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The Infidelity of Regulatory Oversight Affecting the Health Care System

By Stamberger Mar 28, 2013 4645 Words
The Infidelity of Regulatory Oversight Affecting the Health Care System by Mary K. Stamberger
Basic Issues in Community Based Health Care Delivery
HC 465DL
Julia A Buttelmann
November 29, 2012

There is a national tsunami of panic over an unlikely operative in the form of a mold named Exophiala dermatitidis which has infected 430 people, and contributed to the death of 32 patients. The black mold contaminate found a safe harbor in the preservative free steroid injection labeled methylpredinisolone acetate. The Massachusetts’s manufacturer channeled an estimated 7,000 contaminated vials of the steroid to 24 states and clinical communities in which it neglected its duties in oversight an ethical standards as regulated by state and federal government agencies. However, there are additional oversight actors which contributed to the infection of a community and broke the covenant of trust within a society. A cursory review of these actors’ duties will assign negligence and the balance of fault will be assessed by the judicial system. Collectively, I will examine the relative importance of regulatory oversight affecting the standard of medical care; perform a cursory review of mold contaminations occurring nationally prior to the present incident; and how the infidelity of oversight of the manufacturer and regulatory agencies has caused a broken trust within a community. The negligent parties will capture such actors in regulatory agencies, business organizations, medical communities, insurers, and society as a whole. In conclusion, a list of recommendations will be offered which supports a framework for further research to be conducted on this contaminant and heavier oversight of the overseers.

Suggested Citation
Mary K. Stamberger. 2012. “The Infidelity of Regulatory Oversight Affecting the Health Care System”

Key Words: CDC, compounding pharmacies, FDA, fungal meningitis, infidelities, NECC, oversight, technology

