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The Boston Globe

Health & wellness

Framingham firm’s owner pleads Fifth

Barry Cadden, owner of the Framingham pharmacy whose drugs have been linked to hundreds of fungal meningitis cases and at least 32 deaths, invoked his Fifth Amendment rights and declined to answer questions Wednesday during a congressional hearing in Washington on the outbreak.

Cadden walked into the hearing room accompanied by three other men, including two attorneys. After being sworn in, he refused to respond to questions. He read from an index card four times in response to questions:

Comments

It's not like he had a lot of choice. At least the Congressmen got to feel like big shots and got a few minutes in front of the cameras. Which they doubtless knew was all that would come of this.

The sleepy, tawdry Globe apparently denies reporters out-of-state phone calls--even to follow a major event that started nearby. On pharmacy compounding and the fungal meningitis outbreak, the only Globe writer to slip the knots even a little has been Carolyn Johnson, whose cautious story a little over a week ago clearly indicated a national issue--hardly limited to the Boston area. ---------------------------------------------------------------------------------------------------------- [ Carolyn Y. Johnson, Compounding pharmacies fill medical niche, Boston Globe, November 3, 2012, at http://www.bostonglobe.com/metro/2012/11/02/compounding-pharmacies-filled-niche-for-major-hospitals/47MsPtBMEkT67TQmfNXF8O/story.html ] ---------------------------------------------------------------------------------------------------------- Writing today, November 14, in the NY Times, Sabrina Tavernise describes testimony of Dr. Margaret Hamburg, the FDA administrator, to a House subcommittee investigating pharmacy compounding. Her recommendations are similar to the changes in federal law being proposed by Rep. Markey of Malden, the ranking member of the subcommittee. ---------------------------------------------------------------------------------------------------------- [ Sabrina Tavernise, FDA chief asking for more control over pharmacy compounding, New York Times, November 14, 2012, at http://www.nytimes.com/2012/11/15/health/fda-asking-for-more-control-over-drug-compounding.html ] ---------------------------------------------------------------------------------------------------------- [ Testimony of Margaret A. Hamburg, November 14, 2012, available from Drugstore News at http://www.drugstorenews.com/sites/drugstorenews.com/files/HHRG-112-IF02-WState-HamburgM-20121114.pdf ] ---------------------------------------------------------------------------------------------------------- [ HR 6584, 112th Congress, Verifying Authority and Legality In Drug Compounding Act of 2012, filed November 2, 2012, by Edward J. Markey [D, MA-7] with Steve Cohen [D, TN-9], Stephen F. Lynch [D, MA-9], John W. Olver [D, MA-1] and Louise McIntosh Slaughter [D, NY-28], available from the Library of Congress at http://thomas.loc.gov/home/thomas.php ] ---------------------------------------------------------------------------------------------------------- Dr. Hamburg writes that "pharmacies engaged in non-traditional compounding should register with FDA," as though that would be something new. In fact, Section 510 of the Food and Drug Administration Safety and Innovation Act of 2012 [Public Law 112-122] already requires that "every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding or processing of a drug or drugs shall register" with the Department of Health and Human Services, which includes FDA. ---------------------------------------------------------------------------------------------------------- [ PL 112-122 available at http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf ] ---------------------------------------------------------------------------------------------------------- Since 1997, until Rep. Markey filed HR 6584 a couple of weeks ago, not a single bill designed to regulate pharmacy compounding was even filed in either the U.S. House or the U.S. Senate. A flurry of recent activity makes a mockery of claims by Congress, state legislatures and regulatory agencies--all insisting they are looking out for public health and safety. They are mainly scurrying to deflect blame.