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  #876  
Old 11-24-2017, 08:36 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

Turns out there is in fact a real story involved in the Chuck Norris - Gena O'Kelley thing. The story's not so much how the contrast agent used in MRIs is dangerous but instead about how quacks are bilking the everloving fuck out of Gena and Chuck:

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As I read the stories about Chuck Norris and his wife Gena, I kept wondering how on earth they could have racked up such high medical bills to treat his wife’s condition. Obviously, the methods they were using must not have been covered by the presumably very good health insurance that Norris and his wife almost certainly must have. Otherwise, they wouldn’t have been able to deduct them on their taxes. This suggests strongly that the treatments were all of the unproven variety for which insurance doesn’t pay. So which clinic, exactly, in Reno is treating patients for “gadolinium toxicity.” Fortunately, there is Facebook, where patients were more than willing to out the clinic. Basically, it appears to be someone named Bruce Fong at the Sierra Integrative Medical Center in Reno, Nevada.

He’s described thusly:
Dr. Bruce Fong was introduced to natural medicine and homeopathic medicine as a young child and continues with that tradition today. He has followed in the family footsteps of medicine and is rooted in the belief that we must heal and prevent human disease and suffering. Optimal health may be achieved by determining and remedying the root cause of illness. Dr. Fong has been at the forefront of alternative therapies for immune related diseases, including special treatment plans which combine the best options from a broad array of homeopathic, internal, Chinese and traditional medicine. As Medical Director at Sierra Integrative Medical Center, Dr. Fong is focused on solving root causes, not treating symptoms or masking issues falsely with compounded prescriptions.
In other words, he’s a quack. I mean, look at the list of services Dr. Fong offers. There are a lot of quack treatments there. True, the average person might not recognize them as such, but I do, and I’m sure that the vast majority of my readers will too: chelation therapy, homeopathy, lymphatic massage, “detox” footbaths, and more.
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  #877  
Old 11-24-2017, 09:00 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

Strong Evidence Shows Extraterrestrials Have Been Shutting Down Nuclear Missiles Worldwide for Decades, But Why? - Waking Times Media
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  #878  
Old 11-24-2017, 09:18 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

The Dark Secrets Behind the Pope's Audience Hall (It's a Giant Reptile) - Waking Times Media

peacegirl, do you agree with your source Waking Times Media that the Pope's audience hall is in the shape of a reptilian because the reptilians "control our entire world" and "he is speaking from the mouth of the snake. He stands in front of the mouth and speaks the words of the Elite to all those listening. The Elite are telling humanity via symbolism that this is what’s happening"?
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  #879  
Old 12-16-2017, 08:54 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

Mammograms Lead To Invalid Diagnoses, Cause Harm
Posted on: Friday, December 15th 2017 at 10:00 am
Written By: Sayer Ji, Founder


The global juggernaut of unremitting and unapologetic breast cancer overdiagnosis and overtreatment persists.

As we have recently reported on, high gravitas journals such as BMJ have begun to publish studies indicating that 'cancer screening has never saved lives,' or that what conventional medical authorities considered for decades to be 'cancer' really wasn't after all.

In the latest BMJ study on the topic titled, “Effectiveness of and overdiagnosis from mammography screening in the Netherlands: population based study,” researchers analyzed stage specific incidence of breast cancer in the Netherlands in women who had been enrolled to receive mammography screening every other year since since 1989 (ages 50-69) and 1997 (ages 70-75). The study evaluated breast cancer mortality and the rate of breast cancer overdiagnosis.

The main outcome measures for stage specific age adjusted incidence of breast cancer from 1989 to 2012 were described a follows:

“The extra numbers of in situ and stage 1 breast tumours associated with screening were estimated by comparing rates in women aged 50-74 with those in age groups not invited to screening. Overdiagnosis was estimated after subtraction of the lead time cancers. Breast cancer mortality reductions and overdiagnosis during 2010-12 were computed without (scenario 1) and with (scenario 2) a cohort effect on mortality secular trends.”

The authors summarize their findings:

“The Dutch mammography screening programme seems to have little impact on the burden of advanced breast cancers, which suggests a marginal effect on breast cancer mortality. About half of screen detected breast cancers would represent overdiagnosis.”

