Over at my not-so-super secret other blog, one common type of story that I’ve blogged about has been that of the “chemotherapy refusenik.” It’s a topic I write about here not infrequently as well. People like Suzanne Somers and Chris Wark come to mind, mostly people who had effective surgical therapy for their cancers and then decided to forego adjuvant chemotherapy in favor of quackery. Not surprisingly, they attribute their having beaten cancer not to the surgery that saved them but to the woo du jour that they chose instead of chemotherapy, not understanding that such chemotherapy is not the cure; it only reduces the risk of recurrence after surgical extirpation of the tumor. What I haven’t discussed as much here as I have over there are cases of children with cancer whose parents refuse effective chemotherapy to treat their malignancy (other than Daniel Hauser). Because most childhood cancers are not treated with surgery, chemotherapy ± radiation therapy really is the primary therapeutic modality for most of them; so refusing it has a very high probability of resulting in the unnecessary death of a child. Generally pediatric cancers have an 80-90% five year survival, and recurrences after five years are rare, which, as I described recently, is an enormous improvement over 40 years ago.
Sadly, there have been many such cases, such as the aforementioned Daniel Hauser, Abraham Cherrix, Kate Wernecke, and Jacob Stieler. All of these are stories of children who were diagnosed with highly curable cancers who refused either chemotherapy or radiation therapy and were supported in that decision by their parents. Indeed, of these, Cherrix, Hauser, and Wernecke ran away with their parents to avoid chemotherapy. They all came back, but with different results. Hauser came back, started chemotherapy again, and is doing well. Cherrix ultimately came back, but the court made a deal with his parents that let him be treated by an “integrative medicine” doctors who treated him with low dose radiation and a bogus “immunotherapy.” As a result, several years later his tumor recurred, and he was last seen earlier this year asking for money for treatment. His battle in the courts in Virginia also inspired the passage of a supremely bad law that basically allows open season on teens for quackery. Wernecke disappeared when her parents refused radiation therapy after having undergone chemotherapy and took her for intravenous high dose vitamin C. In 2007, her cancer recurred, but the recurrence appeared to have been treated successfully. It’s not clear how much conventional therapy she had received, at least as of 2010, which was the last time I could find anything about her online.
The latest of these cases that has come to my attention is the case of a 10-year-old Amish girl from Medina County in Ohio named Sarah Hershberger, who developed T-cell lymphoblastic lymphoma, an aggressive form of lymphoma, underwent chemotherapy for a few weeks, and then decided she didn’t want it anymore. Her parents, convinced that the chemotherapy was killing her, instead of insisting that she undergo potentially curative therapy, which her doctors estimated to have an 85% chance of eliminating her cancer, refused to let undergo any further therapy. This led to a court case in which Akron Children’s Hospital (ACH) sued to obtain medical guardianship of the girl in order to make sure that she would undergo curative chemotherapy. The first ruling in the case in a Medina County court was for the parents. Then on appeal the 9th District Ohio Court of Appeals ordered Medina County Judge John Lohn to take another look at the case, ruling that he had failed to weigh adequately which course would best serve her interests — the decision of her parents to withhold treatment (at her request) or to appoint a limited guardian to make medical decisions, as proposed by Akron Children’s Hospital. Amazingly, Judge Lohn reiterated his previous ruling, finding that appointment of a guardian would interfere “with Sarah’s need and desire to be cared for by her loving parents” and stating that “the guardianship will not promote Sarah’s interests.” One month ago, Judge Lohn’s decision was reversed on appeal to the 9th District Ohio Court of Appeals, which caused everyone’s favorite quackery supporter to lose his mind in rage.
Since then the case has only gotten stranger, as hard as it is to believe. Indeed, it’s hard to know exactly what is going on, although discussing the case allows me to discuss a both the science and ethics of treating children with cancer using science-based modalities.
Whose rights matter here, anyway?
