Your article on the FTC/Koren Publications battle needs to be clarified on two counts: 1) why Koren Publications was attacked and 2) the legal precedent this action almost certainly portends.
What have I done? I let the public know that there is some fascinating research: preliminary studies, pilot studies, outcome studies and other research published in peer-review and non-peer-review chiropractic, medical and osteopathic journals on chiropractic, spinal care and physical/emotional health. The chiropractic profession alone has over a hundred years of clinical studies. The FTC says we should not give this information to the public. Most DCs assuredly feel the public has a right to know.
The FTC says the public cannot be told about this body of knowledge, even if it is truthfully described and qualified with disclaimers. That is a big part of this fight. It is for freedom of expression. Assuming this FTC ruling is set, if patients ask you if chiropractic can help their headaches or sciatica or their child's ear infection, tonsillitis, or pneumonia, you cannot say, "Come in (bring in your child), there are clinical observations, preliminary or other studies and observations suggesting that subluxation correction may make a difference. I've seen it in my own practice. Either way, you'll be better off subluxation-free than subluxated." The FTC's position is that we can only tell patients that chiropractic can help low-back pain and nothing else.
We can't even tell patients to come in for care if they have other problems. Why? Because the only studies they consider "scientific" are controlled clinical studies. That is their standard. Thus, a big part of this fight is about standards. If we accept the FTC's position that chiropractic effectiveness can be judged solely by controlled clinical trials, then it's true that chiropractic is only effective for (certain types of) low-back pain -- not headaches, sciatica, wellness, or health improvement -- and we cannot tell the public anything otherwise. None of our subluxation research fulfills that standard; nor does our technical research.
Incidentally, 85% of modern medicine is not supported by controlled, clinical trials. Is chiropractic being held to a higher standard than medicine? It certainly appears so. Much of our knowledge of chiropractic's effectiveness is based on clinical observation and other studies (as is most of medicine), not controlled clinical trials.
The ICA has stated (rightfully) that it is concerned about this issue. My attorney tells me that we have a chance to persuade the FTC that sound standards can and should be developed for review of my case. I agreed to a first consent order with the FTC because it had a limited scope. My attorney tells me that the new consent order is much more far-reaching and creates very difficult requirements for substantiation which, if put into effect, will not only be the national standard of the FTC, but are also very likely to become the standard of the little FTC laws that govern in each state. It is important that we band together to insure that the standards the FTC adopts are broad, clear and enforceable enough to be effective in helping consumers get nonmisleading information about chiropractic without being a burden on free speech.
So, what have I really done? I write great reader-friendly brochures with references that repeat what chiropractors have been saying for over a hundred years: subluxation correction can improve one's health and well-being. I do not write that the studies I cite "prove" that chiropractic is a treatment for any condition. Nor do I say the studies prove anything, only that they underline what chiropractors have observed.
(Incidentally, of the 84 brochures published by Koren Publications, containing over 400 references, the FTC didn't like a few of them. The Pero study sponsored by Renaissance International was one. Pero is an internationally respected researcher and I accurately quoted him from a pre-publication interview. His statement that chiropractic care increases the immune competency 200-400% was also published in a major journal. Other references the FTC didn't like dealt with chiropractic care for children and vaccination. One reference was miscited, and when informed of this, I quickly corrected the mistake.)
The FTC has stated that they don't want the public to get the wrong impression that chiropractic was a cure for certain conditions or that various studies "proved" such a thing. I said, "Fine, I do not want to mislead anyone. I'll work with you to rewrite the brochures." After months of discussion, all the brochures now published were rewritten to make the chiropractic message even clearer and the FTC happy.
So why are there any problems? The FTC said my brochures were now OK. We signed an agreement that a senior FTC attorney had written. That should have been the end of it. Then something weird happened. It was rejected! My attorney, as an FTC specialist, had never seen it before. It was very suspicious. I was led down a primrose lane that devastated my finances, and I don't think this was by accident.
The Real Danger
Now we move on to the larger legal ramifications of this case. When I first sent DC a copy of the FTC complaint, I was concerned that the extent of the issues might not initially be clear to DC, as they were not initially clear to me. Let me clarify this:
After we contracted a Washington legal firm, I was hit in the face with the cold reality by one of my attorneys: "Tedd, a major federal regulatory agency does not spend over four years and hundreds of thousands of dollars to make one chiropractor revise a few brochures. When the FDA wanted to make vitamins only available by prescription only they didn't go after every vitamin company in America, just one. When the IRS wishes to change tax law, they just need a precedent: one taxpayer."
As my attorney Charles Brown writes: "Based on my own experience as a former state attorney general and FTC staff lawyer, I have observed that virtually every major case brought by a government agency has a 'send them all a message' aspect. Indeed, a significant reason government agencies justify the commitment of substantial resources for a particular case is that it indeed will affect the entire industry or profession of which the defendant is a part.
