Welcome to choof.org. Unfair. Unbalanced. |
More Links Reenhead
Archive
October 2005 August 2005 July 2005 June 2005 May 2005 April 2005 March 2005 February 2005 January 2005 December 2004 November 2004 October 2004 September 2004 August 2004 July 2004 June 2004 May 2004 April 2004 March 2004 February 2004 January 2004 December 2003 November 2003 October 2003 September 2003 August 2003 May 2003 April 2003 March 2003 February 2003 December 2002 November 2002 October 2002 June 2002 May 2002 April 2002 February 2002 January 2002 December 2001 November 2001 October 2001 September 2001 August 2001 July 2001 |
Choof.org Monthly Archive Xmas Music: Psycho Terrorism Reminder Having just returned from the Safeway where they were playing Alvin and the Chipmunks Xmas music for all to enjoy, I thought it would be appropriate to repost a blog from last year. "From morning to night, for weeks before Christmas, there was the same Christmas music in department stores over and over again, said Gottfried Rieser of the Union of Private Employees. "'Many staff in the retail sector suffer psychologically from it,'" Mr Rieser said. "'They get aggressive. On Christmas Eve with their families, they can't stand Silent Night or Jingle Bells any more.'" I feel the same way about Xmas music. It assaults me when I buy breakfast at Safeway every morning. We must end this Xmas tyranny. Agreements Limit Med Mal Jury Awards The Wall Street Journal reports today on medical malpractice awards, noting that although jury awards are very high, defendants usually pay only a fraction of the amount. But the Redens didn't get $112 million. They got $6 million... ...Many plaintiffs settle for less than a jury's verdict, to eliminate delays and the uncertainty of appeal. Sometimes, even before a jury rules, a plaintiff has signed an agreement that limits how much money actually changes hands... In 2000, Pennsylvania reported three of the largest medical-malpractice verdicts in its history, all of them rendered in Philadelphia: one for $100 million, another for $55 million and a third for $49.6 million... But each of the three biggest Philadelphia verdicts was settled for much smaller sums, according to plaintiffs lawyers and court records. The $55 million case settled for $7.5 million, according to the lawyer for the plaintiff. The $49.6 million case settled for $8.4 million, according to court documents. And the $100 million case settled for an undisclosed sum. Andrew J. Stern, the lawyer representing the plaintiff in that case, says the amount of the settlement was significantly less than $100 million... Last month, the Coalition for Affordable and Reliable Health Care, a Washington-based group that advocates for tort reform on behalf of hospitals, doctors and others, cited in a news release a $269 million verdict in Texas. Although the release didn't say so, the case involved Rachael Martin...she was allegedly given 10 times the recommended dose of the sedative propofol. Her muscle cells began disintegrating, and the content of those cells was secreted through her kidneys. Her urine changed color and eventually turned black. A short while later, Rachael went into cardiac arrest and died... In 2000, a jury awarded the Martins nearly $269 million... The Martins got a fraction of that amount. The jury assigned 25% of the liability in the case -- or $67 million -- to the doctors. But before the trial had even begun the doctors and their professional group had agreed with the Martins to settle the case for just $3 million, says Charla Aldous, the Martins' attorney. That sum was just under the total policy limits of the three physicians involved and their practice group, each of which was insured for $1 million. Equal Sugar Data Sale Send away for information...get your information sold... Two Great Shots from Sealab Church of Alvis Why are cats so cute? WP on BND The Washington Post reports on local iterations of Adbusters'-like Buy Nothing Day. (It should be noted that Adbusters has moved beyond Buy Nothing Day and is now advocating "Buy Nothing Christmas.) Dalton on Materialism Washington Psychologist Patricia Dalton comments on materialism in the Washington Post: The biggest cost I see is intergenerational. Materialism is taking a drastic toll at home. There is considerable strain involved in generating the money needed to acquire so much. Many of the parents who come to my office describe living on the earn-and-spend, earn-and-spend treadmill that Berkeley sociologist Arlie Hochschild describes. Parents are exhausted. Children are neglected. Marriages get put on hold. One professional woman reported to me that she felt so overwhelmed that she came home one evening and started breaking plates on the floor in front of her three little kids. Stories like this make me realize we are allowing ourselves to be robbed of what is most precious and counts the most: free time... I am seeing a new level of competitiveness, not just on the athletic fields and in the classroom but increasingly over possessions. I think of it as the Keds-to-Nike transformation. One status-conscious teenage girl (whose parents checked out my diplomas before they even sat down) said she couldn't understand why she had trouble making and keeping friends. This girl had learned much more about domination than cooperation, and she formed alliances to get what she wanted rather than making real friends. The scientific literature supports my office observations. A comprehensive review of more than 150 studies on happiness and wealth by psychologists Ed Diener and Martin Seligman showed that there has been no appreciable rise in life satisfaction over the past decades, despite our increased material wealth. The Alfred P. Sloan Foundation issued a report that is sure to give ambitious and acquisitive parents pause. It found an inverse relationship between self-reported child happiness and parental income. Blue-collar and middle-class kids identified themselves as happier than wealthy ones. Kids need their parents on site -- in the foreground when they are young, and in the background as they get older. That's simply not possible in many of today's go-getter households. So here we are: a generation of fashionistas and Samurai shoppers with full closets and empty hearts. Instead of listening to our souls, we have fallen for a new field of retail anthropology that advises businesses on how to get people in the mood to buy, buy, buy. I saw a catchy phrase that headlined an article in this newspaper's business section several