The Infidelity of Regulatory Oversight Affecting
The Health Care System
At some point in the course of life our trust may have been punctured by neglectful secrets or infidelity occurring in a relationship. If parties do not regain the trust factor back in a relationship, the social foundation will fracture and relationships could permanently result in an emotional barrier scarring all future social, cultural, political, ethical, economical and medical relationships. Such an example leads our minds to a past infidelity and broken trust involving financial adviser and white collar criminal Bernard Madoff; but in the health care world a real time example involves a pseudo compounding pharmacy and its family of owners the New England Compounding Center, (NECC), who once again demonstrated to a nation greed is hungry and a driver of negligible acts. Such infidelities can bring despair and the social foundation of trust may seem to be broken; however, relationships can rebound and broken trust can be rebuilt with a key of earnest effort and hard work. Nationally, this infidelity involves broken trust among consumers, manufacturers, and regulatory agencies during an incident in which an opportunistic fungi found safe harbor in a preservative free steroid known as methylprednisolone acetate (MPA) and morphed into fungal meningitis causing physical harm to an estimated 480 people with the demise of 32 patients. The fungal panic placed the medical community in familiar, but forgotten clinical territory and lessons learned from prior incidents were stored away on floppy disks from technology which faded into the basement level of a storage cave while the regulatory agencies vigorously pointed their fingers toward a named perpetrator, the compounding manufacturer (NECC). Ostensibly, the public at-large will not consider placing unilateral blame on an amoral manufacturer because the public has learned from past experiences of moral hazards there will be additional actors which contributed to negligible stress to a population and shattered the covenant of trust within a society, yet the penalties of negligence did not deter future acts. A cursory review of these actors’ duties will appropriately assign negligence and the midpoint of fault will be assessed by the judicial system because the judicial system is correct tool to hand down a penalty of civil and criminal negligence to named legal parties; however, it is incumbent on society to examine the facets of the infidelity to ensure future negligent acts are stopped prior to broken trust and the death of citizens. Discussion Contaminant History of Black Mold. In 2002, North Carolina compounding pharmacy experienced contamination of steroid injections which caused five cases of fungal meningitis and one death. The Center for Disease Control and Prevention (CDC) superagency published its findings from the fungal outbreak in its Morbidity and Mortality Weekly Report (MMWR) (Center for Disease Control and Prevention, 2002). The findings extracted from the 2002 MMWR and compared to the fungal outbreak of 2012 attach a causal signage to the agency and respondents investigated because the occurrences arise from the preservative free methylprednisolone acetate and the triggering contaminant has been described as Exophiala dermatitidis second cousin to Exserohilum rostratum a class of black mold. This fungi is so named under the title of black mold because it has “melanin in their cell walls” (Smith, 2012, p. 1). Fungal Opportunists are Skulking in the Shadows. Perfect and Schell (1996) examined the increase of fungal opportunists in the environment between 100,000 to 200,000 opportunists with new species making an appearance at a rate of 1,500 annually. Fungi have a unique ability to infect biological solutions and grow into molds with “yeastlike synanamorph” (Perfect & Schell, 1996, p. 113) which can procreate in a watery environment of the human host. Another way to understand synanamorph is similar to how a jello dessert is formed. The jello’s original form consists of powder, and then when the powder is combined with water it takes on a liquid composition with no physical dimensions; however, pour the liquid form in a jello mold and it takes the form of the mold. Hence, jello has transitioned itself by taking various forms but yet it maintains its true nature and purpose. This example illustrates how the fungi can synanamorph itself into tubes, vials, endoscopes and catheters catching clinicians off guard as hiding in plain sight and determined to infect its human host. But there are other stakeholders who encouraged the development of the fungi and there name is the Food and Drug Administration. Fungi Find Safe Harbor in FDA Form 483. The Federal Drug Administration (FDA) assisted the safe harbor of the fungi under its regulatory Form 483. Albeit, such action was not an intentional aid in the growth of the fungi or assist in contaminating human hosts, but nevertheless, the federal government was an instrument in the demise of consumers. The purpose of FDA Form 483 is used after the inspection of organization that is observed or conditionally practices violations under the Federal Food, Drug, and Cosmetic Act. This grocery list of violations noted volitional acts occurred when the compounding agency (NECC) turned off its air conditioner in the clean room from “8:00 p.m. to 5:30 p.m.” (Serrie, 2012, p. 1). Additional evidentiary sightings occurred when investigators viewed “greenish-black foreign material and a white filamentous material inside” contaminated vials (Serrie, 2012). Additionally, investigators noted there was standing water from leaking boilers 30 feet from the clean room door. Notably, FDA Form 483 bears no legal teeth by assessing criminal or monetary violations against the pharmacy; however, it does serve as evidentiary