"Such thinking permeates the FDA, the FTC, IRS, SEC, state attorneys general, and almost every agency that brings regulatory cases. They hold to a belief in good faith that one case can be the 'silver bullet' that hits everyone. The message is, this is intended for everyone: 'You are now on notice that this is our new enforcement policy, and the policy applies to you.'"
This case has serious ramifications to all chiropractors. Koren Publications is just the first on their list. Many already realize this, and I'd like to thank the ICA and the many doctors supporting this fight. Among them: Dr. Bob Braile, ICA president; Drs. Kent and Gentempo of the Chiropractic Leadership Alliance; the International Chiropractic Pediatric Association; Drs. Larry Markson, Dennis Perman, Donny Epstein, Scott Walker, David Singer, Arno Burnier, Joel Margolies and Eric Plasker; and many others too numerous to mention now. The ACA appears to have a "wait and see" attitude. However, in a letter (carbon-copied to the FTC), the ACA claimed that chiropractic is not limited to low-back pain and expressed concern that their position has been "distorted" by the FTC in this case. I hope to see them come on board.
Astoundingly, and of great concern, at a May 21st meeting the FTC stated that they could regulate speech (such as lay lectures and even one-on-one talk) between a chiropractor and patient if they wished to. At the same meeting the FTC claimed that based on their experts, chiropractic claims should be limited to lower back pain.
Who initiated this attack? The FTC refuses to tell us. Who are their "chiropractic experts?" The FTC refuses to tell us.
I cannot emphasize this enough: I offered to revise my brochures to conform to their standards many times. Ultimately, they said I (and by bureaucratic precedent, everyone else in chiropractic) could only say that chiropractic could help low-back pain.
It became obvious that the profession had to be told of this attack. Many have been appreciative of my taking this burden on and fighting on my own for so long with no help from the profession. I am grateful for the strong support and encouragement of my family. I could have walked away and returned to full-time practice, but it didn't feel right. I have always fought for what I believe.
According to one of my advisors, "The FTC is testing us. If we stand together, they will think twice before attacking us again. If we do not join forces, they will pick us off one by one."
Thomas Jefferson said, "The price of liberty is eternal vigilance." We must be on our guard against a government that has grown too large, too intrusive, and over-regulates our lives.
These are serious times for our profession. DCs are working very hard just to make a living and feed their families. If these regulations are enforced, those DCs will be most seriously hurt in their ability to tell the chiropractic story, to educate, and to attract new patients. DCs, schools and suppliers will be under the constant threat of FTC action. The consequences are if you publish the wrong newspaper ad, even write your own literature that the FTC doesn't like and refuse to stop, your fine could be $10,000 per day, per advertisement or per brochure. We need every DC to donate from $10 to $40 per week. The cost will be much higher (in many ways) if we are gagged and muzzled by the FTC for the rest of our professional careers. To donate, please call 800-510-0151 or fax your credit card number to 202-265-6564 saying how much you can contribute per month. Hopefully this legal battle will last only a few months, but it could be a few years. You can always stop your automatic credit card deductions at any time, but please, start helping.
Donny Epstein, DC, said it well: "We are all on the Titanic; the iceberg is near. Tedd's stateroom is going to be hit first. But we are all in danger."
I expect that all of us, except for those who refuse to see this issue, will eventually understand what serious danger we are in now and support this fight. Those staterooms fore and aft may not be in immediate danger, but they are not safe. Those that are attacked after me may not have the ability, resources, energy or desire to fight. We need donations to prevent this legal precedent limiting our ability to tell the chiropractic story from becoming FTC regulation. We ignore this fight at our peril.
My wife and family appreciate any reader's interest, and I believe your family will, too. For more ongoing developments please call me at 215-699-7906 or e-mail me at tkoren1-aol.com.
Tedd Koren, DC
"Deceit Is a Practice that Destroys Credibility"
Since the 1980s, I have kept my counsel, offering an opinion only when asked. On reading the September 21st article regarding Tedd Koren, I shook my head in confirmation of the inevitable. What can the profession expect? Members of a profession claiming to be a science must observe the scientific and ethical standards of that profession. Members who violate professed scientific and ethical standards in any significant profession are either separated from their profession or are penalized.
Deceit is a practice that destroys credibility and often the character, not only of the guilty, but of his and her professional colleagues. The article in DC strongly suggests that the information published by Dr. Koren was meant to deceive the public into believing he was publishing widely accepted scientific reports. I know, as most readers of DC know, that the practice of exaggerating claims that favor chiropractic have been frequently forgiven "because the claimant was only trying to let people know how good chiropractic really is." It seems to me that when the evidence does not support the claim, there is no justification whatsoever for making the claim, regardless of good intentions.
It is becoming clearer with time that chiropractic's survival is not going to be primarily based on the strategies of the past; that is, reliance on strong public support and testimonials. Congressional committees will most likely be charged with determining what evidence supports the claims of chiropractors and their demands to be included in a variety of health care plans. Consider a scenario in which a congressional committee calls for the evidence of claimed chiropractic results in a variety of disorders that chiropractors maintain they relieve or cure. The committee members make it clear they are unable to allocate funds or to provide access to health care plans until they are satisfied with the results of credible research. What if Dr. Koren's claims were presented to the hypothesized congressional committee as evidence?
