Sen Grassley Tells FDA Commish: "Whistleblowers Are Often Treated Like Skunks At A Picnic"

Following the dustup and Lawsuit (here) filed by employees of FDA:

Whistleblowers Expose FDA's Illegal Surveillance Of Employees

Sen. Grassley (R-Iowa) has written to FDA Commissioner Margaret Hamburg.

Which begins; (emphasis ours)

Dear Commissioner Hamburg:

I write to express my concerns over your agency's treatment of whistleblowers as a result of their disclosures to Congress, and specifically disclosures to my office. Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so while risking their professional careers, they are often treated like skunks at a picnic. Whistleblowers have played a critical role in exposing harmful government actions and retaliation against whistleblowers should never be tolerated. Thus, I am particularly concerned about the treatment of whistleblower P.J. Hardy by the Food and Drug Administration (FDA).

P.J. Hardy is one of 9 FDA physicians and scientists that wrote a letter to the Presidential Transition Team in 2009 advising that, "Managers at CDRH have ignored the law and ordered physicians and scientists to assess medical devices employing unsound evaluation methods " and "ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules, and regulations. A week after that letter was sent I wrote to FDA expressing my concern over such troubling allegations, especially in light of the fact that more than 6 years ago I wrote to the Agency regarding similar allegations at FDA's Center for Drug Evaluation and Research."

There's more. 5 pages worth.

Thanks and a hat tip to Ed at Pharmalot.

Grassley Probes FDA Over Employee Whistleblowers

And Thank You Sen. Grassley

Whistleblowers Expose FDA's Illegal Surveillance Of Employees

Whistleblower Protection Blog has;

Whistleblowers Expose FDA's Illegal Surveillance of Employees

Posted on January 30, 2012 by Lindsey Williams

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FDA Spy Program Documents Linked Here

As reported in today's Washington Post, six current and former employees of the Food and Drug Administration (FDA) have filed a complaint against the FDA in U.S. District Court. The employees are seeking an injunction to stop the agency from illegally spying on employees' private communications to Congress and other oversight agencies.

Linked here are key documents related to this lawsuit and the FDA's spying program.

The complaint details how the FDA targeted its employees with a covert spying campaign that lasted for two years. The FDA began the program after learning that the employees wrote a letter to President-Elect Obama and his transition team in early 2009 detailing government misconduct in approving unsafe medical devices. The Agency installed (or activated) spyware on their workplace computers and used other technology that to monitor their password-protected Gmail-to-Gmail communications.

In addition to reading the whistleblowers' emails, the FDA took contemporaneous screen shots of the employees’ computer screens. Managers used the collected information to learn the identities of confidential whistleblowers and to obtain the details of the public health and safety concerns the whistleblowers intended to disclose to the Office of Special Counsel, Congress and the Agency's own Inspector General.

The FDA also intercepted email communications to and from staff members of the House Committee on Energy and Commerce and the Ranking Member of the Senate Finance Committee. These Congressional intercepts are linked here.

The FDA’s prolonged covert monitoring of the whistleblowers continued even after the HHS Office of Inspector General denied the FDA’s request to take any criminal and/or administrative action against the whistleblowers. In their letter of refusal, the OIG explicitly informed the FDA that the whistleblowers' communications to Congress were protected under law.

The managers who spearheaded the surveillance efforts were the same managers involved with the wrongdoing and corruption that the whistleblowers were seeking to report. Lawyers at the FDA and HHS Offices of General Counsel, who should have understood that the program breached the employees’ confidentiality, helped FDA managers with their obstruction and retaliation.

In their lawsuit, six FDA whistleblowers who were fired by the agency (including two highly respected medical doctors, a Branch Chief, a former Health and Safety Officer employed by the Public Health Service and a 23-year FDA career M.D./Ph.D Scientist) are requesting a nationwide injunction prohibiting the federal government from targeting whistleblowers with selected surveillance and monitoring.

The lawsuit alleges that such targeted monitoring of whistleblowers violates their First Amendment rights of freedom of speech and association.

