WASHINGTON — The call to Congressman Ted Yoho’s office was a matter of life and death: A constituent was seeking help for a 5-year-old great-nephew who was suffering from a terrible brain tumor.

Could the Florida Republican push the Food and Drug Administration to give the boy access to an unapproved drug treatment that the caller had heard would help? Yoho’s office agreed.

“This treatment is the only treatment that has been successful in treating a DIPG brain tumor,” an aide wrote in an email to the FDA last July. “This is an urgent request.”

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Yoho’s office, though, was wrong. The treatment, developed by a controversial Texas doctor named Stanislaw Burzynski to treat a rare form of cancer, has never been shown to be successful. Yet, for years, patients have continued to seek Burzynski out, and to ask their representatives in Congress to intervene on their behalf.

From 2011 to 2016, 37 members of Congress wrote to the FDA about Burzynski, several of them numerous times, according to documents obtained by STAT under the Freedom of Information Act. Most of the lawmakers asked the agency to grants constituents “compassionate use exemptions” so that they could try his unapproved drugs, or to allow his clinical trials to proceed.

Burzynski told STAT that the “interventions by lawmakers were helpful.”

Other letters, however, reflect the long-standing allegations against Burzynski, who has been cited by the FDA in dozens of cases in which patients have reported bad reactions to his treatment — a mix of peptides — or even died. In those letters, the lawmakers ask the agency to shut down the doctor’s clinical trials.

Lawmakers routinely appeal to government agencies on behalf of constituents in need of medical assistance. But in Burzynski’s case, the doctor’s critics say, the congressional advocacy risks giving the terminally ill and their families a false sense of hope, while also conferring a measure of legitimacy on him that many believe he does not deserve.

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On its website, the Burzynski clinic describes itself as a “nationally and internationally recognized cancer center” and promises “cutting edge” treatment. Critics see things differently.

“If Burzynski’s concoction actually cured cancer, we’d know it by now,” said Shannon Brownlee, senior vice president of the Lown Institute, a Boston health care think tank. “I’d be shocked if he’s actually conducting a real clinical trial, so I’m not sure what members of Congress think they are doing for their constituents.”

Appeals that cross party lines

The appeals don’t always work. In the 5-year-old’s case, for example, while waiting for the FDA to make a decision, Burzynski said he used a Texas state law to circumvent the agency and start treatment.

The boy, Nolan Hancock, died three months after starting treatment.

“He was a special kid,” said his father, Richard. “There was nothing he couldn’t do.”

A spokesman for Yoho made no apologies for his actions, saying instead that the congressmen would likely try to help any constituent who was suffering from a terminal illness.

The congressional interventions have come from Republicans and Democrats alike. Besides Yoho, Texas Republican Senators Ted Cruz and John Cornyn, and New Hampshire Senators Jean Shaheen (D) and Kelly Ayotte (R), among others, have advocated for Burzynski’s treatment for their constituents.

Representatives Doug Lamborn, a Republican from Colorado, and Carol Shea-Porter, a Democrat from New Hampshire, who has left Congress, and Joe Pitts, the Pennsylvania Republican chairman of the House health subcommittee, among others, have also pushed the FDA to grant constituents access to either Burzynski’s drugs or one of his clinical trials.

Many of those lawmakers did not respond to requests for comment; spokesmen for others, like Phil Novack, an aide to Cruz, said the senator could not comment on constituent casework, due to privacy concerns.

“The senator believes that patients in consultation with their doctors should be free to choose a course of treatment that fits their individual medical needs,” Novack said.

Some lawmakers have taken a more hands-off approach in cases involving Burzynski, merely passing along a constituent’s request, without weighing in on what the FDA should do. Representative Lamar Smith, the Texas Republican, and California Democratic Senator Barbara Boxer, for example, did just that.

“We receive thousands of letters from Californians each year requesting assistance with federal agencies,” said Boxer’s spokesman, Zachary Coile. “We forward such requests to the appropriate agency for their review and consideration to help ensure that the constituent’s issue or concern is heard and that they obtain a timely response.”

But lawmakers can also be blinded by hope — and pass along unproven claims from Burzynski and his advocates.

In 2014, for example, a Texas mother seeking access to Burzynski’s drugs for her sick daughter wrote to Cornyn and Cruz, telling them that the doctor had seen a “nearly 30 percent cure rate” in clinical trials.

The woman also accused the FDA of denying increased access to Burzynski because of a paperwork dispute, and in other correspondence, a political vendetta.

None of those charges was substantiated, yet Cornyn and Cruz passed them along to the FDA and asked the agency to justify its actions.

