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The Center has aggressively fought for the strict protection of whistleblowers who expose drug safety violations. In 2006 the Center won the landmark case of Fishbein v. DHHS, which established whistleblower protection under the WPA for all Title 42 doctors. Many Title 42 doctors serve in highly sensitive medical positions. The Center also supports medical and pharmaceutical professionals who have raised concerns regarding drug safety and /or improper marketing of drugs. For updated information on the Center’s work in this area visit the Center’s press room. instituted voluntary reforms in an effort to circumvent congressional acts.

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Press Coverage

Federal “Title 42” Employees Granted Whistleblower Protection

Washington, D.C., May 9, 2006. The United States Merit Systems Protection Board (MSPB) unanimously overturned the decision of an MSPB judge which had stripped all “Title 42” federal employees of their protections under the Whistleblower Protection Act (“WPA”). The MSPB ruling sets important national precedent ensuring that the thousands of Title 42 federal employees – many working in highly sensitive health and safety positions within the federal government – are fully protected under the whistleblower laws.

The case arose when Dr. Jonathan Fishbein, a high-ranking National Institutes of Health’s Division of AIDS safety manager was terminated after he disclosed serious violations of “Good Clinical Practices” which are designed to protect human subjects who participate in clinical trials concerning AIDS mediations. After his discharge, Dr. Fishbein sought protection as a whistleblower. The Office of Special Counsel and the MSPB judge threw out his case. In his November 9, 2004 decision, MSPB judge Raphael Ben-Ami, ruled that “Title 42 employees” are not protected under the WPA.

New Articles Govt Doctors Get Whistleblower Protection May 2, 2006, By John Solomon AP NIH reinstates specialist who alleged misconduct in federal AIDS research Grassley Hails NIH Reinstatement of Expert John Solomon, Associated Press Writer Dec 27, 2005 NIH Inquiry Shows Widespread Ethical Lapses, Lawmaker Says July, 14, 2005, By David Willman, LA Times Staff Writer NIH Review Substantiates Fired Expert's Concerns By John Solomon, Associated Press Monday, July 4, 2005; Page A02

In an order dated April 21, 2006, the MSPB reversed the lower court judge. The full Board held that the Whistleblower Protection Act was “remedial legislation” that should be “liberally” interpreted in order to “strengthen and improve” the rights of federal employees to disclosure wrongdoing [page 4]. The Board further held that Title 42 employees “properly appointed” to their positions would be covered under the WPA [page 9].

Dr. Fishbein’s attorney, Mr. Stephen Kohn, issued the following statement:

• The MSPB closed a dangerous loophole. The Board’s decision provides whistleblower protections to thousands of federal employees engaged in highly sensitive work directly related to public health and safety. Dr. Fishbein took a courageous stand in demanding full whistleblower protection in the face of a hostile federal bureaucracy. He is now fully vindicated. Other Title 42 employees with information about wrongdoing can now blow the whistle and obtain protection.

NIH Whistleblower Testifies Before
National Academy Of Sciences’ Institute Of Medicine

Washington, D.C. On January 4, 2005, Dr. Jonathan Fishbein, the leading NIH whistleblower on AIDS research misconduct, presented testimony before a special committee of the National Academy of Sciences’ Institute of Medicine (“IOM”).  This testimony highlighted the failure of NIH to comply with mandatory health and safety requirements in its AIDS research program.  

Prior to testifying before the IOM, Dr. Fishbein had raised allegations of AIDS research misconduct to members of Congress.  The IOM testimony was Dr. Fishbein’s first public testimony on this matter.

The Executive Director of the National Whistleblower Center, Kris Kolesnik, issued the following statement: “NIH officials are presently creating a chilling environment, preventing other potential witnesses from coming forward with similar allegations.  This is undermining the integrity of the regulatory process while reviews are on-going. We call upon the NIH to cease and desist the harassment and intimidation of whistleblowers within its program of AIDS. And Dr. Fishbein should be immediately reinstated as the Director, Office for Policy and Clinical Research Operations.”

