Ineffective alternative medicine is not always harmless

Here's something I wish there was more of, the criminal prosecution of quacks when their quackery results in the death of a patient:

A man who called himself a naturopathic doctor is scheduled to stand trial for the death of one of his patients starting Tuesday in Jefferson County District Court in Golden, Colo.

Brian O'Connell, 37, was charged with manslaughter after he unsuccessfully treated Sean Flanagan, a 19-year-old who suffered from Ewing's sarcoma, a form of cancer.

Sean Flanagan's father, David, 43, said he was desperate when he and his wife Laura, 42, brought their son to O'Connell's Mountain Area Naturopathic Associates office in Wheat Ridge in December 2003. They had tried chemotherapy, radiation therapy, bone marrow transplants and surgery.

David Flanagan said he put his last hope in O'Connell's services, which typically included herbal medicine, nutrition and physiotherapy.

As is often the case, we see a desperate family running out of options being promised by an alternative practitioner that he could succeed where "conventional" medicine could not:

"He assured us that he would be able to save our son," David Flanagan said.

Of course he did. False hope is what quacks like O'Connell sell, whether they realize it or not (and most probably don't realize it because they believe in their own therapies). In this case, he pushed UV blood irradiation (UBI), in which blood is removed from the patient, treated with UV light, and then reinfused back into the patient. The claim is that this treatment somehow "boosts the immune system." This is a claim that is utterly without basis in science. Just thinking about it should suggest to you why it would be unlikely to "boost immune function." UV light is a DNA-crosslinker, making it a mutagen. Normally it doesn't have access to your blood, because your skin stops it. All that's being accomplished by UV-irradiating blood is to induce DNA crosslinking in the lymphocytes and monocytes in the blood, as well as potentially degrading some of the proteins in the cells and plasma. Depending on how much UV radiation is used, that could be harmful or indifferent, but it's unlikely to be beneficial.

Nonetheless, the very biologic implausibility of UBI as a treatment doesn't stop a lot of woo-filled altie posturing about this technique being posted all over the Web:

Unfortunately with the advent of the Salk vaccine, which wiped out polio in the US along with the proliferation of antibiotics in this country, the use of the Ultraviolet Blood Irradiation, technique fell into disfavor. Recently, the resurgence of the use of UBI seems to be the results of educational efforts by The Foundation for Blood Irradiation.

("Unfortunately" the Salk vaccine wiped out the polio virus, leading UBI to fall into disfavor? The polio vaccine was one of the greatest public health triumphs in the history of medicine and these quacks dismiss it as "unfortunate" because it led their favored dubious treatment to fall out of favor. Incredible!)

Ultraviolet Blood Irradiation (UBI), sometimes referred to as Photolumin-escence or Hematologic Oxidative Therapy, is a process where a volume (250 cc) of blood from a patient is withdrawn and exposed directly to ultraviolet light at about 250-260 nanometers. This same volume of blood is then injected into the patient. It is known that this technique kills most organisms that might be present in the patient’s blood. It is also felt that UBI, it in some way, alters the patient’s immune fighting cells to raise the resistance of the host. This results in the patient’s control over many disease processes.

Ultraviolet blood irradiation “energizes” the biochemical and physiological defenses of the body by the introduction of ozone from the oxygen circulating the in the bloodstream. The efficacy of this phenomenon is attested to by the remarkable and consistent recovery of patients with a wide variety of diseases. It is a known method to rapidly detoxify the effects of many toxic substances. Some have referred to UBI as a mini-dialysis treatment in that only a very small amount (about 5 percent) of the blood is actually processed during a treatment.

Hoo boy. It is "felt"? What about evidence, rather than "feelings"? UBI "energizes" the biochemical and physiologic defenses of the body? Where have we heard that one before? Perhaps it's because just about every altie therapy claims somehow to "boost" or "energize" the immune system. UBI generates ozone? Haven't I already pointed out once that ozone therapy is useless for autism? Well, it's useless for cancer, too. Also, it's deceptive to claim that it "kills all the organisms" in the patient's blood, given that only 250 ml (only 5% of the total blood volume) is irradiated. What about the remaining 95% of the blood volume? In any case, although using UVA and a psoralen has been reported as a potential means of decreasing bacterial and viral contamination in banked blood, such methods are undergoing regulatory review because it is not known if they are safe or if they cause problems with the banked blood. There is no evidence that UV light "boosts" or "energizes" the immune system.

So what happened? This:

On Dec. 10, O'Connell administered ultraviolet blood irradiation, in which he removed blood from Flanagan's system, passed it under ultraviolet light and injected it back into his body, according to an arrest affidavit.

The treatment was supposed to stimulate the immune system by increasing oxygen in the blood. However, Sean Flanagan was admitted to a hospital two days later.

