Food & Drug Safety
In 2005, GAP launched a new public health program to marshal our efforts on food and drug safety. Our work in this area has brought forth information on a broad range of major public health issues. These issues include:
- Charges by a prominent, Harvard-trained psychiatrist that four children may have died – and that countless other children and adults may have been harmed – by excessive medication of patients in state custody and other abuses of medicine.
- Allegations by a government investigator that Big Pharma showered gifts, travel expenses, and other inducements on state officials to ensure that their expensive, non-generic drugs would be given to mental patients whether or not the drugs are right or even safe for them. This collusion puts the greed of the pharmaceutical industry before the mental health of patients and the financial health of citizens like you, whose tax dollars are subsidizing this graft.
Please check out either our Food Safety page or our Drug Safety page to read more about GAP's work in each area.
Program Highlight: GAP Hosts Food Safety Conference
November 13, 2009 -- On Friday, November 20, the Government Accountability Project (GAP) and American University will sponsor a day-long conference focusing on problems with the current food safety policy structure in America, and how to improve upon it. The conference, Empowering Employees to Protect Food Integrity, starts at 9:30 next Friday.
This symposium acknowledges the role of employees as a first line of defense against food adulteration. Expert panelists will discuss food integrity issues, as well as new and pending laws (including whistleblower protections). Specifically, panelists will address legal and legislative reforms, immigrant rights, humane handling, corporate farming, and the role of labor in food safety.
Click here to visit the conference homepage
Program Highlight: GAP Releases Drug Safety Report
April 7, 2009 -- Today, GAP is releasing a new “white paper” report, The ABCs of Drug Safety: Accountability, Balance, and Citizen Empowerment, which focuses on the severe problems with the current system for conducting and regulating clinical trials. The report details the urgent need for reform.
Click here to read the press release
Click here to read the report's Executive Summary
Click here to read a copy of the new report
Program Highlight: GAP Applauds DeLauro Letter
June 2, 2008 -- Representative Rosa DeLauro (D.-CT) continues to be a champion for food safety. Below is a link to a recent letter she wrote to Ed Schafer, Secretary of the U.S. Department of Agriculture, regarding the agency’s refusal to recall 16 million products of questionable product and denial to pursue further action into a GAP investigative report on this matter.
Click here to read the letter
Program Highlight: Mushroom Company Consents to Order Finding It Committed Violations of Federal Law
April 15, 2008 -- In a lawsuit brought by the US Department of Agriculture (USDA), Golden Gourmet Mushrooms (GGM) has consented to an order finding that it “committed willful, flagrant and repeated violations” of the Perishable Agricultural Commodities Act (PACA). The USDA charged that GGM operated without a required PACA license for over two years, through the end of 2007. The USDA also charged that GGM misrepresented to its customers in the US and Mexico that its mushrooms were from California.
Last October, GAP submitted a formal complaint to USDA’s National Organic Program (NOP) alleging that GGM sold conventional mushroom products as organic, manipulated organic certification documents, and made false claims regarding the nature and origin of its mushroom products.
Click here to read the press release
Program Highlight: Hearing on Deadly Drug Tomorrow
February 11, 2008 -- Tomorrow, February 12, GAP client Ann Marie Cisneros will testify at a House Subcommittee on Oversight and Investigations hearing titled “Ketek Clinical Study Fraud: What Did Aventis Know?”
Click here to read the full press release
Program Highlight: Senator’s Investigation Details Wyeth, FDA Wrongdoing
February 6, 2008 -- Earlier today, Senate Finance Committee Ranking Member Charles Grassley (R-Iowa) sent a letter to HHS Secretary Michael Leavitt and FDA Commissioner Andrew von Eschenbach detailing how Wyeth Pharmaceuticals engaged in a smear campaign aimed at discrediting an FDA safety officer assigned to review one of Wyeth’s animal care products. After Wyeth met with FDA officers and presented false and misleading information, the FDA wrongfully removed GAP client Dr. Victoria Hampshire from her position as that drug’s reviewer.
Click here to read GAP's press release
Click here to read the letter
Program Highlight: GAP Protests Silencing of Farmers
November 29, 2007 -- GAP has signed onto a letter of protest sent to Governor Edward Rendell regarding the Pennsylvania Department of Agriculture’s recent action that would prohibit farmers from informing consumers that they do not using artificial hormones on their dairy cows.
Click here to read the letter.