tool while compiling a final determination of violations against the perpetrator. How Technology and Clinicians Saved Lives. Due to the astute observance and excellence in medical training one clinician stands out in capturing the fungal opportunists’ dastardly intent. Dr. April Pettit, Infectious Disease Physician at Vanderbilt University Medical Center saw something quirky from a patient’s symptoms and so she tested the patient who received a spinal epidural injection at a local pain clinic. Dr. Pettit emailed Dr. Marion Kainer, Director of Tennessee Department of Healthcare Associated Infections and Antimicrobial Resistance Program the outcome of the tests. Upon receipt of the results, immediately Dr. Kainer rang the alarm bell which resonated to the halls of CDC (Tennessee Department, 2012, p. 1). Dropping a Dime. Dr. Kainer took the lead in sounding the alarm and he contacts State Massachusetts Department of Health to request a telephone conference call with the following parties: TDH (Tennessee Department of Health), CDC, MA staff and NECC to obtain distribution list of clinics that got MPA from NECC. The purpose of the conference was to pinpoint other cases of meningitis and patients who received epidural steroid injections which were compounded by NECC. As a consequence of further outbreaks being reported, all state health departments were contacted by CDC (Tennessee Department, 2012, p. 2-3). The aforementioned actions demonstrate an example how clinicians, federal, and state governments worked to the ticks of the metronome in order to protect and educate the public about a deadly infection. Technology of Web Sites. Web sites from CDC, FDA,TDH begin to populate websites with pertinent information for clinicians and the public relating to a deadly outbreak of the fungal contaminate. For example, the Center or Medicaid and CHP Services circulated a CMCS Informational Bulletin to state health departments providing interim treatment guidelines relating to the infections and contaminated steroid products manufactured by NECC (Center for Medicaid, 2012). Additionally, as the FDA continues its investigation, its website is updated to provide access to any new information on this outbreak and utilizes social mediums such as electronic listserves, Facebook, and Twitter. The Strained Relationships between Physician and Pharmacy. The physician and compounding pharmacy relationship appears to be strained due to the 2012 fungal meningitis outbreak due to the faulty oversight of the FDA, Massachusetts Board, and the perpetrator NECC. In order to rebuild trust among pharmacies and physicians, medical consultants are urging physicians to practice pharmaceutical safety and due diligence when choosing a pharmacy to supply compounded medications. The due diligence undertaking would be to query pharmacies about test results on sterility, request documentation of state licensure and history of infractions, provide pharmacy drug recall protocols lists, and other pertinent information related to practice of safety methods (O'Reilly, 2012). Due diligence is an added cost to physicians and overhead expenditures and budgets would have to be adjusted in order to build this cost into next year’s budget. This added expense to clinicians is not appreciated and strains relationships with threads of resentment. To acquire knowledge about the compounding method of medication, Pegues (2006) states compounding is “the combining, mixing, or altering of ingredients to create a customized medication for an individual patient in response to a licensed practitioner’s prescription” (Pegues, 2006, p. 838). Political Finger Pointing: The Gray Flannel Patches of Tattered Blame. The Hill is and will always excel in political finger pointing and the buck stops everywhere but on the front stoop of the finger pointing superagencies. As an example, a 2008 news article published by the British Medical Journal (BMJ) the media was critiquing the FDA and reported what a poor job it did in monitoring off-label use of prescriptions (Tanne, 2008). It appears the FDA did not receive peer review very well and ignored the journal article in its entirety. Negligent Failures of the FDA. In its 2012 testimony representatives of the FDA stated their hands were tied when it came to enforcement powers over traditional and non-traditional compounding manufacturers. Section 503A sets out to exempt compounded drugs from provisions of the Food and Drug Cosmetic Act (FDCA) as it relates to premarket approval requirement for “new drugs; the drug be in compliance with current good manufacturing practice (cGMP)”; the drug bear adequate directions for public use; and most importantly place a restriction on the advertising or promotion of the drug. Testimony claims these exemptions were construed by Courts and produced ambiguous opinions which caused confusion about the authority FDA held over compounding pharmacies (Food and Drug, 2012) and caused fragmented and weak regulations over the pharmacies. Leadership Qualities of the CDC. Former lessons learned by the CDC placed them ahead of the public curve by anticipating “outbreaks are the result of a widespread lack of knowledge of or adherence to well-recognized regulatory and professional standards for properly handling sterile medications” (Center for Disease, 2012). CDC implemented a national clinical consultation network which advised on patient care, course of treatment, and provided results on patient treatment outcomes. Massachusetts Department of Public Health Infidelities Attributed to Broken Trust in the Relationship with the Public. On November 15, 2012, Interim Commissioner Dr. Lauren Smith presented herself before the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) and remarked she was puzzled by the dysfunction of the Massachusetts Board of Health. Smith reported the