Gelfand On … Media - If you are a local television station and your fictional cop shows are more honest than your 11 O'Clock News, then you have a problem. Our local CBS station, KCBS Channel 2, has that problem. If it were a one time case, that would perhaps be excusable, but a pattern seems to be developing, and it's not pretty.
The problem involves Channel 2 buying into pseudoscientific medical nonsense. Quackery if you will.
The first case involves the fringe cult who oppose childhood vaccination. The second involves a cancer quack who continues to try to peddle a 35 year old nostrum that didn't make much sense when it was introduced, and has not aged well over the years. Let's take up the cancer quack this time around, and get to the other story at another time.
Stanislaw Burzynsky is sort of like an American Idol wannabe who can't sing a note, but thinks that he is Elvis and Sir Paul all wrapped up into one. In this case, we have a bona fide MD who has been stuck in the medieval era of cancer therapy for more than 35 years, but can't seem to figure it out.
Let's introduce the story that KCBS botched. It's the story of Liza Cozad Lauser, the wife of a local musician, the drummer for Sammy Hagar. She's in her 40s, and has come down with a particularly nasty kind of cancer.
It's referred to as Diffuse Intrinsic Pontine Glioma, or DIPG for short. It's a cancer that is characterized by the fact that the malignant cells grow among and around the cells of the brain stem in a way that precludes surgical treatment. The nerve pathways in that area conduct signals from the rest of the brain down into the spinal cord as well as controlling other functions such as eye and facial movements. This is different from some other kinds of brain tumors which are surgically attackable. In this case, some of the most critical nerve pathways get wrapped up in the tumor tissue.
There are a couple of issues with this kind of cancer. First of all, it's mostly a disease of children, and the mortality is horrific. There are a few children who survive it, for reasons as yet to be understood. Radiation is the treatment of choice, but it is at best life prolonging for most of the victims. Still, there are some survivors. Just not many.
There are experiments going on as we speak in which the most advanced thought is being applied to new kinds of treatments. Some involve specially constructed antibodies that go after a particular protein on the cell surface. There are clinical trials going on using the antibody treatment, and other trials using combinations of the latest anti-cancer chemotherapeutic drugs, or using high doses of radiation.
The problem for Liza Cozad Lauser is that she is beyond the age of eligibility for most of the clinical trials currently being offered, and she has been getting worse. That puts her in a kind of Catch 22 that I shall discuss below. It is not a happy discussion, and in this one case, I am going to find fault with the federal regulators and consider an alternative approach.
But first, we have to consider the approach Cozad and her partner have chosen, and the journalistic malpractice committed by KCBS in covering her struggle.
Cozad and her husband, in their need, were pointed to a clinic in Texas that has been using essentially the same unproven drug since 1977. To explain the Burzynski story and KCBS's culpability, I have to turn back the clock a few decades to explain where we have been, how much progress we have made, and why Dr. Burzynski hasn't really been involved in any of this progress.
At the outset of the 1970s, very little was known about cancer biology. That's because little was actually known about biology. In retrospect, it has been a remarkable 40 years in which the biochemical secrets of life have largely been revealed. Let's consider briefly.
As the 1970s opened, essentially nothing was known about genetics that hadn't been known for half a century. We knew that there was something called DNA that carried genetic information, but we didn't know the internal structure, that is to say, the order in which the subunits (the A, G, C, T code you have read about) are arranged.
The genetic control over the ways that cell growth is regulated were pretty much unknown. The ways that cells get out of whack and start multiplying without the usual controls were secrets yet to be revealed. It required the next revolution in genetics to open the way.
The revolution involved the ability to isolate and sequence the DNA in specific genes, and eventually to map and sequence the whole genome. It was a huge undertaking, but it led to a deeper understanding of how the cellular proteins control cell growth and division. And that led to a deeper understanding of all the different functions that can go wrong in the development of advanced cancers.
Since that time, we have identified the approximately 25,000 genes that make us tick, and are currently in the process of mapping out the thousands of small differences between one person and the next that will point to genetic defects that lead to cancer as well as other conditions. If you read about "next generation sequencing" or about "single nucleotide polymorphisms," those are some of the elements of current research.
But before all these advances, trying to cure cancer was at best empirical -- some things like radiation were found to be useful. Some chemicals turned out to help. There was a lot of luck involved. It was sort of like looking for that proverbial needle in a very big haystack.
