Medical Progress Today
  Volume 1, Number 12
  October 8, 2004


Vioxx Weltanshauung

This issue of Medical Progress Today will focus on the Vioxx withdrawal controversy, as it illuminates many of the most important issues of pharmaceutical public policy. Is it a good or bad thing to have multiple drugs in one treatment class, derided as "me-too drugs" by some? Is the FDA's current approach to testing a drug's safety too lenient, too restrictive, or just right? Should the FDA do more to monitor a drug's safety record once it is approved for marketing and use? Does "direct-to-consumer advertising" by pharmaceutical companies give patients more information and expand the use of helpful treatments, or does it drive consumer demand for unneeded and expensive drugs, leading to over prescription and an explosion of health care costs? Should companies be exempt from legal liability for harms caused by their products if they have been approved by the FDA as safe? It is tempting to rush to judgment in light of Vioxx's withdrawal, and move to modify current practices. But there is always a balance between safety and benefit; as noted in one article below, one must balance the risks of side effects versus the benefits a drug has to offer. Policymakers are well advised to heed the Hippocratic Oath in addressing these issues: First, do no harm.

In the Spotlight

Waiting for the 17th plan
Jacob Arfwedson, 10-8-04

Dear Senator Kerry,

I'd like to give you an update on France for your campaign since you regularly refer to it as an example.

As you are well aware, wine consumption in France is financed by government and every citizen is subject to a payroll tax which finances the central wine fund. There are also private wine funds but these are regulated and basically depend on subsidies from the government wine officials.

Continue reading . . .

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Featured News:

Vioxx's Removal May Not Affect Care Much; Other Drugs Can Be Used, Experts Say
Washington Post, 10-1-04

Coping Without Vioxx – Recall of Merck’s Pain Drug Sparks Hunt for Alternatives; Just How Safe is Celebrex?
Wall Street Journal, 10-1-04

Featured Commentary:

A Vioxx Elegy
Wall Street Journal, 10-1-04

Good Riddance to a Bad Drug
Dr. Eric Topol, The New York Times, 10-2-04


News

Vioxx's Removal May Not Affect Care Much; Other Drugs Can Be Used, Experts Say
Washington Post, 10-1-04

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Coping Without Vioxx – Recall of Merck’s Pain Drug Sparks Hunt for Alternatives; Just How Safe is Celebrex?
Wall Street Journal, 10-1-04

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Evaluating Vioxx Alternatives
Wall Street Journal, 10-5-04

Alternative history books are fast becoming popular items. People want to think about things like what if the South had won the Civil War. In the case of the Vioxx withdrawal, the two million people worldwide who take the Merck drug have alternatives, as pointed out in these articles. They can use other patented COX-2 inhibitors, like Pfizer's Celebrex. They can use older and cheaper, off-patent drugs like ibuprofen. Or people can turn to non-pill approaches like injectable painkillers, osteopathic manipulative treatment or acupuncture. People suffering from arthritis may not be as well off as they were on Vioxx, but they should be able to find some treatment that holds the promise of help.

Now suppose an alternate universe where these options did not exist. In this world, a government body had approved Vioxx as the only approved treatment for arthritis, based on its proven ability to reduce pain while simultaneously reducing the threat of bleeding to death through ulcers. People suffering from arthritis would be cast adrift; those at risk of ulcers would have no other COX-2 drugs to turn to, while others would not be at increased risk of death, but find their lives made intolerable through pain. That is not a world most of us would want to live in.

Yet, this world is not wholly imaginary. One of the most vibrant critiques of the pharmaceutical industry is that it is not innovative, that it merely produces versions of the same drug – "me-too drugs" – that do not add to public health. These critics argue that the government should only permit a new drug on the market if it clearly shows in clinical trials that it represents a substantial improvement over drugs currently on the market. (Of course, that itself begs a question – if a new drug is so clearly superior to existing drugs that it should be allowed, why should the sale of the older drug be permitted? If critics argue in response that patients should be permitted to choose a cheaper, less effective version if it works for them, then why isn't the reverse proposition – patients should be permitted to choose a more expensive, potentially more effective version that works for them – also true?)

