Nov 29, 2022·edited Nov 29, 2022Liked by Maryanne Demasi, PhD
In the past we made a decision to give the pharmaceutical companies a monopoly via patents on drugs they developed. We'd decided the trade-off between paying excess in prices was worth it to get the new drugs developed, and to let the industry that benefited pay the cost of developing new drugs, including all the ones that did not pan out. However, the industry has changed a lot over time. Scientists are, relatively speaking, low cost. The computer simulations which used to need extremely expensive computer time on mainframes can now be done on consumer-level machines. And new drug candidates are only rarely the result of some new imaginative insight. More often they are a result of a brute-force technique of trying chemical compounds which are slightly different than the ones already in use. The name of the game here is not to produce a drug which is better than existing ones, though it is nice when that happens, but one that can be patented and sold as a replacement for something that either your competitor has and is making money with, or that you have, but whose patent is due to run out.
Thus for the creative end of drug discovery, the pharmaceutical companies do not need the monopoloy windfall profits. The expensive part of the operation is the trials. But here we have a fundamental misalignment between the goals of the industry and the public weal. The trials are either run by drug companies, or outsourced to testing companies who work for drug companies. And their business is to get the drug approved, and promise to run the trials and only present the data that shows the drugs in a good light and so on and so forth. 'Can we fool the regulators into accepting this?' used to be the name of the game. 'Can we bribe the regulators into accepting this?' is the newer game, and it works.
So. We need to strip the monopoly protection from pharmaceuticals. We need to have the testing done by a new, taxpayer funded organisations (who are allowed to outsource this). We can tax the drugs to afford the trials. We need to work very hard to keep regulatory capture from happening in the new organisations, and to notice it when corruption starts up again, as always happens. This will entail as robust a set of transparency laws as possible, so we can get rid of the secrecy around all of this. Patenting was _supposed_ to give us full disclosure, as that was the deal, you give us full disclosure and we give you a patent. I do not know if this ever worked in the past, but it is not working now where we need FOI requests to find out what ought to be public knowledge. Laws prohibiting the revolving door between regulators and industry and preventing regulators from owning stock in the companies they regulate will be necessary. Over time the problem will lessen as drug companies just aren't that rich any more.
Take away the monopoly protection and the secrecy. We tried the experiment of building the industry this way, and now we know that it does not work in the public interest. Time to do it another way.
Indeed, there's a pattern of implementing policies to improve transparency and then the drug industry finds new and inventive ways to cheat the system. It's not an easy problem to solve.
Thanks Linda, this is the figure that Health Canada gave us this year. We too, thought it was higher, but the regulator confirmed this figure was the correct one.
Thanks Maryanne. I wonder if the reason was because they were giving you funding share of total, rather than funding share of the regulatory branch only. I'm curious now myself. May have to look into it. I'm a big fan of your work, BTW. Thanks for doing it!
They said it was for the regulatory budget - HC's response was:
"For fiscal year 2020-2021, Health Canada recovered 42.5% of its costs for its regulatory activities related to drugs from fees charged to industry (for the scientific examination of drugs before they are authorized for sale, the monitoring of these products once made available to Canadians, and for verifying compliance and acting on non-compliance using tools such as inspections). Specifically for the scientific examination of human drugs, Health Canada recovered 50.5% of its costs that same year. For more information please see the Health Canada Fees Report – Fiscal Year 2020-21."
Hi again, I was in touch with media spokesperson at Health Canada, Mark Johnson, who wrote: "Health Canada is responsible for regulating the safety, efficacy and quality of therapeutic products. The Department charges fees to industry to recover a portion of the costs of some of its regulatory activities. This is consistent with the approach taken by other international regulators. Of note, regulatory reviews are rigorous, science-based and independent, and fees are paid irrespective of whether or not a drug or medical device is authorized. The fees charged to industry were updated in 2020 after extensive consultations (2017-2018) as they were eight years out of date. Based on industry feedback (in 2018), fees for the scientific review of human drugs were set at 75% of costs (down from the originally proposed 90%), delayed by one year, and are being implemented gradually up to 2024. This transition period allows industry time to adjust."
The solution to the corruption of these entities is - taking the TGA as an example
(1) withdraw government underwriting of legal assistance to TGA staff. Why should they have access to legal aid that we don't have when the TGA set their attack dogs on us, or make rulings that mean we lose our jobs and then have to pay for legal help
(2) make the TGA staff responsible for corporate manslaughter arising out of any decision that was subsequently covered up in any form. In the case of the COVID vaccine mandates ALL the TGA's freedom of information responses hid information that it had no right to hide. The information was hidden because they did not want to "undermine the vaccine rollout". That is not their right and people died. People died because they did not have access to transparency of information even though the law says they must have it. Therefore whoever took the decision to hide information that the TGA had, that showed that they did not perform due diligence and safety assessment for vaccines, must be held criminally responsible for every single death.
