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Discussion Starter · #1 ·
http://www.cnn.com/2005/US/01/13/fda.safety/index.html?iref=mpstoryview

of course this attempt at reform failed.

arguing the other side http://works.bepress.com/dorit_reiss/4/

http://www.lawyersandsettlements.com/articles/ssri/paxil-suicide-risk-01960.html#.VhBkgCvRjh4
In his report, Dr Glenmullen sums up the inadequacy of the system, including the FDA, that allowed Glaxo to keep this vital information hidden from prescribing doctors and patients for nearly 2 decades and states, in part:

"One of the most sobering aspects of the story of Paxil-induced suicidality is that GlaxoSmithKline was not forthcoming with its data demonstrating the risk and regulatory agencies like the FDA did not take the initiative to get to the bottom of and expose the true risk."
So, can we trust the FDA to acknowledge problems with vaccines and to act appropriately if they have a track record of not acknowledging problems and acting inappropriately?

Why should a messed up agency be trustworthy on one product (produced by the same companies where failures to regulate effectively have resulted in deaths) and untrustworthy on some other products? How do we decide when they are doing it right and when they are doing it wrong?
 

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If the FDA behaves shamefully providing inadequate regulation around pharmaceuticals that affect the health of millions of people, like Vioxx for example, what makes people think vaccines are any different? The FDA's track record isn't good regarding regulation. The most recent being Essure, not a vaccine but another recent example of failed regulation and thousands of harmed individuals due to inadequacy of the FDA, in which this product was supposedly put through the FDA's most "rigorous safety testing" procedures. Well, that's darn scary that the device put through the FDA's most stringent procedures is causing tons of women pain. Where is the science we hear about so often? The science appears to be incomplete, missing key data such as long-term consequences, in which the public unfortunately become the guinea pigs.

It's a severely flawed system and there aren't any signs of improvement.

On Sept. 24, the Food and Drug Administration held a hearing on the Essure sterilization coil, used to achieve permanent birth control for women.

Hundreds of thousands of young and otherwise healthy women across the world have received Essure coils since 2002. However, over the subsequent decade thousands of severe adverse reactions to the coils have been reported...Another issue became abundantly clear at the FDA hearing: Essure was not adequately safety tested at the time of its approval...The Essure coils were approved in 2002 for use in women through an FDA process known as ?Pre-Market Approval? (PMA). This means that the product was put through what the FDA considers its most rigorous ?safety testing? for medical devices.

But what became very clear at the FDA was that neither Bayer (as the maker of the Essure coils), nor the FDA had considered that the Essure coils contain nickel.

Nickel is one of the most common allergenic metals. What that means is that many people, when exposed to it, will have allergic and hypersensitivity reactions. Many people are familiar with nickel allergies in earrings, watch bands, belt buckles etc. The solution for people who have reaction to nickel is removal of the offending metal. But taking out Essure coils is not as simple as taking off a piece of jewelry.

When these nickel coils are placed in women?s fallopian tubes, an intense inflammatory process is started. The immune system is very strongly primed to respond to offending agents on mucosal surfaces to fend off infections and foreign bodies ? and the Fallopian tubes in women are a mucosal surface.

In most women, this inflammatory response leads to a scarring and blocking of the Fallopian tube, resulting in sterilization in most women.

The Essure nickel is not removed, leaving it in an immunologically sensitive area.

We believe it should be no surprise then, that women, who were completely healthy before getting Essure, are reporting crippling systemic complications that appear very similar to inflammatory conditions which the immune system goes haywire, like lupus or rheumatoid arthritis -- hair loss, rashes, joint pain, weight gain, anemia, swelling, blood clots, migraines, unexplained, debilitating pain.

Removing the Essure coils requires major abdominal surgeries, such as hysterectomies.

Essure's label warns about pelvic pain, bleeding and allergic reactions shortly after the implant procedure, but how could neither Bayer nor the FDA anticipate long-lasting inflammatory consequences?

At the request of patient advocates a respected dermatologist was placed on the FDA?s expert panel on Essure last week. Dr. Peter Schalock is a dermatologist at Massachusetts General Hospital in Boston. ?How can Bayer and the FDA have no knowledge of nickel allergies??? he asked. ?Where did you test these people? How did you test these people? What did you test them with? Are we just making this up just for fun or is there data??
The below sums it up:

We know that congress now sees her charge to protect minority subsets of American citizens. Here again is just another example of individuals being harm by ?benefit of the majority?, ?choice?, ?convenience?, and corporate and federal ethics - gone rogue
http://mobile.philly.com/blogs/?wss=/philly/blogs/healthcare/&id=329977281&
 

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Completely indemnified industries for products labeled vaccine +
Captured regulatory agencies for said products +
A governing body that forces its population to use said products

A perfect storm of millions of injured Americans

USA! USA! USA!
 

