Bartley J. Madden

Bartley J. Madden sees one major flaw in the American effort to bring effective medications to patients at the lowest prices. That flaw is called The Food and Drug Administration (FDA).

Madden, a senior fellow at the National Center for Policy Analysis, is an expert in the application of systems thinking—the study of how elements that can be seen as working together in a system interrelate and affect each other.

In his book, Free to Choose Medicine, Madden advocates bringing free-market competition to the FDA’s regulatory monopoly on the public’s access to new drugs. He suggests the creation of an alternative path to new medications featuring internet-based, up-to-the-minute information which doctors and their patients can use to assess the risks of particular drugs for themselves, free of the hidebound FDA thinking which, Madden believes, often does more harm than good.

In this interview with Life Extension®, Madden explains his view of the problematic nature of the FDA as it currently exists, how the system can be improved, and why he believes a grassroots movement advocating reform is necessary.

LE: What prompted your interest in FDA reform?

BJM: FDA reform became a top priority for me after reading the tragic details of how cancer patients were dying without access to the promising new drugs being tested in clinical trials. This struck me as an enormously important problem crying out for a solution.

LE: What’s your approach to this problem, in a nutshell?

BJM: My two main ideas for FDA reform are, number one, the FDA itself is the bottleneck in the drugs-to-patients system, the goal of which is better drugs, sooner, at lower cost. As a practical matter, the FDA’s continual push for more extensive clinical testing ignores the importance of providing new drugs sooner, at lower cost. Second, the system solution is to introduce consumer choice. Patients could then decide whether to use not-yet-approved new drugs based on their unique health conditions and risk preferences.

Anyone’s death from the denial of access to a promising new drug is profoundly sad for the victim’s family and loved ones. So too is the unnecessary pain and suffering of the much greater numbers of victims who are denied access to drugs that could significantly better manage their diseases.

LE: Could you give a specific example?

BJM: Multiple Sclerosis, or MS, is a disease of the nervous system that can cause difficulty in maintaining balance when walking, a painful loss of eyesight, and an almost constant state of fatigue.

An approved drug for treating MS, Tysabri®, demonstrated in clinical trials a remarkable ability to decrease relapses as well as the formation of additional brain lesions. But in 2005, following some reports of serious side effects, Tysabri® was pulled from the market. Many MS patients immediately pleaded with the FDA to restore access to Tysabri®, and the FDA eventually agreed. Even so, while the drug was off the market, hundreds of thousands of people suffered needless pain and worsening of their disease.

John Calfee, who worked as an economist with the American Enterprise Institute, reported survey responses of MS patients who were asked if they were willing to take their chances with Tysabri® despite its apparent one-in-1,000 chance of causing fatal complications. Roughly half of the patients said yes, they were willing to take the risk.

Additionally, 71% of the MS patients surveyed agreed with the following statements: “If a drug has safety concerns, the FDA should warn people, but I should be free to decide with my doctor whether to use those drugs or not,” and, “I am capable of making my own treatment choices, based on the information I get from my doctor.”

LE: It seems like the situation is more fluid and complex than the FDA allows for.

BJM: The amount of risk patients are willing to accept for potential improvement to their health is not static. Health conditions change over time, pain can become intolerable, the degeneration associated with Parkinson’s disease, MS, or Alzheimer’s often becomes disabling, and for some there is little hope for survival using the drugs that have secured conventional FDA approval.

Further, the sum total of useful data about drugs grows over time, leading doctors and patients to change their opinions about how effective and how risky a new drug might be.

With today’s system, the patient must meet the needs of the FDA’s mandated clinical trial criteria—or, in almost all cases, get nothing. A single arbitrary level of risk is chosen by the FDA’s risk-averse bureaucracy and imposed on everyone. Such a system cannot help but fail to achieve its stated objective of “advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable.”

LE: What do you see as missing from the current healthcare debate?

BJM: An understanding of the overall drugs-to-patients system and of the current government policies that needlessly delay access to drugs and greatly increase cost. Also missing is sufficient appreciation for the lives extended and quality-of-life improvements made possible by innovative drugs and medical devices.

To mention just one type of drug, the estimated monetary value to society of the HIV/AIDS therapies that were introduced by private-sector pharmaceutical companies, beginning in the late 1980s, is $1.4 trillion, according to a 2006 study. Of that total, 95% represented health benefits to patients and only 5% accrued to private-sector drug developers. That seems to have been a remarkably good bargain for society.

Concern over the cost of healthcare so dominates the attention of politicians and reform advocates that little attention is given to the role of innovation. It is innovation that yields highly effective drugs… Ignored is the average billion-dollar cost that drug companies incur to obtain FDA approval for a new drug. Also ignored is the possibility that changing the current drug-approval process could substantially reduce the cost of new drugs.

LE: What about government intervention?

BJM: Imposing government price controls on drugs, rather than addressing innovation and the way patients get access to new drugs may seem easier and faster—a more direct route to solving an apparent problem. It is not. Price controls strict enough to have a substantial impact on drug costs would decimate investment in new drug development because developers would be unable to earn an adequate return on their investors’ capital. Investment capital would go elsewhere. Small biotech companies—the source of so many of the new drugs that are revolutionizing medicine—would become an endangered species.

LE: Why do you think a grassroots movement for your “Free to Choose Medicine” approach doesn’t already exist?

BJM: Firstly, the nightly news keeps most of us frightened about serious side effects (including death) from the use of approved drugs. We rarely see stories blaming deaths on unnecessary regulatory delay by the FDA, even though a great many of such deaths occur for every one death due to an approved drug. Such lopsided coverage leads many people to believe that an even stronger FDA is needed to perform even more stringent testing of drugs. Moreover, few reporters understand that the discovery, testing, and sale of new drugs is a system—one that is failing because of the faulty design of one of its components. Or that suffering and deaths would be greatly reduced if promising new drugs moved faster through clinical testing.

Second, the FDA and its supporters erroneously choose to believe they are serving the public interest when they are highly motivated to preserve their authority by defending the status quo. They maintain their power, in part, by banging the drum of fear that any weakening of FDA powers would unleash a torrent of harmful drugs on the public. So far, that has worked. Pharmaceutical company experts who could contradict this claim are often silent out of fear of antagonizing the regulators whose decisions can spell the difference between their company’s financial success or failure.

Third, most of us have not realized, thought about, or even been able to evaluate what economists call the “opportunity cost” of not being free to make an informed choice about the best drug treatment for ourselves. This freedom to choose is one we actually had prior to 1962, when legislation was enacted that greatly expanded the FDA, in effect granting it a monopoly over access to drugs, and thus preventing people from accessing medicines of their choice.

LE: Throughout your book, you stress a systems mindset that views the FDA as one component of a complex drugs-to-patients system. Why do you adopt this mindset?

BJM: Absent a systems mindset, most extensive FDA clinical testing is automatically viewed as a good thing regardless of the negative consequences elsewhere in the system. A fundamental central point is that the systems perspective provides the compelling argument that the FDA itself is the bottleneck in achieving the system’s goal of better drugs, sooner, at lower cost.

Consumer choice and competition are the heart of a market system. They are especially relevant in achieving truly large-scale benefits from “Free to Choose Medicine.” This becomes apparent when you analyze how the FDA testing process works.

LE: Finally, what do you hope to accomplish with your book?

BJM: It lays out the practical tasks to begin building a reform movement that, if the book does the job I hope it will do, people will want to join. The core reason is this: We all want healthier, longer, and more productive lives for ourselves, our families, and all Americans.

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To purchase a copy of Free to Choose Medicine, visit www.Amazon.com