FDA Sends Harsh Warning Letter to Houston Cancer Doctor
December 12th, 2013 // 2:53 pm @ jmpickett
FDA this week sent a tough warning letter to a doctor in Houston named Stanislaw Burzynski. He has been hailed as a hero by some of his fans, but has been derided as a snake oil salesman by many regular doctors. He long has been claiming that he has the ability in treating cancers that are hard to treat, such as brain stem tumors that normally are fatal. But the National Cancer Institute states that the doctor never published any strong evidence that his drugs save lives. For example, Burzynski has never published a randomized and controlled trial in a peer reviewed publication.
In the FDA warning letter, FDA stated that the doctor has been boosting the success rates for his experimental drug regimen, which he refers to as antineoplastons. FDA also has said that Burzynski is not reporting side effects.
FDA recently put his clinical trial on hold after there was a death of a young boy last year. FDA also has done months of inspections of his research.
But FDA asked to see the boy’s files, the doctor sent FDA records that were not the same as the ones in his office. It gave the impression that the files had been altered in some way.
The warning letter notes that failing to keep accurate patient records raises suspicions about whether the the drugs are safe and that the data is accurate, and also there are concerns about how adequate his safeguards are at his site to protect cancer patients.
If Burzynski will not address the FDA concerns, they are going to terminate his clinical trial, and could disqualify him from doing FDA research in the future.
FDA has found 9 cases where Burzynski misclassified his cancer patients, saying that they had benefited from his drugs. He claimed that their tumors shrank or disappeared. But in reality, FDA stated that the patients did not respond as he claimed, or they were taking some anti inflammatory drugs that may have given the impression that the tumors were shrinking. Burzynski stated taht one patient had a partial response to the drug treatment, which means that the patient’s tumors got 50% smaller. But in reality the tumor got larger.
Burzynski has argued that patients who have brain tumors may need anti inflammatory drugs, known as corticosteroids to bring back normal levels in the body. But FDA rejected this, saying that the doctor had patients who were on high doses of steroids that were far beyond what most doctors would recommend.
