How many deaths is the U.S. Food and Drug Administration directly responsible for every year?
This question may strike you as facetious. After all, it’s the FDA’s mission to protect and advance public health. The regulatory and enforcement powers granted to the FDA in the 1938 Federal Food, Drug and Cosmetic Act were a result of over one hundred deaths caused by an untested drug called Elixir Sulfanilamide. Since then the FDA has been generally perceived as a crucial component of our federal government. Some would say that the FDA serves as an American sentinel of health, helping to ensure the people will indeed live so that they may pursue liberty and happiness.
The Oscar-winning film Dallas Buyer’s Club has cast the FDA in a different light. The movie is based on the true story of Ron Woodroff, a hard-drinking, drug-using, Texas bull-rider/electrician in the midst of the 1980s AIDs epidemic. After discovering he is HIV positive, Woodroff is denied access to an experimental pharmaceutical drug called AZT. Woodroff finds a safe and effective alternative in Mexico, and the rest of the film features the tough cowboy protagonist facing-off with an aggressive FDA that is relentless in its efforts to stop Woodroff from supplying the mixture to other dying AIDs patients. In this movie, the FDA is portrayed as more preoccupied with protecting pharmaceutical profits than public health. Even more shocking is the FDAs complete lack of genuine concern, compassion, or understanding in its treatment of patients faced with certain death and little alternatives.
In the FDA’s defense, Woodroff is hardly qualified to be administering untested medicine to terminally ill patients. The FDA’s pursuit of Woodroff might be justified as an attempt to fulfill its role in protecting “vulnerable” patients from a snake-oil peddling fraud. With Woodroff’s background, profit-motive and no medical licensing whatsoever, it seems that the FDA was actually behaving appropriately. Woodroff’s mixture would need to undergo the FDA’s standardized process, under the supervision of medical professionals, in order to ensure that it is truly beneficial and safe. Qualified individuals or groups that test drugs in adherence to the FDA’s system would be approved once the safety and efficacy of a drug is demonstrated. Fair enough. However for drugs that are not being fast tracked by expensive “user fees”, the approval process can take as long as 15 years even when safety and efficacy can be proven early on. In the meantime, hundreds of thousands of terminally ill individuals are being denied access to lifesaving treatment.
Now it could be argued that as a Federal bureaucratic institution, the FDA is not alone in its long, costly and imperfect process. However, the FDA may be unique in its actual conduct and behavior. Similar to its aggressive pursuit of Woodroff, the FDA has long been battling another Texas resident, Dr. Stanislaw Burzynski. Unlike Woodroff, Dr. Burzynski is highly qualified, graduating at the top of his class from the Medical Academy in Lublin with both an M.D. and PhD in biochemistry. In the late 1960s, Dr. Burzynski discovered that cancer patients tended to have fewer proteins called antineoplastons (ANP) in their blood and urine. For the last 40 years, Dr. Burzynski has been successfully and safely treating terminally ill cancer patients of all ages with ANP therapy, after they have already exhausted traditional cancer-treating surgeries, chemotherapies and radiation. However, the FDA has not approved ANP therapy nor does it support the research in seeing if the therapy is a viable option. Instead, the FDA has taken up a policy of harassment, repeatedly threatening to take away Dr. Burzynski’s medical license and going so far as to raid his office. Numerous criminal cases have been brought against Dr. Burzynski by the FDA, however not one has proven any danger or fraudulence on Dr. Burzynksi’s part. In fact, Dr. Burzynski was eventually allowed to enter clinical studies in which he was able to demonstrate ANPs safety and efficacy, but the FDA suspended these trials supposedly due to minor infractions of protocol. Trials have once again been allowed to resume (for now), but only those at the latest stages of the most severe cancer are admitted. Other terminally ill cancer patients interested in ANP therapy are being denied an opportunity to live by the FDA for reasons having nothing to do with safety or efficacy.
Ultimately, the terminally ill are being condemned to death in the name of FDA power politics.
Take for example Liza Cozad-Lauser who was diagnosed in April 2013 with an extremely rare form of aggressive, inoperable brain cancer known as DIPG. Doctors told Liza and her husband David Lauser that there was no cure, and that even with chemotherapy and radiation Liza would only have 6 to 18 months to live. The doctors made sure to tell Liza and David “if anybody says there is [a cure] they’re lying,” and in the off chance that Liza’s symptoms improved: “it’s a spontaneous remission, a misdiagnosis, or a miracle.” Still wanting to avoid the debilitating side effects of chemo and radiation, Liza and David began seeking less harmful and perhaps more effective “unapproved” alternatives, such as hyperbaric oxygen and vitamin C therapy, before trying to gain access to the blocked ANP therapy.