Back in that 1970s era, it was not unheard of for researchers to look for a "magic bullet" that would cure cancer or make multiple sclerosis go away. After all, some folk remedies worked for things like fevers and congestive heart failure, so it seemed like it was worthwhile to look. The folk remedy willow bark had been translated into the miracle drug aspirin, and the chance discovery of the mold that makes penicillin created its own revolution in medicine.
In this atmosphere, Burzynski, a young researcher in Poland at the time, started looking at chemical differences between cancer patients and healthy people. Burzynski isolated a substance or substances that were less prevalent in the cancer patients than in the healthy people. He left Poland and got an academic position in Texas for a few years. He even got a grant to continue his research, but could not get it renewed. He continued to be interested in the substances he had identified.
So Burzynski set up his own clinic and has continued to practice medicine for all of the intervening years. In 1977, he started infusing his cancer patients with the substances he had isolated from human urine and blood. Since the medical term for cancer is neoplasia, he called his discovery antineoplaston, or ANP for short.
The underlying logic for the use of antineoplastons, if you want to call it logic, is that they might -- by the luck of the draw -- be substances which keep cells normal. In other words, if you are going to look for substances which circulate in the body and which are normally occurring anti-cancer agents, then maybe the ANPs are such compounds.
Of course this conjecture was just that -- a conjecture. The ANPs could just as well be the products of metabolism that just happen to be lower in cancer patients than in normal people. After all, people with advanced cancer have lots of differences, ranging from loss of weight to distinct biochemical changes. In short, if you want to argue that the ANPs might possibly inhibit the growth of cancer cells, the obligation is on you to demonstrate this activity.
In the intervening years, lots of chemical compounds have been discovered and developed which actually work to fight cancer. The process of developing and then testing an anti-cancer agent is laborious and expensive. After all, there are lots of substances that can kill cancer cells growing in petri dishes, but some of them do so only because they are toxic to all cells in general and marginally more toxic to some cancer cells.
Over the years, careful clinical testing found better and better ways to treat diseases that had once been almost universally fatal. Childhood leukemias are one example. Other diseases such as breast cancer show much improved survival rates. A lot of recent progress has come from combining understanding at the molecular level with drugs that are carefully designed to hit a particular target. The drug herceptin and the estrogen receptor blockers have become standards in breast cancer treatment, while androgen receptor blockers have been useful in treating advanced cases of prostate cancer.
Meanwhile, Stanislaw Burzynski kept right on marketing his 1977 miracle cure, seemingly without any attempt to expand on the original discovery or even to test it using the standard methods.
So here we are, having entered the decade of the 2010's, and the Burzynski Clinic has continued to market its treatment. Unfortunately for the patients, the drug is highly toxic to humans and probably doesn't do much against cancer. Still, due to the variable nature of cancer, there are a few people who underwent ANP therapy and continue to live. That's just the nature of cancer by the way -- even in severe kinds of cancer, there are a few spontaneous remissions.
For solid tumors, the process of surgical resection, even for difficult forms of brain tumors, occasionally seems to result in long term survival. So if you look at enough patients who have been operated on, irradiated, and subjected to chemotherapy, a few will survive for a long time even though they have had one of the more dangerous forms of cancer. If some of them later elect to receive the ANP therapy, whatever rare survivors there are will believe that this treatment is what saved their lives. At least, this appears to be the case for some of the survivors.
Burzynski never really tested his ANP mixture in the way that careful scientists expect. That's not because he wasn't afforded a chance. The government actually allowed him to register and carry out clinical trials (what are called Phase II trials) of his treatment. There are lots of Phase II clinical trials going on all over the country at any one time on all manner of illnesses. In general, a Phase II clinical trial is a chance to give the experimental drug or treatment to patients and see whether it is, at the very least, safe, and whether it seems to be helping the patients. Clinicians who carry out these trials are regulated by the federal government because patients have to be protected against unreasonably dangerous or painful experimental treatments.
Researchers who carry out these trials are expected to report accurately and in a timely manner as to whether there are untoward side effects. They are also expected to submit their results to peer reviewed scientific publications, so that medical science can advance.
It's a curious thing. Burzynski had as many as 60 Phase II clinical trials registered with the federal regulators at one time, and never published a complete report of even one of them. If you are averagely skeptical, you might conclude that Burzynski's antineoplastons don't really work. They are not really antineoplastic.
