Medical Progress Today
  Volume 2, Number 16
  April 22, 2005


Featured News:
A Bonus for Health, Payable to the Doctor
The New York Times, 4-15-05
Featured Commentary:
Don’t get old
Tony Blankely, Washington Times, 4-20-05
Featured Research:
Statins May Curb Risk of "Clinically Important" Prostate Cancer
Medscape, 4-19-05

News

Merck to Discount Drugs for Uninsured; Prices to Compare to Canadian Imports
Washington Post, 4-20-05

Editor’s Notes:

We have several articles this week that touch on issues surrounding drug pricing (including this one) and importation (including an op-ed by Elizabeth Whelan).

Merck has announced that it will

…provide uninsured Americans steep discounts on many of its prescription medicines, joining other pharmaceutical firms in slashing some prices during debate over importing drugs from Canada…For instance, Merck will discount Fosamax, its popular treatment for osteoporosis, by 22 percent…


In response Ron Pollack, executive director of Families USA, a liberal health-policy group, said that “uninsured people are often unable to go to a physician because they can’t afford to pay…Therefore they can’t even get a prescription.”

Pollack’s remark highlights the misleading nature of our national debate over importing drugs from Canada. The argument in favor of importation hinges on the fact that some Americans lack health insurance coverage—for prescription drugs or anything else.

Drug pricing, in other words, is a red herring used to bash industry. After all, if prices are the problem, why not demand that hospitals lower their prices to the point where poor Americans without insurance can afford heart bypass surgery?

Merk’s program is laudable, but they cannot offer the health care coverage poor Americans need, and we shouldn’t expect them to.

TOP^

THE NATION; Former FDA Chief Backs Drug Import Plan; The proposal would protect consumers from substandard and counterfeit medicines, Dr. David Kessler tells a Senate committee.
Los Angeles Times, 4-20-05

Editor’s Notes:

Former FDA Commissioner David Kessler has endorsed legislation by Senators Byron Dorgan and Olympia Snowe that would legalize commercial importation from over 20 countries, including Canada and many EU member states. During his Congressional testimony supporting the legislation Kessler told the senators that

“The choice before you is not the choice of imports or no imports…The American public will be safer with a regulated system than with the current system of uncontrollable risk.”


Kessler argues, in short, that drug importation is so dangerous now that we should make it a national policy. Presumably, federal regulations and FDA inspectors would protect Americans from the risks that individual consumers now bear.

This is a very dubious argument. Drugs shipped from many foreign countries would have to be repackaged and relabeled with English instructions. This would make guaranteed sourcing of imported drugs nearly impossible. Graham Satchwell, a member of the United Kingdom’s Government’s Patent Office Investigative Strategy Group, testified at the same hearing. He noted that

The truth is that counterfeit medicines often appear so like the genuine product that no one, not the best specialist can tell the genuine packaging from the counterfeit…unless the product is subjected to chemical analysis. The result is that everyone, poor, ignorant, rich and smart, all are at risk from counterfeit or sub-standard products…


If a pair of fake Nike sneakers are imported into the U.S. no one will perish from wearing them. If Congress opens the U.S. market to large-scale importation of substandard or dangerous drugs, people will die.

TOP^

When Patients Say: Don't Ban My Drug: Emotional lobbying can keep a treatment on the market despite serious side effects
Business Week, 4-20-05

Editor’s Notes:

Patients are increasingly objecting the FDA’s role as consumer surrogate.

Although it’s under pressure from Congress to be more diligent about policing serious drug side effects, the FDA is also besieged by patients eager to take such risks. Besides visits from silicone-implant proponents, FDA panels have recently heard from patients who want Cox-2 arthritis drugs such as Celebrex or Vioxx, which can hike the risk of heart disease, because they think the drugs are the only way to ease their pain…Such lobbying puts patients at odds with watchdog organizations meant to look after their interests.


The FDA’s role as “watchdog,” in short, is being challenged by technological and social developments that empower patients rapidly and effectively. This is a win-win situation for the FDA and its stakeholders. Improvements in health care markets, like any others, are best led by savvy consumers. The FDA can accelerate this trend by shifting its focus to being a better market educator.