(3) Exclude the TGA from FOI exemptions. If they don't like it, so be it. If Pharma doesn't like the fact that every single document can be inspected by the public then they need to take their drugs elsewhere. It's not worth it.
Good suggestions Doc....transparency of documents is a no-brainer. The excuse that information is commercially sensitive, is what they use to justify extensive redactions. Like drug company's that get caught covering up information that results in public harm, regulators should also face criminal consequences - but fines must be large enough to deter bad behaviour and people need to go to jail otherwise, they hide behind the corporation like Pharma executives have all these years.
...wouldn't hold my breath.....CTT won't release the data because they have legally agreed not to release the data in exchange for access to the IPD from statin makers.
I know hearsay and one-off stories bear little weight - but I note that clinicians are sometimes enrolled in drug trials where they dispense trial drugs and placebo (but sometimes only the real drug) from their rooms. For example, a man with Multiple Sclerosis and some decision-making impairment was receiving an active drug and his wife noted that on the feedback chart the physician, a neurologist, had written down inaccurate information about side-effects - minimising the severity. When the wife pointed this out to doctor and her husband, the doctor banned her from the consulting room. I wonder how often clinicians are providing false and inaccurate information in such trials and what rewards they receive for participating in such trials?
Interesting. Along similar lines, Brook Jackson, whistle-blower from Texas overseeing Pfizer's pivotal mRNA trial said that at her site, the vaccinators clearly had the intervention labelled on the participants charts when they came in for visits - both clinician and participant were unblinded.
We know that big pharma is all about profit, but what of all the medical professionals who knowingly pedal these toxic drugs to their trusting patients.
To me this is tantamount to the transfer of wealth through protracted genocide.
To my mind what we need is a 'quadruple blind' protocol, not simply blinding researchers to what arm of study patients are in, but blinding researchers to what the treatment being investigated and who the maker/funder of trial is.
I have known about the surrogate endpoints for a long time. I believe statins, lipitor in particular, was the first drug allowed without showing improvement in clinical outcomes, only showing cholesterol reduction. There is still no proof of decrease in heart attacks or mortality benefit for stations. Of course, we have all learned in the last two years that many trials don't use an actual inert placebo, which is another way of saying that they aren't science at all.
Thanks Jon, I think the statin literature is problematic. My observation - they have demonstrated that statins can reduce cardiovascular (CV) outcomes (but its a composite outcome made up of mainly revascularisations which are more trivial outcomes) - the CV improvement is more obvious in high risk patients but even so, the absolute risk is very small and totally out-of-sink with the dramatic reductions they see in LDL-cholesterol. This tells me that LDL-c reduction (by statins and other cholesterol lowering agents) has a minimal impact on cardiovascular disease, especially in low risk populations. And I agree, there is a real lack of information about what constitutes a 'placebo' - this needs to change.
Thank you for your research. I suspected something was up with the FDA, but it has been the elephant in the room that know one seems to want to address.
Thanks Celeste, though I might add that I think the regulation of both industries (pharmaceutical and natural/alternative) has problems with oversight. Appreciate you reaching out.
All health authorities have no integrity. Having launched 22 prescription drugs in my career I know how bad the regulators are today. In my opinion I have zero trust in Government, works health authorities, all hospitals, all doctors and nurses. To get are financial whores at best
The other day I was reading about the generic drug scandal of the late 80s/early 90s when FDA staff were caught taking bribes from generic drug manufacturers....its like corruption never goes away, it just changes its face.
Part of the problem is that we do not have punishments that fit the crime. All that fining a company that offers bribes does is put a price tag on the cost of doing business that way. What we need, instead, is to revoke the company's license to do business when caught bribing an official. Burn the company down, fire all the employees, put all the intellectual property into the public domain. Put the companies on notice that there is absolutely nothing they are doing which is worth a 'corruption tax'. Take the officials who betrayed the trust, lock them up and don't offer parole for 20 years. What you have done is worse than murder, and we should punish it that way.
