Career Paths Part 1 - Answers to Questions from Soon-To-Be Graduates

In my last post, I discussed my experience as a career mentor and summarized the questions asked by soon-to-be graduates of life sciences programs.  Over the next several posts, I will address each of these questions. 

How did I decide upon my career path?

Ever since I was a child, I knew I wanted to be a chemist.  The funny thing was that I did not know what a chemist was, or what a chemist did.  My influence clearly came from the cool racks of tubes and bubbling solutions shown in sci-fi movies.

As I advanced through school, I was very good at math and science. Furthermore, I was frequently and dangerously curious about electricity, gunpowder and fire. While I am not inclined to elaborate at this time, it is interesting to note that one of the hallmark experiences of almost every chemist I know is an early desire to experiment, coupled with a lack of fear of the consequences.

Entering college I enrolled as a chemistry major at the UC Berkeley and enthusiastically pursued the required curriculum.  However, at that time, I still had not decided on what I wanted to do as a chemist. All this changed when I began to study organic chemistry.  When I realized how organic compounds interact with and influence biological processes, I knew that I wanted to work towards improving the quality of life for people suffering from conditions for which there was no treatment.  From that point on, I embraced organic chemistry, took all available organic chemistry courses, and pursued undergraduate research under the direction of Professor Henry Rapoport.

Through Professor Rapoport's guidance, I began to develop my laboratory skills in preparation for graduate school.  While I knew that a PhD was required in order for me to fully achieve my goals, I had not yet decided if I wanted to pursue a career in academics or in industry.  That decision developed during my graduate studies at MIT under the direction of Professor Satoru Masamune.

Having always been attracted to the idea of designing my own research programs, I initially felt that my best opportunities would be in academics. However, while in graduate school, I realized that there was an intense amount of competition for funding, tremendous politics regarding the tenure track and significant non-scientific activities required in order to keep a research group running.  These observations were contrasted to the fact that in industry, while I would not be required to fund my own programs, I would be required to work on programs to which I was assigned. Both sides had tremendous advantages.  In the end, I felt that even though I would be assigned programs, industry does not dictate how I solve the problems to which I would be assigned.  To this day, I enjoy the tremendous freedom to contribute novel solutions to the design and development of pharmaceutical agents.

Can you describe your industrial experiences and career path?

Industry has been very good to me.  Following completion of my PhD, I took a scientist position at Glycomed.  This was a great fit for me because the pharmaceutical technologies being studied at Glycomed made excellent use of my graduate school experiences involving the chemical modification of sugars.  At Glycomed, I contributed to the design of anti-inflammatory agents (selectin inhibitors and fucosyl transferase inhibitors) as well as drugs targeting angiogenesis, cancer and multiple sclerosis (matrix metalloproteinase inhibitors). As I developed my experience, I ultimately led the matrix metalloproteinase inhibitor efforts and took responsibility over three direct reports.

Following Ligand Pharmaceuticals' acquisition and the subsequent closure of Glycomed, I joined COR Therapeutics.  My charge was to develop a chemistry program targeting selective inhibition of type V adenylyl cyclase for use in the treatment of congestive heart failure. In this role I developed my knowledge of heterocylic compounds and synthetic nucleoside mimics. While this project yielded extremely potent compounds with activity in whole cell assays, corporate priorities resulted in termination of the adenylyl cyclase project.  For the remainder of my tenure at COR, I contributed to the design and synthesis of novel ADP receptor antagonists for use in treating deep vein thrombosis.

When COR Therapeutics was purchased and subsequently closed by Millennium Pharmaceuticals, I took a group leader position at Scios, Inc.  My role as group leader was to design and execute a medicinal chemistry program targeting calmodulin dependent kinase for the treatment of post-operative arrhythmia.  This was by far the largest team I had ever managed. At the peak of this effort, I had a team of ten dedicated scientists and associates.  Furthermore, I managed additional resources operating from contract research organizations (CROs) in the United States and India. Unfortunately, this program was terminated when Scios was purchased by Johnson & Johnson and subsequently shut down.