Liza and David’s experience with the FDA began while undergoing hyperbaric oxygen therapy in Southern California. Their doctor explained that the only way he was to able conduct ozone therapy for cancer was if he maintained that it was for “alleviation”, not “treatment”. The FDA had at one time received word that this doctor was “curing” and promptly sent a SWAT team to raid his office and confiscate his files, just as they had done with Dr. Burzynski. Since the FDA is not required to obtain any kind of search warrant, they can order raids without supervision and override all other possible jurisdictions. This is dangerous because under the guise of regulating food and drugs, the FDA can act like a police force to intimidate doctors into compliance, and unlike any other governmental institution remains unchecked. Any doctor found not to be in accordance with FDA canon is subject to harassment, raids, or even imprisonment. Most doctors are bullied into silence, with one doctor even telling David, “Burzynski cures, but I wouldn’t admit that publicly.” Dr. Burzynski himself advised Liza and David about the FDA, telling them not to “ruffle their feathers.”
Nonetheless, in August of 2013 David contacted the FDA hoping Liza would be granted “compassionate use” access to ANP therapy. David was put in contact with the FDA’s Health Programs Coordinator Deborah Miller who was quick to say “that she would never send anyone to Burzynski.” David made the case that Liza’s disease was incurable, there was nothing to lose, and ANPs had passed the first two phases of clinical trials successfully demonstrating safety and efficacy. Despite these results, Miller rejected Dr. Burzynski’s treatments on the grounds that there was “No proof.”
When considering the documented clinical trials and numerous actual testimonies of Dr. Burzynski patients, one might begin to wonder how Miller and the FDA actually define “proof?” A six-year old child named Noah Stout who, like Liza, has been fighting DIPG, is undergoing ANP treatment with Dr. Burzynski and has outlived his prognosis by almost three years. Like many other terminal cancer patients seeking access to ANP therapy, Liza and David considered these kinds of results as more than enough “proof.” After contacting Miller, Liza and David continued to call and email the FDA for nearly 6 weeks without a single response.
While the FDA continued to actively ignore Liza, her symptoms grew worse. Liza’s story was brought to the media and soon got the attention of politicians such as Senator Diane Feinstein, who sent a letter to Margaret Hamburg, the Commissioner of the FDA. David was also able to rally the support of multiple rock bands such as Sammy Hagar, Van Halen, Night Ranger, and Deep Purple in petitioning Hamburg. Eventually, even the head of the California Department of Health, Dr. Ron Chapman, sent his own letter to Hamburg expressing his support for Liza and urging the FDA to grant her clinical access. This letter from Dr. Chapman was enough to at least prompt a conference call from the FDA, however no progress was made towards getting Liza the treatment she needed.
Featured articles in the Washington Examiner and USA Today may have been what finally brought Deborah Miller to finally call David back and say that the FDA would in fact allow Liza to access to ANP therapy. The catch however was that Liza would not be able to undergo the therapy under Dr. Burzynski, who is the only doctor in the United States administering the treatment. This stipulation amounts to nothing more than a dirty trick on the part of the FDA, meant to “get the heat off” from the public at the expense of a dying woman’s last hope at life. Eventually, the FDA ran out of tricks. Exactly one year after she had been diagnosed, Liza was informed that she had finally been granted her request for treatment with Dr. Burzynski.
The FDA didn’t go down without a fight. It took the combined efforts of Liza, her husband David, a legion of supporters, doctors, politicians, the media and even rock-stars to pressure the FDA into granting this woman her chance to live. Without the enormous attention and support Liza was able to generate, it’s doubtful the FDA would have ever allowed her treatment. Even so, Liza seems to be the exception to the rule. There are still many other terminally ill patients who will never get the treatment they seek.
The FDA’s conduct in its treatment of doctors and terminally ill patients such as Liza reinforces the way it has been depicted in the Dallas Buyers Club. What is shown is a bureaucratic Federal agency that neither answers to the American public, nor cares about them. Unlike any other branch of the government, the FDA is not elected, regulated, or supervised by any other individual or entity. The FDA is an American institution that defies the principles laid out in our Constitution; its unbridled powers have allowed it to essentially operate as a police institution, except, as one doctor admitted to David “we have more power over a bad cop than we do the FDA.” The FDA is unchecked in its misuse of power, it is allowed to intimidate doctors into silence or misinformation, and it arbitrarily interferes in a person’s choice between life and death, distinguishing it from other powerful federal enforcement agencies such as the FBI or NSA. As Liza’s experience demonstrates, the FDA does more than regulate or supervise, it unilaterally dictates in service of its own interests, and often what its demands imply is certain death. The FDA must, like every other American institution, be held accountable to the American public, either directly through elections, or indirectly through other government entities. Its callous, deceitful and shameful treatment of terminally ill patients such as Liza must be cross-examined; American citizens must be allowed the chance at life. The FDA’s rejection of life as a personal choice is an act that serves as an obstruction to the American promises of liberty and the pursuit of happiness. The FDA itself must be tested and regulated for safety and efficacy in order to protect the American public from its truly cruel, unusual and simply un-American practices.
Liza Cozad-Lauser passed away on January 4, 2015.