AP: U.S. Officials Knew of AIDS Drug Risks
UPDATED - Monday December 13, 2004

Washington (AP) - The government's research on using an AIDS drug to protect African babies was so flawed that health officials had to use blood tests after the fact to confirm patients got the medicine. Ultimately, they had to acknowledge the study broke federal patient protection rules.

But the National Institutes of Health never told the White House about problems it found in 2002 with its research on the drug nevirapine before President Bush unveiled a $500 million plan to distribute the medicine across Africa, as documents obtained by The Associated Press show.

Instead, officials inside the government's premier health research agency scrambled to keep its safety experts' concerns from scuttling the use of nevirapine in Africa as a cheap solution to stopping babies from getting AIDS from infected mothers, the memos show.

"Everyone recognized the enormity that this decision could have on the worldwide use of nevirapine to interrupt mother-baby transmission," NIH's AIDS research chief, Dr. Edmund C. Tramont, reported March 14, 2002, to his boss, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

"It seemed to me we were drawing conclusions too quickly across the board, especially the implementation of nevirapine in South Africa," auditor Michael Hensley told AP. Ultimately, NIH did stop the Uganda research for 15 months - from the spring of 2002 to the summer of 2003 - to review the science and take corrective actions.

NIH officials told AP they remain confident after re-reviewing the Uganda study and other research that nevirapine can be used safely in single doses by African mothers and children to prevent HIV transmission during birth.

But they acknowledged their Uganda research failed to meet required U.S. standards and have asked the National Academy of Sciences to investigate.

"I would say there are many lessons that we have learned from this review that will help us do our clinical research, both domestically and internationally, much better," said Dr. H. Clifford Lane, NIH's No. 2 infectious disease official.

The White House said it remains confident in Bush's $500 million plan in 2002 to send nevirapine to Africa, a continent that accounts for more than two-thirds of the world's AIDS cases, with 27 million people infected. The United States approved $2.9 billion to fight global AIDS in 2005.

"The president's mission is to try to stop the spread of AIDS in Africa and to come at it from a new angle, and that is what this is all about," spokesman Trent Duffy said.

Though the White House was never told of the problems, they were serious enough that the U.S. Health and Human Services Department sent a nine-page letter to Ugandan officials identifying violations of federal patient protection rules by NIH's research.

The NIH research "may have represented a failure to minimize risk to the subjects," the Office of Human Research Protections told Ugandan authorities in summer 2002, a month after Bush's announcement of the nevirapine announcement.

NIH officials said a recent closer review of the Uganda research has identified a new concern - that even single doses of nevirapine can create instant resistance. That means patients may not be able to use the drug or others in its class again when their AIDS worsens, Lane said.

"It was unexpected, and what it means is nevirapine probably shouldn't be a drug of first choice if other options are available," Lane said.

Lane said NIH officials were aware in spring 2002 of the impending White House announcement on nevirapine but did not tell presidential aides of the problems because they were confident, even before reviewing the Uganda research, that the underlying science was solid.

In order to reconstruct the research to make sure the science held up, NIH officials in summer 2002 found they couldn't use patient records because of sloppy record keeping and missing files. Instead, they had to review blood samples to determine which patients got the medicines.

Nevirapine is an antiretroviral drug marketed in the United States as Viramune. It has been used since the 1990s to treat adult AIDS patients and is known to have potentially lethal side effects like liver damage and severe rashes when taken over time.

In 1997, NIH began studying in Uganda whether it could be given safely in single doses to stop mother-to-baby HIV transmission. That research showed it could reduce transmission in as many as half the births.

But by early 2002, an NIH auditor, the agency's medical safety experts and the drug's maker all disclosed widespread problems about the U.S.-funded research in Uganda.

Boehringer Ingelheim, the Connecticut-based company that makes nevirapine, told NIH it identified at least one "critical compliance issue" that compromised the integrity of the study and more than four dozen issues it described as serious and major.

Boehringer and NIH auditors cited concerns such as failing to get patients' consent about changes in the experiment, administering wrong doses and delays and underreporting of "fatal and life threatening" problems.

