Viruses / Vaccines 2

brianlux said:

tempo_n_groove said:

Is anyone getting a booster?  I'm still on the fence about it.

I asked my GP about that just this last Friday.  He didn't have a definitive answer.  He said he is hearing the current booster is not showing up very effective with the newest variant.  I have to decide what to do but am leaning toward what Lerxst1992 said above and wait for a more updated booster.  Ah, sigh, life seems like a crap shoot some times. 

I think I need to look seriously at gifting my tickets to see The Dream Syndicate on the 29th.  Tough call there, but my immune system isn't the best so...

static111 said:

I think there was a discussion a couple days ago about distrust of the FDA. Some people seemed to be pretty dismissive. Other than that the FDA was publicly funded pre 1992 but now recieves almost half of it's funding from the industries that it is tasked to regulate, I also  found a couple of disconcerting articles that document potentially shady compensatory practices.  This isn't to say that vaccines don't work or are dangerous.  There isn't anything to back up a statement like that nor do I think anyone was suggesting that.  There is plenty of information available to be critical of the current iteration of the FDA thoughh as it relates to lowering standards and being a tool of generating capital for large pharmaceutical companies.

https://www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-market

“We don’t look at a company and say they’ll have a lower standard because they’re poor, but we’re trying to recognize that, small or large, companies will never work on developing a drug if they won’t make a profit,” said Woodcock"

"Under a 2007 provision in the user-fee law, aimed at spurring treatments for developing nations, Sirturo’s approval qualified Johnson & Johnson for a voucher given to manufacturers who successfully get a tropical disease drug to market. The voucher can be used in the future, for any drug, to claim priority review - within six months instead of the usual 10. Time is money in the drug industry, and beating your competitor to market can be worth hundreds of millions of dollars. Vouchers may also be sold to other drugmakers, and have garnered up to $350 million."

"Post-marketing studies often take far longer to complete than pre-approval trials, in part because it’s harder to recruit patients to risk being given a placebo when the drug is readily available on the market. Plus, since the drug is already on the market, the manufacturer no longer has a financial incentive to study its impact— and stands to lose money if the results are negative. Of post-marketing studies agreed to by manufacturers in 2009 and 2010, 20 percent had not started five years later, and another 25 percent were still ongoing."

"By law, the FDA has the authority to issue fines or even pull a drug off the market if a drugmaker doesn’t meet its post-marketing requirements. Yet the agency has never fined a company for missing a deadline, according to Woodcock.

“We would consider fines if we thought companies were simply dragging their feet, but we would have the burden to show they really weren’t trying, and it’d be an administrative thing that companies could contest,” said Woodcock."

"Even when post-marketing studies belatedly confirm that drugs are dangerous, the agency doesn’t always pull them off the market. Consider Uloric, the gout treatment. Even though it consistently lowered uric acid blood levels, the FDA rejected it in 2005 and again in 2006, because trials linked it to cardiovascular problems. But a third study by the manufacturer, Takeda Pharmaceutical of Osaka, Japan, didn’t raise the same alarms. So the agency decided in 2009 to let the drug on the market, while asking Takeda for a post-marketing study of 6,000 patients to clarify the drug’s cardiovascular effects.

Takeda took more than eight years to complete the study. It found that patients on Uloric had a 22 percent higher risk of death from any cause and a 34 percent higher risk of heart-related deaths than patients taking allopurinol, a generic alternative. The FDA issued a public alert in November 2017, sharing the results of the trial, but left Uloric on the market."

https://www.science.org/content/article/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical

"FDA, headquartered in Silver Spring, Maryland, uses a well-established system to identify possible conflicts of interest before such advisory panels meet. Before the Brilinta vote, the agency mentioned no financial conflicts among the voting panelists, who included four physicians. As Brilinta's sales took off later, however, AstraZeneca and firms selling or developing similar cardiovascular therapies showered the four with money for travel and advice. For example, those companies paid or reimbursed cardiologist Jonathan Halperin of the Icahn School of Medicine at Mount Sinai in New York City more than $200,000 for accommodations, honoraria, and consulting from 2013 to 2016. During that period, for example, AstraZeneca says it paid Halperin more than $11,000 in expenses and fees for work on an advisory board, service on a data monitoring committee for a clinical trial of Brilinta led by the University of California, San Francisco, and for his service chairing the data monitoring committee for an AstraZeneca-sponsored multimillion-dollar clinical trial of Brilinta led by Duke University.

Brilinta fits a pattern of what might be called pay-later conflicts of interest, which have gone largely unnoticed—and entirely unpoliced. In examining compensation records from drug companies to physicians who advised FDA on whether to approve 28 psychopharmacologic, arthritis, and cardiac or renal drugs between 2008 and 2014, Science found widespread after-the-fact payments or research support to panel members. The agency's safeguards against potential conflicts of interest are not designed to prevent such future financial ties."