As it has dozens of times, FDA’s congressional affairs office responded, mentioning the cases in which Burzynski had been cited by the agency for problems or received warnings.

Still, the letters keep coming.

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Sandy Smith wishes they would stop. In 2007, her son Andrew was being treated at Burzynski’s clinic for DIPG — or diffuse intrinsic pontine glioma, a rare form of cancer that attacks the victim’s brain stem.

Anxious about his progress, Smith began looking into the cases of other children treated there for the same cancer. They had all died.

She and her husband Shawn pulled Andrew out of the clinic and eventually brought him to the National Institutes of Health. Andrew lived another two years, an unusually long amount of time for a child with a DIPG diagnosis, and longer than any child who stayed with Burzynski survived.

On the fifth anniversary of Andrew’s death, aware that Burzynski supporters were claiming in widely distributed promotional materials that an upcoming trial would cure 1 out of 3 kids with DIPG, and fearing for those children’s safety, Smith wrote to one of her senators, Michigan Democrat Debbie Stabenow. She asked Stabenow to pass along the record of Andrew’s experience to the FDA.

Stabenow did so, and the FDA called Smith. She hopes their conversation gave the agency ammunition in its long battle with Burzynski. She believes that lawmakers who don’t fully understand what is happening in the clinic, and push for participation, do a disservice to their constituents.

“I think most people do not realize what is going on there,” Smith said. “If you go to the website, it looks amazing, that’s why we went. But we have to be careful.’’

Smith, who is a cancer survivor herself, objects to the notion that desperate patients should have the right to try any treatment – even if the FDA thinks it’s dangerous.

“I can understand why a member of Congress would want to respond to their constituents and want to be helpful, “ Smith said. “But if they really do not know what is going on — and at the Burzynski clinic it is very difficult to know what is going on — then you have to proceed with caution.”

‘A really hard challenge’

The FDA declined to comment on Burzynski’s clinic but said that, “generally speaking, the agency reviews letters from members of Congress and responds directly to the requestor.”

The FDA, a spokesman said, “takes seriously its role in ensuring that research subjects are made aware of the potential benefits and risks of investigational products, and are not exposed to unreasonable risks.”

The agency says that it grants nearly all appeals for compassionate use exemptions.

Burzynski, however, told STAT in a phone interview that prospective patients of his face much longer odds. Between January 2012 and June 2012, the agency permitted 17 compassionate use exemptions for his treatment and rejected five. None has been approved since then.

The FDA has, on and off, permitted him to enroll patients in clinical trials during that time.

The Texas Medical Board, meantime, has been trying to strip Burzynski of his medical license for many years. In its most recent court filing this summer, the board accused Burzynski, now 73, of unethical and unprofessional conduct regarding clinical trials of gravely ill patients, including improper care, deceptive advertising, and the use of unlicensed staff, among other charges. Burzynski has denied all charges.

Former FDA commissioner Mark McClellan, who said he was unfamiliar with the Burzynski case, said most outreach from members of Congress are on behalf of people who really have no good option left.

Generally, McClellan said, the FDA tries to establish criteria to allow individuals to use experimental treatments, with a requirement that the drug manufacturer inform the patients of benefits and risk, and be barred from charging for it.

“It’s a really hard challenge,” he said.

One of the challenges seems to be keeping up with a deluge of correspondence about the controversial Burzynski.

Amanda Chuzi, a legislative correspondent for Senator Tim Kaine, the Virginia Democrat who is now Hillary Clinton’s running mate, passed the FDA a letter regarding the agency’s treatment of Burzynski.

“As your constituent,” the letter said, “I call upon you to launch a full congressional investigation into the FDA’s blatant power abuses. … The damage stemming from FDA’s vendetta against Dr. Burzynski … has extended to dying patients requesting access to Dr. Burzynski’s unique, innovative care.”

Along with the letter, Chuzi wrote, “Happy New Year!” and said the senator had received over 200 copies of that letter. If the agency had any ideas on how to respond, Chuzi said, she’d be eager to hear them.

