The dizziness didn’t much worry Neil Fachon. Neither did the double vision. He was recovering from concussions he had sustained while playing sports, and the symptoms weren’t enough to keep him from his engineering classes at Northeastern University in Boston.

Then came some inexplicable struggles with handwriting and swallowing.

Doctors scheduled an MRI. On March 4, his life came unhinged.

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Oncologists at Massachusetts General Hospital told Neil, 20, that he had a rare and incurable form of cancer known as DIPG, or diffuse intrinsic pontine glioma, which attacks the brain stem and usually kills its victims in a year or less.

The diagnosis dropped the college sophomore into a maelstrom. Doctors laid out one course that seemed of little use. Herbalists recommended dietary changes. Neil and his family grew excited about an experimental therapy offered by a renegade Texas physician, Dr. Stanislaw Burzynski, and he flew to Houston to get infusions — but got them for just for a single day before federal regulators abruptly ordered the treatments to stop.

Soon, Neil’s family was suing the Food and Drug Administration for the right to keep trying the new therapy. Late last week, the Fachons won, and Neil resumed the treatments.

The family drama comes amid growing tension — in Congress and across the US — about how far terminally ill patients can, and should, go in search of a miracle.

The FDA tries to protect patients from unproven remedies that might do more harm than good. But when a child has an incurable brain tumor, does the same cold calculus of risk and benefit apply?

“Neil wanted to be part of this research,” Wendy Fachon, Neil’s mother, told STAT. “What did he have to lose — his life?”

For his part, Neil said in an interview Tuesday that he has been focusing on staying upbeat, even amid the “crazy stress” of fighting the FDA for the right to try the infusions. “I’m thinking ‘What can I still do?’” he said. “I can hold my head up. I can keep the most positive spirit I can, and help my parents get through this the best they can. And that’s precisely what I intend to do.”

Neil Fachon
Neil Fachon after having a catheter inserted in his chest in April. Courtesy Wendy Fachon

No time to wait

Modern medicine is a brutal battlefield: hope spars with fear. Risk with caution.

It’s the FDA’s job to ensure that treatments work, that trials are conducted safely, that potential for gain outweighs potential for harm. But regulators are under constant pressure from patients — and, increasingly, politicians — who feel the agency moves too slowly, demands too much data, and won’t let dying patients take a chance on experimental drugs.

Just this month, for instance, mothers of children with Duchenne muscular dystrophy, which is fatal, raged against regulators who have delayed approval of a drug for the disease. Parents call the treatment promising, but the FDA has expressed doubts about the drugmaker’s data, based on a 12-patient study.

“We’ll never have a perfect drug, but we’re trying to find a way to get the best of both worlds: minimize risk and maximize benefits,” said Karen J. Maschke, a political scientist at the Hastings Center and editor of the journal IRB: Ethics & Human Research.

“It’s a hard conversation to have,” Maschke added. “But we need to keep trying to have it, and have it ongoing so we can have it at times we’re not in crisis.”

The Fachons didn’t have the luxury of waiting for a good time to talk.

They knew that mainstream medicine had little to offer Neil beyond radiation to tamp down the tumor and perhaps buy him a few more months. Neil’s oncologists also said they could biopsy the tumor to see if he might qualify for experimental treatments. But a biopsy on the brain stem can be risky.

As they considered clinical trials, Wendy Fachon plunged into consultations with practitioners of naturopathic medicine.

Neil was soon eating heaps of kale and downing an herbal concoction. He took vitamins and high doses of curcumin, a substance in tumeric, prescribed by a woman with a degree in naturopathic medicine who studied with Cherokee elders.

The family had known about Stanislaw Burzynski, who promotes an experimental treatment made from amino acids and peptides that he says cancer patients lack. Burzynski has tangled for decades with federal and state regulators; they have accused him of unethical conduct, of sloppy record keeping — and of repeatedly jeopardizing his patients with risky treatments and drug overdoses.

Despite his record, the Food and Drug Administration authorized Burzynski to run a clinical trial of his treatment on a brain stem tumor. The clinical trial meant the family would not have to pay for the treatment, which can run in the tens of thousands of dollars and is not covered by insurance.

In mid-April, Neil became the one and only patient enrolled.

The Fachon family, who live in East Greenwich, R.I.,  had read critiques of Burzynski’s treatment on the websites of the National Cancer Institute (which says there’s no known benefit), and Memorial Sloan Kettering Cancer Center (which says it could be useful as a supplemental therapy for breast cancer). They’d read testimony, too, from Burzynki’s many impassioned, though less credentialed, fans. Neil and his sister, Evie, a senior at Northeastern, had even held a Skype conversation with a woman in Argentina who credited Burzynski with curing her fatal brain tumor.