The closure of Scios was particularly difficult for me because it led to my first significant stretch of unemployment.  Jobs were scarce - especially for more experienced scientists looking for leadership roles.  I networked every day and built relationships with many industry insiders and recruiters. Realizing that I could not simply wait for new opportunities to present themselves, I decided to start consulting.  Through my consulting efforts I was able to secure laboratory space.  With this resource available to me, I was able to build on a networking connection and start an independent custom synthsesis effort.  My client was Intradigm Corporation and I was hired to prepare a compound critical to their development programs. My efforts were actually in competition with a CRO preparing the same compound.  In the end, I was able to prepare the target, provide necessary starting materials to the CRO and transfer synthetic protocols enabling the CRO to scale up the process.  Because of my work on this program, Intradigm created the role of Director of Synthetic Chemistry for me - a position which I currently hold.

While I do not know what opportunities lie in the future, I always strive to embrace the possibilities.

Life Science Careers - Questions from Soon-To-Be Graduates

With the tremendous uncertainty regarding today's economy, students are understandably concerned about their job prospects and the overall availability of career opportunities - regardless of the sector they choose to join.  Those with the greatest concern are the ones closest to graduation.  During the course of my education and career development, I had many opportunities to meet with career counselors and mentors to develop strategies for my long term success.  I am eternally grateful for the solid advice that was extended to me.  Indeed, it is largely because of the dedication of those individuals who provided their time and expertise to encourage young and enthusiastic science students that I decided to write this blog.

Last week, I was invited to participate as a mentor in the career networking session of the CSU Biotechnology Symposium.  The goal of this program was to educate students pursuing degrees in the life sciences about the varied career tracks that are available to them.  In all, there were 18 tables able to accommodate up to 10 students each in 4 rotations. Topics covered at each table were:

• Finding a job in today's economy
• How to apply/interview
• Medicinal chemistry
• Clinical trials management
• Intellectual property management
• Discovery research
• Biodevice product development
• Quality and regulatory affairs
• Product development
• Business development
• Engineering
• Food and Drug Administration
• Medical marketing
• Cliical laboratory sciences
• Health IT
• Pharmaceutical manufacturing
• Bioinformatics
• Start up a company

Those of you who follow this blog will recognize that I routinely highlight topics, skills and career opportunities in almost all of the above areas. With respect to the career mentoring session, I was asked to participate at the medicinal chemistry table and, along with a long-time colleague, had the opportunity to address a wide array of questions from some very bright students eager to contribute to all facets of the life sciences industries.

Questions Asked by Life Science Students

I was truly impressed with the questions asked at the mentoring session. These questions, paraphrased below, reflect the ongoing discussions encompassed by this blog.   The questions raised, organized by topic, are:

Questions About Medicinal Chemistry

• What is medicinal chemistry? (Answered 3/7/10)
• Do medicinal chemists participate in the testing of compounds?(Answered 3/7/10)
• What is a typical day like for a medicinal chemist? (Answered 3/7/10)
• How does molecular modeling influence medicinal chemistry?(Answered 3/20/10)
• How does natural product research relate to medicinal chemistry?(Answered 3/20/10)
• How can natural products be matched to enzyme activity?(Answered 3/20/10)
• What is the impact of small protein design? (Answered 4/14/10)
• What are the advantages/disadvantages of biologics vs small molecule drugs? (Answered 4/14/10)

Questions About Career Paths

• How did we decide upon our career paths? (Answered 1/25/10)
• What are the differences between academic and industrial careers? (Answered 2/16/10)
• Is there more competition for academic positions in this economy? (Answered 2/16/10)
• Can you describe your industrial experiences and career path?(Answered 1/25/10)