"It appeared likely, in fact, that many adverse events and perhaps a significant number of serious adverse events for both mother and infant may not have been collected or reported in a timely manner," Westat Corp. found in March 2002. Westat is a medical auditing firm hired by NIH to visit and audit the Uganda site.

Westat reported there were 14 deaths not reported in the study database as of early 2002 and that the top two researchers in Uganda acknowledged thousands of bad reactions that weren't disclosed.

NIH said the subsequent review whittled that list down significantly, all deaths were eventually recorded and the majority of bad reactions are believed to have been caused by the poor health of patients, not the single dose of nevirapine. But they conceded it was incumbent on a U.S. research project to disclose them fully and quickly.

Officials said the problems began when NIH converted the research from determining the drug's usefulness to supporting FDA approval for the drug. Paperwork in Uganda wasn't kept to FDA standards, they said.

"We may not have reported exhaustively, but we reported all serious side effects," said Professor Francis Mmiro, a lead doctor in the Uganda study. "What you may call a serious side effect in the U.S. is not a serious side effect in Kampala."

NIH officials reviewed the bad news in early March 2002.

Meeting minutes, written in shorthand, raised broad concerns: Half the babies in the study were also enrolled in a vitamin A study that could have affected the outcome, and medical staff running the trials didn't follow procedures for divulging serious adverse events (SAEs).

"No mtg minutes, no training doc(umentation), site used their own criteria for grading SAEs. No lab normal values & serious underreporting of SAEs," the minutes stated.

They also quote an NIH official who visited Uganda as saying, "The site staff doesn't know what they don't know."

But Tramont, the AIDS research chief, and other top NIH officials repeatedly dismissed the concerns as preliminary or overblown, and sought to salvage the flawed research's underlying conclusions rather than start over.

"There is presently no evidence that the study's scientific results are invalid," said a report Tramont sent to his staff less than two weeks after getting the March 2002 Westat audit.

In January 2002, Boehringer had sent NIH an early copy of its report. But the drug maker, fearing publicity about the report might destroy its chance to get FDA approval of the drug for domestic use, asked NIH to destroy it before FDA regulators could learn about it.

"Sensitive information. Asked for it to be destroyed when audit is upon us," NIH official Mary Anne Luzar wrote on the cover page of Boehringer's report.

But Boehringer says it never requested the document be destroyed, saying "our actions throughout the study evaluation were proactive and forthcoming."

Lane said the request to destroy the report was inappropriate and NIH never complied. But he conceded his agency inappropriately kept the audit from FDA for weeks, saying, "It shouldn't have happened that way."

NIH at first sought to postpone the FDA review of nevirapine, then top NIH and FDA officials arranged for the drug maker to pull its U.S. application rather than risk a public rejection that might scare African countries looking for U.S. guidance on the drug.

Unaware of the internal NIH concerns, Bush announced in June 2002 the $500 million effort to fight the spread of AIDS in Africa and the Caribbean. The plan's centerpiece was nevirapine.

"This major commitment of my government to prevent mother-to-child HIV transmission is the first of this scale by any government, anywhere," Bush said in a Rose Garden announcement.

African health officials are having second thoughts. South African officials in July recommended ending the single-use treatment because of the new concerns about drug resistance.

African doctors said they weren't aware of the full extent of NIH's concerns but feel comfortable - at least until better options emerge - administering it in single doses to AIDS-sickened mothers who have few other choices to protect newborns.

"It's not ideal, but it works," said Dr. Ashraf Coovadia of Coronation Mother and Child Hospital in Johannesburg, South Africa. Without it, "many, many more babies would be born with HIV."

Boehringer Ingelheim said it has donated enough doses to treat more than 411,000 mothers and infants in Africa, and self disclosed the problems it found with the Uganda research. But it says it has research from other locations, like Thailand and South Africa, showing single dose usage at birth is safe and effective.

"The bottom line is there were these procedural issues, such as the speed of reporting adverse events, and the like. But the important scientific data was intact, and found to be valid," said Dr. Patrick Robinson, a top Boehringer AIDS specialist.

Still, the German-owned company is no longer seeking FDA permission in 2004 to use nevirapine for protecting U.S. infants because better treatments have emerged, he said.