“Neil wanted to be part of this research. What did he have to lose — his life?”

Wendy Fachon

So Neil and his parents flew to Houston, where they were later joined by Evie. There, Neil had an intravenous catheter inserted in his chest; it delivers the treatment every four hours, around the clock.

Camped out in hotel rooms in Houston, the family passed the time playing board games such as Settlers of Catan, Carcassonne, and Pandemic. More recently, Neil has spent more time on the computer, writing about his experience.

“He’s doing OK,” his mom said last week. “He’s very tired. We’re all very tired. But he does feel he’s improving.”

Everyone was shocked when the FDA abruptly ordered the trial shut down, without making public the reason. The agency reversed course just as abruptly, and just as mysteriously, last week, after the Fachon family filed their lawsuit. A federal court order dated May 27 indicated that the FDA would let Neil Fachon continue his therapy.

“I can’t put into words the stress and the mental trauma that the FDA put us through,” Wendy Fachon said. “How they treated us was absolutely abysmal.”

The FDA declined to comment. Burzynski also turned down requests for interviews.

Clinical trials do get stopped midstream occasionally, for various reasons, but Richard Jaffe, an attorney who represented Burzynski for years, said in general such action is taken only when there’s “a strong likelihood” that a participant in the trial will get harmed.

Jaffe has sued Burzynski for nearly $250,000 in unpaid legal fees, but says he still believes in the doctor and his experimental blend of compounds normally found in blood and urine.

“It may not be a perfect treatment and it’s not approved yet for marketing, but there’s some evidence” of benefit, Jaffe said.

Fachon said she understood the side effects of the experimental treatment to be minimal: imbalances in sodium or potassium. “But if you’re aware of that, and you stay away from salty foods and drink lots of water and eat bananas and take potassium supplements, you’re fine,” she said. “I think it’s brilliant.”

Neil, too, said he felt he was in good hands. Asked how he liked Dr. Burzynski, he responded: “I love him.”

Burzynski has “a twinkle in his eye,” Neil added. “But he cares very deeply about what he’s doing. He has a very real intent to help people.”

A doctor under fire

Burzynski has been promoting his experimental treatment, which he calls “antineoplaston therapy,” since the 1970s. He lists a string of scientific papers on his website, but he hasn’t published any data from randomized controlled trials testing the efficacy of his treatment against placebos or more conventional therapies.

Antineoplaston therapy is not approved by the FDA for the treatment of any illness.

Yet Burzynski pitches it as a “cutting-edge,” personalized cancer treatment. His clinic’s slogan: “Tomorrow’s cancer treatment today.”

Two documentaries about the doctor paint him as a visionary persecuted by the medical establishment. Dr. Mehmet Oz, the medical-doctor-turned-TV-personality, has promoted him. But regulators have long been skeptical.

In the 1980s, the Texas Medical Board reviewed Burzynski’s use of antineoplaston therapy on about 60 patients to see if it was safe. The results were inconclusive. In 1988, the board accused him of violating the Medical Practice Act, in part because he had given patients the therapy after the FDA had put a hold on clinical trials. A Texas trial court later threw the case out. The board has called for suspending his license for violating medical standards.

The FDA has come down on Burzynski, too. Of particular interest to the agency: the clinic’s Institutional Review Board, which is charged with approving the protocols of research trials and protecting patient safety. The FDA concluded in 2008 that the board didn’t do enough to minimize risk to trial participants, failed to ensure patients gave informed consent, and otherwise neglected its responsibilities.

Strikingly, the FDA also said that when a member of the review board had a conflict of interest, non-IRB members were allowed to step in as substitutes. FDA regulations prohibit that practice. The FDA sent several warning letters but did not shut down the clinic.

In 2012, a young boy died in one of Burzynki’s trials, and both the Texas Medical Board and the FDA again investigated. The results were troubling for Burzynski.

In a harsh warning letter to Burzynski, dated Dec. 3, 2013, the FDA said the doctor had “failed to protect the rights, safety and welfare of subjects under your care.”

Dr. Stanislaw Burzynski has “failed to protect the rights, safety and welfare of subjects” under his care in clinical trials.

Food and Drug Administration

The agency also noted that Burzynski had failed to report adverse reactions that patients suffered in the clinical trial, as required by law, and neglected to obtain informed consent, especially regarding additional fees for the treatment. He was also cited for failing to maintain accurate case histories — which are crucial to figuring out whether a treatment actually works.

