The reporters examined legal records—yes, there have been lawsuits. And they looked at government reports like the one from the Government Accountability Office, which revealed that too many devices were going via the fast-track process when they required more intense testing. They talked to consumer advocates. Lisa McGiffert who heads a patient safety project at Consumers Union, observed: “The industry keeps saying we’re going to stifle innovation, but it’s not innovative if it’s not safe and does not work.”
They also talked to industry lawyers. One said: “If you want to review the safety and effectiveness of every device starting from scratch, you’re not going to have any medical devices. The device industry would grind to a halt.” The Register presented two sidebars—one, a case study of the device, which delved into how the Newport Beach hospital came to choose the Xoft product, and the other, a case study of Kelly’s medical troubles. Both added oomph to the piece.
The Register’s story sets a high bar, and it offers plenty of consumer warnings. “At least with cancer, we knew we could go in and cut it out,” said Kelly. “With tungsten we’re shooting in the dark. We’re all lab rats.” The Register also shows that digging and dot connection can still produce fine journalism even in this era of declining resources at legacy media. And I expect Orange County Register readers appreciated it.
Yes bring on the human testing!!!!
http://www.americanthinker.com/2012/06/epas_unethical_air_pollution_experiments.html
United States Environmental Protection Agency (EPA) Administrator Lisa Jackson testified before Congress in September of 2011 that small-particle (2.5 microns or less) air pollution is lethal. “Particulate matter causes premature death. It’s directly causal to dying sooner than you should.”
At the hearing, Representative Edward J. Markey (D-MA) asked, “How would you compare [the benefits of reducing airborne PM2.5] to the fight against cancer?” Ms. Jackson replied, “Yeah, I was briefed not long ago. If we could reduce particulate matter to healthy levels, it would have the same impact as finding a cure for cancer in our country.” Cancer kills a half-million Americans a year — 25 percent of all deaths in the U.S. annually.
That same month, September 2011, Environmental Health Perspectives (EHP), a journal sponsored by the National Institutes of Health, reported an experiment that exposed a 58-year-old lady to high levels of small particles in a chamber. After 49 minutes in the chamber, the lady, who was obese with hypertension and a family history of heart disease, who also had premature atrial heartbeats on her pre-experiment electrocardiogram, developed a rapid heart beat irregularity called atrial fibrillation/flutter, which can be life threatening. She was taken out of the chamber, and she recovered, but she was hospitalized for a day. Weeks later, an abnormal electrical heart circuit was fixed by cardiologists, as reported in EHP.
It is illegal, unethical, and immoral to expose experimental subjects to harmful or lethal toxins. The Reference Manual on Scientific Evidence, 3rd Ed. (2011), published by the Federal Judicial Center, on page 555 declares that exposing human subjects to toxic substances is “proscribed” by law and cites case law. The editor of EHP refused a request to withdraw the paper and conduct an investigation.
The EPA’s internal policy guidance on experimental protocols prohibits, under what is called the “Common Rule,” experiments that expose human subjects to lethal or toxic substances. Milloy referenced the “Common Rule” that governs EPA policy on research conduct in human experimentation in his letter to the inspector general of the EPA requesting an investigation of the matter.
A full report on the research study shows that 41 other people were exposed to what the EPA says are harmful or lethal levels of small particles, with some enduring up to 10 times the EPA’s declared safe level of 35 micrograms per cubic meter of air. The EPA human experiments described were conducted from January 2010 to June 2011, according to the information obtained by JunkScience.com on a Freedom of Information Act request, and ended three months before Ms. Jackson’s congressional testimony, but she still asserted dramatic claims of PM2.5′s lethality — thousands of deaths at stake and hundreds of billions in economic consequences from the deaths and disabilities caused by small particles.
According to the congressional testimony of Lisa Jackson, these experiments risked the lives of these 42 people. So what could have possessed these EPA researchers to do the experiments? The authors reveal the reason in their case report on the lady:
#1 Posted by robotech master, CJR on Thu 7 Jun 2012 at 04:11 PM
Although epidemiologic data strongly support a relationship between exposure to air pollutants and cardiovascular disease, this methodology does not permit a description of the clinical presentation in an individual case. To our knowledge, this is the first case report of cardiovascular disease after exposure to elevated concentrations of any air pollutant.
The people at the EPA claim that they must control air pollution to prevent the deaths of thousands. Then they expose human subjects to high levels of air pollution. Is it possible that they are lying, or unethical, or both?
In the experimental protocol, seven subjects were exposed to levels 10 times greater than the 24-hour safe limit for small particles, and all of the other 40 subjects were exposed to more than the 35 micrograms per cubic meter that the EPA says is the 24-hour safety limit. The researchers failed to report that none of the other subjects had any adverse effects, which is unscientific, since researchers are obligated to report results both for and against their hypothesis.
The only way out for the EPA in this episode is to acknowledge the reality that ambient levels or even higher levels of PM2.5 are not toxic or lethal, based on their own research, and to admit that their claims of thousands of lives lost from small particles is nonsense. Or they can stay with their assertions about small particle toxicity and face charges of criminal and civil neglect.
The individuals who were the subjects of this experiment certainly might be concerned if the EPA claim of small particle toxicity and lethality is true. There is good reason to believe that the EPA itself doesn’t believe the claims. However, based on congressional testimony by EPA officials, any death now or later of the subjects of this experiment from heart and lung disease or cancer would be under the cloud of concern about the EPA claims that small particles kill. What were the EPA officials and researchers thinking?
John Dale Dunn MD JD Consultant Emergency Services/Peer Review Civilian Faculty, Emergency Medicine Residency Carl R. Darnall Army Med Center Fort Hood, Texas
You would think one of the biggest and most unethical scandals in US history would get front page news on the environmental section.
#2 Posted by robotech master, CJR on Thu 7 Jun 2012 at 04:13 PM
In addition to the article under discussion, many past articles byCourtney Perkes rise to the point of excellence. My hope is that Perkes will have an exciting career ahead of her.
#3 Posted by Fancia, CJR on Fri 8 Jun 2012 at 11:14 AM
So the FDA approves the thing if it's substantially similar to something already on the market? What's that process do to the patentability of the "new" device?
I see a potentially fun follow-up piece looking at the U.S. Patent Office's treatment of these devices--and at the companies' patent claims.
#4 Posted by Edward Ericson Jr., CJR on Fri 8 Jun 2012 at 01:31 PM