months ago: Appliance Lust. It referred to hunger for eight-burner Viking ranges, built-in woks and Sub-Zero refrigerators with custom wood paneling and door alarms. Those of us who lived through the '60s seem to have forgotten the warning that everything you buy owns you. WP on Repubs, Anti-Americanism in Canada All sorts of fun nuggets in the Washington Post today. Juliet Eliperin notes: Nora Jacobson describes her post-2000 election move to Canada, urging Americans not to expatriate. The full article is worth reading: Although I enjoy my work and have made good friends here, I've found life as an American expatriate in Canada difficult, frustrating and even painful in ways that have surprised me. As attractive as living here may be in theory, the reality's something else. For me, it's been one of almost daily confrontation with a powerful anti-Americanism that pervades many aspects of life. When I've mentioned this phenomenon to Canadian friends, they've furrowed their brows sympathetically and said, "Yes, Canadian anti-Americanism can be very subtle." My response is, there's nothing subtle about it. Is the FDA Smearing a Whistleblower? I wish I had blogged this earlier! Less than a week ago, the Washington Post reported on the testimony of David Graham, a drug safety official at the FDA. Now, most of the time, agency testimony is not at all dramatic. Everyone knows what is going to be said before it is said. Trust me on this, I've testified half a dozen times in Congress. Graham bucked the trend: Describing the agency he works for as incapable of stopping dangerous drugs from entering and staying on the market, David J. Graham, associate director of the Office of Drug Safety, told the senators that the FDA's role in reviewing and approving new drugs sometimes conflicts with its duty to address safety issues. Asked by Sen. Jeff Bingaman (D-N.M.) to identify the five drugs, Graham hesitated and then named them to the startled listeners: the popular cholesterol-lowering drug Crestor, the weight-loss drug Meridia, the painkiller Bextra, the acne medication Accutane and the asthma medication Serevent. Each poses different issues, Graham said in response to senators' questions, but all require more aggressive FDA action. Damn! This never happens. But retaliation for this type of speech happens all the time. Today's Washington Post describes underhanded attempts at the FDA to undermine Graham: Managers at the Food and Drug Administration last month anonymously called a group that protects whistle-blowers in an attempt to discredit an outspoken agency safety officer who was challenging the FDA's drug safety policies, the legal director of the whistle-blower group said yesterday.
Secret History of the Credit Card--Tonight! Tonight at 9 PM on PBS, Frontline is airing an important show on the credit industry and how it hooks individuals on debt. I helped with some of the research for the program. Here is the press release and here is coverage in the NY Times. Tune in! Here is the show's website: People Really Do Hunt with Assault Rifles It's really not funny, but I wanted to point out for all the advocates of gun control that yes, people do go hunting with assault rifles. So perhaps you shouldn't be so quick to ban them. The Washington Post reports: Vang climbed down and walked about 40 yards. He took the scope off his rifle, turned and opened fire, Sawyer County Sheriff James Meier said Monday. One of the wounded men radioed for help. Others headed to the rescue, but Meier said Vang also opened fire on them, leaving five dead and three seriously wounded. Abu Ghraib in the WSJ More great reporting in the Wall Street Journal on the Abu Ghraib torture. Today's article focuses on Charles Graner, a Corporal "with a strong personality and red flags in his record [who] apparently triggered a descent into horrific behavior while a distracted Army hierarchy failed to stop it." ...The prison's population ballooned to nearly 7,000. From outside, insurgents pummeled it with mortars. Abu Ghraib had a hellish reputation under the Hussein regime as a place of torture and execution. To the Americans it was a different kind of hell: cold, cramped and full of detainees prone to riot. Some soldiers felt like prisoners themselves. Those assigned to Tier 1A worked in a particular dank place, rotten with the smell of feces and body odor. Yet in some ways they were more fortunate, working in a strong building and handling only about 50 detainees. Those on the night shift operated with little oversight.... In 1973, a psychology professor at Stanford University conducted a famous academic exercise in which students played the role of either prison guard or inmate. The professor, Philip Zimbardo, says that once the "guards" grew acclimated to their work, those with the most aggressive personalities began behaving sadistically -- and then "guards" with more passive personalities followed. Soon, "guards" began abusing "prisoners," and even students who didn't condone the abuse made no effort to stop it. Sgt. Davis, asked by investigators why he didn't refuse to go along with the abusive conduct at Abu Ghraib and report it, answered with a comment that could have been lifted from the Stanford experiment: "I assumed that if they were doing things out of the ordinary or outside the guidelines, someone would have said something." Sgt. Davis faces a military trial next year. His lawyer plans to argue that his client was following orders from the highest levels of government... Sgt. Frederick said he wrapped a wire around one of the detainee's fingers, while Sgt. Davis attached a wire to the Iraqi's hand, Spc. Harman attached one to his toe, and someone attached a wire to the detainee's penis. While the naked and hooded prisoner waited, anticipating a jolt, Sgt. Frederick and Spc. Harman snapped pictures with a digital camera. An attorney for Sgt. Davis says that his client denies attaching wires and that other soldiers have given sworn statements clearing his client. The Taguba report listed more misbehavior, most of it over just a few days in early November 2003: "Breaking chemical lights and pouring the phosphoric liquid on detainees; pouring cold water on naked detainees; beating detainees with a broom handle and a chair; threatening male detainees with rape; allowing a military police guard to stitch the wound of a detainee who was injured after being slammed against the wall in his cell; sodomizing a detainee with a chemical light and perhaps a broomstick; and using