• "Of 107 physician advisers who voted on the committees Science examined, 40 over a nearly 4-year period received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms; 26 of those gained more than $100,000; and six more than $1 million.

• Of the more than $24 million in personal payments or research support from industry to the 16 top-earning advisers—who received more than $300,000 each—93% came from the makers of drugs those advisers previously reviewed or from competitors.
• Most of those top earners—and many others—received other funds from those same companies, concurrent with or in the year before their advisory service. Those payments were disclosed in scholarly journals but not by FDA."

"Rheumatologist Daniel Solomon of Harvard Medical School in Boston chaired the Amjevita panel. Neither FDA nor Solomon disclosed publicly that about 3 months before that meeting, Amgen provided $232,000 for his study of etanercept (Enbrel), another arthritis drug made by Amgen, and 1 month before the meeting AbbVie provided $819,000 for a Solomon study of Humira.

That support was for "in-kind donations" of drugs "evaluated as part of a NIH-funded research study for which I am one of the principal investigators," Solomon wrote in an email. He does not regard them as a conflict with Amjevita's approval. Drug donations, a common practice, benefit both parties. Donated drugs help ensure that leading academic specialists will prioritize a company's product in major studies that also enhance the researcher's professional standing and influence. Solomon says he described the payments in an FDA disclosure, but he hadn't kept a copy. The agency rejected a FOIA request for the document, calling its release "a clearly unwarranted invasion of personal privacy."

From such responses, it's not clear whether the agency knew about those potential conflicts and, if so, whether officials decided they didn't warrant a waiver. FDA would not discuss any individual adviser or detail what, if anything, the agency does to validate advisers' disclosures."

"The European Medicines Agency in London, the closest analog to FDA, does force such choices. It has no policy on payments to advisers after serving on a drug advisory panel. However, it bars advisers who have concurrent financial ties to drug companies whose products are under consideration, and it prohibits or strictly limits the participation of advisers whose connections to a company go back at least 3 years before an advisory meeting. Disqualifying factors can include speaking fees, consulting contracts, and research grants—both for scientists conducting industry-sponsored studies and for those, like Halperin, who work on data monitoring committees. The agency investigates financial disclosures on its own initiative or after tips from whistleblowers."

https://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/independent.html This one is from 2003 and interviews several people involved in the higher levels of big pharma and it's regulation.  Worth a read.

https://www.nytimes.com/2021/09/02/opinion/fda-drug-approval-trust.html

"In the early 1960s, an unflappable Food and Drug Administration scientist named Frances Kelsey spared the nation from the horrors of thalidomide. The drug had become popular around the world as a remedy for a variety of ailments, including morning sickness in pregnant women. Although there had not been many studies of its safety, thalidomide’s manufacturers marketed it as exceedingly safe. Regulators in many countries, including Canada and across much of Europe, approved its sale.

Thalidomide’s American licensee had expected officials at the Food and Drug Administration to follow suit. But the application was assigned to Kelsey, a pharmacologist new to the agency who set an unusually high threshold for approval: She wanted to see thorough clinical evidence of thalidomide’s safety.

For much of 1961, Kelsey repeatedly held up U.S. sales of the drug, each time demanding more data. The drugmaker’s executives became irate and bombarded Kelsey and her bosses with letters and phone calls complaining of what they considered bureaucratic nit-picking.

Kelsey wouldn’t budge. Thalidomide was kept off the American market. And in late 1961, when doctors in Europe began to link the drug to a wave of birth deformities, Kelsey’s diligence was validated. Thalidomide was eventually blamed for causing birth defects in thousands of children around the world. Thanks to one heroic bureaucrat’s insistence on strong clinical data, cases in the United States were estimated to be in the dozens. (Some 1,200 American doctors were offering the drug to patients through loosely run clinical trials sponsored by the drugmakers.)

Lately I have been wondering: What might Frances Kelsey think of today’s F.D.A., an agency that has grown alarmingly cozy with the industry it is supposed to oversee? What would she make of Americans’ deep mistrust of the drug companies it regulates? And how would she rate its performance on some of the most important health issues we face — its often confused response to the pandemic, its role in surging drug costs and, most damningly, the central role it played in accelerating the opioid epidemic?

I realize this is a tricky moment to criticize the F.D.A. We live in a conspiratorial age of meme medicine — an era when lots of people would rather take untested snake oil hawked by politicians, pundits and B-list celebrities than vaccines whose effectiveness and safety have been proved in clinical studies and that have been approved by the F.D.A. Calling attention to the agency’s failures might only deepen distrust in the F.D.A. when its mission is more vital than ever — at the very least to remind Americans that they are not horses and should consequently refrain from taking horse medicine.

