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Thursday, September 16, 2010

The Pharmaceutical Industry - The Economy and The Press

Over the past several months, articles appear in the news describing the bleak state of various industries contributing to the overall economic and employment situation facing both future graduates and workers of today.  One such article, "The 10 American Industries That May Never Recover," was on Yahoo this morning.  In this article, the pharmaceutical industry was listed as number 5.  The bleak outlook presented read as follows:

"This industry has bled workers for three years, and that trend is likely to continue. The largest companies in the sector, such as Pfizer and Merck, have a number of blockbuster drugs that have lost their patent protection in the last decade. They have other pharmaceuticals that will lose that protection in the next decade. Sales of most of these drugs will move to generic companies that will sell them for far less, and erode critical revenue sources for the huge pharma firms. Most companies in the industry admit that they cannot replace the drugs that go off patent fast enough to keep their revenue high. The other reason employment in the sector will stay down and may drop further is that big drug companies are merging to save costs, and most of those costs are people. Pfizer has cut 30,000 people since the start of the recession. Merck has cut 25,000, and these companies and their peers expect that they will have to bring down costs even more."

While there is first amendment protection regarding freedom of speech and press, such abbreviated analyses of the present situation provide a far gloomier picture than what can be obtained by applying just a little rational thought.  After all, among all of my colleagues and connections, no one is suggesting that the pharmaceutical industry will collapse altogether.  Furthermore, there remains considerable need for the discovery of new and better therapeutics addressing indications for which there is an unmet medical need.  As long as there is a need, there will be a market.

In looking at the above analysis of the pharmaceutical industry, the author is correct regarding the downsizing trend affecting this sector. Furthermore, with major products subject to patent expiration, this trend is likely to continue - at least in the short term.  However, a greater understanding of the industry should provide hope.  With products losing patent protection and becoming generic, one of the first casualties is sales and marketing.  Employment in these areas is dependant upon two areas - currently marketed drugs and drugs soon-to-be marketed.  With research pipelines being downsized to focus on development, the development pipeline has a limited lifetime.  This trend would lead to the conclusion that employment in drug development may suffer.  However, without research, there will be no new products to develop or market.

While research has been a primary casualty over the past 3-5 years, many experts (professionals and recruiters) are beginning to see a change in the market.  This should bring some hope to those preparing to enter the workforce.  To those graduating with BS/MS degrees, jobs have always been more abundant.  To those completing PhD work, a little more time may be necessary before reasonable opportunities present themselves.  In today's economy, pursuit of postdoctoral research activities may provide the necessary time and additional experience necessary to enter the workforce from the most competitive perspective.

The Pharma Industry Casualties - WHAT IS THERE TO DO?

The above discussion, while providing hope to those entering the workforce, does not really address the problem faced by the thousands of scientists who have lost their jobs due to downsizing, outsourcing and company closures.  To this sector, I refer to the many previous posts I have published regarding maintaining up-to-date and diverse skill sets.  There is work out there and one must be creative in order to identify the appropriate opportunities.  Do not be hesitant to try your hand at consulting or applying your skills to related industries. Such industries include:
  • agrochemical
  • food
  • textiles
  • polymers
  • biofuels
  • medical devices
  • patent law
  • contract research organizations
While it may take some time to adapt to different industries, or to build a consulting practice, the payoff will be recognized in the diversity of new skill sets.  Most importantly, it is critical to maintain a level of visible activity within your chosen sector.  Potential employers will recognize continued efforts and creative thought. Remember, in today's economy, there are plenty of reasons for not getting paid.  However, there is no excuse for not working.

Tuesday, September 14, 2010

Pharmaceuticals and Food Products - Regulation and Marketing

Over the past few days, news has emerged focused on two areas of high importance to consumers - pharmaceuticals and food products. From the pharmaceutical side, attention focused on Genentech's Avastin and its potential as a cancer therapy.  While approved for the treatment of lung and colon cancer, Avastin was also being marketed for the treatment of breast cancer - an indication not supported by clinical trials.  This issue, covered in detail by Ed Silverman (see "BCA's Brenner: Avastin and FDA Approval Standards", Pharmalot, 9/14/10), goes hand-in-hand with a post by Derek Lowe (see "A New Way to Approve Drugs", In the Pipeline, 9/14/10) focused on new paradigms for accelerated drug approval through the combined use of biomarkers, conditional approval and adaptive clinical trials.  I will not comment further on these areas, instead referring to the referenced posts, except to say that there still remains significant issues regarding pressure leading to premature drug approval and marketing to consumers.