One of the most disturbing things about this case is the reaction of so many people to it. The predominant reaction was outrage that the hospital and state would attempt usurp parental rights, combined with undue credulity that “natural therapies” could cure patients. Indeed, on the hospital’s Facebook page, there are still people ranting about it, with posts like this:
You should all be ashamed of yourselves. You want people to vote on something in November? I can tell you that I won’t be voting for anything for your hospital. Was it worth it? Putting this family through all of this? Was it WORTH IT? You’ve ruined your public image. You’ve ruined the confidence of parents trusting you and bringing their children to your doctors and hospital. I can tell you that I am not the only person who feels this way about your hospital now. People are scared to death to bring their children to you now. People talk and they don’t trust your hospital any more.
Even today, a month after the ruling, ACH’s Facebook page is still deluged with posts by people claiming all sorts of evil intent on the part of the hospital, much of it based on two articles, one from a week ago, one from just the other day. The first is entitled Amish Girl Being Forced into Experimental Chemotherapy Taken Out of US and Recovers with Natural Treatment. The second is an interview with Isaac Keim, Sarah Hershberger’s grandfather, that appeared on the Chris Beat Cancer website over the weekend. (Yes, it’s that Chris.)
If this article is to be believed (and, as you will see below, it’s hard to know whether to believe it or not), sadly, but not entirely unexpectedly, the Hershbergers have apparently taken their daughter out of the country to avoid chemotherapy. The longer they do that, the more likely it is that their daughter will die a horrible death, and it will be her father Andy Hershberger’s fault. I realize that he has nothing but the best intentions and believes he is doing the best thing for his daughter, but he is wrong, so very wrong. If his decision is not reversed, his daughter will almost certainly pay a very unpleasant price. The author of the piece, David Michael, writes for a website called the Journal of Natural Food and Health. He’s also very obviously antivaccine and pro-quackery. Let’s take a look at what he claims:
Early in October 2013, the entire nation heard about how Sarah Hershberger, a 10-year old Ohio Amish girl with leukemia (now recovered), is being forced into a two-year unproven experimental chemotherapy study by Akron Children’s Hospital (ACH). It was just learned the parents, Andy and Anna Hershberger, took their significantly recovered daughter out of the United States before the court ruled that a hospital-affiliated, attorney-nurse, Maria Schimer, was made the medical guardian to make sure Sarah will get her treatments. Parents reported this week the child is fully recovered through natural treatments. Schimer is General Counsel (chief legal advisor) for Northeast Ohio Medical University (NEOMED), a close affiliate and business partner of the hospital. According to Andy, Ms. Schimer has never met Sarah or him and his wife and they were never told their child was being used in a research study—among other things.
Although they do not know it yet, the hospital now has a big problem they must deal with. Sarah is completely recovered, as of October 23, according to Andy. The hospital told them and the news media that Sarah would die in a few months without the treatment they recommend. Three doctors that have treated her with a natural, biochemical protocol using nutrition, supplements and plant extracts have declared Sarah cancer free based on cat scans and blood tests—confirmed three times.
Well, this is mighty convenient. Now that court has ruled that Sarah Hershberger has to undergo conventional treatment, suddenly the father claims that Sarah is cancer-free, thanks to the unnamed “nutritional therapies” to which he has subjected her. The three doctors who allegedly treated her with “natural therapies” are not identified, and no evidence that Sarah Hershberger is, in fact, cancer-free is presented. All of this puts the hospital at a profound disadvantage, because it can’t comment on Sarah Hershberger’s condition because of patient confidentiality laws. In contrast, Andy Hershberger can say whatever he wants and doesn’t have to produce any actual evidence. I’d love to know the names of the three doctors to see what sorts of treatments they recommend for cancer and what sorts of tests they order to determine if someone is “cancer-free.”
None of this should be construed to mean that I think Mr. Hershberger is lying. He is almost certainly telling the truth as he sees it, but he also clearly grossly misunderstands cancer treatments, specifically why pediatric oncologists do what they do. Unfortunately, quack apologists are taking advantage of Mr. Hershberger’s ignorance about cancer, an ignorance shared by most people. Most likely what happened is that the chemotherapy shrank Sarah’s tumors to the point where they are no longer detectable on CT scans. This is a common initial outcome after early rounds of chemotherapy. The problem with lymphoma is that, although it is fairly easy to put lymphoma into an apparent complete remission, making that remission permanent is difficult.
