|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 10-05-2004
Evaluating Vioxx Alternatives
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.
Vioxx Recall May Bring Flood of Suits to Merck
Vioxx Lawsuits May Focus on FDA Warning in 2001
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.
Putting Side Effects in Perspective – Despite Vioxx Withdrawal, The Benefits of Medicines Can Outweigh the Risks
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.
Task Force: Americans Don’t Have to Look North to Find Cheap Prescription Drugs
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.
U.S. Will Miss Half of Its Supply of Flu Vaccine
Shortage Was Predicted
This year’s flu vaccine shortage has taken the average person by surprise, but as this article notes, experts have long seen this coming. This article nicely summarizes the problem and notes that one reason we have the shortage is that companies have not had the proper incentives to enter the flu vaccine market. ‘We have to be willing to pay more for the wonderful protection we get from vaccines,” the article quotes Dr. William Schaffner as saying. “When there is more profit, it will be an incentive for companies to enter the market.” For an analysis of where government vaccine policy has gone wrong and what can be done to correct the problem, see this week’s spotlight article by CMP Director Robert Goldberg.
Fixing Vaccine Supply System; Task Will Not Be Easy, Say Health and Drug Industry Officials
Flu Shortage Shows System Flaws; Fewer Companies Making Vaccines
Sometimes it takes a crisis to focus policymakers' attention on a problem, and this year's flu vaccine shortage might finally be enough to force Washington to fix our nation's vaccine production system. This article lays out the problem nicely: only one company now makes MMR vaccine, and only three make flu vaccine, with two of them controlling over 95% of the market.
The cure for the crisis is thus not too hard to discover: enact policies which encourage more investment in new vaccines, and improve the incentives to produce existing ones. Many existing policies serve to discourage vaccine investment and production, including payments through the Vaccines for Children program that are too low, pre-approval study requirements that are as much as ten times as stringent as would be required for approval of a normal drug, and uncertainty among manufacturers about their potential legal liability. Widespread vaccination was among the earliest public health successes in the 19th and early 20th Centuries; it would be a policy failure of epidemic proportions to permit such a success to undo itself.
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