What slows progress in scientific research? Some fairly direct pointers in these two recent articles:
In the past decade, funding of biomedical research has doubled, the human genome has been sequenced and the drug approval process has been speeded up considerably. But, disturbingly, the result has been virtually no new treatments for conditions of the brain.
"Why are there not more drugs?" Dr. Martin asked.
The reason is that a lot of pharmaceutical companies are more interested in producing blockbuster lifestyle drugs and "me too" medications that mimic their competitors' successful products than in investing in treatments for the likes of Alzheimer's and Parkinson's.
The regulatory system doesn't promote innovation, Dr. Martin said. And intellectual property (patent) laws promote secrecy and discourage collaboration, undermining the type of co-operation that is needed to tackle complicated brain conditions.
One big question is how FDA will handle the changing paradigm. The agency is used to weighing a drug's side-effect profiles against the severity of the condition and the drug’s overall effectiveness. Highly targeted drugs, perhaps linked to a genetic test, call for a completely different regulatory mindset. Side effects may suddenly be verboten--and volumes of genetic data will be a stiff challenge to FDA’s reviewers.
How will the agency react? Probably slowly as it has so far, Galas says. The agency is underfunded, and that makes it difficult to keep up with current research trends. That uncertainty in turn makes investors nervous, potentially slowing the growth of the industry--and employment opportunities.
In anticipation of targeted medicines, pharmaceutical and biotechnology companies are increasingly performing genetic studies of clinical trial participants in hopes of identifying genetic profiles that predict therapeutic outcomes. A drug that only benefits 15% of participants might seem like a clinical failure--but if those respondents share a genetic profile, the drug might be admitted to the market with an accompanying genetic test.
But such data can be difficult to interpret, so it could even slow down an approval process. This could be a disincentive to doing such tests in the first place. Until FDA’s stance is clarified, pharmacogenomics will be a volatile and unpredictable business and career path. "Young companies trying to get into pharmacogenomics and personalized medicine are facing daunting challenges because of uncertainties with FDA and just the inherent difficulties of trying to change the paradigm to something where side effects are unacceptable," says Galas.
Despite these new opportunities, genetics remains a field defined by uncertainty, as both FDA and industry wrestle with questions of data analysis, side effects, and other issues. The uncertainty is likely to be a drag on job growth in medical genetics. "If you’re coming into the field now, the market for your type of jobs may not grow as fast as you had hoped," says Galas. "We always underestimate the impact of these types of technologies, but we also overestimate the speed at which they’ll be adopted. There’s going to be a huge need for people to do this work. The better the people and the more of them there are, the faster it will happen."
Large pharmaceutical companies will follow the safest profit-bearing line - which is determined by regulation they help shape to protect their business from competitors in the short term. At the same time, government employees are following their own political goals and urge to power with no regard to long-term negative effects on the regulated. The way in which those in charge of large companies and government employees collaborate to ruin progress for the many in the name of short-term gain for a few was recently clearly laid out (again) at Mises.org:
The Chicago School of economics favored and still favors the theory of "regulatory capture." Under this theory, an industry or some portions of an industry cultivate government to obtain laws and rules that favor the industry.
The government trades favors for what it wants. Politicians gain political contributions, side payments, and votes for being seen to control the industry. The industry captures the regulators. End of story.
North went much further. He called the first step of obtaining favors "baiting the trap." But matters do not stop there, he pointed out. The trap is set when the industry becomes comfortable with its subsidy, tax break, tariff, exclusive position, license, or whatever. It then begins to extract monopoly rents and to lower product quality.
This then leads to further steps such as public outcry and a government demand for the industry to police itself. Then come crisis, further regulatory intervention, and eventually a government stranglehold over the entire industry via a panoply of boards and price controls. This is when the trap is sprung. The market is replaced by government power and bureaucrats. Government, its aim being control, traps and captures the industry.
In the shorter term, the interest groups use the state against the public. In the longer term, the state and its bureaucrats rule the roost. In the end, the government bureaucracies expand. Paperwork and soft jobs rule the industry, innovation and competition are eclipsed, and the public suffers from poor product quality and high prices.
Medical research and development in Western-style democracies has slid into an unfortunate position: dragged down by regulation, and no let-up in sight in the growth of government and its willingness to impose costs upon progress towards better medical technologies. The true cost of this state of affairs lies in what you do not see: the vast and encompassing commercialization of new and innovative medicine that would be taking place in a free market - or even just one far less regulated.
If telomerase inhibitors were a new kind of computer chip, they would have been on every Wal-Mart pharmacy shelf and selling for ten dollars a bottle by now. ... In a free system, life insurance companies, consumer magazines, and other competing interests would provide medical databases. Maybe even the AMA would become a force for "truth-in-medicine," as it was to some degree before the creation of the FDA. Under common law but free of arbitrary regulation, drug development would be as fast as computer development. Cancer would be extinct and human beings would finally, really, own their own bodies.
How else will your future health be harmed because a large government allows the unscrupulous to manipulate their way to short-term gain at the cost of slow progress in medicine?