Program Highlight: GAP and Consumer Interest Group take Gassed Meat to Hearing
November 2, 2007 -- On October 30, GAP and the nonprofit group Food and Water Watch took samples of carbon-monoxide (CO) infused meat packages to a hearing of the House Committee on Agriculture aimed to “review technologies in the meat industry.” At this hearing, the main topic of discussion was the use of CO in case ready meat packages, which maintains its red color for upwards of one year despite spoilage.
Click here to see pictures of GAP and F&WW showing old (but still pink) meat at the hearing
Click here to read GAP Food & Drug Safety Officer Jacqueline Ostfeld's op-ed on the topic
Program Highlight: GAP Files Complaint against Mushroom Company for Organic Standards Violations
October 18, 2007 --
Today, GAP requested that the USDA’s National Organic Program (NOP) initiate an investigation into violations of organic standards allegedly committed by Golden Gourmet Mushrooms, Inc., a mushroom production company based in California.
Click here to read GAP’s press release and full explanation
Click here to read the Formal Complaint
Evidence and Documentation Cited in Complaint (Citation Number)
Click here to read GAP’s Affidavit (1)
Click here to read the GGM Certification Documents (2)
Click here to read the Hokuto Certification Documents (3)
Click here to read the Doctored Organic System Plan Summary (4)
Click here to view GGM’s Web site from April 2007 (5)
Click here to read the Shipment Schedules from March – April 2007 (6)
Click here to read GGM’s invoices to anonymous customers from March – April 2007 (7)
Click here to views examples of GGM’s Product Labeling (8)
Click here to read Noncompliance Letters (9)
Click here to read Order Confirmations (10)
Click here to read Emails between GAP and QAI (11)
Program Highlight: Graham Testifies About Avandia
July 30, 2007 -- GAP client Dr. David Graham is testifying today at an FDA Advisory Committee meeting regarding the serious dangerous side effects of the diabetes drug Avandia.
Click here to read the Bloomberg story
Program Highlight: Farm Bill Undermines Important Food Safety Protections, Again
July 27, 2007 -- Yesterday, GAP joined the Safe Food Coalition in urging House members to oppose a provision in the Farm Bill that would seriously undermine national food safety protections. The provisions would permit meat and poultry products inspected by state inspectors to be sold in interstate commerce. Unfortunately, state inspections have historically been substantially less stringent than federal meat inspections, and passage of this provision would jeopardize food safety standards and increase the risk of food poisoning in the US.
Click here to see the letter
Program Highlight: Whistleblowers and Dangerous Drugs: GAP and the FDA
June 21, 2007 -- GAP held a conference call with David Ross, former FDA medical officer who blew the whistle on the mishandling of the approval process for the antibiotic Ketek, and Mark Cohen, GAP Food and Drug Safety Director.
The revelations that Dr. Ross and others made resulted in significant restrictions in the approved uses for Ketek. Reforms being discussed by Congress during the time of this conference call could go some way toward changing the way the agency balances the interests of rapidly bringing new drugs to market and the interests of ensuring that news drugs are truly safe and effective.This call was an update for the public on the progress of these reforms, allowing for questions to be put to David Ross and Mark Cohen GAP’s work on drug safety and the experience of being an FDA whistleblower.
Click here to listen to the conference call!
Program Highlight: Farm Bill Undermines Important Food Safety Protections
June 19, 2007 -- Today, GAP joined consumer, environmental, farmer and animal welfare groups in opposing a sneak attack on critical food safety protections in the 2007 Farm Bill. Section 123, “Effect of USDA Inspection and Determination of Non Regulated Status,” states: “Notwithstanding any other provision of law, no State or locality shall make any law prohibiting the use in commerce of an article that the Secretary of Agriculture has – (1) inspected and passed; or (2) determined to be of non-regulated status.”
At a time when the country faces one food safety scare after another, from E. coli-contaminated spinach to melamine-laced pet food, it is critical that states and localities have the authority to continue protecting their citizens. Write Representative Collin Peterson today and ask him to remove Section 123 from the Farm Bill and stop usurping the power of States and municipalities to protect the public!
Click here to read the letter.
GAP Sends Congress Letters Addressing FDA Safety Measures
June 12, 2007 -- GAP has signed on and sent, with a number of other nonprofit organizations, a letter to the Subcommittee on Health (House Committee on Energy and Commerce). The letter addresses the subcommittee’s PDUFA, MDUFA and other related legislation that would significantly improve the FDA’s drug approval process and establish a viable post-marketing surveillance system. The letter suggests focusing on several areas.
Click here to read the letter.