The Vioxx controversy shows how untenable that approach is in the real world. If Vioxx and other COX-2 inhibitors had never been approved because their effect on reducing ulcers was deemed not substantial enough, thousands of people would have died each year. If the drugs were approved but permitted only to be prescribed to people at risk of developing serious bleeding ulcers, the price of the inhibitors would have skyrocketed because the cost of developing them would have to be spread out over a much smaller class of recipients – which would itself discourage use of the drugs by those it is proven to benefit. And if Vioxx had been approved as the treatment of choice for all, we would have had precisely the scary scenario outlined above.

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Promise and Peril of Vioxx Cast Harsher Light on New Drugs
Washington Post, 10-3-04

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Vioxx Recall Raises Questions on FDA's Safety Monitoring
Wall Street Journal, 10-4-04

These articles discuss the ongoing questions of the FDA's role in overseeing the safety of the nation's drug supply and it role in permitting drug companies to advertise their wares to individuals, known among the pillerati as "direct-to-consumer advertising". They raise the usual arguments – the FDA doesn't monitor existing drugs closely enough to ensure their ongoing safety and shouldn't let uneducated consumers hear about drugs whose risks and benefits they cannot possibly understand or evaluate.

On the advertising point, blaming ads for overprescription (if it occurs) is like shooting the messenger. Patients demand these drugs in part because they do not have to pay for them – a faceless insurance company does. And doctors give in to patients because they know that saying yes helps them keep patients while costing them or their patients nothing. If we moved away from third party payment as the basis for non-medical costs, consumers would have to decide for themselves if the latest drug fad was worth the expense – just as they do with every other product in their lives.

When it comes to drug safety, one has to remember that benefits come with risks. As the Post article notes, "The process for getting a new drug approved in the U.S. is rigorous but it isn't designed to detect every possible risk. That would require studies so large and long that few new medicines would ever hit the market."

Still, more could be done to monitor drug safety in practice. Millions of people take prescription drugs daily, but their experiences are rarely recorded except by their physicians. That means every day data of real world experiences is being collected and hidden, much like the Ark of the Covenant was stored away in some government basement in the first Indiana Jones movie. FDA could move to collect that data and obtain the details of each patient – redacting names and other information that would identify a single individual – and run studies to see if certain harms (or benefits) arise among patients with certain characteristics. This technique, called Clinical Practice Improvement – would dramatically cut the time and expense that traditional clinical trials entail, and lead to the sort of revolution in medical safety and treatment protocols that other information-driven techniques have created in other sectors of the economy.

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Vioxx Recall May Bring Flood of Suits to Merck
The New York Times, 10-5-04

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Vioxx Lawsuits May Focus on FDA Warning in 2001
Wall Street Journal, 10-5-04

When does the rule of law give way to the rule of lawyers? No one doubts that manufacturers that knowingly produce an unsafe product should be held accountable for the damage they cause. But it's not always clear when someone knows something for certain, or whether something is in fact unsafe before damage is actually caused. It's these gray areas that can cause problems.

Property rights and the rule of law are important in part because they provide people and companies with predictable boundaries. If people could not be certain when they could do something without risk of penalty, they would be afraid to take risks. That's what happens in countries without enforceable property rights or the rule of law; the innovators emigrate or lie low, while the rich send their money out of the country or invest in tangible property like land because that sort of wealth is harder to expropriate.

In the case of drugs, there's a simple rule that ought to be followed. If the FDA has approved a drug for a certain use and the drug manufacturer is not withholding information about safety from the FDA, then the manufacturer should be immune from suits for damage caused by approved uses. That gives the FDA, which has the scientific knowledge to evaluate drug safety, the ability meet its Congressional mandate to assure drug safety; it gives drug companies the predictability they need to invest in and market new drugs; and it gives individuals the right to sue when there is fraud.

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Putting Side Effects in Perspective – Despite Vioxx Withdrawal, The Benefits of Medicines Can Outweigh the Risks
Wall Street Journal, 10-5-04

This article's title says it all, but in case it need reinforcing, listen to Dr. Richard Roberts, professor of family medicine at the University of Wisconsin Medical School. "Anything we do to patients has a risk. But deciding not to do something also has risks."

The article also makes an interesting point that supports the idea that continued sole reliance on clinical trials to establish safety is outmoded and unwieldy. "Doctors say that clinical trials are often too small and specific to unearth all side effects. It is only when drugs are used by millions of people, many of whom are taking other medications, that more rare effects and drug-drug interactions are revealed." This suggests that Clinical Practice Improvement, or something like it, can be a crucial tool for making drug treatment safer and more effective.