Unfortunately, it takes a lot more than just a round or two of chemotherapy, a lesson painfully learned by pioneering pediatric oncologists back in the 1960s and 1970s. For example, for the type of tumor that Sarah has, lymphoblastic lymphoma, the duration of one standard treatment is two years. For chemotherapy for lymphoma, there are at least three phases. The induction phase is designed to put the patient into remission. Consolidation chemotherapy is given to patients who have gone into remission and is designed to kill off any residual cancer cells that might be present, thus increasing the chance of complete cure. Maintenance chemotherapy is the ongoing, longer term use of chemotherapy to lower the risk of recurrence after a cancer has gone into remission. It’s basically lower-dose chemotherapy given for two to three years to help keep the cancer from returning. In Sarah Hershberger’s specific case, her oncologist, Dr. Prasad Bodas, testified that her chemotherapy would have five phases: induction (5 weeks), consolidation (seven weeks), interim maintenance (eight weeks), delayed intensification (six weeks), and maintenance (90 weeks), for a total duration of two years, three months.
At this point, it is quite possible that Sarah has no detectable cancer. If that’s the case, it’s the chemotherapy that she’s received thus far that almost certainly caused that result, not the herbs and vitamins her father has been giving her. If she is apparently tumor-free, it also means that failing to consolidation and maintenance chemotherapy greatly increases the chance that Sarah Hershberger’s lymphoma will relapse, a chance that is probably a near certainty if she only received her induction chemotherapy. Worse, relapsed cancer is always harder to treat. The first shot at treating cancer is always the best shot, with the best odds of eradicating the cancer. Letting cancer relapse through incomplete treatment breeds resistant tumor cells the same way that not finishing a complete course of antibiotics contributes to the development of resistant bacteria. It’s evolution in action.
The next part of Mr. Michael’s analysis is even more unbelievable:
The Hershberger family says they never were told the chemotherapy was part of a research project using experimental chemicals. They also said the hospital did not get their signature for the second phase of different chemicals and only Sarah was asked to “put her name on the line.” They claim they were not told of the serious side effects. They said Sarah’s confidential medical information was given to the news media violating federal privacy laws. After a significant improvement in killing the cancer, they saw that the chemo was starting to kill Sarah and decided to stop the treatment and employ a better option to stop the cancer altogether. This is when the hospital took legal action to keep Sarah in the treatment study.
One thing that you need to understand about pediatric cancer is that a very high percentage of patients with pediatric cancers are enrolled in clinical trials, well over 50%. Compare this to the 5% or so of adults with cancer who participate in clinical trials. This is a very good thing indeed for children and one of the reasons why survival rates for pediatric cancers have improved so much over the last four decades. So it would not be the least bit surprising if ACH had enrolled Sarah Hershberger in a clinical trial. In fact, I’d be disappointed in the hospital if its doctors didn’t at least offer her parents participation in a clinical trial.
The other thing you need to know is that clinical trials run by facilities that receive any federal funding or grants (as Akron Children’s Hospital surely does) are overseen by the Office of Human Research Protections (OHRP) Department of Health and Human Services, and children are considered a vulnerable population for which extra protections are mandated. I find it highly unlikely that Akron Children’s Hospital didn’t get the appropriate informed consent. However, I never completely dismiss the possibility that I could be wrong. So here’s what I propose. If Andy Hershberger really thinks that Akron Children’s Hospital failed to obtain proper informed consent for a clinical trial, then he has only to report it to the OHRP. If the drug in the study is a new drug, then he could report the issue to the FDA as well. In fact, I would very much urge him to do so if he thinks that he was not offered adequate informed consent for a clinical trial.
Next up, Michael accuses the hospital of being all about the money:
ACH will lose as much as $1,000,000 or more by not treating Sarah the full 110 weeks in this study and, according to our sources close to the case, has already billed $130,000 for the first five weeks. Add to this the various pediatric cancer research grants and other funds it is receiving directly or indirectly for this type of study. This is not counting the billings for treatments for the long-term side effects such as other cancers, kidney dysfunction, heart problems and nerve damage—all common for those that survive chemotherapy.
