THE BLOG

It's Not Working

04/10/2013 11:11 am ET | Updated Jun 10, 2013

Click here to read an original op-ed from the TED speaker who inspired this post and watch the TEDTalk below.

Drug studies with negative results are frequently withheld from publication while positive studies are more commonly published. This practice, referred to as "publication bias", makes it difficult to evaluate a medication's true efficacy. Ben Goldacre in his TEDTalk accurately points out how these skewed data affect the FDA's approval process. Medications are accepted for public use based on the FDA's analysis of available published studies in peer-reviewed journals. Unfortunately, the FDA's decision is often based on incomplete information. Since studies that show a benefit are more likely to make it to print than studies that show no effect, the positive benefits are exaggerated and medications, which justly should not be granted approval, receive FDA accreditation.

A problem of even greater importance is that the FDA routinely approves medications and medical devices that provide only marginal benefit at exorbitant costs, even when it has all relevant data. By law, the FDA considers efficacy and safety, but not cost, in its deliberations. If a statistically significant benefit can be proven, regardless of the expense, the FDA will approve the medication. Medicare, in turn, is legally bound to cover FDA accepted treatments that are reasonable and necessary without regard to cost[1].

Many of the newly approved, very expensive medications are classified as "biologicals". Biologicals are large molecule drugs that modulate a variety of cellular and immunological functions. They are produced by pharmaceutical companies in technically complex ways, often involving recombinant DNA. Because of the complexity of their structure and production, unlike most medications, it is difficult to produce cheap generic equivalents. The lack of generics allows enormous financial windfalls to the companies that developed these drugs. Many biologicals, such as Remicaide, Enbrel, and Humira, are widely advertised because they are so lucrative.

Biologicals, which are frequently used in cancer treatment, have, at times, provided some impressive advances in therapy. At other times they show a minimal, yet statistically significant, benefit that prompts FDA approval but comes with a large price tag. One of many examples is Aflibercept which is used for advanced colon cancer[2]. The study which convinced the FDA to approve this medication showed that if a patient was treated for 13.5 months, at $11,063 per month cost, survival is extended by almost six weeks. This calculates to $25,000 per week for the medication alone. Cancer treatment centers have become a major industry in the U.S, with franchises of university medical schools and private centers springing up all over the country. This growth is because of the enormous costs and profits involved in cancer treatment -- not because of outcomes. To challenge the appropriateness of these treatments and the need for these centers, or to challenge the advocacy groups that promote them like the American Cancer Society, is political suicide for any elected official.

Our health care system is deteriorating, struggling under bipartisan failure. Obamacare, which solves some problems, creates new ones and is not the answer.-- Dr. Dennis Gottfried

Life is priceless and, as a physician, if I err, I err on the side of life. As a people, we are all sympathetic to victims of cancer, especially those whose outlook is bleak and hopeless. But resources are finite and difficult decisions need to be made. Our health care system is deteriorating, struggling under bipartisan failure. Obamacare, which solves some problems, creates new ones and is not the answer. Countries with better systems than ours already demand value for their health care dollars. Many use concepts such as cost-effectiveness which analyze data to answer the question, "is the benefit worth the price?"

Laws need to be changed and the FDA similarly needs to define and factor in "value" in its approval process. Insurers should be allowed to withhold reimbursement for treatments that do not provide adequate value or offer more expensive policies that reimburse for lower value services. To pretend that cost and value play no role in American medicine is naïve and short-sighted. It is already there and the FDA should make it work on behalf of the American people by helping us fashion an affordable, high quality healthcare system.

Sources

[1] Bach PB, Limits On Medicare's Ability To Control Rising Spending On Cancer Drugs, NEJM, Feb 5, 2009, 360(6), 626-633

[2] Clombor K, Berlin J, Chan E, Aflibercept, Clinical Cancer Research Abstract, Feb 26, 2013 published online.

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