Latest Drugwonks' Blog
AEI's Joe Antos in The American on how quickly and conveniently CMS is using post market evidence on cancer drugs to suit it's needs and screw patients: "The CMS action is breathtaking for its speed and its incursion into the practice of medicine. As a long-time observer of CMS, and as a former official in the agency during the 1980s, I have never seen a proposal with this level of detail emerge from the thicket of clearances in such a short period of time. Perhaps CMS has found some new efficiency that permits it to release rules in record time?"
Want an idea of how patients will fare under this farce called a federally funded R and D center for comparative effectiveness, read Balancing the Budget on The Backs of Cancer Patients.
http://american.com/archive/2007/june-0607/balancing-the-budget-on-the-backs-of-cancer-patients
Want an idea of how patients will fare under this farce called a federally funded R and D center for comparative effectiveness, read Balancing the Budget on The Backs of Cancer Patients.
http://american.com/archive/2007/june-0607/balancing-the-budget-on-the-backs-of-cancer-patients
Note: This is Peter's blog...I am posting for him because his computer is experiencing technical difficulties that were not detected by meta analysis.
FDA reform, real reform, requires hard work, partnership, and candor -- not politics-as-usual.
As Matt Herper over at Forbes writes:
"One change that seems inevitable is the creation of more Steven Nissens--that is, more outside scientists looking over the FDA's shoulder. A Senate-passed bill from Senators Edward Kennedy (D--Mass.) and Michael Enzi (R--Wyo.) seeks to force manufacturers to make all study results public. Nissen was able to do his Avandia analysis because Glaxo, in order to get then New York attorney general Eliot Spitzer off its back, agreed three years ago to put drug-trial results up for public viewing. The bill would put all drug firms in this boat.
Think of this as the open-source FDA. Already outsiders have pinpointed valid safety issues, such as Vioxx. But open source can be an invitation to a lynching. AstraZeneca's blockbuster cholesterol pill Crestor was originally maligned over kidney worries but has since been cleared. Expect "a free-for-all" as academic researchers get more access to data from companies and from electronic health records, says FDA Deputy Commissioner Janet Woodcock. “You could imagine tort lawyers running those analyses," she says."
Matt’s article (“Lynch ‘Emâ€) can be found at www.forbes.com
Herper continues:
"Still, big pharma is backing the Kennedy-Enzi plan, which would also give the FDA more power to change drug labels and force companies to conduct studies. New Pfizer Chief Jeffrey Kindler praised the bill in a speech at the Economic Club of Washington, saying drug firms should absolutely support a bill that requires candor about clinical trials."
And candor is something this debate needs. And honesty and a focus on advancing the public health rather than settling private scores (both within the FDA and elsewhere).
Nobody said it was going to be easy.
FDA reform, real reform, requires hard work, partnership, and candor -- not politics-as-usual.
As Matt Herper over at Forbes writes:
"One change that seems inevitable is the creation of more Steven Nissens--that is, more outside scientists looking over the FDA's shoulder. A Senate-passed bill from Senators Edward Kennedy (D--Mass.) and Michael Enzi (R--Wyo.) seeks to force manufacturers to make all study results public. Nissen was able to do his Avandia analysis because Glaxo, in order to get then New York attorney general Eliot Spitzer off its back, agreed three years ago to put drug-trial results up for public viewing. The bill would put all drug firms in this boat.
Think of this as the open-source FDA. Already outsiders have pinpointed valid safety issues, such as Vioxx. But open source can be an invitation to a lynching. AstraZeneca's blockbuster cholesterol pill Crestor was originally maligned over kidney worries but has since been cleared. Expect "a free-for-all" as academic researchers get more access to data from companies and from electronic health records, says FDA Deputy Commissioner Janet Woodcock. “You could imagine tort lawyers running those analyses," she says."
Matt’s article (“Lynch ‘Emâ€) can be found at www.forbes.com
Herper continues:
"Still, big pharma is backing the Kennedy-Enzi plan, which would also give the FDA more power to change drug labels and force companies to conduct studies. New Pfizer Chief Jeffrey Kindler praised the bill in a speech at the Economic Club of Washington, saying drug firms should absolutely support a bill that requires candor about clinical trials."
And candor is something this debate needs. And honesty and a focus on advancing the public health rather than settling private scores (both within the FDA and elsewhere).
Nobody said it was going to be easy.
Welcome to the Age of YouTube.
We will be doing regular podcasts, where we will ask experts as well as average folks what they think about some of the most pressing health care issues we face as a nation.