As discussed more specifically in the study,

“Overdiagnosis has increased over time with the extension of screening to women aged 70-75, and with the replacement of film based mammography by digital mammography. In 2009-11, 51% of in situ tumours and stage 1 cancers found in women aged 50-74 and 52% of screen detected cancers would represent overdiagnosis.”

The study makes clear that the primary goal of cancer screening, namely, to decrease cancer mortality, is not being reached. Instead, as high as 1 in every 2 persons diagnosed with cancer are overdiagnosed -- a euphemistic term to describe being falsely labeled with a potentially life-threatening disease. In situ 'cancer,' for instance, is profoundly misunderstood within the conventional medical establishment. Despite a 2012 study commissioned by the National Cancer Institute and published in NEJM which found that ductal carcinoma in situ was misunderstood as cancer over the past three decades, and should in fact be reclassified as benign or indolent lesion of epithelial origin, both medical professionals, the media, and the lay public still depend on outdated and outright false information, the consequences of which can be devastating to the health of the public. For instance, it has been estimated that 1.3 million women have been wrongly diagnosed and treated for 'breast cancer' over the past 30 years.

Overdiagnosis, and subsequent overtreatment, for breast cancer also has profound adverse psychospiritual and physical effects. As I have reported previously in, “'Hidden Dangers' of Mammograms Every Woman Should Know About,” women who have been falsely diagnosed with breast cancer, even three years after being declared free of cancer, "consistently reported greater negative psychosocial consequences compared with women who had normal findings in all 12 psychosocial outcomes."

Moreover, not only do these women often undergo lumpectomy, mastectomy, chemotherapy and/or radiation treatment, and follow up drug therapy with highly toxic agents like Tamoxifen and Arimidex -- the former of which is classified as a carcinogen by the WHO and ACS -- but their mistaken diagnoses are acknowledged to be ‘overdiagnoses’ and therefore contribute to the illusion that their lives ‘were saved,’ and that mammography and agressive treatment is improving survival outcomes. To the contrary, these woman have survived despite their overdiagnosis and overtreatment (even though, assuredly, both the quality and duration of their lives have been significantly reduced).

The study concluded with the following highly provocative assessment, which implies that x-ray mammography not only doesn’t save lives but is probably increasing mortality:

cont. at: Mammograms Lead To Invalid Diagnoses, Cause Harm | GreenMedInfo
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  #880  
Old 12-16-2017, 09:23 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

Encyclopedia of American Loons: #1793: Sayer Ji


Quote:
Diagnosis: One of the most influential infectious-disease advocates on the Internet, Ji is also one of the craziest. It’s comforting to imagine that most of those who visit his site are people fascinated by critical-thinking trainwrecks, but that’s probably not the case.
:yup:
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  #881  
Old 12-16-2017, 09:28 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

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Originally Posted by But View Post
Encyclopedia of American Loons: #1793: Sayer Ji


Quote:
Diagnosis: One of the most influential infectious-disease advocates on the Internet, Ji is also one of the craziest. It’s comforting to imagine that most of those who visit his site are people fascinated by critical-thinking trainwrecks, but that’s probably not the case.
:yup:
Anyone who is into integrative medicine is classified as a loon in that stupid encyclopedia. Loons are also people who cannot think for themselves. You should be #1794! :D
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  #882  
Old 12-16-2017, 09:44 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

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Anyone who is into integrative medicine coffee in the butt and garlic up the vagina is classified as a loon
:fixed:
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  #883  
Old 12-16-2017, 10:38 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

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Quote:
Originally Posted by peacegirl View Post
Anyone who is into integrative medicine coffee in the butt and garlic up the vagina is classified as a loon
:fixed:
Who knew?

How to Treat a Vaginal Infection with a Clove of Garlic – Midwifery Today

Coffee enemas are controversial but if used as directed, some people swear by them.