In a separate letter to Rep. John Tierney (D-Ma), GAP and cooperating organizations expressed their support for H.R. 788, the Food and Drug Administration Safety Act of 2007, which would create a separate center at FDA for reviewing the safety of drugs once they are on the market. Currently, the very office and people who approve new drugs later decide whether they committed what are too often fatal errors.
Click here to read the letter.
Program Highlight: GAP Challenges National Organic Program Changes
5/31/07 -- Last week, GAP submitted comments to the US Department of Agriculture’s National Organic Program concerning its proposed rule to allow the use of 38 conventionally produced substances in “organic” products. GAP is deeply troubled by the NOP’s decision to limit its notice and comment period to 7 days for such an important proposed rule. The standard time for public comment on a rule change is generally between 30 and 90 days.
Among the conventional items proposed for addition to organic foods are casings (made from intestines of cows, sheep and pigs) used for sausages. Acceptance of non-organic casings in organic food would unnecessarily put organic consumers at risk for contracting the human form of mad cow disease.
Click here to read GAP’s comments to the agency.
Program Highlight: Time to Get COOL!
5/21/07 -- This morning, GAP joined other food safety advocates in urging Congress to authorize adequate funding in the next appropriations bill so that the US Department of Agriculture might immediately implement mandatory country of origin labeling (COOL) for food. Currently, the US imports over 80 million shipments of food from abroad each year and inspects less than 0.3% of them. Apart from seafood, these foods are not labeled and many consumers have no idea where their food comes from. Following the recent pet food scandal, where workers in China intentionally spiked wheat gluten with melamine to falsely increase the appearance of protein in the food, it has become increasingly clear that all food safety inspection systems are not created equal.
Click here to read the letter to Congress
Program Highlight: GAP Pushes for USDA Transparency
As the USDA launches ahead with its new Risk Based Inspection (RBI) system for meat and poultry processing plants, it is crucial that the agency proceed in a careful, deliberate, scientific and open manner. This morning, GAP joined the Safe Food Coalition in sending a letter to members of the House of Representatives urging them to support a provision requiring the USDA to undergo public notice and comment rulemaking on its proposal for development of the RBI system. GAP believes it is critical that the public have an opportunity to comment on regulatory decisions that impact their lives.
Click here to read the letter.
Program Highlight: GAP Questions USDA’s Commitment to Eradicating “Mad Cow” Disease
3/12/07 -- The United States Department of Agriculture recently published a proposed rule which would authorize the transport of Canadian cows over thirty months (OTM) old into the US. Cows OTM old are at greater risk of harboring ‘mad cow’ disease than younger cows, and Canada just discovered its ninth case of the disease in February. GAP is deeply troubled by the agency’s proposal as it unnecessarily increases the potential for another cow to enter the US with ‘mad cow.' GAP Food & Drug Safety Officer Jacqueline Ostfeld submitted comments about this development to the USDA.
Click here to read GAP’s comments to the agency!
Program Highlight: GAP Heavily Involved in House Hearing
February 13, 2007 -- Several GAP clients will testify at a hearing focusing on drug safety and the Food and Drug Administration’s (FDA) lapses in protecting the public. The Subcommittee on Oversight and Investigations, under the Energy and Commerce Committee, will hold the hearing entitled “The Adequacy of FDA to Assure the Safety of the Drug Supply” at 9:15 a.m. at 2123 Rayburn House Office Building.
Click here to watch the hearing!
Click here to read yesterday's press release about today's hearing!
Program Highlight: Grassley Presses FDA about GAP Case in New Letter
November 1, 2006 -- Sen. Chuck Grassley is continuing to press the FDA for an explanation of how it handled an investigation of its own scientist, GAP client Dr. Victoria Hampshire. Last year, Grassley announced he would investigate charges that Wyeth Pharmaceuticals smeared Hampshire, who negatively reviewed one of Wyeth's animal care products, and that the FDA subsequently removed her from that product's review. Hampshire had “concluded that Wyeth's drug (ProHeart6) was killing hundreds of dogs,” according to Grassley.
Grassley sent a letter, dated October 25, 2006, to FDA Acting Commissioner Andrew Von Eschenbach, specifying how several of his investigatory questions over the last year have gone unanswered. Click here to read the letter!
GAP Food & Drug Safety Director Mark Cohen, Hampshire's attorney, stated "We need to put a stop to the backdoor influences drug companies wield over FDA management. Otherwise, the unconscionable abuses visited on diligent FDA safety officers like Dr. Hampshire will continue."
Click here to read the letter!