military working dogs to frighten and intimidate detainees with threat of attack, and in once instance actually biting" one. Abu Ghraib detainees questioned by the Army described most MPs by their appearance or uniform, but some knew Cpl. Graner by name. They described him as being at the center of the action, while others stood by taking pictures. Cpl. Graner, one inmate told the Army, "cuffed my hands with irons behind my back to the metal of the window, to the point my feet were off the ground and I was hanging there for about 5 hours just because I asked about the time, because I wanted to pray. And then they took all my clothes and he took the female underwear and he put it over my head. After he released me from the window, he tied me to my bed until before dawn ... Graner and the other two soldiers were taking pictures of everything they did to me." ...The pyramid of naked Iraqi detainees was "no big deal," according to Mr. Graner's lawyer: "Cheerleaders all across America form pyramids every day, and it doesn't hurt people," he says. "This was a control technique." He also contends that guards in civilian prisons routinely put collars on inmates' necks. "This was not the result of soldiers becoming sadistic and brutalizing people," the lawyer says. "It was a matter of the intelligence community being under tremendous pressure to produce and get evidence that could be turned into intelligence. I think everything that was done there was perfectly lawful." His client, Spc. Graner, suffered no moral crises, Mr. Womack adds. "He wasn't ashamed of it. His psyche was fine. He was following orders." Eisner's Corporate Governance Outed in Ovitz Trial The Wall Street Journal today gives us a taste of the boardroom politics at Disney. The article concerns the Ovitz case, a shareholder lawsuit involving the hiring and firing of Michael Ovitz, who received a huge compensation package for a short stint at the company. Check it: Time and again, testimony in the Ovitz case -- including Mr. Eisner's own account -- illustrates how he operated with little regard for conventional rules of corporate play. He allowed rivalries to fester until they become irreparable, lied publicly when it was convenient, and once hatched a plot with a director to report details of a private conversation with Mr. Ovitz. TRAC Finds Civil Rights Enforcement Down Under Bush The Transactional Records Access Clearinghouse reports: Daily Data Marketing Wake Up Call: Omaha Steaks Buy those steaks and they'll sell your name and dress size. Swipe Updated Check out Swipe's new website. Swipe now has a loyalty card to serve you better! New Swipe drinks include the PATRIOT, Cat Eyes, the MATRIX, and CALEA. We Use Your Information To Serve You Better The Wall Street Journal reports: The operator who picks up the phone is trained not to let on that the caller has been recognized. "That would be too creepy," says Rich Mirman, Harrah's senior vice president in charge of development, and a trained mathematician and economist... Unlike rivals such as MGM Mirage, Harrah's tries hard to keep less profitable nongambling customers out of its hotels by calculating their customer value and making them pay through the nose. In October, a room at the aging Harrah's Las Vegas was quoted to a caller at a nightly rate of $199, only $14 cheaper than a super-luxury room at Bellagio. A frequent gambler could be charged anything from nothing to $199 at the Harrah's casino, the company says. The price is based on a complex mathematical formula that takes into account how long the customer typically stays and what games he or she plays, among other details. Tivo Adding Ads to the Ad Skip Button So, many blogs (Boing Boing, PVR, etc) are commenting on Tivo adding ads to their ad-skipping service. People literally buy Tivo to avoid ads, and the company's representations about the 30 second skip are centered around avoiding ads...so why isn't this a deceptive or unfair trade practice? Someone (perhaps even a TV advertiser) should sue... A Quick Response to Anne Applebaum I wrote a little response to Anne Applebaum's column in today's Post, in which she wrote: By Anne Applebaum When the ATM asks whether I want a receipt, I usually say no. When a Web site wants my credit card number, I usually say yes. When I pay bills online, there is no paper record of the transaction. In my failure to demand physical evidence when money changes hands, I am not very unusual. Most Americans now conduct at least some of their financial transactions without paper, or at least sleep happily knowing that others do. Yet when it comes to voting -- a far simpler and more straightforward activity than electronic bank transfers -- we suddenly become positively 19th century in our need for a physical record. It is, if you think about it, quite inexplicable. I really don't like this attitude of inevitability when it comes to new technology. Designed properly, new technologies can give us more, not less. When we settle with this attitude we are ensured that we will get less. Also, there is a major problem with the people who write about technology--they tend to be members of the "elite," and they simply don't think about the problems and consequences that others face when consumer protections are not in place. Anyway. Greetings Ms. Applebaum, Troy Resigns from FDA Good News: Daniel Troy is resigning from the Food and Drug Administration. The Washington Post reports: Why is this good news? Troy is in the pocket of industry. He is one of the big forces behind creating constitutional protections for drug advertising, thus placing it outside of consumer protections that currently exist (such as disclosing adverse side effects and requiring proof of effectiveness). Representative Maurice Hinchey has assembed quite a dossier on Troy: FDA is Placing Corporations Above Public
Daniel Troy, Chief Counsel of the Food and Drug
Administration, is taking the counsel's office in a wholly
unprecedented direction, repeatedly interceding in civil suits on
behalf of drug and medical device manufacturers that were accused of
harming patients who had used their products. In doing
so, Troy has worked in cooperation with the
manufacturers, ignoring serious conflicts of interests. The FDA
has attempted to mislead Congressman Hinchey in his efforts to look
onto this matter.
A narrative with built-in links appears below. Or you may access specific documents here.
To read these documents, you must have Adobe Acobat Reader. Click on the icon below to download.
