When is a serious side effect not a serious side effect?
When the people who are at risk or talk about it receive support from drug companies.
At least that's what the WSJ implies in it's article about people with epilepsy who suffer seizures when they are switched -- without their consent -- to a generic version of an anti-convulsant to save a few bucks.
PILL PUSH
Industry Fights Switch
To Generics for Epilepsy
Big Drug Makers Help
Patient Groups Lobby;
More Attention to States
By SARAH RUBENSTEIN
In state legislatures across the country, the Epilepsy Foundation has been campaigning for bills that would make it harder for pharmacists to switch patients to inexpensive generic epilepsy pills. The effort is getting behind-the-scenes support from drug companies -- a sign of how the industry, long a potent lobbying force in Washington, is increasingly looking to states to achieve its goals.
http://online.wsj.com/article/SB118426152232264867-search.html?KEYWORDS=epilepsy&COLLECTION=wsjie/6month
I will get to the science behind this issue -- and there is science, though you wouldn't know it from reading the piece -- in a second. But consider this:
The WSJ piece depicts the epilepsy drug switch-side effect issue as anecdot dotted campaign led by Big Pharma to keep their drugs on formulary. Yet Steve Nissen receives money from drug companies and did a slap dash study about heart attack risk of Avandia and that was front page news. He had to pool studies of widely varying quality and size (basically pooling anecdotal information) and he was hailed by the media as a whistleblower.
Now AP reports that the FDA is getting anecdotal reports of heart attacks from Avandia users (no surprise since diabetics are 2x likely to have heart problems than others) and claims that this is evidence of Avandia's dangers previously being under-reported. "Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet."
http://news.yahoo.com/s/ap/20070713/ap_on_he_me/diabetes_drug_risks_8
Now to the evidence of drug switching triggering seizures. Anti-convulsants have very narrow therapeutic windows. So switching, whether from one brand to another or from a brand to a cheaper older med can cause problems. That is fact.
Here is one study "Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes." Epilepsia. 2007 Mar;48(3):464-9. The study found: These results reflect poor acceptance of switching AEDs (anti-epileptic drugs) to generic compounds. They may also indicate increased toxicity and/or loss of seizure control associated with generic AED use."
So what did we learn class?
Take adverse reports after hysterical reporting of a sloppy and politically motivated meta analysis on Avandia seriously. Why? Not generated by Big Pharma.
Ignore the reports of seizures associated with compulsory drug switching to generic anti convulsants. Why? Obviously generated by Big Pharma.
And what about the scientific basis behind the seizures? Too bad. If someone is supported by Big Pharma, then they obviously deserve to get seizures anyway.
When the people who are at risk or talk about it receive support from drug companies.
At least that's what the WSJ implies in it's article about people with epilepsy who suffer seizures when they are switched -- without their consent -- to a generic version of an anti-convulsant to save a few bucks.
PILL PUSH
Industry Fights Switch
To Generics for Epilepsy
Big Drug Makers Help
Patient Groups Lobby;
More Attention to States
By SARAH RUBENSTEIN
In state legislatures across the country, the Epilepsy Foundation has been campaigning for bills that would make it harder for pharmacists to switch patients to inexpensive generic epilepsy pills. The effort is getting behind-the-scenes support from drug companies -- a sign of how the industry, long a potent lobbying force in Washington, is increasingly looking to states to achieve its goals.
http://online.wsj.com/article/SB118426152232264867-search.html?KEYWORDS=epilepsy&COLLECTION=wsjie/6month
I will get to the science behind this issue -- and there is science, though you wouldn't know it from reading the piece -- in a second. But consider this:
The WSJ piece depicts the epilepsy drug switch-side effect issue as anecdot dotted campaign led by Big Pharma to keep their drugs on formulary. Yet Steve Nissen receives money from drug companies and did a slap dash study about heart attack risk of Avandia and that was front page news. He had to pool studies of widely varying quality and size (basically pooling anecdotal information) and he was hailed by the media as a whistleblower.
Now AP reports that the FDA is getting anecdotal reports of heart attacks from Avandia users (no surprise since diabetics are 2x likely to have heart problems than others) and claims that this is evidence of Avandia's dangers previously being under-reported. "Only five heart attacks were reported in the 35 days before the study, compared with 90 in the same period afterward. Heart-related hospitalizations went from 11 to 126. The reports involve rosiglitazone, sold as Avandia and Avandamet."
http://news.yahoo.com/s/ap/20070713/ap_on_he_me/diabetes_drug_risks_8
Now to the evidence of drug switching triggering seizures. Anti-convulsants have very narrow therapeutic windows. So switching, whether from one brand to another or from a brand to a cheaper older med can cause problems. That is fact.
Here is one study "Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes." Epilepsia. 2007 Mar;48(3):464-9. The study found: These results reflect poor acceptance of switching AEDs (anti-epileptic drugs) to generic compounds. They may also indicate increased toxicity and/or loss of seizure control associated with generic AED use."
So what did we learn class?
Take adverse reports after hysterical reporting of a sloppy and politically motivated meta analysis on Avandia seriously. Why? Not generated by Big Pharma.
Ignore the reports of seizures associated with compulsory drug switching to generic anti convulsants. Why? Obviously generated by Big Pharma.
And what about the scientific basis behind the seizures? Too bad. If someone is supported by Big Pharma, then they obviously deserve to get seizures anyway.