Letter from the Publisher

To Vaccinate or Not to Vaccinate

If there has ever been any issue that has separated readers of the Townsend Letter from public health authorities and mainstream medical scientists, it is the vaccination question. Like it or not, there is a line in the sand – those who unquestionably vaccinate versus those who question vaccination. And among those who question vaccination are those who do vaccinate only if the circumstances and options are clearly defined and overwhelmingly prudent, versus those who derail vaccination as a harbinger of future illness or adverse event and an intrusion of the government on our liberties. The anti-vaccination doctors and public are now being smeared as the “anti-vax” causers of the recent spate of measles and pertussis that are on the rise here in the US and abroad. Social media and the press are questioning whether the philosophical and religious reasons for foregoing vaccination should be eliminated, that vaccinations should be compulsory. Needless to say libertarians are fuming at the notion that “immunizations” be mandated. Of course, public health has always held that parental refusal to provide “standard of care” to children with serious illness is grounds for the legal removal of the child’s custody from the parents. Certainly the uptick of viral infectious disease is reason for concern given the model for “treating the herd”; if enough individuals are unvaccinated, the risk of contagion jumps. Nevertheless, homeopathic physicians despise vaccination, thinking that the vaccine imprints the system with negative “energetic factors” that potentiate risk for developing illness. Yes, science concedes that there are minimal adverse events incurred with receiving a vaccination; and for a few, very awful neurologic events do take place. That is the chance that public health is willing to take – make the majority “immunized” against disease, eliminating the scourge of childhood deaths that occurred before mandatory vaccination versus the minority who experience the unexpected and horrible. The child who incurs encephalitis is rare and tragic, and medicine dreads when this happens. That is not the same as attributing the majority of autism cases to vaccinations; the antivaccinationists who make that claim are arguing against the science. Concern about homeopathy’s tenet that vaccines imprint us with the wrong energetic information and worry about an adverse event makes sense, not the fear of having an autistic child. And let’s stop the make-believe stories that vaccination has had no effect in curbing infectious disease. Smallpox has been eradicated, and the reason is not good hygiene, lifestyle, and improved waste-management systems – it is a long and steadfast vaccination program that started in the 19th century and continued through the 20th. There are individuals who love to rewrite history denying the truth – let’s not go there with vaccinations – the polio vaccine has eliminated polio (except now in some Syrian refugee camps and other nonvaccinating Third World spots), and who would want to chance that their child develop polio?

So the question that we face is “to vaccinate or not to vaccinate.” The standard of care is set in stone. Without having a serious egg allergy – a serious allergy, not a positive IgG test to egg – or an immune-compromised disorder, one should receive immunizations as advised by pediatric health schedules. In the hope that there may be a chance to lessen the small risk that a horrible complication may develop with a vaccination, some parents opt to modify the vaccination schedule, lengthening the time between advised vaccinations. There may be some prudence to this – perhaps a delay between vaccinations might decrease the risk of an adverse event, although there is no science that validates this. The homeopaths do offer homeopathic medicine to counter the adverse effect of vaccination. Certainly, those children who have experienced minor adverse effects from vaccination deserve such treatment. But the key question is to vaccinate or not. One naturopathic physician contends that the naturopathic profession is “losing its soul” to medical standard of care and that naturopaths are abandoning their mission to fostering natural care and engendering immunity through individuals’ experiencing the illness. Another libertarian ND argues that physicians should not forsake individual choice in deciding whether to vaccinate – there will be no end to government’s becoming Big Brother ordering us to undergo diverse compulsory medical treatments. And a third ND makes the homeopathic argument that vaccines are brutal instruments that follow the allopathic model of one medicine for everyone – not individualized medicine based on understanding an individual’s genomic, metabolic, and gastrointestinal microbiologic characteristics.

To vaccinate or not to vaccinate … that is the question. As naturopathic and integrated physicians, let’s not belittle the issue. Every parent needs to make a prudent choice.