downfall of the Board began in 1999 when the Board received its first complaint about NECC and pre-printed prescriptions it sent to a provider. Notably, pre-printed prescriptions are prohibited by state laws. Additional infractions occurred over the years by NECC and the organization was continually given a slap on the wrist for these violations. For example, in 2006 NECC entered into an amended consent agreement and in the structure of the agreement an independent evaluator identified as Pharmaceutical Systems, Inc. (PSI) was to oversee that NECC be in compliance with the terms of the agreement. Because the Board did not conduct its due diligence on PSI, the overseer, the Board did not know PSI had executives who were convicted of federal crimes related to defrauding FDA and selling unapproved sterilization equipment to health care organizations. What sleight of hand caused the Board to look in the opposite direction? Case law contributed to the plaid of ambiguity, however, only in a miniscule way. Case Law Contributed to the Infidelity; Albeit, in a Subtle Manner. In Thompson v. Western States Medical Center, (01-344) 535 U. S. 357 (2002) 238 F.3d 1090, the Court upheld a Section of the FDCA, Section 503A, aforementioned in the body of this paper, in which the 503A prohibited advertising and promotion of compounded drugs. The logic behind this exemption was if medicine was compounded for one patient, why advertise to the public? However, the Court upheld the use of free speech in favor of the compounders and found they have the right to advertise their drugs. Thus began the complex regulatory mechanisms the FDA has in place and lays blame, in part, on fragmented court opinions. Property Insurers and their Culpability. Property insurers were contributing factors to the infidelity and hiding secrets of NECC. If company insurers had properly conducted their annual risk management investigations, the alarm bell would have been sounded and they would adhered to their duty to contact the appropriate authorities to report environmental hazards. It appears from a Rhode Island lawsuit Travelers Casualty & Surety Insurance Company and Providence Washington Insurance Company, Inc. may have insured NECC. More discovery will be conducted and get sorted out in court. HELP Senate Committee Staff Report Sums Up the Infidelities. The conclusions reached thus far by the HELP Committee puts into perspective stakeholders’ role and their failures in prohibiting NECC from producing any compounded drugs. The Senate’s conclusions is a must read for all who even consider breaking the outer rims of the law let alone the core essence and found “but bureaucratic inertias appears to be what allowed a bad actor to repeatedly risk public health” (United States Senate: Health, Labor, & Pensions Committee, 2012). Ethics? We don’t need no stinking ethics. The aspect of displaying and modeling ethics has contributed to the cultural rot of the United States. Year-in and year-out more leaders display lack of ethics and prescribe to moral hazard philosophy. One example of cultural rot would be Bernard Madoff, white collar criminal who stole millions of dollars from his clients. Presently, we have a company who has one-up Madoff and set precedence in the medical world - the three Conigliaro family who made an abomination of ethical standards and contributed to the system of cultural decentralization at various levels. Lisa Conigliaro and Barry Cadden have a systemic part in contributing negligence to the demise of dozens and the infection of thousands of citizens. Lisa Conigliaro is the daughter to Douglas and Carla Conigliaro who own 65% of NECC with Lisa and Barry owning 25% of the company. Barry Cadden, a pharmacist was employed as the COO of NECC and it is in this position his novel moral hazard plan begins to be implemented. The untruths Cadden spilled to the FDA are many and one example occurred in 2004 regarding an improper production of an injectable dye used in eye procedures, Trypan Blue. Cadden denied that the Trypan was in stock at NECC, however, FDA found contrary evidence of Trypan being located at the organization totaling an amount of 189 vials. Albeit, the Massachusetts Board assisted in the deterioration of the Cadden’s/NECC’s moral hazard path by appointing him to a Task Force to study oversight of the compounding pharmacy industry while simultaneously being the subject of a joint investigation by the Board and FDA. Another accomplice in the broken trust tryst was Pharmacy Support, Inc. (PSI) who was selected to oversee the compliance requirements set out in the Consent Agreement executed by NECC and the Board. However, their part in abetting the negligible acts of NECC was acting as hidden spies. The overseer was a former NECC employee and assured the Board NECC had fulfilled the requirements in the Consent Agreement and signed off on their practices. Consequently, PSI’s CEO and Chief Compliance Officer were criminally convicted on 19 counts “including fraud, mail fraud” and a violations of the FDA. U.S. Caputo, No. 03 CR 0126 (N.D. III. Oct 16, 2003). Fiscal Evidence of Infidelity Were Political Contributions used as hush money? It appears the Cadden lived high and large on family and company money. They own large estates and most likely have money tucked away on some foreign island. However, what other stakeholders assisted in Cadden’s political savvy? In 2012, Senator Scott Brown was campaigning for re-election and received an estimated $15,000 contribution from the Cadden’s. Cadden and wife donated blood, tried to fund a wild life horse program and contributed to Mercymount Country Day School (Mercy Mount, n.d.). There are most likely countless other contributions and philanthropy acts conducted by Cadden over the years, however, it does not make up for a single life let alone 34 lives.