And that wasn’t all. “Overdoses have been reported to you on a weekly basis during your Monday, Wednesday and Friday staff meetings. There is no documentation to show that you have implemented corrective actions during this time period to ensure the safety and welfare of subjects,” reads one federal inspection report from 2013.

At the same time, the Texas Medical Board revved up its pursuit of the Houston doctor.  In November 2014, the board filed another case against him, accusing him of violating ethical standards and the standard of care, among other charges. That case is pending.

Through it all, his fans have remained loyal. Rita Starr, who said the doctor successfully treated her mother in 1994, cofounded the Burzynski Patients Group to rally support. The doctor is now treating her husband for lymphoma. And she said she “personally knows” patients who have overcome brain malignancies after being treated by Burzynski.

Starr visited the clinic last week, gave Neil Fachon a new backpack to carry his treatment supplies in, and showed him photos of Burzynski patients who have survived cancer.

“The family knows they’re in a good place,” she said.

Fachon family
Dean, Evie, Neil, and Wendy Fachon at the Burzynski clinic last month. Courtesy Wendy Fachon

‘One of the worst tumors’

DIPG “is one of the worst tumors we have in pediatrics,” said Dr. Peter Manley, who directs the pediatric neuro-oncology outcomes clinic at the Dana-Farber Cancer Institute. There are about 300 cases a year in the US, mostly in  younger children.

The standard treatment is radiation to the brain stem. Manley said patients usually improve as a result, but the tumor tends to grow again within six to nine months. Most patients die within a year of diagnosis.

Research on alternative therapies is actively underway, however — including a clinical trial at the Translational Genomics Research Institute and the University of California, San Francisco, and another at St. Jude’s Children’s Research Hospital in New York.

In addition, Manley said researchers at Memorial Sloan Kettering and Weill Cornell Medicine are studying methods of injecting chemotherapy directly into the brain stem. The idea is to overcome a big weakness of standard chemotherapy — that it often does not effectively cross the blood-brain barrier.

“We’re hoping that we’ll learn more about these tumors and target them directly,” Manley said.

“What can I still do? I can hold my head up. I can keep the most positive spirit I can. … And that’s precisely what I intend to do.”

Neil Fachon

Wendy Fachon, who works for a magazine called Natural Awakenings Rhode Island, said she and her husband, Dean, a freelance writer, considered other clinical trials, but none of them appealed as much as Burzynski’s, given how many people had testified about positive experiences with the Houston doctor. She also continues to pursue herbal and naturopathic remedies.

Dr. Naoki Umeda, a staff physician at the Cleveland Clinic’s Center of Integrative and Lifestyle Medicine, said herbal treatments can effectively support — but should not replace — traditional cancer treatments, because they can boost the body’s immune system.

Remembering to smile

As the drama has unfolded, Neil Fachon has remained positive.

It comes easily to him.

In high school, Neil spent his summers in a student leadership program in Massachusetts — the last two as a volunteer, training the younger participants to hold fundraisers in which they read a particular book to elementary school students.

The book was “The Jester Has Lost His Jingle,” written by David Salzman, who died of Hodgkin’s lymphoma in 1990 at age 22.

In it, a jester regains his lost humor with the help of a girl who is battling brain cancer.

After Neil’s diagnosis in March, friends from his program sent him a copy of the book and a jester doll.

Neil said he wants to give copies to two young patients with DIPG who recently checked into Burzynski’s clinic. He wants them to know, he said, that “no matter how bad it seems, how down they are, there’s always, just around the corner, a smile.”

“Especially for kids going through this kind of thing — myself included — it’s something we need to be reminded of, because the whole situation can become so oppressive at times,” he said. “So to have that message of positivity and laughter and love for life … that’s the message I’m trying to bring to people.”

Meanwhile, Wendy Fachon said she is considering supporting legislative initiatives that might help patients in similar situations gain more control over their medical treatment. She has already heard of at least one other child who was blocked by the FDA from joining her son on Burzynski’s trial.

“My heart goes out to those families, because I know what it’s like,” she said.

As for Neil’s future, she said: “We are very optimistic for his recovery. His story can’t end now. I think his story is just beginning.”

Neil agreed.

“I’m feeling pretty good,” he said. “I don’t plan to stop feeling pretty good any time soon.”