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Completely indemnified industries for products labeled vaccine +
Captured regulatory agencies for said products +
A governing body that forces its population to use said products

A perfect storm of millions of injured Americans

USA! USA! USA!
Exactly. The corruption isn't a great dark secret either. There was a paper written and published in JLME two years ago titled "Institutional Corruption and the Pharmaceutical Industry" highlighting the dangers of such corruption and financial conflicts of interest:

The systematic corruption of medical knowledge, ranging from clinical trials and new diagnostic categories through practice guidelines to physician prescribing practices, is highlighted in a special fall issue of the Journal of Law, Medicine & Ethics(JLME, 41:3). In the seventeen articles of this JLME symposium issue, Institutional Corruption and the Pharmaceutical Industry, Lab Fellows from the Edmond J. Safra Center for Ethics at Harvard University present findings from their in-depth, multi-disciplinary investigations of corruption in pharmaceutical policy, and propose methods to mitigate these critical problems. Their research shows that widespread practices in the medical and pharmaceutical industries can lead to doctors who are psychologically, financially, or intellectually dependent on drug companies, a phenomenon which has resulted in insufficiently tested drugs, many of which cause harmful side effects...Their research also reveals how top medical researchers can be financially tied to drug firms. For example, researchers have been found to conduct clinical trials on medications while simultaneously calling for their consumption and guaranteeing that insurance companies will pay for them. Doctors who take such misleading information at face value prescribe drugs that are often unnecessary, harmful to patients, or more costly than equivalent medications. Fellows uncovered how pharmaceutical marketing also distorts medical practice, and how drug firms are even funding social network websites for doctors in order to quietly track their opinions on issues that affect their bottom lines.
Drawing on insights from law, medicine, behavioral psychology, economics and finance, business, sociology, political science, and philosophy, the Fellows’ research also shows how lawmakers and patient advocacy organizations can be dependent on money from drug companies, resulting in representation that serves the interests of big pharma rather than the public. The pharmaceutical industry’s own mission and purposes are often undermined, the investigation concluded.
http://ethics.harvard.edu/news/jlme-issue-institutional-corruption-and-pharmaceutical-industry

The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created. Since 1906, heavy commercial influence has compromised Congressional legislation to protect the public from unsafe drugs. The authorization of user fees in 1992 has turned drug companies into the FDA’s prime clients, deepening the regulatory and cultural capture of the agency. Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients. Unless this corruption of regulatory intent is reversed, the situation will continue to deteriorate. We offer practical suggestions including: separating the funding of clinical trials from their conduct, analysis, and publication: independent FDA leadership; full public funding for all FDA activities; measures to discourage R&D on drugs with few if any new clinical benefits; and the creation of a National Drug Safety Board
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2282014
 

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Discussion Starter · #5 ·
This must be why the pro-vaccine people keep talking about all those independent studies of vaccine safety and efficacy.

Although I also see arguments that the FDA and CDC are completely trustworthy and the vaccine testing and evaluation program are exceptionally thorough.

Evidence?
 

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Looking at Essure, here is what an expert dermatologist (mentioned in the link in my previous post about Essure) specifically asks of the FDA and Bayer regarding the nickel in the product and the thousands of harmed women due to nickel allergy: "How can we not have data on nickel allergy when you have a device that is 55 percent nickel and 20 percent of women are known to be nickel allergic?” asked Dr. Peter Shalock of Harvard Medical School, one of the experts on the panel. “Why is there no data on that in your package."

So, clueless as it seems, they didn't even look into the effects of nickel, especially long-term effects, when nickel is known to cause allergies. That is pathetic. When it comes to vaccines, and when we hear of awful deaths and severe reactions, like Gardasil and flu vaccines for example, and they tell the public "it's safe," what simple information are they failing to review prior to approval?? Knowing that the FDA could miss something so simple as the impact an allergen could have on the human body long term like nickel, which is science 101, is really very sad. What else are they/have they missed that they are continuing to explain away as "coincidental findings" in people harmed by vaccines?
 

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Discussion Starter · #8 ·
Great question. Maybe someone will chime in with some of what they use as evidence that the FDA and pharmaceutical companies can be trusted, because I surely can't help you out there!
Here is what the FDA says about themselves http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194586.htm

How does FDA assess the safety of vaccines?