The only comparable case to even a hint as to how much money this will cost stakeholders would to refer to Robert Courtney, a pharmacist who was convicted of diluting cancer medicine. Courtney victims received an estimated $71 million in settlement from drug companies to be divided among 350 plaintiffs (Professional Risk Advisor, n.d.). The Courtney case sets the framework for negligible settlement negotiations and provides a perspective how greed will effect various stakeholders’ economies’. However, the monetary sky is the limit should attorneys find the defendant with the deepest pockets. Recommendations

It highly important federal and state practice the cooperative federalism theory in which they collaborate and fix conflicting regulations and avoid “this is my turf” syndrome of arrogance. Massachusetts has begun a special task force to find ways to strengthen their oversight over compounding pharmacies and federal agencies are reviewing all compounding and pseudo compounding actions in the nation. However, it seems a bit trite to re-invent the wheel when it would have been simpler to observe their own regulations and rules. Therefore, the proposed recommendations include the following factors at a minimum: State Board Recommendations. 1) Ask committee members to resign who were involved in the broken trust of negligence and cultural arrogance; 2) commission new members who undergo a thorough vetting and due diligence to ensure they have no conflicts of interests in their charge as commissioners; 3) Query the Attorney General to investigate the matter with conflict of interests with board members and their political and/or friendship with NECC. If the investigation proves fruitful, press for criminal charges and refer any ethical charges to the Ethics Board of the State for civil actions against violating board members; 4) Begin analysis of insurance exposure due to the negligence of the Board and sketch a picture of liability exposure which would involve various levels of settlement figures; 5) Involve legislators involved with the rules committee of the state to begin to draft new legislation for the oversight of compounding pharmacies. Such legislation will look at fines, ethical violations, moral hazard clauses, and if such breaches of trust occurs, who will be named as violating stakeholders. Additionally, provide a secure safety net of contacts if such an opportunist infection occurs with immediate contact of the CDC, EPA, and the other pertinent agencies. Proposed Federal Recommendations. The court system is a congested system, however, germane to the gray flannel areas of authority which has occurred between state boards of pharmacy and the FDA, the courts will need to opine clear lines of authority. Perhaps this disaster will assist the courts in crafting recommendations which will provide revisions of regulations at both the state and federal level.