Questions About Employment Opportunities

• What will industrial employment opportunities look like in the next 5 years? (Answered 5/15/10)
• What is the future of in-house dedicated medicinal chemistry programs? (Answered 5/15/10)
• Are opportunities available in pharma/biotech for people with experience outside of the life sciences? (Answered 5/15/10)
• Are part time opportunities with tuition assistance available in pharma/biotech companies? (Answered 6/3/10)
• For new hires, what degrees are more valuable - organic chemistry or medicinal chemistry? (Answered 6/3/10)
• Is there job security in the life sciences? (Answered 6/3/10)
• What are the trends in outsourcing? (Answered 6/3/10)

Questions About Relevant Knowledge and Experience

• How important are analytical techniques (NMR/HPLC/MS/etc.) for new hires? (Answered 7/26/10)
• What opportunities exist for BS/MS level chemists in this economy? (Answered 7/26/10)
• What are the requirements for an entry level chemistry job?(Answered 7/26/10)
• How do supervisors interact with BS/MS level chemists in the lab? (Answered 7/26/10)
• How can I learn more about molecular modeling? (Answered 7/26/10)

While some of the above questions were addressed or touched on in previous postings, most present opportunities to share insight in areas highly relevant to our continually evolving job climate.  Future blogs will address each of these questions in turn.  Furthermore, it is my hope that those of you following this blog will add your voices and opinions thus enhancing the breadth of insight provided herein.

Green Technology and "Climategate" - Opportunities in Environmentally Friendly Chemistry

Recent news suggesting the use of manipulated and/or manufactured data supporting the global warming phenomenon has simultaneously created a political nightmare for advocates and perceived vindication for skeptics.  Regardless of the politics behind climate change, one thing is absolutely clear - ALL TRUE FACTS CAN BE BACKED UP WITH DATA.  This axiom applies as much to scientific disciplines as it does to the media.  If data is manipulated in order to support a hypothesis, the validity of that hypothesis becomes questionable.  Furthermore, if a journalist presents data out of context, the credibility of that journalist becomes questionable.  Finally, if a scientist manipulates data to support a hypothesis, the credibility of that scientist becomes questionable.  As a scientist, I can tell you that there is nothing more important to me than my credibility.

In disciplines where ongoing activities and policies rely on developing data, the introduction of manufactured data or the convenient omission of recorded data serves no one except those with vested interests in validating their theories.  Whether an advocate or a skeptic of global warming, there is one philosophy that we can all agree upon - it is a good idea to take care of our environment.  This philosophy, applied to both established and developing industries, automatically gives rise to tremendous opportunities in the sciences.  For example:

• the finite supply of accessible natural resources gives rise to the development of alternative fuels and more efficient means of utilizing currently accessible fuels, 
• the current reliance upon combustion of fossil fuels gives rise to the development of emission containment technology, and
  
• the constant accumulation of waste materials gives rise to the development of technologies for the recycling and/or reprocessing of discarded products.

While the current "climategate" scandal may impinge upon idealistic views of science and politics, it should not be a barrier to innovation.  Each of the points mentioned above have direct implications to the carbon cycle and, through the creative minds of our current and emerging scientific talent, economically viable technologies will emerge.  Already, academic institutions are designing curricula focused on "green chemistry" or chemistry incorporating solvents, reagents and reaction conditions that are compatible with the health of the environment.

Organic Chemistry and Clean Technology

Since the industrial revolution, our economy has become increasingly more dependent upon the combustion of fossil fuels.  After all, the energy provided by oil, coal and natural gas is already contained within the natural materials mined for human use.  All we have to do is recover the fuel.  Furthermore, these natural resources also provide components useful as, for example,

• raw materials for the manufacture of chemicals,
• monomeric units for polymer synthesis, and
  
• paving materials for roads.
  

While organic chemistry is the core science in the processing of petroleum-based materials, organic chemistry also provides solutions to dealing with the abundance of petroleum-based materials being discarded on a daily basis.  Just as an understanding of the chemical composition and properties of oil, coal and natural gas led to advances in efficiency of recovery and refinement, similar understandings of polymer chemistry led to creative ways to reuse discarded polymeric materials and reclaim useful decomposition products.