This is, of course, a misrepresentation of how clinical trials work. In clinical trials, the funding agency pays for all clinical trial-related treatments and tests that are not standard-of-care. The rest are billed regularly. Moreover, for the most part, hospitals do not make money off of clinical trials. The infrastructure to run them is hideously expensive, and funding agencies often don’t quite cover the full cost, particularly in these days of the sequester, which has hit NIH-funded clinical trials hard.
Ironically, Michael asks a question that should make all of people ranting about how greedy and evil Akron Children’s Hospital supposedly is wonder. Namely, “Why is the hospital going to all the time and expense, even with the risk of tarnishing their reputation, all to make sure their advice is taken as opposed to other available treatments widely known in Europe as well as clinics in the U.S.?” I’ve been asking the same question myself. It would have been so much easier for ACH to do nothing, to shrug its collective shoulder and let the Hershbergers do whatever they wanted with Sarah. It would have been far easier, far less trouble, and far less expensive. By any stretch of the imagination, it would have been the easy way out. But ACH didn’t take the easy way out. While conspiracy theorists might fantasize that this is because there is some amazing prize that makes all the bad publicity and harassment by the “health freedom” crowd worthwhile, the more likely conclusion is that ACH was willing to go through all this hassle because to make sure that Sarah Hershberger is treated according to science-based medicine.
I should also point out at this point that I have as yet been unable to find any corroborating evidence that the Hershberger family has, in fact, actually fled the country. Make no mistake, I searched a whole bunch of mainstream news sites, including the local news site for the Akron Beacon-Journal, and I found no stories of the Hershbergers fleeing the country last week, only reprints of the original story claiming that she fled and reports of a fundraiser to let her come back into the country. My guess is that she and her family are probably still in Medina County, but who knows?
In which we learn what likely caused the Hershbergers to reject chemotherapy
Over the weekend, as I alluded to above, I learned that Isaac Keim, Sarah Hershberger’s grandfather, gave an interview to Chris Wark of Chris Beat Cancer fame. (To reiterate, Chris did beat cancer, but it was the surgery, not his quackery, that cured him.) In any case, here is the telephone interview:
As you will see, the interview with Isaac Keim is enlightening in that he and Chris Wark inadvertently confirm that what I’ve written thus far is very likely spot on accurate in describing what probably happened.
We learn from Mr. Keim that the family first noticed something wrong when they found a lump on Sarah’s neck. So they took her to the doctor, and she ended up being referred to ACH. Ultimately she was diagnosed with a T-cell lymphoblastic lymphoma, and a workup revealed tumor in her neck, kidneys, and “in her body,” whatever Mr. Keim means by that, which seems to be elsewhere in her abdomen and chest. The Hershbergers were told that this is an aggressive tumor, but treatable with an 85% five year survival achievable with a 27 month course of chemotherapy consisting of five phases. All of this is consistent with what’s been reported and what I’ve just discussed.
Mr. Keim relates next that Sarah underwent the first phase of chemotherapy, which lasted 4-5 weeks and resulted in the lump on her neck nearly disappearing within a week. She also tolerated this first phase very well. It was at this point that the Hershbergers started to wonder why more chemotherapy was needed, given how good her response had been. Here’s where the story gets dicey. According to Mr. Keim, the doctors wanted to start the second phase but didn’t have the parents’ permission. Yet, according to him they just went ahead with the chemotherapy anyway. Clearly, there had to have been a breakdown in communication here, because, having worked in multiple hospitals over the years, I know that, if there’s one thing that major academic center hospitals are very, very compulsive about, particularly pediatric academic medical centers, it’s getting informed consent for almost everything, particularly now. Indeed, most such hospitals take it to an extreme, getting formal informed consent for tiny procedures like a punch biopsy of the skin. It stretches belief that ACH would subject a girl to further chemotherapy involving what sounded like intrathecal chemotherapy (chemotherapy injected by lumbar puncture into the central nervous system), requiring general anesthesia to administer and have a visiting nurse come out to administer chemotherapy at home, without having had the parents’ permission. At the very least, no anesthesiologist would put a child to sleep without the parents first signing permission, and no interventional radiologist would put a catheter into the spinal canal without permission. If it is really true that the hospital did all this without their consent, the parents would have a hell of a lawsuit that they could file, and I would urge them to file it.