On the other hand, would as many Americans be resorting to veterinary medicine if over the years the F.D.A. had more successfully done its one job, inspiring trust in the safety and effectiveness of the drugs it regulates? Sure, there are lots of conspiracy theorists who will accept lunatic ideas no matter what the F.D.A. says or does. Still, if the drug industry and its regulators are mistrusted, one plausible reason is that they have not been doing a lot to inspire trust lately.

“What we’ve seen since the 1990s is an F.D.A. that has been putting industry interests consistently ahead of public health,” said Andrew Kolodny, an opioid policy researcher at Brandeis University who has studied how the agency’s failures contributed to the opioid crisis.

The F.D.A. is embroiled in a scandal over aducanumab, a $56,000-per-year Alzheimer’s drug that the agency approved even though an advisory panel of experts declined to endorse it because evidence that it worked wasn’t persuasive enough.

The aducanumab approval fits a worrying pattern: Since the 1980s, the F.D.A. has been approving more new drugs, at a faster pace and with fewer and weaker studies to support their safety and effectiveness. The agency has also been faulted for poor oversight of the clinical trials used to decide whether a drug is safe.

Both Donald Trump and President Biden have referred to F.D.A. approval as the “gold standard” of drug safety. It is a pretty tarnished gold. One-third of the drugs approved from 2001 to 2010 were found to have major safety issues years after approval, a study by researchers at the Yale School of Medicine found. The F.D.A. was once criticized for taking too long to approve drugs, but now it is much quicker to approve drugs than its European counterpart."  continues....

mrussel1 said:

static111 said:

I think there was a discussion a couple days ago about distrust of the FDA. Some people seemed to be pretty dismissive. Other than that the FDA was publicly funded pre 1992 but now recieves almost half of it's funding from the industries that it is tasked to regulate, I also  found a couple of disconcerting articles that document potentially shady compensatory practices.  This isn't to say that vaccines don't work or are dangerous.  There isn't anything to back up a statement like that nor do I think anyone was suggesting that.  There is plenty of information available to be critical of the current iteration of the FDA thoughh as it relates to lowering standards and being a tool of generating capital for large pharmaceutical companies.

https://www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-market

“We don’t look at a company and say they’ll have a lower standard because they’re poor, but we’re trying to recognize that, small or large, companies will never work on developing a drug if they won’t make a profit,” said Woodcock"

"Under a 2007 provision in the user-fee law, aimed at spurring treatments for developing nations, Sirturo’s approval qualified Johnson & Johnson for a voucher given to manufacturers who successfully get a tropical disease drug to market. The voucher can be used in the future, for any drug, to claim priority review - within six months instead of the usual 10. Time is money in the drug industry, and beating your competitor to market can be worth hundreds of millions of dollars. Vouchers may also be sold to other drugmakers, and have garnered up to $350 million."

"Post-marketing studies often take far longer to complete than pre-approval trials, in part because it’s harder to recruit patients to risk being given a placebo when the drug is readily available on the market. Plus, since the drug is already on the market, the manufacturer no longer has a financial incentive to study its impact— and stands to lose money if the results are negative. Of post-marketing studies agreed to by manufacturers in 2009 and 2010, 20 percent had not started five years later, and another 25 percent were still ongoing."

"By law, the FDA has the authority to issue fines or even pull a drug off the market if a drugmaker doesn’t meet its post-marketing requirements. Yet the agency has never fined a company for missing a deadline, according to Woodcock.

“We would consider fines if we thought companies were simply dragging their feet, but we would have the burden to show they really weren’t trying, and it’d be an administrative thing that companies could contest,” said Woodcock."

"Even when post-marketing studies belatedly confirm that drugs are dangerous, the agency doesn’t always pull them off the market. Consider Uloric, the gout treatment. Even though it consistently lowered uric acid blood levels, the FDA rejected it in 2005 and again in 2006, because trials linked it to cardiovascular problems. But a third study by the manufacturer, Takeda Pharmaceutical of Osaka, Japan, didn’t raise the same alarms. So the agency decided in 2009 to let the drug on the market, while asking Takeda for a post-marketing study of 6,000 patients to clarify the drug’s cardiovascular effects.

