MS Awareness Week
So it's perhaps past time to flog my horse, as it were (the week's more than half over....). So pull out something orange (an orange even) and wear it (or eat it) while you read.
The stimulus package might have some good news ("hundreds of millions" are scheduled to be disbursed to health-care related facilities, some of which research multiple sclerosis).
But one of its provisions may be very bad news indeed for people like me: the establishment of some kind of apparatus for comparing the efficacy (efficiency?) of all kinds of drug treatments. $1.1 billion worth of apparatus. Whether efficacy or efficiency (i.e. some kind of cost to benefit ratio) will be their guiding concern (and how one might define both those terms) is the question. And it seems it's the latter that is uppermost on the administration's mind. It's going to be important to scrutinize who's appointed to the fifteen member council that will be the final arbiter.
As many people are reminding us, Europe's ahead of the curve, and we should NOT follow them up that hill:
The U.S. won’t be the first to perform comparative effectiveness research. England has the National Institute for Health and Clinical Effectiveness (NICE), which evaluates the cost and effectiveness of treatments, as do France, Denmark and Germany. While NICE guides England's National Health Service, it's been criticized for recommending against the use of drugs for certain patients with breast cancer, multiple sclerosis and Alzheimer's disease.
Beta-interferon (Rebif, Avonex, Cinnavex) is infamously one of those drug classes that gets the short end of the NICE stick:
NICE gave a "provisional view" in July 2000, just under a year after being asked to appraise beta interferon, that the drug should not be made available on the NHS, except to those already taking the medication, because its "modest clinical benefit appears to be outweighed by (its) very high cost". In other words, Nice argued that the money spent on beta interferon (around £10,000 a year for each patient) would be better spent on other forms of treatment for MS, such as physiotherapy.* The MS Society and various pharmaceutical companies appealed against this preliminary ruling, forcing Nice in November 2000 to re-assess its costing methodology. Having done this, Nice delivered a second preliminary ruling in August 2001, largely repeating its original conclusions, while urging the DoH to examine ways of securing the drug for the NHS in "a manner which could be considered to be cost-effective". On January 26 2002, Nice rejected a final appeal against its decision. On February 4 2002, it reconfirmed its original recommendation.
Now I may be too close to determine whether they're justified in this (I've come around, as y'all have seen, to embrace my Avonex), the situation w/r/t drug therapies for MS is complex enough for that ruling to seem really really unfortunate. The Alliance for Human Research Protection asks the right questions, I think. In addition to further research into the actual cause(s) of MS, more accountability for Big Pharma is absolutely necessary:
An essential element of science-based medicine is to ensure that the science is honest. To achieve that goal: legislation is needed requiring an independently maintained, internet registry of drug trials. Information to be included: reported findings accompanied by the collected raw data; including protocol design and the statistical inferences drawn from the data.** Only then can independent scientists assess and replicate the reported findings. Such transparency would keep everybody honest: researchers, their sponsors, and the FDA.
I find myself in very regrettable company in worrying about this (Rush Limbaugh has been yapping about it apparently. [No I'm not providing a link, fucker can get his own page hits]).
So this week maybe you can help stimulate (ha) discussion of this aspect of the stimulus package: it's going to have consequences for all of us.
AND OH YEAH I'M WALKING NEXT MONTH. GIVE ME MONEH.***
----
*Yeah, like that's going to help with optic neuritis or loss of bladder control. :/
**The interpretation of data in preparation of reports to the FDA (that is, statistical data analysis) is depressingly susceptible to dirty dealing (which shouldn't be surprising, but is). SK, the BFF mentioned earlier this week, has unfortunate amounts of first hand experience with this. I was privy to the whole SARAFEM travesty, myself: Eli Lilly cooking the data and INVENTING A DISEASE IN THE PROCESS, to get their recently-patent-protection-expired drug Prozac BACK ON THE MARKET (and patent protected). Cash-cows suited up in pink and lavender and trotted out to the pages of women's magazines. Guh.