In any case, from Mr. Keim’s account, it sounds as though the second phase was what caused Sarah to become really ill. He described her as feeling so weak that she wouldn’t get out of bed for a week and wouldn’t eat. At some point a nurse came to give the first of three weekly injections. She apparently was going to leave the remaining two injections at the Hershberger’s house and instructed them to keep them on ice. I found this to be rather odd, not the least of which because this was Amish territory and there was likely no refrigeration. True, the Hershbergers probably have an ice box, but if it’s so critical to keep a drug refrigerated, I doubt that a hospital would leave it in an Amish household where there might or might not be adequate ice to keep it cold enough long enough.
Whatever the case, if Mr. Keim’s account is accurate, that nurse then did something that arguably set the whole family off. She told the family to keep the syringes away from any children, which is certainly reasonable advice given that these were undoubtedly powerful chemotherapeutic agents, although I would wonder why the nurse would leave the drugs in a household where syringes of powerful chemotherapeutics would likely be placed next to food sitting in the icebox where children might be able to get at them. That wasn’t what set the family off, though. What set the family off was when the nurse also told the family that the chemotherapy in the syringes could cause cancer.
That’s when all hell broke loose. That’s when the Hershbergers decided to stop the chemotherapy.
At this point, Mr. Keim said that the Hershbergers were never told that cancer was a risk from chemotherapy, leading to an exchange with Mr. Wark castigating cancer doctors for not telling patients everything where Mr. Wark claims that most cancer patients aren’t told that chemotherapy can cause cancer. Again, this claim stretches credulity beyond the breaking point. If you’ve ever read the consent forms for chemotherapy regimens, you know that it’s right there in black and white, a statement that the chemotherapy can increase the risk of cancer years down the road. For childhood cancers, the risks are clearly listed as Dr. Bodas testified: infertility, an increased risk of cardiovascular disease, damage to various organs, an increased risk of contracting other cancers, and a “small but appreciable risk” of dying from the treatment itself. Yes, these are significant risks, but lymphoblastic lymphoma will kill without treatment; so these risks are not unreasonable weighed against the rewards. I’d be willing to bet that those risks are listed on the informed consent that the Hershbergers signed when induction therapy was begun, and I’d be doubly willing to bet that the oncologists who discussed chemotherapy with the parents mentioned those standard risks.
At this point, the Hershbergers went to ACH and brought Mr. Keim along to tell the doctors that they had decided to quit chemotherapy and go for “natural” healing. Sarah didn’t want any more, and they were convinced that the chemotherapy was killing her. To say that the session was contentious would be an understatement. The hospital must have been expecting trouble, because apparently within an hour it was able to mobilize a lawyer, “PR people,” doctors, and nurses. One thing that disturbed me to learn was that the hospital first referred the case to Medina County Job and Family Services in June, but that MCJFS refused to file neglect and dependency charges against the Hershbergers. This is confirmed in the second ruling that went in favor of the Hershbergers. All I can say here is that MCJFS completely dropped the ball here, and I agree with the doctor’s characterization of this decision as “child abuse.”
Much of the rest of the interview consists of attacks on ACH and Maria Schimer, the general counsel for the Northeast Ohio Medical University (NEOMED), the medical school with which ACH is affiliated and the person petitioning the court to be Sarah Hershberger’s medical guardian; conspiracy mongering, and unverifiable claims. For example, Wark and Keim claim that Schimer’s only qualification to be Sarah’s medical guardian is that she had been appointed guardian to people who had been on life support for over a year but had no guardians, all so that the hospital could “pull the plug,” characterizing her as a “witch” standing their ready to “pull the plug” by getting Sarah back on chemotherapy. Yes, they not-so-subtly implied that Ms. Schimer wants to kill Sarah. This is pure slander, as a reading of the actual opinion of the Ohio Appeals Court, Ninth Appellate District reveals. Yes, she was appointed ward of the court for people on life support in the 1990s, but she has also served as ward for “several medically compromised, developmentally disabled adolescents, who were unable to speak for themselves and had no family members to speak for them.”
