Stop Bullying the Compounding Pharmacy | VitalityLogix

In the wake of the meningitis outbreak stemming from theNew EnglandCompoundingCenter?s methylprednisolone, the spotlight is suddenly on this small but important sector of the retail pharmacy market.

Compounding pharmacies specialize in making customized formulations of existing medications to fit special needs of their patients. This ranges from simple customization of a flavored antibiotic mixture for a child or as complex as chemotherapy for sterile infusion into the epidural space (spine). The NECC made a formulation from a common steroid used for spine injection for patients with back pain. This batch became contaminated with fungus and caused deadly meningitis in dozens of cases. Sounds bad, right?

Well, let?s put this into perspective. While this incident is undoubtedly a terrible and unfortunate event (and my sympathies go out to those affected by this event), it pales in comparison to the social and financial cost of Big Pharma?s practices and incidents. Let?s examine a few examples.

Sibutramine (now off the market) was developed as a treatment for obesity and was approved by the FDA, only to be pulled from the market after killing thousands of people from cardiovascular events. This drug underwent the requisite randomized controlled trials (which then became the focus of a Senate committee review) and after several years on the market it was withdrawn by the manufacturer under pressure from the FDA (the same agency that approved it a few years before).

Erythropoetin Stimulating Agents, now at the center of the hot-off-the-presses USADA and federal report of the Armstrong dropping scandal, was developed as a treatment for anemia. It was, and is extremely effective. It reduced fatigue, improved quality of life, improved exercise capacity (and illegally made its way into the bodies of countless athletes, of which Lance Armstrong has been made an example of). The manufacturer reaped the financial rewards of their discovery. Now the drug carries a black box warning (something the FDA puts on a drug to warn prescribers and consumers of its danger) for increased risks of death from cardiovascular events such as strokes, heart attacks and blood clots in a wide range of patients, including those simply undergoing surgery and taking this drug.

Estrogen and Progestin hormone replacement therapy became a popular treatment for menopause in the late 1990s and beyond, until the drug-sponsored Women?s Health Initiative trial, along with a few others, reported increased risks of breast cancer after tens of thousands of women were already prescribed the drug. This led to a black box warning, a very embarrassing and financially costly situation for the manufacturer and had far-reaching implications for menopause treatment henceforth. This drug study is now the focal point for opponents of HRT for women. This study and HRT became a hot topic for compounding pharmacies and Big Pharma.

The Women?s Health Initiative was the study of a single drug that, like most pharmaceutical agents is completely unlike our own innate physiology and therefore exerts adverse events when introduced into the human body. While bio-identical hormones have been around for many years, they are not amenable to patent since the structure is already part of human physiology and thus Big Pharma has little interest in bio-identical hormones as a commercial venture. Bio-identical hormones are largely made by compounding pharmacies into customized, patient specific creams. Big Pharma generally has nothing to gain from this, just like most of the other compounded products. Big Pharma is interested in patents, profits, and protection of their market share. And there is no reason to blame them for this as they are a business and a business needs to profit. However, their business deals with human lives.

In the wake of the negative Women?s Health Initiative and the growth of the compounded bio-identical hormone market (supported by encouraging trials from Europe), extensive lobbying efforts were exerted on the FDA and medical associations to come out against bio-identical hormones and compounding pharmacies as an unsafe alternative to the traditional Big Pharma methods. Claims were made that compounded bio-identicals are not safer than the Big Pharma products (and are often dangerous) and that there is no evidence to support their use. That is (and was) just not true. Large studies have been conducted inEuropeclearly supporting lower breast cancer risks and possibly even null risks in women using bio-identical compounded HRT. The lobbyists, politicians, and many medical groups jumped to support Big Pharma and bully the small compounding pharmacists with faulty claims and skewed evidence.

Yes, the compounding pharmacies need licensing, oversight, and regulation. But when you compare the damage inflicted by compounding pharmacies and Big Pharma, it?s like comparing the populations ofVatican CityandChina.

Compounding pharmacies serve a vital role in the retail pharmacy market and provide a fundamental service for many practitioners and patients alike. How do you treat a cancer patient with mouth sores from chemotherapy that are so bad that he cant even swallow water? A compounding pharmacist developed a pain-relieving and sore coating mouthwash. It can only be compounded. How do you infuse chemotherapy into the spine of a 3 year old child? A compounding pharmacist, under sterile conditions, has to make a formulation for that purpose. How do you give someone with a fear of needles an injectable medication? Compound it into a nasal spray. How do you effectively treat menopause while minimizing the breast cancer risks and providing an alternative to Big Pharma products? Compound bio-identical HRT.

The problem is that compounding offers patients and practitioners an alternative to Big Pharma and that?s bad for business. I?m not blaming Big Pharma ? they have accomplished amazing things and saved countless lives in generally safe ways. But they are an aggressive, highly lobbied and connected business that will attack any and all competition, often to the detriment of patients and practitioners alike.

So let?s put this NECC incident into perspective and treat it for what it is ? an unfortunate sentinel event (defined by the Joint Commission as an unexpected occurrence involving death or serious physical or psychological injury). According to the Joint Commission website ?Such events are called ?sentinel? because they signal the need for immediate investigation and response.? Rather than bully compounding pharmacies into extinction and financial ruin, this NECC incident should prompt politicians, regulators, and medical watch groups, and medical professional organizations to support compounding pharmacies in developing, instituting and enforcing guideline for safe practice. So let?s stop bullying and start working together to make sure this is a lesson that leads to change and improvement rather than a witch hunt.

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Source: http://www.vitalitylogix.com/blog/stop-bullying-the-compounding-pharmacy/

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