Ask the (Science-Based) Pharmacist: What are the benefits of coffee enemas? – Science-Based Medicine
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Last edited by peacegirl; 12-16-2017 at 10:51 PM.
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  #884  
Old 12-17-2017, 07:37 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

Quote:
Originally Posted by peacegirl View Post
Mammograms Lead To Invalid Diagnoses, Cause Harm
Posted on: Friday, December 15th 2017 at 10:00 am
Written By: Sayer Ji, Founder


The global juggernaut of unremitting and unapologetic breast cancer overdiagnosis and overtreatment persists.
peacegirl, the global juggernaut of unremitting and unapologetic breast cancer overdiagnosis and overtreatment did nothing wrong.

peacegirl, don't you believe in second chances?
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  #885  
Old 12-17-2017, 08:04 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

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Originally Posted by peacegirl View Post
Mammograms Lead To Invalid Diagnoses, Cause Harm
Posted on: Friday, December 15th 2017 at 10:00 am
Written By: Sayer Ji, Founder


The global juggernaut of unremitting and unapologetic breast cancer overdiagnosis and overtreatment persists.
Quote:
Originally Posted by Chuck
peacegirl, the global juggernaut of unremitting and unapologetic breast cancer overdiagnosis and overtreatment did nothing wrong.
Something went wrong if women are being told they have breast cancer when they don't. :scary:

Quote:
Originally Posted by Chuck
peacegirl, don't you believe in second chances?
I do. You would probably put someone in jail and throw away the key.

It would have been unethical if the doctors knew what they were doing, and purposely misled women. I doubt if that was the case. Most likely the procedures were producing inaccurate results which are leading to overdiagnosis and treatment. If that's the case, they need to change their methodology, don't you think? At the very least they need to let women know the rate of false positives so women can get retested. Who is saying anything different Chuck? Your trying to make an analogy to my other post is humorous! :yup:
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  #886  
Old 12-17-2017, 08:42 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

[Insert literally any Big Pharma misconduct here]

Now obviously I have put zero effort into acquainting myself with any facts or underlying science - or even reading the article - but that is neither here nor there. I am sure that, if I looked, I could find some idiot on YouTube who may or may not say something vaguely supportive of whatever my viewpoint is. Why haven't you looked at those videos?

I mean, I am sure that any mistakes they made were entirely unintentional. And maybe they didn't follow the right protocols, I don't know. But also maybe they just didn't know what the correct protocol was, which presumably somehow makes that better. It's a matter for debate. And they weren't doing anything wrong, so I don't know why people are trying to make it seem like they were doing something wrong!

And even if they did make a mistake, they should get a second chance! We can't throw the baby out with the bathwater every time a doctor makes a mistake, after all. Perhaps they made a poor judgment call, but that doesn't mean they deserve to be made an example of.

Whatever it is we're talking about, I am sure that the doctors were trying to do the right thing, which obviously cures any ethical, legal, or moral shortcomings of their conduct, because that is definitely a thing I believe. And the things that I personally believe are really, really relevant to that.

Shame on you, for trying to dishonor these honorable people, who were obviously just trying to help people, probably. I hope people see!
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  #887  
Old 12-17-2017, 08:59 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

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[Insert literally any Big Pharma misconduct here]

Now obviously I have put zero effort into acquainting myself with any facts or underlying science - or even reading the article - but that is neither here nor there. I am sure that, if I looked, I could find some idiot on YouTube who may or may not say something vaguely supportive of whatever my viewpoint is. Why haven't you looked at those videos?
Everybody is an idiot on YouTube?

Quote:
Originally Posted by Chuck
I mean, I am sure that any mistakes they made were entirely unintentional.
It was due to the newer digital screening methods.

Overdiagnosis has increased over time with the extension of screening to women aged 70-75, and with the replacement of film based mammography by digital mammography. In 2009-11, 51% of in situ tumours and stage 1 cancers found in women aged 50-74 and 52% of screen detected cancers would represent overdiagnosis.”

Quote:
Originally Posted by Chuck
And maybe they didn't follow the right protocols, I don't know. But also maybe they just didn't know what the correct protocol was, which presumably somehow makes that better. It's a matter for debate. And they weren't doing anything wrong, so I don't know why people are trying to make it seem like they were doing something wrong!

