Selected news articles which highlight important policy issues.

News: Weekly Archives

News for the week of 04-05-2007

Cancer Thriver
Wall Street Journal, 4-5-07

Editor's Notes:

Presidential candidate John Edwards and his wife Elizabeth announced on March 23 that her breast cancer had returned—and that it was incurable. They also announced that he would continue his campaign while she sought treatment. "You can see—I mean, I don't look sickly, I don't feel sickly," she said in the Washington Post. "Right now, we feel incredibly optimistic."

That optimism—a mixture of hope and determination to carry on with their daily lives—is shared by many cancer patients, who are helped in their struggle by a new generation of cancer treatments that have substantially fewer side effects than previous types of chemotherapy.

The Wall Street Journal this week chronicles the story of Paul Schaye, another cancer patient facing an incurable diagnosis, and how Schaye manages to maintain an exercise and work routine that many healthy people would envy:

The 54-year-old Manhattan investment banker has incurable gastrointestinal cancer. Statistics suggest he may have two years to live. But he's living as hard as ever—making deals at work, taking trips with his wife, indulging his passion for extreme sports. Last weekend, he biked 55 miles, ran 17 miles and swam 132 laps. "I'm a cancer thriver," he says.

In another age, people would see Mr. Schaye as a man in denial, who'd be better off resting, praying and getting his affairs in order. But today, there are new cancer drugs with no debilitating side effects, and new attitudes that have transformed people's view of the illness.

These breakthroughs explain why we're now having a national discussion about how cancer patients should conduct themselves. Elizabeth Edwards vows to stay on the campaign trail, despite breast cancer. White House press secretary Tony Snow hopes to return to work after treatment for colon cancer. Mr. Schaye sees these high-profile cases as proof that the parameters of cancer have changed.

For some cancers, "we can now give people a pill so they can keep enjoying their lives, without having the chemotherapy that can be so disabling," says Mr. Schaye's oncologist, Gary Schwartz of Memorial Sloan-Kettering Cancer Center. "Even with chemo today, we can minimize side effects."

Critics of some of the newest cancer medicines argue that they are vastly overpriced, given that they may only offer patients a few extra weeks or months of life on average. And the cost of these medicines is a real concern. But they also are valuable insofar as they allow patients to live vital, engaged lives even as they struggle with their illnesses.

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Your drug gets pulled? What now?
Wall Street Journal, 4-5-07

Editor's Notes:

What happens after a company pulls a drug that the FDA thinks is unsafe? Patients who used the drug Zelnorm, for instance, are now casting for other alternatives—including drugs that are prescribed "off-label", meaning they have not been approved by the FDA for that specific condition.

Mary Ellen McDonald, a 55-year-old in Florida, has taken Zelnorm for three years to treat her abdominal pain and constipation. Now that the drug's maker is pulling the medicine from the U.S. market over safety concerns, Ms. McDonald says she is going to try to buy Zelnorm online from overseas.

Zelnorm was one of few drugs approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome, a digestive disorder that affects as many as 20% of adults in the U.S., though only some have severe symptoms, according to the National Institutes of Health. Swiss drug maker Novartis AG recently suspended sales of the drug in the U.S. at the request of the FDA, which was concerned that Zelnorm could be tied to risks including angina, heart attack and strokes.

Mary Ellen McDonald, a 55-year-old in Florida, has taken Zelnorm for three years to treat her abdominal pain and constipation. Now that the drug's maker is pulling the medicine from the U.S. market over safety concerns, Ms. McDonald says she is going to try to buy Zelnorm online from overseas.

Zelnorm was one of few drugs approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome, a digestive disorder that affects as many as 20% of adults in the U.S., though only some have severe symptoms, according to the National Institutes of Health. Swiss drug maker Novartis AG recently suspended sales of the drug in the U.S. at the request of the FDA, which was concerned that Zelnorm could be tied to risks including angina, heart attack and strokes.

