Governmental influences on drug development: striking a better balance.

There is currently considerable debate in many countries over the effects of public policy - in particular, governmental regulation - on the development of innovative pharmaceuticals. Regulators must balance patients' access to therapies with ensuring the safety of drugs. The consequences of poor decisions can be dire: if access is promoted at the expense of safety, a dangerous product can cause incalculable harm; conversely, if safety is over-emphasized at the expense of access, patients can suffer from the absence of life-saving and life-enhancing medications. Using the United States as an example, we discuss the influence of governmental bodies such as the US Food and Drug Administration (FDA), as well as recent legislative initiatives, on pharmaceutical innovation. We argue for a balanced approach to governmental interventions.

Flawed scientific studies block progress and sow confusion.

Research in crop science in recent years has advanced at an unprecedented rate, and the intermingling of old and new crop breeding technologies has made the term "genetically modified" - and its variant, Genetically Modified Organism, or "GMO" - virtually obsolete. A kind of pseudo-category, it is primarily used pejoratively to refer to the use of the newest, most precise, most predictable, molecular genetic techniques. Prodigious amounts of time, effort and care have been expended to ensure that crops developed for commercialization using molecular techniques are safe, and that new traits are beneficial. Â Yet, despite these advances, some skepticism persists about them, partly due to the publication of fraudulent, poorly designed, and biased studies by a few "rogue scientists" whose intention is to contaminate the scientific literature and sow mistrust about molecular genetic modification among regulators and the public. We discuss how such flawed studies make it to publication and how the scientific community can combat such disinformation.

Is biotechnology a victim of anti-science bias in scientific journals?

Primarily outside the scientific community, misapprehensions and misinformation about recombinant DNA-modified (also known as 'genetically modified', or 'GM') plants have generated significant 'pseudo-controversy' over their safety that has resulted in unscientific and excessive regulation (with attendant inflated development costs) and disappointing progress. But pseudo-controversy and sensational claims have originated within the scientific community as well, and even scholarly journals' treatment of the subject has been at times unscientific, one-sided and irresponsible. These shortcomings have helped to perpetuate 'The Big Lie' - that recombinant DNA technology applied to agriculture and food production is unproven, unsafe, untested, unregulated and unwanted. Those misconceptions, in turn, have given rise to unwarranted opposition and tortuous, distorted public policy.

Genetic engineering applied to agriculture has a long row to hoe.

In spite of the lack of scientific justification for skepticism about crops modified with molecular techniques of genetic engineering, they have been the most scrutinized agricultural products in human history. The assumption that "genetically engineered" or "genetically modified" is a meaningful - and dangerous - classification has led to excessive and dilatory regulation. The modern molecular techniques are an extension, or refinement, of older, less precise, less predictable methods of genetic modification, but as long as today's activists and regulators remain convinced that so called "GMOs" represent a distinct and dangerous category of research and products, genetic engineering will fall short of its potential.

The flower industry gets the genetic engineering blues.

The genetic engineering of plants over the past two decades has led to significant scientific, commercial and humanitarian successes, with more than 2.1 billion hectares cultivated worldwide. The vast majority of cultivation has been huge-scale commodity crops - corn, cotton, canola, soybean, sugar beet and alfalfa - while specialty crops such as fruits, nuts, vegetables and ornamental plants have been underrepresented. The commercialization of genetically engineered (GE) flowers has been especially neglected. Various laboratories worldwide are conducting research on various traits and flowers, the most intense interest focusing on carnation, rose, chrysanthemum and petunia, but the expense and uncertainty of government regulation is a hindrance. There are untapped economic opportunities in this sector, but for it to blossom, a regulatory climate that can spur development is critical. We need regulation that is scientifically defensible and risk-based.

The U.N. celebrates a regulatory debacle.

During the early 2000s, delegates to the U.N.-sponsored Convention on Biological Diversity negotiated a "biosafety protocol" to regulate the international movement of organisms genetically modified with the newest, most precise techniques, which they dubbed "living modified organisms," or LMOs. The protocol is based on the bogus "precautionary principle," which dictates that every new product or technology - including, in this case, an improvement over less-precise technologies - must be proven completely safe before it can be used. Rather than creating a uniform, predictable, and scientifically sound framework for effectively managing legitimate risks, the U.N.'s biosafety protocol established an amorphous global regulatory process that encourages overly risk-averse, incompetent, or corrupt regulators to hide behind the precautionary principle in delaying or denying approvals. It has become a self-defeating impediment to the development of new and better products. To "celebrate" the 15th anniversary of the Protocol, the UN Environment Program is seeking articles about various aspects of it, illustrating yet again the poor judgement and audacity of United Nations' programs and officials.

A Plea for the Renewal of the ISBR.

The recent meeting of the International Society for Biosafety Research (ISBR) focused on so-called genetically modified organisms. For decades, in most regulatory frameworks, recombinant DNA-modified organisms have been the wrong focus of unbalanced agri-food regulations. The ISBR should instead adopt a scientifically defensible and truly risk-based perspective, abandoning a misleading pseudo-category.

Biotech's defining moments.

Confusion about terms related to biotechnology--genetic modification, GMOs, genetic engineering, transgenic, and all the rest--has been around for decades. This definitional dysfunction has created myriad opportunities for mischief and given rise to widespread over-regulation, diminished agricultural R&D, ill-advised conferences and risk assessment studies, flawed analyses (including a recent tome from the OECD), fear-mongering by NGOs, and a perplexed public. Greater precision in terminology would improve the lot of scientists, the quality of public policy and, eventually, human and environmental health.

Food from cloned animals is part of our brave old world.

When confronted by pressure from activists and Congress, the US Food and Drug Administration (FDA) has not always adopted policies and made decisions about individual products that accord with the scientific evidence. An example was the unnecessarily and markedly prolonged review of the veterinary drug bovine somatotropin (bST), or bovine growth hormone, during the 1980s. The FDA now faces a similar situation surrounding the question of whether meat and milk from cloned animals and their offspring are safe for human consumption. Having made a preliminary decision in the affirmative - based on an exhaustive analysis of scientific articles, health records, blood samples and studies of the composition of meat and milk - the agency has been beleaguered by criticisms. It remains to be seen whether, ultimately, science will trump anti-technology, anti-consumer activism.

A proposal for FDA reform.

Since the current system for the regulation of drugs in the United States was established in 1962, the FDA has steadily increased the scope of its responsibilities and activities, and, concomitantly, the regulatory burden on drug developers. The costs and time that are required for drug development have spiralled upwards. Reform of drug regulation is necessary; it must be fundamental in nature, and it must come from outside the agency through new legislation.

As biotech turns 20...

Biotechnology applied to pharmaceuticals has made significant contributions to medicine during the past 20 years. Although important products will continue to emerge, benefiting patients and perhaps lowering medical costs, there are too many biopharmaceutical companies chasing too few products, which are themselves over-regulated and incredibly expensive to test and bring to market.