In a brazen effort to further expand its empire, the FDA has ordered 23andMe to stop marketing its genetic tests to consumers. Don't underestimate the danger this move poses to individual rights.

23andMe does not sell nutritional or therapeutic products. There are no legitimate safety issues. 23andMe provides consumers with information. It's not a stretch to say that the FDA is denying the right of free speech to 23andMe and its customers. Halting the sale of 23andMe's genetic tests is tantamount to censorship.

The FDA argues that the information provided by 23andMe could be wrong or misinterpreted. The same could be said for any source of medical advice--whether it's an article found on Wikipedia or the recommendation of a licensed physician.

The FDA's complaint against 23andMe is disingenuous for at least two reasons. 23andMe does not provide specific diagnoses. 23andMe identifies genetic susceptibilities. As the Home page on its website says, "Find out if your children are at risk for inherited conditions...," "Understand your genetic health risks," and "Arm your doctor with information on how you might respond to certain medications." [My emphasis.] Plus, the dangers cited by the FDA are purely imaginary: consumers are not able to prescribe their own drugs or surgeries.

As the Wall Street Journal points out, "The FDA lacks any specific statutory authority to regulate genomic sequencing technologies... Yet in 2010 the FDA simply decreed by fiat that these tests are considered new medical devices that require premarket testing and approval."

It's the FDA that is circumventing the law, censoring free speech, and impeding innovation. Who will order the FDA to halt its illegal actions?

I heartily recommend Freedom and Individual Rights in Medicine to anyone who wants affordable health care and the right to make their own health care decisions. FIRM "promotes the philosophy of individual rights, personal responsibility, and free market economics in health care. FIRM holds that the only moral and practical way to obtain medical care is that of individuals choosing and paying for their own medical care in a capitalist free market. Federal and state regulations and entitlements, we maintain, are the two most important factors in driving up medical costs. They have created the crisis we face today."

Here is an excerpt from an article (Moral Health Care vs. “Universal Health Care”) by FIRM's founders Lin Zinser and Paul Hsieh.

Although American scientists, doctors, and businessmen have produced the most advanced medical technology in the world, American health care is in a state of crisis. Technologically, we are surrounded by medical marvels: New “clot buster” drugs enable patients to survive heart attacks that once would have been fatal; new forms of “keyhole surgery” enable patients with appendicitis to be treated and discharged within twenty-four hours, whereas previously they would have spent a week in the hospital; advances in cancer treatment enabled bicyclist Lance Armstrong to beat a testicular cancer, which, had he lived fifty years ago, would have killed him; and so on.

From an economic perspective, however, such medical treatments are increasingly out of reach to many Americans. Health care costs, as reported by the New York Times, are rising twice as fast as inflation.1 And health insurance, as reported by USA Today, “is becoming increasingly unaffordable for many employers and working people.”2 A decreasing percentage of employers are offering health insurance benefits to their workers, and many of those who are offering benefits are requiring their employees to pay a greater percentage of the costs.3 The U.S. Census Bureau reported in 2007 that nearly forty-seven million Americans had no health insurance, a sharp increase of ten million people from a mere fifteen years earlier.4 In short, there is a major disconnect between existing life-saving medical technology and the ability of Americans to afford it.

This discord is affecting doctors as well. The American Medical Association warns physicians that, due to the lack of affordable health insurance, “more patients will delay treatment and . . . doctors will likely see more uncompensated care.”5 Hence, each year doctors are working harder and harder but making less and less money, resulting in a “critical level” of stress and burnout. According to a recent survey of doctors, “30 to 40 percent of practicing physicians would not choose to enter the medical profession if they were deciding on a career again, and an even higher percentage would not encourage their children to pursue a medical career.”6

Total spending on health care in the United States amounts to nearly 17 percent of the entire economy, and this is expected to rise to 20 percent by 2015, “with annual spending consistently growing faster than the overall economy.”7 Because of skyrocketing health care costs, the U.S. federal Medicare trust fund is expected to go bankrupt in 2019, less than twelve years from now, potentially leaving millions of elderly Americans without health insurance coverage.8 American health care is in dire straits and will continue to worsen—unless Americans demand fundamental political change to reverse the trend. Unfortunately, the kinds of changes currently being proposed by politicians will only exacerbate the problem.

