Do Compounding Pharmacies Need FDA Regulation?
When the Senate subcommittee approved Senate Bill 959 giving the FDA greater regulatory control over compounding pharmacies, the vote was unanimous. A house version of S. 959 offers the FDA even broader authority to regulate compounding pharmacies. Correspondence with legislators opposed to the bill appears to be received with deaf ears. Washington State Democratic Senators Murray and Cantwell agree completely with FDA oversight. While the congressional parties remain divided on nearly every political issue, there is little disagreement about the need to give the FDA far-reaching police powers to examine compounders. Iowa Republican Senator Harkin, who has been an important voice for alternative medicine and the nutritional supplement industry, strongly supports regulating compounded prescriptions and injectables. It would appear that the only hope to avert passage of this legislation is not reason but disagreement between the House and Senate as to the contents of the bill. Perhaps it is a sign of the times that dysfunctionality, the inability for politicians to accomplish anything, may be the only means for the compounders to preserve their freedom.
Five years ago injectable vitamins, minerals, amino acids, and herbals were routinely manufactured by pharmaceutical companies. There was little need to obtain injectables from compounders except for unusual nutrients and herbals. However, the FDA initiated intensive inspection of injectable-manufacturing facilities, and a number of the major manufacturers were found to be faulty and deficient in their quality control. Rather than accept the rigorous requirements needed for quality control manufacture of injectables, most of these facilities shut down. This led to an immediate shortage of injectables including vitamin B12, ascorbic acid, magnesium chloride, B vitamins, trace minerals, even sodium bicarbonate (an approved drug agent used widely in hospital emergency rooms). Of course, a shortage of injectables was not limited to alternative medical clinics – at the same time there have been widespread shortages of injectable chemotherapy drugs. The problem for manufacturers is that improving the manufacturing process requires building completely new facilities having updated drug plants – retrofitting the old facilities is not only expensive but inadequate. While some drug manufacturers are building new facilities, it will be years before the factories are completed. Hence, compounding pharmacies are needed to fill the demand for providing injectables.
And here's the rub: compounders are by law not supposed to be manufacturing. A compounder is supposed to receive a prescription for compounding the injectable or drug for a patient. And that is where the process becomes impossible – it makes sense to produce 50, 100, 500, or 1000 vials of vitamin C – it makes little sense labor-wise or cost-wise to compound 1, 2, or 5 vials of vitamin C. The FDA has allowed the production of injectables in small quantities to be shipped to a medical office in the same state; it has deemed the production of large number of vials to be shipped across state lines to be "manufacturing" and illegal for a compounder. So if the pharmaceutical companies are not manufacturing injectables, there are only compounding pharmacies available to fill the need – or the need will be filled by illegal entities. There is nothing clear cut about this issue except that we need compounders to provide injectables that are available to be shipped across state lines and manufactured in high quality control facilities and production. Perhaps the compounders need to establish an independent board to certify quality control manufacturing?
Dan Cohen: Music and Memory
In this issue of the Townsend Letter we explore brain health, focusing on autism and dementia. Our emphasis is on biochemical and nutritional factors leading to these disorders. What about a support for Alzheimer's that does not involve nutrition or a pill – something as simple as listening to music? In the nursing home many patients suffering with Alzheimer's sit and stare into space, doing nothing, unresponsive except when being fed. Could listening to music bring the patient back to his/her original self?
In 2006 my cousin Dan Cohen, an Apple aficionado, had a brainstorm. He was concerned that when he became aged, he might lose his memory and would be vegetating all day long. What if he recorded his favorite songs from the 1960s on his iPod and listened to them instead of doing nothing? He hypothesized that an Alzheimer's patient would respond better to his/her favorite music rather than just listening to music piped in from the radio. Dan wanted to customize the music list for each patient and arrange for the iPod to be loaded with that music.
He did a survey of 16,000 nursing homes and discovered that none used iPods with their residents. Dan volunteered at a local nursing home and customized iPod music lists for the residents. It was tremendously successful with staff, patients, and families; they were enthusiastic about how the patient listening to his/her own music becomes "alive." His initial work at one nursing home became the model for an organization dedicated to providing residents of nursing homes throughout the country iPods with customized music lists. Now more than 140 nursing homes are using patient customized music for their residents. Dan's organization is called Music & Memory.
A documentary about Music & Memory and Dan's work was screened in 2012: Alive Inside: The Story of Music and Memory. The movie is awe inspiring and very absorbing – it did bring tears to my eyes. Watching a lackluster, vacant-eyed, folded-up patient spring to life in seconds is invigorating, not only for the patient but for all those around – other patients and staff. There is a video clip that you can watch of a nursing home resident, "Henry," as he "reawakens" listening to Cab Calloway, one of his favorites: https://www.youtube.com/watch?v=5FWn4JB2YLU.
