Turning the Tide: the Prosecution of Innovative Medicine
How many more doctors and alternative practitioners will be dragged before their medical boards and disciplined before we take action and form a coalition to end this persecution of integrative medicine and natural practitioners forever? Every year a new study comes out documenting the increasing numbers of people availing themselves of alternative medicine. Still the medical boards insist that alternative therapies are dangerous to the public and outside the accepted "standard of care". It is time to turn the tide and insure the freedom of access to innovative therapies!
Historical Background: Of course, the story of suppression of natural medical alternatives started a long time ago. But there have been some victories. In1987, the chiropractic profession filed an antitrust suit, Wilk et al v. the AMA, and won a key federal court decision against the AMA. As a result of this suit, chiropractic has become the most accepted of all the alternative therapies out there, and the AMA has ever since been wary of putting its foot back into the waters of attacking alternative therapies as quackery. However, several organizations interestingly came on the scene shortly after the 1987 decision, including the Federation of State Medical Boards which is a private corporation that acts as a clearing house for the theory and practice of states investigating licensed medical doctors. With the encouragement of the FSMB and other quack-buster organizations, the prosecution of holistic doctors and practitioners and alternative therapies has continued.
Dr. Sica's Story: This particular story is about how one doctor, Robban A. Sica, MD, went on the offensive to try and establish a national precedent to protect practitioners whose only "crime" is using an innovative therapy to help patients get well. In 2002, investigators for the Connecticut Department of Public Health (DOPH) started an investigation of Dr. Sica's use of chelation when they noticed on a website that she was offering that alternative treatment. They filed a statement of charges against Dr. Sica in the fall of 2003, alleging that she "violated the applicable standard of care" because she allegedly treated coronary artery disease with EDTA Chelation therapy. Without either regulating, codifying or publishing any guidelines for the undisclosed "standard of care", the Connecticut State health officials sought to restrict or revoke Dr. Sica's license, on the basis of one "expert" witness certified in occupational medicine, who claims that Dr. Sica fails to meet the standard of care as defined by …him.
Connecticut's History of Oppression of Integrative Therapies: This is not the first time that Connecticut DOPH has investigated doctors and dentists who practice innovative treatments and tried to revoke their licenses. Many remember the case of Dr. Mark Breiner, the dentist who was charged with removing mercury amalgam fillings from patients' mouths, even though mercury is well known to be a toxic substance. Chelating physicians have fallen prey to DOPH over the past 20 years, most recently Tadeus Skowron, MD of Bridgeport, CT. Initially, the DOPH had successfully forced Dr. Skowron to sign a consent order agreeing to probation and review of his charts. The doctor assigned by the DOPH to conduct the chart review then accused him of negligence and failure to treat cancer appropriately (Dr. Skowron was using alternative methods). The doctor's defense attorney even presented a clinical professor of medicine from Yale who testified that Dr. Skowron's treatment was thorough and that his charts were impeccable. The Board of Medical Examiners revoked Dr. Skowron's license, on May 18, 2004, giving him only five days warning. They found the expert from Yale "not credible". After attempting to fight to regain his licence for a couple more years, Dr. Skowron sadly gave up and moved his family back to his native country of Poland. Unfortunately, there are many other doctors and non-licensed natural practitioners who are casualties of this war, including several physicians forced to stop using chelation therapy and a growing number of physicians being persecuted for treating chronic Lyme disease. Even nutritionists and homeopaths have been told by the CT DOPH to "cease and desist".
Non-licensed practitioners are not safe either. One CTHFC member who is a certified clinical nutritionist, with a Master's degree in Nutrition and years of formal study in homeopathy, was sent a "cease and desist" letter by the Department of Public Health and was threatened with criminal charges. (Practicing medicine with out a license is considered a felony.) What was her crime? Offering FREE seminars to educate the public about nutrition and homeopathy! Another nutritionist was sent a similar letter, threatening her with charges for practicing naturopathic medicine without a license. Her crime? Making diagnoses and providing naturopathic medical care? NO. Because her office was called "The Natural Path".
(Read more on the Connecticut Health Freedom Coalition website: www.cthfc.org.)
Dr. Sica Fights Back: In response to these trumped up charges, Dr. Sica's attorney, Jacques Simon, formulated and brought a federal lawsuit brought against the Connecticut Department of Public Health and the medical board in 2004. This suit was unprecedented in its very approach; Dr. Sica sued that charges were filed against her for misconduct without first giving "fair warning" of what action one might take that would be misconduct, in other words, on the basis of a due process violations. While there are many examples of the Connecticut health department observing Connecticut statutes and promulgating standard-of-care regulations, after public notice and comment, on medical and dental practice as well as issuing advisories, where treatments and methods have been clearly defined, the DOPH has never written any regulations or advisory on EDTA chelation, or for that matter, on any topic relating to the chelation of heavy metals. In short, in Connecticut, there is no written, codified or otherwise regulated standard of care regarding this therapy. Her lawsuit contended that, in Dr. Sica's case, the department attempted an end run around the sate laws which govern administrative agencies, by accepting one expert's "standard of care" for enforcement.