And even if they did make a mistake, they should get a second chance! We can't throw the baby out with the bathwater every time a doctor makes a mistake, after all. Perhaps they made a poor judgment call, but that doesn't mean they deserve to be made an example of.

Whatever it is we're talking about, I am sure that the doctors were trying to do the right thing, which obviously cures any ethical, legal, or moral shortcomings of their conduct, because that is definitely a thing I believe. And the things that I personally believe are really, really relevant to that.

Shame on you, for trying to dishonor these honorable people, who were obviously just trying to help people, probably. I hope people see!
Wakefield is an honorable man. These people are probably honorable too but mistakes are being made due to a change in equipment. I'm sure they want to correct the false/positives as much as possible. It is causing harm to many women. I can't imagine going through all of the therapy only to find out that it was completely unnecessary. :sad:

Overdiagnosis, and subsequent overtreatment, for breast cancer also has profound adverse psychospiritual and physical effects. As I have reported previously in, “'Hidden Dangers' of Mammograms Every Woman Should Know About,” women who have been falsely diagnosed with breast cancer, even three years after being declared free of cancer, "consistently reported greater negative psychosocial consequences compared with women who had normal findings in all 12 psychosocial outcomes."

Moreover, not only do these women often undergo lumpectomy, mastectomy, chemotherapy and/or radiation treatment, and follow up drug therapy with highly toxic agents like Tamoxifen and Arimidex -- the former of which is classified as a carcinogen by the WHO and ACS -- but their mistaken diagnoses are acknowledged to be ‘overdiagnoses’ and therefore contribute to the illusion that their lives ‘were saved,’ and that mammography and agressive treatment is improving survival outcomes. To the contrary, these woman have survived despite their overdiagnosis and overtreatment (even though, assuredly, both the quality and duration of their lives have been significantly reduced).

Mammograms Lead To Invalid Diagnoses, Cause Harm | GreenMedInfo

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  #888  
Old 12-17-2017, 09:07 PM
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Default Iffy therapies given thumbs up by the FDA. SCARY! I'm

Look, I just saw some idiot on YouTube and then read an article by a Holocaust denier, and that is really all the information I need to conclude that nobody did anything wrong here. This is a case of putting the cart before the horse and throwing the baby out with the bathwater, because that is what you are doing! Whatever we’re talking about (I still have no idea, because I really don’t know all or any of the details, see), what you have to understand is that these are honorable people doing whatever it is that they are doing. And they may make some mistakes and not follow the correct protocol from time to time - but it is probably just because they didn’t know what the correct protocol was. That is certainly no one’s fault! I am sure they did the right thing some other time, too. So all of these things make whatever it is we’re talking about a really noble thing, and I can’t believe you are trying to turn it into something bad!
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  #889  
Old 12-17-2017, 09:15 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

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Look, I just saw some idiot on YouTube and then read an article by a Holocaust denier, and that is really all the information I need to conclude that nobody did anything wrong here. This is a case of putting the cart before the horse and throwing the baby out with the bathwater, because that is what you are doing! Whatever we’re talking about (I still have no idea, because I really don’t know all or any of the details, see), what you have to understand is that these are honorable people doing whatever it is that they are doing. And they may make some mistakes and not follow the correct protocol from time to time - but it is probably just because they didn’t know what the correct protocol was. That is certainly no one’s fault! I am sure they did the right thing some other time, too. So all of these things make whatever it is we’re talking about a really noble thing, and I can’t believe you are trying to turn it into something bad!
Some people are honorable; some people aren't. Dr. Wakefield is honorable. Stop trying to turn this into a mockery Chuck.
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  #890  
Old 12-17-2017, 09:21 PM
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Default Iffy therapies given thumbs up by the FDA. SCARY! I'm

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Some people are honorable; some people aren't. Dr. Wakefield is honorable.
Well that doesn’t sound right, because of how he unethically experimented on children, and all his other proven misconduct.

peacegirl: this is why defending disgraced fraudulent quack Andy Wakefield is counterproductive for anti-vaxxers. It requires you to appear ignorant and immoral, and the pathetically tortured defense also excuses a HUGE range of misconduct by pharmaceutical companies.