The conspiracy mongering was of the standard variety, in which it was claimed that ACH was paid a million dollars by a medical company to win this case, echoing the accusations of David Michael’s article. The claim was bookended by Mr. Keim saying, “I have no proof of this but I have been told by several people” and then, “I don’t know this to be true, but I’ve heard that.” One wonders who those “several people” were, one does. One also wonders why Mr. Keim would repeat something that he himself does not know to be true. Could it be to poison the well? There’s no “could” about it. At the very least, it allowed our friend Mr. Wark to go off on a rant about tyranny and how “they” (whoever “they” are) don’t want parents to make decisions for their children and how “they” don’t want people to have “options” and “they” want to force therapy. No such rant would be complete without that old alt-med cancer trope that “it’s not about a cure, it’s about healing” and how “only the body can heal cancer.”
The unverifiable or very difficult to verify claims fly fast and furious, as well Mr. Keim claims that Sarah was taken to “one of the top cancer centers in the U.S.,” but doesn’t mention what that cancer center was. He claims that all her tests there show that she is free of cancer. He claims that county sheriffs have been out to the house but that they don’t want anything to do with this case unless they’re forced. (I actually believe that one; police generally don’t like the idea of taking children away from their parents.) He claims that a doctor in Cleveland took over her care but doesn’t know who that doctor is. One notes that Mr. Keim’s claims conflict with claims made earlier that Sarah Hershberger is being treated by three doctors and that she was on “experimental” chemotherapy in a clinical trial without her parents having been given informed consent.
Finally, Mr. Keim laments that he contacted several television stations to try to give the family’s side of the story but that they wouldn’t do it unless the Hershbergers appeared on camera, which they would not do because they are Amish. This, too, is hard to believe. No, it’s not hard to believe that television news producers wouldn’t present the family’s side of the story if the Hershbergers wouldn’t appear on camera. What’s hard to believe, given that this story has made international news, is that a newspaper wouldn’t eagerly interview the family if approached or that a radio station wouldn’t eagerly have the Hershbergers phone in, as Chris Wark had Isaac Keim phone in. No, what the Hershbergers likely wanted was an outlet sympathetic to their point of view that wouldn’t challenge them, and Isaac Keim got it in Chris Wark.
Here’s the final irony. At about 29:00 in the interview, Mr. Wark basically admits that my interpretation of events described above could well be correct. In other words, he admits that chemotherapy could well be what rendered Sarah Hershberger cancer-free, if cancer-free she is at the moment:
I do want to be fair about this. Leukemias and lymphomas and testicular cancers respond better to chemotherapy than most cancers do, and it is entirely possible that those few treatments she did got rid of her cancer…Even if that’s the case, if that is what got rid of her cancer—now typically chemotherapy only gets rid of it for a short time; it’s only a temporary solution; it doesn’t address the root cause of disease—the point is freedom. It’s about the freedom of choice, the freedom that a parent has to make decisions for their child, medical or otherwise…It’s a bigger fight about a parent’s right to choose what’s best for their child, what medical treatment is best for their child versus whether or not chemo is going to help her. And that decision belongs to the parents and belongs to Sarah.
This is what I’ve been saying all along, that to people like Chris Wark, parental rights trump all else. It doesn’t matter if the child is only 10 and thus too immature to make such a monumental decision. The life of the child apparently doesn’t matter to Wark, at least not in comparison to parental “rights” to choose quackery. He’s perfectly willing to sacrifice Sarah Hershberger on the altar of “health freedom” to the point that he’s willing to help raise money for the Hershbergers to fight for the right to let their daughter die using a Pledgie and a GoFundMe campaign.
In the meantime, Isaac Keim also revealed that the Hershbergers have been subpoenaed to appear in court on November 6. We’ll see what happens.