Politicians from across the political spectrum, including Democratic presidential candidate Hillary Clinton and Republican candidate Mitt Romney, have argued that the government should guarantee “universal coverage” to all Americans, making health care a “right.”9 And politicians are not alone; numerous businessmen, union leaders, and insurance executives are united in saying that this will solve our problems.10

It will not.

Contrary to claims that government-imposed “universal health care” would solve America’s health care problems, it would in fact destroy American medicine and countless lives along with it. The goal of “universal health care” (a euphemism for socialized medicine) is both immoral and impractical; it violates the rights of businessmen, doctors, and patients to act on their own judgment—which, in turn, throttles their ability to produce, administer, or purchase the goods and services in question. To show this, we will first examine the nature and history of government involvement in health insurance and medicine. Then we will consider attempts in other countries and various U.S. states to solve these problems through further government programs. Finally, we will show that the only viable long-term solution to the problems in question is to convert to a fully free market in health care and health insurance.

Almost everyone says that you must have health insurance. Here is why that isn't necessarily true:

• If you have a family to insure or are over age 50, you can buy quite a bit of health care for the same amount you will pay for premiums, deductibles, and copays under Obamacare.

• If people paid directly for their own health care, prices would plummet. About 50% of the prices you are charged are for overhead—much of it the office staff and systems needed to track insurance claims. Hospitals and doctors would be forced to publish and guarantee their prices. Competition—the only genuine means of driving down prices without sacrificing performance and quality—would ensue.

• Hospitals set highly inflated prices because that gives them negotiating leverage with insurance carriers. No one—not even the wealthiest—really pays those prices. Many hospitals will give you an automatic 25% discount just for being a self-pay patient. Many doctors will negotiate a 50% discount if you pay directly. Depending on your income and outstanding bills, you may be able to obtain even higher discounts. Demand an itemized bill.

• Hospitals and physicians groups are happy to accept monthly payments. Those who pay for their own health care establish personal credit with local hospitals and doctors. People who pay for their own health care receive better service. These things could come in handy if the government begins denying expensive health care services to older or sicker patients insured under Obamacare.

• You may be able to enhance your standing with your preferred hospital by doing volunteer work, fundraising, and/or making regular donations.

• Yes, there are risks associated with being uninsured. Uninsured patients are usually disqualified from receiving organ transplants. Long hospital stays are rare these days—less expensive home care is usually, but not always, an option. Be sure you fully understand the risks before choosing to be a self-pay patient.

The public was told that we needed Obamacare to enable people with pre-existing medical conditions to get health care. That's not quite true.

Two-thirds of the states had high-risk health insurance pools for people with pre-existing medical conditions. These programs were severely undersubscribed. The average state had fewer than 10,000 enrollees. The total number of enrollees in the 30+ states was roughly 250,000. That's a small number compared to the 48 million Americans said to lack health insurance.

Obamacare also included an interim federal high-risk health insurance pool. That means that since 2010 anyone in the United States with a pre-existing medical condition could buy health insurance. The Pre-Existing Condition Insurance Plan (PCIP) was also severely undersubscribed. (The enrollee numbers were consistent with the state high-risk pool numbers.)

Comparing Obamacare plans to the high-risk pool plans shows that there is very little savings for people with pre-existing medical conditions. The premiums are about the same. The deductibles and copays for Obamacare appear to be slightly lower. However, in some scenarios a person with a pre-existing medical condition pays more under Obamacare.

For example, the Missouri Health Insurance Pool (MHIP) has a coinsurance requirement while Obamacare has a copayment requirement. Under Obamacare, a patient must pay a portion of the bill whenever they visit a doctor. Under MHIP, there is no copayment due at the time of the visit, but after the patient meets their deductible they are responsible for 20% of the bills up to a limit. Both Obamacare and MHIP have out-of-pocket maximums: The maximum under Obamacare is lower, but the patient starts paying out-of-pocket sooner.

A permanent federal high-risk health insurance pool would have ensured that anyone with a pre-existing medical condition could buy health insurance. This could have been accomplished without imposing mandates on employers and individuals, and without providing waivers to select companies and government employees.

Mobile Health Marketplace has a concise and well organized directory of mobile health apps and devices. The directory covers apps for health and wellness, illnesses and injuries, medical treatment support, and workplace health and safety.

An interview last month with Rick Valencia, VP and GM of Qualcomm Life, at U-T San Diego offers insights about why some big names are investing in wireless health—and why success has so far been elusive.

