two only responded to very high doses.”

The finding is important because it may lead to a test to identify patients whose treatment is resistant to current therapies, and lead to new treatments. This is critical because currently “about 20% of patients with major depression don’t respond to antidepressants, according to Thomas R. Insel, director of the National Institute of Mental Health.”

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Chemical Compound Shows Promise Against Tuberculosis; New Medicine Is Best Hope Against Disease in 40 Years
Washington Post, 12-10-04

A new compound – with the inglorious name R207910 – has shown early promise in animal tests of becoming a powerful treatment for tuberculosis, “the second leading cause of death worldwide, surpassed only by AIDS.”

In a study reported in the journal Science, “the compound easily overcame the two biggest hurdles facing TB therapies today: their ineffectiveness against resistant strains and the long period of treatment required to achieve a cure.” The current three drug cocktail used against TB is over 40 years old, and must be taken every day for 6-9 months, leading to serious problems with patient compliance. When patients stop taking the drugs before all the TB bacteria in their bodies have been killed, drug resistant strains of the bacteria emerge. One researcher speculated that the new compound, used in conjunction with two drugs from the old cocktail, might shorten treatment duration by 50%.

The drug also doesn’t interfere with the body’s metabolism of several important AIDS drugs, a side of effect of one of the drugs in the current cocktail. That is a critical benefit since more than 11 million people worldwide have both diseases, and TB often hastens death in AIDS patients.

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Nonprofit Drug Company Gets Gates Grant to Target Malaria
Wall Street Journal, 12-13-04

The Institute for OneWorld Health, a nonprofit drug company devoted to creating affordable and accessible cures for diseases that afflict the world’s poorest nations, is expected to receive a $42.6 million dollar grant from the Bill and Melinda Gates Foundation a develop a synthetic version of the antimalarial drug artemisinin.

Artemisinin is currently harvested from a Chinese shrub, a very time-consuming and expensive process. The Institute for OneWorld Health worked with a chemical engineer at the University of California at Berkeley to genetically engineer E. coli bacteria to produce artemisinin. Later, the “the university issued a royalty-free license to OneWorld Health and Amyris Biotechnologies, a private Biotech company in Emeryville, Calif., which will begin scaling up production of the synthetic artemisinin compound. In return, Amyris has agreed to sell the drug at cost. OneWorld will handle drug development and regulatory work to demonstrate that the synthetic version is equivalent to the natural product.”

OneWorld is a promising example of the new philanthropic partnerships and innovative thinking required to bring new medicines to developing nations that are unable to afford standard treatments.

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Making Vaccines Good Business
The New York Times, 12-12-04

The authors of a new book on infectious diseases in developing nations, Strong Medicine: Creating Incentives for Pharmaceutical Research on Neglected Diseases, “argue [that] Western governments and foundations should make a legally binding promise to pharmaceutical and biotech companies: if you invent a safe and effective vaccine for malaria, tuberculosis or H.I.V., we'll buy the first (say) 200 million doses at a respectable profit-guaranteeing price. One great virtue of this scheme, the authors suggest, is that the public would pay for only a successful product. If a company invests millions in research but fails to develop a vaccine that meets the contract's specifications, no money would change hands.”

This is basically the way markets work now: no company gets a return on its investment for a drug that fails to meet FDA approval. The difference is that developing nations are often poor markets to begin with, with little money to spend on even critical medicines. Compounding the problem is that drug companies are leery of investing hundreds of millions of dollars in developing a new product only to see its patent overturned by governments eager to make the drug themselves at a huge discount.

The bottom line: the absence of financial incentives hinders research and deployment of new medicines in developing nations. Rather than berating companies for not being charities, activists and policymakers should find better ways to make markets work. Hopefully, this book will turn out to be an important first step in that direction.