Stephen M. Kohn, NWC Executive Director and attorney for six FDA whistleblowers, issued the following statement:

The FDA declared war on employees who were trying to warn Americans about threats to public health and safety.

The federal government cannot---and should not---spy on whistleblowers. The First Amendment prohibits targeting whistleblowers and selectively monitoring them using highly intrusive electronic surveillance without a warrant.

Targeting the employees who raise health and safety concerns---or who try to report waste, fraud and abuse to the proper authorities---will have a massive chilling effect on employees.

The FDA's illegal spying program is not just a problem for the six victims in this case. The day we allow the government to spy on employees based on their lawful whistleblower activities is the day we give up privacy for every honest public servant in America.

If permitted to stand, the FDA's whistleblower surveillance program will be used by government agencies throughout the United States to silence employees who want to report misconduct. Those who are not silenced will be subjected to years of intrusive covert spying designed to dredge up embarrassing information that the agencies can use to destroy the whistleblowers' reputations and careers.

Today, the NWC issued an Action Alert seeking public support for the FDA whistleblowers and demanding an end to the federal government's targeted and selective surveillance of whistleblowers.

The NWC obtained the intercepted emails as a result of a lawsuit filed under the Freedom of Information Act and from documents produced by the FDA as a result of administrative actions taken against three of the whistleblowers.

Links:

FDA Whistleblower Complaint

Intercepted Emails from FDA Whistleblowers

Letter from the HHS OIG

Support FDA Whistleblowers Page

NWC Action Alert

TAGS: FDA, News, federal employee, osc, whistleblower

Thank You, Whistleblowers Protection Blog

FDA CDRH: Nov 17 2008: The Letter

On November 17 2008 US Representatives John Dingell and Bart Stupak fired this rocket back to then FDA Commissioner Andrew von Eschenbach. We've JPG-ed it from:

energycommerce.house.gov/Press_110/110nr383.shtml

We suggest you save it, print it, and carry it in your wallet.






And then the Next time some Damn Fool tells you that the solution to America's Health Care Crisis lies in "Single Payer, Let GOVT raise Your Taxes to Pay for Everything, National Socialist Bull Hockey", ...... hand that God Damn Fool This letter, ...... and make that God Damn Fool Read This letter back To You, .....

Then ask that God Damn Fool if even MORE OF THIS CRAP is what they Really want, when They or Their Own Family Need Health Care.

At Over $2 Billion Dollars a year FDA has Plenty of budget. What it Needs is to get Rid of its Half a $Billion Dollar "User Fee" addiction which makes Letters like This one an Absolute Inevitability. There Will be more coming. Count on it.

Congressman Dingell and Stupak are Lawfully ELECTED Representatives, Not, APPOINTED Apparatchiks who Unlawfully Intimidate the Real Scientists under them. If you live in either of these Lawfully ELECTED Representative's districts; call their office and say Thank You.

Visit Hissey Kientz LLP on youtube for video clips.

http://www.youtube.com/hkllp

Preventing Crap like this is why we Have a Constitution. Demand it be reinstated, To, ..... The ..... Letter.


"I cannot undertake to lay my finger on that article of the Constitution which granted a right to Congress of expending, on the objects of benevolence, the money of their constituents."

James Madison

FDA Approves Brain Implant For OCD Based On 26 Patients

Health News.com has:

FDA Approves Implant Device For OCD Treatment

Now, FDA has approved mechanical, electrical Brain Implants, ...... to control your Mental Behavior.

"Approximately 1 in 50 U.S. adults suffer from obsessive-compulsive disorder (OCD) which is the fourth most common mental disorder."

Reuters has this gem using electrodes planted IN your brain.

Obsessive Compulsive Disorder used to be called being stuck in a rut before Psych started turning a buck on it. And the FDA has approved the 1st Implant Device to Treat severe OCD.

