Senators Ted Cruz and John Cornyn went to bat for constituents seeking cancer treatment from a Houston physician who used to collect urine from public restrooms to make his alleged wonder drug, which also allegedly treats everything from AIDS to genital warts.
According to STAT, a site that covers medical news, more than three dozen members of Congress have pushed the FDA to grant last-resort care for cancer sufferers from Houston's controversial internist, Stanislaw Burzynski, who has been battling state and federal regulators for decades.
Burzynski's treatment uses something called an "antineoplaston" (a word Burzynski obtained a trademark for in 1992, showing that this is one doctor who has his priorities straight), which uses peptides originally extracted from human urine. Antineoplastons — which are currently made sans pee-pee — have been in clinical trials off and on since the 1990s, while Burzynski and his associates have touted the drug's supposed success rate in obscure medical journals. (Burzynski has also toiled away in the lab to attack the other dreaded Big C — crow's feet. His anti-aging moisturizer, conjured from a centuries-old Polynesian "sacred oil," is said to work wonders.)
Investigators from the FDA and the Texas Medical Board have accused Burzynski and other doctors at his Hedwig Village clinic of putting patients at risk, misleading them about what treatments they'd receive, not following federal clinical study protocols and engaging in deceptive advertising, among other infractions. (One of the more serious allegations, from the Texas Medical Board, accuses Burzynski of allowing some of his unlicensed staff to be introduced as "doctors" to patients and allowing these staff members to diagnose and treat patients.)
Although clinical trials are free — patients don't pay for antineoplastons — insurance generally doesn't cover the clinic's exorbitant ancillary charges, like $3,500 "monthly case management" fees, and expensive prescriptions that patients are encouraged to buy from a Burzynski-owned pharmacy.
Despite the lack of evidence supporting Burzynski's claims, in the past five years, 37 members of Congress wrote to the FDA on behalf of constituents seeking antineoplaston treatment, STAT reported. Such intervention has been necessary because, following the 2012 death of a child enrolled in one of Burzynski's clinical trials, the FDA put a partial hold on new enrollment.
Since then, patients like Neil Fachon — a 20-year-old with cancer of the brain stem — have generated a lot of exposure, and sympathy, for patients who feel they've been failed by mainstream medicine. But families who say they were swindled have also received attention, perhaps most notably in an extensive USA Today investigation.
Burzynski has responded to these critics in the sort of level-headed, professional, intelligent manner you would expect from a man of science, telling USA Today:
"We see patients from various walks of life. We see great people. We see crooks. We have prostitutes. We have thieves. We have mafia bosses. We have Secret Service agents. Many people are coming to us, OK? Not all of them are the greatest people in the world. And many of them would like to get money from us. They pretend they got sick and they would like to extort money from us."
Frankly, we're shocked and appalled to find that United States Secret Service agents are extorting a Houston physician, and Cruz and Cornyn are doing absolutely nothing about it.
But, thanks to the recent STAT story, we can see what they are doing: standing up for terminally ill constituents' ability to choose, while completely ignoring the ramifications.
An aide for Cruz told STAT that Cruz wrote a letter on behalf of a constituent because “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."
The publication also reported:
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.
This Texas mother is typical of Burzynski's supporters, who are not swayed by the lack of scientific data, and prefer the David versus Goliath model that Burzynski has perpetuated for years. While they believe that Burzynski has been persecuted by the greedy FDA-Big Pharma Complex, these supporters don't have much of a problem with Burzynski — a guy who is supposedly sitting on the frickin' cure for certain types of cancer — making some families spend every cent they have on a treatment that, after 30-odd years, has not proven effective.
Make no mistake, the Burzynski Clinic takes its fees very seriously: In January 2013, Gary Harvey, a longtime member of the review board for the Burzynski Research Institute, the clinic's research and development arm, was diagnosed with a form of brain cancer called glioblastoma multiforme. Harvey's widow, Jill, told the Houston Press that, because her late husband couldn't afford it, he was denied treatment at the clinic to which he devoted 20 years of his life. He died six months later, at age 59.
Still, she said she fully believes in antineoplaston treatment. (We reached out to the clinic for a comment and will update if we hear back.)
Sadly, glioblastomas are one area where Burzynski has claimed remarkable success, saying that he's seen patients doomed to die by mainstream oncologists who are living happy, full lives 19 years later.
It was especially ironic that Harvey couldn't be treated at the clinic, since, as a member of the Burzynski Research Institute's review board, he approved many patients for clinical trials, according to a 2013 letter from the FDA. This, despite the fact that Harvey was "self employed in water rehabilitation services; therefore he does not have the clinical expertise necessary to make the required informed evaluation of the risks to subjects and their reasonableness in relation to anticipated benefits."
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But groundbreaking medical research was only one aspect of the Burzynski Research Institute — much of its filings with the U.S. Securities and Exchange Commission concern future licensing and international distribution plans, should antineoplastons ever make it to market.
According to the institute's most recent annual report, filed with the SEC, Burzynski began claiming his financial stakes in antineoplastons as early as 1983. He entered into a licensing agreement with the institute whereby it would have "exclusive rights" in the U.S., Canada and Mexico to manufacture, sell, sub-license and "otherwise exploit" all of Burzynski's interests in antineoplastons.
The USA Today investigation noted that, since Burzynski launched his clinical trials in the 1990s, the FDA has approved 108 cancer drugs. It must be frustrating for Burzynski to sit on the sidelines. When we interviewed him in 2008, he scoffed at our "stupid questions," saying, "Maybe in three years I get Nobel Prize, and you'll look like a shit."
Since Burzynski's patients include terminally ill children whose families have had to fork over every penny they have as they watch their child fade away, we'd love nothing more than for Burzynski's prediction to come true.