---
AP reporter Alexandra Zavis in Johannesburg, South Africa, contributed to this story.

Documents gathered by AP for this story are available at: http://wid.ap.org/nevirapine1.html

NIH Whistleblower Stripped Of Protection

             Washington, D.C., December 20, 2004.  In a dramatic setback for drug safety, an Administrative Judge with the Merit Systems Protection Board (MSPB) ruled that Dr.Jonathan Fishbein is not protected under the Whistleblower Protection Act (“WPA”).

             The MSPB judge ruled that “Title 42 employees” are not protected under the WPA.  Dr. Fishbein had been hired under “Title 42,” and thus falls outside of the statutory protections afforded most federal employees. 

             According to Kris J. Kolesnik, Executive Director of the National Whistleblower Center, “This is a major setback for drug safety.  In the NIH, over 1000 federal employees are under Title 42.  Many of these employees, such as Dr. Fishbein, hold sensitive health and safety-related positions.  Without protection, these employees will not blow the whistle.  They cannot effectively disclose misconduct that threatens the safety of hundreds of thousands of people.  Congress should act immediately to close this dangerous loophole in the law.”

             Stephen M. Kohn, Dr. Fishbein’s counsel, stated that Dr. Fishbein appealed the ruling last week to the full MSPB board in Washington, D.C.   However, Kohn warned that “given the MSPB’s history of giving short shrift to whistleblowers” he was not optimistic about the appeal:  “The loopholes in the WPA must be fixed.  The breakdown in drug safety can be directly traced to the intimidation of employees who know of misconduct, but are afraid to speak.  By stripping thousands of such employees of their rights, the MSPB has once again failed to recognize the importance of protecting federal employee whistleblowers.  Congress must act.”

             Title 42 was enacted by Congress in order to facilitate the recruitment of highly skilled professionals, such as experienced medical doctors, into federal service. “Agencies, such as NIH, have misused the Title 42 program in order to recruit and hire employees who are excluded from essential whistleblower protections.  It is a game of cat and mouse, in which the real losers are the American people,” Kohn added.

             Dr. Fishbein was the whistleblower who first disclosed scientific misconduct at the National Institute of Allergy and Infectious Diseases’ Division of AIDS (NIAID/DAIDS).  This wrongdoing includes the failure of NIH to disclose to the White House significant health problems associated with a key component of the President’s World-wide AIDS initiative.  It also includes the wrongful death of a participant in a U.S. AIDS clinical trial and the improper re-writing of a critical drug safety report.

             Documents provided to Congress expose gross mismanagement in the conduct of the DAIDS-sponsored clinical trial.  This includes the failure of the researchers to adhere to the study protocol and explain their many deviations, the mishandling of study drugs, poor maintenance of patient records, poor physician oversight of the trial, and inadequate collection and reporting of adverse events, including deaths.  According to one audit report, thousands of adverse events in the HIVNET 012 study were never documented.

Related Articles:

Protection Denied In NIH Dismissal(The Washington Post)
By Christopher Lee, Page A17, December 29, 2004 

Congress Presented With Evidence of a
Cover-Up in the Landmark AIDS Study

AP Reports on Whistleblower Disclosure

Washington, D.C., December 13, 2004.  A whistleblower at the National Institutes of Health (NIH) has informed the U.S. Congress of widespread scientific misconduct at the National Institute of Allergy and Infectious Diseases’ Division of AIDS (NIAID/DAIDS). His allegations have been corroborated by substantial documentary evidence and other employees in the Institute.  The allegations of this whistleblower are the subject of a story being reported this week by the Associated Press.   

NIAID is a component of the National Institutes of Health (NIH), which is overseen by the Department of Health and Human Services.

The whistleblower, Jonathan M. Fishbein, M.D., hired as the Director of the Office for Policy in Clinical Research Operations, DAIDS, alleges that senior officials of NIAID/DAIDS conspired to alter the conclusions of an internal audit of a landmark AIDS clinical trial. Their goal, he asserts, was to conceal serious deficiencies in the conduct of the study to spare the reputations of the researchers, their institution, and the Institute that funded the trial. 