Expanding on the above, the study of organic chemistry opens doors to careers in the development of environmentally friendly technologies including:

• biodiesel,
• synthetic/semi-synthetic fuels,
• motor oil from polymer waste,
• catalysts for more efficient fuel combustion, and
  
• biodegradable polymers.

Finally, it is comforting to know that the development of these technologies will continue - even if climate change is identified as a purely natural and cyclic process.

Drug Discovery - The Cost of Innovation

In today's political and economic climate, all industries are forced to respond to public perceptions/pressure and adjust business plans accordingly.  Perhaps the most visible sector, and the one receiving the most scrutiny, is the healthcare industry.  Unfortunately, this scrutiny is generally politically motivated and therefore, information is filtered to the public to support various agendas.  Oftentimes, the information is misleading and incomplete.

The healthcare industry is comprised of multiple sectors including insurance companies, healthcare providers, and pharmaceutical companies.  Without delving into the intricacies influencing the overall cost of healthcare, it is important to understand that healthcare is dependent upon both medical services and medical products.  Furthermore, in order to advance the quality and efficiency of healthcare, medical products must continually evolve to incorporate state of the art technology guaranteeing that future generations of products perform better than their predecessors.  This philosophy is continually relevant in the design and development of new pharmaceutical agents.

Pharmaceuticals, being medical products, require years of research in order to understand the properties enabling them to be safely marketed.  The processes associated with the development of new medicines include:

• initial screening of thousands of chemicals against a biological target
  
• identification of hit compounds that show activity against the desired biological target
• chemical optimization of hit compounds to generate pharmaceutical lead molecules
• optimization of lead molecules to impart favorable pharmacological properties
• evaluation of optimized lead molecules in disease efficacy models, toxicology and stability
  
• design of processes for the synthesis and formulation of drug candidates
• execution of pre-clinical animal studies
  
• submission of an IND (investigational new drug) application to the FDA
  
• execution of human clinical trials
• submission of an NDA (new drug application) to the FDA

While the above list seems straightforward, it is not a complete representation of the entire drug discovery process.  In fact, the full process of bringing a new drug to market takes approximately 15 years and costs around $800 million dollars.  Furthermore, as only 1 in 8 drug candidates entering clinical trials ever reach market, the cost of failed programs must be added to the $800 million dollar investment.  The net result is that pharmaceutical companies must recover the costs associated with one successful product and seven failed programs just to break even!

As with the development of any new product intended for market, the company presenting new products is entitled to recover its investment and recognize some profit.  This is a fundamental incentive at the core of a capitalist society.  If companies are restricted from selling their products at market-competitive prices, there is little incentive for the development of new and/or next-generation innovations.

Due to set limits on patent lifetimes, pharmaceutical companies have approximately 5 years of market exclusivity post FDA approval to recoup thier $800 million dollar (plus the costs associated with failed programs) investment.  Realization of this fact helps us to understand how pharmaceutical companies price their products.  Of course, this fact does nothing to appease concerns associated with out-of-pocket expenses incurred by those requiring medications not covered by their insurance policies.  To this point, I respectfully argue that this is an issue better addressed with insurance companies and not through government imposed price controls.

Chemistry Opportunities and the Impact of Price Limits

The previously stated processes associated with the development of new medicines also defines opportunities for those interested in careers in the sciences.  For example:

• initial screening of thousands of chemicals against a biological target
• identification of hit compounds that show activity against the desired biological target
• Biochemists and biologists are employed to design relevant assays required in the above two points.  Patent attorneys provide legal protection for novel compounds/formulations throughout the discovery/development process.
  
• chemical optimization of hit compounds to generate pharmaceutical lead molecules
• Organic and medicinal chemists design new molecules.  Biologists and biochemists execute biological screening.  Analytical chemists determine molecular composition and purity.
  
• optimization of lead molecules to impart favorable pharmacological properties
• In addition to those listed in the above point, biologists design relevant disease models in animals.  Pharmacologists study the effects of drug candidates on animals.  Bioanalytical chemists study drug metabolites.  Formulation chemists develop drug formulations for administration to animals.  Computational chemists help in understanding the interactions between potential drug candidates and biological targets.
  