Valencia sees wireless health serving different purposes in different settings. In developing countries, it provides access to care in remote and rural areas. In developed countries, wireless health has the potential to reduce the cost of care by helping people stay well and providing services outside of expensive “acute care settings” (hospitals and emergency rooms).

Honeywell HomMed has made a similar point. Remote monitoring can be used to avoid hospitalizations by detecting problems before they become acute and to shorten hospital stays by allowing patients to be released earlier (to be closely followed at home).

Qualcomm’s 2net Hub and new 2net Mobile devices suggest that the industry still needs help connecting mobile and remote devices to the network and managing them.

Valencia’s last comment was interesting but enigmatic. He said that under new health care laws we are moving away from fee-for-service to a “capitated” environment. In the past, when a patient showed up it was a revenue opportunity. In the new system, when a patient shows up it will be viewed as a cost. Valencia believes this will motivate physicians and hospitals to reduce costs. “They can make a choice to pay for something and not get reimbursed at all if they know that by paying for that, it is going to bring down the total cost of care.”

Valencia is right in that consumers will do everything they can to avoid expensive acute care settings. But I don’t see how a “capitated” (top-down) environment will lead to lower costs. It may seem counterintuitive to many people, but experience shows that (regardless of intentions) top-down systems end up being wasteful and expensive. Competition is the only force that drives down prices to the marginal cost.

President Obama and top Democrats promoted Obamacare as a boon for people with pre-existing medical conditions. Finally, people with pre-existing medical conditions could “get health care.” However, the sales pitch ignored two key facts. No one in the United States is denied life-saving treatment just because they are unable to pay. And two-thirds of the states already had high-risk health insurance pools.

It’s hard to compare the cost of Obamacare plans to the state high-risk pool plans that are now being phased out. There are multiple plans and they are structured differently. The total out-of-pocket expenses for Obamacare plans appear to be somewhat less than the total out-of-pocket expenses for the Missouri Health Insurance Pool (MHIP) plans that I examined.

What’s interesting is that the Obamacare plans, which do not discriminate against people with pre-existing conditions, resemble the high-risk pool plans. A middle class family that doesn’t qualify for a subsidy could end up spending $20,000 per year on health care despite being insured and having no pre-existing conditions.

The Obamacare plans may hurt people with pre-existing conditions in other ways. For instance, some Obamacare plans restrict coverage to a local network. People with genetic disorders, many of which are life-threatening, need the freedom to visit out-of-network physicians who have significant experience or who are developing new treatments. There are also higher copayments for visiting specialists--something that people with pre-existing conditions are more likely to do.

People with pre-existing conditions will suffer disproportionately if Obamacare leads to problems predicted by some critics such as waiting lists and rationing. Some may even be denied treatment and sent home with a bottle of pain pills as a presidential candidate once suggested.

Prior to the 20th century there were only a handful of truly effective drugs. Oliver Wendell Holmes, Sr. quipped, "If all medicines in the world were thrown into the sea, it would be all the better for mankind and all the worse for the fishes.”

The most potent medicines at the time included opium, quinine, and anesthetics such as cocaine, ether, and nitrous oxide. Acting independently, druggists created the United States Pharmacopoeia (USP) and National Formulary to promote standards for composition, purity, and strength.

Federal drug laws were often enacted in the wake of a tragic event. The Biologics Act of 1902 passed after several children died from contaminated smallpox vaccines and diphtheria antitoxins. The Pure Food and Drugs Act passed in 1906 after a group of volunteers demonstrated the harmful effects of specific additives and preservatives on their own (!) digestive systems.

Even most critics of today’s Food and Drug Administration (FDA) recognize that the Biologics Act boosted safety and the Pure Food and Drugs Act promoted accurate labeling. However, the U.S. Supreme Court ruled that the government could not prosecute manufacturers for making debatable therapeutic claims because efficacy is often a matter of opinion. There had to be evidence of intentional fraud.

Harvey Washington Wiley, the U.S. Department of Agriculture’s first chief chemist, campaigned vigorously for the Pure Food and Drugs Act. However, his career shows that he also believed in industry self-regulation. He left the USDA Bureau of Chemistry in 1912 to run the Good Housekeeping Seal of Approval program.

The Harrison Narcotics Act of 1914 initiated federal regulation of opium. The Act required prescriptions for products exceeding specific dosages—forcing physicians and pharmacists to keep accurate records. Though the U.S. Constitution doesn’t grant the federal government the right to regulate either drugs or physicians, Congress cited the Commerce Clause as justification.