Takeda took more than eight years to complete the study. It found that patients on Uloric had a 22 percent higher risk of death from any cause and a 34 percent higher risk of heart-related deaths than patients taking allopurinol, a generic alternative. The FDA issued a public alert in November 2017, sharing the results of the trial, but left Uloric on the market."

https://www.science.org/content/article/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical

"FDA, headquartered in Silver Spring, Maryland, uses a well-established system to identify possible conflicts of interest before such advisory panels meet. Before the Brilinta vote, the agency mentioned no financial conflicts among the voting panelists, who included four physicians. As Brilinta's sales took off later, however, AstraZeneca and firms selling or developing similar cardiovascular therapies showered the four with money for travel and advice. For example, those companies paid or reimbursed cardiologist Jonathan Halperin of the Icahn School of Medicine at Mount Sinai in New York City more than $200,000 for accommodations, honoraria, and consulting from 2013 to 2016. During that period, for example, AstraZeneca says it paid Halperin more than $11,000 in expenses and fees for work on an advisory board, service on a data monitoring committee for a clinical trial of Brilinta led by the University of California, San Francisco, and for his service chairing the data monitoring committee for an AstraZeneca-sponsored multimillion-dollar clinical trial of Brilinta led by Duke University.

Brilinta fits a pattern of what might be called pay-later conflicts of interest, which have gone largely unnoticed—and entirely unpoliced. In examining compensation records from drug companies to physicians who advised FDA on whether to approve 28 psychopharmacologic, arthritis, and cardiac or renal drugs between 2008 and 2014, Science found widespread after-the-fact payments or research support to panel members. The agency's safeguards against potential conflicts of interest are not designed to prevent such future financial ties."

• "Of 107 physician advisers who voted on the committees Science examined, 40 over a nearly 4-year period received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms; 26 of those gained more than $100,000; and six more than $1 million.

• Of the more than $24 million in personal payments or research support from industry to the 16 top-earning advisers—who received more than $300,000 each—93% came from the makers of drugs those advisers previously reviewed or from competitors.
• Most of those top earners—and many others—received other funds from those same companies, concurrent with or in the year before their advisory service. Those payments were disclosed in scholarly journals but not by FDA."

"Rheumatologist Daniel Solomon of Harvard Medical School in Boston chaired the Amjevita panel. Neither FDA nor Solomon disclosed publicly that about 3 months before that meeting, Amgen provided $232,000 for his study of etanercept (Enbrel), another arthritis drug made by Amgen, and 1 month before the meeting AbbVie provided $819,000 for a Solomon study of Humira.

That support was for "in-kind donations" of drugs "evaluated as part of a NIH-funded research study for which I am one of the principal investigators," Solomon wrote in an email. He does not regard them as a conflict with Amjevita's approval. Drug donations, a common practice, benefit both parties. Donated drugs help ensure that leading academic specialists will prioritize a company's product in major studies that also enhance the researcher's professional standing and influence. Solomon says he described the payments in an FDA disclosure, but he hadn't kept a copy. The agency rejected a FOIA request for the document, calling its release "a clearly unwarranted invasion of personal privacy."

From such responses, it's not clear whether the agency knew about those potential conflicts and, if so, whether officials decided they didn't warrant a waiver. FDA would not discuss any individual adviser or detail what, if anything, the agency does to validate advisers' disclosures."

"The European Medicines Agency in London, the closest analog to FDA, does force such choices. It has no policy on payments to advisers after serving on a drug advisory panel. However, it bars advisers who have concurrent financial ties to drug companies whose products are under consideration, and it prohibits or strictly limits the participation of advisers whose connections to a company go back at least 3 years before an advisory meeting. Disqualifying factors can include speaking fees, consulting contracts, and research grants—both for scientists conducting industry-sponsored studies and for those, like Halperin, who work on data monitoring committees. The agency investigates financial disclosures on its own initiative or after tips from whistleblowers."

https://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/independent.html This one is from 2003 and interviews several people involved in the higher levels of big pharma and it's regulation.  Worth a read.

https://www.nytimes.com/2021/09/02/opinion/fda-drug-approval-trust.html

"In the early 1960s, an unflappable Food and Drug Administration scientist named Frances Kelsey spared the nation from the horrors of thalidomide. The drug had become popular around the world as a remedy for a variety of ailments, including morning sickness in pregnant women. Although there had not been many studies of its safety, thalidomide’s manufacturers marketed it as exceedingly safe. Regulators in many countries, including Canada and across much of Europe, approved its sale.

Thalidomide’s American licensee had expected officials at the Food and Drug Administration to follow suit. But the application was assigned to Kelsey, a pharmacologist new to the agency who set an unusually high threshold for approval: She wanted to see thorough clinical evidence of thalidomide’s safety.

For much of 1961, Kelsey repeatedly held up U.S. sales of the drug, each time demanding more data. The drugmaker’s executives became irate and bombarded Kelsey and her bosses with letters and phone calls complaining of what they considered bureaucratic nit-picking.

Kelsey wouldn’t budge. Thalidomide was kept off the American market. And in late 1961, when doctors in Europe began to link the drug to a wave of birth deformities, Kelsey’s diligence was validated. Thalidomide was eventually blamed for causing birth defects in thousands of children around the world. Thanks to one heroic bureaucrat’s insistence on strong clinical data, cases in the United States were estimated to be in the dozens. (Some 1,200 American doctors were offering the drug to patients through loosely run clinical trials sponsored by the drugmakers.)