BACKGROUND On August 20, 2001 President Bush appointed Daniel Troy to be Chief Counsel of the Food and Drug Administration. Previously, civil servants held this position. Troy was the first political appointee to the FDA post. Congressman Hinchey has been following Mr. Troy's activities for several years now and has done extensive research and investigative work beginning in early 2004. The FDA is the government agency charged with protecting the public by ensuring that foods are safe, wholesome, sanitary and properly labeled; and by ensuring that drugs and medical devices are safe and effective. The FDA is failing in that mission in large
part because of a radical new direction that Daniel Troy has taken FDA's Office of Chief Counsel, at the behest of the pharmaceutical industry.
RADICAL DEPARTURE For the first time in FDA's history the FDA's Chief Counsel is actively soliciting private industrial company lawyers to bring him cases in which the FDA can intervene in support of drug and medical device manufacturers. The cases he is seeking out are private state civil litigation cases. These are cases in which in which drug companies and medical device manufacturers are being sued by people harmed by their products. The court has not asked for FDA involvement in these cases. In other words, FDA is spending taxpayer dollars to defend drug companies who are being sued in state court. Since August 2001, the FDA has expended over 600 hours to file at least six briefs on behalf of these companies in four such cases across the country. Mr. Troy is using the argument of preemption to
shut down these cases before they can even begin and has stated that there is a well-documented precedent. Yet when Congressman Hinchey's office contacted several former FDA officials and Justice Department officials, not one had ever heard of such an action by the United States before Dan Troy came to power. Moreover, Mr. Troy's immediate predecessor stated clearly in 1997 that FDA long had a policy against preempting courts in this way. Explaining the reason for that policy she wrote, "Even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems presented by the product. ... Preemption of all such [tort liability] claims would result in the loss of a significant layer of consumer protection."
Legal scholars agree as well. Professor James O'Reilly from the University of Cincinnati Law School is one of the country's preeminent legal scholars on FDA issues. He is also acknowledged by the Supreme Court as an expert on FDA legal matters and is a former drug industry lawyer. Professor O'Reilly has stated that he knows of no precedent for FDA's actions. In fact, in 1996, the United States argued before the Supreme Court that the private lawsuits Mr. Troy is seeking to kill should be allowed and are necessary to hold companies accountable for their actions (Medtronic v. Lohr). For Mr. Troy to now be arguing the opposite, and to do so without any precedent, is completely outside the bounds of normal jurisprudence. The overwhelming response from Mr. Troy's fellow lawyers is that what he is doing represents a radical departure from past government efforts. Not one person Mr. Hinchey's office spoke with could identify anything remotely similar to what Troy is doing at FDA. MASSIVE CONFLICTS OF INTEREST
Prior to Mr. Troy's appointment to the FDA he was a partner at Wiley, Rein and Fielding - a large Washington, DC law firm. He was also involved with the Washington Legal Foundation, which is a "public interest" that supports weaker government regulations of drug companies and medical device manufacturers.
One of Mr. Troy's clients at Wiley, Rein was Pfizer, which in the three years prior to his appointment at FDA paid Wiley, Rein $415,000 for "services provided directly by" Mr. Troy. In July of 2002 Malcolm Wheeler, an attorney for Pfizer, called Mr. Troy, then FDA's chief counsel, and requested that FDA get involved in a private state lawsuit against Pfizer that was ongoing in California. Mr. Troy obliged and in September, less than two months later, FDA, through the Department of Justice, filed a court brief in support of Pfizer. That same July Mr. Troy also had a meeting with Michele Corash from Morrison and Foerster on "Proposition 65 issues." Morrison and Foerster, one of the world's largest firms, is based in California. At the time of this meeting, it was representing Glaxo Smith Kline in a private lawsuit in California that revolved around California's Proposition 65 or the Safe Drinking Water and Toxic Enforcement Act. Michele Corash was the lead attorney. On September 12, less than two months after that meeting, Mr. Troy's FDA filed a brief in support of Ms. Corash's client - GSK. This pattern continued in 2003. On December 12, 2003 FDA filed a Statement of Interest in the case of Murphree v. Pacesetter in support of the medical device manufacturer Pacesetter. The company was being sued in Tennessee state court for a faulty pacemaker. Congressman Hinchey's office obtained a letter to FDA, dated November 25, 2003 from the law firm of Feldman, Gale and Weber directing FDA on how it should assist its case. The firm was representing Pacesetter. In re Paxil is a fourth case in which
FDA submitted an unsolicited. According to remarks by Mr. Troy, he involved FDA because he thought a California state judge's ruling in the case was "crazy."
What these few cases describe are massive conflicts of interest and a pattern of collusion between a federal agency and the industry it is supposed to regulate. If FDA did for some reason need to get involved in these cases, it should have done so independently of the drug companies, not in coordination with them. Mr. Troy is supposed to be acting to protect the public's health, not his former drug company clients. Instead, he is actively seeking opportunities to help the drug companies. On December 15, 2003 Mr. Troy was the featured speaker at the 8th Annual Conference for In-House Counsel and Trial Attorneys, entitled "Drug And Medical Device Litigation." Conspicuously, this event was not noted on FDA's public calendar, which listed 44 other speeches Mr. Troy has delivered. The conference program uses his official title. It seems unlikely that omission was accidental. According to a signed affidavit of a conference participant Mr. Troy took credit for FDA's involvement in private civil litigation cases and solicited cases in which the FDA could intercede. He told the audience "we can't afford to get involved in every case, we have to pick our shots," so "make it sound like a Hollywood pitch." Mr. Troy also outlined his reason for getting involved in these cases: tort reform. He specifically stated that FDA is "deeply immersed in tort reform issues," and that it was FDA's goal to "control the flow of risk info regarding these [drug and medical device] products."
