The FDA´s metamorphosis from the consumer protectors to the industry buddys.
Once upon a time, food and drugs were not safe. It was the dark, dark ages before the 1906 US Pure Food and Drugs Act. Since that time, a government agency has been built up to protect Americas health. It was shortly after Upton Sinclair, in his novel „The Jungle“, drastically described the disgusting methods in America´s meatpacking industry. In 1930, this agency, however, first received the following name: US Food and Drug Administration (FDA). Since then, the FDA has had a lively history: it has approved food, drugs, ingredients, it has recalled some of them.
Blow the whistle, lose your job
In the last years, the FDA has often become criticized for its rude treatment of whistleblowers.
In 2012, a scandal has rocked the agency to the core. It had surveilled its employees personal computers. The National Whistleblowers Association published FDA Screenshots that were taken on their employees computers: emails, the picture of a dog. And, especially problematic: confidential communication between the whistleblower and his lawyer-they were planning to sue the FDA. What a story: the FDA monitored the communication between seven of its scientists who had talked about the excessive radiation coming from mammography and colonoscopy machines. They already complained to the Congress. And, as was reported in July 2012, the FDA´s top lawyers Oked the spying. The FDA managers also produced an enemy list of employees, congressmen and journalists that were allegedly trying to „defame“ the agency.
Revolve the door, buddy
A practice that has become known a longer time ago is the „revolving door“: government agents changing jobs, becoming industry employees, and industry lobbyists becoming government employees. This does not only happen in the FDA, but in the entire system. Take the US Dept. For Agriculture, the USDA
USDA Revolving Door, 2004, according to Morgan Spurlock, „Don´t eat this book“
Former Secretary Ann Veneman, Board of Directors, Calgene Biotechnology
Bureau Director Dale Moore, former manager Cattlemen´s Beef Association
Press Spokeswoman Alisa Harrison, Cattlemen´s Beef Association
Department Manager Floyd Gaibler, former Board of Directors, National Cheese Institute
Assistand State Secretary for Agriculture, James Moseley, shareholdeer, Infinity Pork LLC.
Director, Information Division Scott Charbo and Director, Office for parliamentary affairs, Mary Kirtley Waters, both former employees, ConAgra Foods
State secretary Joseph Jen, former Campell Soup employee
Or the US Environmental Protection Agency. Many of its Administrators came from waste managment firms. And Linda J. Fisher- have a look at her various EPA positions: Deputy Administrator of EPA; EPA Assistant Administrator – Office of Prevention, Pesticides and Toxic Substances; EPA Assistant Administrator – Office of Policy, Planning and Evaluation; and Chief of Staff to the EPA Administrator- also was vice president of Government Affairs for Monsanto and now works for DuPont, a major competitor of Monsanto in the international seed business.
Let us come back to the FDA. The website „OpenSecrets“ lists 294 revolving door cases in the US Dept. Of Health and Human Services (64 FDA cases). Take Tracy L. Acker, for example: she worked for St. Barnbas Healthcare Services, then for Montgomery General Hospital. In 1995, she was employed by the FDA and five years later, she used the always revolving door to work at Johnson and Johnson. Since 2004, she also was employee of the Reed Smith lobbying firm and the corporations Acker and Amgen. The employment history of Dave Boyer might also be interesting: Biotechnology Industry Organization (2005/06) Food & Drug Administration (2006/07) White House (2007/09) Pharmaceutical Research & Manufacturers of America (pharmaceutical industry representative group 2009/10) BGR Group (lobbying firm, since 2011). But let us take a complete look at industry´s methods, taking Pfizer as an example (Date:Opensecrets.org)
Pfizer Lobbying Profile
64 out of 87 Pfizer Inc lobbyists in 2012 have previously held government jobs
CONTRIBUTIONS TO CANDIDATES 2011-2012
Congress Members who own Pfizer Inc shares: 43
In total, according to the Union of Concerned Scientists (2012), the lobbying expenditures of the drug and healthcare industry between 2009 and 2011 reached about $700 million.
Consumer Interest vs. Profits: in November 2012, the consumer activist Sidney Wolfe was thrown out of a FDA commitee that investigated risks of controversial drospirenone anti-baby-pills. The same commitee, however, did NOT throw out three other members, three professors who had received money from Bayer, the world´s leading drospirenone marketer.
Two old friends: Monsanto and the FDA
The ties between the top producer of GMO (genetically modified organism/s) seeds for agriculture, Monsanto, and the FDA, are so thick that they are worth a whole article section. In a five-year-period (2007-2012), Monsanto spent 42415000 Dollars on Lobbying. The mutual past of Monsanto and the FDA reaches beyond the last years, until the time of the approval process for rBGH/rBST, an artificial bovine growth hormon, which is surrounded by controversies. One of these controversies is the agressive tactics the company used to stop a critical TV broadcast. Another is the dramatic battle on the FDA. In her book „The World According to Monsanto“, journalist Marie Monique Robin describes the case of Dr. Richard Burroughs, who worked as a veterinarian in the FDA´s Center for Veterinary Medicine. In 1985, he was told to work on the approval request for rBST. Even though the papers that Monsanto had handed in were a pile of the height of Dr. Burroughs, he found them to be incomplete. They proved that cows produced more milk, but they did not answer the most important questions: what was the health effect of this severe intrusion into the animal’s life? So, understandably, he asked Monsanto to revise the data and hand in more material. They did it, but, as he told Robin: „that they (the results of the new data) were not of a great scientifical value“. But he still managed to extract some facts from the material: that the incidence of mastitis was higher. He informed his superiors, who reacted correctly: writing a letter to Monsanto. But somehow, Dr. Burroughs career was ending. He was not allowed to access the data, the case was taken away from him, and then, in November 1989, he was fired.