His “honor” is completely irrelevant. Because he is a fraud and a quack. Defending his misconduct forfeits whatever credibility anti-vaxxers could try to claim.
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  #891  
Old 12-18-2017, 07:52 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

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Quote:
Originally Posted by peacegirl View Post
Some people are honorable; some people aren't. Dr. Wakefield is honorable.
Well that doesn’t sound right, because of how he unethically experimented on children, and all his other proven misconduct.

peacegirl: this is why defending disgraced fraudulent quack Andy Wakefield is counterproductive for anti-vaxxers. It requires you to appear ignorant and immoral, and the pathetically tortured defense also excuses a HUGE range of misconduct by pharmaceutical companies.

His “honor” is completely irrelevant. Because he is a fraud and a quack. Defending his misconduct forfeits whatever credibility anti-vaxxers could try to claim.
How many times do I have to tell you that he made a mistake in taking blood samples at his child's birthday party, but this does not make him a quack or someone like Josef Mengele who justified experimenting on innocent people. You know as well as I that your dislike for him has everything to do with his Lancet paper. It has nothing to do with his ethics or morality.
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  #892  
Old 12-18-2017, 10:15 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

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How many times do I have to tell you . . .
peacegirl, do you seriously believe that repetition alone can render your faith-based claims regarding Andy Wakefield true? Cuz that's simply not true.
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  #893  
Old 12-18-2017, 11:22 PM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

peacegirl, I'm reasonably entertained that you continue, suo moto, to sputter out comparisons between Andy Wakefield and Josef Mengele.
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  #894  
Old 12-19-2017, 12:09 AM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

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peacegirl, I'm reasonably entertained that you continue, suo moto, to sputter out comparisons between Andy Wakefield and Josef Mengele.
No, you are. Your effort to confuse the newcomers isn’t working. In fact, it’s failing.
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Old 12-19-2017, 01:15 AM
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Quote:
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peacegirl, I'm reasonably entertained that you continue, suo moto, to sputter out comparisons between Andy Wakefield and Josef Mengele.
No, you are. Your effort to confuse the newcomers isn’t working. In fact, it’s failing.
:lol: peacegirl, what newcomers? What are you talking about?
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  #896  
Old 12-19-2017, 01:20 AM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

Newcomers are like levers. The imaginary ones are always the worst.
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  #897  
Old 12-19-2017, 02:07 AM
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Default Re: Iffy therapies given thumbs up by the FDA. SCARY! I'm

45 minutes later I am 45 minutes into an episode of Alien Nation on YouTube.

Not a good series.
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See what researchers found when they tested a bottle of Fiji Water against a glass of tap water.
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Old 01-12-2018, 02:02 PM
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If this doesn't make you concerned over the approval process, nothing will.

The New England Journal of Medicine

The FDA and the Case of Ketek
David B. Ross, M.D., Ph.D.

N Engl J Med 2007; 356:1601-1604April 19, 2007DOI: 10.1056/NEJMp078032

ArticleReferencesCiting Articles (70)
AUDIO INTERVIEW
Interview with David Ross on the FDA review process for the antibiotic Ketek.

Interview with David Ross on the FDA review process for the antibiotic Ketek. (16:52)


Three years ago, the Food and Drug Administration (FDA) approved the drug Ketek (telithromycin), lauding it as the first of a new class of antimicrobial agents that circumvent antibiotic resistance. Since then, Ketek has been linked to dozens of cases of severe liver injury, been the subject of a series of increasingly urgent safety warnings, and sparked two Congressional investigations of the FDA's acceptance of fraudulent safety data and inappropriate trial methods when it reviewed the drug for approval. As a former FDA physician who was involved in the Ketek review, I believe there are lessons to be learned from an examination of the events surrounding the approval of this product.

Ketek is a ketolide antibiotic manufactured by Sanofi-Aventis and proposed for use in community-acquired respiratory tract infections. It was reviewed by the FDA three times (see timeline
Ketek Timeline.). During the first round, reviewers identified substantial safety concerns, including multiple potential drug interactions, unique effects on visual acuity, and an apparent association with hepatocellular hepatitis, with pathological characteristics resembling those caused by drugs that have been withdrawn from the market because of hepatotoxicity. A federal advisory committee asked Sanofi-Aventis to obtain additional safety data by conducting a study involving patients who were likely to receive Ketek if the drug were approved.