Just joined your Substack & boy, you did not disappoint! Thank you. I got off all Rx drugs (and OTC) a dozen years ago when I realized they were only making me sicker. Natural remedies and alternative medicine worked. I learned the hard way, pharmaceuticals are just business (corrupt business unfortunately). There is no health care. I vote with my dollar & pay out of pocket for alternative providers. More expensive in the short term, but not in the long term. I wish the big pharma industry could be given a good cleaning & that regulators & systems weren’t corrupt but I don’t see it changing any time soon. They have too much to lose. They aren’t in the business of making you well. It’s super obvious now to those who can connect the dots. Keep shining a light on this & informing us! We need you. 
Thanks for your continuing work to shine a light on the many dark places that exist within the pharmaceutical industry. The extent of the criminality that goes on is truly appalling and would rock public trust in modern medicine if they knew.
The system as it is set up now is not working for the benefit of people in general and the government and other stakeholders are not implementing procedures and practises to safeguard all aspects of medical oversight which is contributing to the harm of many many people. These systems take too long to change with too much push back. A privately funded organisation needs to be created with the mission statement 2 oversee these government bodies and their connections to private Enterprise University monies vaccine makers and drug producers, and should cover all aspects including funding. Gov't bodies failure to protect the public. Even bureaucrats are giving pathetic excuses phone not giving information There is no other option other than to set up a privately funded organisation to oversee all these issues and more that I have not listed and need to have enough financial support to backup their work with legal proceedings. I think the public would be willing to support this because they no longer trust or support the government or connections to educational institutions medical journals government bodies government oversight manufacturing practises etcetera. That may be difficult to get off the ground and one may need to request retired volunteers in the legal medical journal and other aspects to support the establishment such a company until such time it is financially viable. Public donations govt donations
And reliance on pro bono part-time. There's a lot of knowledge out there in the retirement sector.
In the past we made a decision to give the pharmaceutical companies a monopoly via patents on drugs they developed. We'd decided the trade-off between paying excess in prices was worth it to get the new drugs developed, and to let the industry that benefited pay the cost of developing new drugs, including all the ones that did not pan out. However, the industry has changed a lot over time. Scientists are, relatively speaking, low cost. The computer simulations which used to need extremely expensive computer time on mainframes can now be done on consumer-level machines. And new drug candidates are only rarely the result of some new imaginative insight. More often they are a result of a brute-force technique of trying chemical compounds which are slightly different than the ones already in use. The name of the game here is not to produce a drug which is better than existing ones, though it is nice when that happens, but one that can be patented and sold as a replacement for something that either your competitor has and is making money with, or that you have, but whose patent is due to run out.
Thus for the creative end of drug discovery, the pharmaceutical companies do not need the monopoloy windfall profits. The expensive part of the operation is the trials. But here we have a fundamental misalignment between the goals of the industry and the public weal. The trials are either run by drug companies, or outsourced to testing companies who work for drug companies. And their business is to get the drug approved, and promise to run the trials and only present the data that shows the drugs in a good light and so on and so forth. 'Can we fool the regulators into accepting this?' used to be the name of the game. 'Can we bribe the regulators into accepting this?' is the newer game, and it works.
So. We need to strip the monopoly protection from pharmaceuticals. We need to have the testing done by a new, taxpayer funded organisations (who are allowed to outsource this). We can tax the drugs to afford the trials. We need to work very hard to keep regulatory capture from happening in the new organisations, and to notice it when corruption starts up again, as always happens. This will entail as robust a set of transparency laws as possible, so we can get rid of the secrecy around all of this. Patenting was _supposed_ to give us full disclosure, as that was the deal, you give us full disclosure and we give you a patent. I do not know if this ever worked in the past, but it is not working now where we need FOI requests to find out what ought to be public knowledge. Laws prohibiting the revolving door between regulators and industry and preventing regulators from owning stock in the companies they regulate will be necessary. Over time the problem will lessen as drug companies just aren't that rich any more.
Take away the monopoly protection and the secrecy. We tried the experiment of building the industry this way, and now we know that it does not work in the public interest. Time to do it another way.
Indeed, there's a pattern of implementing policies to improve transparency and then the drug industry finds new and inventive ways to cheat the system. It's not an easy problem to solve.
You're doing very important work! Love it!
Thanks Andrea
I think your Health Canada info needs updating: Historically, Health Canada has used pharma fees to fund 50% of its operating costs in regulating prescription medication, but in 2018 planned to raise that to 90%: https://datac.ca/health-canada-switches-mainly-pharmaceutical-funding/?fbclid=IwAR09iI_xnIt-m3ErSacTwSF3kwXqPGwgBWcY3S6tfZGK7jyrTkHOEga3TE8
Thanks Linda, this is the figure that Health Canada gave us this year. We too, thought it was higher, but the regulator confirmed this figure was the correct one.
