Medical Progress Today
  Volume 2, Number 17
  May 2, 2005


In the Spotlight

Congress is stalling real Medicaid reform.
Let the states lead the way.


David Gratzer, Medical Progress Today, 4-29-05

On April 28, House and Senate budget negotiators agreed to follow a recommendation from the National Governor’s Association and cut about $8.6 billion in Medicaid spending next year. They also agreed to create a bipartisan panel to study Medicaid reforms and their effects on the states.

Continue reading . . .


Featured News:
20 arrested in crackdown on Internet drug pipeline
Washington Times, 4-21-05
Featured Commentary:
Taxed to Death
Jasson Urbach, Richard Tren, Roger Bate, AEI-Brookings Joint Center for Regulatory Studies, 4-21-05
Featured Research:
Herceptin® Combined With Chemotherapy Improves Disease-Free Survival for Patients With Early-Stage Breast Cancer
National Cancer Institute, 4-25-05

News

Breast Cancer Recurrence Is Cut in Half by a Drug
The New York Times, 4-26-05

Editor’s Notes:

Herceptin is a targted cancer drug designed to treat the approximately 25 percent of women whose breast cancer has a particular genetic mutation, so-called HER2 positive. Initially, the drug was only approved to treat late-stage cancer, in combination with chemotherapy. A recent study, however, has shown that it reduces recurrence in women whose cancer was caught early by 52 percent compared to chemotherapy alone.

The two trials, which began enrolling patients in 2000, involved a combined total of more than 5,000 women, though the analysis that resulted in the trials' being stopped was based on only 3,300 of them. All were so-called HER2 positive, a reference to the genetic characteristic of the tumors that makes a patient a candidate for Herceptin. All had operable cancer that in most cases had spread to the lymph nodes. All patients were given chemotherapy, and some were also given Herceptin. Dr. Clifford A. Hudis, chief of breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York, called the results ''big news'' because using the drug in early-stage treatment could have an impact on a greater number of women and perhaps help keep them free of cancer.

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Number of Uninsured May Be Overstated, Studies Suggest
Los Angeles Times, 4-26-05

Editor’s Notes:

Health insurance—and the lack thereof—is a hot topic for Washington policymakers. Every few months, it seems, we hear a sermon on the rising number of uninsured. The most recent estimate of 45 million uninsured Americans, however, may be significantly inflated.

Four government surveys attempt to estimate the number of Americans who are without coverage for a full year. The results range from a high of 45 million in the Current Population Survey to a low of 19 million… ."There is an undercount of Medicaid coverage," said Charles T. Nelson, the census official. "We are looking at ways of improving our estimate so people covered by Medicaid report. There are people with coverage out there who are not reporting coverage."


There are still, of course, millions of uninsured Americans. But any rush to expand government coverage could drive private insurers out of the market, and exacerbate the problem.

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A ripple effect for painkillers
Los Angeles Times, 4-25-05

Editor’s Notes:

When it comes to drug safety, everything is truly relative. Pulling nonsteroidal anti-inflammatory painkilling drugs like Vioxx off the market may make sense if we have other painkillers available that are safer for that use. But what if those drugs, which carry a small risk of heart problems for some patients, can have large postive effect on patients at high risk of cancer prevention?

The discovery of a potential cardiovascular risk [for Cox-2 drugs like Vioxx] comes at a time when nonsteroidals have moved into the forefront of [cancer] chemoprevention research. Years of animal studies and observational studies showed the drugs seemed to prevent cancer. Drug companies making nonsteroidal drugs may back away from cancer prevention studies, said Dr. Raymond DuBois, a professor of molecular oncology at Vanderbilt University Medical Center in Nashville. "One of the issues is that when you do a large trial like this they cost upwards of hundreds of thousands of dollars," he said. "They are not going to invest that kind of money when it leads to a negative image."