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FDA Says Intercepted Canadian Drugs Unsafe
Associated Press Newswires, 9-30-04

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Task Force: Americans Don’t Have to Look North to Find Cheap Prescription Drugs
Associated Press Newswires, 10-6-04

Price and safety are the yin and yang of the drug importation issue. "Same quality, half the price", shout the importation advocates. OK, is this true? The first article notes that 439 recently seized packages of prescription drugs sent from Canadian pharmacies contained no drugs that had been manufactured in America. "Many had unstated dosages and suspicious labels," the article notes.

As lawyers say, let's engage in a counterfactual. Big business A tells consumer B that it has drugs for sale that are safe and suitable for the use consumer B needs. It ships them drugs from which it is wholly uncertain whether the drugs are safe or suitable. Is company A liable for any harm that it may cause? If company A is a Big Pharma firm and the drug is openly sold in the U.S., the trial lawyers' answer is "darned tootin' it is." If company A is a Canadian Internet pharmacy and the drugs in question are imported from overseas, the answer is "nope – let the consumer decide." There's a Scott Turow novel in there somewhere.

But, as the second article notes, the consumer may not even be getting the deal she anticipates when she orders overseas. The article cites William Hubbard, an FDA associate commissioner, as saying that one of the drugs in the intercepted shipment, Amiodarone, costs $116.97 from the Canadian importer. Buying the same drug in the same quantity from Costco: $41.89. Another generic diuretic in the package cost $28 - $13 for the drug and $15 to ship. The cost at a corner drug store: $5.

Dorothy had to go all the way to Oz before she realized home wasn't so bad after all. If American consumers start treating drugs the way they do other products, shopping around to get the best price, they'll come to the same conclusion without having to leave home at all.

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Kucinich Wants Government to Oversee Drug Research
The Cleveland Plain Dealer, 9-29-04

Apparently not satisfied with having driven his home city into bankruptcy when he was mayor in the 1970s, now the former enfant terrible has set his sights on the pharmaceutical industry. His proposal would "create a federal Institute for Biomedical Research and Development" which would "oversee pharmaceutical research by government labs, and universities and private companies working under government contracts. Their research would be made public, and the formulas they develop for new drugs would be available to any manufacturer" approved by the FDA.

One major problem in pharmaceutical research is under funding of the basic research on which specific discoveries rely. It's human nature – people will act when they get a benefit from it, so basic research, research that does not directly lead to a saleable product, would be perennially under funded if we relied solely on private companies to finance it. That's why we have the National Institutes of Health.

If Kucinich's proposal became law, private companies would produce fewer drugs because they could not own the formulas for the products they develop with the publicly-financed basic research. Investors' capital would flow toward other fields not encumbered by this encroachment on property rights. It's basic economics, but perhaps it's not surprising that a man who ignored economic realities while mayor remains ignorant of them today.

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Commentary

A Vioxx Elegy
Wall Street Journal, 10-1-04

Good Riddance to a Bad Drug
Dr. Eric Topol, The New York Times, 10-2-04

Letter to the Editor: Europe’s Drug Import Example
Panos Kavanos, Washington Post, 10-30-04

Alternative history books are fast becoming popular items. People want to think about things like what if the South had won the Civil War. In the case of the Vioxx withdrawal, the two million people worldwide who take the Merck drug have alternatives, as pointed out in these articles. They can use other patented COX-2 inhibitors, like Pfizer's Celebrex. They can use older and cheaper, off-patent drugs like ibuprofen. Or people can turn to non-pill approaches like injectable painkillers, osteopathic manipulative treatment or acupuncture. People suffering from arthritis may not be as well off as they were on Vioxx, but they should be able to find some treatment that holds the promise of help.

Now suppose an alternate universe where these options did not exist. In this world, a government body had approved Vioxx as the only approved treatment for arthritis, based on its proven ability to reduce pain while simultaneously reducing the threat of bleeding to death through ulcers. People suffering from arthritis would be cast adrift; those at risk of ulcers would have no other COX-2 drugs to turn to, while others would not be at increased risk of death, but find their lives made intolerable through pain. That is not a world most of us would want to live in.