With drug regulators growing increasingly concerned about side effects, more medicines are being pulled from the market, leaving patients scrambling to find alternative treatments.

Some IBS patients say they have been calling the FDA asking for the drug's return to market. Jeffrey Roberts, founder of the Irritable Bowel Syndrome Self Help and Support Group, says he is encouraging the Web-based organization's 20,000 members to write to the FDA to complain.

Other patients are returning to the makeshift remedies they used with mixed success before Zelnorm became available in 2002, including taking fiber supplements and laxatives. Some patients have also expressed interest in probiotics, the dietary supplements that contain bacteria that can help smooth digestion. But doctors caution that there is limited evidence that the supplements are effective in IBS.

Doctors say they are recommending that some patients try other medications that aren't specifically approved for IBS, but that can be prescribed off-label. "We've been fairly inundated with phone calls about it," says Arnold Wald, a gastroenterologist and professor of medicine at University of Wisconsin School of Medicine and Public Health in Madison, Wis.

Ironically, the FDA's decision to withdraw drugs may force patients to use off-label drugs or dietary supplements whose risks and benefits may be much less well understood than the medicines they are replacing.

Drug safety should be the FDA's preeminent concern. But it seems that in the vast majority of cases the public is better served by letting a drug remain on the market with appropriate warnings than by removing the drug altogether.

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Lessons of Heart Disease, Learned and Ignored
The New York Times, 4-8-07

In this, the first in a series of articles on the nation's leading diseases, the New York Times explores why, despite enormous strides in the treatment of heart disease, many people still die unnecessarily from heart attacks.

Medical research has revealed enough about the causes and prevention of heart attacks that they could be nearly eliminated. Yet nearly 16 million Americans are living with coronary heart disease, and nearly half a million die from it each year.

It's not that prevention doesn't work, and it's not that once someone has a heart attack there is little to be done. In fact, said Dr. Elizabeth Nabel, director of the National Heart, Lung and Blood Institute at the National Institutes of Health, age-adjusted death rates for heart disease dropped precipitously in the past few decades, and prevention and better treatment are major reasons why.

But the concern, Dr. Nabel and others say, is that much more could be done. In many ways, scientists' hard–won and increasingly detailed understanding of what causes heart disease and what to do for it often goes unknown or ignored.

Studies reveal, for example, that people have only about an hour to get their arteries open during a heart attack if they are to avoid permanent heart damage. Yet, recent surveys find, fewer than 10 percent get to a hospital that fast, sometimes because they are reluctant to acknowledge what is happening. And most who reach the hospital quickly do not receive the optimal treatment—many American hospitals are not fully equipped to provide it but are reluctant to give up heart patients because they are so profitable.

And new studies reveal that even though drugs can protect people who already had a heart attack from having another, many patients get the wrong doses and most...stop taking the drugs in a matter of months. They should take the drugs for the rest of their lives.

"We've done pretty well," Dr. Nabel said. "But we could be doing much better. I've heard some people refer to it as the rule of halves. Half the people who need to be treated are treated and half who are treated are adequately treated."

The undertreatment of heart disease is also the by–product of a health care system that focuses on episodes of care (seeing a doctor, getting a prescription) rather than the overall quality of care for chronic disease, which requires aggressive long term management.

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Congress Seeks Compromise on Generic Biotechnology Drugs
The New York Times, 4-8-07

Editor's Notes:

While Congress is intent on passing a bill that would create an FDA approval process for cheaper follow-on biologics, otherwise known as "biogenerics", there is evidence that a compromise bill will be worked out between the House and Senate that will help balance access to less expensive follow–on biologics with protecting patient health and incentives for companies to continue to produce innovative new biotech medicines.

[Rep.] Hatch is trying to work out a compromise, more acceptable to brand-name drug makers, in negotiations with Mrs. Clinton and Senators Edward M. Kennedy, Democrat of Massachusetts, and Michael B. Enzi, Republican of Wyoming.