For information on how you can bring Dan's technology to your local nursing home or to donate to the program, see www.musicandmemory.org.
Copper and Zinc: A Key to Brain Health?
George Brewer, MD, and John MacArthur make the case in this issue that an excess of copper and deficiency of zinc play a pivotal role in memory loss in Alzheimer's disease. MacArthur terms an individual with this condition a "copperhead." In addition to excess levels of copper, the authors believe, iron excess contributes to the copper accumulation. The explanation for how copper and iron might cause neurodegenerative disease is by free radical damage to brain cell DNA: first, excess copper and iron generate excess free radicals, damaging the DNA; second, the enzymes responsible for repairing DNA are interfered with by copper and iron. Since copper is needed for brain cell functioning, it is given privileged entry into the brain cell, permitting "facilitated" damage. Copper's role in causing brain damage should be considered of notably greater importance than aluminum's.
Dr. Brewer thinks that with the escalating incidence of Alzheimer's disease, the role of copper toxicity should be considered a public health problem. One of the leading sources for copper excess is from drinking water that is provided through copper piping. Water that has been sitting too long in copper pipes is obviously discolored red, but even water used continuously leaches minor amounts of copper. Another source of copper, much to the chagrin of the naturopathic community, is in multiple vitamin supplements. Brewer and MacArthur make the case that Alzheimer's prevention requires the reduction of copper intake and the supplementation of zinc to block copper intake and utilization.
One of the pioneers of orthomolecular psychiatry (now called orthomolecular medicine) was Carl C. Pfeiffer, MD, PhD. Pfeiffer's work focused on nutritional approaches to mental illness, particularly schizophrenia and bi-polar disorder. Pfeiffer hypothesized that mental disorders could be approached biochemically into three distinct categories: (1) pyroluria; (2) histadelia; and (3) histapenia. In pyroluria (excess mauve factor) the body produces excess "pyrroles" from abnormal hemoglobin metabolism. Pfeiffer thought that the excess pyrrole production was similar to porphyria, the group of metabolic disorders caused by abnormalities of enzymes needed in heme and porphyrin synthesis. The mauve factor, a "pyrrole," is not exactly a porphyrin and most testing laboratories offer no means to test for pyrroles (www.vitamindiagnostics.com offers Pfeiffer's diagnostics including the mauve factor). The mauve factor abnormality is addressed clinically by supplementation with zinc and pyridoxine and reduction of copper. Histapenia is characterized as a low level of histamine and high copper. Histapenia would also be addressed using zinc supplementation and avoiding copper. Histadelia, on the other hand, is noted as having high levels of histamine and basophils. Here the focus would not be on copper reduction; instead, pyridoxine and methionine are employed. It is curious that Pfeiffer's work on schizophrenia and bipolar disorder that focused so heavily on copper excess and the need for zinc supplementation is now seen as a primary mechanism for brain health and Alzheimer's disease. I think it behooves us to take a closer look at our patients' copper and zinc levels.
Kurt Woeller, DO
If you read only two articles in this issue, be sure that one of those is George Brewer, MD, and John MacArthur's piece on the role of excess copper in Alzheimer's disease. The second "must" read is the interview of Kurt Woeller, DO, by Nancy Faass on the clinical workup for autism. Autistic disorder is becoming an increasingly prevalent part of pediatric practice. Unfortunately, the conventional medical practice offers little in the way of diagnostic workup for the autistic patient. Woeller offers a road map for evaluating autism that is sadly largely ignored in pediatrics.
Woeller makes the case that two GI organisms play a surprisingly major role in autistic disorder: Clostridium difficile and Candida albicans. Medicine generally ignores candida as playing any role in systemic disorders, including autism. Woeller not only argues that candida is an important player in contributing to autistic disorder but asserts that organic acid testing helps to define the extent of candida's involvement. As important as candida may be, even more concerning is Clostridium difficile, another frequent organism populating the GI tract. Clostridium is also diagnosed by organic acid testing. Woeller observes that treatment of candidiasis without treating clostridia may result in treatment failure. The two organisms potentiate each other and both deserve treatment. Woeller also notes that Lyme disease may be a causative organism for autism disorder and should be considered later in the diagnostic work-up.
Woeller examines autistic patients for their immune competency, viral exposure, food allergies, metal toxicity burden, and nutritional deficiencies. A comprehensive lab examination is critical for management of the patient. The depth of Woeller's testing increases the likelihood of successful treatment. Additionally, the laboratory results confer legitimacy for treatment that may be disputed by conventional authorities.
Jonathan Collin, MD