Canada - The Battle Against Bill C-6

The battle continues...

The Battle Against Bill C-6
September 2009 Features
How Proposed New Legal Principles are Undermining Your Health Freedom

by Shawn Buckley
Introduction by Helke Ferrie

“The numbers on the Bills have changed, but whether the Prime Ministers are Liberal or Conservative, the message remains unchanged. Bills C-27 and C-28 of 2004 became C-51 and C-52 in 2008, and now we have C-6.

The first batch of bills, a “modernization” of the Food and Drugs and Hazardous Products Acts, would have “prevented Canadians from suing Health Canada for negligence, even for flagrant failures like … the tainted-blood scandal [and] greatly increased the likelihood that unsafe drugs and hazardous products make their way to market” (The Globe and Mail, November 10, 2004). The shift was from the international “precautionary principle” to the corporate “risk management” – meaning all industries regulate themselves without any independent oversight. Agricultural chemicals, drugs untested and of mysterious chemistry, pest control products, and food additives were completely exempted from being identified as “adulteration” at residues higher than internationally permitted. Ottawa’s The Hill Times wrote on April 25, 2005: “Hocus-pocus, adulteration is not adulteration if the Minister of Health says so! The effect of bill C-28 is to eviscerate the Minister of Health’s statutory duty to protect the public from health hazards and fraud…”

When the Liberals lost to the Conservatives, Stephen Harper continued where Paul Martin had left off by re-introducing the same Bills, only now far meaner, namely C-51 and C-52. In an open letter to the PM, I observed that if these bills were “passed into law, they would pose a threat to public health, the rule of law, and the freedom of scientific research. Both Bills, to my mind, display an equally unparalleled disregard for the spirit, and most probably also the letter, of Canada’s Charter of Rights and Freedoms.” An analysis of these four Bills is found in my book What Part of No! Don’t They Understand? available for free downloading from kospublishing.com.

Article continues here.

F.D.A. Reveals It Fell to a Push by Lawmakers

F.D.A. Reveals It Fell to a Push by Lawmakers

By GARDINER HARRIS and DAVID M. HALBFINGER
Published: September 24, 2009

WASHINGTON — The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.

The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money. Dr. Andrew C. von Eschenbach, the former drug agency’s commissioner, said he had acted properly.

The agency has never before publicly questioned the process behind one of its approvals, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.

“The message here is that there were problems with the integrity of F.D.A.’s decision-making process that have solutions,” Dr. Joshua Sharfstein, the agency’s principal deputy commissioner, said in a conference call with reporters.