Dear Mr. President:

The purpose of this letter is to draw your attention to the frustration and outrage that FDA physicians and scientists, public advocacy groups, the press, and the American people, have repeatedly expressed over the misdeeds of FDA officials. Recent press reports revealed extensive evidence of serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, Center and Office Directors, and many others in prominent positions of authority at FDA. As a result, Dr. Frank M. Torti, Acting Commissioner and the FDA’s first Chief Scientist, abruptly left the Agency. But, the many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place.

On Monday, March 30, 2009, Dr. Joshua Sharfstein, newly appointed Principal Deputy Commissioner, assumed the position of Acting Commissioner until Dr. Margaret Hamburg is confirmed. Numerous FDA physicians and scientists are certain that Dr. Hamburg and Dr. Sharfstein will bring the necessary change to FDA to guarantee integrity, accountability, and transparency, to ensure that all future decisions are solely based on science and in accordance with the laws, rules, and regulations. However, sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too
long.

The latest example of wrongdoing was reported on March 23, 2009 from a Federal District Court Judge who ruled that FDA’s decision on the Plan B drug1 was “arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.” FDA’s top leaders at the Center for Drug Evaluation and Research (CDER) testified that they “didn’t have a choice, and . . .
[weren’t] sure that [they] would be allowed to remain [in their positions if they] didn’t agree” to ignore the science and the law. To the contrary, they should be removed from their positions of authority precisely because they didn’t follow the science and the law. The judge further ruled that there was “unrebutted evidence that the FDA’s [decision] stemmed from political pressure rather than permissible health and safety concerns.” The “improper political influence” and the many “departures from its own policies” reveal that such FDA officials are incapable of ensuring integrity and science at FDA.

On October 14, 2008, FDA physicians and scientists wrote to members of the House Energy and Commerce Committee reporting that top FDA officials at the Center for Devices and Radiological Health (CDRH) had distorted the scientific review of medical devices and then retaliated against those who brought this to light.2 Congressman John Dingell (then Chairman) and Congressman Bart Stupak (Chairman, Subcommittee on Oversight and Investigations) wrote to then FDA Commissioner Dr. Andrew C. von Eschenbach (since resigned), stating that there were “well-documented allegations that senior managers within CDRH” had “acted in violation of the law … [and that] sweeping measures may be necessary to address the distortion of science alleged by so many CDRH scientists.”3

On January 7, 2009, FDA physicians and scientists wrote to Mr. John Podesta4: “Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out. Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around.
Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal. … America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfill its mission, and because re- establishing a proper and effectively functioning FDA is vital to the physical and economic health of
the nation.”5

On January 13, 2009, the NY Times6 reported that FDA officials allowed “improper political influence”7 to guide official FDA actions. The Director of the Office of Device Evaluation, Dr. Donna-Bea Tillman, approved8 a medical device used for the detection of breast cancer despite the fact that all of the FDA experts involved recommended against approval of the device three times. Dr. Tillman’s decision to overrule the FDA experts “followed a phone call from a Connecticut congressman [Christopher Shays].”

On January 26, 2009, FDA physicians and scientists wrote to you directly9 seeking your help and recommending that “you remove and hold accountable all managers who have ordered, participated in, fostered or tolerated the well-documented corruption, wrongdoing and retaliation at the Agency.” That letter was prompted by concerns that FDA officials were planning to investigate physicians and scientists in retaliation for the January 13, 2009 story in the NY Times. These concerns were well-
founded.

On March 13, 2009, one week after another episode detailing wrongdoing and improper political influence involving top FDA officials was published in the Wall Street Journal,10 Acting Commissioner Dr. Frank M. Torti and FDA attorneys sprung into action. Their solution— send an FDA-wide email11 admonishing FDA employees that they “must comply with … obligations to keep certain information … confidential … [including] e-mail to and from employees within FDA [that document the] deliberative process” and threatening that “violation … can result in disciplinary sanctions and/or individual criminal liability.”

These threats did not escape the scrutiny of Senator Chuck Grassley,12 Ranking Member of the U.S. Senate Committee on Finance. In a letter to Dr. Torti on March 24, 2009, Senator Grassley wrote:
“Your memorandum … appears to run contrary to many statutes protecting executive branch communications with members of Congress. … I am concerned with the timing of your memorandum, given some recent high profile matters concerning your Agency and the release of information that has shown failures in FDA’s regulatory mission. [This] could be viewed … as an effort to chill and/or prevent FDA employees from exercising their rights under whistleblower protection laws. … Whistleblowers are some of the most patriotic people I know—men and women who labor, often anonymously, to let Congress and the American people know when the Government isn’t working so we can fix it.”

The Wall Street Journal13 and FDA documents14 revealed efforts by top FDA officials (including Dr. von Eschenbach, Dr. Torti, Mr. William McConagha, and other FDA attorneys) to cover-up their attempts to improperly influence, obstruct, impede and distort the due and proper administration of the FDA scientific regulatory process involving a knee implant device. According to the Columbia
University Journalism Review,15 “the [Wall Street] Journal describes a process in this case that’s, well, corrupt. I don’t know what else you’d call it. It even has a smoking gun.”16 An advisory committee of outside experts, convened to provide advice on the safety and effectiveness of the knee implant, was misled and manipulated by Dr. Daniel Schultz (Director of CDRH) as well as top FDA attorneys. Dr. Schultz was accused of “stacking the committee to get the decision the company wanted,” and of falsely stating in an official document that the conclusions reached by the advisory committee were “clear” and “unanimous”—to the contrary, they were not. A letter17 from Senator Grassley to Dr. Torti dated March 6, 2009 indicated that Dr. Schultz and top FDA attorneys had concealed the fact that two of the authors of a major publication presented to the advisory committee in support of the knee implant device, had affiliations with the device manufacturer (“the first author of the article is [the manufacturer’s] Vice President of Scientific Affairs,” Senator Grassley noted). Dr. Jay Mabrey, Chief of orthopedic surgery at Baylor University Medical Center in Dallas and Chairman of the advisory committee, should be commended for his integrity and willingness to speak out once he became aware of what had transpired. Dr. Larry Kessler, former Director of the Office of Science and Engineering Laboratories at FDA, who had direct knowledge of the advisory committee meeting and process, characterized the process as “show[ing] the FDA at its worst.”

