This week the U.S. Food and Drug Administration (FDA) has announced a strategic plan for Advancing Regulatory Science at FDA. At a time when technological breakthroughs as well as profit motive drive advances, the FDA needs to stay a step ahead of the game. This ensures that our kids have healthy food and drugs, and that our kids inherit the economic power of technological leadership. We read between the lines to imagine seven future scenarios from which our kids will benefit.
1. Personalized Health Care
We may think of our doctor as god-like, a healer, a technical genius. But face it: medicine relies on trial-and-error. If one treatment does not show improvement, another one is tried. Perhaps the biggest breakthrough on the medical horizon is personalized healthcare. The idea is simple: identify the genetic and biochemical patterns at work in the individual patient. Then select the treatment most likely to show success for that patient's specific type. A lot of advances must come together to achieve personalized healthcare. It starts with management of large bodies of data sufficient to allow a correlation between patient type and treatment outcome. And patient type? Where does one start? Metabolism, genetics, differences in molecular processes, and more must be studied to understand and define the "person" in personalized health care.
Where does the FDA come in? Effectiveness of treatment and reduction of negative impacts stands at the center of the FDA mission. In a simple example of personalized health care, imagine one patient with diabetes and a sensitive stomach, another with diabetes and heart problems. Assume there are two diabetes drugs. One might reduce stomach side-effects but have a higher risk of heart failure, and another could be tough on the stomach but not linked to heart failure. Doctors could run a couple of diagnostics to determine which patient should receive which drug, perhaps even to fine-tune the dosage. The real sci-fi future: a quick handheld scanner, and perhaps a pinprick of blood, can be used to micro-develop the perfect drug just for you.
2. Gene Therapies
Cancer treatment is the wild west of gene therapy: a place where some of the rules can be broken because the ultimate safety of treatment is of little use to patients that are fighting a deadly disease. In gene therapy, scientists put a gene sequence that can kill cancer cells into a virus. The virus delivers the gene sequence, which is taken up predominantly by faster-growing cancer cells. Current obstacles include the body's own defense systems, which can eliminate the virus before its payload of cancer-killing genetic material is delivered. Ethical questions also abound. Genes are the blueprints for life. How much can humans play around with these fundamental building blocks without paying a price for unintended consequences?
3. Predictive Toxicology
Most of our current state of knowledge about the effectiveness and side effects of drugs relies on small-scale trials followed by epidemiology, or the statistical study of affected populations. It is a model with some huge loopholes: side effects that appear in a small percentage of trial candidates may affect a substantial number of people once a treatment is given approval. Predictive toxicology uses better knowledge of the biochemical pathways used by a drug to create computer models which can predict potential side effects, perhaps even help engineer a better solution without side effects. Even better, predictive toxicology can decrease the costs of developing treatments, leading to better options for those who suffer from rare or unusual diseases.
4. Nanotechnology
Scientists today are using nanotechnology in creative ways. For example, the manufacturing techniques developed to make cell phones smaller are also being used to make teensy-weensy obstacles courses for cancer cells. Researchers can apply various drugs and measure the effect on the cancer cells' progress through the obstacle course. Nanotechnology is also behind dreams of tiny machines that, like the sumbarine that journeys through blood vessels in Fantastic Voyage, can enter our bodies and go straight to the location of the problem.
Of course, nanotechnology represents new threats as well. It is important for the FDA to stay well ahead of science that can help predict when a new material is a genius breakthrough that can rush to the market, and when the risks should keep the science restricted to the petri dish a bit longer.
5. Robotic Prosthetics
It is a parent's worst nightmare: an accident deprives their child of the full function of the faculties most of us are lucky to enjoy. Great hope is already on the horizon for technologies that can interface our own brains to robotic body parts, giving control and perhaps ultimately even sensation back to the injured person. Advances in energy storage and generation may make it possible to implant wireless devices that are powered by our own motion or biochemistry. While a generation is already growing old on the dance floor -- or even the surfboard -- thanks to hip and knee replacements, the newest generation can look forward to a future in which the limits of the human machine are pushed as far as our imaginations can reach.
6. Food Safety
The recent EHEC outbreak in Germany is a reminder that even countries with advanced food safety surveillance are not immune from tragic deaths, even caused by "health foods" like bean sprouts. The FDA plan puts a lot of focus on reacting to and preventing the spread of food contamination emergencies. But one bullet point mentioning "enhanced detection" spurs the best futuristic visions, scenes in which the food you buy has a small detector built into the packaging. Like a turkey with a thermometer that pops when it is done, food packaging could turn colors when pathogens are detected at dangerous concentrations.
7. Forever Flu Vaccine
Currently, the flu vaccine must be reformulated every year to protect against the quickly evolving influenza viruses. An end to the annual flu vaccinations is close at hand. Scientists have identified parts of the vaccine that do not change quickly and are already targeting that part of the virus in vaccine development. When an effective vaccine can be found, it should work on many variations of the flu virus, including newly evolved versions, leading to a vaccine that lasts forever.