John A. Borneman, III, Founder's Day Address, University of Sciences in Philadelphia
USP awards Jack Borneman honorary doctorate
John A. Borneman & Sons Homeopathic Laboratory was founded in 1908 by my granddad. John was a PCP&S graduate, class of 1902. My dad, John Jr., continued the PCP&S tradition, as did I. Most recently, my son, Jay, earned a Doctorate in Public Health Policy here at USP.
I spent many hours working in our family lab. Even before high school, I worked at the lab during summers, weekends and after school: washing bottles, general maintenance, tasks like painting, weeding, roofing, and in the summer collecting botanicals, (ask me about belladonna), preparing tinctures, making ointments, ampoules, capsules, hand molded pills, triturating and shipping.
Then, I graduated from PCP&S in 1952 and became a full time homeopathic manufacturing pharmacist, working evenings and weekends in a traditional community pharmacy.
My duties at the lab expanded to dealing with FDA, ATF, DEA, Commonwealth of PA, finances and administration. Later, I was given a sales territory extending from Jersey; Scranton; Westminster; MD; Harrisburg; and all points within.
At this point, you may expect to hear how I took a languishing family company and built a big-pharm player. Not so. This is instead the story of a failing industry and it's struggles: regulatory, economic and popularity.
As you probably know, homeopathy is a system of medicine using serially diluted and potentized remedies, most frequently of botanical origin. The basic principle let likes cure likes is often compared to, but not the same as, vaccination. The homeopathic medical system was begun in the mid 18th Century by Samuel Hahnemann. Homeopathy became a part of US FDC Act in 1938 with the inclusion of the Homoeopathic Pharmacopoeia of the United States (HPUS). The HPUS is a source for monographs, identity, methods of manufacture, standards and controls and potency levels of homeopathic remedies. However, despite inclusion in the Act, homeopathy was not specifically regulated for another 50 years.
Homeopathy was often thought to be an easy target for politicians, but as they did not know and were not permitted to make surveys regarding the magnitude of the business or the number of consumers of homeopathic drug products, they were at a clear disadvantage. They could not approximate the political power of the homeopathic constituency. In the 60's, attempts were made by Senators H. Humphrey (pharmacist), E. Kefauver, J. Kennedy and L. Johnson to neutralize the industry and put an end to homeopathy. Kefauver's drug reform legislation would permit no new homeopathic remedies and all existing ones would have become prescription only.
In 1981, members of the homeopathic industry were invited to meet with Jerome Halperin, Deputy Director, Bureau of Drugs, FDA regarding a proposal by Senator Kefauver to restrict all homeopathic drug products (HDPs) to prescription status. The agency postponed any action at that time, but they kept the proposal on their desk and kept up the dialog. We met with the agency, June 1982, continuing the "Who We Are " theme and following up on the proposed Rx status of HDPs.
I received notice that the FDA was required to make a ruling regarding homeopathic drug products, from Europe, which were being detained at US customs. I was informed that FDA was not prepared to make this determination and that the results could be detrimental to homeopathy in the U.S. The FDA sought our assistance in resolving their customs issue.
Following the meetings, we were informed that the agency did not have the education, training, personnel or experience to regulate homeopathy. Therefore, the agency asked us to prepare a Compliance Policy Guide (CPG), a directive from the agency to their personnel, providing guidance regarding a particular issue.
The minutes of this meeting are available on the web. The meeting had moments that were adversarial, but we developed a sufficient level of empathy with significant members, resulting in our crafting a document referred to as Compliance Policy Guide (CPG), 7132.15 Conditions Under Which Homeopathic Drugs May be Marketed. We sent them a streamlined document in 1983, and a revision in June 1986. They circulated it internally for review & comment, including the Justice Department, and published a document in the Federal Register in June 1988. It was enforced in 1990 and still, unmodified, continues to be effective today. The CPG put to rest the OTC/Rx controversy.
With the CPG well established, homeopathy in the US was investable and the Europeans seized the opportunity and purchased outright or appropriated almost all of the languishing American firms. My son, Jay, then a student at St Joseph's University had joined John A Borneman & Sons and recognized an opportunity to move ahead as part of a joint venture with the world's largest homeopathic company. This relationship was short lived and Jay was destined to join Standard Homeopathic Company (SHC), the manufacturer of Hyland's brand homeopathic consumer products and the largest homeopathic firm in the USA. Jay is now SHC's C.E.O.
After a short stint with chain pharmacy, during which I did consulting for the booming homeopathic industry, SHC and I formed a joint venture with Arrowroot Natural Pharmacy in Paoli. At this location, I was able to perform preceptor-ship duties for USP.
My attention now shifted to focus on the HPUS organization. The HPUS has been in continuous printing since 1841 and made a part of the FD&C Act of 1938. Seven editions had been printed by its then current owners, the American Institute of Homoeopathy, but once the CPG became effective, the HPUS no longer addressed the FDA concerns regarding safety and the monograph review process. The Homoeopathic Pharmacopoeia Convention of the United States and the Homoeopathic Pharmacopoeia of the United States needed to be refurbished.