It's the Reclaim DBS Therapy Device from Medtronic. This ghost roaster shoots out electrical impulses to control the "Symptoms" of OCD. And like everything else to do with Symptom Control, Reduction, and Flat Out Sledgehammering, ..... it Ain't going to Cure Nothing, ..... because there's nothing To cure. And of course, ....... it's a DSM 'Incurable Mental Illness', ..... so, ..... once Diagnosed by a College Degreed Ideate, ....... there go your Rights, ........ and the rest of your Life.

DSM-IV-TR Billing Code: 300.3: Obsessive Compulsive Disorder

This device is already in use to treat Parkinson's Disease, Tremors and Dystonias, ..... and they approved it with its 4 electrodes, ...... to Bury IN your brain, ...... after examining data on a Whole 26 patients who experienced a 40% reduction in Symptoms. The article does Not however tell us what Else those 26 experienced.

But Wait! There's More!

IF, ..... you order the Ginsu Knives in the Next 4 Minutes, .........

Online Health News has:

FDA Fails To Check Medical Devices

The Project on Government Oversight (POGO) has called for an investigation into the U.S. FDA’s early laboratory inspections of high-risk medical devices, saying that the agency conducts far too few of them. The watchdog group urged lawmakers to give the FDA more funding to hire and train additional inspectors. FDA records show that early lab inspections dropped from 33 in 2005 to just 1 in 2008. A number of FDA scientists have complained that the agency's Center for Devices and Radiological Health (CDRH) stopped requiring device makers to undergo FDA preclinical lab inspections.

This $60K Ghost Zapper, implanted IN your brain, is currently used to control Parkinsons, Tremors, and Dystonias:

All of which can be, and are, Also Implanted into Your Brain and Life, By Symptom Controlling Antipsychotic Poisons, ....... prescribed INTO your brain, ..... to Control, ..... Symptoms.

Psychiatrists make a LOT of MONEY, implanting those Billable 'Mental Illnesses', ...... Into Your Brain.

DSM-IV-TR Billing Code: 332.1 Neuroleptic Induced Parkinsonism
DSM-IV-TR Billing Code: 333.1 Medication Induced Postural Tremor
DSM-IV-TR Billing Code: 333.7 Neuroleptic Induced Acute Dystonia
DSM-IV-TR Billing Code: 333.82 Neuroleptic Induced Tardive Dyskinesia
DSM-IV-TR Billing Code: 333.90 Medication Induced Movement Disorder NOS





Newspeak. Learn, Listen, but above All, ...... Obey,

and Pay.

FDA: Agency Whistleblowers Seek Presidential Intervention

NYT Gardiner Harris has:

Dissidents At FDA Complain Of Inquiry

In an escalating war between FDA Scientists who complained of Intimidation BY FDA Brass, and FDA Brass themselves, yet another shot has been fired.

This time, After the Dissidents went to the US House with a pile of Documents which launched a letter from the House To FDA Commish von Eschenbach, it appears that the Dissidents may have been Counter Attacked By FDA Brass: whom They accuse of launching a criminal Investigation against them in retaliation, ...... for complaining.

"Heidi Rebello, an F.D.A. spokeswoman, said she could neither confirm nor deny the existence of a criminal investigation."

The Dissidents are asking President Obama to Intervene immediately.

FDA: Quashing Science Through Managerial Reprisals

NYT Gardiner Harris has:

FDA Scientists Accuse FDA of Misconduct

The US House Energy and Commerce Committee News Release of Nov 17.

Serious, and Lawless Misconduct, Coercion and Intimidation from top FDA officials, ..... is under Congressional Investigation.

Eight FDA Scientists in May this year contacted FDA Commissioner Andrew von Eschenbach: voicing their concerns. Frustrated, on Oct 14, 2008, these Eight then contacted Rep. John Dingell of the House Committee on Energy and Commerce to revoice their concerns. Their redacted letter opens with:

"This letter seeks your urgent intervention because serious misconduct by managers of the U.S. Food and Drug Administration (FDA) at the Center for Devices and Radiological Health (CDRH) is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA's mission to protect and promote the health of all Americans. Managers at CDRH have failed to follow the laws, rules, regulations and Agency Guidance to ensure the safety and effectiveness of medical devices and consequently, they have corrupted the scientific review of medical devices. This misconduct reaches the highest levels of CDRH management including the Center Director and Director of the Office of Device Evaluation (ODE)."