Oh yes, and some that aren't so pressing -- like whether or not Michael Moore should be trusted to direct American health care.
To view our initial effort, click on the link below and follow it to the "Podcast" box:
http://www.cmpi.org
Enjoy. (We did.)
We will be doing regular podcasts, where we will ask experts as well as average folks what they think about some of the most pressing health care issues we face as a nation.
Oh yes, and some that aren't so pressing -- like whether or not Michael Moore should be trusted to direct American health care.
To view our initial effort, click on the link below and follow it to the "Podcast" box:
http://www.cmpi.org
Enjoy. (We did.)
Before you read any media reports, read Derek's balanced analysis of both the FDA and Sanofi's documents on the risks and benefits on Accomplia. As usual, he tees up the issue with insight and objectivity:
The incidence of suicidality – specifically suicidal ideation – was higher for 20 mg
rimonabant compared to placebo. Similarly, the incidence of psychiatric adverse events,
neurological adverse events and seizures were consistently higher for 20 mg rimonabant compared to placebo. . ."
They're also concerned about other neurological side effects, and seizures as well. The seizure data don't look nearly as worrisome, except in the obese diabetic patients, for whom everything seems to be amplified. And all of this happens at the 20-mg dose, not at the 5 (which doesn't do much for weight, either, as noted above). And for those who are wondering, yes, on my first pass through the data, I find these statistics much more convincing than I did the ones on the Avandia (rosiglitazone) association with cardiac events.
I had my worries about rimonabant a long time ago, but not for any specific reason. It's just that I used to work on central nervous system drugs, and you have to be ready for anything. Any new CNS mechanism, I figured, might well set off some things that no one was expecting, given how little we understand about that area."
Another important element that I think favors approval: Sanofi-Aventis is proposing labeling and prescribing limits to take into account the increased risk of a variety of pyschological side effects ranging from anxiety to suicidal thoughts (primarily among schizophrenics and others with a history of mental illness). Importantly, people in Accomplia trials had to go off antidepressants while on the drug so the label and risk management plan will limit use of the drug to people who are either on antidepressants or who are depressed. In Europe, compliance with such limits is around 95 percent.
Watch the fearmongers rise up and scream that no one should be allowed to have access to a drug that demonstrates the ability to reduce weight and glucose levels safely in a specific population. If Accomplia is NOT approved with the RISKMAP in place, with a pledge for post market studies and surveillance, no DTC ads for at least half a year, then what good is PDUFA?
Accomplia is a litmus test for the backbone of the agency and the political strength of the fearmongers.
The incidence of suicidality – specifically suicidal ideation – was higher for 20 mg
rimonabant compared to placebo. Similarly, the incidence of psychiatric adverse events,
neurological adverse events and seizures were consistently higher for 20 mg rimonabant compared to placebo. . ."
They're also concerned about other neurological side effects, and seizures as well. The seizure data don't look nearly as worrisome, except in the obese diabetic patients, for whom everything seems to be amplified. And all of this happens at the 20-mg dose, not at the 5 (which doesn't do much for weight, either, as noted above). And for those who are wondering, yes, on my first pass through the data, I find these statistics much more convincing than I did the ones on the Avandia (rosiglitazone) association with cardiac events.
I had my worries about rimonabant a long time ago, but not for any specific reason. It's just that I used to work on central nervous system drugs, and you have to be ready for anything. Any new CNS mechanism, I figured, might well set off some things that no one was expecting, given how little we understand about that area."
Another important element that I think favors approval: Sanofi-Aventis is proposing labeling and prescribing limits to take into account the increased risk of a variety of pyschological side effects ranging from anxiety to suicidal thoughts (primarily among schizophrenics and others with a history of mental illness). Importantly, people in Accomplia trials had to go off antidepressants while on the drug so the label and risk management plan will limit use of the drug to people who are either on antidepressants or who are depressed. In Europe, compliance with such limits is around 95 percent.
Watch the fearmongers rise up and scream that no one should be allowed to have access to a drug that demonstrates the ability to reduce weight and glucose levels safely in a specific population. If Accomplia is NOT approved with the RISKMAP in place, with a pledge for post market studies and surveillance, no DTC ads for at least half a year, then what good is PDUFA?
Accomplia is a litmus test for the backbone of the agency and the political strength of the fearmongers.