PCP&S had prepared me well to undertake this massive endeavor. Who would have believed botany and pharmacognosy would be so integral to my career? It occurred to me that anyone who could survive Dr. Rubin's organic chemistry class could do anything. Our class trip had taken me West to Indianapolis and Kalamazoo. Now, I had to meet and get to know the key players in Boston, St Louis, California, Denver and Nevada; maintain the family business; and deal with all of the above named state & federal agencies.
My knowledge of the rest of the industry, the consumers, market and politics was meager at that time. Homeopathic practitioners, by nature, are strong willed and fiercely independent. I could not do this alone. I needed to take time, discern issues and build a team. The first step was to identify and organize key homeopathic physicians and pharmacists to form the Joint Action Committee for the Regulation of Homeopathic Pharmaceutical Industry, an ad hoc committee of the American Association of Homeopathic Pharmacists where I was a director.
It was time to get organized and prioritize. Several issues became obvious.
I understood that regulators would not act favorably if it appeared I was looking out for the industry or myself. Economics could not be an issue. I had to make the argument that the consumer had rights and FDA could not disenfranchise them. They were obligated to accommodate the consumer. This struck a chord and the work began.
Our mandates were determined:
- We needed to create a clear and investable regulatory environment.
- The HPUS needed to be updates since it had not been updated since 1976.
- I needed to meet, greet and motivate the key industry players.
- I had to learn to discern hidden agendas and subtly diffuse them, keeping the players on track.
- The HPUS needed to be identified as an official compendium with legal status.
- An updated document to protect the homeopathic remedies that were in use and anticipate those which should be in use had to be developed. This document became the Compendium of Homeotherapeutics; it was not great but would buy the industry time.
- We needed to re-incorporate and revitalize the Homoeopathic Pharmacopoeia Convention of the United States (HPCUS).
- Within the HPCUS, I needed to create an environment of trust.
- We needed to develop a sustained financial structure for the HPCUS.
- We needed to develop credibility with the regulators.
- We needed Directors who would enforce those principles we had proposed to the FDA.
- Procedures needed to be open, transparent, with checks and balances between committees and notices of conflicts of interest at all meetings.
Despite understood mandates, I was soon to learn that the industry and practitioners had some basic shared understanding about homeopathic drug products and methodology, but they had developed independently and were widely varied. The American industry was very regional. Methodologies were widely disparate and there were lingering animosities and distrust among different nationalities, German, French, and Italian. Even our East coast and West coast homeopathic pharmacies had developed differently.
The issue became how to discern and maximize those beneficial common attributes, minimize their idiosyncrasies and pull together without compromising the basic principles of homeopathy. The challenge was to be certain we defined and communicated the issues, the urgency, and channel our collective energies to create a regulatory environment, which would foster the development of our industry. Homeopathy was very successful in Europe, but was viewed as risky or un-investable in the United States.
After my mentor, Wyrth Post Baker, reincorporated the HPCUS, we staffed the Board with bright young physicians. We also established new procedures for the management of the Convention that met our standards for transparency and were filled with checks and balances between committees, including signed conflict of interest statements at all meetings. The processes for admitting new substances for monographing in the HPUS were rigorous.
There was a FDA meeting in April 1993. The Directors of Homoeopathic Pharmacopoeia Convention of the United States met with Mark Novatch, MD, Deputy Commissioner FDA. The agency's attention focused upon understanding how homeopathic products were entering the market place, how the HPUS might be used by some outsiders to circumvent the NDA process and the safety of HDPs. The Physicians, notably Dr. Chase and Shevin, educated the FDA regarding Basic Tenets, Corollaries, basic features, provings and methods of Cure. The pharmacists discussed general manufacturing methods and we all discussed the HPCUS structure, procedures, relationships with other countries, and OTC/Rx determinations. Harmonization was a big topic at this time, so we addressed our relationship with European Pharmacopoeia.
There was a pause. I believed the meeting went well, but was not prepared for what was to follow. Dr. Novich told us the Agency was not prepared to run a new drug review and approval process for homeopathic drugs. Another pause. Dr. Novich liked what he had seen and heard and asked if we would serve as the gatekeeper for new homeopathic drugs. We eagerly accepted the task and have been rigorous in its implementation since.
To advance the credibility of the HPUS, on Feb 25, 1995, I assembled world experts at a meeting in Philadelphia under the auspices of the HPCUS Counsel on Pharmacy. The purpose was to discuss proving or testing of HDPs. Participants were key homeopathic physicians and pharmacists from US, Europe Central and South America and Europe. My son, Jay, framed the agenda and led the discussions. One of the speakers was Wayne Jonas, who was eventually became Director of the NIH Center for Complementary and Alternative Therapies (now office). Experience with and methodologies for determining processes for acceptance of homeopathic remedies (provings) were discussed and formalized. This was a tremendous breakthrough.
As the regulatory environment was now established, we also became aware that the FDA had concerns about safety. We shared this concern. It became mandatory that we validate the popular perception that HDPs are safe.