In the second review, the FDA examined the results of such a study. Known as study 3014, it was an unblinded, randomized, controlled trial comparing the incidence rates of hepatic, cardiac, and visual adverse events in patients receiving Ketek and those receiving amoxicillin–clavulanate. Sanofi-Aventis recruited more than 1800 physicians to conduct the study, many of them new to clinical investigation, and paid them as much as $400 per patient enrolled, primarily to cover the costs of recruiting and gathering research data; more than 24,000 subjects were enrolled. The study was completed in 5 months and purported to show that Ketek was as safe as the other treatment.

A routine FDA inspection of the practices of the physician who enrolled the most patients — more than 400 — uncovered fraud, including complete fabrication of patient enrollment. The inspector notified FDA criminal investigators, and the physician is currently serving a 57-month sentence in federal prison for her actions. Inspections of nine other sites enrolling high numbers of patients revealed serious violations of trial conduct, raising substantial concerns about the overall integrity of the study. In the end, 4 of the 10 inspected sites were referred for criminal investigation.

Despite these discoveries, FDA managers presented study 3014 to the advisory committee in January 2003 without mentioning the issues of data integrity.1 The managers have stated that they were legally barred from disclosing the problems to the committee because there was an open criminal investigation, but they have not explained why the data were presented at all, in view of the evidence of the study's lack of integrity. Unaware of the integrity problems, the committee voted 11 to 1 to recommend approval of Ketek.

The undisclosed problems with study 3014 led to a third review, during which FDA managers proposed using foreign postmarketing reports on Ketek as evidence of the product's safety, despite the unreliability of such data.2 Although drug sponsors are required to submit such reports as part of an application, it is extremely unusual to use these data to address critical preapproval safety issues in place of a controlled study. The postmarketing data submitted by Sanofi-Aventis were reviewed by the FDA without any verification of their accuracy or completeness, even though 3 months before the third review, FDA criminal investigators recommended examining whether Sanofi-Aventis had been involved in systematic fraud in connection with Ketek. The FDA never conducted the recommended investigation or reviewed study 3014–related records showing that Sanofi-Aventis was aware of potential fraud in the study when it submitted the results to the FDA. The failure to look into or respond to concerns about integrity represented a marked deviation from FDA policies.

Against this backdrop of concerns about both safety and fraud, critical questions also arose about the efficacy of Ketek, which had been examined only in noninferiority trials. Such trials are not designed to demonstrate directly a new intervention's superiority to an active control or a placebo but instead involve the selection of a maximum margin by which the new intervention may be less effective than older interventions but still be considered better than placebo.3 Throughout the 1990s, noninferiority trials had been standard procedure in the development of antimicrobial agents for the outpatient treatment of self-resolving respiratory tract infections. But by 2004, FDA workshops and advisory committee meetings on this topic had concluded that the use of noninferiority trials in this setting was not justifiable, since there is no evidence of a substantial treatment effect of antimicrobial drugs in self-resolving respiratory tract infections such as acute bacterial sinusitis and acute exacerbation of chronic bronchitis — the diseases for which clinicians most frequently prescribe antimicrobials, for which the market is largest, and for which treatment with Ketek was proposed.

Nevertheless, the FDA approved Ketek entirely on the basis of noninferiority trials. The reason given for the agency's continued acceptance of such trials in the study of antibiotics for self-resolving respiratory tract infections was the need to stand by prior agreements with industry sponsors regarding adequate trial designs — the Ketek trials, after all, had been designed and largely conducted before the adequacy of noninferiority trials had been called into question. Once it had been established that such trials could not demonstrate efficacy, however, it might reasonably have been argued that the welfare of prospective patients ought to outweigh any promise to manufacturers. Yet the FDA accepted the trials without discussion of either the patients who might be exposed to a drug that had serious toxic effects — and for which there was no evidence of effectiveness — or the failure of the trials to meet the FDA's own standards at the time of approval.

cont. at: MMS: Error

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