Previously we have discussed the half-baked and benighted ideas of Representative Maurice Hinchey -- author (along with Representative Bart Stupak) of a bill that would prohibit the agency from collecting fees from the companies it regulates. Instead, the money would be deposited into the general fund of the U.S. Treasury (see blog entry "Slo Mo," posted on 5/21/07).
Well, he's at it again. Here's what he had to say yesterday ...
"The FDA has essentially become the government affairs office of the pharmaceutical industry," Hinchey said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate."
This is anticipation of today's sitting of the House Energy and Commerce Subcommittee on Health.
A "Mo" untrue, unjust, and unfair statement is hardly imaginable.
The FDA is staffed with public health professionals on personal public health missions. They care, deeply, about safety and efficacy and about doing the right thing.
Mr. Hinchey, it seems, cares about headlines and hysteria.
An apology is in order.
Well, he's at it again. Here's what he had to say yesterday ...
"The FDA has essentially become the government affairs office of the pharmaceutical industry," Hinchey said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate."
This is anticipation of today's sitting of the House Energy and Commerce Subcommittee on Health.
A "Mo" untrue, unjust, and unfair statement is hardly imaginable.
The FDA is staffed with public health professionals on personal public health missions. They care, deeply, about safety and efficacy and about doing the right thing.
Mr. Hinchey, it seems, cares about headlines and hysteria.
An apology is in order.
I am trying to be nice... A kinder, gentler post that doesn't take media bias and laziness personally, that doesn't degenerate into childish namecalling...
Oh, screw it.
Rita Rubin's latest assault on the current PDUFA bill gets it exactly wrong.
"The FDA has essentially become the government affairs office of the pharmaceutical industry," Hinchey said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate." Hinchey is the author, and Bart Stupak, D-Mich., the chief co-sponsor of an FDA reform bill that would prohibit the agency from collecting fees from the companies it regulates. Instead, the money would be deposited into the general fund of the U.S. Treasury.
According to the Appropriations Committee, two officials of the Biotechnology Industry Organization and two officials of the Pharmaceutical Research and Manufacturers Association attended at least half of the 112 meetings."
Hey Rita, what's the punchline? So what? Did you ask how many times Hinchey and Stupak met with the lobbyists of organizations that are looking for earmarks from the Appropriations committee? Why don't Hinchey and Stupak post those numbers?
Now, unlike the done in the dark earmarking orgy, companies and the FDA are legally required to meet as part of the PDUFA reauthorization. But of course, the implication is that the companies run the show. Now if that were the case, if PDUFA were just a way to bend the drug approval process to the companies need, why have the percentage of drugs getting from Phase 1 to Phase 3 actually declined since PDUFA was implemented. Are companies deliberately conspiring with the FDA to take over the agency just to flush as much cash down the toilet as possible. Way to think through the logic, Rita!!!
Now extending that logic, should company representatives not meet with the FDA to discuss design of clinical trials, to explain endpoints, cooperate in sharing data to improve safety, design those safety trials the critics drool over while ignoring the need for new medicines?
I am one of those who actually agree that PDUFA has outlived its usefulness as a funding mechanism. It is too inflexible and keyed to one part of the drug development process. And it has not -- as I noted earlier -- done much to improve the efficiency of overall drug development (and that includes the efficiency of PM surveillance.) But don't believe - as the critics do -- that it has compromised safety. That is a silly and unscientific assertion.
I feel better now.
For the entire article go to: http://www.usatoday.com/news/health/2007-06-11-fda-drugmakers_N.htm
Oh, screw it.
Rita Rubin's latest assault on the current PDUFA bill gets it exactly wrong.
"The FDA has essentially become the government affairs office of the pharmaceutical industry," Hinchey said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate." Hinchey is the author, and Bart Stupak, D-Mich., the chief co-sponsor of an FDA reform bill that would prohibit the agency from collecting fees from the companies it regulates. Instead, the money would be deposited into the general fund of the U.S. Treasury.
According to the Appropriations Committee, two officials of the Biotechnology Industry Organization and two officials of the Pharmaceutical Research and Manufacturers Association attended at least half of the 112 meetings."
Hey Rita, what's the punchline? So what? Did you ask how many times Hinchey and Stupak met with the lobbyists of organizations that are looking for earmarks from the Appropriations committee? Why don't Hinchey and Stupak post those numbers?