He was not the only whistleblower: Alexander Apostolou, director of the FDA’s Division of Toxicology was „pressured to leave“ and Chemist Joseph Settepani was stripped of his duties after testifiyng at a public hearing. The pressure on whistleblowers was so extreme that on 16th March 1994 (the day of the final Posilac/rBGH approval) they wrote a letter to the Congress: „“afraid to speak openly about the situation because of retribution from our director, Dr. Robert Livingston“
In addition, the FDA had to form a new category to make rBGH „approvable“. The agency managers invented the „managable risk“ .
„Dissent [at CVM] is not tolerated if it could seriously threaten industry profits“ J. Settepani
„rBGH is the most controversial product that the FDA ever approved“ Michael Hansen, Consumer Policiy Institute
Want more to chew on? Here it is: revolving doors. Margaret Anne Miller, Ph.D in Endocrinology-Reproductive Physiology, was hired by Monsanto in 1985. Her job was to supervise laboratory research and studies on recombinant products, similar to rBGH. Just four years later, she went through the revolving door to the FDA’s Center for Veterinary Medicine. Just in time to influence the Posilac process. And while she worked for the FDA, she continued publishing scientific papers- along with Monsanto employees!The approval of Posilac and its excessive use in American agriculture is the main reason for the European ban on imports on US bovine meat. Before the 1999 ban, the trade volume of beef exports to Europe was about 20 million dollars per year. Thank you, Monsanto. And thank you, FDA!
Even Big T does not like it
An absurd anecdote to finish this article: Big Pharma’s influence has reached such dimensions that even the tobacco giants are unhappy. In January 2013, a US District Court has allowed a lawsuit filed by R.J. Reynolds and Lorillard Tobacco. The companies complain about the conflicts of interest on the FDA Center for Tobacco Products’ Tobacco Science Advisory Committee (TPSAC). Of the eight TPSAC members, three seem to present a conflict of interest because of their ties to the pharmaceutical industry. What the cigarette producers do not tell you: RJ Reynolds spends about $ 3 million annually on lobbying. In 2012, 32 lobbyists worked for RJ Reynolds, of which 25 have previously held a government job. In Total, Big Tobacco has spent about 20 million dollars annually in the last years and about 175 lobbyists.
Sources include: OpenSecrets, „The World According to Monsanto“ by Marie-Monique Robin, Der Spiegel, „Don’t eat this book“ by Morgan Spurlock, NewsWithViews.com, Councilforresponsiblegenetics.org, toxforum and sourcewatch
Pictures taken from: sothisisaugust.wordpress.com synd.org dissidentvoice.org
EPA Revolving Door
- William Ruckelshaus, EPA Administrator 1971-73. Director of Weyerhaeuser, Monsanto, and other companies with severe environmental problems.
- Douglas Costle, EPA Administrator 1977-81. Chairman of Metcalf & Eddy, hazardous-waste consultants and Superfund contractor.
- Walter Barber, Acting EPA Administrator 1981. Vice-president of Chemical Waste Management, the country’s largest hazardous-waste management company–and a subsidiary of Waste Management, Inc..
- William Ruckelshaus, EPA Administrator 1983-85. CEO of Browning-Ferris Inc., the country’s second largest non-hazardous-waste-management company.
- Lee Thomas, EPA Administrator 1985-89. CEO of Law Environmental, hazardous-waste consultants and Superfund contractor.
- Alvin Alm, Deputy EPA Administrator. Senior vice-president of SAIC, Superfund contractor and major EPA contractor.
- Joan Z. Bernstein, EPA General Counsel. Vice-president of Chemical Waste Management.
- Christopher Beck, EPA Assistant Administrator for Hazardous Waste. Chairman and CEO of Air & Water Technologies, hazardous-waste consultants and Superfund contractor.
- Frank Moore, Chief legislative liaison for President Carter. Vice-president of Waste Management, Inc..
- Rita Lavelle, EPA Assistant Administrator for Solid Waste and Emergency Response (sent to prison for perjury). Consultant to hazardous-waste management industry.
- Jack Ravan, EPA Regional Administrator in Atlanta. President of Rollins Environmental Services, the country’s second largest hazardous-waste company.
- John Schramm, EPA Regional Administrator in Philadelphia. Director of government affairs in Waste Management, Inc.’s Washington office.
- Angus Macbeth, Deputy Assistant Attorney General for Environmental Affairs in the Justice Department. Attorney representing Chemical Waste Management.
- James Range, On staff of Senate Environment and Public Works Committee; helped write hazardous-waste laws. Vice-president of Waste Management, Inc..
- Marcia Williams, Director, EPA Office of Solid Waste. Washington representative for Browning-Ferris, Inc..
- James Sanderson, Advisor to EPA Administrator Anne Gorsuch. Attorney representing Chemical Waste Management (held both positions simultaneously).
- Gary Dietrich, Director, EPA Office of Solid Waste. Vice-president of consulting firm that writes permit applications and does other consulting work for Waste Management, Inc..
- Brian Molloy, EPA enforcement attorney who helped write hazardous-waste regulations. Attorney representing Chemical Waste Management.
- Susan Vogt, EPA Deputy Assistant Administrator for Pesticides and Toxic Substances. Washington representative for Law Environmental.
- Richard Fortuna, Congressional legislative aide, helped write hazardous waste laws. Director and lobbyist for the Hazardous Waste Treatment Counsel, which represents most large hazardous-waste management firms.
- Jeff Miller, Head of EPA hazardous-waste enforcement task force. Attorney representing Chemical Waste Management.