Tag: academic medical centers

Bioethics Blogs

The FDA Proposes Roadblocks to Laboratory Diagnostics

The American laboratory industry and its ability to serve patients is being challenged by a Food and Drug Administration (FDA) proposal that will create a new bureaucracy to regulate some of the most important tests that labs perform.

On July 31, the FDA issued a 60-day notice that it planned to issue proposed guidance that would give the agency the authority to regulate clinical laboratory tests developed in certified and accredited clinical laboratories around the country. Laboratory developed tests (LDTs) are best-in-class diagnostics that are developed at individual labs. They are commonly used when there is no FDA-approved test or when a lab makes improvements over an existing kit. LDTs are not sold to other labs or to the public; they are only used by the lab that develops them.

Treating LDTs as medical devices will reduce access to life-saving tests. LDTs are currently regulated by the Center for Medicare and Medicaid Services (CMS) under the authority of the Clinical Laboratory Improvement Amendments (CLIA). Since its inception in 1987, CLIA has been very effective. The FDA, on the other hand, has no native expertise in the regulation of lab tests; it will need to create a massive and redundant bureaucracy to oversee these tests now regulated by CMS and through local and state regulations.  

The Scope of Bureaucratic Expansion

If issued, this authority would require that the thousands of highly complex clinical laboratories in the United States, most of which reside in hospitals, submit information to the FDA about hundreds of thousands of distinct tests.

The agency has not yet clearly explained how it will oversee all of these LDTs.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

To Properly Care for Veterans, Do We Really Need a VA Health System?

The
ongoing VA scandal is indeed unfortunate and sad. In a speech on May 30, 2014,
in Washington, DC, Eric K. Shinseki apologized for the “systemic, totally
unacceptable lack of integrity” shown by some administrators in managing the Veterans
Administration health care system hospitals and clinics.
Within hours of the apology, Secretary Shinseki resigned.

It
is clear that the trouble within the VA has been brewing for some time. The
fuse that set off this latest explosion may have been
whistleblower claims that
managers at the Phoenix VA Medical Center were keeping two sets of books which
logged wait times for veterans seeking primary care appointments. There are allegations that some of the delays resulted in veteran deaths.
Acting VA Inspector General Richard J. Griffin issued a
preliminary report
confirming that Phoenix VA administrators had manipulated wait times possibly
to assure more favorable annual performance reviews and higher bonuses and
compensation for staff.  The unethical behavior by those entrusted with the care of our veterans is
inexcusable.

So,
the question again: Does America really need a separate VA Health System to
properly care for veterans? It may be a far-fetched idea, particularly since
we’ve had a stand-alone health system for veterans in America since World War
I. To some it may even sound unpatriotic and disrespectful. It’s not meant to
be. But, it’s a very practical question given the America today as compared to
the US of 75 years ago when the Veterans’ Bureau (as the VA was called then)
was first established. After World War I, the federal government was not in the
health care delivery business to any great degree.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

The Cost of Missing Information

109403306_26c1db655c_zThe medical research enterprise produces a massive amount of information that is critical for effective medical care, public health, innovation, and sound public policy. Yet only a fraction of this information is actually captured. Thus, for example, recent studies show that 17% of healthy volunteer phase 1 trials are published in scientific journals, whereas only 43% of phase 2 to 4 trials are published. Moreover, the trials that ultimately get published are not a random sampling of all the conducted trials. Rather, investigators and journals are biased towards publishing positive results. Famously, Peter Doshi and colleagues describe how documents unearthed through cumbersome processes dramatically altered the clinical utility picture for the influenza drug Tamiflu. They also describe the stonewalling by Roche and regulators when trial reports were sought. A real travesty.

In a 2012 report in JAMA “Clinical Trial Data as a Public Good,” Rodwin and Abramson argue for greater transparency in clinical trial reporting practices and suggest mandating the disclosure of standardized Clinical Study Reports (CSR) for all clinical trials. These CSRs are the documents that drug manufacturers produce in order to meet international and national regulatory requirements, which the authors contend are less likely to contain altered data than trials published in journals. The authors argue that mandatory disclosure would promote research integrity, is more reliable than other published summaries, and would ultimately reduce biases in biomedical research. They further justify CSR disclosure by claiming that clinical trials are public goods used by many different actors and that large public subsidies go towards supporting the drug industry in the form of drug patents, public drug insurance plans, and R&D subsidization. 

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.