• evaluation of optimized lead molecules in disease efficacy models, toxicology and stability
• In addition to those listed in the above points, toxicologists and analytical chemists are required. 
• design of processes for the synthesis and formulation of drug candidates
• Process chemists develop routes for the efficient synthesis of drug candidates on industrial scales.  Analytical chemists assess the quality of large-scale synthesis at each synthetic step.
  
• execution of pre-clinical animal studies
• Pharmacologists and biologists study drug effects on higher animals.  Analytical chemists evaluate drug metabolites through blood, urine and feces.
  
• submission of an IND (investigational new drug) application to the FDA 
• Contributions from synthetic chemists, analytical chemists, pharmacologists, biologists and biochemists are required to generate a complete IND package.  In addition, clinicians must design clinical trials and define trial endpoints.
  
• execution of human clinical trials
• Clinicians, medical doctors, pharmacologist, analytical chemists and statisticians all contribute to the generation and evaluation of human clinical data.
  
• submission of an NDA (new drug application) to the FDA
• In addition to those contributing to an IND package, statistical evaluation of clinical endpoints, final synthetic/formulation processes and analytical specifications of drug product contribute to successful NDA packages. 
  

Summarizing the above, drug discovery efforts require:

• analytical chemistry
• organic/medicinal chemistry
• formulation chemistry
• computational chemistry
  
• cell biology
• molecular biology
• biochemistry
• pharmacology
• clinical medicine
• animal care
• patent law

Thus, the pharmaceutical industry provides numerous science-based career opportunities - all of which require some study of organic chemistry.  However, if we allow government-imposed restrictions on the pricing of pharmaceuticals, the results will be fewer new products, less innovation and fewer available jobs.  Considering the benefits to

• society from the development of new therapeutic agents,
• the economy from employment of professionals with scientific backgrounds, and
  
• the government from the generation of tax revenues based on personal and corporate profits,

let's keep the pharmaceutical industry out of the healthcare debate and maintain the values of our free-market society.

Chemistry Outsourcing - New and Challenging Career Opportunities

Recent years have seen increased chemistry outsourcing activities - largely perceived as corporate strategies designed to maintain productivity while reducing the load of full time staff.  From a business perspective, this makes a great deal of sense.  For example:

• in-house projects require in-house staff
• in-house staff requires dedicated equipment, facilities and overhead
• dedicated equipment, facilities and overhead require sufficient operating capital that is inherently more expensive than simple office space. 

Outsourcing, on the other hand, provides reasonable solutions. Specifically:

• outsourced projects require off-site staff
• off-site staff requires off-site equipment, facilities and overhead
• off-site equipment, facilities and overhead require support from corporate clients with a need for outsourcing activities.

As a bonus, commitments to contract organizations are limited by the duration of contracts, while commitments to full time staff are generally long-term relationships.

From the above arguments, we must all come to the realization that OUTSOURCING IS HERE TO STAY.  While the above arguments support the decisions of businesses to incorporate outsourcing as part of their corporate strategies, they do little to offer hope and comfort to those individuals who see their jobs vanishing in favor of low-cost offshore contract activities.  From a pragmatic point of view, this does not matter.  Hope and comfort are highly overrated and they do not pay the bills.  Now is the time to take charge of our career paths, create opportunities for ourselves and forget about hope and comfort.

Careers in Chemistry - Defining Our Own Roles

From the moment we decide to study chemistry, we are faced with choices such as:

• whether to enter the workforce or pursue an advanced degree
• whether to pursue a career in academics or in industry
• what industry to contribute to
• whether to follow a scientific path or a management path

Each of these decision points lead to additional choices which, if we are not careful, can ultimately define us.  In this rapidly changing corporate world, we are far better off if we can control how we are defined by maintaining significant diversity/flexibility in our skill sets.  We don't have to lose our jobs to changing markets if we can adapt our skill sets to changing needs.