Recommendation 1: set aside a special investigatory department within the FDA which will be charged in oversight of compounding and manufacturing pharmacies which do not require drug approval. This would ease a strained relationship between the health care organizations and pharmacies in that health care organization will be relieved of conducting their own due diligence and they will be able to purchase compounded products to meet patient needs knowing there is a stamp approval from the FDA that such a purchase qualifies for safety for the patient. Collect a sur tax from compounding pharmacies to assist in the funding of this special department.

Recommendation 2: the FDA team members involved in the broken trust is reprimanded to the fullest degree after an investigation has provided the essence of the violations occurring within the department.

Recommendation 3: the FDA prepares a host of health policies to be delivered to states and federal legislators to distinguish the levels of power over traditional and non-traditional compounding pharmacies. The FDA should have authority to perform a random drug test on compounding pharmacies as well as the state authorities. Dual testing and inspections will ensure the safety net is secure and the public will not be exposed to violations which would harm their lives.

Recommendation 4: When contamination and infections occur in compounding pharmacies, the EPA should be contacted as a resource or in an investigatory capacity. If the investigation merits penalties this superagency would be able to assess them appropriately. How the Medical Community Can Protect Itself Against Compounding Pharmacy Negligence. Physicians, as well as the compounding pharmacy, take additional responsibility to ensure patients will be free of contamination by health care professionals developing policies and procedures for “strict aseptic techniques” (Pegues, 2006, p. 839). This procedure places physicians in a change of cultural atmosphere to infuse a culture of excellence for their entire organization. For example, you may initiate a patient harm index which holds the organization accountable for successes and errors. Patient Due Diligence. For patients who seek medical services, be proactive and protect your health by researching the medical facility for violations of any type. You can call your state licensing department, conduct research on your computer, or ask for a physician for their negative survey reports. Conclusion It is incumbent on society to examine the facets of the infidelity to ensure future negligent acts are barred prior to broken trust and the death of citizens. Such watch dogging occurs in any relationships where a threat of an opportunist seeks to destroy and place a wedge of distrust into the system. There exists a reason in human relationships when one partner is referred to the old ball-and-chain. It is because the partnership needs constant vigilance to detour any threats which may seduce the relationship. Such an illustration needs to be demonstrated to future law-breakers such as NECC who demonstrated to the nation greed is an opportunist and a driver of negligible acts. Such infidelities can bring despair and the social foundation of trust may seem to be broken, however, relationships can rebound and broken trust can be rebuilt with a key of earnest effort and hard work. The prominent parties to the tryst are NECC, FDA, the Massachusetts Board of Pharmacy, health policy regulation ambiguities, property and casualty insurers. The nation is required to send a message to opportunists such fidelities will cease to exist and harm innocent parties who assume the system is functioning with intent purpose. References Center for Disease Control and Prevention. (December 13, 2002). Morbidity & Mortality Weekly Report (Version 51(49);1109-1112) [Report]. 2002. November 29, 2012, CDC Web site: http:/​/​​mmwr/​preview/​mmwrhtml/​mm5149a1.htm Center for Disease Control and Prevention. (November 15, 2012). The CDC and Public Health Response to the 2012 Fungal Meningitis and Other Infections Outbreak [2012 Testimony for HELP]. Available November 21, 2012, from U.S. Senate Web site: http:/​/​​imo/​media/​doc/​Bell.pdf Center for Medicaid and CHIP Services. (October 31, 2012). CMCS Informational Bulletin (Version Unknown) [Meningitis Outbreak: Interim Treatment Guidance]. Available November 9, 2012, from Department of Health & Human Services Web site: http:/​/​​Federal-Policy-Guidance/​downloads/​CIB-10-31-12.pdf Food and Drug Administration. (November 15, 2012). Statement of Margaret A. Hamburg, M.D [Testimony before HELP]. Available November 21, 2012, from U.S. Senate Web site: http:/​/​​imo/​media/​doc/​Hamburg3.pdf Mercy Mount. (n.d.). In unknown (Ed.), Mercy Mount Country Day School. Retrieved December 3, 2012, from Mercy Mount Web site: http:/​/​​Capital/​CapitalListofDonors.htm O'Reilly, K. B. (2012, October 29). In AMA (Ed.), Meningitis outbreak tests physician trust in compounding pharmacies [Article]. Retrieved October 29, 2012, from AMA Web site: http:/​/​​amednews/​2012/​10/​29/​prl21029.htm Pegues, D. A. (2006). Improving and Enforcing Compounding Pharmacy Practices to Protect Patients. Oxford Journal, 43(7), 838-840. Retrieved November 21, 2012, from JSTOR: http:/​/​​stable/​4484978 Perfect, J. R., & Schell, W. A. (1996). The New Fungal Opportunists Are Coming. Clinical Infectious Disease, 22(2), S112-S118. Retrieved November 22, 2012, from JSTOR Web site: http:/​/​​stable/​4459452 Professional Risk Advisor. (n.d.). In Unknown (Ed.), Professional Risk Advisor. Retrieved December 3, 2012, from Professional Risk Advisor Web site: http:/​/​​0303-settlement.html Serrie, J. (2012, October 28). FDA Finds Pharmacy Failed to Maintain Clean Rooms as Cases Rise in Meningitis Outbreak. Fox News, p. unknown. Retrieved October 28, 2012, from Fox News Web site: http:/​/​​health/​2012/​10/​26/​fda-finds-pharmacy-failed-to-maintain-clean-rooms-as-cases-rise-in-meningitis/​ Smith, M. (2012, November 5). Meningitis: Bug Infecting More than 400 an Unlikely Culprit. Medpagetoday, pp. 1-5. Retrieved November 8, 2012, from Web site: http:/​/​​Neurology/​GeneralNeurology/​35764 Tanne, J. H. (2008). FDA is Criticised for Poor Oversight of Drug Companies'

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