The New Hampshire Union Leader reported on October 26th that McKenzie Lowe, 13, who, in November 2012 was diagnosed with diffuse intrinsic pontine glioma (DIPG), is the latest patient to die after receiving the unapproved intravenous drug treatment called antineoplastons manufactured by a Houston, Texas-based pharmaceutical company called the Burzynski Research Institute (BRI).
This news came two days after BRI announced that “the U.S. Food and Drug Administration (FDA) has given the company permission to conduct an open-label study of Antineoplastons A10 and AS2-1 in patients > 3 months of age with a diffuse intrinsic brainstem glioma (DIPG).”
Antineoplastons have been sufficiently studied to be regarded as disproven therapy. Treatment protocols for antineoplastons were developed by physician and biochemist Stanislaw Burzynski from his studies of substances he found in urine.
I’m not just pissed off—I’m outraged that FDA would allow inadequately controlled studies for such a failed, toxic treatment.
A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future…Miracle of miracles, all of Burzynski’s patients were now on FDA-approved clinical trials, and he would be able to treat almost any patient he would want to treat!
In March, the Food and Drug Administration granted a compassionate use exemption for McKenzie to receive the drug if she could find a local physician to oversee her care. A physician who noted that the odds were against her agreed to take on this role.
But the grandfather said the treatment caused crippling side effects and “her body just couldn’t handle it.”
McKenzie’s ordeal with antineoplaston treatment is not surprising. The American Cancer Society notes:
Proponents claim that antineoplaston therapy is “nontoxic” However, reported side effects range from mild to serious, including fatigue (extreme tiredness), anemia (low red blood cell counts), headaches, numbness, skin rash, swelling of the hands and face, chills, fever, dizziness, changes in blood pressure, unpleasant body odor during treatment, and sleepiness. High levels of blood sodium and abnormal calcium levels can also cause significant problems with this therapy. Other serious side effects can involve the brain, and include confusion, seizures, and swelling in the brain. This has required that the treatment be stopped in some patients.
McKenzie’s story is important because, for many years, Dr. Burzynski and the Burzynski Patient Group Web site have promoted supposed success stories of antineoplaston therapy for many different types of cancer, while ignoring the many stories of poor outcomes such as those told by Bob Blaskiewicz at The Other Burzynski Group Web site.
Well-designed clinical trials, rather than patient stories or inadequately controlled studies after decades of treatment failures, are needed to evaluate effectiveness of cancer treatments. According to the American Cancer Society:
Many of the clinical trials at the Burzynski clinic have included certain standard cancer treatments such as radiation and chemotherapy treatments along with antineoplastons. However, according to the FDA’s website, a 2013 clinic observation reported that some of the patients who were classified as being in either complete or partial remission didn’t meet all the requirements to be classified as in remission. This would cast doubt on some of the reported successes in treatment.
While many articles have been published and dozens of clinical trials against many types of cancer have been ongoing at Dr. Burzynski's clinic for several years, there have not been any results of randomized controlled trials—the type of study that is required to prove that a new anti-cancer drug works – published in peer-reviewed medical journals. These types of clinical trials are required if a drug is to be approved by the FDA. In October 2013, the FDA sent a warning letter (reproduced on the FDA website) to Dr. Burzynski about making promotional claims on his website about unproven therapies.
- Failure to ensure proper monitoring of the investigations and failure to ensure that investigations are conducted in accordance with the general investigational plan and protocols contained in the IND. [IND stands for Investigational New Drug application]
- Failure to obtain from an investigator sufficient financial information to allow the sponsor to submit complete and accurate certification or disclosure statements required….
So why has FDA now approved an open-label clinical trial for antineoplaston treatment of DIPG? Some in-depth investigative journalism is needed to follow the money and to uncover the role played by Burzynski’s powerful friends in elected offices. It would be good to start with quackophilic Representative Joe Barton (R-Texas), who intervened on Burzynski’s behalf in the fall of 1995 after a grand jury charged Burzynski with 75 counts of criminal contempt, mail fraud, and violations of the Food, Drug and Cosmetics Act. Instead of supporting prosecutors, FDA made a deal with Burzynski that kept him in business with the artifice of clinical trials.
Promoters of bogus treatments often argue that the FDA is in cahoots with pharmaceutical companies and that we should follow the money. Well according to the National Council Against Health Fraud:
The claim that Burzynski is a victim of the big drug companies is refuted by the fact that from 1988 to 1994 the BRI grossed $40 million from marketing his ‘Antineoplastons’ and Burzynski and his wife made $5 million personally. It is a curious thing that quackophiles, who are so fond of pointing to the money that is made by the medical establishment, never seem to notice the financial gains of the promoters of quackery.
Note this quote:
"Burzynski had said he agreed to donate the medicine required for McKenzie's treatment, but the family received a $28,000 bill during the first month that charged for clinical costs associated with the therapy. Every bill after that was expected to cost $16,000."
"...the treatment was administered for 20 hours a day for six to eight weeks. McKenzie wore a backpack that would carry around the bag of liquid antineoplastons."