Now, unlike the done in the dark earmarking orgy, companies and the FDA are legally required to meet as part of the PDUFA reauthorization. But of course, the implication is that the companies run the show. Now if that were the case, if PDUFA were just a way to bend the drug approval process to the companies need, why have the percentage of drugs getting from Phase 1 to Phase 3 actually declined since PDUFA was implemented. Are companies deliberately conspiring with the FDA to take over the agency just to flush as much cash down the toilet as possible. Way to think through the logic, Rita!!!
Now extending that logic, should company representatives not meet with the FDA to discuss design of clinical trials, to explain endpoints, cooperate in sharing data to improve safety, design those safety trials the critics drool over while ignoring the need for new medicines?
I am one of those who actually agree that PDUFA has outlived its usefulness as a funding mechanism. It is too inflexible and keyed to one part of the drug development process. And it has not -- as I noted earlier -- done much to improve the efficiency of overall drug development (and that includes the efficiency of PM surveillance.) But don't believe - as the critics do -- that it has compromised safety. That is a silly and unscientific assertion.
I feel better now.
For the entire article go to: http://www.usatoday.com/news/health/2007-06-11-fda-drugmakers_N.htm
I take strong objection to the AP Headline "Children With Austism Get Day in Court" which Forbes.com helpfully picked up.
Sorry to say, but this headline is misleading. It should be, tragically misguided and overzealous parents with the help of greedy trial lawyers pursue junk science on mercury-autism link. For the facts of the matter, folks should go to http://www.stats.org to see how most of the media coverage is giving way too much credence to the fringe group that has been pursuing this case.
The claim that mercury causes autism has as much science behind as the claim that witches and Jews caused the Black Plague in the middle ages. It has been investigated again and again. Like most safety signals, they were first detected by the same sort of people who see danger lurking in every public health advance, who see a government or corporate conspiracy to first introduce and then cover up the spread of the poison.
The case is only a first step towards a large junk science inspired civil court suit since the hearing this is before a federal vaccine injury compensation board (Rosemary Johan-Liang is now a medical reviewer with this board.:
My colleague Paul Offit, MD who developed the rotavirus vaccine -- who has been threatened with murder by autism conspiracy theorist crazed parents -- has a good article about the stakes in this trial.
http://www.boston.com/news/globe/ideas/articles/2007/06/03/at_risk_vaccines?mode=PF
Sorry to say, but this headline is misleading. It should be, tragically misguided and overzealous parents with the help of greedy trial lawyers pursue junk science on mercury-autism link. For the facts of the matter, folks should go to http://www.stats.org to see how most of the media coverage is giving way too much credence to the fringe group that has been pursuing this case.
The claim that mercury causes autism has as much science behind as the claim that witches and Jews caused the Black Plague in the middle ages. It has been investigated again and again. Like most safety signals, they were first detected by the same sort of people who see danger lurking in every public health advance, who see a government or corporate conspiracy to first introduce and then cover up the spread of the poison.
The case is only a first step towards a large junk science inspired civil court suit since the hearing this is before a federal vaccine injury compensation board (Rosemary Johan-Liang is now a medical reviewer with this board.:
My colleague Paul Offit, MD who developed the rotavirus vaccine -- who has been threatened with murder by autism conspiracy theorist crazed parents -- has a good article about the stakes in this trial.
http://www.boston.com/news/globe/ideas/articles/2007/06/03/at_risk_vaccines?mode=PF
Interesting article in today's edition of the New York Times. Authored by David Carr, the column, "Call the Doctor" calls into question whether health care policy blogs help or hinder our national (and international) health care debate. He uses the Avandia situation as an example and, as it turns out, a rather personal one.
He went online looking for information, "And here is what I found: everything except insight."
Ouch? Not necessarily. What he writes is that he found a lot of "polarized discourse." And his point is that, from a patient perspective, it didn't really tell him what to do.
Maybe so, but it clearly made him think.
He quotes from (among others) drugwonks.com, newstarget.com, pharmalot.com, corante.com/pipeline, and peterrost.blogspot.com, so it should come as no surprise that he got a plethora of differing viewpoints. But what's a patient to do?
Here's how Carr ends his column:
"This Wednesday, I will see my endocrinologist. We will chat for a few minutes about Avandia and no doubt he’ll smile when I entertain him with all that I have learned on the Web. Then after he tells me what he thinks, I will follow my doctor’s orders."
And sanity prevails.
He went online looking for information, "And here is what I found: everything except insight."
Ouch? Not necessarily. What he writes is that he found a lot of "polarized discourse." And his point is that, from a patient perspective, it didn't really tell him what to do.
Maybe so, but it clearly made him think.