As you know, most homeopathic remedies are botanicals. The starting point of preparing the homeopathic remedy is the crude herb and the mother tincture. These are not necessarily safe. There is a point in the process of dilution or deconcentration and potentization where there is no toxicity. The HPCUS had always had a simple procedure for making this determination. It became mandatory that this determination had to be more scientific and rigorous. Enter Dr. Der Marderossian. Through an arrangement among the HPCUS, USP and the good offices of Dr. Der Marderossian, we are now able to establish potency levels that assure the safety of Homeopathic Drug Products. Thank you, Ara.
With the order to serve as the gatekeepers for homeopathic drugs, we organized the HPCUS is such a manner that the Board was the ultimate authority. In April 1994, members of European and Anthroposophic Coalition confronted the board for Homeopathy (E.A.C.H.) who felt that an American organization should be more democratic and they were being disenfranchised and were now attempting a coupe. Their effort was defeated and we continued with our duties. One of their leaders maintained his chairmanship and now, twelve years later, because the quality of his work has been exemplary, he was elected to be a director of HPCUS, where he continues his role as a remarkable asset. Which guiding principal applies? From the Boy Scouts, Be Prepared.
A new opportunity to work with my son, Jay, became a new division of SHC, the Homeopathic Laboratories of PA and TxOptions Pharmacy, located in King of Prussia. We fill prescriptions for homeopathic remedies, perform extemporaneous manufacturing of homoeopathic remedies, and distribute, nationally, finished products to medical practitioners, consumers, health food stores and pharmacies. We welcome an opportunity to show you around.
Part of my practice at HLPA, TxOptions Pharmacy is responding to consumer inquiries. It is incredibly satisfying to be able to say homeopathic remedies are natural, safe, effective and have no known side effects or contraindications. In addition, at TxOptions, I am able to direct patients with conditions requiring professional treatment to homeopathic health care professionals.
Dr. Gerbino has asked me about challenges. The biggest challenge has been financial. The HPUS is not a hot item. There are a limited number of users. The HPUS is available online and I have tried to make access reasonable to accommodate everyone's needs. A student can subscribe for a day, or a month. A company or researcher can subscribe for a week or a month. Large companies, a year, and international or multi-locations can get a corporate subscription. Even with these subscriptions, we depend on corporate giving. Still there are never sufficient funds to meet our statutory obligations.
Another challenge is Drug Listing compliance at FDA. The sheer number of products, dosage forms and potencies exceeded the FDA computer's capacity. They made concessions and now HDPs are listed and archived although data is not readily retrievable.
Another challenge. There continues to be those who do not understand homeopathy or view it as an unwelcome medicine. In March 2002, APhA's annual meeting must have lacked punch and they became a sycophant to our traditional adversaries. A distinguished member of PCP&S and the President of the County pharmacist association, who was a member of the APhA, accompanied our defense team. Any victory by APhA was not readily apparent. Major advertisers in traditional drug trade journals still promote homeopathic products. Even negativity from Consumer's Report, BBB (Better Business Bureau), NAD (National advertising Division of BBB) and FTC have had negligible effect upon marketing HDPs because many consumers understand and want to use this safe and effective medicine.
Doctor Gerbino asked about:
- Challenges - The bar always seemed very high, but we accepted the challenges, met them and persevered.
- Disappointments - Not being with the family as the family grew.
- Accomplishments were many including,
It is wonderful to have benefited from a process that took a failing industry, that was practically non-existent in 1982 and which had many powerful adversaries, to help it become a world class industry that reports sales figures for 2008 at about $820 million (according to Mintel research).
- Adding the word homeopathy to almost everyone's lexicon.
- Bringing safe, reliable, affordable homeopathic drug products to many consumers.
- Earning acceptance by regulators, academia and industry.
- Creating a world-class homeopathic pharmacopoeia.
- And establishing a favorable regulatory environment for homeopathy
It is even more satisfying to receive this honor by my peers. The irony is the corporations benefiting from a lifetime effort, like Coldeeze, Zicam and Similisan, probably don't recognize my name. Yet I know what I have been a part of and what I have accomplished with my life's work.
What did I learn and would like to share with each of you?
I learned about many important character attributes and skills, including trust, integrity, discernment in identifying issues, prioritization, communication, transparency, motivation, teamwork, delegation and accountability.
I have also learned the Six Clarities, important resources and an easy checklist for establishing an organization.
The Six Clarities are a system that fosters communication while building a platform to maximize resources (time, people and money). They include:
1) Clear Purpose
A clear, principle-based mission that is customer focused. Broad, but establishes the essence of being an employee and who the company is to the marketplace
2) Clear Direction
Tangible goals and priorities (strategy and tactics) usually business plan based. Needs to be measurable.
3) Organizational Structure and Accountability
Needs to be clear and public. Essential for maximizing resources, motivation and decision-making.
4) Clear Decision making process
How do things get decided at the company. Who decides what?
5) Measurement and Review
Individual and group performance based on effectiveness of meeting tangible goals as defined by 2) Direction and 4) Decision-making. Balance of the group and individual take place.
If "Measurement and Review" is functioning, this is relatively painless. Some companies solve this with the individual performance component effecting salary, and group component affecting a bonus. Am I motivated in a way that supports the Mission?
I hope it helps and thank you for this time with you today.
Posted on 18 Feb 2009
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