Congressmen Dingell and Stupak returned This Letter on 17 Nov '08 to FDA Commissioner von Eschenbach. (para. 2)

"These Scientists make well documented allegations that senior managers within CDRH "ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law." The CDRH scientists also state that CDRH managers ordered them "to make safety and effectiveness determinations that are not in accordance with scientific regulatory requirements, to use unsound evaluation methods, and accept clinical and technical data that is not scientifically valid or obtained in accordance with legal requirements such as obtaining proper informed consent from human beings."

But what do you expect when FDA funds itself, in part, through $500 Million in "User Fees" from the very Drug and Device manufacturers FDA is Supposed to be regulating. Freedom Works tagged This palm greasing scam 11 years ago as the headache it's Continued to prove itself .

Reuters in Feb '08 had FDA looking for even More Industry money in 2009.

"The spending plan includes $628 million in user fees paid by industry in exchange for the agency meeting targets in speeding review of new product proposals."

Do you Really think that even More Industry Money/Incentive to FDA is going to accrue to the patient's benefit over the "User Fee" payers benefit?

"The White House requested an FDA budget of $2.4 billion for the 2009 fiscal year starting in October, a 5.7 percent increase over last year's budget.

The proposal comes as the FDA faces heightened criticism for inadequate staffing, lax oversight of drug and food safety and out-of-date technology. Last week, lawmakers met to discuss a report by an independent board that concluded lives are at risk because the agency is so underfunded and behind in cutting edge science."

FDA Compensation Practices, considering the tug of war between FDA Scientists who are Doing the research, and FDA management who are "speeding review" of the "User Fee" paying manufacturers products, ..... might suggest a solution, ..... in just 2 words. It's under "Employees Exceeding Compensation Threshold in 2007"

The House Energy and Commerce Committee has been investigating FDA for 2 years, and they make available a whole Pile of documents here.

Eye On FDA closes their post hoping that FDA can rehabilitate its image. That is a sentiment we can get on board with. However;

Image over substance is Why FDA Has its Image problem. If the "World's Gold Standard" wants to stand as the 8th Wonder of the World, rather than the shivering, Parkinsonian afflicted Colossus of Rhodes it currently appears to be, it 1st needs to get its Antipsychoticed and Antidepressed head out of its Antipsychoticed and Antidepressed culture of managerial "User Fee" reprisal, butt.

The global spread of those Psychiatric symptom poisoning toxins is a cancer of as yet undreamt, let alone unrecognized, proportions. Left unchecked it Will eat out Western Civilization itself. No branch of medicine is, or ever was, Less deserving of legitimacy than Psychiatry: which derives its Diagnoses of Illness from its own, Money Making, self vested show of hands Opinions.

There are No 'Ill' neurons which can be Poisoned, or Electrocuted, out of Anyone's mind.

Psychiatry cannot cure the Illnesses it claims to Diagnose, and admits it. Psychiatry has devised a Billing Code to Profit from the Illnesses Psychiatry itself creates, and not only Admits it, but charges $85 just to buy its Billing Codes. Psychiatry has Code after Code, to continue Billing with, for the Iatrogenic Illnesses which are its annually compounded bite.

Its current Drug Money Treatment presents only an ever expanding capture net to homogenize humanity through poisoning out as many people as it can Profitably Label. And into that Poisonous, Dope Dealing Mire unwittingly trek, ..... our future Einsteins (backstory), ..... along with all lesser mortals. Psychiatry in its aggregate is the sum total of its Billing codes: a perpetual motion, self deepening pit of FDA approved, Real illness, suffering, death, and debt.

DSM-IV-TR Billing Code: 301.9: Personality Disorder, Not Otherwise Specified