What we do know is that Burzynski charged huge amounts of money to provide treatment. This is, in and of itself, a red flag. It is the normal practice that clinical trials are not billed to the patient. If you are a cancer patient who agrees to enroll in a clinical trial, you will probably get billed for your regular treatment, but the additional experimental drug you receive comes without charge. This is standard in the drug industry. In case you were wondering, the costs for the additional treatment may come from a drug company (which wants its experimental drug tested and, they hope, validated) and some of the costs may come from grant funding.
Stanislaw Burzynski apparently took a different tack from the very beginning. He offered his ANP treatment, which he owned, and he charged patients a lot of money.
He also marketed his approach to cancer patients. This is kind of a harsh way of describing it, but over the years, Burzynski managed to create an image of himself -- at least among some people -- as the brave rebel whose innovative approach was being suppressed by orthodox medicine.
It's the sort of argument that appeals to conspiracy buffs of all types, and is laughed off by serious researchers who endure the frustrations of repeated failures in the hopes of finding success a few times around.
Burzynski was so far off the legitimate track that he was eventually investigated, ordered to cease from peddling his therapy, and finally indicted. That's where the complexities of cancer, cancer survival, and human beliefs came in.
As I mentioned above, even in extremely serious cancers such as melanoma (which only recently is being successfully attacked at the molecular level), there were always a few survivors. Doctors called it spontaneous remission, and left it at that, pending deeper understanding of the disease mechanism.
Since Burzynski was offering an experimental treatment to people who thought he was their last refuge, and since a few of them survived, Burzynski has accumulated a collection of patients and their families who have supported his right to continue providing ANP and who have supported the rights of patients to receive this treatment. They provide testimonials and attest to their belief that Burzynski's treatment saved their lives.
Burzynski had a support group and apparently a very good lawyer. He managed to get a hung jury on one of his criminal trials, and was acquitted in another. The government figured out that they couldn't touch him at the criminal level, and what with Burzynski's ability to get patients and their families to go to bat for him, he got some political support as well. Not all elected officials are trained in science. Burzynski managed to cut a deal in which he was allowed to offer his antineoplaston therapy as long as he went through the motions of calling it a clinical trial.
Recently, the FDA has come back to the Burzynski story because of a patient's death. A six year old boy died, and the cause was most likely due to the side effects of infusing ANP into him at high levels. This resulted in an extreme overload of sodium in the boy's blood, in this case a lethal level.
The FDA looked carefully at Burzynski's operation, and in view of their findings, closed down his ability to enroll any new patients, child or adult, in antineoplaston therapy. The FDA found that the "clinical trials" that Burzynski was ostensibly running in order to justify antineoplaston usage were anything but that. The latest round of investigations suggests that Burzynski has not been straight with the scientific world or with federal regulators regarding what he has been doing. It's not just an administrative issue. To put it bluntly, the way Burzynski has been doing business without adequate evaluation of patients, and with the wholesale destruction of patient records, suggests that the antineoplaston story is phony and that the so-called clinical trials have been a sham.
So now we come to Liza Cozad Lauser, her inoperable tumor, and the fact that she has few, if any, alternatives remaining. It's not surprising that she and her husband would have become aware of the Burzynski Clinic and the promise of therapy. The internet is full of alternative medicine supporters, conspiracy mongering, and general nonsense.
When they investigated further, Cozad and her partner discovered, much to their chagrin, that the federal government has forbidden Burzynski to enroll any more patients in clinical trials. The effect on seriously ill people of closing off hope, even that which is obtainable from quackery, is itself a pretty strong dose of harsh medicine. Cozad has joined a couple of other brain cancer patients in asking for an exemption. Cozad and her husband made a video asking people to sign an online internet petition, requesting that the government allow Cozad to get the treatment she desires. You can see it here.
The major problem with the video is that it presents a lot of propaganda that has obviously been obtained from the Burzinski Clinic and its supporters. The most unbelievable assertion is that ANP treatment will give Cozad a 27% chance of a good outcome. This is, to put it as gently as possible, a lot of nonsense. To the best of our knowledge, there is no way of knowing that ANP has any effectiveness at all when it comes to this kind of cancer. Burzynski certainly has not completed a published study. That number goes contrary to everything we actually know about this drug and its ugly history of misuse.
One experienced cancer surgeon, Dr David Gorski, has been following the Burzynski story for several years. He has analyzed the history of government inaction and has done the definitive critique of the nonsense that is antineoplaston therapy. You can read one of his articles here. Gorski (using the name Orac for his blog name) points out just how ridiculous the 27% success rate assertion actually is.