Lately I have been wondering: What might Frances Kelsey think of today’s F.D.A., an agency that has grown alarmingly cozy with the industry it is supposed to oversee? What would she make of Americans’ deep mistrust of the drug companies it regulates? And how would she rate its performance on some of the most important health issues we face — its often confused response to the pandemic, its role in surging drug costs and, most damningly, the central role it played in accelerating the opioid epidemic?

I realize this is a tricky moment to criticize the F.D.A. We live in a conspiratorial age of meme medicine — an era when lots of people would rather take untested snake oil hawked by politicians, pundits and B-list celebrities than vaccines whose effectiveness and safety have been proved in clinical studies and that have been approved by the F.D.A. Calling attention to the agency’s failures might only deepen distrust in the F.D.A. when its mission is more vital than ever — at the very least to remind Americans that they are not horses and should consequently refrain from taking horse medicine.

On the other hand, would as many Americans be resorting to veterinary medicine if over the years the F.D.A. had more successfully done its one job, inspiring trust in the safety and effectiveness of the drugs it regulates? Sure, there are lots of conspiracy theorists who will accept lunatic ideas no matter what the F.D.A. says or does. Still, if the drug industry and its regulators are mistrusted, one plausible reason is that they have not been doing a lot to inspire trust lately.

“What we’ve seen since the 1990s is an F.D.A. that has been putting industry interests consistently ahead of public health,” said Andrew Kolodny, an opioid policy researcher at Brandeis University who has studied how the agency’s failures contributed to the opioid crisis.

The F.D.A. is embroiled in a scandal over aducanumab, a $56,000-per-year Alzheimer’s drug that the agency approved even though an advisory panel of experts declined to endorse it because evidence that it worked wasn’t persuasive enough.

The aducanumab approval fits a worrying pattern: Since the 1980s, the F.D.A. has been approving more new drugs, at a faster pace and with fewer and weaker studies to support their safety and effectiveness. The agency has also been faulted for poor oversight of the clinical trials used to decide whether a drug is safe.

Both Donald Trump and President Biden have referred to F.D.A. approval as the “gold standard” of drug safety. It is a pretty tarnished gold. One-third of the drugs approved from 2001 to 2010 were found to have major safety issues years after approval, a study by researchers at the Yale School of Medicine found. The F.D.A. was once criticized for taking too long to approve drugs, but now it is much quicker to approve drugs than its European counterpart."  continues....

This is way too much to dig into, but I found it interesting that the criticism is of payments to PRIVATE physicians who sit on boards, not FDA employees.  Is it possible to post some articles from Pro Publica about all of the employees at the FDA that do their job every day without a potential conflict of interest?  Surely there are some employees and surely these magazines wrote glowing articles about how much longer and healthier we live today thanks to drugs manufactured and approved in the US.  Surely there are some drugs that fit these definitions... 

Full disclosure, I'm on Brilinta and every cardiologist I've talked to speaks very highly about it's effectiveness in treatment post stent and other heart issues.  

static111 said:

mrussel1 said:

static111 said:

I think there was a discussion a couple days ago about distrust of the FDA. Some people seemed to be pretty dismissive. Other than that the FDA was publicly funded pre 1992 but now recieves almost half of it's funding from the industries that it is tasked to regulate, I also  found a couple of disconcerting articles that document potentially shady compensatory practices.  This isn't to say that vaccines don't work or are dangerous.  There isn't anything to back up a statement like that nor do I think anyone was suggesting that.  There is plenty of information available to be critical of the current iteration of the FDA thoughh as it relates to lowering standards and being a tool of generating capital for large pharmaceutical companies.

https://www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-market

“We don’t look at a company and say they’ll have a lower standard because they’re poor, but we’re trying to recognize that, small or large, companies will never work on developing a drug if they won’t make a profit,” said Woodcock"

"Under a 2007 provision in the user-fee law, aimed at spurring treatments for developing nations, Sirturo’s approval qualified Johnson & Johnson for a voucher given to manufacturers who successfully get a tropical disease drug to market. The voucher can be used in the future, for any drug, to claim priority review - within six months instead of the usual 10. Time is money in the drug industry, and beating your competitor to market can be worth hundreds of millions of dollars. Vouchers may also be sold to other drugmakers, and have garnered up to $350 million."

"Post-marketing studies often take far longer to complete than pre-approval trials, in part because it’s harder to recruit patients to risk being given a placebo when the drug is readily available on the market. Plus, since the drug is already on the market, the manufacturer no longer has a financial incentive to study its impact— and stands to lose money if the results are negative. Of post-marketing studies agreed to by manufacturers in 2009 and 2010, 20 percent had not started five years later, and another 25 percent were still ongoing."