(The Commerce Clause says that the federal government has the power to regulate trade between the states. It was obviously intended as a limited power. However, the Commerce Clause has repeatedly been stretched to assert federal power over products that are produced, sold, and used in more than one state.)

The FDA is Born
In 1927 the USDA Bureau of Chemistry became the Food, Drug, and Insecticide Administration. The name was shortened to Food and Drug Administration in 1930. By this time aspirin, codeine, morphine, digitalis, nitroglycerin, and insulin were added to the list of truly effective drugs. Sulfa drugs and penicillin were introduced over the next decade.

The FDA enlarged its power following yet another tragedy. The pharmaceutical firm Massengill introduced a liquid form of a sulfa drug that had already passed repeated tests. However, the company neglected to test the solvent. More than 100 patients died from kidney failure. The FDA argued that existing laws were insufficient because the drug did not contain additional regulated ingredients and the company had not made fraudulent claims. Though the company was successfully sued for gross negligence, Congress went ahead and passed the Food, Drugs, and Cosmetic Act of 1938.

The Food, Drugs, and Cosmetic Act required manufacturers to file new drug applications (NDAs) before marketing new drugs. If the FDA did not respond within 60 days, then the drug was automatically approved. However, labeling and prescription requirements were also expanded. The Act made it clear that (regardless of the Commerce Clause) the FDA’s authority extended over all drugs and many dubious medical devices. More important, the FDA was empowered to take action against what it judged to be false claims.

The Durham-Humphrey Amendment passed in 1951 expanded the FDA’s power. The FDA became the sole judge of whether a new drug required a prescription. Physicians benefitted from the arrangement: If a consumer wanted a prescription drug, then that consumer had to visit a licensed physician.

Over the next decade the FDA acquired powers over pesticide residues and additives in food. Meanwhile, the list of truly effective drugs continued to expand. In fact, there was exuberance for what some were calling “magic bullets.” But to others the pharmaceutical industry’s success justified more regulations. A few politicians demanded federal control over competition and pricing.

The proposed Kefauver-Harris Amendments promised mandatory patent sharing. The amendments also required manufacturers to prove that their new drugs were safe and effective. At first, the Kefauver-Harris Amendments seemed destined to fail, as supporters did not have enough votes.

Once again, proponents exploited a human tragedy to snatch victory from the jaws of defeat. This tragedy did not even occur in the United States. The West German pharmaceutical company Grünenthal GmbH introduced thalidomide in 1957 to relieve morning sickness during early pregnancy. By 1962 it was clear that the drug caused still births and arrested limb development. An NDA for thalidomide had been submitted to the FDA, but fortunately the FDA delayed approval to investigate an unrelated problem.

Though there really was no urgent need for additional action in the U.S., the media sensationalized the “Thalidomide babies” and the Kefauver-Harris Amendments were passed in 1962. Only now the provisions concerning pricing and patents were dropped and new provisions requiring more exhaustive testing and granting the FDA greater power over manufacturing were added. The net effect was that it became harder for pharmaceutical companies to gain approval for new drugs, depriving physicians and patients of additional choices. Meanwhile, the FDA entered a period of rapid growth, expanding from 1,000 to 6,500 employees over the next 20 years. The FDA’s authority to approve or deny new drugs based on efficacy was now firmly enshrined in the laws of the land.

The folly of testing efficacy is that a drug does not have to help all or even most patients to be of value. Plus, there is as much to learn about a drug after it has been introduced, but almost nothing is learned once it has been denied. As we will see in Part 2, the delays incurred performing exhaustive tests often contribute to the deaths of patients who have otherwise run out of options. The net effect of the Kefauver-Harris Amendments was that fewer new drugs were developed, and obtaining FDA approval now took as long as 20 years.

The FDA and Medical Devices
At first the FDA tried to regulate medical devices such as pacemakers simply by classifying them as drugs. That didn’t work—but the Dalkon Shield tragedy certainly did. The Dalkon Shield was a contraceptive intrauterine device (IUD). Manufactured by Dalkon Corporation and marketed by the A.H. Robins Company, the product caused severe pelvic infections, leading to more than 300,000 lawsuits.