Vaccines undergo rigorous and extensive testing to determine their safety and effectiveness. Highly trained scientists and medical personnel at FDA carefully review all of the information in a marketing application before a vaccine can be approved for use by the public.
Following approval, FDA also carefully monitors the quality of vaccines—all manufactured lots must pass tests before they can be used. And as with all manufacturers of medical products, vaccine manufacturers must follow strict manufacturing standards. In addition, FDA conducts routine inspections of manufacturing sites.
FDA also works closely with the Centers for Disease Control and Prevention (CDC) to monitor reports of side effects (adverse events) of vaccines. FDA and CDC take all reports seriously, and work together to evaluate and address any potential problems.
And here is an example of a failure of transparency in relation to a birth control product. http://www.raps.org/focus-online/news/news-article-view/article/2524/
 
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Discussion Starter · #9 ·
And, of course, there is the mumps vaccine (part of the MMR), where the young virologists working for Merck called in the FDA. The FDA inspector completely missed the fakery and the virologists were eventually fired and became whistle-blowers. In the meantime, there have been thousands of cases of mumps in the US.
 

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Discussion Starter · #10 ·
http://cspinet.org/new/200606271.html

http://archive.onearth.org/fda

http://www.ucsusa.org/our-work/cent...-scientific-integrity/vioxx.html#.VhE1ZivRjh4

https://www.organicconsumers.org/ne...failed-consumers-genetically-engineered-foods

http://www.amazon.com/FDA-Deception-Out-Control-Government/dp/1607660016

http://www.theatlantic.com/health/a...-still-using-antibiotics-on-livestock/251442/
The failure to limit antibiotics in animal feed is connected to the horrendous death rate from antibiotic resistant bacterial infections--over 20,000 deaths per year at this point.

http://www.centerforfoodsafety.org/...for-food-safety-sues-fda-over-food-additives#

Nevertheless, somewhere in the FDA is this little protected space where vaccines are tested and regulated and this space is completely free of the problems that are being pointed out in the rest of the agency.

Does this sound reasonable to anyone?

By the way, all the links above were found on the first page of a search for "FDA failure". Obviously, it isn't hard to find the problems.
 

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Nevertheless, somewhere in the FDA is this little protected space where vaccines are tested and regulated and this space is completely free of the problems that are being pointed out in the rest of the agency.

Does this sound reasonable to anyone?

.
So, according to the vaccine supporters here, the FDA only gets sloppy, approves medications/drugs prematurely on incomplete sets of data, and makes horrendous errors affecting millions everywhere else but vaccines? No, doesn't sound reasonable at all.
 

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I wish that I had more to contribute to this thread because it is an excellent topic. :grin:
 

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Discussion Starter · #13 ·
I'm doing a series based on pro-vaccine claims I've seen here and elsewhere.
 
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Discussion Starter · #14 ·
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Discussion Starter · #15 ·
Also note that the vaccine supporters generally won't participate in threads that are inside "our frames". We should probably return the favor and not participate in threads that try to lock us into an untenable position. If a topic is of interest we can always start our own thread to discuss it.
 

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Discussion Starter · #16 · (Edited)
There are also plenty of examples of regulatory capture wreaking havoc (lovely word combination there) in other industries.

For example, the Savings & Loan debacle that ended up costing American taxpayers billions was due in large part to regulatory laxness, coziness, defunding, deregulation (to save the taxpayer money), etc. Very sad story. http://www.econlib.org/library/Enc/SavingsandLoanCrisis.html wanted to add that this is a conservative take on the crisis, so that the emphasis has a particular slant.
This bit resonated with me:
Yet others were desperate attempts to postpone addressing a rapidly worsening situation.
I wonder if some of the craziness about pharmaceuticals and vaccines is an attempt to avoid dealing with a rapidly worsening situation. Pretending, for example, that it is normal for millions of children to have chronic diseases, developmental problems or both. Pretending that it is normal for 7 out of 10 adults in the US to be on prescription drugs. Pretending that the people who go crazy and shoot people are suffering from a lack of mental health services...when the problem might be too much mental health services in the form of drugs and more drugs.

This link gives a different slant on the story, mentioning some of the factors left out in the first link. Good example, actually, of two different frames around the same series of incidents and how they change the emphasis. http://useconomy.about.com/od/grossdomesticproduct/p/89_Bank_Crisis.htm
 

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I think this is the madness of progressive mothers. I certainly don't think I speak for all progressive mothers as many, no doubt, are anti-recovery, I mean pro-vax. I just wish progressive women could consider helping us obtain a safer, more effective, way of attaining immunity against dangerous infectious disease, AND protect our young from neurological damage.

I think we can do both, but not when we treat the practice of attempting to synthetically generate immunity against infectious disease like a holy sacrament; never to questioned, never to be disparaged, never to be safe, never to be useful.
 

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http://www.cnn.com/2005/US/01/13/fda.safety/index.html?iref=mpstoryview

of course this attempt at reform failed.

arguing the other side http://works.bepress.com/dorit_reiss/4/

http://www.lawyersandsettlements.com/articles/ssri/paxil-suicide-risk-01960.html#.VhBkgCvRjh4

So, can we trust the FDA to acknowledge problems with vaccines and to act appropriately if they have a track record of not acknowledging problems and acting inappropriately?

