4 ms·

Yes, yes, yes, yes. Signed and donated. This is a great effort, and I suggest others help out as well. The amount of fake trials and hidden experiment data th

by kyro 14y ago

Yes, yes, yes, yes. Signed and donated. This is a great effort, and I suggest others help out as well. The amount of fake trials and hidden experiment data that pharmas participate in is absurd. I can't recall the exact incident ('carbocation probably will) but within the last decade there was a rather large scandal where a particular drug was known to have a fatal side effect -- suicidal ideation, I believe [wrong, valvular heart damage - see below] -- and more than 90% of the trial data that pointed to said effect was hidden and concealed. The drug hit the market and was later pulled off the shelves because, you guessed it, people started dying! While I don't believe the reporting of all trials will fix that level of deceit, it's certainly a great step in the right direction. Pushing for public reporting of data concerning meds that people might eventually put into their bodies only makes sense. Next up: Abolishing sponsored research clinical trials, or at least increasing the transparency of research sponsorship instead of burying the fact that the research PI is actually an employee of Pfizer somewhere deep in the appendices. It's amazing how we have organizations like Consumer Reports to give us objective reviews of toasters and cars, yet nothing like that exists for medications or medical devices, isn't it? Edit: So I'm confusing 2 things: 1) Fen-phen was a diet pill pushed to market despite evidence that it caused valvular heart damage. It was pulled from the market. Read: http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/fenphen.html http://www.pbs.org/wgbh/pages/frontline/shows/prescription/h... 2) SSRIs were the drugs that increase suicidality (something commonly known now) and the data confirming that was reportedly hidden by pharmas. Read: http://reason.com/archives/2007/07/10/can-caution-be-too-risky http://reason.com/archives/2007/07/10/can-caution-be-too-ris...

carbocation 14y ago
Good examples. I'll add Vioxx (rofecoxib), a Merck COX-2-specific NSAID that was released in 1999 and pulled in 2004 [1]. Merck hid evidence that the drug caused cardiovascular events and death. Eventually, the evidence became impossible to suppress [2]. Meta-analyses demonstrated that, given the ongoing trials at the time, Merck could have (and almost certainly did) observe internally that there was an excess of cardiovascular mortality in the Vioxx arm of their (combined) trials [3]. Eventually, the drug was removed from the market, but not before what has been estimated as nearly 100 thousand attributable heart attacks [4]. [1] = http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInfo... [2] = http://www.slate.com/articles/health_and_science/medical_examiner/2011/11/sandusky_cover_up_why_is_kenneth_frazier_leading_the_investigation_at_penn_state_.html http://www.slate.com/articles/health_and_science/medical_exa... [3] = http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)17514-4/fulltext http://www.thelancet.com/journals/lancet/article/PIIS0140-67... [4] = http://www.consumersunion.org/pub/core_health_care/001651.html http://www.consumersunion.org/pub/core_health_care/001651.ht...
ianfernz 14y ago
My thoughts exactly. How many lives would this save? I think on the order of several thousand a year, minimum.
EvanKelly 14y ago
I read your second article on SSRIs and I'm confused at the point you're trying to make. The article (written in 2007) concludes that an over-reaction to the British journal's reports that SSRIs increase suicidal ideation (ergo suicide) may have actually caused more suicides due to under-prescription of SSRIs in adolescents. The article cites many university studies which show that use of SSRIs actually coincided with a decreased risk of suicidal ideation. Is there more recent evidence to suggest the British studies were correct? I hear a lot of anecdotal evidence when SSRIs and other anti-depressants are discussed, which I agree is important because everyone can react differently to them and doctors and patients should be aware of what may occur, but the article you linked to actually states that the clinical evidence is in support of SSRI prescription in all age groups with major depression. EDIT: I do note that the article mentions the GSK settlement with Spitzer, and regardless of whether the studies hold true, they should not have been covered up unless there was a question to the scientific standards of the trials.
refurb 14y ago
Abolish sponsored clinical trials? How do you plan to fund them then? A very large part of the multi-billion dollar a year R&D budgets of the pharmaceutical companies go to pay for clinical trials. How would you replace that money?
- justsee 14y ago
  Simple really. Establish an independent entity to conduct them, and fund those activities as part of the approval process. Having a vested interest control scientific studies is poor regulatory system design.
  - refurb 14y ago
    So who controls the budgets or do you just hand the "independent entity" a pile of cash and let them do what they want? Also, drug companies often hire physicians and researchers (often the best ones) to help with drug development far before any trial is run. Would you like to exclude those experts from input on the trial design? From your comment I get the sense you have a limited understanding of what is really involved in drug development.
    - justsee 14y ago
      If we agree that a conflict-of-interest free system is the goal (and non-negotiable) then an independent entity is essential in a properly-functioning regulatory system. However you appear to have retired undefeated as devil's advocate, as if the questions you put are unanswerable. I would admit that there are more questions and answers that need to be given before we fully implement my HN comment, but that is hardly a refutation of the core idea: that a system free of conflict-of-interest requires independent entities and umpires that are more empowered than the conflicted interests in that system. A recent Forbes opinion piece has its own take on inserting independent entities into the system [0]: What we need is a construct with teeth, an established network of industry-independent researchers (not contractors) equipped to evaluate trial design, statistical power, data analysis, and interpretation, not as regulators but as contributors to final research publications. It would be a sort of Congressional Budget Office for clinical trial results. Admittedly the position outlined in that article does not go as far as a completely independent entity operating all clinical trials for the purposes of regulatory approval, but it's in the right direction. [0] http://www.forbes.com/sites/emilywillingham/2012/11/26/how-can-big-pharma-restore-a-reputation/ http://www.forbes.com/sites/emilywillingham/2012/11/26/how-c...
ekianjo 14y ago
> It's amazing how we have organizations like Consumer Reports to give us objective reviews of toasters and cars, yet nothing like that exists for medications or medical devices, isn't it? That's what you get when you end up with an overly-regulated market for drugs. You cannot publish anything about them without governmental authorization. I agree with the premise of the petition but a petition is a very weak tool to reach that goal. It will get you nowhere.
- jgamman 14y ago
  i think the root cause has more to do with under-regulation, regulatory capture and proactive efforts to confuse and blur the boundaries. Bad Pharma is a good intro if you care to move past entry level comments.
  - ekianjo 14y ago
    Haha. I have read Bad Pharma and I have been following Goldacre for years and I agree mostly with what he says. Please do not assume my ignorance just because I disagree with your view. I fail to see where there is "under-regulation" in the pharma industry. Try setting up a Pharma business, you will be surprised how hard it has become.

