There’s a viral video spreading about a San Diego man’s experience at the airport when he decided to opt-out of the TSA’s “new and improved” security process.
When John Tyner was picked to be taken out of the regular, metal-detection security line, he was given the choice to either be subjected to the new, “whole body image scan,” or undergo a pat-down procedure. He refused both, stating that he didn’t find either necessary simply to board an airplane, that he felt his rights would be violated, and made clear his wishes to withdraw and leave the airport.
Seems somewhat obvious that if he didn’t want to be subjected to either procedure, he should have just been allowed to leave immediately. But he couldn’t, because TSA told him he couldn’t, and now he’s been threatened with a civil penalty of $10,000 for his non-cooperation in the matter.
Good thinking on his part – he filmed the whole thing and posted it to YouTube, which is available here via Raw Story.
GAP’s television show discussed this very issue – the rise of whole body imaging in American airports – in a episode of Whistle Where You Work earlier this year (you can click on the video below – the segment runs for the first 20 minutes).
Is this option the best way to go? A coalition of privacy and civil liberty groups certainly doesn't think so, believing that we are sacrificing too much with this technology. Some religious groups also believe that the technology is in violation with their beliefs.
What are the alternatives to Whole Body Imaging? What is the real impetus here?
Lillie Coney is Associate Director with the Electronic Privacy Information Center (EPIC) in Washington, DC. EPIC was established in 1994 to focus public attention on emerging civil liberties issues and to protect privacy, the First Amendment, and constitutional values.
Corey Saylor is Legislative Director for the Council on American-Islamic Relations (CAIR). CAIR's mission is to enhance understanding of Islam, encourage dialogue, protect civil liberties, empower American Muslims, and build coalitions that promote justice and mutual understanding.
Yesterday, the Washington Post had an article about how the drug industry is the foremost source of fraud-related Department of Justice settlements. Drug companies comprised 8 of the government’s top 10 fraud settlements in the past year, according to the nonprofit organization Taxpayers Against Fraud. Today, ironically, pharmaceutical giant GlaxoSmithKline (GSK) made headlines with yet another multi-million dollar settlement over the sale of 20 adulterated drugs.
In this latest case of drug industry fraud, GSK will pay the government $750 million to settle criminal and civil complaints that the company knowingly sold bad drugs from a contaminated plant in Puerto Rico. Cheryl D. Eckard, Glaxo’s former quality control manager and the whistleblower in the case, maintains that she warned the company about problems with its drugs, including Paxil, Tagament, Coreg, and (yet again!) Avandia.
On Friday, the FDA announced that Abbott Laboratories has withdrawn its diet drug Meridia (also known as sibutramine), stating that the advantage of a small amount of weight loss does not outweigh the heightened risk of heart attack and stroke. The FDA’s request trails a study called the Sibutramine Cardiovascular Outcomes Trial, which found a 16 percent increase in “the risk of serious heart problems” (these “problems” include death).
Yet Meridia has been making appearances in the media for years. Concerns about the drug’s safety date back at least to 2002, when the nonprofit organization Public Citizen petitioned the FDA (it re-petitioned in 2009) to ban Meridia. Then in 2004, GAP client Dr. David Graham testified before a Senate Finance Committee hearing that sibutramine may be more dangerous than the conditions it was being used for. The hearing focused on the latest controversy at the FDA at the time – the FDA’s disastrous handling of the pain medication Vioxx– the horrific effects of which (tens of thousands of Americans died) were exposed by Dr. Graham.
But the hearing also provided an opportunity for Dr. Graham to speak out about additional regulatory failures, and other problematic drugs. From a November 2004 article in the NYT, which covered the hearing:
Dr. Graham, with more than 20 years of service with the Food and Drug Administration, cited the anti-cholesterol drug Crestor, the pain pill Bextra, the obesity pill Meridia, the asthma drug Serevent and the acne drug Accutane. Makers of each drug defended the medicines as safe.
Let’s look at the story of each of these five drugs:
In the hearing, Dr. Graham stated that federal drug regulators were “virtually incapable of protecting America.” So take heart – perhaps the FDA isn’t totally incompetent; it’s just incompetently slow. It only took six (!) years for the agency to take action regarding Meridia, despite the abiding existence of evidence of the drug’s dangerous side effects.
How many years will it take before the FDA will be capable of responding to drug safety threats in a timely manner?
Lindsay Bigda is Communications Fellow for the Government Accountability Project, the nation's leading whistleblower advocacy organization.
As of last Wednesday, NYC restaurant patrons are now able to choose dinner based not only on reviews of cuisine and service, but also on information about restaurant cleanliness. Each restaurant will receive a health department letter grade, ranging from a coveted A to an unwanted C, which will be displayed in prominent locations of entrances to dining establishments.