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Commentary

Capital: Time to Cure the Health-Choice Headache
David Wessel, Wall Street Journal, 12-9-04

This article lauds the principle of consumer choice in health insurance, but notes that there is one important element missing that would make it work: easily available, standardized information that would allow consumers to directly compare health insurance costs and benefits without wading through an ocean of confusing jargon. Wessel says that after reviewing the employer sponsored insurance plans offered by his and his wife’s employers he threw up his hands in frustration. “I majored in economics in college . . . [but] after staring at the grids our employers provided, I surrendered: There was no way I could make a rational choice, and it’s not just because its impossible to predict if someone in the family will get sick next year.”

Wessel discovers that the government’s Office of Personnel Management has found a simple way to help millions of federal employees pick the right plan for themselves. The OPM “told all insurers who want to pitch to federal employees to organize information the same way to make it easier for people to compare [plans and options].” He goes on to ask, “is it so unreasonable to ask big employers and insurance companies to come to a similar compact for the rest of us so they all use the same understandable acronym free-language to describe their offerings?”

It certainly isn’t unreasonable, but one of the forces inhibiting standardization is that employers usually only offer one or two plans to their employees, and thus have little incentive to require standardization from providers. If, on the other hand, as in the federal government, employees could choose from dozens of plans, insurers would have powerful incentives to make their offerings employee friendly. Health savings accounts (controlled by individuals, not employers) should help to spur more consumer friendly insurance information, but additional help from Congress is needed, i.e. creating a single health insurance market for the entire nation. Once insurers could offer plans on a national basis, they’d have powerful incentives to standardize the way they present their policies to consumers.

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Minnesota's Health Care Gamble
David Broder, Washington Post, 12-9-04

In Minnesota, Republican Governor Tim Pawlenty has helped to create the “Smart Buy Alliance,” “an unprecedented partnership of state government and private employers that will mobilize the purchasing power of three out of every five consumers in Minnesota to raise the quality, improve the efficiency and reduce the cost of health care.”

Frustrated by rapidly rising public health care costs (by 2016 public health care expenditures could consume 85% of the Minnesota state budget) Pawlenty is using health savings accounts and performance data on health care providers to help spur innovation and efficiency. Although each member of the Smart Buy Alliance will be able to negotiate its own contracts with providers, “by setting uniform performance standards and reporting requirements, the alliance will empower its members to press for better coordination of treatment, more use of technology and fuller information to consumers about the results each hospital or doctors’ group is achieving for its patients.” Says Pawlenty, “We’ll do this by harnessing market forces, without a new government bureaucracy micromanaging what providers do.”

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No Silver Bullet
Grace-Marie Turner, Galen Institute, 12-10-04

Grace Marie-Turner, founder and president of the Galen Institute, writes that allowing individual tax deductions for all health care expenses, an idea recently floated on the editorial pages of The Wall Street Journal, is no silver bullet for America’s health care crisis.

“While reforming the tax treatment of health insurance is much needed, full tax deductibility would not produce fairness…since the progressive tax system automatically builds in unfairness.” In other words, affluent tax payers would get a much larger deduction for their health care spending than citizens in lower income tax brackets, who may not even have the initial resources to make health insurance purchases out-of-pocket.

Turner thinks that free market advocates can do better by providing “refundable tax credits to the uninsured. A tax credit of $1,000 is worth $1,000 to that person in the 15% tax bracket, giving him more resources and a bigger boost to purchase health insurance.” Tax deductions, on the other hand, do little for low-income Americans and might encourage “affluent Americans to push up health costs by heavily subsidizing every dollar they spend on health care and health insurance.”

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Fixing Medicare
Laurence J. Kotlikoff, Forbes, 12-13-04

Kotlikoff offers a novel idea for making Medicare and Medicaid solvent as the nation’s huge baby-boomer generation ages and then retires: vouchers.

