Category Archives: Position Papers

The FDA’s Preclinical Study Requirements Need to be Changed (April 29, 2015)

The FDA’s Preclinical Study Requirements Need to be Changed (April 29, 2015)

Summary – The 60 Minutes report on the use of polio virus to kill brain cancer indirectly highlights the need to better balance safety concerns in early stage research versus the excessive delays in bringing promising treatments to market.  Research is not linear so a twenty-five year review process for one approach is indirectly stifling progress in multiple directions.  The FDA’s current approach is not the way to win the war on cancer.


The CBS 60 Minutes report on the use of polio virus to kill brain cancer is remarkable in more than one way. To me, I was taken aback to learn that the FDA had delayed this promising treatment for over a decade with pre-clinical study requirements.

As a general matter, the FDA has designed a drug approval process where a new treatment takes, on average, 10 -15 years and costs over a billion dollars to bring to market – AFTER the treatment has passed the FDA’s pre-clinical safety concerns.

Taken together, twenty-five years is a very long time to get government approval of a treatment that shows promise in the lab.  Moreover, in many cases, the FDA’s safety concerns relate to people who only have months to live and who would like to volunteer to participate in clinical trials despite the risk to their lives.

During the wait for better treatments, about 600,000 people will die of cancer in the United States this year. Another 1.7 million people will be diagnosed with cancer.  Roughly $100 billion will be spent treating cancer.  Many people will get radiation and chemotherapy, which oftentimes are ineffective and have hideous side effects.

The medical community strongly defends this approach based on safety concerns.  However, the overall impact of the approach should be considered.

For example, if the FDA had imposed fewer obstacles to the polio virus research 10 years ago, what would have happened?  How many people would have died prematurely in trials?  On the other hand, how many people would have avoided radiation and chemotherapy? How many people would still be alive and now be cured of cancer?  Who should be responsible for balancing the implicitly conflicting objectives of safety versus time to market: research scientists, social scientists, the FDA, individuals acting in their own interests, or some other authority?

My own view is that the majority of the 1.7 million people who will be diagnosed with cancer this year will not have an effective advocate for their cause.  Many will die as an unintended consequence of the FDA’s safeguarding of people who would otherwise like to volunteer for trials but are denied that opportunity.

It just so happens that the pharmaceutical companies are the biggest beneficiaries of the current system.   The system has created enormous barriers to entry and has successfully insulated the enormous profits streams of the pharmaceuticals for oftentimes ineffective treatments.  Yet the pharmaceuticals have the medical professional standing behind firmly behind consumer safety to help shield them from potentially competitive cures such as the polio virus.

In listening to the 60 Minute broadcast, I have to wonder how many other promising treatments the FDA has been holding up for years or even decades with “safety concerns” in pre-clinical research?

More to the point, who is keeping score of what the FDA is doing regarding pre-clinical research study requirements?  Who is measuring the costs and benefits of the FDA actions and reporting the results?

While these questions raise some murky issues, it is clear that the current system is extraordinarily slow and costly and the proper incentives and industry structure are not in place to drive significant improvements in health care in a reasonable time frame.

Nonetheless, leadership on healthcare issues is beginning to emerge from the technology industry as “big data” capabilities open the door to personalized medicine.  However, even here, the FDA has taken the tack of slowing down progress, for example, by finding the provision of personal genetic information to individuals by companies such as to be unlawful.  This decision can be described in its most favorable light as government paternalism.

Unfortunately, the FDA will continue to bring progress to a crawl unless political leaders reorganize the role and responsibilities of government to include advancing healthcare care for those who are most in need (rather than primarily focusing on protecting people in clinical trials particularly those who do not want the FDA’s protection).

In a nutshell, the 60 Minutes report highlights an important step in cancer research, but also exposes the need to recalibrate the overall costs and benefits to society imposed by the FDA drug approval scheme, particularly including pre-clinical study requirements. The impact of the FDA’s actions should be reported on a regular basis to the public, who after all pay for salaries and other budgetary expenses of the FDA.  There is ample room for improvement in the current system, despite the veracity in which it is defended by the medical community.

Steve Zecola, author and entrepreneur

Potomac Falls, Virginia


The FDA’s Approach to Personal Genetics: Tilting at Windmills (January 9, 2014)

Summary – The FDA’s warning letters to personal genetic firms undermines the ability of these firms to provide valuable information to researchers for the development of personalized medical advancements. The Department of Health and Human Services and the FDA should be reorganized to focus on exploiting technology to improve health care and lower cost, rather than undermining it at every turn.

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A Call to Action on Breast Cancer: How Management Science Can Improve Performance Outcomes (October 23, 2013)

Summary – To address the increasing incidence of breast cancer, we all must rally around a realistic objective such as reducing by 1,000,000 women the projected levels of breast cancer by the year 2023 and, during the same time period, increasing the 10-year survival rates of those afflicted to 95%. Once these objectives are set, detailed plans should be put in place for each type of breast cancer including plans for education, prevention, detection, research, regulation, benchmarks, reporting, allocation of resources and recognition programs.

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Understanding Telecommunications Policy (January 9, 2009)

Summary – the most effective way to address AT&T’s and Verizon’s re-monopolization of the telecommunications industry is to: 1) require AT&T and Verizon to divest their wireless divisions to their existing shareholders and let them operate as standalone business; 2) have the FCC undertake a detailed analysis and subsequent frequency reallocation to enable the wireless carriers to offer a complete package of services to their customers, and 3) require all facilities-based providers to allow unencumbered attachments to their networks and unfettered resale of their facilities.

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