"He had an infection to the bronchial line, which he never had," David Flanagan said.

The UV light treatment was then administered at home, which caused his oxygen saturation levels to drop from a normal range down to 17% in the next couple days, David Flanagan said.

"O'Connell was scared," he said. "He didn't know what to do."

On Dec. 18, O'Connell allegedly treated Sean Flanagan by injecting his blood with hydrogen peroxide.

"Please God, no more," Sean Flanagan said before dying the next day, according to his father.

Flanagan's cause of death was listed as probable complications from the hydrogen peroxide treatment.

David Flanagan is certain that O'Connell hastened his son's death.

"His medical doctor, who was treating him for an entire year, said he had months to live. Within two weeks after seeing O'Connell, he was dead," David Flanagan said.

I'm not sure what a "bronchial line" is, but I guessed that it is a misprint or a mistake by the reporter and is in fact referring to a permanent implantable intravenous line of some kind, such as a Portacath or a Broviac catheter (used for long-term delivery of chemotherapy). It appears that this line became infected through O'Connell's nonexistent sterile technique. Indeed, I found out more here, where the actual legal complaint from the parents previous wrongful death suit can be read:

4. Sean Flanagan had been diagnosed with Metastatic Ewings Sarcoma in December of 2002 and medical treatment had included, among other things, amputation, chemotherapy, radiation therapy. and bone marrow transplants. By December, 2003, Sean Flanagan, who was at that time eighteen (18) years of age, had exhausted all medical cures, he was terminal with only months to live, and he was weakened, ill and heavily medicated.

5. On or about December 10, 2003, the plaintiffs, David and Laura Flanagan, took their son Scan to see the defendant Brian E. P. B. O'Connell in the hopes that naturopathic treatments could possibly benefit Sean.

6. The defendant Brian E. P. B. O'Connell recommended a number of claimed treatments which included various vitamins, teas and other materials as well as the withdrawal of blood from Sean's body using syringes and tubing and exposing the blood to photo luminescence or ultra-violet (UV) light before returning the blood to the body, together with infusion of hydrogen peroxide into Sean's blood stream.

7. On December 10, 2003, the Flanagans paid to the defendant Brian E.P.B O'Connell $7,400.00 for a series of these claimed treatments.

8. On December 10, 2003, the defendant Brian E.P.B O'Connell performed the UV light procedure and repeatedly withdrew blood from Sean's body with syringes via a Broviac Port in his right chest. ran the blood through tubing, past an ultra-violet light tube, and re-infused it into the body with an infusion of hydrogen peroxide.

9. The defendant Brian E.P.B. O'Connell failed to utilize the most basic sterile techniques in this procedure despite knowing that Sean was already significantly immunocompromised due to his cancer treatments. .

10. On December 12,2003, Sean Flanagan was admitted to The Children's Hospital with a blood infection known as Klebsiella Bacteremia or Septicemia which developed into pneumonia and he remained hospitalized until December 15, 2003, at which time he was discharged home on five (5) liters of oxygen, with an oxygen monitoring device known as a pulse oximeter. .

11. The blood infection was caused by the unsterile UV light procedures with Sean's blood performed by the defendant Brain E.P.B. O'Connell on December 10, 2003.

12. On December 16, 2003, the defendant Brain E.P.B O'Connell came to the Flanagans' residence and brought with him equipment and supplies so that the family could do the UV light procedures with hydrogen peroxide infusions at home. On this visit, and only after insistence by the Flanagans, a sterile technique was utilized during the procedures. However, when the procedures were performed, the pulse oximeter showed oxygen saturation levels dropping from a normal in the over 90% range to levels in the 60% range, which slowly then returned to normal.

13. Per the directions of the defendant Brian E.P.B. O'Connell, the Flanagan's performed the UV light and hydrogen peroxide procedures on their own on December 17 and, once again, the oxygen saturation levels dropped. this time into the 40% range, before slowly rising. Concerned, the Flanagan's contacted the defendant Brian E.P.B. O'Connell who assured them that he would find a "fix" for the problem.

14. On December 18,2003, the defendant Brian E.P.B. O'Connell returned to the Flanagan's family home to perform a similar procedure but included a more rapid infusion of hydrogen peroxide with the UV light procedure. -:.

15. As the procedure was completed, Sean's oxygen saturation level dropped to 16, his skin turned gray, and he collapsed after begging "Please God, no more".