The government would end the current Medicare/Medicaid fee-for-service schedule for those programs and then offer vouchers to buy insurance based on health condition and (presumably) some form of means testing. That way, insurers would have an incentive to take in sick patients, and still keep the lid on health care costs. The vouchers would only increase as fast as rising wages, no faster. Kotlikoff says that under his plan “competition among insurers would ensure that participants got the best care per voucher or dollar spent. And the insurers would have an incentive to keep their customers from overusing the health care system, which would help restrain the growth in health care costs throughout the country.”

We think that Kotlikoff’s plan, as described, while an interesting idea, is overbroad. Most people should be encouraged to save for health care expenditures through health savings accounts; there is no reason for the government to provide blanket coverage for the many citizens who can afford to pay for it themselves. However, vouchers are an excellent idea for low-income Americans who couldn’t afford to purchase health insurance without some assistance, and might even help them build equity for retirement.

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The Bell Curve
Atul Gawande, The New Yorker, 12-11-04

This article is a must-read for anyone interested in personalized medicine, consumer-driven health care, and the practice of medicine in general. The classic “bell curve” dictates that for any given performance measurement there will be a balanced distribution of outcomes: about 20% at the low end, 60% in the middle, and 20% at the high end. When it comes to medicine, this means that there will be (for heart disease, cancer, cystic fibrosis) “a handful of teams with disturbingly poor outcomes for their patients, a handful with remarkably good results, and a great undistinguished middle.”

For instance, Gawande tells us, “a Scottish study of patients with treatable colon cancer found that the ten-year survival rate ranged from a high of sixty-three percent to a low of twenty percent, depending on the surgeon.” The question, then, is which doctor would you want to treat yourself and your loved ones: an average doctor or an excellent one?

The answer is obvious but getting to the point where medical care is driven by the outlying high-performers is another story entirely.

For most of medicine’s history, doctors have operated (literally and figuratively) behind a veil of ignorance separating practitioners from patients, with the patient assuming that they were getting state of the art care. However, as we collect more and more data on risk-adjusted patient outcomes, the illusion of omnicompetence that surrounds doctors and hospitals is evaporating – and generating plenty of angst in the profession as well.

Not everyone is greeting the change with apprehension. Donald Berwick, the head of a nonprofit organization called the Institute for Healthcare Improvement, is looking for better and better ways to improve patient care – and is focused on making more information available to the public. He calls it “going naked.” Berwick believes that “to fix medicine”, “we need to do two things: measure ourselves and be more open about what we are doing.” He believes that “openness would drive improvement, if simply through embarrassment.”

This is exactly the argument that advocates of market-driven medicine have been making for years; the only difference is that health care providers have had, until now, few parameters for success and little inclination to expose themselves to outside scrutiny. However, as health care costs rise, consumers and policymakers are demanding that health care providers be paid for performance, not fee-for-service.

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The High Cost of Cheap Drugs
Jacob Arfwedson, Wall Street Journal Europe, 12-13-04

Arfwedson reminds his European readers of a painful truth: the once-innovative European pharmaceutical industry is a shell of its former glory. Why? “Price controls and reimportation.” Thanks to these two policies EU pharmaceutical companies have seen their global market share for R&D shrink from 32% to 22% over the last decade. The big winner from these socialist-inspired policies is not the European consumer, but the U.S., which has experienced a windfall in biotech and pharmaceutical investment during the same period and where more new drugs are now first launched than anywhere else in the world.

Unfortunately, U.S. policymakers at both the state and federal level are not letting Europe’s failed experiment deter their efforts to bring price controls and reimportation to the U.S. Arfwedson warns Americans that the “short term benefits [of these policies] are likely to be outweighed by the negative longer-term effects of approving price controls. Reimportation may be good for politicians re-election chances, but not for the health of their constituents.”

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U.S. Health Care Needs a Spark
Newt Gingrich, The Philadelphia Inquirer, 12-15-04

Gingrich believes that it is high time that the United States learns to think of its investments in health care as a golden economic opportunity, rather than a lamentable state of affairs that should be rectified as soon as possible.

