The Skeptical Teacher

Musings of a science teacher & skeptic in an age of woo.

Posts Tagged ‘FDA’

Fight Against Cancer Quack Burzynski Goes to Congress

Posted by mattusmaximus on April 8, 2014

Last year I blogged about how this blog has joined a coalition of skeptical blogs titled the Skeptics for the Protection of Cancer Patients (SPCP).

The impetus for this is a particularly loathsome man – Stanislaw Burzynski – who is a quack that promises to cure people of their cancer, despite the fact that decades of research show that his claimed cancer cures don’t work.  Unfortunately, Burzynski has been able to skirt common decency, good medical science, and the FDA regulators and continue to practice his quackery, resulting in an unfortunate number of people going to him in the hopes that he can cure them.  A good rundown of Burzynski’s history of fraud can be found by listening to this recent podcast of Skeptic’s Guide to the Universe.

As I mentioned in my previous post, the SPCP has decided to take down Burzynski due to the particularly flagrant manner in which he practices his dangerous pseudoscience; it will also serve as a message to all other medical quacks and charlatans to be on notice because we in the skeptical community are watching.

Burzynski SI Title

Well, now things are going to the next level – straight to Congress.  Burzynski has been able to get away with so much for so long because he has political allies in high places, so we’ve decided to fight fire with fire.  My skeptical colleagues at the SPCP have put together a petition asking Congress to step in and force the FDA to do its job and properly investigate, regulate, and (hopefully) put out of business Burzynski and his quack clinic.

Please consider signing and passing along this petition; the text of the petition follows – click here to sign:

Protect Desperate Patients from the Houston Cancer Quack

Petition by Skeptics for the Protection of Cancer Patients

We are writing to request your urgent attention to a matter that involves the exploitation of cancer patients, their families, and their communities.

For nearly 40 years, Houston cancer doctor Stanislaw Burzynski has been treating cancer patients with an unproven chemotherapy he calls “antineoplastons.” Following an agreement in the 1990s with the FDA, he has recently only been able to administer the drug under the auspices of clinical trials. For this questionable treatment, he charges patients exorbitant fees (often hundreds of thousands of dollars) to participate in a trial, and he claims to cure the most difficult, almost uniformly fatal pediatric brain cancers. His claims are not supported by science and evidence; despite opening more than 60 trials in the last 15 years, he has not published the results of a single completed clinical trial.

On Friday, November 15, 2013, many concerning issues about Dr. Burzynski were detailed in a front-page exposé in USA Today, including his past use of antineoplastons as an AIDS and Parkinson’s treatment. Sickeningly, critics of the Clinic have found a pattern going back 20 years of patients publicly celebrating unambiguous signs of disease progression as signs that antineoplastons were working.

The FDA recently released site inspection notes about Stanislaw Burzynski’s clinic. Their findings were horrific:

– Burzynski “failed to protect the rights, safety, and welfare of subjects under your care.”
— “Forty-eight (48) subjects experienced 102 investigational overdoses“
— Burzysnki allowed overdoses continue: “Overdose incidents have been reported to you [....] There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects.”
— All baseline tumor measurements were destroyed: “Your [...] tumor measurements initially recorded on worksheets at baseline and on-study treatment [...] studies for all study subjects were destroyed and are not available for FDA inspectional review.” Without any measurement there is no way to determine any actual efficacy of the treatment, making Burzynski’s claims unsupported and unpublishable.
— Burzynski’s reported success rates are inflated: He “failed to comply with protocol requirements related to the primary outcome, therapeutic response [...] for 67% of study subjects reviewed during the inspection.” Nonetheless, these inaccurate outcomes are used to convince dying patients antineoplastons can save them.

Other issues cited by the FDA included:

– Paying patients who failed to meet the inclusion criteria for the study were admitted to Burynski’s trials;
— Burzynski did not report all adverse events as required by his study protocols, and many exhibiting toxic effects were not removed from treatment;
— Adverse events were not reported in a timely fashion (in one case 7 years);
— The FDA received two different versions of a pediatric patient’s records during an inspection, especially significant because the child apparently died of a known side effect of antineoplastons.

Shockingly, these observations were made after a decade of abysmal site reviews by the FDA. Currently, Burzynski’s trials are subject to a partial clinical hold, which means Burzynski is still treating patients already on his protocol.

