It is generally assumed that a Democratic government would move quickly to increase its control over the economy. Through increasing taxes and redistribution the government would increase the number of people who receive money from its coffers and enlarge its partisan base. People can argue how much good or bad this would be for the economy (and I have certainly suggested it would be harmful) however, there are additional ways in which the government can expand its power and that is my interest here.
A Democratic government would almost certainly increase regulation of business.* This would be done in the name of abstract "goods" like the environment, or people's health, or fairness, with the details of how such regulations would actually work ignored. Increasing regulation can always be made to seem a public good without an apparent price because most often the costs are hidden. In the Medical field the hidden costs will play out over an extended time frame as opportunity costs.
*(One aspect of our recent economic trials and tribulations that has escaped mention in the MSM is that while the Democrats have blamed deregulation of the financial sector for the meltdown, a plausible case can be made that lack of oversight of governmental and quasi-governmental agencies is at least as contributory to the present mess. Since the Democrats actively blocked oversight of Fannie Mae and Freddie Mac, they have little interest in investigating this aspect of the problem.)
To take one very limited example: The FDA demands extensive testing of drugs for safety and efficacy before allowing them to be marketed. In real terms this means that new drugs must be tested by the Pharmaceutical companies to the tune of close to $1 Billion for each drug approved. Even with such extensive testing, significant problems are missed. For one recent example, Vioxx was tested extensively. While I do not know the exact research protocol, typically extensive testing means that a drug is given to approximately 3000 people for between 6 weeks to 6 months. In very rare circumstances, as with the recently released sleep medication Lunesta, the drug is given for 6 months, which supposedly establishes its safety and efficacy for long term use. There are some obvious problems here. First, serious side effects that occur as often as in 1 or 2% of the population will be missed in many of these studies. In the case of Vioxx the increased risk of myocardial infarction (heart attack) only showed up after the patients had been on the drug for 18 months; these are called "treatment emergent side effects". Second, in a great many cases, and especially as time goes on without serious side effects being identified, higher doses than tested become more and more likely, leading to treatment emergent side effects. Third, since studies are only required to show results at the 95% confidence level, that means that as many as 1 out of 20 drugs will appear to be safe and effective but in fact prove to be ineffective and sometimes unsafe.
In a fortuitous coincidence, Dave Schuler took a look recently at another problem that can arise from our drug approval processes, Off-Label, Ethics, and Economics. While his comments could be construed to suggest that more regulation might be warranted, ultimately I completely agree with his conclusion:
IMO we need a major revision in the entire system by which drugs come to market. The incentives today are so high, the methods so antiquated, the conflicts of interests so manifest, the resources of the government agencies so limited, and the consequences possibly so severe that change is really overdue.
The reasons for "off-label" use are complicated but the primary issue is that with a limited pharmaceutical armamentarium, once a drug is approved for any use, the urge to see if formerly untreatable conditions can respond to a new medications can become overwhelming. Neurontin, or Gabapentin, which Dave writes about in his post, is a perfect example. Peripheral Neuropathy is a near impossible condition to treat involving nerve pain in the extremities, especially the legs and feet. The pain can be intermittent or continual and responds very poorly to conventional pain killers. When anecdotal reports reached the literature that Gabapentin seemed to reduce PN pain, its use for such indications increased dramatically. Unfortunately, the early anecdotes probably were more indicative of a placebo effect than of a real physiological effect yet the only way to differentiate placebo for actual response is to do a large scale study (costing close to the aforementioned billion dollars.) There was no incentive for anyone to do the study, few people were harmed by Gabapentin, and only with the passage of time and the decay of response characteristic of placebo effects was the lack of efficacy noted. I do not think there are any real villains here; there was a company excited about the potential of its drug, doctors and patients excited about a new treatment, and a regulatory system that made it prohibitively expensive to do the requisite studies to ascertain efficacy.
Whether we are discussing Gabapentin, Vioxx, or any number of other drugs or interventions, in all of these situations there is a ready rationale for those so inclined to press for increased regulation, as well as increased liability for "evil" big pharma, a popular enemy of many populist politicians.
Under a Democratic government friendly to trial lawyers and hostile to the Pharmaceutical industry, the stage is set for the government to increase regulation on medications. Even without increasing regulation, our current regulatory climate is retarding medical progress.