When I first entered the workforce, my supervisor made a very disturbing prediction.  He observed the growing trend in outsourcing and knew that opportunities would begin to diminish.  This was approximately 15 years ago and, to this day, I credit my former supervisor for his warning and for his foresight.  In fact, it was largely because of this prediction that I began reaching out into different areas related to drug discovery.  Such areas include:

• management
• intellectual property
• due diligence
• contract synthesis

Management skills are essential and relate not only to working with other people, but also working within our own time/resource constraints.  These skills enable meeting personal objectives, meeting cross-departmental goals, and interacting with others - whether in-house or overseas.

Understanding intellectual property law and strategies enables us to organize our contributions into recognizable inventions essential for the strength of the technology base of companies for which we work. Furthermore, we are able to directly contribute to the design of patent strategies, work with patent attorneys and address concerns from the patent office.

Corporate due diligence is essential for investors to make decisions on where to invest their funds.  It is also essential for employment candidates to make decisions on which companies best suit their professional and scientific goals.  Through due diligence, rational decisions can be made regarding program resource allocation, academic/industrial collaborations and projected headcount needs.

Contract synthesis is not only a service for hire, it is also a tool for temporary expansion of in-house resources.  Decisions to utilize contract research organizations are made based on the requirements of individual programs.  Those chosen to manage these activities must be skilled in due diligence, intellectual property and management. Specifically, in working with CROs, due diligence is essential for evaluation and selection of appropriate firms. Furthermore, understanding intellectual property is essential for the protection and preservation of present and future inventions being developed with the assistance of CROs.  Finally, regardless of domestic or offshore locations, management skills are required for the successful negotiating and engagement of CRO activities, troubleshooting project issues and guiding programs to successful outcomes.

Reiterating that we don't have to lose our jobs to changing markets if we can adapt our skill sets to changing needs, the skills I addressed above are of tremendous importance.  With core competencies in these area, employment is available in parent companies, contract research organizations, law firms, consulting firms and venture capital firms.  The trick is to face this changing market with confidence, focus on present and future needs, and make ourselves essential professional resources.

Academic Institutions and Drug Discovery

The ability to manipulate the chemical composition of matter has led to new products and technologies emanating from almost every sector of industry. Of these sectors, among the most challenging and time-intensive activities is the discovery and development of new therapeutic agents. These challenges stem from:

• our increased need for safer and more effective products
• inherently long timelines from discovery to market
• the desire of the venture community to realize rapid returns on investments.

Examining these points from the perspective of cause and effect, the well justified need for safer and more effective products results in longer timelines from discovery to market. Unfortunately, long timelines are not compatible with rapid returns on investments. As such, investment capital has been shifting from high risk discovery programs to less risky development programs. In fact, it is not uncommon for investors to reserve capital for products already in clinical trials. The unfortunate consequence of this paradigm shift is that reduced capital for discovery programs has led to a reduced number of products transitioning from discovery to development. This transition begs the question FROM WHERE WILL THE NEXT GENERATION OF DRUG CANDIDATES EMERGE?

In previous posts, I highlighted issues relevant to this question including:

• Where big pharmaceutical companies will rebuild their pipeline of new drug candidates
• Large pharmaceutical firms turning to biopharmaceutical companies to fill their discovery pipelines
• Paradigm shifts incorporating outsourced services as replacements for high cost internal capabilities
• Academic institutions must continue to provide solid educational programs and degrees in chemistry - incorporating broad based and generally useful knowledge/skills

With the shrinking volume of venture capital funds available for early stage discovery startups and the continuing trend of large pharmaceutical companies filling their discovery pipeline through small company acquisitions, there is a sector looking to academic institutions to fill this gap. Having both attended graduate school and contributed to industrial drug discovery efforts, I can state with complete certainty that THIS IS A VERY BAD IDEA!!!

