Latest Drugwonks' Blog
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
She was not fired, though Gardiner Harris makes it seem like she was or at least force it. She is quitting. My prediction: She will reappear at some drug safety shop but not before being a star witness at a Senate hearing on her Avandia's warnings..
Re Gardiner Harris' article about the safety reviewers at the FDA (notice he did not mentioned David Graham):
First of all, I think Harris raises one set of important questions. Unfortunately, the analysis is "old school", the idea that FDA has two cultures nonsense that came out of the clueless and conflicted IOM panel (full of folks who failed to disclosed their connections to trial attorneys, Soros, Chubb,)... And ironically he proves his point: you want safety and efficacy to be reviewed at the same time, especially as you develop tools to make drugs more targeted in terms of risk and benefit..
In the wake of Avandia, companies had better wake up and realize that if they do not get ahead of the curve, stop being defensive about drugs, pretend problems don't exist, stop asking questions because they are afraid of the answers, other people will ask and answer those questions anyway. These questions are going to come fast and furious and will not die down after PDUFA is passed and certainly not in a Democrat administration. So companies had better step up their investment in targeting which drugs work best in which people -- to make medicines safer and to respond to a growing movement to impose comparative effectiveness on Medicare.
But people are also interested in life saving medicines. Would Harris - or has Harris -- ever written about the FDA reviewer leaving because a drug that could extend life or help someone suffering from disease -- where was he on Provenge -- as if he or she were a lonely crusader?
Has he ever looked at the scientific evidence surrounding SSRIs or Ketek ), the drug Ketek replaced (in terms of it's side effect profile) or the impact running to Congress and the media has on public fears about drugs or the drug approval process. In other words, is such reporting responsible? We go back to the fact that fewer kids are using SSRIs and that has been associated with an increase in suicides.
Given that most, if not all, safety signals cannot be confirmed, except through biomarkers and post market surveillance or huge randomized trials, what is the consequence of what is Harris effort to carry water for the IOM-trial attorney wing of the drug safety movement..."no signal too small to scuttle a drug approval or require a randomized clinical trial to establish drug safety" . Everyone knows what this will mean to drug development: fewer drugs that -- because companies are forced to do one size fits all post market studies and can't do adaptive trials for approval -- will have fewer targeted drugs on the market. That means more targets for headline seeking pols and tort seeking trial attorneys. It creates a permanent state of fear at the FDA.
To my way of thinking, people like Johann-Lianng, Ross and Graham aren't leaving fast enough...Let them have their 15 minutes of fame griping to Gardiner. And let them be replaced with biologically-based reviewers who don't think it's a sin to work with industry to improve the risk benefit profile of medicines.
The question is, can the NY Times ever run a story on the FDA that covers the safety story from this angle?
http://www.nytimes.com/2007/06/11/washington/11fda.html?pagewanted=2&_r=1&adxnnl=0&adxnnlx=1181564577-4YOVzl9UTftu+7qzVNmnvg
First of all, I think Harris raises one set of important questions. Unfortunately, the analysis is "old school", the idea that FDA has two cultures nonsense that came out of the clueless and conflicted IOM panel (full of folks who failed to disclosed their connections to trial attorneys, Soros, Chubb,)... And ironically he proves his point: you want safety and efficacy to be reviewed at the same time, especially as you develop tools to make drugs more targeted in terms of risk and benefit..
In the wake of Avandia, companies had better wake up and realize that if they do not get ahead of the curve, stop being defensive about drugs, pretend problems don't exist, stop asking questions because they are afraid of the answers, other people will ask and answer those questions anyway. These questions are going to come fast and furious and will not die down after PDUFA is passed and certainly not in a Democrat administration. So companies had better step up their investment in targeting which drugs work best in which people -- to make medicines safer and to respond to a growing movement to impose comparative effectiveness on Medicare.
But people are also interested in life saving medicines. Would Harris - or has Harris -- ever written about the FDA reviewer leaving because a drug that could extend life or help someone suffering from disease -- where was he on Provenge -- as if he or she were a lonely crusader?
Has he ever looked at the scientific evidence surrounding SSRIs or Ketek ), the drug Ketek replaced (in terms of it's side effect profile) or the impact running to Congress and the media has on public fears about drugs or the drug approval process. In other words, is such reporting responsible? We go back to the fact that fewer kids are using SSRIs and that has been associated with an increase in suicides.