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  • Our 20-year-old son is into his fifth month of ANP therapy for DIPG, and I am very disappointed in the bias this article presents against Dr. Burzynski. I happened to have been on the phone yesterday afternoon with Robin Ressel, mother of DIPG long-time survivor Jessica Ressel, who was “cured” by Dr. Burzynski. Later in the evening I spoke with Jessica Ressel herself. They shared with me the challenges Jessica faced at the age of 11 while going through ANP therapy, and provided me with information that is helpful for me to share with our son as he faces similar challenges. Jessica is now married and a mother of two children herself. During my phone conversation with Robin, she mentioned another DIPG survivor, Jody Fenton, who was in her twenties when she was diagnosed. I hope to get in touch with Jody to hear her story. I’m friends on facebook with DIPG survivor Celeste Sabaugh, a 29-year-old from Argentina. I have yet to reach out to the mother of Tori Moreno (California), who was treated for DIPG by Dr. Burzynski as a baby. Tori graduated from high school this past June. These stories ARE REAL. These facts are REAL. Why is mainstream media overlooking these stories?

    • If it is so great why are there no double blind tests? Four decades should be enough time. Or some other legit cancer facility replicating the results?

      Had a girlfriend go to him, she died. I could not convince her to go to MD Anderson, she might have died there instead, but it would have been covered on insurance. She went thru a lot of money on him, money she could have left that for her grandchild.

      Cancer can spontaneously regress for no known reason. Proof would change this guy from a zero to a hero. People can become canonized Saints for this, but that does not prove it is real.

      People want to believe in astrology, just don’t call it science. After 4000 years, just one double blind test is all it takes to go from a precursor of astronomy to real science.

    • Hoping everything is going well with yr son. Was wondering if u could give me a way to contact people who have been cured of a DIPG by any means. knew a 16 yr old who tried a targeted therapy that seems to be working at 5 months the mri showed the tumor shrinking and breaking up plus his symptoms(trouble walking, talking and eating) abaited in just under 3 wks but he stopped at 5.6 months [the medical research group(developers) wanted him to stay on the treatment for at least a yr and until no evidence of tumor on mri] and then lived 4 yrs and died at 20 .

  • When people have terminal diseases they get desperate.
    The fact that this shill is pulling them in after decades of no proven efficacy, says a lot about how badly the system is broken.

    • Many tried many got cured. If you dont know much dont leave comments. I hope someday when you get cancer you will try your “conventional way ” approved by your FDA Fraudulent Disease Administration

    • @dorota. He has had decades and resources to prove it, bupkis. I have more respect for people who burn candles and sacrifice chickens to get rid of cancer. If you don’t like the FDA, present one country that considers this actual medicine.

  • Not the first time I have run into this name. He has been shilling for years, and made lots of money doing it. I’m just shocked that he has been allowed to practice.

  • Burzynski is a reprehensible quack, who has taken millions of dollars from desperate patients and cured no one. STATnews is helping him by giving him a pass in too many ways. In June, you called him a “renegade doctor” who was the only hope (as you wrote) for a young man with brain cancer. Now you call him a “controversial doctor.” He’s not controversial: he’s a quack who ought to have his license revoked and he should be thrown in jail for offering false hopes and taking people’s money. He uses the media shamelessly – and now STATnews is falling for it too – to draw attention to himself and make more money. Don’t call him a “renegade” or “controversial” until you first find evidence that his treatment, so-called antineoplastons, has cured anyone’s cancer. He’s been selling this snake oil for decades and it has never worked.

    • Is he really a nut or a visionary? Same could be said about first explorers or space exploration it has to start someplace.What’s even more insane is we’re exposed to thousands of chemicals in our lifetime so a select few can be extremely rich and wonder why ourselves and children are sick?If he’s so crazy why are they trying to steal or copy his research?To the negative responses I wonder what your true motives are?

    • @Bo, behind door number three is con man. Starting with a scientific method impresses me. If you want to sail into sunset off the edge of world, or go into outer space knowing you might not make it back, fine your call. Start telling people you have a solution to their incurable problem, and still can’t prove anything after decades using human guinea pigs; all together different.

      Any real scientist or honest medical doctor, operate on the principal that people will be able copy what they doing and get the same result, for the benefit of humanity. If this clown was good as some people think, including you, he would have gotten the Nobel Prize after decades of pushing his method on desperate people not wanting to die. Instead he hides behind his medical license, hiring a pack of lawyers.

      My motives? As a mathematician & biochemist, his statistics don’t add up, and his chemical analysis is bogus. That is: no proof, after decades of patients; just lacking a silly thing called facts. Never met him, hope I never do. Knew one of his patients, she is not around to talk about its success.

      As for Burzynski, he typifies what is broken within the medical community. Once a person gets licensed with a Doctorate in Medicine, it is almost impossible for the medical community to make them act correctly when it comes to facts or practicing medicine, or for governmental bodies to revoke their license even if they commit heinous criminal acts or demonstrate gross medical incompetence.