We are asking that you:

– Encourage the FDA to dissolve the Burzynski Research Institute’s clearly deficient Institutional Review [ethical oversight] Board and toplace a permanent hold on any more cancer patients receiving antineoplastons;
— Investigate how Burzynski has been allowed to conduct experiments on pediatric cancer patients while repeatedly cited for violating rules designed to prevent uncontrolled human experimentation.
— Investigate why the FDA allowed this abysmal researcher to advance to phase 3 clinical trials without publishing a single phase 2 trial;
— Protect cancer patients from abuse through legislation and FDA oversight reform.

Please help end a medical ethics scandal that involves eight times as many patients as the Tuskegee Experiment. I look forward to your response on this important matter.

Click here to Sign the Petition!

Posted in medical woo, politics, skeptical community | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | 2 Comments »

Skeptics for the Protection of Cancer Patients: Battling Burzynski’s Dangerous BS

Posted by mattusmaximus on January 17, 2013

Sometimes pseudoscience is stupid, sometimes it is annoying, sometimes it hurts our educational institutions… and sometimes it is outright frakking deadly.  Case in point, medical frauds who perpetuate nonsense to vulnerable, desperate people; such as when quacks push supposed “cures for cancer” which are anything but or have yet to be proven, such as in the case of Stanislaw Burzynski and his “cancer clinic”.  In such situations, it is literally a matter of life and death because when cancer patients delay reliable medical treatments in favor of pseudoscientific B.S. the delay can cost them their lives.  Skeptic James Randi helps to break it down in more detail here:

The Randi Show – The Burzynski Clinic and Cancer Quacks

But rather than curse the darkness, let us instead light a candle… :)

I am happy to announce that the Skeptical Teacher will be joining a coalition of skeptical activists called the Skeptics for the Protection of Cancer Patients (SPCP).  The Skeptics for the Protection of Cancer Patients is a grassroots group devoted to the promotion of promising, ethical, and transparent cancer research. For more about this project and the group sponsoring it, visit thehoustoncancerquack.com or visit their Facebook page.  Also, please consider donating either some of your time  by promoting the cause (if you have a blog or media contacts) and/or your money to the legitimate scientific research of cancer.

Some more background and info on Burzynski:

*Dr. David Gorski has a new Science-Based Medicine post out as of this past Monday on Burzynski’s antineoplastons treatment. Science-Based Medicine » Dr. Stanislaw Burzynski’s antineoplastons versus patients.

*Burzynski gets warning from FDA: Stop promoting your treatment as “safe” and “effective”

The U.S. FDA has sent a letter to the Burzynski Research Institute to cease claiming that their brain tumor treatment, antineoplastons, are safe and/or effective for the purposed for which they are being investigated. In other words, Burzynski’s claims on websites and promotional materials that this treatment WORKS is a violation because supposed to be testing that!

* Supporters often use patient anecdotes to sell his unproven treatments at the Burzynski Patient Group. We have started curating a collection of patient stories at The OTHER Burzynski Patient Group, the ones Burzynski would rather you not hear. Also, these stories can be exported to your own website IN THEIR ENTIRETY via the storify site they were created on. Free content, people. Just sayin’.

*Orac, an oncologist, cancer researcher, and patient advocate, has written extensively about Burzynski at Respectful Insolence.

*Learn the whole story at Josephine Jones’s Blog. She has kept a comprehensive list of content about Burzynski, his clinic, and his chemotherapy on the web. An invaluable resource!

*You might be interested that the EMPLOYER of one of our members (of SPCP) was recently contacted by one of Burzynski’s misguided supporters.

Posted in medical woo, skeptical community | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , , | 1 Comment »

FDA: Mercury Fillings Safe; Mercury Militia Goes Nuts

Posted by mattusmaximus on July 29, 2009

Good for the FDA!  :)  After that last blog post it’s nice to see some good news.  Of course, this research simply affirms what we (you know, the folks who follow science as applied to medicine) have known all along.  But to the “mercury militia” or other purveyors of anti-science-based “medical” nonsense, it will do little to sway them.  I can’t wait to see the backlash from the alt-med woosters on this one…


Mercury in dental fillings not risky, officials say

The U.S. government declared Tuesday that silver dental fillings contain too little mercury to harm the millions of Americans who have had cavities filled with them — including young children — and that only people allergic to mercury need to avoid them.

