 boards, you’d be surprised to learn there are no special licenses nor mandatory requirements for special training, nor is there a routine background check on physicians doing clinical research. The system relies on ethics review boards–institutional review boards (IRBs) at academic medical centers, or commercial CROs hired by corporate sponsors. In both cases–IRBs and CROs–are dependent on those that employ or hire them.
A Congressional sting operation demonstrates that the current system whose purpose is to protect the integrity of science and the safety of human subjects–is a mirage.
The New York Times and The Wall Street Journal reported earlier this month about a Congressional sting operation carried out by the Government Accountability Office that found it mighty easy to gain approval from an ethics review boards to conduct medical experiments on human beings.
In fact, even a fictitious company with a fictitious address, and a fictitious medical product, headed by a businessman with fraudulent credentials can hire a "licensed" independent research review board to lend the illusion of legitimacy dubious medical experiments conducted on human subjects.
Five months after Coast Independent Review Board (a commercial CRO) gave the fictitious company, Device Med-Systems, approval to begin testing the fictitious adhesive, its clinical trial. Prompting that credential check was a letter from Mr. Stupak’s panel inviting Mr. Dueber to Washington to testify about the study.
Further adding to the discomfort level: the FDA did nothing to protect the safety of patients, allowing Coast IRB to continue operating despite serious concerns, taking action only after the Times and Journal disclosed some of the facts.
The Wall Street Journal reports (below) that another research scam uncovered by the GAO sting involved a "bogus IRB with a pet dog as its CEO."
Another FDA warning letter addressed to Dr. Charles Cote, involves Harvard Medical School affiliate, Massachusetts General Hospital.
"This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address these deficiencies and establish procedures to ensure that any on-going or future studies will be in compliance with FDA regulations.
If you can’t trust that medical research conducted at Harvard University affiliated hospitals would be in compliance with MINIMAL federal regulations, who can you trust?
FDA failed to excercise its authority until a month after the violations were reported by the NY Times and the WSJ.
Perhaps the GAO, rather than the FDA should be entrusted with oversight over medical research–the GAO staff do a far better job than either FDA or academic institutions at preventing unethical human experiments, or feretting out bogus tests from genuine research.
"The fraudulent trial was apparently commenced as part of a Congressional ‘sting’ operation," Coast, which is based in Colorado Springs, said in its release.
The company’s president, Daniel Dueber, said he believed the operation was an unwarranted effort by the House Energy and Commerce Committee’s Subcommittee on Investigations and Oversight to embarrass firms like his.
The undercover investigation of the trial industry was conducted by the Government Accountability Office, a research arm of Congress, at the subcommittee’s request, a G.A.O. spokesman said.
In a telephone interview, Mr. Dueber said his firm began investigating the bona fides of the Adhesiabloc study last week – five months after it gave Device Med-Systems approval to begin its clinical trial. Prompting that credential check was a letter from Mr. Stupak’s panel inviting Mr. Dueber to Washington to testify about the study.
He added that the only issue raised in October by Coast’s medical board, which includes several real doctors, was a request for revisions in the study’s patient consent form. A Coast official, he said, had spoken by phone with the supposed head of Device Med-Systems, who identified himself as Paul Jennings and agreed to make the requested changes. "It was very congenial,"
Mr. Dueber said.
He said that Coast had followed all federal rules in approving the Adhesiabloc study, but that the company had now revised its own policies.
But another tidbit expected to surface today is the panel’s plan to also set up a "bogus IRB with a pet dog as its CEO," according to a congressional memo seen by Health Blog.
The invented IRB’s CEO was to have been named "Trooper," after a Capitol Hill staffer’s beloved three-legged dog, Health Blog was told.
The canine (not pictured above) is said to have hung out on occasion with the attack dogs of then-Chairman John Dingell’s investigative team, and apparently liked to sniff around almost as much they do.
Hearing update: Rep. Greg Walden, R-Ore., criticized Health and Human Services officials for failing to catch the fictitious IRB and registering it despite numerous red flags. "Nobody picked up on names like Phake Medical Devices, April Phuls, Timothy Witless and Alan Ruse – in the town of Chetesville, Ariz.?" he asked department reps.
"We realized it was a terrible risk for the patient … It is the worst thing I have ever seen," an Argus IRB reviewer said, according to a slide shown at the hearing.
Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.
Coast CEO Dan Dueber said in an interview that the congressional case was illegal entrapment. At the hearing, Mr. Dueber testified, "The GAO perpetrated an extensive fraud against my company. You pulled the wool over our eyes — congratulations." Because the product was fake, it was never used.
The committee, working with the Government Accountability Office, Congress’s investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer’s three-legged dog, now deceased. Other fake names included "April Phuls" and "Timothy Wittless," which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.
At Thursday’s hearing, the toughest complaints were reserved for HHS. Rep. Joe Barton of Texas, the committee’s ranking Republican, asked one HHS official: "Do you have any sense of outrage?" Referring to Coast, he continued, "What steps are being taken right now to decertify these charlatans?"
Posted by Vera Sharav | Friday, April 17, 2009 |	Categorized Fraud | Tagged FDA, Informed Consent, Scientific Misconduct, Harvard, The Wall Street Journal Bookmark the permalink.18-Jun-2019 An investigation on the effects of forest fragmentation and channel migration on wildlife habitat in sonai rupai wildlife sanctuary assam Jahan Saherah Kalita Sarveswar and Baruah Binod Kr.
24-Jan-2019 Land resources evaluation for sustainable development in remi watershed in east siang district of arunachal pradesh a geo environment study using remote sensing and GIS techniques Dutta Harekrishna Goswami Dulal C and Karmakar R.M.
28-Nov-2018 A geo environmental study for restoration of kolong river in nagaon and morigaon distirct of assam Bora Minakshi Goswami D.C.
18-Nov-2016 Geo environmental study of dhansiri south river basin assam using spatial technology Barman Plabita Goswami D.C.
15-Nov-2016 Traditional water harvesting systems of north east india selected case studies SARMA ANGKITA Goswami D.C.
Recently I’ve been working on a painting inspired by the post-impressionist French painter Édouard Vuillard. I am really drawn to his work – so full of colour and pattern! Vuillard was a member of the Les Nabis group, including Pierre Bonnard, Maurice Denis, Paul Ranson, Paul Sérusieer, Félix Vallotton and Édouard Vuillard. What draws me to Vuillard and Bonnard especially is their depiction of the everyday, infused with a delightful patchwork of colour.
Bonnard and Vuillard’s “intimism” drew from the everyday, forcing us to reconsider the beauty of our household objects and unthinking rituals.
I chose the The Flowered Dress, by Vuillard as my inspiration. This painting depicts the artist’s mother, a dressmaker and presumably her employees at work. This busy composition, in a profusion of greens, feels like it shouldn’t work, yet it works so well at leading the viewer around the canvas – from the mother in the strikingly patterned dress, to the peach fabric on the mantle piece, the reflection in the mirror and back to the mother.
In my piece, I began with a reference photo I’d taken of a woman half turned to look towards a window. Beginning here, I set out with a desire to add pattern as much as I could whilst keeping a balanced composition. My reference had a woman seated in t-shirt and trousers, so you can see how far I took this, adding visually but also adding a sense of narrative. I deliberately gave the painting a green palette and used The Flowered Dress as a direct reference in my back wall pattern.
I really enjoyed painting this, playing with what I could add