One of the most interesting features of the rating system is a new website, where patrons can view information about each restaurant’s latest inspection, including its egregious violations (think rodents, roaches). The system’s advanced search options allow users to compare eateries’ ratings using parameters such as cuisine or zip code, thus helping diners gain greater control over the food they consume, as well as the businesses they choose to support. The website uses the same rating system for 5-star restaurants to burger joints, and has the potential to dispel myths about the perceived cleanliness of establishments.
A similar system piloted in Los Angelesin 1998, as well as the NYC Health Department’s own six-month research process, reflects a growing public concern about holding restaurants accountable to the clientele they serve. Not surprisingly, many restaurants themselves oppose the new system, claiming that it will harm B- and C-rated restaurants and that it allows for too much government intrusion. Others agree – TIME calls New York and Los Angeles “downright draconian in their urge to oversee the inner workings of small businesses like restaurants.”
This is a red herring. Hand-wringing over big versus little government gets a bit off-topic, largely ignoring the fact that even those who oppose government oversight may still care about what they put into their bodies. Given the fact that restaurant inspection records have always been public (albeit more difficult to find), the new system is more about increased visibility, and is a clear victory regarding consumer rights.
The Inspector General of the Department of Health and Human Services, Daniel R. Levinson, is issuing a report today, according to Gardiner Harris in The New York Times, finding that FDA approvals of ten medicines in the US in 2008 were based exclusively on clinical trials conducted abroad. The report found that, overall, fewer than one percent of the foreign trial sites were inspected by the FDA, that 80 percent of the drugs approved for sale in the US in 2008 were based at least in part on trials conducted abroad, and 78 percent of trial participants were enrolled at foreign sites.
These numbers may be shocking but should not be surprising. Last year GAP published a monograph titled “The ABCs of Drug Safety” (pdf) providing a “Roadmap for Conducting Credible Clinical Drug Trials and Protecting Drug Trial Participants.” Here is an excerpt from that report (please see report for citations):
a) Unaddressed Gap
The federal government only regulates clinical trial research that is under HHS or FDA oversight. Several pre-Phase I, Phase IV, and investigator-initiated trials do not fall under the control of either agency. State, local, or institutional research or health laws may provide some trial participant safeguards, but none of these laws or policies effectively protects all human subjects in all research in this country.
If research is eventually submitted as part of a drug application to the FDA, it must comply with federal human subject regulations. But, clinical trials are increasingly conducted abroad, “where oversight is slim and patients plentiful.” And, drug companies get the results they want: One review found that 99 percent of controlled trials published in China gave the investigative drug the green light. This challenges credulity. The number of foreign clinical investigators seeking FDA approvals increased 16-fold during the 1990s. San Petersburg (Florida) Times reporter Kris Hundley found that in the past three years, FDA had inspected only eight out of thousands of clinical trial sites in India. Hundley writes: “In the burgeoning clinical trial business, says Amar Jesani, a doctor and medical ethicist in Mumbai, every layer of oversight is compromised by cash, and independent monitoring is nonexistent. He has resigned from supposedly independent ethics committees that rubber-stamp drug companies’ proposals and overrule any objections. Said Jesani: ‘We’re sitting on a time bomb that may explode at any time.’”
The Vermont Attorney General announced today that arrest warrants have been issued for former Bushway Packing, Inc. owner Frank Peretta and former Bushway worker Christopher Gaudette on charges of animal cruelty in the Bushway case. The case attracted national attention last fall, when the Humane Society of the United States released shocking video footage of operations at Bushway showing animals being repeatedly stunned with electrical prods, too weak to stand on their own, and stabbed for bloodletting while still conscious.
However, while the Humane Society footage spurred action, GAP client and USDA Public Health Veterinarian Dr. Dean Wyatt had been warning of problems at Bushway for months before. As detailed in Dr. Wyatt’s testimony earlier this year in front of the Domestic Policy Subcommittee of the House Committee on Government Oversight and Reform, Dr. Wyatt had attempted to stop inhumane handling practices not only at Bushway, but also at his previous assignment at the Seaboard pork plant in Guymon, Oklahoma. How did Dr. Wyatt’s supervisors at the USDA Food Safety Inspection Service react? They overturned his reports of animal cruelty based solely on the word of plant ownership, they forced him out of his job in Oklahoma, and the Director of the Office of Field Operations for FSIS even wrote a letter to Congress calling Dr. Wyatt “incompetent” for his charges of animal cruelty.
Fortunately for Dr. Wyatt, the Humane Society video tape vindicated his charge that there was something very wrong in the way Bushway was treating its animals. To the credit of USDA leadership, once the video evidence became clear, the agency was very aggressive in taking action on Bushway in conjunction with state and federal law enforcement.
GAP is happy to see real consequences for the people who engaged in animal abuse at Bushway. However, not every whistleblower is lucky enough to have an independent secret videotape investigation to surface and support his or her claims. How many others like Dean Wyatt are out there, being ignored and marginalized for speaking out against industry interests?