Halting market access to a promising drug is no way to encourage medical innovation. Hopefully, further research on personalized medicine will help identify which NSAIDs and Cox-2 drugs can be used safely in which patients, allowing research to more forward.

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20 arrested in crackdown on Internet drug pipeline
Washington Times, 4-21-05

Editor’s Notes:

Federal agents broke up a $6 million online smuggling ring yesterday that peddled drugs to tens of thousands of people, mostly teenagers, through at least 20 different Web sites.

These arrests highlight how difficult it is for law enforcement and federal regulators to monitor drug imports. Drug Enforcement Administration Administrator Karen Tandy said that

Today is every parent's nightmare…The Internet has become an open medicine cabinet. Strangers are peddling drugs in your home, and you don't even know it. There is no visit to a doctor, no pharmacist to vouch for the integrity of the medication and no prescription.


Legalizing commercial importation, as Congress is now considering, would only expand opportunities for fraud, counterfeit drug smuggling, and place more American lives at risk. As U.S. Attorney Patrick Meehan notes, "All you need is a keyboard and a credit card and you're able to order drugs like codeine, ketamine [a popular club drug] and steroids."

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Ariad gets FDA cancer drug fast track
Associated Press Newswires, 4-21-05

Editor’s Notes:

While researchers have been making enormous strides in many areas of cancer research and treatment, there are still no effective drug treatments for sarcoma, a type of highly aggressive cancer that attacks bones or soft tissue. Each year 12,000 persons are diagnosed with the disease. Fewer than 15% of patients with metastatic sarcoma survive five years after diagnosis.

Recognizing the need for better sarcoma treatment, the FDA has given Ariad Pharmaceuticals a fast-track designation for its experimental cancer drug, AP23573.

Dr. Harvey Berger, Ariad's chief executive, said that with the accelerated timetable made possible by fast-track designation, the firm might seek final approval for the drug as early as next year, even though another round of clinical trials remains to be completed. The designation means the firm will work more closely with regulators, and may be able to design a final trial with an end point that is easier to reach quickly. …Berger said that compared to traditional chemotherapy drugs, Ariad's experimental treatment has an extraordinarily low incidence of side effects.


As the saying goes, time is money, but when it comes to cancer, time is counted in lives lost before treatments reach the market. Fast track and accelerated approval are needed to expedite new treatments like AP23573 to patients with life threatening diseases.

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Commentary

The 'European disease'
Robert Goldberg, Ph.D., Washington Times, 4-28-05

Robert Goldberg, Ph.D., is a senior fellow at the Manhattan Institute who writes widely on health care issues. In this op-ed, he argues that policymakers who advocate prescription drug-importation and price controls threaten U.S. leadership of the global biopharmaceutical industry.

…European companies that moved here to escape price controls [in Europe] are already preparing to move again, to Asia, if Congress [passes the Pharmaceutical Market Access Act, legalizing drug importation].


Already, one CEO, Sir Tom McKillop, has said that he would relocate his pharmaceutical company Astra Zeneca from the U.S. to India or China if Congress legalizes importation. Mckillop said that "there is real danger for the United States to catch the European disease…Europe lost its prominent position in pharmaceutical research because of policies that favored parallel trading of drugs between states."

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A Lethal Guardian: The Canadian Government's Ban on Prescription Drugs
John R. Graham, The Fraser Institute, 4-28-05

Graham chronicles how regulatory restraints on the availability of new drugs in Canada endangers patient health and well being.

When any new drug is invented and ready for distribution in Canada, the Canadian government responds by enforcing an automatic ban on its use. This ban is removed for patients who need the drug immediately only under extraordinary circumstances. The general ban is only lifted after the manufacturer has paid a user fee and waited for Health Canada to undertake a lengthy review to certify the safety and efficacy of the medicine. This ban is harmful to Canadians’ health and is implicated in the deaths of hundreds of Canadians annually. …

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FDA in a pain-pill panic
Washington Times, 4-26-05

Can statistics guarantee safety? Not according Donald Devine, Professor at Bellevue University. Devine says that it is impossible to eliminate all risk and that the FDA is overreliant on statistics to establish “safety.”