Mr. Kennedy represents a state with scores of biotech companies and is chairman of the Senate committee with authority over the issue. Mr. Enzi is the senior Republican on that panel.

They are seeking a balance like the one struck in the 1984 [Hatch–Waxman] law, which fostered a booming generic drug industry while protecting the patent rights of brand–name drug makers—a crucial incentive for research on new drugs.

The manufacture of biotech drugs is more complex and costly than the production of conventional medicines. But economists cite another reason for the high prices: biotech medicines generally face no competition from copycat drugs.

When the first generic copy of a conventional drug becomes available, it may cost 15 percent less than the brand–name product. If several competing generic versions are available, the price often falls by 60 percent or more.

Prof. Henry G. Grabowski, a health economist at Duke University, said prices would decline less for biotechnology drugs. But Scott McKibbin, an aide to Gov. Rod R. Blagojevich of Illinois, said biotech drugs were so expensive that discounts of just 10 percent to 20 percent would save tens of millions of dollars for the state's Medicaid program and the state employees' health plan.

The debate over biotech drugs is filled with paradoxes. Brand–name drug companies, which have for years criticized the regulation of drug prices in Europe, now point to Europe's strict regulation of "follow–on biologics" as a possible model for the United States. Democrats, who have often criticized the F.D.A. as lax in enforcing drug safety laws, now say they trust the agency to decide whether copies of biotech drugs are safe and effective, without the full range of tests required for new products.

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Firms gang up on diabetes
Chicago Tribune, 4-8-07

Editor's Notes:

The Tribune reports on a growing trend among employers to lower or even eliminate co–pays and deductibles for medicines that treat chronic diseases like diabetes and asthma.

After years of raising co–payments and deductibles for prescription pharmaceuticals, some employers are taking an unorthodox approach to lowering health–care costs in an experimental program by—get this—paying for diabetes drugs and consultations.

For patients the savings could amount to $2,000 a year.

If the program proves successful it could be expanded to include other common diseases and chronic conditions such as asthma, depression or arthritis and extended beyond its one–year pilot phase, according to the Midwest Business Group on Health, a Chicago–based coalition of employers that is coordinating the program.

Nationally, more than 30 employer groups are rolling out similar programs this year in cities including Milwaukee, Pittsburgh and Los Angeles.

Results from a model project launched in 1997 by the city of Asheville, N.C., show a 50 percent reduction in sick days and no worker's compensation claims filed by the diabetes patients in the program between 1997 and 2003.

Asheville has expanded its program to people with asthma and high blood pressure.

So far, Chicago–area employers Pactiv Corp., the City of Naperville and the Jewish Federation of Metropolitan Chicago have agreed to participate in the program.

"Employers are beginning to realize that cost–shifting by itself will not change behaviors," said Larry Boress, chief executive of the Midwest Business Group on Health. "This is not just an isolated incentive where you are giving away trinkets or dollars but is part of a change in employee–benefits strategy to move people away from an entitlement mentality. The idea is that in order to change employee behavior and change the attitude in the way employees manage their health, employers are moving to value-based benefit designs."

This movement lends support to an argument that some researchers have advanced: that prescription drugs tend to replace other, more expensive forms of health care like hospital and emergency room visits. Rather than viewing drug spending in isolation, employers and policymakers should pay careful attention to how prescription drugs may affect other health care costs.

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Caterpillars may help boost flu vaccine
Los Angeles Times, 4-11-07

Editor's Notes:

Currently, the entire U.S. vaccine supply is manufactured using an outdated process that relies on incubating flu viruses in millions of chicken eggs. The process is notoriously slow, inefficient, and prone to contamination. Prodded by fears of avian flu and routine production mishaps, regulators and companies have been hoping to move to a new process wherein vaccines are grown in mammalian or insect cell lines.

