TV programs like The Swan and Extreme Makeover demonstrate that when medicine meets the marketplace, the results can be stunning. But while new technologies and investments drive the latest health services, entrenched political interests threaten progress. Take, for instance, the recent controversy over ultrasounds in California.
California’s overloaded medical system often shoves parents-to-be out the door so fast that they hardly get a chance to view the ultrasound of their baby. Prenatal portrait studios have arisen to fill the demand for viewing time.
For between US$130 and $300, businesses such as Little Sprout Imaging offer 3D still and video ultrasound images better than the ones most patients receive in doctors’ offices. For expectant parents, this is a fabulous new service, but it’s been predictably opposed by doctors and others reluctant to relax their grip on healthcare.
Prenatal ultrasound expert Dr. Roy Filly was so offended by the new portrait studios that he said they are “a repulsive notion, born out of anything to make a buck.” Assemblyman Alan Nakanishi must share this feeling, as he recently introduced a bill to force prenatal studios to tell patrons that the U.S. Food and Drug Administration (FDA) disapproves of such use of medical technology.
Thinly Veiled Political Move
In January, the FDA warned that “the long-term effects of repeated ultrasound exposures to the fetus are not fully known.” Given that it’s not unusual for expectant mothers to get more than one ultrasound in a doctor’s office, either the FDA is saying it’s okay for doctors to expose women and their babies to unknown technologies, or it’s a thinly veiled political move.
Indeed, ultrasounds are just one of the well-tested technologies meeting with FDA disapproval. Another example is a drug called polidocanol that’s been used in Europe for four decades to treat varicose veins.
“I used to use this stuff all the time when I practiced in Europe,” said thoracic surgeon Dr. Robert Szarnicki, “and it’s not just useful for veins, it can also help solve other problems like hemorrhoids and ulcers.” But the FDA has banned the use of polidocanol, putting it through expensive clinical trials that are currently stalled.
Andrew Burrows, vice president of investor relations at BTG, a UK-based technology commercialization company, said it normally costs about $50 million to $75 million to get regulatory approval for a drug, and that the extra delay in polidocanol’s case will likely add an extra $10 million to $20 million to that total — plus lost revenue because of the delay in getting to market.
On the Upside
On the upside, however, Burrows noted that once polidocanol is rubber-stamped, the company will use the FDA’s approval as a positive element of its marketing. That kind of marketing budget makes a Super Bowl ad spot look like a bargain — and pretty much ensures that Americans suffering with painful varicose veins will have to pay much more for the product than they might have otherwise.
Of course, it’s no surprise that the FDA is overly cautious. Regulators don’t get credit for every safe procedure they approve, but they are subject to enormous outcry when they approve something that is later found to have serious flaws; recall the Thalidomide mistake.
Need for Reform
As Milton Friedman recently pointed out, from the regulator’s point of view, “it doesn’t matter how many mistakes you make in not approving a drug that turns out to be good.” That certainly explains how the FDA could oppose technologies with a 40-year track record and clearly demonstrates the need for reform.
Just as the Internet changed communications, the steady infusion of capital into human improvement techniques is producing amazing new healthcare procedures. These procedures should be allowed to reach consumers as fast as possible, without being hamstrung by politics and poorly constructed government agencies. Consider the experience of a firm not subject to FDA scrutiny.
Epoch, a company that uses computer programs to change neural pathways to fix the problem of dyslexia, boasts a 96 percent success rate. The program is a true health advance for many, but it’s significant that Epoch CEO Michael Fox is quick to point out that the company is not strictly medical.
If Given a Chance
Instead, Fox says that although his software will greatly improve performance of dyslexics, and perhaps of Alzheimers and Parkinsons patients in the future, his company is squarely set in the nontraditional healthcare space. While this distinction is a good way to avoid FDA and other interference, it’s not an option available to all new firms entering the market.
As for how customers will know Epoch’s programs are safe and worthwhile, Fox explains that “to build a business that will last 25 to 50 years, we need to prove to the marketplace that everything we say about our product is real.”
Fox is right that the market is an efficient regulator. Legislators who want to enhance the healthcare of Americans should expand the role of the market and limit that of the FDA.
Sonia Arrison, a TechNewsWorld columnist, is director of Technology Studies at the California-based Pacific Research Institute.
This story was originally published on May 5, 2004, and is broughtto you today as part of our Best of ECT News series.
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