The Sica suit challenged whether the Connecticut medical board acted outside its jurisdiction and scope of power. In Connecticut, in order for the board to have the jurisdiction to request patient charts or to otherwise investigate a physician, the law requires a specific complaint or a blatant act that violates a particular statute or regulation. In Dr. Sica's case, there was no such complaint or act. DOPH had not gone through the process to adopt into lawful standard-of-care regulation for heavy metal toxicity or EDTA. Yet they charged Dr. Sica with violating this non-existent regulation and an "applicable standard of care" from the mind of one man. Which begs the question, can you make up a law after you've charged someone with violating it? How can you be in violation of a law or of a "standard of care" that does not exist? You can't just make up a law after the fact, after you've charged someone with violating that law!
The Lawsuit in Summary: The lawsuit was set upon three basic principles:
· There is no law prohibiting the care that Dr. Sica was charged with giving. Nothing in CT or federal law has made treating coronary artery disease or heavy metals with EDTA chelation illegal.
· Had DOPH wanted to lawfully regulate a standard of care, through administrative procedure notifying all residents of the proposed standard and providing a public comment period, they could have.
The law cited to give them jurisdiction in this case has to do with the "incompetent, illegal or negligent" practice of medicine, yet nowhere are the vague terms, "incompetent" and "negligent," defined, and remember, chelation is not otherwise illegal as the off-label use of an approved medication by a physician was upheld by the 5th Circuit Court of Appeals. Therefore, they must either disprove this modality, or make a regulation against it, before they can commit a charge against it.
Why Federal Court? Traditionally, state appeals courts have declined to second-guess findings of guilt made by state boards of professional peers, leaving an accused practitioner with no state remedy for abuse by the health officials. In most states, failure to comply with a demand made by a medical board can be the basis for charges all by itself. The assumption of correctness benefits the board at every juncture from investigation to appeal, but what if the board is simply wrong?
Due process: the art of fairness: Dr. Robban Sica's suit filed in federal court against the Connecticut Department of Public Health and officials including the commissioner, the presiding board members, the DOPH expert and attorneys, charged them with numerous failures of due process and for violating Dr. Sica's constitutional rights,. The suit sought a preliminary and a permanent injunction against the state officials prohibiting them from going forward with the prosecution of the charges and with the administrative hearing. In addition, an emergency motion to stop the administrative hearings regarding her license. Unfortunately, despite an Order from the federal judge allowing the emergency injunction to be heard and allowing Dr. Sica's attorney to conduct unprecedented "limited discovery" of the state including depositions of state officials (almost un-heard-of), this injunction was not successful. But it was a major step forward as frequently federal judges refrain from taking on state issues such as this.
This was the very first time that we know of, that a doctor has gone directly to Federal Court before submitting to a medical board administrative hearing, what pundits call a kangaroo court. Connecticut is part of the Second Federal Circuit which has a different set of standards, federal standards. In 2003 the Second Circuit Court of Appeals reviewed very similar state medical board due-process questions and decided in the favor of the New York physician. See DiBlasio v. Novell. The difference is that De Blasio was appealing a summary suspension, his NY license was already taken due to an alleged "imminent threat to the public." What made DiBlasio relevant to Sica's case is the finding by the second circuit court that, viewed from the federal standard, the relationship between the Office of Professional Medical Conduct (OPMC) prosecutors and the judges from the Board of Professional Medical Conduct (BPMC), both being under the aegis same health department was way too cozy and potentially unfair.
An Unprecedented Positive Outcome: As a result of the lawsuit and successful negotiations by Dr. Sica's attorneys, Jacques Simon and Al Augustine, a reasonable settlement was arrived at in which Dr. Sica agreed to provide informed consent containing the health officials concerns to all patients who wish to undergo chelation therapy but, thankfully, Dr. Sica's license and right to practice remains intact as well as patients' rights to choose chelation therapy.
How Dr. Sica Came to Practice Integrative Medicine: When asked what first led her to the practice of medicine, Doctor Sica replied: "That's a huge question. I have always wanted to help people solve problems and have a better life. Actually, I was always interested in holistic medicine. I don't come from a medical family so I was pretty naive to the politics of medicine, how medicine is practiced etc, and in medical school I got pretty disillusioned. I started in internal medicine, then switched to a psychiatry residency in Hartford. During this time, I took a year-long program at Interface in Boston and it really opened my eyes. I found this program life-changing, learning about many holistic therapies including energy healing, homeopathy, psychotherapy, and acupuncture."
Dr. Sica continued taking courses in nutrition and integrative medicine, and started into private practice in 1985, working with several doctors with holistic practices. She joined several national organizations and became certified in chelation and heavy metal toxicology in 1996. In 1992, she opened a large integrative practice with several other practitioners in Orange CT, called the Center for the Healing Arts.
