When caring puts a child at risk

You may have seen petitions about children with cancer who have been deemed untreatable.

The petitions request compassionate use exemptions to an FDA hold on new patients undergoing antineoplaston therapy. One petition tells the devastatingly sad story of a 6 year old Jewish boy named Elisha Cohen.

The petitions sound reasonable, except it turns out that “there is no convincing evidence showing that antineoplastons actually work,” as the American Cancer Society concluded. In fact, due to numerous known side effects, there are many reasons to think that antineoplastons would be worse than no treatment at all.

Last year, the FDA introduced the antineoplaston hold after the death of Josia Cotto, another 6 year old. A November USA Today investigation revealed that the boy’s blood sodium was measured at deadly levels the day he died.

Sodium overdose (i.e. hypernatremia) is a documented frequent side effect of the antineoplastons that the Cotto family was so convinced would cure Josia.

There are few things more heartbreaking than a child being diagnosed with cancer. Surely a parent of such a child would do anything or pay any price to ensure a full recovery.

Shamefully, there are individuals in this world who sell sham medicines to vulnerable parents, consuming precious time and money with no or potentially deadly results.

Stanislaw Burzynski, founder of the Burzynski Clinic, has peddled antineoplastons as a cancer antidote for 36 years, but has never even submitted an application for FDA approval.

Burzynski and his supporters market remedies based on antineoplastons for diverse diseases, including Lupus, AIDS, Parkinson’s Disease, and many cancers. Burzynski often prescribes antineoplastons within suspect clinical trials his own lawyer deemed a “joke”, saying, “It was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment.”

The government has been alleging federal law violations as far back as 1978. Decades later, attempts by the Texas Medical Board and the federal government to stop Burzynski have been largely unsuccessful.

Last week, the USA Today reported on a scathing FDA letter, which expands upon the grave irregularities at the Burzynski clinic, including the discovery of apparently altered and incorrect patient records. Due to alleged misclassifications of tumor size over time, the records may give the false impression that antineoplastons have some cancer-retarding effects.

Moreover, noting multiple cases of overdosed patients, the FDA concluded that Burzynski “failed to protect the rights, safety, and welfare of subjects” under his care. Based on the letter, it seems unlikely that the “FDA is nearing approval to resume this treatment,” as the Cohen petition claims.

Burzynski stands to gain publicity from a 100% discount offered on Elisha’s treatment. Regardless of the costs, the evidence against Burzynski and antineoplastons is too abundant to ignore.

The Cohen family has been fortunate to have the aid of the Jewish community during their ordeal. Generous donors have helped out with everything from meals to raising over $109,000.

Out of ideas and convinced that antineoplastons might work, Elisha’s caring parents Rabbi Yaakov and Devorah Cohen are attempting to bypass the FDA’s restrictions.

In 1915, Clark Stanley was fined $20 under U.S. law for peddling an ineffectual concoction.

Burzynski’s advocates promote him as a maverick who is uncorrupted by money in spite of the millions he’s made from desperate families. A common tactic is to demonize their opposition, the FDA, pharmaceutical companies, life-saving chemotherapy, and the medical industry as a whole while minimizing the significant evidence that antineoplastons are toxic and don’t treat cancer.

They also cherry pick anecdotal stories by those claiming to have been helped by Burzynski but discount victims like Josia who were not so lucky. It’s easy to praise the quality of a fruit stand if the imperfect and rotten fruit is dead on the vine and never displayed.

As of last week, Elisha reportedly was taking 9 trial drugs at a total cost of about $9,000 per month. However, while it was allegedly routine for Burzynski to charge 6 figure “management” fees in connection with his trials, it is unusual and possibly unethical to charge volunteers for experimental medicines.

It is unknown if there might be irregularities in the different trials or in multiple experimental drugs being combined. When asked for comment, the Cohens’ fundraising coordinators declined to provide specifics.

More than 130,000 signatures, including Senator Kelly Ayotte’s, have endorsed the petitions for Elisha and McKenzie Lowe (a girl with a story similar to Elisha’s). Since politics can often override evidence in making governmental decisions, it is important to decline signing the petitions and to speak out against those who promote snake oil medicine.

Steve Jobs—someone many would consider a genius and who died of cancer— reportedly postponed surgery in favor of nonfunctional alternative medicines. His biographer attributed this to “magical thinking. It had worked for him in the past. He would regret it.”

This situation evokes a parable about a drunk who loses his keys while stumbling home. When asked why he was looking under a streetlamp down the road, he replied, “This is where the light is.”

The only thing more tragic than Elisha’s terrible illness would be if his well-meaning family and friends stood underneath the Burzynski streetlight, not only giving credibility to a dangerous and ineffective treatment, but wasting time and other resources that could be used more productively.