Program Highlight: GAP Client Blogs His Thoughts
August 11, 2006 -- GAP client Dr. Aubrey Blumsohn recently started a blog entitled “Scientific Misconduct,” which records his commentary on corporate scientific misconduct. Last April, Blumsohn triumphed over Proctor & Gamble (P&G) after a four year battle to obtain data that supported his allegations of data manipulation and false marketing against the company.
Click here to read Blumsohn’s blog!
Program Highlight: Landmark Drug Settlement Favors Consumers
August 10, 2006 -- The Prescription Access Litigation (PAL) Project, a national coalition of nearly 120 organizations including GAP, recently announced a proposed settlement agreement was filed in the Average Wholesale Price (AWP) case. First filed in December 2001, the AWP suit alleged that drug companies were defrauding consumers by charging inflated process for critical medications. The $70 million settlement is with GlaxoSmithKline, one of the 19 pharmaceutical companies named as defendants in this suit. This settlement marks a landmark victory in the pursuit of greater transparency in the pharmaceutical industry.
Click here to go to PAL’s website!
Program Highlight: Proctor & Gamble Surrenders Data to GAP Client, Drug Data Verified False
June 16, 2006 -- Under pressure from Government Accountability Project (GAP) client Dr. Audrey Blumsohn, Proctor & Gamble finally (P&G) released the full research data set for its osteoporosis drug Actonel. Blumsohn had sought these data for four years. As Blumsohn anticipated, the data fail to support P&G’s claim that Actonel is as effective as industry leaders in treating osteoporosis.
Click here for the press release!
Program Highlight: Bone Researcher Charges Procter & Gamble with Continuing Data Concealment
March 1, 2006 -- Procter and Gamble (P&G) continues to subvert the integrity of research regarding its osteoporosis drug Actonel by suppressing critical data even as the company touts its new openness, charges GAP client Dr. Aubrey Blumsohn.
Click here for the press release!
Program Highlight: GAP Client Exposes Flawed Procedure in Proctor & Gamble Osteoporosis Drug Study
February 22, 2006 -- GAP client and Sheffield University senior faculty member Dr. Aubrey Blumsohn is in Washington, D.C. today, beginning a week-long effort to inform Congressional officials and interested parties about data concealment and manipulation performed on behalf of Proctor & Gamble (P&G) regarding that company’s osteoporosis drug, Actonel. The drug is primarily used by post-menopausal women to strengthen bones and help prevent fractures. Blumsohn, the intended lead author on a P&G commissioned study, believes the data actually disprove P&G’s therapeutic claims for Actonel, and says the company used his name in medical reports regarding the drug despite his not having full access to data sets – information that he repeatedly asked for.
Click here to read the Associated Press article!
Click here to read GAP's press release!
Program Highlight: GAP Creates Drug Fact Squad
December 9, 2005 -- According to polls, Americans no longer trust the pharmaceutical industry. Simultaneously, there is a crisis of confidence in the Food & Drug Administration (FDA) as an impartial arbiter of drug safety and effectiveness. More than half of the agency’s drug budget comes from industry user fees earmarked for speeding up the approval of drugs. As a result, the FDA, long established as the “gold standard” of consumer protection against industry’s dangerous drugs, now treats the industry as its primary client.
If we, the public, can’t rely on either industry or FDA to tell it to us straight, then where can we turn for independent and reliable information about prescription drugs?
With others, GAP has set out to help fill this void with our own “Fact Squad” of experts. In commending this “Fact Squad” to the public and the news media, we ask that you take note of their backgrounds, education and accomplishments, and give due consideration to their perspectives. Our “Fact Squad” will help complete the picture by bringing into focus the findings of experts whose first concern is the public interest.
Click here for the Fact Squad!
11/18/05 - Senator Grassley Investigates Charges of FDA and Wyeth Misconduct
Yesterday on the Senate floor, Senate Finance Committee Chairman Charles Grassley (R-Iowa) announced that he is investigating charges that Wyeth Pharmaceuticals smeared an FDA safety officer who negatively reviewed one of Wyeth’s animal care products, and that the FDA subsequently removed her from that product’s review. Dr. Victoria Hampshire, the safety officer, “concluded that Wyeth’s drug (ProHeart6) was killing hundreds of dogs,” according to Sen. Grassley. Dr. Hampshire is represented by GAP.
Click here to read the press release!
Click here to read Senator Grassley’s floor speech!
Click here to read Senator Grassley’s letter to Wyeth!
Meet Food & Drug Safety Director Mark Cohen
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