"By law, the FDA has the authority to issue fines or even pull a drug off the market if a drugmaker doesn’t meet its post-marketing requirements. Yet the agency has never fined a company for missing a deadline, according to Woodcock.

“We would consider fines if we thought companies were simply dragging their feet, but we would have the burden to show they really weren’t trying, and it’d be an administrative thing that companies could contest,” said Woodcock."

"Even when post-marketing studies belatedly confirm that drugs are dangerous, the agency doesn’t always pull them off the market. Consider Uloric, the gout treatment. Even though it consistently lowered uric acid blood levels, the FDA rejected it in 2005 and again in 2006, because trials linked it to cardiovascular problems. But a third study by the manufacturer, Takeda Pharmaceutical of Osaka, Japan, didn’t raise the same alarms. So the agency decided in 2009 to let the drug on the market, while asking Takeda for a post-marketing study of 6,000 patients to clarify the drug’s cardiovascular effects.

Takeda took more than eight years to complete the study. It found that patients on Uloric had a 22 percent higher risk of death from any cause and a 34 percent higher risk of heart-related deaths than patients taking allopurinol, a generic alternative. The FDA issued a public alert in November 2017, sharing the results of the trial, but left Uloric on the market."

https://www.science.org/content/article/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical

"FDA, headquartered in Silver Spring, Maryland, uses a well-established system to identify possible conflicts of interest before such advisory panels meet. Before the Brilinta vote, the agency mentioned no financial conflicts among the voting panelists, who included four physicians. As Brilinta's sales took off later, however, AstraZeneca and firms selling or developing similar cardiovascular therapies showered the four with money for travel and advice. For example, those companies paid or reimbursed cardiologist Jonathan Halperin of the Icahn School of Medicine at Mount Sinai in New York City more than $200,000 for accommodations, honoraria, and consulting from 2013 to 2016. During that period, for example, AstraZeneca says it paid Halperin more than $11,000 in expenses and fees for work on an advisory board, service on a data monitoring committee for a clinical trial of Brilinta led by the University of California, San Francisco, and for his service chairing the data monitoring committee for an AstraZeneca-sponsored multimillion-dollar clinical trial of Brilinta led by Duke University.

Brilinta fits a pattern of what might be called pay-later conflicts of interest, which have gone largely unnoticed—and entirely unpoliced. In examining compensation records from drug companies to physicians who advised FDA on whether to approve 28 psychopharmacologic, arthritis, and cardiac or renal drugs between 2008 and 2014, Science found widespread after-the-fact payments or research support to panel members. The agency's safeguards against potential conflicts of interest are not designed to prevent such future financial ties."

• "Of 107 physician advisers who voted on the committees Science examined, 40 over a nearly 4-year period received more than $10,000 in post hoc earnings or research support from the makers of drugs that the panels voted to approve, or from competing firms; 26 of those gained more than $100,000; and six more than $1 million.

• Of the more than $24 million in personal payments or research support from industry to the 16 top-earning advisers—who received more than $300,000 each—93% came from the makers of drugs those advisers previously reviewed or from competitors.
• Most of those top earners—and many others—received other funds from those same companies, concurrent with or in the year before their advisory service. Those payments were disclosed in scholarly journals but not by FDA."

"Rheumatologist Daniel Solomon of Harvard Medical School in Boston chaired the Amjevita panel. Neither FDA nor Solomon disclosed publicly that about 3 months before that meeting, Amgen provided $232,000 for his study of etanercept (Enbrel), another arthritis drug made by Amgen, and 1 month before the meeting AbbVie provided $819,000 for a Solomon study of Humira.

That support was for "in-kind donations" of drugs "evaluated as part of a NIH-funded research study for which I am one of the principal investigators," Solomon wrote in an email. He does not regard them as a conflict with Amjevita's approval. Drug donations, a common practice, benefit both parties. Donated drugs help ensure that leading academic specialists will prioritize a company's product in major studies that also enhance the researcher's professional standing and influence. Solomon says he described the payments in an FDA disclosure, but he hadn't kept a copy. The agency rejected a FOIA request for the document, calling its release "a clearly unwarranted invasion of personal privacy."

From such responses, it's not clear whether the agency knew about those potential conflicts and, if so, whether officials decided they didn't warrant a waiver. FDA would not discuss any individual adviser or detail what, if anything, the agency does to validate advisers' disclosures."