From the food product side, recent news indicating that manufacturers of high fructose corn syrup are petitioning the FDA to rename the product "corn sugar" have emerged.  Particularly appalling is the report that "two new commercials try to alleviate shopper confusion, showing people who say they now understand that whether it's corn sugar or cane sugar, your body can't tell the difference. Sugar is sugar."  Let me make my perspective absolutely clear - THIS IS A COMPLETE DECEPTION!  To back up this statement, the term "sugar" is loosely used to describe the class of organic molecules known as simple carbohydrates.  More commonly, the term "sugar" relates to table sugar (sucrose, produced from sugar cane or sugar beets). Sucrose is one example from a class of molecules known as disaccharides (chemically joined combinations of two monosaccharide units).  The monosaccharide (simple sugar) units making up sucrose are glucose and fructose.

High fructose corn syrup, obtained from corn starch, begins primarily as glucose.  Enzymes are then added to convert the glucose into fructose.  The resulting product is a mixture of two separate monosaccharides - glucose and fructose.  This mixture is different from sucrose because the glucose and fructose molecules are not chemically bound to one another.  It is interesting to note that fructose is not even the major sugar component isolated from corn - its presence in corn syrup is ENHANCED THROUGH ARTIFICIAL MEANS.

Reasons for wanting to include fructose in food products include cost of production and sweetness.  High fructose corn syrup is cheaper to produce than sucrose due, in part, to corn subsidies.  Regarding relative sweetness compared to sucrose, glucose is less sweet and fructose is almost twice as sweet.

In biology, glucose plays important roles in energy and metabolism. In fact, it is critical to the production of proteins and lipids and is a precursor to the production of vitamin C.  Fructose has no such biological roles.  Additionally, while fructose is introduced into our bodies through consumption of sucrose, this introduction is the result of natural sucrose metabolism.  Consumption of high fructose corn syrup essentially results in flooding our bodies with a non-essential and non-nutritive sweetener.  DOES THIS MAKE SENSE?  DO WE REALLY WANT TO FEED THIS CONCOCTION TO OUR CHILDREN?  The food, candy and soft drink industries were doing just fine before high fructose corn syrup.  Certainly, we can do without it today.

Science and Ethics - CAN WE DO IT? vs SHOULD WE DO IT?

At the Boston ACS meeting, I had the pleasure of speaking with Professor Roald Hoffmann.  Our conversation centered around the principle tenants of his lecture that morning entitled "Science and Ethics: A Marriage of Necessity and Choice for the Millennium." During his speech, Professor Hoffmann focused on public suspicion of science relating to ecological, environmental and ethical/moral issues.  Of these three areas, I would like to focus on ethical/moral considerations.

In his lecture, Professor Hoffmann stated that "The invention or implementation of a tool without consideration of the consequences of its use is deeply incomplete.  Science is not ethically neutral."  He went on to say that "we must consider potential abuses of our well intended work."  While both of these statements are absolutely true, scientists are also humans and subject to the same human flaws as the rest of society.  This is never more apparent than when we make plans for selfish purposes or simply because there is a high likelihood that such plans can be successfully executed.  From this philosophy, consider the following:
  • We can plagiarize or falsify data, but we shouldn't.
  • We can generate harmful chemical or biological warfare agents, but we shouldn't.
  • We can withhold negative clinical data from regulatory agencies, but we shouldn't.
  • We can promote pharmaceuticals for unproven off-label use, but we shouldn't.
  • We can promote herbal remedies and dietary supplements for unproven health benefits, but we shouldn't.
  • We can argue the equivalence between natural substances and manufactured alternatives, but we shouldn't.
For all of the above, there are examples highlighted by the press. Certainly, such examples are exceptions rather than common practice.  However, such exceptions, when impacting high profile topics such as food and medicine, have the potential to make big headlines.  As alternatives to the above, consider the following - all of which are standard practices:
  • We can maintain high ethical standards in all publications, and we should.
  • We can generate useful chemical and biological agents for the benefit of society, and we should.
  • We can fully disclose all clinical data to regulatory agencies, and we should.
  • We can promote pharmaceuticals, herbal remedies and dietary supplements for proven health benefits, and we should.
  • We can anticipate the potential for abuse of pharmaceutical and biological agents, and we should.
  • We can focus our efforts on commercialization of products for constructive uses and not simply because we can make money, and we should.
Whether arguing for Avastin as a treatment for breast cancer or that high fructose corn syrup is the same as table sugar, such examples do nothing more than degrade the trust that is essential between the public and the scientific community.