Pain sufferers would not even have access to aspirin if it had to be tested under [current] FDA procedures. Aspirin existed before FDA and did not pass through its bizarre bureaucratic process. Aspirin creates stomach problems for some, which is why other drugs were developed. If the FDA had existed when aspirin was developed, there simply would be no unrestricted pain medicine on the market today. Human beings desire certainty. So the myths of purely objective science and absolute safety are very popular. FDA's actions are unsurprising. It must deal with a Congress and public that want certainty over science. FDA desperately needs a less bureaucratic process that gives patients choice.

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Cracks in High Drug Prices; Change is in the air as Congress looks at legalizing orders from foreign companies.
Los Angeles Times, 4-22-05

The Times supports importation as a measure to equalize world prices for prescription drugs, since U.S. consumers are now paying the lion’s share of the cost of developing medicines that benefit global markets.

If importation became legal, simple and widespread (which is not a sure thing even under the Dorgan/Snowe bill), U.S. prices would almost certainly sink closer to foreign prices. Drug makers would have to figure out the premium that U.S. consumers would be willing (not forced) to pay for the convenience of buying American. Drugs that patients take for emergencies or one-time prescriptions would probably remain relatively costly. Prices in Canada, Europe and Japan might rise slightly as companies bargained harder to make up some of the difference. Drug makers would be likely to maintain healthy profitability, according to a dense mathematical model developed at the University of Alabama, though perhaps at less astronomical levels. Makers could then consider shifting some of the billions of dollars they spend yearly on marketing to maintain research and development. In effect, the rest of the world would do the bargaining for U.S. consumers. Good deal, eh?


Cost shifting—getting Europeans and Japan to pay their fair share—is a good idea. However, the Times underestimates the monopoly power these nations have over drug sales. If push comes to shove, policymakers in those countries could just threaten to seize the patent of any drug that pharmaceutical companies refused to sell at a steep discount.

The more likely result of U.S. importation would be that the industry would shift its emphasis from branded drugs to generics, and move much of their U.S. based R&D efforts to India and China. In other words, we might have some cheaper drugs, but fewer new ones, and we’d lose billions of dollars in jobs and investment that come with innovative research. That sounds like a terrible deal.

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Taxed to Death
Jasson Urbach, Richard Tren, Roger Bate, AEI-Brookings Joint Center for Regulatory Studies, 4-21-05

This report documents how poor nations inhibit access to life-saving medicines through tariffs and taxes on imports that make them prohibitively expensive.

While aid has increased in recent years and the price of many drugs has fallen, access to medicines and devices has not increased greatly. There are numerous reasons for this. The major one, discussed in this paper, is the barrier imposed by recipient countries themselves. For example the combined tax and tariff barrier in India until recently was over 60% and in Morocco it currently stands at 38%. Only just over a third of Indians have access to essential drugs and it is likely that a reduction of these financial impediments would increase access. Removal of these barriers would therefore likely save thousands of lives across the developing world.

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WHAT'S NEEDED ON PRESCRIPTION LABELS
Steven Wolosin, Lisa M. Schwartz, The Boston Globe, 4-20-05

Doctors trying to understand prescription-drug labels are overwhelmed by a litany of potential side effects and disclaimers. Most often, the information provided by drug manufacturers and the FDA can’t tell doctors what they really need to know: is this the right treatment for this patient?

Woloshin and Schwartz are proposing a change to drug labeling to help consumers and doctors: a box much like the nutritional labels now found on food packaging, that would compare the average benefits and risks to other medications commonly used for the same conditions.