TOP^

Roche looks into heart attack test for COX-2 users.
Reuters News, 4-19-05

Editor’s Notes:

The all-or-nothing marketing approach taken by the FDA and the pharmaceutical industry is quickly being overtaken by technologies that will help doctors give the right medicine to the right patient at the right time.

For instance, the Cox-2 drugs Bextra and Vioxx are currently off the market due to rare but potentially deadly cardiovascular side-effects in a small number of patients. But what if we had a technology that could help doctors identify those patients before they ever swallowed a single pill?

Roche Holding AG is analyzing whether one of its tests could help identify heart attack risk for users of a class of painkillers including Vioxx, which has been linked to heart problems…the company was looking at whether a tool which measures a chemical marker pointing to heart dysfunction…could also be of use used to identify Cox-2 users who are at risk of developing heart problems…Roche, the world’s biggest maker of diagnostics, believes that such tests will increasingly play a major role in the way drugs are administered by helping doctors dose correctly.


As tests like these become increasingly common, drug safety will improve and drug withdrawals—which cost companies billions of dollars in revenues—will become a thing of the past.

TOP^

Are we taking too many drugs?
Newsday, 4-19-05

Editor’s Notes:

Poor countries complain about having too little health care. Rich countries obsess about having too much. This article, for instance, crystallizes the conventional wisdom that Americans are now immensely over-medicated.

Alice and Ken Heckman each begin their morning by cracking open a rattling plastic tray carting scores of pills in a rainbow of pastel colors. Between the two of them, they gulp 29 pills every day: a regimen of 14 drugs, with a chaser of dietary supplements. Here’s the curious part: They feel pretty hale for people in their early 70s…They each had heart fixes years ago…She has well controlled diabetes. He has worked his way through heartburn, arthritis, an enlarged prostate and occasional mild depression. Do we need all these drugs?


Are all these drugs necessary? Well, that’s a good question. The other question, however, is how much pain and disability should Americans tolerate as they age?

Duke University researcher Kenneth Manton has found that between 1982 and 1999, disability rates for Americans over age 65 fell by 25% and there were 415,000 fewer seniors in institutional care (26.3%) than expected. There are undoubtedly several factors at play here (including better overall health care), but better drugs are certainly among them. America’s seniors are healthier and more productive today than perhaps any other time in history. Every country in the world should have this “problem.”

TOP^

More good news for Genentech drug / Avastin helps those with breast cancer, clinical study shows
The San Francisco Chronicle, 4-16-05

Editor’s Notes:

Genentech’s cancer drug, Avastin, is turning out to be as versatile as it is powerful.

…[the] pioneering colon cancer drug Avastin, already showing potential as a lung cancer treatment, delivered significant benefits to breast cancer patients in clinical trial results announced Friday by the company and the National Cancer Institute. In positive data that emerged earlier than expected from the late-stage study, Avastin delayed the worsening of metastatic breast cancer when combined with chemotherapy. “[Dr. Andrew von Eschenbach, Director of the NCI said that] This is an important step in our journey to ultimately eliminate the suffering and death due to cancer.”


Dr. von Eschenbach has called for eliminating “suffering and death due to cancer” by 2015. Perhaps this is too optimistic. But drugs companies like Genentech are racing to see if they can make his prediction come true.

TOP^

A Bonus for Health, Payable to the Doctor
The New York Times, 4-15-05

Editor’s Notes:

Mark McClellan, Administrator of the Centers for Medicare and Medicaid Services, is a physician and an economist who is trying to redefine how the nation reimburses providers in its public health care programs.

A quiet revolution is taking place in Medicare, one that could set a new standard for the way medicine is practiced in this country. For the first time in its history, Medicare is starting to embrace an approach that has changed industries as diverse as carmakers and fast-food restaurants -- giving employees financial incentives to meet goals for quality. By the end of this year, more than 600,000 Medicare recipients will be in test programs that pay doctors and hospitals bonuses for achieving better results, like increasing the number of diabetic patients whose blood sugar is under control. Some see this experiment as the last best hope for a medical system in crisis, facing soaring costs and questions about what all that money is buying.