Earlier, Saul Green, writing in Quackwatch.com, analyzed Burzynski's record and the scientific record, and concluded that antineoplastons are not effective anti-cancer drugs. Green was particularly careful to explain that other institutions had tried antineoplastons and failed to find anti-cancer effects. One pharmaceutical company and two public institutions tried.
More recently, USA Today did its own expose' on Burzynski, in a story titled Doctor Accused of Selling False Hope to Families.
Readers can also look up the work of Peter Bowditch, who blogs at The Millenium Project. Bowditch has been debunking the Burzynski claims for many years.
Put it all together, and you have the saga of a once promising researcher who failed to grow as a scientist, a quack nostrum that was being sold to desperate patients and their families, and a government regulatory apparatus rendered impotent in the face of public pressure and political infighting.
Now to KCBS
The other night, your local CBS news station ran a story on Cozad's attempt to get an exemption so that she can get ANP treatment. The story showed the husband arguing emotionally that Liza should at least be allowed this 27% chance. There was no trace of an attempt by CBS, not so much as a hint, that this number and the promise behind it were totally imaginary. The news story treated the request as unrefuted and legitimate.
Here is one really remarkable line spoken by KCBS newscaster Andrea Fujii: "Now, studies have shown ANP to have a twenty-seven percent success rate. The FDA did not return my request for comment tonight."
To be blunt, this is craziness. It is bad enough when the truly desperate, hoping against hope, buy into quackery. But when a major American news organization fails to check a wild assertion, that is journalistic malpractice. Why didn't some producer point out that if this drug were the miracle cure that its supporters claim, then UCLA, USC, Cedars Sinai, and the City of Hope would have tested it and put it to use in treating patients.
By the way, the local KCBS news producer did not return my phone call.
You have to be either a desperate patient or family, or else be a believer in vast conspiracies, to fall for this kind of thing. It's all part and parcel of the cultish belief among a small percentage of our population that some wonderful cancer cure is being kept a secret from us. The conspiracy is blamed on the FDA, or the pharmaceutical companies, or the greed of doctors. Aliens from another galaxy could be part of the mix for all I know. And now this group is joined by one more, the lazy producers and editors of a local news outlet.
What I do know, and as I have written in previous stories here, is that most scientists are pretty honest, that a lot of medical research is openly and honestly reported, and that lots of new things fail to pass the testing phase. This is as true for new cancer therapies as it is for other drugs. But when something does work, it is put to good use, which is why a large number of childhood cancers that used to be fatal are now highly treatable.
There are two more issues that I feel a need to cover.
In news coverage of anxious sufferers trying to raise money to pay for treatment at the Burzynski Clinic or, more recently, trying to sway the FDA to change its mind, one word keeps coming up. The petitioners keep referring to Burzynski's so-called antineoplastons as an "experimental drug." There is an underlying, implicit suggestion here. It is that there actually is something new and possible in the use of Burzynski's ANP cocktail. That implicit assumption is the biggest nonsense of all. It's not an experimental drug at all. It's just a drug that was tried, and which failed. How could there be anything more to experiment about in this, the 37th year since it was introduced?
Finally, we come back to Liza Cozad and her predicament. Absent some kind of therapy, she will probably die fairly quickly. With radiation, she will get some extra months. As her husband points out, she has nothing to lose by trying an experimental treatment. That being the case, I think that the medical profession and the government should bend over backwards to allow Cozad and other people in a similar predicament a chance to try experimental drugs and procedures.
Just not antineoplaston, because it most likely doesn't help. But the FDA could invite researchers doing serious clinical trials to admit otherwise ineligible patients into their treatment programs, or perhaps just to allow them to be treated outside of the formal studies.
The FDA could offer a list of treatments that stand some chance of being useful. In Cozad's case, perhaps she can receive some of the new drugs now being tested on childhood cancers, or the monoclonal antibody treatment.
The FDA should rightly omit Burzynski's ineffective snake oil from its list of compassionate usages, but there ought to be a list. Getting insurance companies to cover compassionate use exceptions to experimental treatments could be a topic for the next round of improvements to the Affordable Care Act.
Alternatively, the federal government could create a special fund to cover such treatments.
(Bob Gelfand writes on culture and politics for City Watch. He can be reached at [email protected])
-cw
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