The L.A. Times reports that one company may have a caterpillar cell–based vaccine on the market within a year.

A genetically engineered flu vaccine made in caterpillar cells is as effective as traditional vaccines and can be produced more efficiently, according to a preliminary study released Tuesday.

This experimental method could make more vaccine per batch than the traditional method, which uses hens' eggs, and shave about a month off production time, said study leader Dr. John J. Treanor, a researcher at the University of Rochester in New York.

"When we're talking about a scenario where every day makes a difference, saving even a week or two weeks is a big plus," he said.


The makers of the experimental vaccine, Protein Sciences Corp. of Meriden, Conn., altered an insect virus to produce a human version of a flu protein capable of sparking an immune response.

The virus was grown in caterpillar cells, which are relatively easy to manipulate.

"This is promising technology," said Dr. Arnold S. Monto, a University of Michigan infectious diseases researcher who was not involved in the study.

"This is really the first of a number of different vaccines which are innovative and different."

At least five companies are working on cell-based flu vaccines. The Department of Health and Human Services awarded more than $1 billion for research in this area in 2006 to GlaxoSmithKline, MedImmune Inc., Novartis, Baxter International Inc. and Solvay Pharmaceuticals.

Protein Sciences has been developing the insect-based vaccine for about 20 years. The vaccine is on track for accelerated approval by the Food and Drug Administration and could be on the market by next year, President Dan Adams said.

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Abbott to cut AIDS drug cost in poor nations
Chicago Tribune, 4-11-07

Editor's Notes:

In the wake of its patent fight with Thailand, Abbott has signaled that it will slash the price of its AIDS drug Kaletra in low–income countries, a move that is being hailed by activist groups.

Moving to defuse a potentially damaging international controversy, Abbott Laboratories said Tuesday that it will cut the price of its AIDS–fighting Kaletra drug by more than half in many developing nations.

The North Chicago-based pharmaceutical and health–care products giant billed its discount pricing plan as a "balanced approach" that will make the drug available to more people in more nations, while still protecting the patent rights that provide drugmakers with the financial incentive for developing new medicines.

The plan, which has the backing of the World Health Organization, is designed to help Abbott avert a pending patent–rights showdown with the government of Thailand, where officials have been threatening to break Abbott's patent and produce a low–priced generic version of Kaletra.

"We applaud Abbott" for its action, said an official with the Los Angeles-based AIDS Healthcare Foundation, which has long been a harsh critic of the qcompany's pricing practices.

Abbott's discount plan, which promises to save thousands of lives in Thailand and other less-developed nations, "is really a huge victory for AIDS activists worldwide over one of the most formidable opponents in the drug industry," said the foundation's president, Michael Weinstein.

The dispute between Abbott and Thailand has been closely followed by governments and drug producers alike because it involves what could prove to be a new battlefield in the ongoing debate over the pricing of AIDS drugs.


In the U.S., treatment with Kaletra costs approximately $7,500 a year. But Abbott, in response to criticism that it is profiting from human misery, had already slashed the price it charges for Kaletra in more than 100 nations.

For example, in 69 of the world's most impoverished countries, including all of Africa, Abbott sells a year's worth of Kaletra for $500, a price the company says provides it with no profit.

Last summer Abbott expanded its price–cutting to include an additional 45 countries that are not poor but that are considered "low income," such as Pakistan and Vietnam, and "low middle-income," such as China and several countries in South America.

In those nations, where a year's worth of Kaletra had cost between $3,300 and $5,000, Abbott lowered the annual cost to $2,200.

One of those second-tier nations is Thailand. In January the government that was installed following a military coup last autumn announced that it wanted to pay less for the drug, which it supplies to Thai residents who have HIV or AIDS.

Activists seem to assume that the chief enemy of AIDS patients is not the disease, but the companies that make medicines to fight it. And so they prioritize access to cheaper medicines today even if it may lead to fewer medicines tomorrow.

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Project FDA.


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