Why should a messed up agency be trustworthy on one product (produced by the same companies where failures to regulate effectively have resulted in deaths) and untrustworthy on some other products? How do we decide when they are doing it right and when they are doing it wrong?
I think this illustrates my issues in relation to the current state of medicine: the huge (and growing) problem in the increasingly incestuous connections and conflicts of interest in those who create medicine and study them (drugs, vaccines, etc.), those who regulate them, and then the media which markets them. The problem is certainly not just vaccines, but many psychiatric drugs, statins, etc. While I'm NOT against allopathic medicine, I don't think outcomes are better than in countries with less "advancement". Case in point, the WHO did a replicated study (would have to find the citation if anyone is interested) that showed outcomes of psychiatric disorders were better in third world countries than in first world countries. In the West, patients became more debilitated rather than less. Whereas in India and Nigeria (I think that was the second country), the patients went on to get married, keep jobs, etc.

Of course when some Western researchers read this they thought it must be do to differences in diagnosing diseases such as schizophrenia. SO then they redid the study and had the exact same results, as one would assume they were pretty shocked that all of our advancement really didn't affect one's quality of life.

There are certainly other things at play, culturally, diet, etc.,... but it is pretty interesting overall. Too bad we don't gather data on outcomes (maternal deaths, adverse effects, etc.) because we could see our real outcomes to assess the effects and effectiveness of our practices.
 

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There are also plenty of examples of regulatory capture wreaking havoc (lovely word combination there) in other industries.

For example, the Savings & Loan debacle that ended up costing American taxpayers billions was due in large part to regulatory laxness, coziness, defunding, deregulation (to save the taxpayer money), etc. Very sad story. http://www.econlib.org/library/Enc/SavingsandLoanCrisis.html wanted to add that this is a conservative take on the crisis, so that the emphasis has a particular slant.
This bit resonated with me:
I wonder if some of the craziness about pharmaceuticals and vaccines is an attempt to avoid dealing with a rapidly worsening situation. Pretending, for example, that it is normal for millions of children to have chronic diseases, developmental problems or both. Pretending that it is normal for 7 out of 10 adults in the US to be on prescription drugs. Pretending that the people who go crazy and shoot people are suffering from a lack of mental health services...when the problem might be too much mental health services in the form of drugs and more drugs.

This link gives a different slant on the story, mentioning some of the factors left out in the first link. Good example, actually, of two different frames around the same series of incidents and how they change the emphasis. http://useconomy.about.com/od/grossdomesticproduct/p/89_Bank_Crisis.htm
This is exactly what I thought of when there was the constant repeating that vaccines are completely safe and rigorously tested (despite the evidence I saw),.. the words that kept repeating in my head were "too big to fail". Remember when the banks could do no wrong and participate in billion dollar (trillion?) schemes to trick others and make money off of defaulting loans? Oh the mortgage backed securities?!?! Wasn't there a whisper of insiders saying that something was wrong here, but no one did anything especially NOT the regulators.... There is a connection here,....
At least a metaphorical connection in how businesses are regulated,....
 

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I think this illustrates my issues in relation to the current state of medicine: the huge (and growing) problem in the increasingly incestuous connections and conflicts of interest in those who create medicine and study them (drugs, vaccines, etc.), those who regulate them, and then the media which markets them. The problem is certainly not just vaccines, but many psychiatric drugs, statins, etc. While I'm NOT against allopathic medicine, I don't think outcomes are better than in countries with less "advancement". Case in point, the WHO did a replicated study (would have to find the citation if anyone is interested) that showed outcomes of psychiatric disorders were better in third world countries than in first world countries. In the West, patients became more debilitated rather than less. Whereas in India and Nigeria (I think that was the second country), the patients went on to get married, keep jobs, etc.

Of course when some Western researchers read this they thought it must be do to differences in diagnosing diseases such as schizophrenia. SO then they redid the study and had the exact same results, as one would assume they were pretty shocked that all of our advancement really didn't affect one's quality of life.

There are certainly other things at play, culturally, diet, etc.,... but it is pretty interesting overall. Too bad we don't gather data on outcomes (maternal deaths, adverse effects, etc.) because we could see our real outcomes to assess the effects and effectiveness of our practices.
Of-course psychiatric outcomes are better in countries where minors are not dosed up with meds that alter their perception of reality. It's the (economy) medications stupid!

Ok, obviously Nemi27, in no way, shape, or form do i think you stupid, in fact quite the opposite, i was just trying to make a play off of the Clinton campaign slogan years ago. Hope did not offend! Hope you know the joke?
 
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