The Medical Device Amendments of 1976 defined three classes of medical devices. Class I devices are disposable products such as gauze and are subject to Good Manufacturing Practices (GMP) regulations. Class II devices are subject to additional controls and include products such as surgical drapes and infusion pumps. Class III devices are products such as pacemakers that are used to sustain health. The approval process for Class III devices is as rigorous and extensive as the approval process for new drugs.

Bizarrely, all new medical devices were assumed to be Class III devices. If the manufacturer could show that a new medical device was “substantially equivalent” to a pre-amendment device or any currently marketed Class I or Class II device, then the premarket approval process could be avoided. However, “substantially equivalent” devices still had to comply with the 510(k) premarket notification process. And in another bizarre twist, the FDA failed to develop any medical device performance standards until 1997, rendering Class II irrelevant for the first twenty years.

Reversing the Damage
As the FDA’s power continued to mushroom, and as winning approval for new drugs and devices became more arduous, more patients suffered. The investment required to win approval for a new drug discouraged the development of drugs for niche markets—drugs for rare diseases (including, for example, cystic fibrosis) and drugs targeting a subset of patients.

The Orphan Drug Act of 1983 was designed to encourage development of drugs for conditions affecting fewer than 200,000 people in the United States. This was to be accomplished not by relaxing the approval process but by offering subsidies, tax breaks, and exclusivity (temporary monopolies).

Government regulations often have unintended consequences. Some companies discover ways around the regulations. Other companies find unanticipated ways to profit from regulations. While many drugs have been granted orphan drug status, not all deserved the perks. For example, a drug may be granted orphan status for one condition and then granted orphan status for another. And because orphan status is based on the U.S. market, there may still be a large global market for an orphan drug. Finally, the number of people who suffer from a condition may grow significantly over time. AZT started as an orphan drug but with the spread of AIDS has racked up sales in the billions of dollars.

Another problem caused by FDA regulations concerns patents. Drugs may be patented, but patent protection is only good for seventeen years. For most products seventeen years seems generous. But what about a drug that takes fourteen years to win approval? A generic version may be marketed by competitors just three years after the original drug is approved.

The Waxman-Hatch Act of 1984 extended patent protection for drugs delayed by the approval process. It also made it easier to gain approval for generic drugs (which up to then had to repeat much of the safety and efficacy testing performed by the inventor). Specifically, the Waxman-Hatch Act allowed the manufacturer of a generic drug to submit an abbreviated new drug application (ANDA).

The Drug Export Amendment Act of 1986 reversed the FDA decision that made it illegal for manufacturers to export drugs that had not been approved for sale in the United States. However, there were three major restrictions. The Act required that the manufacturer be actively seeking FDA approval, that the drug be covered by a U.S. investigational exemption, and that the drug be for export to a country that has already approved it through a regulatory process meeting specific standards.

Subsequent legislation repaired some of the damage caused by the FDA while inflicting new damage. The Safe Medical Device Act (SMDA) of 1990 finally enabled the approval of Class II products by facilitating performance standards and adding controls such as post-market surveillance. In other words, approval would be granted with the understanding that manufacturers would closely monitor the products in the field.

The Prescription Drug User Fee Act (PDUFA) of 1992 was designed to speed review of new drug applications. The FDA had a backlog of NDAs but Congress was unwilling to increase the FDA’s budget. The PDUFA allowed the FDA to charge pharmaceutical companies approximately $200,000 per application, which could be used to hire more application examiners. However, there was one catch: the PDUFA had to be renewed by Congress every five years. While the average time to review an NDA dropped from 30 months to 18 months, the user fees increased. However, there is evidence that the savings to manufacturers (due to faster drug approval) exceeded the added user fees.

Criticism from all Directions
The FDA aspires to do much more—to regulate more products and to educate citizens about more threats. However, the more power the FDA has to control products and tell citizens what to believe, the less freedom there is for individuals. A government can continue piling on laws and regulations in an effort to eliminate all safety hazards, but after the first layer or two there are diminishing returns. The only way to eliminate all product safety hazards is to eliminate all products.

Governmental zeal for teaching citizens what is and is not good for them is beyond the pale. At a minimum, it assumes that government knows what is best with absolute certainty. In the worst case, it puts the country on a path to totalitarianism.

The FDA has tried to regulate herbs, vitamins, and other dietary supplements since the 1950s. However, the FDA crossed the line when it prosecuted retailers for selling books along with vitamins, claiming that the books served as surrogate product labels. Many people saw these actions as an assault on freedom of speech.