"The European Medicines Agency in London, the closest analog to FDA, does force such choices. It has no policy on payments to advisers after serving on a drug advisory panel. However, it bars advisers who have concurrent financial ties to drug companies whose products are under consideration, and it prohibits or strictly limits the participation of advisers whose connections to a company go back at least 3 years before an advisory meeting. Disqualifying factors can include speaking fees, consulting contracts, and research grants—both for scientists conducting industry-sponsored studies and for those, like Halperin, who work on data monitoring committees. The agency investigates financial disclosures on its own initiative or after tips from whistleblowers."

https://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/independent.html This one is from 2003 and interviews several people involved in the higher levels of big pharma and it's regulation.  Worth a read.

https://www.nytimes.com/2021/09/02/opinion/fda-drug-approval-trust.html

"In the early 1960s, an unflappable Food and Drug Administration scientist named Frances Kelsey spared the nation from the horrors of thalidomide. The drug had become popular around the world as a remedy for a variety of ailments, including morning sickness in pregnant women. Although there had not been many studies of its safety, thalidomide’s manufacturers marketed it as exceedingly safe. Regulators in many countries, including Canada and across much of Europe, approved its sale.

Thalidomide’s American licensee had expected officials at the Food and Drug Administration to follow suit. But the application was assigned to Kelsey, a pharmacologist new to the agency who set an unusually high threshold for approval: She wanted to see thorough clinical evidence of thalidomide’s safety.

For much of 1961, Kelsey repeatedly held up U.S. sales of the drug, each time demanding more data. The drugmaker’s executives became irate and bombarded Kelsey and her bosses with letters and phone calls complaining of what they considered bureaucratic nit-picking.

Kelsey wouldn’t budge. Thalidomide was kept off the American market. And in late 1961, when doctors in Europe began to link the drug to a wave of birth deformities, Kelsey’s diligence was validated. Thalidomide was eventually blamed for causing birth defects in thousands of children around the world. Thanks to one heroic bureaucrat’s insistence on strong clinical data, cases in the United States were estimated to be in the dozens. (Some 1,200 American doctors were offering the drug to patients through loosely run clinical trials sponsored by the drugmakers.)

Lately I have been wondering: What might Frances Kelsey think of today’s F.D.A., an agency that has grown alarmingly cozy with the industry it is supposed to oversee? What would she make of Americans’ deep mistrust of the drug companies it regulates? And how would she rate its performance on some of the most important health issues we face — its often confused response to the pandemic, its role in surging drug costs and, most damningly, the central role it played in accelerating the opioid epidemic?

I realize this is a tricky moment to criticize the F.D.A. We live in a conspiratorial age of meme medicine — an era when lots of people would rather take untested snake oil hawked by politicians, pundits and B-list celebrities than vaccines whose effectiveness and safety have been proved in clinical studies and that have been approved by the F.D.A. Calling attention to the agency’s failures might only deepen distrust in the F.D.A. when its mission is more vital than ever — at the very least to remind Americans that they are not horses and should consequently refrain from taking horse medicine.

On the other hand, would as many Americans be resorting to veterinary medicine if over the years the F.D.A. had more successfully done its one job, inspiring trust in the safety and effectiveness of the drugs it regulates? Sure, there are lots of conspiracy theorists who will accept lunatic ideas no matter what the F.D.A. says or does. Still, if the drug industry and its regulators are mistrusted, one plausible reason is that they have not been doing a lot to inspire trust lately.

“What we’ve seen since the 1990s is an F.D.A. that has been putting industry interests consistently ahead of public health,” said Andrew Kolodny, an opioid policy researcher at Brandeis University who has studied how the agency’s failures contributed to the opioid crisis.

The F.D.A. is embroiled in a scandal over aducanumab, a $56,000-per-year Alzheimer’s drug that the agency approved even though an advisory panel of experts declined to endorse it because evidence that it worked wasn’t persuasive enough.

The aducanumab approval fits a worrying pattern: Since the 1980s, the F.D.A. has been approving more new drugs, at a faster pace and with fewer and weaker studies to support their safety and effectiveness. The agency has also been faulted for poor oversight of the clinical trials used to decide whether a drug is safe.

Both Donald Trump and President Biden have referred to F.D.A. approval as the “gold standard” of drug safety. It is a pretty tarnished gold. One-third of the drugs approved from 2001 to 2010 were found to have major safety issues years after approval, a study by researchers at the Yale School of Medicine found. The F.D.A. was once criticized for taking too long to approve drugs, but now it is much quicker to approve drugs than its European counterpart."  continues....

This is way too much to dig into, but I found it interesting that the criticism is of payments to PRIVATE physicians who sit on boards, not FDA employees.  Is it possible to post some articles from Pro Publica about all of the employees at the FDA that do their job every day without a potential conflict of interest?  Surely there are some employees and surely these magazines wrote glowing articles about how much longer and healthier we live today thanks to drugs manufactured and approved in the US.  Surely there are some drugs that fit these definitions... 

Full disclosure, I'm on Brilinta and every cardiologist I've talked to speaks very highly about it's effectiveness in treatment post stent and other heart issues.  

