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.