These days, regulation by the Food and Drug Administration (FDA) requires complex and lengthy testing before any new drugs become available. Nobody I know wants to make this process less safe for consumers, but here’s what drug trials now require:
- Phase 1: Screening for safety
- Phase 2: Establishing the testing protocol
- Phase 3: Final testing
- Phase 4: Postapproval studies
In Phase 2 trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
In Phase 4 trials, postmarketing studies delineate additional information, including the drug's risks, benefits, and optimal use.
Shepherding a new product through this gauntlet is a long, expensive affair which only the giants of Big Pharma can afford. It certainly seems we’d be well served by the proliferation of new, smaller, hungry, more agile drug companies; consumers benefit from this kind of competition and innovation in almost all other industries. Not drug development.
One key reason our monthly prescription tab is so high is NOT because the ingredients in our pills cost so much to produce. It’s because the drug companies (which generate profits some characterize as “obscene”) must cover the monster costs of moving their products through the established protocols.
The Perils of R&D
Even before the long test phase, there’s research and discovery.
Consider Big Pharma’s situation. They’re creating products they aren’t certain will work. They have specific targets and bulls-eyes they aim to hit – high blood pressure, cholesterol, lung function, cognitive impairment, etc – but they must create mysterious new concoctions that might not work. As we see so often these days, even the pills and supplements already available to us sometimes do more harm than good. Imagine the perils inherent in undeveloped, untested products!
What chance does a new, small, eager-to-innovate upstart have in this environment? Slim to none. Score another point for the continuing domination by Big Pharma.
Personalized Medicine to the Rescue?
If there’s anything on the horizon that might stem the tide of drug industrialization, it’s the promise of personalized medicine, particularly DNA-based solutions. We know there are limits to what I’ve called “one-size-fits-all medicine.” To be sure, those individualized approaches won’t be cheap, but they certainly won’t perpetuate continued drug industrialization by Big Pharma.
Even so, it won’t surprise me if Big Pharma positions itself to reap the lion’s share from personalized medicine. We can bet the ranch that the issue is already front and center on long-range planning charts of the pharmaceutical giants.