On Monday, Reason noted that for certain, common conditions you are better off being a dog or a horse than a human being:
Veterinary Medicine Gets the Best Stuff First
One of the effects of oppressive regulation in medical research is that animals have better access to cutting edge therapies than people:
Veterinary science continues to provide the shining example of where we could be with even just a little less waste, less socialism and less pointless, self-serving bureaucracy.
In the race to perfect 'regenerative medicine,' stem cell therapy for animals is ahead of treatment for humans because it is not so strictly regulated. It's not experimental - it's here. ... There are no side effects and no problems with rejection, because the patient is also the cell donor. ... I don't see any reason why humans aren't doing it."
Here is another example of the sort of work presently taking place in veterinary medicine, but that is many (government-enforced, largely unnecessary) trials away from reaching human clinics:
Tendon injuries can be career-killers for horses: only 5 to 15 percent of those with damaged tendons will ever make it back to the track, he says. But a novel treatment that Casey developed - injecting adult tendon cells grown in a lab into horses’ injured core lesions - has had remarkable success. The first 10 of 14 horses treated have returned to intensive training, and seven of these racers are back in full competition, he says. “We’re putting back natural tissue into a defect that has formed,” says Casey. “It’s minimally invasive. So far so good.”
The article Reason quotes notes some perfectly reasonable concerns about extending these procedures to humans, yet there is a particular point that suggests that waiting for a guarantee of safety will prove to be problematic.
One of the effects of oppressive regulation in medical research is that animals have better access to cutting edge therapies than people:
Veterinary science continues to provide the shining example of where we could be with even just a little less waste, less socialism and less pointless, self-serving bureaucracy.
In the race to perfect 'regenerative medicine,' stem cell therapy for animals is ahead of treatment for humans because it is not so strictly regulated. It's not experimental - it's here. ... There are no side effects and no problems with rejection, because the patient is also the cell donor. ... I don't see any reason why humans aren't doing it."
Here is another example of the sort of work presently taking place in veterinary medicine, but that is many (government-enforced, largely unnecessary) trials away from reaching human clinics:
...however, there’s work to do, Casey says, including safety studies to determine that once injected, cells stay where they’re supposed to and don’t travel. Another would be to determine that the cellular signaling message to “turn on” or divide gets “turned off” again. Therapy Cells has hired a legal team in Washington, D.C. to work toward approval from the U.S. Food and Drug Administration. “It will revolutionize how you treat tendon injuries,” predicts Casey.
Casey says he and his team will await guidance from the FDA about the next steps to take. “But our first target is to hopefully gain FDA approval and in short order have human applications in human tendons,” he says. If that day arrives, he may finally end up with patients who can actually talk to him about their treatment.
Cells that do not stay where they're supposed to and have confused cellular signaling tend to become cancerous. This is a of course a concern. The problem is that cancers often take a very long time to develop and require a whole series of metabolic mistakes before they can grow and metastasize. That means that of necessity for the first 15-20 years during which stem cell procedures in humans take place, we will not know if there are going to be frightening treatment emergent side effects. If we insist, as the FDA does now, that a treatment must be proven "safe" before it is approved, we will never approach the promise of much of biotechnology.
[Reason has explored some other dimensions of this issue in Envisaging a World Without the FDA. I recommend it unreservedly.]
I have suggested that we treat patients as consenting adults and allow them to take more active responsibility for their care. To those who posit that this would leave patients, who lack the requisite knowledge to make such decisions, in danger, I woudl merely point out that the Health supplements market is completely unregulated, products either contain inert (ie, ineffective) or active ingredients (potentially unsafe), and the market is huge, in the many billions of dollars range. Consider an alternative regimen that would offer medications that are provisionally approved and explain to the patients the known unknowns and the existence of unknown unknowns and then allow adults to decide for themselves the level of risk they are willing to take. I would very much like to have the choice between, for example, chronic pain and disability from a damaged knee or Achilles tendon and an experimental treatment that works well in horses or dogs but may contain hidden risks for humans. My choice would depend on my level of impairment and my tolerance for risk. I woudl prefer having the option to having a government agency tell me my only choice is a life time of problematic drugs and chronic impairment and pain. We are on the cusp of amazing progress in medicine as we unravel the secrets of our biology. The question we will soon face is how to facilitate the miracles that are going to be here soon (and are already showing up.) Who would you prefer to make these choices for you, you or the government?
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