Thanks Maryanne. I wonder if the reason was because they were giving you funding share of total, rather than funding share of the regulatory branch only. I'm curious now myself. May have to look into it. I'm a big fan of your work, BTW. Thanks for doing it!
They said it was for the regulatory budget - HC's response was:
"For fiscal year 2020-2021, Health Canada recovered 42.5% of its costs for its regulatory activities related to drugs from fees charged to industry (for the scientific examination of drugs before they are authorized for sale, the monitoring of these products once made available to Canadians, and for verifying compliance and acting on non-compliance using tools such as inspections). Specifically for the scientific examination of human drugs, Health Canada recovered 50.5% of its costs that same year. For more information please see the Health Canada Fees Report – Fiscal Year 2020-21."
Ok, thanks. I will ask them specifically for the breakdown for the directorate responsible for regulating drugs (see below). To find out who funds the Biologic and Radiopharmaceutical Drugs Directorate you have to contact the Policy, Planning and International Affairs Directorate. I'll keep you posted! https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/biologic-radiopharmaceutical-drugs-directorate.html
Thanks Linda
Hi again, I was in touch with media spokesperson at Health Canada, Mark Johnson, who wrote: "Health Canada is responsible for regulating the safety, efficacy and quality of therapeutic products. The Department charges fees to industry to recover a portion of the costs of some of its regulatory activities. This is consistent with the approach taken by other international regulators. Of note, regulatory reviews are rigorous, science-based and independent, and fees are paid irrespective of whether or not a drug or medical device is authorized. The fees charged to industry were updated in 2020 after extensive consultations (2017-2018) as they were eight years out of date. Based on industry feedback (in 2018), fees for the scientific review of human drugs were set at 75% of costs (down from the originally proposed 90%), delayed by one year, and are being implemented gradually up to 2024. This transition period allows industry time to adjust."
The solution to the corruption of these entities is - taking the TGA as an example
(1) withdraw government underwriting of legal assistance to TGA staff. Why should they have access to legal aid that we don't have when the TGA set their attack dogs on us, or make rulings that mean we lose our jobs and then have to pay for legal help
(2) make the TGA staff responsible for corporate manslaughter arising out of any decision that was subsequently covered up in any form. In the case of the COVID vaccine mandates ALL the TGA's freedom of information responses hid information that it had no right to hide. The information was hidden because they did not want to "undermine the vaccine rollout". That is not their right and people died. People died because they did not have access to transparency of information even though the law says they must have it. Therefore whoever took the decision to hide information that the TGA had, that showed that they did not perform due diligence and safety assessment for vaccines, must be held criminally responsible for every single death.
(3) Exclude the TGA from FOI exemptions. If they don't like it, so be it. If Pharma doesn't like the fact that every single document can be inspected by the public then they need to take their drugs elsewhere. It's not worth it.
Good suggestions Doc....transparency of documents is a no-brainer. The excuse that information is commercially sensitive, is what they use to justify extensive redactions. Like drug company's that get caught covering up information that results in public harm, regulators should also face criminal consequences - but fines must be large enough to deter bad behaviour and people need to go to jail otherwise, they hide behind the corporation like Pharma executives have all these years.
? restrict statin prescription severely until Oxford University releases all the raw trial data they hold on statins??
...wouldn't hold my breath.....CTT won't release the data because they have legally agreed not to release the data in exchange for access to the IPD from statin makers.
Thanks for the summary. Its an area most of us don't understand.
Glad you find this informative.
I know hearsay and one-off stories bear little weight - but I note that clinicians are sometimes enrolled in drug trials where they dispense trial drugs and placebo (but sometimes only the real drug) from their rooms. For example, a man with Multiple Sclerosis and some decision-making impairment was receiving an active drug and his wife noted that on the feedback chart the physician, a neurologist, had written down inaccurate information about side-effects - minimising the severity. When the wife pointed this out to doctor and her husband, the doctor banned her from the consulting room. I wonder how often clinicians are providing false and inaccurate information in such trials and what rewards they receive for participating in such trials?
Interesting. Along similar lines, Brook Jackson, whistle-blower from Texas overseeing Pfizer's pivotal mRNA trial said that at her site, the vaccinators clearly had the intervention labelled on the participants charts when they came in for visits - both clinician and participant were unblinded.
Brava! I admire your courage.
We know that big pharma is all about profit, but what of all the medical professionals who knowingly pedal these toxic drugs to their trusting patients.