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  • My sister died from chemotherapy.
    She was misdiagnosed for years by a nurse practitioner that she was seeing in her small town in Texas.
    By the time I found out about her dilemma she was bed ridden for months and was praying to God to stay alive long enough to see her expecting daughter bring her granddaughter into the world.
    I was talking with a trusted friend of mine about the situation and he recommended a product from APEX-WATER.COM. It was durring the winter months and she had to wait for the product to be shipped from Colorado when it was warm enough because the product can not freeze or it will be rendered useless.
    It took a few weeks to finally get shipped but once she started taking the solution, within three days she was out of bed and feeling pretty good. After three weeks she was able to get out of the house and go back to church where she would love to sing in the choir. After six months, the church was going to take her name off the prayer list because she looked so good, but she told them to keep praying because she wasn’t out of the woods yet.
    I’m sure her doctor’s have good intentions but they are limited in their practice.
    Even though the APeX was working she wouldn’t dismiss her doctors recommendations and she went into a chemo trial that literally killed her within a month.
    Once she was feeling better after starting the APeX, I started to use it on a daily basis in lower dosage to prevent illness for myself. I can testify that the product works for me. I haven’t been sick since I started taking the APeX. The inflammation in my lower back has gone away completely, something that would keep me bedridden for weeks at a time before.
    When people around me are getting sick from the flu, I drink a little more APeX and never get sick. I don’t even see a doctor anymore and it’s been 5 years and counting. The cost is about $500 per year. Way less than the cigarettes I smoke.

  • Looks like he passed away in 2017, could be too little too late, could be the FDA is right, but without a proper clinical trial being done we won’t really know. I watched a video on him and a lot of his patients had their tumors disappear entirely.

  • In order for us to know if medication is to work or if the Dr. Is in the right path Of good let the man proof him self…. The FDA shouldn’t & has no right to tell me who why where & how I would like to die with treatment or not they can suggest … I hope is not with the Elite deep state corrupted FDA but a better chance with this doctor… In god we trust.

  • I’ve lost 4 friends/relatives to cancer and they all were given the AMA’s standard protocol. We need to look hard at the more promising alternatives!

  • My wife had died on year 2017 despite undergone chemo thearapy treatment, why they stop this medication that helps cancer patients succesfully than chemo,

  • I am a nurse and could no longer work in oncology as it simply a money maker! When my mom was diagnosed with terminal metastatic cancer in her 50’s she was given 1-2 weeks at most to live. An oncologist friend gave me book “The Essiac Report A Herbal Canadian Remedy for Cancer. I was a amazed. I bought the Flor Essence and after just 3 doses, mom was sitting up in bed eating for the first time in days. She enjoyed 4 more months on no medication until the day before she passed. The cure for cancer I believe was found a long time ago, but the greed for money is much greater than anything else!

  • I’m a Polish immigrant who lost a father
    to cancer and I am appalled that our government thru the FDA has decided to play games with our lives! I would love to help in any way I can.

  • Dr Burzynski has had a difficult time with having his antineoplastin treatment accepted in the medical profession, and by vested interests in the Federal Drug Administration. Surprising he did not leave the US or set up his laboratory in another jurisdiction, as the world also has an issue with many of these cancers. What happens when Dr Burzynski is too old to carry on? It is clear that conventional medicine has no inquiring mind when it comes to investigating the properties of these peptides, and how they may combine to fight cancers which have very low success rates. prostate and Breast cancers may also be “Treated” with these compounds. I hope Dr Burzynski sets up laboratories in alternative jurisdictions to continue research into these cancers. The number of investigations and trails the FDA put the doctor through, and then attempted to patent his discoveries places the FDA and their agenda in an extremely poor light.

    • Dr. Burzynski’s son works in his practice. I’ve had an appointment with him and was very impressed. He was honest and sent me on my way saying he didn’t feel like there was any indication that I had cancer. In other words, he didn’t want to milk me for $$$. My best friend had terminal cancer for 2 years (2015-2017) previous to my appointment and I was terrified (and paronoid) that I’d have to endure what she’d been through until she went to Dr. Burzynski (the senior). She showed huge improvement from the first treatment and every treatment thereafter. She went from hospice care for a year to living large in San Miguel, Mexico. She literally had cancer all over her body and he cured her. Now, my son has just been diagnosed with a very rare form of cancer (chordoma) of the spine at the base of the skull and, unable to sleep, I’m here on line researching to see if Dr Burzynski can help him. I’m praying that he’ll at least have one appointment with their practice before letting anyone cut on him. My BFF never had to have surgery and I’m convinced that’s why she’s recovered completely.

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