If FDA wants consumers to have the information needed to make good choices, it should think outside "black box" warnings. Last year we tested consumer reactions to the benefit part of a Vioxx prescription drug facts box. Before seeing the box, fewer than 20 percent of people believed that Motrin was as effective as Vioxx for arthritis pain. After seeing the box, this proportion almost tripled. The 200 consumers in our study found the box easy to understand, and more than 90 percent preferred ads with a box rather than the standard version without it. If drug companies are allowed to continue direct-to-consumer advertising (the United States is one of two countries allowing it), they should have to provide a prescription drug facts box to tell consumers how much help they can expect from this drug and how big the benefit (or risk) is compared to others with more-established safety records.


Drug labeling is confusing enough for professionals, let alone consumers. But Woloshin and Schwartz miss the point: for an individual arthritis sufferer, Vioxx might provide better pain relief.

Drugs don’t work on average, they work for individuals. Developing personalized medicine—diagnostics that help physicians match treatment to a patient’s genetic background or particular disease state—is the objective way to increase safety and efficacy. The reality is that any label, not matter how well meaning, is still just a statistician’s best guess. More guessing is not what we need.

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What ails health care
David Gratzer, The Public Interest, 4-1-05

Gratzer, a senior fellow at the Manhattan Institute, has written a short but panoramic history of American health care from World War II to the present. What he finds is that America's health care system is driven by third-party coverage (employer or government based) that labors under an ever growing list of state and federal regulations. As a result, costs steadily escalate even as individuals grow more resentful of the system. Gratzer concludes that the key missing component of American health care is consumer choice.

While the American healthcare system has gone through much "reform," relatively little of its overall economics has changed. Reform, thus, has largely been an exercise in shifting costs from payer to patient, from insurance plan to hospital, from hospital to physician, from uninsured to insured. Since the 1970s, much has been made of the idea of managing care-but really, these have been exercises in managing cost. For most Americans, the end result has been less control over basic health-care decisions, a prescription for universal dissatisfaction.

If we really want to address the system's shortcomings-to tame health inflation and broaden coverage-a new approach is needed. We must recognize that the structure of American health care is flawed, and we must seek to address this by giving people more control over their own health care.

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Research

Herceptin® Combined With Chemotherapy Improves Disease-Free Survival for Patients With Early-Stage Breast Cancer
National Cancer Institute, 4-25-05

Researchers at the National Cancer Institute have reported their findings from two large randomized clinical trials on early-stage HER-2 postitive breast cancer.

Patients are considered "HER-2 positive" if their cancer cells "overexpress," or make too much of, a protein called HER-2, which is found on the surface of cancer cells…These tumors tend to grow faster and are generally more likely to recur than tumors that do not overproduce HER-2…

Patients in the clinical trials who received trastuzumab [Herceptin] in combination with standard combination chemotherapy had a 52 percent decrease in disease recurrence compared to patients treated with chemotherapy alone. This difference is highly statistically significant. "This is a major advance for many thousands of women with breast cancer," said NCI Director Andrew C. von Eschenbach, M.D. "These results are one more example that we are at a major turning point in the use of targeted therapies to eliminate suffering and death from cancer," he added.

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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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SPOTLIGHT

Congress is stalling real Medicaid reform.

NEWS

Breast Cancer Recurrence Is Cut in Half by a Drug
Number of Uninsured May Be Overstated, Studies Suggest
A ripple effect for painkillers
20 arrested in crackdown on Internet drug pipeline
Ariad gets FDA cancer drug fast track

COMMENTARY

The 'European disease'
A Lethal Guardian: The Canadian Government's Ban on Prescription Drugs
FDA in a pain-pill panic
Cracks in High Drug Prices; Change is in the air as Congress looks at legalizing orders from foreign companies.
Taxed to Death
WHAT'S NEEDED ON PRESCRIPTION LABELS
What ails health care

RESEARCH

Herceptin® Combined With Chemotherapy Improves Disease-Free Survival for Patients With Early-Stage Breast Cancer
Center for Medical Progress 
Copyright Manhattan Institute for Policy Research
52 Vanderbilt Avenue
New York, NY 10017
(212) 599-7000
mpt@manhattan-institute.org