You can write your own scenario of that calamity with your own conclusions. At this point, we can only speculate, but consider further. What if Dr. Koren recruits a number of chiropractors to support him, what could they possibly say, except to make matters worse? Perhaps it might result in irreparable damage, or it might awaken many more to seek the only honest solution, which clearly must be properly designed and conducted research to justify any published claim. Without critical research, the profession's only recourse is to seek solace in becoming a full-blown cult. If any chiropractic association believes chiropractic should be considered a science-oriented profession, that association believes chiropractic should make it clear they do not support Dr. Koren's position in any way. In my opinion, he made a serious mistake.
Dr. Koren most likely believes he is doing the right thing, but he is wrong, dead wrong. I wonder what he would say if he found an MD knowingly publishing varnished truths. What if the AMA did the same? What is wrong in demanding that the chiropractic profession live up to the standards of science-based health care? We are all aware that every proponent of an untested remedy or "cure" claims the product or system "works." Some of the more sophisticated Palmer faculty used to say among themselves, "You could line up 100 men and women with a disorder and hit them with a shovel, and some would recover."
The chiropractic profession cannot afford to support in any fashion anyone of us who deceives the public by dishonest claims. It does not happen very often, but fraud by respected scientists does occur. Two come to mind: the "cold fusion" fraud, and the study by Jacques Beneveniste, a French homeopathic researcher whose work was published in the British journal Nature. He claimed that an antibody solution diluted to 30X, far beyond the dilution limit, continued to evoke a reliable immunological response in cells. The report was received with frank skepticism by the scientific community because at a dilution of 30X, there would be no more antibody molecules in that solution.1
In the 1940s, I was approached by a couple with an infant suffering from Down's syndrome. I was enthusiastic about treating the child because I had just read in an Educator Bulletin (a PSC publication) a testimonial by parents who claimed that their child with Down's syndrome had recovered under chiropractic care. She had learned to read and to play the piano.
The local child was treated by me for months without any significant change. I always wince when I recall that episode. It was not until a few years later when I was exposed to a broader view that I learned not all Down's syndrome children are retarded. Their IQs range between 30-80, some lower and a few higher.
It appears most of our chiropractic colleges are trying hard to teach science-based chiropractic. It is very difficult because our reliable and pertinent studies are limited. It's not very likely that any major study will come from the practicing field for a number of obvious and good reasons. Schools are limited to what they can do to promote research. Research is expensive, but if the will of a dedicated group is strong enough, it is likely those means will be made available.
I do not regret writing with indignation. I do regret the reason for it. One last word to the profession. If the morality of such acts of deception does not bother you, the economic impact eventually will.
1. Park RL. Alternative medicine and the laws of physics. Skeptical Inquirer Sept/Oct 1997; vol. 21, no. 5, pp. 24-28.
W. Heath Quigley, MS, DC
"It's Time to Stand Together"
Today, I will be making my first donation to help Dr. Tedd Koren fight the FTC. It took awhile to make this decision. Below are the reasons why I chose to help Dr. Koren.
I do not honestly know if what Dr. Koren is saying is true: that the government is looking to do us in. It may be that Dr. Koren has gotten to the end of his rope and is just trying to hang on any way he can. I have come to the conclusion that even this just doesn't matter.
If the FTC is just starting with Koren Publications and has plans to go after all of us, then of course we need to donate to the cause. But what if they are just after Tedd? Well, I still believe that he should get our help. Tedd Koren is a leader in our profession. He loves chiropractic as much as you and I. His brochures have helped all of us turn countless people onto chiropractic. He is not malicious, and I believe that he always had our best interests at heart. He is a friend to each and every DC. If your partner or fellow chiropractor got in trouble for writing a brochure or giving a lecture, wouldn't you do what you could to help? Tedd is my friend simply because he loves what I love, chiropractic.
I can't help thinking about Nazi Germany. I am sure that when the Germans were rounding up the Jews, many Jews were saying, "They certainly can't uproot all of us. They are only taking away the troublemakers." Of course, the Nazis did round up everyone. By the time the Jews realized this, it was too late.
Maybe Dr. Koren's case will prove to be only about Dr. Koren, but are we willing to take that chance? By the time we find out, it may be too late. What's the worst that will happen if you donate and it turns out that the FTC is not a threat to our profession? Well, you've just helped out a friend in need, and you should feel good about that. Tedd would do it for you. It's time to stand together!
Finally, to the doctor who stated that he thought Dr. Koren's showing of old chiropractic movie clips was not "valuable to my practice": Lighten up, dude! I've always enjoyed that part of Tedd's lecture.
Lewis G. Singer, DC
Boynton Beach, Florida