MISLEADING CONGRESS Congressman Hinchey raised this issue with acting-FDA Commissioner Lester Crawford when he testified before the House Appropriations Agriculture Subcommittee on March 11, 2003. He asked about Mr. Troy's relationship with Pfizer prior to his appointment. The answer FDA provided for the record sought to minimize that relationship. According to FDA, Mr. Troy worked an average of less than 80 hours per year on matters related to Pfizer. Congressman Hinchey later discovered that Pfizer paid Mr. Troy's law firm $415,000 over three years for work performed directly by Mr. Troy. This included over $358,000 in 2001, the year Mr. Troy was appointed to his FDA post. On a bipartisan basis, the House Appropriations Committee included language written by Congressman Hinchey in the Agriculture Appropriations report, expressing concern about the misleading nature of FDA's answer. Subsequently Hinchey uncovered additional
evidence that FDA provided misleading or even false answers on the record.
In that same response, FDA asserted that Mr. Troy "became involved in a case affecting Pfizer more than a year after leaving private practice." According to press reports, however, Pfizer's lawyer contacted Mr. Troy in July of 2002 about his case, which was less than a year after Mr. Troy left his firm. In response to another question Mr. Hinchey asked about FDA's history of involvement in these lawsuits, FDA again provided a misleading answer. The response sought to imply precedent for FDA actions by citing previous cases, failing to note that these cases were in response to court requests. None of the pre-Troy cases cited involved the FDA actively seeking to intervene in private lawsuits. That same answer also failed to list two other lawsuits in which FDA filed briefs under Mr. Troy, unsolicied by the court. And finally, in response to another question from Rep. Marcy Kaptur, FDA provided a list of cases and stated that those "that do not name the government (FDA, United States or HHS) are cases in which FDA has been subpoenaed to produce a witness or documents." This is simply false. There are at least four cases in which FDA got involved without being subpoenaed. Mr. Troy himself has even stated that he was "the initiator" of such cases. These five instances of misleading or false
answers in response to questions from members of Congress are deeply troubling and severely undermine the credibility of the FDA.
PEOPLE HARMED Over the last few months it has been widely reported that drug companies are providing the public and federal officials with less and less information about possible harmful side effects of their products. We know that these companies often do not share the results of clinical trials that demonstrate problems with their drugs. This has spurred the American Medical Association and the editors of several major medical journals to call for a public registry of all clinical trials for FDA-approved drugs. The lawsuits that Mr. Troy is seeking to shut down have become the last line of defense to get that information and hold companies accountable for misleading consumers. With whistleblowers becoming more and more rare, most scandals involving consumer products are uncovered through lawsuits just like these. Our country has relied on them for decades to ensure that consumers have a remedy and an avenue to defend their interests. ACTION TAKEN BY HINCHEY On July 13, 2004, Congressman Hinchey offered an amendment to the Agriculture Appropriations bill, taking $500,000 away from FDA' Chief Counsel's office. In offering the amendment,
Mr. Hinchey stated his intention that the funds be cut from FDA's Office of General Counsel, which is housed in the Commissioner's office, and added to FDA's Division of Drug Marketing, Advertising, and Communication, the office responsible for monitoring drug advertisements. The amendment was accepted without opposition.
Since then, Mr. Troy and FDA have sought to restore the funding. Mr. Troy has visited legislators on Capitol Hill, distributing a copy of a letter from five former FDA chief counsels. This letter has also been submitted to the Congressional Record to refute Congressman Hinchey's assertions. The letter contains several false claims. Rep. Hinchey's argument is mischaracterized in the letter from the counsels, which reads in part, "Representative Hinchey states that Mr. Troy 'has taken the agency in a radical new direction' by submitting amicus curiae briefs in cases in which courts have been asked to require labeling for pharmaceutical products that conflicts with FDA decisions about appropriate labeling for those products." That is not what Rep. Hinchey has argued. The "radical new direction" refers to Mr. Troy's practice of soliciting lawyers for drug companies and medical device companies to come to him with cases in which to intervene; and submitting briefs in private civil cases in which FDA has not been asked for its opinion.
The letter then cites four examples of cases to show that in fact this type of activity on the part of the FDA predates Mr. Troy's term in office. None of the cases, however, provide such precedent. Here's why:
Weinberger v. Bentex: FDA had no choice but to file briefs since the agency was the defendant, not an intervener. Rep. Hinchey is arguing that the FDA never before intervened without being requested to do so. Jones v. Rath Packing: The FDA submitted a brief to the U.S. Supreme Court in a case involving a government agency and the labeling of flour. Again, far different from interceding in a state civil case between two private parties about product liability. Bernhardt v. Pfizer: The court requested FDA's statement of interest. Eli Lilly v. Marshall: According to the court's decision, FDA did not submit anything in this case and the case had nothing to do with product liability.
The former chief counsels wrote, "In none of these cases did any court request FDA's opinion. Thus, there is ample precedent for the actions that Mr. Troy has recently been undertaking. His action is not radical or even novel." That assertion is inaccurate. Congressman Hinchey has written a letter to Acting Commissioner Crawford, requesting further documentaion in this matter. He has also written to Agriculture Appropriations Subcommittee Chairman Henry Bonilla to refute the claims of the former chief counsels.
|
» Hinchey Questions FDA's Weakening Of Drug Warning Label (9/23/2004) » Hinchey Refutes Claims Of Former FDA Chief Counsels (8/5/2004)
|
Daily Data Marketing Wake Up Call: Infomercials Sell Your Data
Big time! Trust me on this one. Don't buy anything from an infomercial. These companies sell your data, and a lot of them also sell your credit card number to shady businesses.