Yes, I said it. I mean it and I make no apologies for the frankness of my statement. Academic institutions are not suitable engines for both drug discovery and the training of our next generation of scientists. To qualify this statement, consider that the drug discovery process requires activities including:

• Compound synthesis/purification/analysis
• Enzyme assays
• Cell-based assays
• Animal models of disease
• Pharmacology
• Formulations
• Metabolite ID/bioanalytical

Each one of these activities requires the involvement of highly trained and knowledgeable scientists. Furthermore, each of these areas must be coordinated with one another in order to enable generation of the data required to accurately evaluate all potential drug candidates. In an academic setting - the setting responsible for much of the cutting edge advancements ultimately benefiting the pharmaceutical industry - such activities are not likely to be implementable without a detrimental effect on the training grounds of the next generation of scientists.

Put another way, where are we to generate the next generation of innovative, highly trained and knowledgeable scientists if our educational resources are diverted to commercial interests?

Organic Chemistry vs Medicinal Chemistry

During my undergraduate research activities with Professor Henry Rapoport at UC Berkeley, I found that my greatest interest was in the discovery of new medicines. Recognizing that the career opportunities I sought required an advanced degree, I began asking about which type of graduate program to pursue - organic chemistry or medicinal chemistry. The input I received overwhelmingly favored a PhD in organic chemistry. The rationale behind this bias was quite simple - the most important skill for a chemist in drug discovery is the mastery of organic chemistry.

Education in organic chemistry programs is not limited solely to reactions. The diverse set of skills, generally applicable to drug discovery (and other industries) are:

• Synthetic organic chemistry technique
• Practice in hundreds of different reactions
• Exposure to many more reaction types
• Scales from mg to multigram
• Training in the logic behind synthetic pathway selection
• Training in all spectroscopic/analytic/purification techniques

While organic chemistry and medicinal chemistry programs both teach organic chemistry, medicinal chemistry programs tend to dilute the breadth of chemistry exposure with the biological aspects of drug discovery activities. These biological aspects, as my colleagues explained to me, are skills that can be learned on the job. However, the on-the-job expansion of organic chemistry knowledge is considerably more difficult to accomplish. From this philosophy, it is not surprising that at every company I worked, the most successful job candidates had degrees in organic chemistry with a strong focus on synthesis.

In my August 21 post, I pointed out that in order to motivate our next generation of scientists,

• Industry must work to prevent chemistry, a discipline requiring intensive education/training, from evolving into a service
• Academic institutions must continue to provide solid educational programs and degrees in chemistry - incorporating broad based and generally useful knowledge/skills

I am, and always have been, enthusiastically in favor of graduate and undergraduate level curricula focusing on the practical and philosophical aspects of the pharmaceutical industry. Such coursework can only serve to prepare students for what will be expected of them as they progress through their professional development. However, replacing or diluting the development of core skills can only compromise our next generation's ability to maintain a competitive edge in a global marketplace. Industry must look elsewhere for its discovery pipeline lest the current trickle of new drug candidates dries up completely.

Fear Mongering: Good for Nutraceuticals, Bad for You

Until now, my posts focused on philosophies regarding the current state of education and industry. In fact, when I started this blog, my intent was to focus solely on issues which are constructive to the advancement of science and innovation. I had no desire whatsoever to address divisive political topics. However, with the continued onslaught of negative press and political agendas targeting the pharmaceutical industry, I feel compelled to add my voice. To this end, I want to thank Dr. Andrew Weil for providing me with material for this posting.

While I do not know Dr. Weil and I doubt that I will ever have any personal interaction with him, I know that he is extremely knowledgeable and well respected. It is not my intent to detract from his stature and I apologize if this posting does that. My intent here is to engage in an intelligent debate based upon Dr. Weil's blog of September 2, 2009 as published in the Huffington Post (http://www.huffingtonpost.com/andrew-weil-md/disease-mongering-good-fo_b_275616.html). In this posting, Dr. Weil, discusses the term "disease mongering" as a mechanism used by the pharmaceutical industry to take advantage of uninformed consumers. As Dr. Weil states,

"A central disease-mongering tactic is to attach polysyllabic, clinical-sounding names to what used to be seen as trivial or transient conditions. In most cases, the new, formidable names come complete with acronyms, which add even more gravitas."