To me this is tantamount to the transfer of wealth through protracted genocide.
All should be held accountable!
Very informative and well presented. Thank you.
To my mind what we need is a 'quadruple blind' protocol, not simply blinding researchers to what arm of study patients are in, but blinding researchers to what the treatment being investigated and who the maker/funder of trial is.
I have known about the surrogate endpoints for a long time. I believe statins, lipitor in particular, was the first drug allowed without showing improvement in clinical outcomes, only showing cholesterol reduction. There is still no proof of decrease in heart attacks or mortality benefit for stations. Of course, we have all learned in the last two years that many trials don't use an actual inert placebo, which is another way of saying that they aren't science at all.
Thanks Jon, I think the statin literature is problematic. My observation - they have demonstrated that statins can reduce cardiovascular (CV) outcomes (but its a composite outcome made up of mainly revascularisations which are more trivial outcomes) - the CV improvement is more obvious in high risk patients but even so, the absolute risk is very small and totally out-of-sink with the dramatic reductions they see in LDL-cholesterol. This tells me that LDL-c reduction (by statins and other cholesterol lowering agents) has a minimal impact on cardiovascular disease, especially in low risk populations. And I agree, there is a real lack of information about what constitutes a 'placebo' - this needs to change.
What a great work ! Thank you and congratulations !
Thank you
Thank you for your research. I suspected something was up with the FDA, but it has been the elephant in the room that know one seems to want to address.
Indeed, the inconvenient truth.
Good Job Maryanne!
Appreciate it, thanks Henry
Thanks Celeste, though I might add that I think the regulation of both industries (pharmaceutical and natural/alternative) has problems with oversight. Appreciate you reaching out.
All health authorities have no integrity. Having launched 22 prescription drugs in my career I know how bad the regulators are today. In my opinion I have zero trust in Government, works health authorities, all hospitals, all doctors and nurses. To get are financial whores at best
The other day I was reading about the generic drug scandal of the late 80s/early 90s when FDA staff were caught taking bribes from generic drug manufacturers....its like corruption never goes away, it just changes its face.
Part of the problem is that we do not have punishments that fit the crime. All that fining a company that offers bribes does is put a price tag on the cost of doing business that way. What we need, instead, is to revoke the company's license to do business when caught bribing an official. Burn the company down, fire all the employees, put all the intellectual property into the public domain. Put the companies on notice that there is absolutely nothing they are doing which is worth a 'corruption tax'. Take the officials who betrayed the trust, lock them up and don't offer parole for 20 years. What you have done is worse than murder, and we should punish it that way.
I agree that often, the punishment is not enough of a deterrent.
Just joined your Substack & boy, you did not disappoint! Thank you. I got off all Rx drugs (and OTC) a dozen years ago when I realized they were only making me sicker. Natural remedies and alternative medicine worked. I learned the hard way, pharmaceuticals are just business (corrupt business unfortunately). There is no health care. I vote with my dollar & pay out of pocket for alternative providers. More expensive in the short term, but not in the long term. I wish the big pharma industry could be given a good cleaning & that regulators & systems weren’t corrupt but I don’t see it changing any time soon. They have too much to lose. They aren’t in the business of making you well. It’s super obvious now to those who can connect the dots. Keep shining a light on this & informing us! We need you. 
Thanks for your continuing work to shine a light on the many dark places that exist within the pharmaceutical industry. The extent of the criminality that goes on is truly appalling and would rock public trust in modern medicine if they knew.
Thanks Ben, I think few people understand just how vital drug regulation is for public safety...
The system as it is set up now is not working for the benefit of people in general and the government and other stakeholders are not implementing procedures and practises to safeguard all aspects of medical oversight which is contributing to the harm of many many people. These systems take too long to change with too much push back. A privately funded organisation needs to be created with the mission statement 2 oversee these government bodies and their connections to private Enterprise University monies vaccine makers and drug producers, and should cover all aspects including funding. Gov't bodies failure to protect the public. Even bureaucrats are giving pathetic excuses phone not giving information There is no other option other than to set up a privately funded organisation to oversee all these issues and more that I have not listed and need to have enough financial support to backup their work with legal proceedings. I think the public would be willing to support this because they no longer trust or support the government or connections to educational institutions medical journals government bodies government oversight manufacturing practises etcetera. That may be difficult to get off the ground and one may need to request retired volunteers in the legal medical journal and other aspects to support the establishment such a company until such time it is financially viable. Public donations govt donations
And reliance on pro bono part-time. There's a lot of knowledge out there in the retirement sector.