What's Wrong with our Nation in Brief?
Check out the first sentence of the articles in today's Nation in Brief: ROCHESTER, N.H. -- A woman and her boyfriend are accused of plotting to sacrifice the woman's three children on a church altar. KITTANNING, Pa. -- A man was sentenced to life in prison without parole Friday in the starvation death of his 4-year-old daughter, whose body was found in a picnic cooler left for trash pickup outside his home. GOLDEN, Colo. -- A 20-year-old man pleaded guilty Friday to aggravated animal cruelty for stealing five puppies and burning two of them to death. SALT LAKE CITY -- Attorneys for a man accused of kidnapping Elizabeth Smart have asked a judge for additional competency evaluations, potentially delaying a trial already held up for months over the issue. MIAMI -- Police have acknowledged using a stun gun to immobilize a 12-year-old girl just weeks after an officer jolted a first-grader with 50,000 volts.
Singletary on Commercialized Kids
Michelle Singletary reviews a new book by Juliet Schor on commercial influences on children called Born to Buy: We let the enemy into our house when we allow our children to watch endless programming surrounded by a steady stream of messages that communicate they aren't worthy -- a somebody -- without certain products. We deliver our children to the enemy every time we choose to entertain them by shopping.
Advertisers and marketers are turning our children into materialistic monsters. And sadly, we are aiding and abetting the enemy.
Daily Data Marketing Wake Up Call: Birthday Clubs
Ever join one of those birthday clubs for your kid at a restaurant?
Daily Data Marketing Wake Up Call: Victoria's Secret Whores Your Data!
Who else knows about your underwear buying habits?
Daily Data Marketing Wake Up Call: Ethnic Marketing
How do you think the Department of Justice was able to so quickly locate Arabs after 9/11????
Even Preschoolers Are Targeted by the Data Marketers
Much of this marketing is probably directed at the parents...but sometimes it is directed at the children themselves.
DOD Invokes Geneva Conventions to Defend Bad SSN Practices
Hey, you remember that "quaint" document, the Geneva Conventions? Well, in a letter (PDF) to the General Accounting Office, the Department of Defense has invoked one of the Conventions to defend its use of Social Security Numbers to enumerate members of the military! So, I guess our administration has some use for the Conventions after all. This really isn't funny. Military members are at particular risk of identity theft because they are frequently overseas, and not at home to receive the bills that arrive as a result of impostors using their credit. The ubiquity of the Social Security Number contributes to the incidence of the crime.
2 Firm Items
1. Great article in the Wall Street Journal yesterday describing Adrienne Ashby, a lawyer who left a firm to work for Atlanta Legal Aid: 2. What do you do when you're an administration official and you have to resign because you have allegedly assaulted someone? You join a corporate lobbying firm. There is a place for every rotten person in this world.Ms. Ashby, a then-28-year-old graduate of the University of Virginia law school, had recently left a six-figure salary as an associate in a private law firm to become a $39,000-a-year legal-aid lawyer. "I wasn't doing what I was supposed to be doing," says Ms. Ashby, who grew up in a Norfolk, Va., public-housing complex, the daughter of a single, teenage mother. Her conscience, she says, "was picking at me."
Georgia's Who's Rich Data Marketing Wake Up Call
Ouch! Drawn from public records!
Duplex Diner Shut Down for Health Code Violations
The Washington Post reports: [...] Duplex Diner 2004 18th St. NW Closed last Thursday for no certified food supervisor, improper temperatures of potentially hazardous foods and unclean food contact surfaces and equipment. Reopened Friday.Health code Violations
Daily Data Marketing Wake Up Call
Subscribe to Columbia House? You've been sold! Even your musical tastes are for sale.
Flying? Don't Drink the Coffee
The Washington Post reports: In September, the EPA found that drinking water in an estimated 12.6 percent of the nation's aircraft tested positive for various forms of bacteria, including coliform, and failed to meet EPA standards... Tanks in an aircraft's belly supply water to the lavatories as well as the plane's galley. While most aircraft serve either bottled or canned water to passengers, the onboard supply is used for coffee and tea. Twelve airlines agreed to abide by the new procedures: Alaska, Aloha, American, America West, ATA, Continental, Hawaiian, JetBlue, Midwest, Northwest, United and US Airways... In its earlier study, the EPA found that of the 158 planes that were tested, the water in 20 had coliform bacteria, which generally do not cause illness, while two planes tested positive for potentially harmful E. coli...Some of the nation's largest airlines yesterday agreed to stricter inspection and monitoring of the drinking water used on their aircraft, two months after a federal study of 158 planes found that 1 in 8 failed government health standards...
FTC Warns Media Companies Carrying Ads for Bogus Products
Historically, media companies have been one of the biggest opponents of consumer protection law. Why? Because they benefit from advertising revenue generated by scam products. They also can "come to the rescue" with news pieces exposing the very products that they advertise. The FTC just warned media outlets about advertising bogus products:...the FTC staff has sent reminder letters to media outlets that ran advertisements challenged in the six law enforcement actions announced today. The purpose of these letters is to assist media in identifying and rejecting weight-loss ads that contain facially false claims. The media letters include: (1) a copy of the problem advertisement; (2) a copy of the Commission’s Reference Guide for Media on Bogus Weight Loss Claim Detection; and (3) a description of each Red Flag Claim contained in the problem advertisement.