Many of the same people who don’t trust pharmaceutical companies also don’t want the FDA restricting access to herbs, vitamins, and dietary supplements. After all, there have been conflicting studies regarding the efficacy of these products. Should the FDA be able to restrict access to specific products just because they have not been proven beneficial?

After 38 deaths were (falsely) attributed to L-tryptophan, the FDA announced plans to regulate a wide range of dietary and nutritional supplements. Millions of consumers were outraged. The Dietary Supplement Health and Education Act (DSHEA) of 1994 ordered the FDA to revoke its plans. The Act further allowed supplement manufacturers to make nutritional claims—but not disease-fighting claims. However, supplements making nutritional claims were required to include the disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” (The first sentence is clearly true, but the second sentence is mere bluster.) The DSHEA also prohibited the FDA from taking action against retailers selling dietary supplements plus books and magazines about such supplements.

The FDA Modernization Act of 1997 was part of a larger deregulation push, though it ended up being a much tamer piece of legislation than its originators hoped. The Act mainly codified changes already being practiced and added a few half measures. It did not substantially rollback the FDA’s power.

How the FDA Got to Where It Is
The FDA’s history can be divided into three stages. The first stage, the period from roughly 1902 to 1930, saw the development of safety and labeling regulations that were for the most part beneficial. During the second stage, from approximately 1930 to 1983, the FDA exploited a few human tragedies to greatly expand its powers. The FDA even turned disastrous events in Europe to its advantage. During the third stage, the period from about 1983 to today, there have been multiple attempts to reform the FDA, with very little success. Only the dietary supplement industry has been able to muster the forces needed to resist FDA aggression.

The FDA remains extremely powerful and has successfully deflected efforts to enact badly needed reforms.


Sources:

Klein, Daniel B. and Tabarrok, Alexander, “History of Federal Regulation: 1902–Present,” The Independent Institute. http://www.fdareview.org/history.shtml

Madden, Bartley J., Free To Choose Medicine: Better Drugs Sooner at Lower Cost, Second Edition, LearningWhatWorks, Naperville, Illinois, 2012

“History of the Food and Drug Administration,” Wikipedia, https://en.wikipedia.org/wiki/History_of_the_Food_and_Drug_Administration


Next: How the FDA Harms Patients, Physicians, and the Health Care Industry

While there are legitimate roles for government in health care, denying life-saving drugs to seriously ill patients, discouraging innovation, and driving up costs are not appropriate functions. The Food and Drug Administration (FDA) in particular is often an obstacle to new technologies and consumer empowerment.

Please stay tuned for the three part series: Reform the FDA!

Part 1: How the FDA Amassed Tremendous Power.
Part 2: How the FDA Harms Patients, Physicians, and the Health Care Industry.
Part 3: It’s Not Too Late to Fix the FDA.

There is a fascinating article in today's Wall Street Journal about Theranos, a company that is automating and miniaturizing laboratory tests. Founded by Elizabeth Holmes, Theranos uses a fingerstick to draw a large drop of blood from the skin rather than poking a vein to fill one or more vials.

The basic concept is not entirely new. The fingerstick method is routinely used by diabetes sufferers and people on anticoagulants. What's unique about Theranos is that they have or are developing fingerstick versions of a long list of blood tests. The fingerstick method is less expensive, safer, faster, and less error prone. For example, sticking a vein can cause a bruise. The blood must be put into vials and the vials sent to a lab that does the analysis. As Ms. Holmes points out, more people are involved when the traditional method is used, so there are more opportunities for error.

While Theranos does not currently support self-testing, a strategic alliance with Walgreens promises to bring testing closer to the consumer. Going to a hospital outpatient lab typically means driving to the hospital, parking a distance from the closest entrance, registering for the test, and sitting in a waiting room. Hopefully, Walgreens will offer testing in the evenings and on weekends when many hospital labs are closed.

The article ends with the suggestion that Theranos' technology could lead to wearable diagnostic devices using silicon microneedles. See my previous article about Gentag.

I was recently invited by the British Medical Journal to debate whether mobile medical apps should be regulated.

Mobile medical apps and hardware add-ons present a golden opportunity to make modern medicine more accessible, effective, and affordable. In fact, this could be our best chance to retool healthcare. But to make the most of it, we must ensure that entrepreneurs are free to innovate and that physicians and patients enjoy the widest choice of apps.