Jonathan Cantú is Food and Public Health Counsel at the Government Accountability Project, the nation's leading whistleblower advocacy organization.
The stricter standards follow a 2009 investigation by USA Today that found safety standards set by the Agricultural Marketing Service (AMS), a part of the USDA that buys meat for school lunches, were lower than those set by many fast food restaurants. The investigation found cases in which the AMS bought ground beef that retailers and fast-food chains would have rejected because of high amounts of so-called indicator bacteria – which can indicate an increased probability that the product contains dangerous pathogens.
In addition, the investigation found that the AMS testing procedures for ground beef are sorely deficient. Regardless of how long the production day runs, AMS combines eight samples of school-bound ground beef for a single combined pathogen test. That means 100,000 pounds of ground beef could be tested only once for pathogens. In comparison, many fast food chains take samples of their ground beef every 15 minutes and test the combined sample every one or two hours. So, basically, a fast food restaurant tests their ground beef five to 10 times more often than the USDA tests school lunch beef. Thankfully, the new school lunch standards will require that AMS test their ground beef at the same rate as fast food restaurants.
The investigation also found that the school lunch program purchases tons of chicken for schools that KFC or the Campbell Soup Company wouldn't use. The chicken bought by the USDA might otherwise go to compost or pet food if it weren't being eaten by schoolchildren.
As Senator Kristen Gillibrand (D-NY), an advocate of school lunch reform put it:
"Our schools and parents have a right to know where food is coming from and whether it's high-quality. I don't know why we're not putting better protections in place for our most vulnerable population. We have to reform how we feed our children in schools."
USA Today, which should be commended for its work, also found many other problems with school lunch safety during its examination of the program last year.
A solid piece that was buried in The New York Times today takes a look at the Obama administration’s enactment (or proposal of) tougher worker safety and consumer protection standards across a host of federal agencies. Sure, regulation buttressing is not really sexy, but its tremendously important. And the administration deserves some credit here.
What kind of regulations are we talking about here? Everything from construction site water runoff to safeguarding eggs. These include (from the article and its corresponding piece):
SALMONELLA AND EGGS
Final rule, July 2009
Mandates measures to prevent salmonella on eggshells during production, storage and transportation, like refrigeration of eggs or rodent-control efforts, to prevent an estimated 79,179 illnesses a year.
STOPPING DISTANCE FOR TRUCKS
Final rule, July 2009
Cost: At least $50 million a year. Savings: at least $169 million a year. New tractor-trailers will be required to be able to break from 60 m.p.h. to a complete stop within 250 feet, a 30 percent reduction, a change that is estimated to prevent 227 deaths annually and 300 serious injuries.
Final rule, October 2009
The first federal requirement to report and monitor greenhouse-gas emissions from about 10,000 industrial facilities representing 85 percent of such emissions in the United States.
The piece also talks about the upticks and generally favorable trends of inspection rates across agencies. FDA inspections are up significantly (still nowhere near what they should be, [example, example] but still headed in the right direction).
But what caught GAP’s eye today was the heavily-increasing number of inspections coming out of the Consumer Product Safety Commission (CSPC). That agency has the not-so-insignificant task of making sure products on store shelves don’t kill or significantly hurt people. Like toys from China with oodles of lead parts.
A new study of insiders who blow the whistle on drug company fraud has found that all of the whistleblowers were primarily motivated by ethics rather than possible financial rewards.
However, the study also found many of the whistleblowers paid a tremendous personal cost for their disclosures and a vast majority experienced retaliation from employers, including being harassed, blackballed, and fired. Many were unable to secure other jobs during and after the investigations and some experienced personal health problems including panic attacks.
The lead author of the study, Dr. Aaron Kesselheim, an instructor in medicine at Harvard Medical School, stated:
"A lot of them express a very strong ethical compass that they think guides them but, boy, they really do suffer a lot for the public good that they perform."
"The whistle-blowers need more support in the process of bringing the case forward."
As the article notes, the Justice Department currently has more than 1,000 whistleblower cases waiting to be investigated. From 1996 through 2005, health care fraud whistleblowers have led to the recovery of more than $9 billion.
GAP has long known that whistleblowers come forward because they "want to right a wrong, or bring to light something that was ethically compromised."
We have seen many whistleblowers come forward with no possibility of any financial reward. Instead, many are either forced to leave their jobs or choose to leave after experiencing retaliation.
GAP coalition partner Public Citizen is calling on the FDA to stop a trial that compares the effects of diabetes drugs Avandia and Actos.
The group argues that the study, named TIDE, endangers the health of the 16,000 participants it intends to study because "a wealth of data now suggests" that Avandia poses significant risk to the heart. Public Citizen contends that TIDE is "exposing thousands of high-risk patients with diabetes to a drug with an unfavorable safety profile and no clinical advantage over [Actos]."