More Patients Are Beginning To Lose Patience With FDA
BY PETER BENESH
INVESTOR'S BUSINESS DAILY
Posted 4/13/2006
When a drug gets pulled off the market because a relatively few patients have adverse reactions, plenty of other patients lose a treatment that might help them.
A couple of recent surveys show that patients want the right to decide for themselves whether to use potentially risky drugs for chronic diseases.
One of the surveys was from the American Enterprise Institute for Public Policy Research (AEI), a think tank that polled multiple sclerosis patients.
The other, from the National Consumers League, an advocacy group, polled a cross section of the national population.
In both surveys 90% of respondents said patients, in consultation with their doctors, should be able to choose a prescription drug that might have side effects.
Patients don't want the Food and Drug Administration restricting drugs that might benefit them, says John Calfee, an AEI resident scholar and author of its report.
"Once patients know the risks, they really think that the decisions should be made by them and their doctors," Calfee said.
The AEI survey was paid for by Biogen Idec, (BIIB) which, with Elan, (ELN) partnered to make the MS drug Tysabri.
The companies pulled the promising drug off the market in February 2005 after two deaths from a rare brain disorder that might have been caused by a drug combination.
Costs/Benefit Analysis
Tysabri exemplifies the right-to-choose issue, says Greg Simon, president of FasterCures, an organization that lobbies for quicker drug approvals. He says the FDA should analyze facts about drug efficacy and risk, then leave it to patients and doctors to decide about use of a drug.
"The FDA communicates risks on extremes of a curve," Simon said. "It either tells people the drug is safe, or it tells them the drug will kill enough people that everyone thinks they're in danger. We must separate the drug analysis function from the risk analysis function."
That position is shared by Biogen, which is campaigning to get the FDA to re-approve Tysabri.
"We want patients and physicians to have the option to have access to Tysabri, together weigh the product's risks and benefits, and then make decisions about therapy," spokeswoman Amy Brockelman said in an e-mail.
Biogen executives would not comment.
The FDA, which also wouldn't comment, has said it will decide Tysabri's future in late June. The release of the AEI survey coincided with a unanimous recommendation from an FDA panel to restore Tysabri to the market.
It's not hard to figure out why Biogen and Elan want the drug reinstated. Biogen's stock traded near 67 before Tysabri was pulled. After it was pulled, shares crashed 44% to less than 38. Now they trade near 45.
Elan's stock traded near 27 before the withdrawal. It fell as low as 3 in April 2005 and now trades near 14.
Biogen underwrote the AEI study because it wants to bolster its argument before the FDA, Calfee says. "Their purpose is to show that some MS patients are willing to take some chances to get a drug that's more effective than other therapies."
Calculated Risk
When FDA officials make these kinds of rulings, they should weigh various ethical questions, says Michelle Mello, associate professor of health policy and law at Harvard University.
"Is it fair to make a decision that looks at an overall effect of a drug on a population, and binds subgroups of that population to that decision even if the results for them might be different and possibly better?" she said. "Is it fair to impose a burden on some groups of very sick patients?"
She says some patients are so sick, they have nothing else to lose. "For them, our assumptions about wanting people to weigh all the evidence go out the window."
One advocacy group is suing the FDA over a related issue. The Abigail Alliance for Better Access to Developmental Drugs wants desperately ill people to be able to get drugs that have proved their safety but are still in clinical trials for efficacy.
The Tysabri case shows how the cost of not allowing some risks can be too high, says Frank Burroughs, president of the Abigail Alliance.
"If there's a .01% chance of a lifeboat sinking, do we let everybody go down with the ship?" he said.
Before patients can have a right to choose risky drugs, they should be required to sign waivers, Burroughs says. And most everyone agrees that patients should be willing to relinquish certain rights in order take certain risks.
"In order to make their own decisions, patients must give up the right to sue drug companies," Simon said.
INVESTOR'S BUSINESS DAILY
Posted 4/13/2006
When a drug gets pulled off the market because a relatively few patients have adverse reactions, plenty of other patients lose a treatment that might help them.
A couple of recent surveys show that patients want the right to decide for themselves whether to use potentially risky drugs for chronic diseases.
One of the surveys was from the American Enterprise Institute for Public Policy Research (AEI), a think tank that polled multiple sclerosis patients.
The other, from the National Consumers League, an advocacy group, polled a cross section of the national population.
In both surveys 90% of respondents said patients, in consultation with their doctors, should be able to choose a prescription drug that might have side effects.
Patients don't want the Food and Drug Administration restricting drugs that might benefit them, says John Calfee, an AEI resident scholar and author of its report.
"Once patients know the risks, they really think that the decisions should be made by them and their doctors," Calfee said.
The AEI survey was paid for by Biogen Idec, (BIIB) which, with Elan, (ELN) partnered to make the MS drug Tysabri.
The companies pulled the promising drug off the market in February 2005 after two deaths from a rare brain disorder that might have been caused by a drug combination.
Costs/Benefit Analysis
Tysabri exemplifies the right-to-choose issue, says Greg Simon, president of FasterCures, an organization that lobbies for quicker drug approvals. He says the FDA should analyze facts about drug efficacy and risk, then leave it to patients and doctors to decide about use of a drug.
"The FDA communicates risks on extremes of a curve," Simon said. "It either tells people the drug is safe, or it tells them the drug will kill enough people that everyone thinks they're in danger. We must separate the drug analysis function from the risk analysis function."
That position is shared by Biogen, which is campaigning to get the FDA to re-approve Tysabri.
"We want patients and physicians to have the option to have access to Tysabri, together weigh the product's risks and benefits, and then make decisions about therapy," spokeswoman Amy Brockelman said in an e-mail.
Biogen executives would not comment.
The FDA, which also wouldn't comment, has said it will decide Tysabri's future in late June. The release of the AEI survey coincided with a unanimous recommendation from an FDA panel to restore Tysabri to the market.
It's not hard to figure out why Biogen and Elan want the drug reinstated. Biogen's stock traded near 67 before Tysabri was pulled. After it was pulled, shares crashed 44% to less than 38. Now they trade near 45.
Elan's stock traded near 27 before the withdrawal. It fell as low as 3 in April 2005 and now trades near 14.
Biogen underwrote the AEI study because it wants to bolster its argument before the FDA, Calfee says. "Their purpose is to show that some MS patients are willing to take some chances to get a drug that's more effective than other therapies."
Calculated Risk
When FDA officials make these kinds of rulings, they should weigh various ethical questions, says Michelle Mello, associate professor of health policy and law at Harvard University.
"Is it fair to make a decision that looks at an overall effect of a drug on a population, and binds subgroups of that population to that decision even if the results for them might be different and possibly better?" she said. "Is it fair to impose a burden on some groups of very sick patients?"
She says some patients are so sick, they have nothing else to lose. "For them, our assumptions about wanting people to weigh all the evidence go out the window."
One advocacy group is suing the FDA over a related issue. The Abigail Alliance for Better Access to Developmental Drugs wants desperately ill people to be able to get drugs that have proved their safety but are still in clinical trials for efficacy.
The Tysabri case shows how the cost of not allowing some risks can be too high, says Frank Burroughs, president of the Abigail Alliance.
"If there's a .01% chance of a lifeboat sinking, do we let everybody go down with the ship?" he said.
Before patients can have a right to choose risky drugs, they should be required to sign waivers, Burroughs says. And most everyone agrees that patients should be willing to relinquish certain rights in order take certain risks.
"In order to make their own decisions, patients must give up the right to sue drug companies," Simon said.
Related Resources:
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