Yet, this world is not wholly imaginary. One of the most vibrant critiques of the pharmaceutical industry is that it is not innovative, that it merely produces versions of the same drug – "me-too drugs" – that do not add to public health. These critics argue that the government should only permit a new drug on the market if it clearly shows in clinical trials that it represents a substantial improvement over drugs currently on the market. (Of course, that itself begs a question – if a new drug is so clearly superior to existing drugs that it should be allowed, why should the sale of the older drug be permitted? If critics argue in response that patients should be permitted to choose a cheaper, less effective version if it works for them, then why isn't the reverse proposition – patients should be permitted to choose a more expensive, potentially more effective version that works for them – also true?)

The Vioxx controversy shows how untenable that approach is in the real world. If Vioxx and other COX-2 inhibitors had never been approved because their effect on reducing ulcers was deemed not substantial enough, thousands of people would have died each year. If the drugs were approved but permitted only to be prescribed to people at risk of developing serious bleeding ulcers, the price of the inhibitors would have skyrocketed because the cost of developing them would have to be spread out over a much smaller class of recipients – which would itself discourage use of the drugs by those it is proven to benefit. And if Vioxx had been approved as the treatment of choice for all, we would have had precisely the scary scenario outlined above.

Beware of Doing More Harm
Ruth Rosenberg, Washington Post, 10-3-04

Money is the Catalyst for Good Medicine
Charles Stein, The Boston Globe, 10-3-04

These articles discuss the ongoing questions of the FDA's role in overseeing the safety of the nation's drug supply and it role in permitting drug companies to advertise their wares to individuals, known among the pillerati as "direct-to-consumer advertising". They raise the usual arguments – the FDA doesn't monitor existing drugs closely enough to ensure their ongoing safety and shouldn't let uneducated consumers hear about drugs whose risks and benefits they cannot possibly understand or evaluate.

On the advertising point, blaming ads for overprescription (if it occurs) is like shooting the messenger. Patients demand these drugs in part because they do not have to pay for them – a faceless insurance company does. And doctors give in to patients because they know that saying yes helps them keep patients while costing them or their patients nothing. If we moved away from third party payment as the basis for non-medical costs, consumers would have to decide for themselves if the latest drug fad was worth the expense – just as they do with every other product in their lives.

When it comes to drug safety, one has to remember that benefits come with risks. As the Post article notes, "The process for getting a new drug approved in the U.S. is rigorous but it isn't designed to detect every possible risk. That would require studies so large and long that few new medicines would ever hit the market."

Still, more could be done to monitor drug safety in practice. Millions of people take prescription drugs daily, but their experiences are rarely recorded except by their physicians. That means every day data of real world experiences is being collected and hidden, much like the Ark of the Covenant was stored away in some government basement in the first Indiana Jones movie. FDA could move to collect that data and obtain the details of each patient – redacting names and other information that would identify a single individual – and run studies to see if certain harms (or benefits) arise among patients with certain characteristics. This technique, called Clinical Practice Improvement – would dramatically cut the time and expense that traditional clinical trials entail, and lead to the sort of revolution in medical safety and treatment protocols that other information-driven techniques have created in other sectors of the economy.

"Hollywood" Extortion
Robert Goldberg, Ph.D., Washington Times, 10-5-04

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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.

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HOME

SPOTLIGHT

Waiting for the 17th plan

NEWS

Vioxx's Removal May Not Affect Care Much; Other Drugs Can Be Used, Experts Say
Coping Without Vioxx – Recall of Merck’s Pain Drug Sparks Hunt for Alternatives; Just How Safe is Celebrex?
Evaluating Vioxx Alternatives
Promise and Peril of Vioxx Cast Harsher Light on New Drugs
Vioxx Recall Raises Questions on FDA's Safety Monitoring
Vioxx Recall May Bring Flood of Suits to Merck
Vioxx Lawsuits May Focus on FDA Warning in 2001
Putting Side Effects in Perspective – Despite Vioxx Withdrawal, The Benefits of Medicines Can Outweigh the Risks
FDA Says Intercepted Canadian Drugs Unsafe
Task Force: Americans Don’t Have to Look North to Find Cheap Prescription Drugs
Kucinich Wants Government to Oversee Drug Research

COMMENTARY

A Vioxx Elegy
Good Riddance to a Bad Drug
Letter to the Editor: Europe’s Drug Import Example
Beware of Doing More Harm
Money is the Catalyst for Good Medicine
"Hollywood" Extortion
Center for Medical Progress 
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