16. Sean never recovered and died the next day, December 19, 2003.

17. Sean Flanagan's death was caused by the procedures performed by the defendant Brian E.P.B. O'Connell.

It's hard not to have one's heart go out to Sean and his surviving family. They suffered a devastating loss, and it sounds as though O'Connell's ministrations resulted in considerable additional and unnecessary suffering. Nonetheless, as sympathetic as I am for a grieving family and as much as I might understand how desperate for any hope they must have been, my first question, after having found this, was what the heck was wrong with the parents? I can see their giving O'Connell one chance to see if he could help. Unbelievably, though, they gave him another chance, even after he had demonstrated himself to be careless and incapable of meeting even the most minimal of medical standards, namely doing something as basic and obvious as maintaining meticulous sterile technique when accessing the young man's Broviac catheter. The result was sepsis requiring hospitalization complicated by pneumonia. And yet, even after this, the parents nonetheless let this quack into their house to administer the treatment again, even though they had to insist to him that he use sterile technique? Then, after Sean's oxygen saturation dropped to dangerously low levels immediately after the procedure, they let O'Connell talk them into doing themselves again the very next day, at which time Sean's oxygen saturation dropped to levels that were even more dangerously low.

I just don't understand.

But that's not all. After three incidents demonstrating that using UBI on Sean was not a good idea and that O'Connell was a dangerous quack, what did they do? They let O'Connell one final time to do the same thing, but this time with even more hydrogen peroxide. This led Sean's oxygen saturation to drop to levels incompatible with life, leading him to cry out, "Please God, no more!"

It led to his death a day later.

Why on earth did the parents trust this man enough to take his advice four times, even after he had made it abundantly clear after the first treatment that he had no idea what he was doing? Well, for one thing, O'Connell had claimed that he personally had "cured" many cancer patients, including patients with metastatic Ewings sarcoma and shown the patient's family a plastic baggy with a "tumor" that he had claimed to have removed from one of his patients, a "black salve" that, according to him, would "draw out" the tumor, and slides of Sean's blood, in which he claimed to point out "toxins" and "impurities."

The parents' desperation and gullibility aside, O'Connell clearly belongs in jail for some form of negligent homicide.

More disturbing to me, however, is this passage from the original story:

O'Connell's case has spurred a heated debate over Colorado's current non-licensing of naturopaths. The Colorado Association of Naturopathic Physicians has lobbied for licensure to ensure patients' safety.

"We are just matching what is commonplace in North America for [traditional] medical professionals and what the other licensing states do for naturopathic physicians, which is four years of pre-med, four years in an accredited graduate naturopathic program and passing an exam," said naturopath Rena Bloom, the association's president.

"Brian O'Connell is a fake," she said.

However, the Colorado Naturopathic Medical Association, where O'Connell was an elected vice president, maintained that such criteria were unnecessary.

"In naturopathy, you have a tradition where you come out of an allopathic world. To say you need to go back into a traditional school is redundant," said naturopath Steve Colton, the organization's president.

Medical doctors have opposed licensure out of fear of naturopathic results.

Actually, licensing naturopaths brings up a rather interesting question. In medicine, there are all sorts of objective markers and clinical data to support the efficacy of various treatments. There is all sorts of basic science that doctors have to learn to understand the basis of their treatments. All of this can be tested. The tests are admittedly imperfect, but there is objective evidence on which to test students and residents. When it comes to naturopathic medicine, on what basis would such tests be written? What data would serve as the basis? Who would decide what standards? How would those standards be measured? The Naturopathic Medical Association, the way that the various specialty Boards in medicine have a large responsibility for certifying physicians as competent in their specialties? Remember, a quack like O'Connell was one of its Vice Presidents. Who would decide what would be within the purview of their specialty? For example, why was a "naturopath" accessing a Broviac catheter when he either didn't know or was indifferent to the most basic sterile technique? Why was using a machine to irradiate someone's blood within his purview? That hardly sounds "naturopathic" to me.

Finally, I can't speak for anyone but me, but, contrary to the credulous tone of the discussion of this story, I don't "fear" naturopathic results. Rather, I fear what such unfounded "therapies" can do to desperate patients. Before licensing the practitioners of such dubious techniques, I would just like some hard data from basic science experiments and clinical trials supporting those supposed naturopathic results and the claims of naturopaths to treat various diseases. As I've said many times before, I'd be more than happy to appropriate the use of herbal medicines for use in my practice--if someone can show me hard data that they are both safe and effective. (It also wouldn't hurt if they were either effective with fewer side effects than present medications available or if they were cheaper than present medications.) In the case of Sean Flanagan, they were neither. I've often heard the defense of treatments like UBI that go along the lines of "the patient is dying, so what has he got to lose trying something like UBI?"

You can see what Sean had to lose.

ADDENDUM: A more detailed report is here. Not surprisingly, O'Connell is claiming the mantle of persecuted martyr:

O'Connell has declined interviews.

However, in a letter soliciting defense funds from members of his group, O'Connell characterized the case as a challenge to the right to practice naturopathy.

"We are being used to set a precedent that naturopaths are dangerous and it is my feeling that the MDs are trying to use my case to shut down naturopathy in Colorado altogether," he wrote.