Rael: 85% Chance of Self Destruction
Our friend Rael announces: BUSH RE-ELECTED: HUMANITY FACES 85% CHANCE OF SELF DESTRUCTION
Revenue Generating States Went For Kerry; Drains on the Country Went for Bush
I was reading this essay, and remembered this little nugget of information:All those Federal taxes you love to hate? It all comes from us and goes to you, so shut up and enjoy your fucking Tennessee Valley Authority electricity and your fancy highways that we paid for. And the next time Florida gets hit by a hurricane you can come crying to us if you want to, but you're the ones who built on a fucking swamp. "Let the Spanish keep it, it’s a shithole," we said, but you had to have your fucking orange juice.
Who's Who [for Sale]
I recently bought a copy of the SRDS Direct Marketing List Source on efraudbay on the cheap. I've had a lot of fun scanning in the listings of consumer information that are for sale. I've scanned in dozens of pages. Major retailers, including Williams & Sonoma, Victoria's Secret, tons of magazines, and even non-profit groups like the ACLU, sell lists of information on their customers/members. Today I came across this one--Who's Who. Yeah, you're flattered because you're in Who's Who, right? Well, the marketers are getting your information! Note that although probably most people appear in Who's Who for their professional responsibilities, the company has home addresses on people in the book. I think I'll scan in one of these listings every day to make you sick to your stomach. You're welcome.
I came across Tom Otterness' sculpture, Miser on Broadway at 83rd. I think it should be renamed "Trickle Down."
One Half Of One Percent of Aviation Employees Test High, Less Are Drunk
The Federal Aviation Administration is going to keep its current rate of alcohol and drug testing, because last year, less than one percent of employees tested positive for drugs. Even less tested positive for alcohol. It's interesting to see that the current standards require a random testing of 25% of employee for drugs, but just 10% of employees for alcohol....Pursuant to 14 CFR part 121, appendix I, section V.C, the FAA Administrator's decision on whether to change the minimum annual random drug testing rate is based on the reported random drug test positive rate for the entire aviation industry. If the reported random drug test positive rate is less than 1.00%, the Administrator may continue the minimum random drug testing rate at 25%. In 2003, the random drug test positive rate was 0.56%. Therefore, the minimum random
drug testing rate will remain at 25% for calendar year 2005.
Similarly, 14 CFR part 121, appendix J, section III.C, requires the decision on the minimum annual random alcohol testing rate to be based on the random alcohol test violation rate. If the violation rate remains less than 0.50%, the Administrator may continue the minimum random alcohol testing rate at 10%. In 2003, the random alcohol test violation rate was 0.10%. Therefore, the minimum random alcohol testing rate will remain at 10% for calendar year 2005.
Craig's List Starting to Suck
You've probably heard that ebay picked up a 25% interest in Craig's List. Although we haven't seen any major changes to CL, I have notice a huge increase in the number of Ebay-like scammers on CL. Check out this posting. This jackass is selling a Time Magazine from 2001, claiming: Water has been spilled on this book! It's in fair condition. Once you plastic it, you got a investment! Start Bidding Worth $$$ now, and will really be worth $$ after his capture or departure!
Selective Service to Match Records with Department of Education
I'm not a conspiracy theorist, but it is a little weird to find this notice in the Federal Register just a day after the election. It calls for a new "matching" system, which is a data mining program, between the Selective Service and the Department of Education. 1. Name of participating agencies: The Selective Service System (SSS) and the Department of Education (ED).
2. Purpose of the match: The purpose of this matching program is to ensure that the requirements of Section 12(f) of the Military Selective Service System Act [50 U.S.C. App. 462 (f)] are met...
[Federal Register: November 4, 2004 (Volume 69, Number 213)]
[Notices]
[Page 64353]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no04-86]
=======================================================================
-----------------------------------------------------------------------
SELECTIVE SERVICE SYSTEM
Computer Matching Between the Selective Service System and the
Department of Education
AGENCY: Selective Service System.
ACTION: Notice.
-----------------------------------------------------------------------
In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as
amended by the Computer Matching and Privacy Protection Act of 1988
(Pub. L. 100-503), and the Office of Management and Budget (OMB)
Guidelines on the Conduct of Matching Programs (54 FR 25818 (June 19,
1989)), and OMB Bulletin 89-22, the following information is provided:
1. Name of participating agencies: The Selective Service System
(SSS) and the Department of Education (ED).
2. Purpose of the match: The purpose of this matching program is to
ensure that the requirements of Section 12(f) of the Military Selective
Service System Act [50 U.S.C. App. 462 (f)] are met.
3. Authority for conducting the matching: Computerized access to
the Selective Service Registrant Registration Records (SSS 10) enables
ED to confirm the registration status of applicants for assistance
under Title IV of the Higher Education Act of 1965 (HEA), as amended
(20 U.S.C. 1070 et seq.). Section 12(f) of the Military Selective
Service Act, as amended [50 U.S.C. App. 462(f)], denies eligibility for
any form of assistance or benefit under Title IV of the HEA to any
person required to present himself for and submit to registration under
Section 3 of the Military Selective Service System Act [50 U.S.C. App.