There are sure to be some bugs—and criticism—as the government fine-tunes the pay-for-performance model. But the fiscal crisis facing Medicare and Medicaid demands bold action, and Dr. McClellan is delivering it.

TOP^

No headache cure for costly drug regulation: Testing procedures vary greatly between the US, Europe and Japan. Wyeth says the system must be harmonised
Financial Times, 4-15-05

Editor’s Notes:

Pundits and policymakers like to rail at the high price of prescription drugs. Yet there is little understanding that the price of medicines is driven by the enormous expenditures required to develop them.

Much of this cost is due to the convoluted regulatory barriers companies must negotiate to bring new products to market:

…there is no doubt that the cost of clinical trials is high and rising fast, in turn contributing significantly to the spiraling costs of bringing a new drug to market. Bain, the management consultancy, recently estimated that total figure at $1.5 billion. Demands for multiple, more complex and longer running trials using more patients have a clear impact on cost. [Said Robert Ruffolo, head of R&D at Wyeth] “It is not uncommon to spend $10,000 to $20,000 per patient in a Phase III trial.…In cancer, it can be $100,000 per patient.”


To add insult to injury, there is little consistency between the demands of regulators in the U.S., the EU, and Japan. “To have to satisfy all three is almost irrational in an age of modern medicine.”

TOP^

Commentary

Don’t get old
Tony Blankely, Washington Times, 4-20-05

Blankley asks a question that has long plagued writers who follow American politics: “What is the difference between squirrels and members of Congress?”

Answer: “Squirrels make provision for the future.” Blankley notes that the timid creatures who populate the halls of Congress are putting off enacting meaningful Social Security and Medicare reform for yet another year, even as the fiscal burdens of these two entitlement programs spiral out of control.

If the Social Security financial wave that will hit us is a scary 25-foot wave of water, the Medicare wave will be something the wrathful Old Testament God would send if he was in an apocalyptic mood…Any way it is calculated, it can’t be afforded. Medicare is not only challenged by all the same demographic forces that are hitting Social Security, but also by the fact that demand for health care is going up, on average, about 3 percent more than the gross domestic product every year...If we don’t have the political will to solve the easier problem of Social Security, my advice to boomers as they get older is—don’t get sick.

TOP^

The Drug Approval Pendulum
Anne Applebaum, Washington Post, 4-19-05

Applebaum points out that whether the FDA is perceived as a regulatory roadblock that keeps patients from lifesaving drugs (as AIDS activists claimed in the 1980s) or as an industry shill (as Public Citizen claims today), is largely the result of shifting political fashions.

Clearly, caution is now “in.” Patients’ rights re “out.” Risk-averseness is “in.” Hot new research is “out.” “There is no doubt there has been a cultural change,” the director of the FDA’s Office of New Drugs told a reporter last week. And there is no doubt that Congress, along with everybody else, sincerely believes that the change is, will be and should be permanent. How little we know of fashion!


We can only hope that innovation will be “in” again soon.

TOP^

Bargain fares on Rx express?
Elizabeth Whelan, Washington Times, 4-18-05

Whelan notes that the rush to legalize commercial importation of drugs from countries with price controls rests on a fundamental misunderstanding of how innovative drugs are treated by international law:

Today’s new lifesaving, life-enhancing pharmaceuticals, almost all developed and produced in the U.S., are cheaper in Canada because international law treats prescription drugs differently than other consumer products. U.S. pharmaceutical companies are required under a 1994 treaty to sell their drugs at drastically cut price to countries with price controls. Any pharmaceutical company that fails to comply risks losing its patent protection—its drugs can be stolen and copied. To comply with this treaty, pharmaceutical companies slash prices for countries with price controls—most countries in the developed world. The purchasing countries in this ‘deal’ are supposed to agree not to turn around and resell the drugs to Americans. Technically, drug importation is now illegal, but the law is almost never enforced.