I'm more worried about the unethical issues surrounding payouts to drug approvers than I am with "just plain folks" doing there job everyday.  Why would someone write an article about that?  It would be a needless waste of time, unless they were of course approving a drug that eradicated cancer, in which case I would hope that any number of pages would be dedicated to them.  Otherwise it would serve no more of a purpose than to write an article about those "just plain foolks" that make your latte everyday.  I'm sure there are many people just like you and me that do fine work and never blur any ethical lines in the pursuit of self promotion and wealth accumulation.  Maybe there surely are many safe life prolonging drugs that have recieved glowing reviews, off the top of my head I can think of two made by Moderna and Pfizer.  But that wasn't the point of my post, nor do I think it was the point of the posters that were dismissed for voicing concern with some parts of the FDA apparatus.

 My point was that there are reasons to be concerned with the current iteration of the FDA that just may be on its way to becoming a captured agency.  Sure there are many good drugs that are available now, it sounds like you are on one and that is great I like having you here and interacting from time to time, and if that is due to Brilinta all the better. It also appears that standards have been relaxed in many cases and some drugs have been rushed to market specifically to generate capital without much proof that they actually help patients.

Both things can be true...That the FDA does in fact provide some service to the people of our country by monitoring foods and drugs pre and post market and that the FDA is working closer and closer with corporations in it's public/private partnership blurring the lines of who actually runs the show, whichmay give some people concern to question the methods currently being used especially if the major beneficiaries are the drug companies.

hedonist said:

mrussel1 said:

hedonist said:

Screw the FDA. They don’t actually care about the people; it’s more about kickbacks and their questionable (to put it lightly) relationship with the Pharm industry.

Fuck em. 

Kickbacks?  Have any examples of kickbacks?

Oxy and lots of other drugs. The film Dope Sick comes to mind. Kinda think many insurance companies are in on it too. Personally, I find it interesting that I can get virtually any opioid prescribed for my post-cancer pain, but alternative medicine like acupuncture? No bloody way — not enough money to be made.

If you’re pro FDA and not cynical of their “work”, that’s great for you. I disagree. I think they’re made up of some pretty shitty people. 

static111 said:

TJ25487 said:

hedonist said:

mrussel1 said:

hedonist said:

Screw the FDA. They don’t actually care about the people; it’s more about kickbacks and their questionable (to put it lightly) relationship with the Pharm industry.

Fuck em. 

Kickbacks?  Have any examples of kickbacks?

Oxy and lots of other drugs. The film Dope Sick comes to mind. Kinda think many insurance companies are in on it too. Personally, I find it interesting that I can get virtually any opioid prescribed for my post-cancer pain, but alternative medicine like acupuncture? No bloody way — not enough money to be made.

If you’re pro FDA and not cynical of their “work”, that’s great for you. I disagree. I think they’re made up of some pretty shitty people. 

Ding! Ding! Ding! We have a winner folks! If you ever want to know the truth about something just follow the money trail. It corrupts us all. "He who has the gold makes the rules." It used to be be Big Oil ran the show behind the scenes but now we have another juggernaut called Big Pharma. They got busted and sued by the government a few years ago for exploiting Opiodes which we all know about. Covid is their next cash cow! 

Look at all the pushback that Fauci and friends (media) made about people wanting to use Hydroxychloroquine and or Ivermectin as a treatment for Covid. In reality both of those antiviral drugs have been around for many years and prescribed very successfully to treat a variety of infections. The problem is that they are cheap and not as nearly profitable as the new "Experimental Vaccine" and it's 4000 boosters. 

Case and point: Last year I got a legal prescription for Ivermectin and the local Pharmacy gladly filled it once but a week later told me that I could not have it refilled and they don't know why. All they said is that somebody above them told them not to fill Ivermectin if the prescription said it was prescribed for Covid. 

Do the math. 

 

Ivermectin and Hydroxychloquine are both anti parasite drugs not anti virals








Tell that to India

https://rumble.com/vn8v7a-india-govt.-declares-most-populated-state-officially-covid-free-after-wides.html

TJ25487 said:

In case the link doesn't work. Here is the jist of the story:

While the mainstream media condemns the use of ivermectin, the most populated state in India just declared they are officially COVID free after promoting widespread use of the safe, proven medicine. One America’s Pearson Sharp has more.

Halifax2TheMax said:

TJ25487 said:

In case the link doesn't work. Here is the jist of the story:

While the mainstream media condemns the use of ivermectin, the most populated state in India just declared they are officially COVID free after promoting widespread use of the safe, proven medicine. One America’s Pearson Sharp has more.

Ummmm, sure. One America, lol.

https://www.politifact.com/factchecks/2021/nov/12/facebook-posts/no-scientific-basis-claims-ivermectins-success-utt/