It was something of an about-face for the Food and Drug Administration, which last year settled a lawsuit with anti-mercury activists by posting on its Web site a precaution saying questions remained about whether the small amount of mercury vapor the fillings can release were enough to harm the developing brains of fetuses or the very young.

On Tuesday, the FDA said its final scientific review ended that concern. Still, the agency did slightly strengthen how it regulates the fillings, urging dentists to provide their patients with a government-written statement detailing the mercury controversy and what science shows.

Waiting for the alt-med “Big Government, Big Pharmaconspiracy-mongering machine to start up in… 3… 2… 1…

Anti-mercury activists accused the agency of bowing to the dental industry and said they would go back to court to try to force a change.

“FDA broke its contract and broke its word that it would put warnings for children and unborn children,” said Charles Brown of Consumers for Dental Choice. “This contemptuous attitude toward children and the unborn will not go unanswered.”

Whoops, too late.  Yup, that’s right folks, the FDA is out to kill children!  Aaagghh!!!

Give me a break… reasoning with nutbags like this is like pulling teeth.

Posted in environmental hysteria, medical woo | Tagged: , , , , , , , , , , , , , , , , , , , | Leave a Comment »

$2.5 Billion Spent, No Alternative Cures Found

Posted by mattusmaximus on June 11, 2009

Well, since I’ve been bagging on the alt-med nonsense lately, I simply couldn’t pass up this headline.  And folks… the headline says it all… “No Alternative Cures Found”… Zilch… Nada… Zip… Zero!  Despite their inability to understand the most basic aspects of science and the associated math, I think that zero is a number that even alt-med woo-meisters can grasp :)

$2.5 billion spent, no alternative cures found

Big, government-funded studies show most work no better than placebos

Ten years ago the government set out to test herbal and other alternative health remedies to find the ones that work. After spending $2.5 billion, the disappointing answer seems to be that almost none of them do.

Echinacea for colds. Ginkgo biloba for memory. Glucosamine and chondroitin for arthritis. Black cohosh for menopausal hot flashes. Saw palmetto for prostate problems. Shark cartilage for cancer. All proved no better than dummy pills in big studies funded by the National Center for Complementary and Alternative Medicine. The lone exception: ginger capsules may help chemotherapy nausea.

As for therapies, acupuncture has been shown to help certain conditions, and yoga, massage, meditation and other relaxation methods may relieve symptoms like pain, anxiety and fatigue.

However, the government also is funding studies of purported energy fields, distance healing and other approaches that have little if any biological plausibility or scientific evidence.

Taxpayers are bankrolling studies of whether pressing various spots on your head can help with weight loss, whether brain waves emitted from a special “master” can help break cocaine addiction, and whether wearing magnets can help the painful wrist problem, carpal tunnel syndrome.

The acupressure weight-loss technique won a $2 million grant even though a small trial of it on 60 people found no statistically significant benefit — only an encouraging trend that could have occurred by chance. The researcher says the pilot study was just to see if the technique was feasible.

“You expect scientific thinking” at a federal science agency, said R. Barker Bausell, author of “Snake Oil Science” and a research methods expert at the University of Maryland, one of the agency’s top-funded research sites. “It’s become politically correct to investigate nonsense.”

Read the rest of this entry »

Posted in medical woo, politics | Tagged: , , , , , , , , , , , , , , , , , , , , , , | 1 Comment »

Alternative “Medicine” Quackery Goes Mainstream

Posted by mattusmaximus on June 10, 2009

Since I’m on a kick about alt-med lately, let me just throw one more thing into the mix… a recent news story about how alt-med quackery has gone mainstream:

AP IMPACT: Alternative medicine goes mainstream

The news article is very revealing in its analysis of how pseudoscientific nonsense such as reiki, touch therapy, and “natural” herbal supplements have wormed their way into the medical profession over the years.  One of the big reasons is due to a political push…

Fifteen years ago, Congress decided to allow dietary and herbal supplements to be sold without federal Food and Drug Administration approval. The number of products soared, from about 4,000 then to well over 40,000 now.

Ten years ago, Congress created a new federal agency to study supplements and unconventional therapies. But more than $2.5 billion of tax-financed research has not found any cures or major treatment advances, aside from certain uses for acupuncture and ginger for chemotherapy-related nausea. If anything, evidence has mounted that many of these pills and therapies lack value.

Read the rest of this entry »

Posted in medical woo | Tagged: , , , , , , , , , , , , , , , , , , , , , , | 5 Comments »

 
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