He quotes from (among others) drugwonks.com, newstarget.com, pharmalot.com, corante.com/pipeline, and peterrost.blogspot.com, so it should come as no surprise that he got a plethora of differing viewpoints. But what's a patient to do?
Here's how Carr ends his column:
"This Wednesday, I will see my endocrinologist. We will chat for a few minutes about Avandia and no doubt he’ll smile when I entertain him with all that I have learned on the Web. Then after he tells me what he thinks, I will follow my doctor’s orders."
And sanity prevails.
India -- a nation known for its innovation in many areas -- has decided that incremental innovation in pharmaceuticals isn't important -- at least when it comes to patent protection.
In an interesting and important new paper, Trevor Jones (a member of the WHO's Commission on Intellectual Property Rights, Innovation and Public Health) points out that a new Indian law contains a clause (Clause 3D) that restricts innovation through incremental advances.
Here's a link to the complete paper:
http://www.law.gwu.edu/NR/rdonlyres/B1AA54BE-46F2-4203-964C-0430248BA36B/0/InnovationattheCrossroads.pdf
In short, unless the new medicine can show "proven additional efficacy," patent protection can be denied under 3D.
Now, besides being a pretty obvious violation of TRIPS (27-1 -- coincidentally the same clause used to shut down compulsory licensing in Canada, but that's another story), it's another example of how healthcare technology assesment (HTA) aka: evidence-based medicine (EBM) is being used to deny not only appropriate patient care, but now case patent protection.
And the two are linked because if you don't get the patent protection, the innovator company can't earn back what it invested in R&D, ergo they can't reinvest their profits in further R&D -- further delaying crucial incremental innovation which is how medical progress is made.
There's another link between 3D and evidence-based (read "cost-based") medicine, and that's the reliance on RCTs as the comparative evidence used to make the decision as to patentability (in the case of Clause 3D) or patient care (in the case of organizations such as NICE).
This is as much a Developing World issue as a First World one. Relative to treatments for HIV/AIDS Jones writes,
"Some that are very similar in chemical compositions have been referred to as me-too products, but all the drugs have been vital to the pandemic ... In fact, we need more, not less, me-too products."
Before we deny care (or patents) to the new medicines that take us down the path of incremental innovation, let's remember that such economically-driven, short-term decisions can have deadly unintended consequences.
In an interesting and important new paper, Trevor Jones (a member of the WHO's Commission on Intellectual Property Rights, Innovation and Public Health) points out that a new Indian law contains a clause (Clause 3D) that restricts innovation through incremental advances.
Here's a link to the complete paper:
http://www.law.gwu.edu/NR/rdonlyres/B1AA54BE-46F2-4203-964C-0430248BA36B/0/InnovationattheCrossroads.pdf
In short, unless the new medicine can show "proven additional efficacy," patent protection can be denied under 3D.
Now, besides being a pretty obvious violation of TRIPS (27-1 -- coincidentally the same clause used to shut down compulsory licensing in Canada, but that's another story), it's another example of how healthcare technology assesment (HTA) aka: evidence-based medicine (EBM) is being used to deny not only appropriate patient care, but now case patent protection.
And the two are linked because if you don't get the patent protection, the innovator company can't earn back what it invested in R&D, ergo they can't reinvest their profits in further R&D -- further delaying crucial incremental innovation which is how medical progress is made.
There's another link between 3D and evidence-based (read "cost-based") medicine, and that's the reliance on RCTs as the comparative evidence used to make the decision as to patentability (in the case of Clause 3D) or patient care (in the case of organizations such as NICE).
This is as much a Developing World issue as a First World one. Relative to treatments for HIV/AIDS Jones writes,
"Some that are very similar in chemical compositions have been referred to as me-too products, but all the drugs have been vital to the pandemic ... In fact, we need more, not less, me-too products."
Before we deny care (or patents) to the new medicines that take us down the path of incremental innovation, let's remember that such economically-driven, short-term decisions can have deadly unintended consequences.
Better coverage on Liang leaving the FDA which answers some questions I asked in an earlier post. .....Dr. Johann-Liang is leaving because she wants more regular hours consistent with her responsibilities as a parent with two autistic children. Harris' piece made it sound like she was driven out. Her new job is as a medical safety officer with the Vaccine Compensation Injury Board which of course will review claims of parents who believe their kids are harmed by vaccines and who often believe vaccines cause autism. http://www.usatoday.com/news/health/2007-06-10-fda-insider_N.htm?csp=34
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