Given that most, if not all, safety signals cannot be confirmed, except through biomarkers and post market surveillance or huge randomized trials, what is the consequence of what is Harris effort to carry water for the IOM-trial attorney wing of the drug safety movement..."no signal too small to scuttle a drug approval or require a randomized clinical trial to establish drug safety" . Everyone knows what this will mean to drug development: fewer drugs that -- because companies are forced to do one size fits all post market studies and can't do adaptive trials for approval -- will have fewer targeted drugs on the market. That means more targets for headline seeking pols and tort seeking trial attorneys. It creates a permanent state of fear at the FDA.
To my way of thinking, people like Johann-Lianng, Ross and Graham aren't leaving fast enough...Let them have their 15 minutes of fame griping to Gardiner. And let them be replaced with biologically-based reviewers who don't think it's a sin to work with industry to improve the risk benefit profile of medicines.
The question is, can the NY Times ever run a story on the FDA that covers the safety story from this angle?
http://www.nytimes.com/2007/06/11/washington/11fda.html?pagewanted=2&_r=1&adxnnl=0&adxnnlx=1181564577-4YOVzl9UTftu+7qzVNmnvg
According the NY Post Paris Hilton was ". let go because she was on the verge on a nervous breakdown."
The problem? Inadequate access to appropriate preventive care.
"..Hilton repeatedly pressed a medical-alert button, making herself a major nuisance, inmates said.
The Post quotes a friend: "It's so cruel what has happened to her. She wasn't allowed to wax or use a moisturizer. Her skin is so dry right now!"
If we had universal health care, this would not be a problem..
The problem? Inadequate access to appropriate preventive care.
"..Hilton repeatedly pressed a medical-alert button, making herself a major nuisance, inmates said.
The Post quotes a friend: "It's so cruel what has happened to her. She wasn't allowed to wax or use a moisturizer. Her skin is so dry right now!"
If we had universal health care, this would not be a problem..
Lot of debate going on globally on the subject of compulsory licensing of pharmaceuticals.
Most of the chatter focuses on what's going on in Thailand and Brazil -- but what about Switzerland?
Switzerland? Well, actually to be more specific -- Geneva. And to be even more direct, the World Health Organization (WHO).
The issue at hand is, who's going to make the drugs whose patents have been stolen by Brasilia and Bangkok?
And who's going to certify that these pirated products are safe and effective, manufactured to the highest public health standards?
In many cases, that certification process is handled by the WHO. But, while the WHO does say who passes their GMP tests -- the organization does not say who fails.
According to the folks at WHO, such transparency would deter facilities from applying for certification. That's nonsense. All that allows is for facilities that have failed to gain WHO certification to claim that they have applied for that global imprimatur.
And that allows many substandard facilities to fake it so they can make it. The result -- counterfeit and substandard medications for the less developed world. Not acceptable. Kind of like claiming "patent pending." (But maybe talking about "patents" is a mixed metaphor considering the circumstances.)
(Could you imagine if the FDA only sent out public notification for medicines that the agency approved?)
The folks down in WHOville need to step up to the plate and embrace transparency in their pharmaceutical GMP certification process.
Most of the chatter focuses on what's going on in Thailand and Brazil -- but what about Switzerland?
Switzerland? Well, actually to be more specific -- Geneva. And to be even more direct, the World Health Organization (WHO).
The issue at hand is, who's going to make the drugs whose patents have been stolen by Brasilia and Bangkok?
And who's going to certify that these pirated products are safe and effective, manufactured to the highest public health standards?
In many cases, that certification process is handled by the WHO. But, while the WHO does say who passes their GMP tests -- the organization does not say who fails.
According to the folks at WHO, such transparency would deter facilities from applying for certification. That's nonsense. All that allows is for facilities that have failed to gain WHO certification to claim that they have applied for that global imprimatur.
And that allows many substandard facilities to fake it so they can make it. The result -- counterfeit and substandard medications for the less developed world. Not acceptable. Kind of like claiming "patent pending." (But maybe talking about "patents" is a mixed metaphor considering the circumstances.)
(Could you imagine if the FDA only sent out public notification for medicines that the agency approved?)
The folks down in WHOville need to step up to the plate and embrace transparency in their pharmaceutical GMP certification process.
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.