***Those of you who haven't yet, that is!
The stimulus package might have some good news ("hundreds of millions" are scheduled to be disbursed to health-care related facilities, some of which research multiple sclerosis).
But one of its provisions may be very bad news indeed for people like me: the establishment of some kind of apparatus for comparing the efficacy (efficiency?) of all kinds of drug treatments. $1.1 billion worth of apparatus. Whether efficacy or efficiency (i.e. some kind of cost to benefit ratio) will be their guiding concern (and how one might define both those terms) is the question. And it seems it's the latter that is uppermost on the administration's mind. It's going to be important to scrutinize who's appointed to the fifteen member council that will be the final arbiter.
As many people are reminding us, Europe's ahead of the curve, and we should NOT follow them up that hill:
The U.S. won’t be the first to perform comparative effectiveness research. England has the National Institute for Health and Clinical Effectiveness (NICE), which evaluates the cost and effectiveness of treatments, as do France, Denmark and Germany. While NICE guides England's National Health Service, it's been criticized for recommending against the use of drugs for certain patients with breast cancer, multiple sclerosis and Alzheimer's disease.
Beta-interferon (Rebif, Avonex, Cinnavex) is infamously one of those drug classes that gets the short end of the NICE stick:
NICE gave a "provisional view" in July 2000, just under a year after being asked to appraise beta interferon, that the drug should not be made available on the NHS, except to those already taking the medication, because its "modest clinical benefit appears to be outweighed by (its) very high cost". In other words, Nice argued that the money spent on beta interferon (around £10,000 a year for each patient) would be better spent on other forms of treatment for MS, such as physiotherapy.* The MS Society and various pharmaceutical companies appealed against this preliminary ruling, forcing Nice in November 2000 to re-assess its costing methodology. Having done this, Nice delivered a second preliminary ruling in August 2001, largely repeating its original conclusions, while urging the DoH to examine ways of securing the drug for the NHS in "a manner which could be considered to be cost-effective". On January 26 2002, Nice rejected a final appeal against its decision. On February 4 2002, it reconfirmed its original recommendation.
Now I may be too close to determine whether they're justified in this (I've come around, as y'all have seen, to embrace my Avonex), the situation w/r/t drug therapies for MS is complex enough for that ruling to seem really really unfortunate. The Alliance for Human Research Protection asks the right questions, I think. In addition to further research into the actual cause(s) of MS, more accountability for Big Pharma is absolutely necessary:
An essential element of science-based medicine is to ensure that the science is honest. To achieve that goal: legislation is needed requiring an independently maintained, internet registry of drug trials. Information to be included: reported findings accompanied by the collected raw data; including protocol design and the statistical inferences drawn from the data.** Only then can independent scientists assess and replicate the reported findings. Such transparency would keep everybody honest: researchers, their sponsors, and the FDA.
I find myself in very regrettable company in worrying about this (Rush Limbaugh has been yapping about it apparently. [No I'm not providing a link, fucker can get his own page hits]).
So this week maybe you can help stimulate (ha) discussion of this aspect of the stimulus package: it's going to have consequences for all of us.
AND OH YEAH I'M WALKING NEXT MONTH. GIVE ME MONEH.***
----
*Yeah, like that's going to help with optic neuritis or loss of bladder control. :/
**The interpretation of data in preparation of reports to the FDA (that is, statistical data analysis) is depressingly susceptible to dirty dealing (which shouldn't be surprising, but is). SK, the BFF mentioned earlier this week, has unfortunate amounts of first hand experience with this. I was privy to the whole SARAFEM travesty, myself: Eli Lilly cooking the data and INVENTING A DISEASE IN THE PROCESS, to get their recently-patent-protection-expired drug Prozac BACK ON THE MARKET (and patent protected). Cash-cows suited up in pink and lavender and trotted out to the pages of women's magazines. Guh.
***Those of you who haven't yet, that is!