Before I go any further, I would like to point out that when a significant population experiences a common symptom, illness, syndrome or disorder, it makes good sense to classify these indications under a common name. This helps doctors to identify patient populations they may be able to help. Furthermore, patients are supported through the knowledge that there are others sharing their discomfort. Finally, pharmaceutical companies are assisted through the identification of populations suffering (for whatever reason) from indications for which there is no treatment. Through the identification of disorders with established unmet medical needs, pharmaceutical firms are able to identify markets and drive research activities to the eventual benefit of these patient populations.

Dr. Weil, in his September 2 posting, highlights five indications that are established disorders requiring, in many cases, medical intervention. These indications, along with Dr. Weil's "disease mongering" examples are:

• Occasional heartburn becomes "gastro-esophageal reflux disease" or GERD.
• Impotence becomes "erectile dysfunction" or ED.
• Premenstrual tension becomes "premenstrual dysphoric disorder" or PMDD.
• Shyness becomes "social anxiety disorder" or SAD.
• Fidgeting legs becomes "restless leg syndrome" or RLS.

In listing these example, Dr. Weil does nothing more than trivialize these indications and the patients who suffer from them. I, myself, suffer from GERD. For many years, I experienced chronic heartburn independent of diet. At one point, the pain was so severe that it was debilitating. I began taking proton pump inhibitors and eventually had surgery to tighten my lower esophageal sphincter muscle. While I am doing much better, I still have to take occasional medication to control lingering symptoms. I must also submit to periodic esophageal endoscopy procedures to monitor my Barrett's esophagus - a precancerous condition caused by GERD. For me, GERD is not an indication that can be treated by giving my body's "healing mechanisms a chance to find equilibrium."

Pharmaceuticals and Nutraceuticals - Marketing on an Equal Playing Field

In reading Dr. Weil's posting, I understand that part of his message relates to the practice of drug companies marketing their products directly to consumers. Personally, I see no problem with this practice. If a consumer is to be able to make informed decisions regarding healthcare, that consumer should know about all possible medical treatments - including pharmaceuticals. After all, if vitamins, dietary supplements and herbs (all classified as nutraceuticals) can be directly marketed to consumers, why can't prescription medications?

In the interest of fairness, I fully support the right of consumers to seek whatever medical interventions are best for them. I fully respect the history behind folk remedies and I do not pass any judgement upon those who choose alternatives to prescription medications. After all, herbs have served as sources for many modern therapeutics from aspirin to morphine.

While nutraceuticals, derived from herbal remedies, may deliver some potential therapeutic benefits, they are not regulated or controlled under the same requirements as prescription drugs. For example:

• Prescription drugs must be proven safe and efficacious through human clinical trials - nutraceuticals are not held to this standard
• Prescription drugs, when marketed, must have a package insert detailing adverse effects, dosage information and potential drug-drug interactions - nutraceuticals are not held to this standard

Because herbal remedies and dietary supplements contain naturally occurring pharmaceutically active components, patient who use these alternatives through self medication are putting themselves at risk based upon uncontrolled or arbitrary dosing and potential interactions with medications they may be taking by prescription.

If consumers are to have the ability to make informed choices regarding their healthcare options, all products marketed as potential health remedies must be held to the same standards. Unfortunately, they are not. This is the result of two issues:

• It is not in the best interests of nutraceutical companies to fund clinical trials demonstrating efficacy when they are not required to do so
• It is not in the best interest of pharmaceutical companies to fund head-to-head clinical trials of any competing product against their own

WHERE DO THE BEST INTERESTS OF THE CONSUMERS COME IN???

In order for consumers to be able to make the most informed healthcare decisions, all alternative medications must be held to the same clinical and regulatory standards as prescription medications. Only in this scenario can patients, with the assistance of their doctors, objectively evaluate the best course of care while minimizing adverse events and drug-drug interactions.