  • Is anyone curious why Ted Cruz believes patients should, in consultation with their doctor, choose the medical care that is best for them, even if it is an unproven cancer treatment that could cause harm? The government should stay out of your medical choices in that case. But of course if you are a woman facing an unwanted or dangerous pregnancy, you should not be able to make choices on your medical care in consultation with your physician. In that case the government should step in? Can’t pick and choose Ted, sorry.

  • Until Burzynski publishes his results in reputable peer-reviewed journals, there is only anecdotal evidence that his concoction works. Furthermore, he uses traditional chemotherapy regimens with his “antineoplastons” and charges a huge mark-up on them. Complete scam artist.

    • A Peer-reviewed journal here in the US? Oh, you mean one of those prestigious journals….one of the ones that ISN’T owned by one of the 6 Corporations that control editorial content. Yeah, good luck. See, you need to go to a country that has been corrupted less by a Medical Cabal. A country that cares more about the Persons health, then the bottom line.
      Try Japan…..they’ve been using Antineoplastons for decades with DOZENS & dozens of PEER-REVIEWED Papers/Journals. Have at it, go do the research. Why do you think the US Government TRIED to file patents on Antineoplastons? Because it doesn’t work? HMM? How many times have the Powers that Be HARRASED this brilliant man?….but still couldn’t put him in jail? There is no 100% CURE for Cancer, but there are CURES out there. Poisoning yourself & burning yourself are not the answers (they in themselves the TREATMENT….CAUSES CANCER alone, Wow!). The rabbit hole is far and wide my friend. Cars should be running on water right now, not gas. How come? You should be able to get Dr. B’s treatment if you want & have your insurance co. pay for it. Dr. B is the ONLY PERSON to take a drug to the 3rd Phase of Clinical Trials within the FDA (other than BIGPHARMA of course). That’s not too impressive is it? That only costs 100 MILLION or 200 MILLION or 300 MILLION to do right? Yeah, not to impressive of a man or Cancer Treatment in deed.

      What ever you do…..don’t go to Latvia of all places and take the Rigga-Virus protocol that has shown a efficacy rate of over 90% if Poison & Burn Method isn’t used at all. ALL of Burzynski’s Patients that got to use the Antineoplastons Treatment HAD to undergo Poison & Burn Modern Medicine 1st…..then after the patients IMMUNE SYSTEM is DESTROYED, the Dr. B get to try and save their life AFTER Mainstream FAILED. Get it!!!
      Oh, yeah… Rigga Vira Therapy has been around since 1989 in LATVIA….100’s, over 1,000 peer-reviewed/scientific studies performed….no negative side effects like POISON & BURN….CURE RATE ABOVE 80% for most Cancers….YET no ONE in the United States, let alone a DOCTOR knows about this….HMM? Wonder why? Oh, WHOOPS!!! LOL!!!

      Everybody deserves what they get….especially if you vote for the Devil-Hitlery.

      Peace Brothers & Sisters
      It’s US against THEM….There’s Far Too Many Conflicts of Interest for THEM to be Honest. Simple.

    • Josh, your conspiracist thinking has blinded you to the rather obvious fact that America is not the world. There are cancer researchers around the world, charities, individual scientists, academics, doctors, and of course politicians and regulators. A vast range of people with obviously completely different political and ideological motivation. There is no way this broad group of people could possibly be coerced into suppressing something that cures a disease that kills their own families just as much as it kills everyone else.

      What we do know is that a lot of science is wrong. Most scientific hypotheses turn out to be incorrect. The problem with Burzynski is that he refuses to accept that he might be wrong, even though nobody else can replicate his results and he’s failed to show any credible evidence of effect.

    • >Dr. B is the ONLY PERSON to take a drug to the 3rd Phase of Clinical Trials within the FDA

      And the results are???
      Prove it.
      Can’t prove it? Facts don’t support your claims?
      There is a difference between science and snakeoil, called real medicine.
      At least with science when false claims are proven for what they are, the proponents back down in the face of real evidence (e.g., Piltdown Man).

      After decades of making money, Burzynski has yet to prove his claims (someone who has medical training), the evidence should be clear. Astrology has the same problem: people believe in it, but after a couple thousand years where is the proof?

      He should have his license pulled, something rare after getting one.
      Quack.

  • The problem is that no politician wants to be seen as not helping a sick constituent. That’s why some states have been coerced I to licensing naturopaths or protecting “chronic Lyme” charlatans from their medical peers. Politicians rarely have any medical background and the groups that form around quacks and charlatans are adept at mixing emotive appeals with deceptive promotional claims, so one can hardly blame representatives for being sucked in.

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