She explains her point of view: "I have been practicing integrative medicine for over 22 years, blending the best of what I found in both conventional and alternative medicine. I do frequently test for and find heavy metal toxicity because, honestly, the world is a pretty toxic place these days. I would say that a large percentage of patients with chronic illness test positive for more than one heavy metal."
Lead at the Heart of the Matter: What's ironic about the state's charges is that, while a few of Dr. Sica's patients also had cardiovascular disease, a few of them had cerebral vascular disease, and most of them had chronic fatigue, memory loss, neurological problems etc. -- all of them had documented high levels of heavy metals. One had high blood pressure and was seeking preventive chelation. When tested, he had very high lead level. After chelation, his blood pressure came down because lead in his body was causing the elevation. Hypertension related to lead toxicity is well documented in the scientific literature. Lead is also a well-known risk factor for cardiovascular disease. AND Chelation therapy is the INDICATED treatment for lead and other heavy metal toxicity.
What's Lead Got to Do With It? The level of lead considered to be toxic has been lowered repeatedly from what was considered safe only a few years before, making one wonder -- is there a line in the sand where on one side of it, lead is safe to have in your body? In Connecticut, the reportable blood lead level is 10 nanograms per deciliter. Fifteen to twenty years ago it was 25. But that's just the "reportable" level. In its lead regulations, EPA recognizes that there is no "safe" level of lead when it comes to human health. There is evidence that even very low levels cause significant damage. This was documented in a New England Journal of Medicine article in April 2003. For more documentation of the public health concerns regarding lead, mercury, cadmium, etc, visit the CDC's website for the Agency for Toxic Substances and Disease Registry: www.atsdr.cdc.gov.
To complicate matters, we are all genetically and biochemically unique. There is a lot of data about the difference in reactivity of subgroups of the population to various heavy metals. The most research done on sub-population reactivity is in relation to mercury toxicity and autism. It has been noted that because autistic children have genetic differences resulting in inadequate methylation, metallothionein and glutathione levels, they cannot tolerate the same amount of mercury that a normal child can. Both of these antioxidants bind to heavy metals to protect the brain.
How Do You Recover from Toxicity: Conventional toxicologists fail to recognize chronic, low grade exposures leading to high tissue levels of these very toxic metals. Even when they are able to recognize this condition, they claim that treating the toxicity is too "dangerous" despite the chronic, devastating, disabling and even life threatening effects of such retention of heavy metals in the body. They simply stick a "lead star" on the patient's forehead and tell them that they have to live with it. Dr. Sica, however, is one of the specifically trained and certified physicians who understand how to safely and effectively detoxify the body, utilizing chelating agents. She is a Board member of the American Board of Clinical Metal Toxicology (www.abcmt.org)
The principle of innovation: Integrative medicine is dedicated the principle that medicine must change over time. It must innovate. It must respond to new concerns, new information, new understanding about chemistry and biology, about the relationship between our bodies and our minds and our changing environment. Looking back at Dr. Sica's explanation of how she came to be here, practicing this medicine in this place at this time, it seems only logical that she would choose to arise to the occasion to take a stand for innovation.
A Tough Choice: She explains, "When I got that letter from the state, followed later by the statement of charges, I knew I had a choice. One is to play ball and the other is to fight. If I had played ball and accepted their settlement, it would have severely limited my treatment of metal toxicity; eliminated any use whatsoever of EDTA; I'd be on probation for five years, paying over $2,000 a month for the privilege of supervision, and possibly have my license revoked (as has happened to other physicians) -- and I had done nothing wrong! Furthermore, my patients would have been denied a life changing treatment."
"So, on the one hand, I could have just done what was needed to stay in practice, but on the other hand, I thought, what right do they have to deny patients proper treatment? Or, for that matter, any reasonable healthcare option that the person needs and wants." There was no question in her mind.
"My practice is rather unique in that likely half of my patients are suffering from chronic fatigue and/or fibromyalgia. I myself suffered from chronic fatigue years ago and was severely disabled. When I found that my illness was caused by lead, cadmium and mercury toxicity, it was EDTA chelation therapy that saved my life. I would have been totally disabled today had it not been for EDTA chelation. I would have most likely been disabled for life. So I feel pretty passionate as a patient, as a patient, that these therapies need to be available. That's why I chose to fight for our rights."
"This battle, however long, expensive, stressful and difficult, has ignited my passion for health freedom. No one should ever have to suffer what I and my family went through." Moved by her experience, Dr. Sica serves as a Board member for the American Association for Health Freedom (www.healthfreedom.net) and is a founding member of the Connecticut Health Freedom Coalition, a state affiliate of AAHF. Through healthcare access legislation, education, litigation, and formation of coalitions with other like-minded organizations, the mission of these organizations is to defend the right of the practitioner to practice and the consumer to choose among healthcare options.
Perhaps Thomas Jefferson said it best:
"If people let government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as the souls of those who live under tyranny."