The charges center on the HIVNET 012 study, a clinical trial conducted in Uganda by researchers from The Johns Hopkins University.  The results reported in the prestigious medical journal The Lancet, concluded that single doses of nevirapine (ViramuneTM), administered to an HIV-infected mother in labor and her newborn infant substantially reduced the incidence of viral transmission.

The single dose nevirapine regimen has been widely touted by U.S. AIDS experts as effective, safe, convenient, and affordable.  Owing to the results of the HIVNET 012 findings, senior NIH officials advised President Bush to adopt the regimen as part of his New Mother and Child HIV Prevention Initiative, an integral part of his $15 billion Emergency Plan for AIDS Relief. 

However, audits of HIVNET 012 revealed gross violations of clinical research standards that the whistleblowers allege DAIDS officials tried to suppress.  These violations forced Viramune’s manufacturer, Boehringer Ingelheim, to withdraw its application for approval from the FDA. 

Boehringer was advised by the FDA that its application, supported primarily by the HIVNET 012 data, would not survive the scrutiny of the Agency’s reviewers.  Furthermore, the Medicines Control Council (MCC), South Africa’s drug regulatory authority, declared that the study’s questionable data would no longer be used to justify the drug’s approval in that country.

Documents provided to Congress tell of gross mismanagement in the conduct of the DAIDS-sponsored clinical trial.  This includes the failure of the researchers to adhere to the study protocol and explain their many deviations, the mishandling of study drugs, poor maintenance of patient records, poor physician oversight of the trial, and inadequate collection and reporting of adverse events, including deaths.  According to one audit report, thousands of adverse events in the HIVNET 012 study were never documented.

The implications of these violations are that the rights and the safety of patient-volunteers were compromised and the results of the study are suspect.

Emerging evidence about the toxicity of nevirapine and the high rate of resistance created by single dosing in expectant mothers has raised concerns throughout the AIDS scientific community.

Notes the complainant, “The issue I am raising is not whether nevirapine is safe and effective as its supporters claim, but rather how the U.S. Government goes about validating those claims through rigorous scientifically-based clinical trials.  In this instance, NIH regulators failed in their duty to ensure that Hopkins researchers conducted their trial according to universally accepted Good Clinical Practice (GCP) standards.

DAIDS is the focal point for most U.S. Government sponsored HIV/AIDS.

 “Dr. Fishbein’s allegations cast serious doubt on the entire process whereby the U.S. Government sponsors and supervises research into AIDS prevention and treatment,” said Kris J. Kolesnik, Executive Director of the NationalWhistleblowerCenter.  “We applaud the courage and public spirit of the whistleblower who first brought these allegations to light.  It is only through the efforts of such individuals that government can be held accountable and the trust of the American public maintained.”

The NIH Policy Manual section 1754 states, “All NIH employees have a responsibility to assist in efforts to combat fraud, waste, and abuse in all NIH programs and have the responsibility to report such matters to the appropriate official...”

The National WhistleblowerCenter will be tracking developments in this case as they unfold.  “We encourage anyone with knowledge of these accusations to step forward,” added Kolesnik.  “The Center stands ready to assist other whistleblowers in securing their rights under the law and in helping Congress in pursuing its investigation.”

Stephen M. Kohn, the attorney for Dr. Fishbein, stated:  “Dr. Fishbein’s whistleblowing is protected speech under the First Amendment.  The NIH must stop retaliating against Dr. Fishbein and concentrate its efforts on fixing a broken oversight system. “ 

Because of the public interest in these matters, the National Whistleblower Center is calling attention to a new web site,  HonestDoctor.org.  This website is sponsored by a confidential network of concerned medical and scientific professionals dedicated to assuring that clinical trials sponsored by the National Institutes of Health (NIH) are conducted in full compliance with all applicable statutes and regulations. According to HonestDoctor.org, “Government sponsored clinical research must preserve the rights, safety, and well-being of human test subjects consistent with the principles of the Declaration of Helsinki and with the aim of producing clinical data with the highest degree of scientific integrity.”

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