The FDA’s plan to regulate medical apps will only discourage investment and limit choices. By burdening developers with confusing rules and bureaucratic procedures, the FDA will drive up costs, add delays, and prevent potentially game changing products from getting off the launch pad.

Wireless gadgets offer the mobility and low price points that up to now have been sorely lacking in healthcare technology. They also lower the entry barriers for entrepreneurs with fresh ideas. Smartphones and tablet computers are relatively inexpensive platforms that come loaded with processing power, memory, and connectivity and feature developer friendly operating systems. The huge installed base of wireless gadgets offers a ready market, and online app stores provide convenient distribution. If the FDA leaves developers free to experiment, then we will surely witness an explosion of innovative, money saving products and services.

Dinosaur attitudes
Government agencies are often last to understand new technologies. When the FDA looks at wireless devices, it sees yesterday’s medical products repackaged to evade its oversight. This defensive attitude was on display in the FDA’s 2011 press release announcing draft guidelines for medical apps. The FDA emphasized that it is seeking to regulate only the “small subset of mobile medical apps” that work with devices that are already regulated or that transform wireless gadgets into devices that are already regulated. So what’s all of the fuss about?

Actually, medical apps and hardware add-ons are not the same old products in new packages. They are new tools with unique benefits. Consider Mobisante, a developer of smartphone and tablet based ultrasound imaging systems. These systems sell for a fraction of the price of the ultrasound machines found in large hospitals. Mobisante’s products are not intended to replace the high end machines. They are designed to extend the benefits of ultrasound imaging to locations such as small clinics and field hospitals.

FDA regulations create unnecessary obstacle courses for anyone bringing new medical devices to market. MIM Software introduced an app that displays diagnostic images on the iPhone in 2008 but was forced by the FDA to pull it from the market. After more than two years, including studies of the app’s performance under different lighting conditions, the company was finally granted approval. But the FDA stipulated that the app should be used “only when there is no access to a workstation.” Apparently, the FDA does not trust the judgment of trained medical professionals. But what makes FDA staff so much smarter?

Even supporters of medical app regulations urge the FDA to quit stalling and publish its final guidelines. The mHealth Regulatory Coalition, which speaks for some developers of mobile health technology, warns that uncertainty discourages investment. It should also question the propriety of a government agency putting products through the wringer when it still hasn’t told developers the rules. The coalition claims that medical app regulations are “deregulatory” because the FDA could have regulated even more types of health apps. That’s like politicians who call a smaller increase in this year’s national budget a “cutback.” No matter how it’s spun, regulating medical apps expands the FDA’s empire.

Too much power
The FDA is already too powerful. Most reasonable people agree that drugs and implants should be regulated because these products pose safety risks to ordinary consumers. But medical apps aren’t ingested or implanted and are typically used by tech savvy professionals and early adopters. Requiring FDA approval defeats two key benefits of medical apps: quick time to market and the ability to fix bugs and add features in a timely manner via downloadable updates.

The FDA was established to ensure safety but through mission creep has acquired the authority to judge effectiveness. However, we’ve learnt that specific drugs can be effective for specific people, so it’s counterproductive to evaluate drugs based on overall effectiveness. It makes even less sense to assess the effectiveness of medical apps because they are new and rapidly evolving.

FDA regulations favor large corporations over start-ups. Small developers often lack the resources and experience needed to win FDA approval. Big corporations engaged in multiple development efforts can spread the costs around. And large corporations often lobby government agencies to ensure that new regulations are in sync with their products and strategies.

None of this means that the FDA can’t play a positive role. The FDA could work with app developers, physicians, and patients to promote high standards, voluntary testing, and accountability. Rather than imposing regulations on all developers, the FDA could serve as a watchdog, taking action only when warranted.

Physicians and patients don’t want medical apps that meet stodgy government standards—they want medical apps that deliver exciting new capabilities at attractive prices. Developers free from constraints will give them what they want and retool health care for the 21st century.

Ira Brodsky is author of The History and Future of Medical Technology.

The Personal Health Tech Blog was cited as one of the Top Ten Health Technology Blogs:

2. Personal Health Tech Blog – Ira Brodsky blogs about health technology from a personal perspective in an easy-to-understand format. While this blog is relatively new, we’ve included it in this list thanks to the easily digestible news on health technology that’s relevant to patients and caregivers. Definitely one to watch.