TOP^

Letters to the Editor: Dying While Waiting for the FDA to Act
Wall Street Journal, 4-15-05

We do not, normally, cite letters to the editor, but since over the past two weeks we have posted links to two Wall Street Journal editorials highlighting the saga of Kianna Karnes, a kidney cancer patient who died waiting for access to experimental cancer treatments, we are making an exception. This letter to the Journal is from David Minor, president of the Kidney Cancer Foundation, who writes that

We agree with [the Wall Street Journal] that the [FDA’s] insistence on placebo-controlled trials is unscientific and antiquated, and is followed only erratically. AIDS drugs are routinely approved on the basis of “surrogate endpoints,” not requiring placebo controls, but we suppose cancer patients must, like AIDS patients before them, demonstrate in Washington to get the needed attention and FDA recognition of appropriate, cancer-specific scientific endpoints… Kidney cancer patients need help, and don’t care whether it comes from Congress, Dr. Richard Padzur (head of FDA cancer drugs evaluation), Dr. Lester Crawford (acting commissioner of the FDA) or President Bush. They just want some help before it’s too late.

TOP^

Research

Living Donor Pancreas Transplant Successfully Treats Patient With Diabetes
Medscape, 4-19-05

For the first time, Japanese researchers have successfully performed a pancreas transplant from a living donor to a woman with diabetes.

Researchers in Japan have successfully performed a pancreatic islet transplantation to a woman with brittle, insulin-dependent diabetes, for which her mother was the living donor. As reported Monday in an early online edition of The Lancet, the recipient was a 27-year-old woman with onset of insulin-dependent diabetes at age 15, after she had developed chronic pancreatitis at 4 years of age. The woman had frequent hypoglycemic episodes of which she was unaware…The recipient became insulin independent on day 22, and has remained so for the 2 months since transplantation, "with excellent glycemic control."

TOP^

Statins May Curb Risk of "Clinically Important" Prostate Cancer
Medscape, 4-19-05

Researchers have reported results from a large observational study that that “statin therapy may protect against the development of advanced prostate cancer.”

Dr. Elizabeth A. Platz, from the Johns Hopkins Bloomberg School of Public Health, and colleagues at the National Cancer Institute and Harvard University used data from the Health Professionals Follow-up Study to evaluate the possible protective effects of cholesterol-lowering drugs including statins on the risk of prostate cancer…Data analysis showed men who used any type of cholesterol-lowering agent had roughly half the risk of developing advanced prostate cancer and roughly one third the risk of developing metastatic or fatal prostate cancer as those who did not use these agents.

"If the conclusions continue to hold up over time, there is great translational potential for preventing invasive and metastatic prostate cancer," Dr. Platz said.

TOP^


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

NEWS

Merck to Discount Drugs for Uninsured; Prices to Compare to Canadian Imports
THE NATION; Former FDA Chief Backs Drug Import Plan; The proposal would protect consumers from substandard and counterfeit medicines, Dr. David Kessler tells a Senate committee.
When Patients Say: Don't Ban My Drug: Emotional lobbying can keep a treatment on the market despite serious side effects
Roche looks into heart attack test for COX-2 users.
Are we taking too many drugs?
More good news for Genentech drug / Avastin helps those with breast cancer, clinical study shows
A Bonus for Health, Payable to the Doctor
No headache cure for costly drug regulation: Testing procedures vary greatly between the US, Europe and Japan. Wyeth says the system must be harmonised

COMMENTARY

Don’t get old
The Drug Approval Pendulum
Bargain fares on Rx express?
Letters to the Editor: Dying While Waiting for the FDA to Act

RESEARCH

Living Donor Pancreas Transplant Successfully Treats Patient With Diabetes
Statins May Curb Risk of "Clinically Important" Prostate Cancer
Center for Medical Progress 
Copyright Manhattan Institute for Policy Research
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New York, NY 10017
(212) 599-7000
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