by kyro 14y ago

carbocation 14y ago

Good examples. I'll add Vioxx (rofecoxib), a Merck COX-2-specific NSAID that was released in 1999 and pulled in 2004 [1]. Merck hid evidence that the drug caused cardiovascular events and death. Eventually, the evidence became impossible to suppress [2]. Meta-analyses demonstrated that, given the ongoing trials at the time, Merck could have (and almost certainly did) observe internally that there was an excess of cardiovascular mortality in the Vioxx arm of their (combined) trials [3]. Eventually, the drug was removed from the market, but not before what has been estimated as nearly 100 thousand attributable heart attacks [4]. [1] = http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInfo... [2] = http://www.slate.com/articles/health_and_science/medical_examiner/2011/11/sandusky_cover_up_why_is_kenneth_frazier_leading_the_investigation_at_penn_state_.html http://www.slate.com/articles/health_and_science/medical_exa... [3] = http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(04)17514-4/fulltext http://www.thelancet.com/journals/lancet/article/PIIS0140-67... [4] = http://www.consumersunion.org/pub/core_health_care/001651.html http://www.consumersunion.org/pub/core_health_care/001651.ht...

ianfernz 14y ago

My thoughts exactly. How many lives would this save? I think on the order of several thousand a year, minimum.

EvanKelly 14y ago

I read your second article on SSRIs and I'm confused at the point you're trying to make. The article (written in 2007) concludes that an over-reaction to the British journal's reports that SSRIs increase suicidal ideation (ergo suicide) may have actually caused more suicides due to under-prescription of SSRIs in adolescents. The article cites many university studies which show that use of SSRIs actually coincided with a decreased risk of suicidal ideation. Is there more recent evidence to suggest the British studies were correct? I hear a lot of anecdotal evidence when SSRIs and other anti-depressants are discussed, which I agree is important because everyone can react differently to them and doctors and patients should be aware of what may occur, but the article you linked to actually states that the clinical evidence is in support of SSRI prescription in all age groups with major depression. EDIT: I do note that the article mentions the GSK settlement with Spitzer, and regardless of whether the studies hold true, they should not have been covered up unless there was a question to the scientific standards of the trials.

refurb 14y ago

Abolish sponsored clinical trials? How do you plan to fund them then? A very large part of the multi-billion dollar a year R&D budgets of the pharmaceutical companies go to pay for clinical trials. How would you replace that money?

justsee 14y ago
Simple really. Establish an independent entity to conduct them, and fund those activities as part of the approval process. Having a vested interest control scientific studies is poor regulatory system design.
- refurb 14y ago
  So who controls the budgets or do you just hand the "independent entity" a pile of cash and let them do what they want? Also, drug companies often hire physicians and researchers (often the best ones) to help with drug development far before any trial is run. Would you like to exclude those experts from input on the trial design? From your comment I get the sense you have a limited understanding of what is really involved in drug development.
  - justsee 14y ago
    If we agree that a conflict-of-interest free system is the goal (and non-negotiable) then an independent entity is essential in a properly-functioning regulatory system. However you appear to have retired undefeated as devil's advocate, as if the questions you put are unanswerable. I would admit that there are more questions and answers that need to be given before we fully implement my HN comment, but that is hardly a refutation of the core idea: that a system free of conflict-of-interest requires independent entities and umpires that are more empowered than the conflicted interests in that system. A recent Forbes opinion piece has its own take on inserting independent entities into the system [0]: What we need is a construct with teeth, an established network of industry-independent researchers (not contractors) equipped to evaluate trial design, statistical power, data analysis, and interpretation, not as regulators but as contributors to final research publications. It would be a sort of Congressional Budget Office for clinical trial results. Admittedly the position outlined in that article does not go as far as a completely independent entity operating all clinical trials for the purposes of regulatory approval, but it's in the right direction. [0] http://www.forbes.com/sites/emilywillingham/2012/11/26/how-can-big-pharma-restore-a-reputation/ http://www.forbes.com/sites/emilywillingham/2012/11/26/how-c...

ekianjo 14y ago

> It's amazing how we have organizations like Consumer Reports to give us objective reviews of toasters and cars, yet nothing like that exists for medications or medical devices, isn't it? That's what you get when you end up with an overly-regulated market for drugs. You cannot publish anything about them without governmental authorization. I agree with the premise of the petition but a petition is a very weak tool to reach that goal. It will get you nowhere.

jgamman 14y ago
i think the root cause has more to do with under-regulation, regulatory capture and proactive efforts to confuse and blur the boundaries. Bad Pharma is a good intro if you care to move past entry level comments.
- ekianjo 14y ago
  Haha. I have read Bad Pharma and I have been following Goldacre for years and I agree mostly with what he says. Please do not assume my ignorance just because I disagree with your view. I fail to see where there is "under-regulation" in the pharma industry. Try setting up a Pharma business, you will be surprised how hard it has become.