Fecal Microbiota Transplantation

In our February/March 2015 issue, Mark Davis, ND, wrote about fecal microbiota transplantation (FMT). Davis is one of a growing number of physicians and clinics in the US and internationally who are transplanting stool microorganisms from healthy individuals to sick individuals. FMT has been demonstrated to be particularly effective in resistant C. difficile infections. Many patients who have had resistant C. difficile have been repeatedly treated with antibiotics, including vancomycin. The resistant infection has been so difficult to treat that FMT has been the only effective means for controlling the disease. Unfortunately, the FDA’s position has been that FMT is a “drug therapy” and has not been through the rigorous evaluation required of all drugs; consequently it is not a permitted procedure without a research IND. However, physicians treating resistant C. difficile are permitted to transplant stool organisms without an IND

In the December 2, 2014, issue of the New Yorker, Emily Eakin reports about FMT treatment in her “The Excrement Experiment” article. Ben Eiseman, MD, a surgeon in Denver, reported in 1958 about four patients treated with stool transplants in the journal Surgery. The patients had been given routine preoperative antibiotics and became desperately ill. When Eiseman transplanted stool obtained from maternity patients, each of the patients recovered. In Australia, a gastroenterologist, Thomas Brody, MD, read Eiseman’s report and decided to use the technique on a patient who had a major GI infection after traveling to Fiji. The patient recovered and Brody implemented the procedure in his practice treating thousands of patients.

FMT has gained so much popular regard among ill individuals that many have opted to self-administer stool transplants. The Internet provides all the information needed to prepare a treatment. Eakin describes how one Crohn’s disease patient requested a healthy neighbor in his apartment building to provide stool so that he could do his own home transplants.

In the meantime there has been a commercial interest in providing licensed FMT. A company called Rebiotix has designed an FMT enema that is undergoing clinical studies needed for FDA approval. Another venture, OpenBiome, developed by graduate students at MIT, is supplying clinics with “food-removed” stool slurries from screened healthy volunteers that are prepared to optimize microbiota content. OpenBiome’s charge of $250 for a prepared stool transplant has not received FDA approval but is being used to treat resistant C. difficile. A research group at Massachusetts General Hospital is engineering a pill preparation of stool microbiota that appears to provide equally effective treatment as a stool transplant.

While FMT has been especially useful for treating chronic gastrointestinal illness, there is evidence that it may be useful for other inflammatory disorders. If so we may find that stool will be the centerpiece for medical treatment in the 21st century.

Triple Negative Breast Cancer

Breast cancer diagnosis and treatment is predicated on determining whether the cancer is estrogen receptor positive and/or progesterone receptor positive. Many tumors are characterized as HER2-positive. However, there are some breast cancers that are neither estrogen or progesterone receptor positive, nor are they HER2-positive. Such tumors are termed triple-negative breast cancer (TNBC), and they are estimated to represent 15% of invasive breast cancer in the US. Barbara MacDonald, ND, LAc, writes about TNBC in this issue of the Townsend Letter.

As a more aggressive form of breast cancer, TNBC has a greater prevalence in African-Americans than in Caucasians. Because TNBC is invasive, it is recommended that chemotherapy be administered early in its diagnosis. MacDonald outlines natural therapies that complement chemotherapy for managing TNBC.

MacDonald is the author of The Breast Cancer Companion: A Complementary Care Manual: The Practitioner’s Guide to Support Women Through Conventional Cancer Treatment. A fourth edition of this book that includes an expanded review of TNBC will be published later this year. MacDonald’s practice in Camden, Maine, facilitates treatment for cancer and chronic illness.

FDA Threat to Compounding Pharmacies Heats Up

Over the past year, the FDA has proceeded in determining new regulations for the operation of compounding pharmacies as well as the pharmacopoeia of what drugs and chemicals that will or will not be permitted to be compounded. As most readers recall the outbreak of fungal meningitis caused by the injection of adulterated corticosteroids produced by a New England compounding pharmacy led to congressional approval of new FDA regulatory control of compounding pharmacies in 2013. While the FDA initially was open to advisement about the scope of these regulations, its current activity has been closed to scrutiny by the industry, physicians, and other interested parties. Among the major changes that the FDA is proposing is the division of compounding pharmacies into two separate entities, the compounding pharmacy limited to what may be compounded, and the large outsourcing facility that will manufacture drugs under strict FDA manufacturing guidelines. The compounding pharmacy will be limited to compound only 5% of its prescriptions to out-of-state patients. Perhaps the greatest change that the FDA is requiring is that compounded prescriptions may no longer be provided for general “office use.” Hence a physician providing a treatment that requires a compounded prescription, such as an injectable vitamin or mineral, would be obligated to arrange for individually prescribed injections for each patient.

The potential that the FDA regulations will upend compounding pharmacies and physician practices is immense. Allison Murphy, legislative director of the Alliance for Natural Health, examines these implications in this issue.

Jonathan Collin, MD