"Despite America's well-documented health-care delivery problems, America's actual health care is the best in the world. U.S. firms are responsible for some of the most important innovations in pharmacology and medical technology. Wealthy foreigners routinely come to the United States for advanced medical services with the best possible outcomes. To take advantage of this position, President Bush should create a new undersecretary for health in the Department of Commerce to promote the American system of health care worldwide.”

America’s gain, however, has been met with apprehension by other countries like Japan and France “who have recently imposed what are called ‘foreign reference prices’ on U.S. technology that prevent firms from pricing products at a rate appropriate to the actual costs of doing business in their countries. Fewer than 1 percent of U.S. products launched in Japan over the last 10 years have received a new product price distinct from its predecessor, resulting in an unfair disadvantage for U.S. manufacturers.”

The newly created undersecretary for health “would have the important task of ensuring that overseas markets provide a level playing field for exports of the U.S. health economy. He or she could help break down these barriers by accelerating patient access to medical innovations; encouraging robust research and development opportunities (much of which is spurred by small U.S. start-up firms that require venture capital); ERM promoting transparent and consistent product approval policies at home and abroad; and helping ensure predictable pricing that consistently rewards innovation.”

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Research

Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer
ATAC Trialists' Group, The Lancet , 12-8-04

As noted above, the standard treatment for postmenopausal women with hormone-receptor-positive localised breast cancer is 5 years of tamoxifen, but “recurrences and side-effects restrict its usefulness.”

In this study, “the aromatase inhibitor anastrozole was compared with tamoxifen for 5 years in 9366 postmenopausal women with localised breast cancer. After a median follow-up of 68 months, anastrozole significantly prolonged disease-free survival...and time-to-recurrence...and significantly reduced distant metastases...and contralateral breast cancers.” In addition, there were fewer patient withdrawals from the aromatase inhibitors than with tamoxifen thanks to fewer side-effects, “especially gynaecological problems and vascular events, but arthralgia and fractures were increased.” The study concludes that anastrozole “should be the preferred initial treatment for postmenopausal women with localised hormone-receptor-positive breast cancer.”

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A Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast Cancer
Soonmyung Paik, M.D., New England Journal of Medicine , 12-10-04

Researchers here tested the likelihood of distant cancer recurrence in breast cancer patients with no involved lymph nodes and estrogen-receptor-positive tumors. They used the results of a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of 21 genes (16 cancer related and 5 reference genes) in tumor tissue from each patient to prospectively define a “cancer recurrence score” and create a risk profile for each patient in the study.

“The proportions of patients categorized as having a low, intermediate, or high risk by the RT-PCR assay were 51, 22, and 27 percent respectively…In a multivariate Cox model, the recurrence score provided significant predictive power that was independent of age and tumor size. The recurrence score was also predictive of overall survival…and could be used as a continuous function to predict distant recurrence in individual patients.”

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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.

Press inquiries regarding Medical Progress Today can be directed to Lindsay Young, executive director, communications at communications@manhattan-institute.org, or via telephone at 212.599.7000, x315.

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NEWS

Certain Type of Breast Cancer Drug Shows Better Result in Study
Genetic Mutation Tied to Depression, Drug Response
Chemical Compound Shows Promise Against Tuberculosis; New Medicine Is Best Hope Against Disease in 40 Years
Nonprofit Drug Company Gets Gates Grant to Target Malaria
Making Vaccines Good Business

COMMENTARY

Capital: Time to Cure the Health-Choice Headache
Minnesota's Health Care Gamble
No Silver Bullet
Fixing Medicare
The Bell Curve
The High Cost of Cheap Drugs
U.S. Health Care Needs a Spark

RESEARCH

Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer
A Multigene Assay to Predict Recurrence of Tamoxifen-Treated, Node-Negative Breast Cancer
Center for Medical Progress 
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