453] who fails to do so in accordance with that section and any rules
and regulations issued under that section. In addition, Section
12(f)(2) of the Military Selective Service System Act specifies that
any person required to present himself for and submit to registration
under Section 3 of the Military Selective Service System Act must file
a statement with the institution of higher education where the person
intends to attend or is attending that he is in compliance with the
Military Selective Service System Act. Furthermore, Section 12(f)(3) of
the Military Selective Service System Act authorizes the Secretary of
Education, in agreement with the Director of the Selective Service, to
prescribe methods for verifying the statements of compliance filed by
students.
Section 484(n) of the HEA [20 U.S.C. 1091(n)], requires the
Secretary to conduct data base matches with SSS, using common
demographic data elements, to enforce the Selective Service
registration provisions of the Military Selective Service Act [50
U.S.C. App. 462(f)], and further states that appropriate confirmation
of a person's shall fulfill the requirement to file a separate
statement of compliance.
4. Categories of records and individuals covered:
1. Federal Student Aid Application File (18-11-01). Individuals
covered are men born after December 31, 1959, but at least 18 years old
by June 30 of the applicable award year.
2. Selective Service Registration Records (SSS 10).
5. Inclusive dates of the matching program: Commence on January 1,
2005 or 40 days after copies of the matching agreement are transmitted
simultaneously to the Committee on Government Affairs of the Senate,
the Committee on Government Operations of the House of Representatives,
and the Office of Management and Budget, whichever is later, and remain
in effect for eighteen months unless earlier terminated or modified by
agreement of the parties.
6. Address for receipt of public comments or inquires: Richard S.
Flahavan, Associate Director, Office of Public and Intergovernmental
Affairs, Selective Service System.
Dated: October 28, 2004.
Jack Martin,
Acting Director.
[FR Doc. 04-24634 Filed 11-3-04; 8:45 am]
BILLING CODE 8015-01-P
Norquist: Dems Neutered, Must Accept Their Powerlessness
Richard Leiby reports in the Reliable Source that:Rock-ribbed Republican Grover Norquist, president of Americans for Tax Reform [said] that Democrats must accept the finality of their powerlessness. "Once the minority of House and Senate are comfortable in their minority status, they will have no problem socializing with the Republicans. Any farmer will tell you that certain animals run around and are unpleasant, but when they've been fixed, then they are happy and sedate. They are contented and cheerful. They don't go around peeing on the furniture and such." Norquist assured us that he meant neutered "psychologically" and his metaphor was "facetious."
Cheney O' Lantern
Maureen's Ashcroft o' Lantern was a hit last year. This year, Mark has made a Cheney o' Lantern:
Should We Be Surprised?
The Wall Street Journal reports: But internal Merck e-mails and marketing materials as well as interviews with outside scientists show that the company fought forcefully for years to keep safety concerns from destroying the drug's commercial prospects... As academic researchers increasingly raised questions about Vioxx's heart safety, the company struck back hard. It even sued one Spanish pharmacologist, trying unsuccessfully to force a correction of an article he wrote. In another case, it warned that a Stanford University researcher would "flame out" unless he stopped giving "anti-Merck" lectures, according to a letter of complaint written to Merck by a Stanford professor. A company training document listed potential tough questions about Vioxx and said in capital letters, "DODGE!" The revelations shed new light on the interplay between marketing and science at Merck as bad news piled up about a blockbuster drug used by some 20 million Americans. Amid growing danger signs, Merck fought a rearguard action for 4½ years, clinging to a hope that somehow Vioxx's safety could be confirmed -- even though its research chief had already privately acknowledged its risks... A Merck internal marketing document reviewed by The Wall Street Journal, addressed to "all field personnel with responsibility for Vioxx," provided an "obstacle handling guide." If a doctor said he was worried that Vioxx might raise the risk of a heart attack, he was to be told that the drug "would not be expected to demonstrate reductions" in heart attacks or other cardiovascular problems and that it was "not a substitute for aspirin." This wasn't a direct answer. One training document is titled "Dodge Ball Vioxx" and consists of 16 pages. Each of the first 12 pages lists one "obstacle," apparently representing statements that might be made by a doctor. Among them are, "I am concerned about the cardiovascular effects of Vioxx" and "The competition has been in my office telling me that the incidence of heart attacks is greater with Vioxx than Celebrex." The final four pages each contain a single word in capital letters: "DODGE!"... Merck also went on the offensive against academic researchers who began to question Vioxx's safety. Gurkirpal Singh of Stanford University, a prominent Cox-2 expert who was giving lectures sponsored by Merck and other companies, says he pressed Merck repeatedly for more cardiovascular safety data. When Merck refused, Dr. Singh added a slide to his presentations that showed a man -- representing the missing data -- hiding under a blanket. "This was the first time they didn't answer my questions," he says. "With Vigor, suddenly it was a clampdown."When Merck & Co. pulled its big-selling painkiller Vioxx off the market in September, Chief Executive Raymond Gilmartin said the company was "really putting patient safety first." He said the study findings prompting the withdrawal, which tied Vioxx to heart-attack and stroke risk, were "unexpected."
Commercial Child Molestors Strike
Found on Bay Street, Toronto, Canada.
IRS Audits Down
The Transactional Records Access Clearinghouse reports:The latest available data from the IRS show that the pace of corporate audits is running well below the record-low levels of FY 2003...The finding about slumping corporate audits conflicts with repeated statements by IRS Commissioner Mark W. Everson in the weeks before the April 15 tax-filing day asserting that the agency had halted the long slide in the government's efforts to police corporate non-compliance. Both the IRS Oversight Board and the GAO have expressed concern about the impact of the decline in IRS audits.
This weblog is licensed under a Creative
Commons License.
Powered
by
Movable Type 3.2b2