The culture of wrongdoing and cover-up is nothing new but is part of a longstanding pattern of behavior. For example, in July 2005,18 Dr. Daniel Schultz “approved a medical device against the unanimous opinion of his scientific staff,”19 overruling “more than twenty FDA scientists, medical officers and management staff.”20 According to the New York Times21, the decision represented the first time in the agency’s history that a director “approved a device in the face of unanimous opposition from staff scientists and administrators beneath him.” As described in a Senate Finance Committee report following an investigation led by Senator Grassley,22 Dr. Schultz never revealed to the public that the FDA scientists, medical officers, and all other staff involved, completely
disagreed with his decision. The report also stated that “what remains the same in FDA’s approval of a device or a drug is the requirement that data supporting a sponsor’s application for approval be scientifically sound. Otherwise health care providers and insurers as well as patients may question the integrity and reliability of the FDA’s assessment of the safety and effectiveness of an approved product.”– We completely agree.

Amazingly, just 3 weeks ago, on March 6, 2009, it was reported by the consumer advocacy organization Public Citizen that Dr. Tillman “approved a [medical] device that has failed to demonstrate any clinical benefit” and that showed “trends toward higher risks of death.”23 According to Public Citizen: The March 6, 2009 approval by Dr. Tillman24 “bears an eerie resemblance to another device, Intergel, an anti-scarring device intended for pelvic surgeries that also demonstrated reduced scarring without clinically validated outcomes. … Less than two years after Intergel was approved [by Dr. Schultz25], the company removed the product from the market26 due to reports of post-operative pain, foreign body reactions and tissue scarring requiring repeat surgery, including three deaths among women who received it. This history should have given the FDA pause before once again approving a similar device with a questionable safety record.”27

But now, things may finally change at FDA and meeting the expectations of the public may become a reality. On March 14, 2009, an FDA-wide e-mail was sent from the Acting Secretary of HHS:
“Dr. Margaret “Peggy” Hamburg will be nominated by the President to serve as the next Commissioner and Dr. Joshua “Josh” Sharfstein will serve as the Principal Deputy Commissioner of the FDA. … The FDA is the premier agency of its kind in the world, and President Obama wants to revitalize the agency and empower it to make the best possible decisions for the American people based on the best science available. Dr. Hamburg and Dr. Sharfstein will work hard to support scientific integrity at FDA, strengthening the ability of the agency’s professionals to do their work on behalf of the American people. They are the perfect people to translate the President’s vision for the FDA into reality.”

We share your vision and we urge that you provide all necessary support to enable your new leadership to bring change to FDA without delay as part of your planned healthcare reform. As stated in a recent NY Times editorial, you must “send a clear signal to the bureaucracy that the days of neglect are over. Officials [must] make clear that the … practice of distorting science and weakening regulation to favor industry also is over.”28 – We completely agree.

FDA must carry out its work in a transparent manner based on sound science in order to improve the lives of all Americans, reduce health care costs, and expand health care access. Much work remains to be done at FDA and all pending matters need to be addressed. The wrongdoing revealed in the Wall Street Journal involves top FDA officials and requires immediate investigation. Astoundingly, since May 2008,29 Dr. von Eschenbach, Dr. Torti, Mr. McConagha, and numerous top FDA officials, have been well-aware of other serious wrongdoing, and failed to take any actions, while the physicians and scientists who spoke out and refused to comply have suffered retaliation.

The clearance/approval of medical devices that were not made in accordance with the laws, rules and regulations, need to be re-visited. Furthermore, those FDA employees who have engaged in wrongdoing, who have violated laws, rules, and regulations, who have abused their power and authority, and/or who have engaged in retaliation, should be dealt with swiftly. Immediate and decisive disciplinary action will send a strong message FDA-wide that wrongdoing will no longer be tolerated and those who engage in wrongdoing will be held accountable. Some wrongdoing may be beyond the scope of FDA’s jurisdiction and may need referral to the U.S. Attorney General.

All FDA employees who are committed to public integrity, who follow the laws, rules and regulations, who use science to promote public safety and health, and who have the courage and patriotism to speak out, must be protected and have their professional lives restored. We ask that you accept nothing less.

Sincerely,

[Names Redacted]

Click here for a copy of the Original Letter

Dr. Carmen Del Cueto, 65, and Alexis Dagnesses, 44, each pleaded guilty to one count of conspiracy to commit health care fraud before U.S. District Judge Paul C. Huck. Both defendants admitted to working at Midway Medical Center Inc. (Midway), a Miami clinic that purported to specialize in the treatment of patients with HIV.

According to plea documents, Del Cueto was a co-owner of and practicing physician at Midway. Del Cueto and her co-conspirators billed Medicare routinely for services that were medically unnecessary and, in many instances, never provided. Del Cueto admitted to purchasing only a small fraction of the medication that was purportedly being administered to Midway’s patients.

Most of the services allegedly provided to patients at Midway were billed to the Medicare program as treatments for a diagnosis of thrombocytopenia, a disorder involving a low count of platelets in the blood. According to court documents, none of Midway’s patients actually had low blood platelet counts. To make it appear that the patients actually had low platelet levels, Del Cueto admitted that she and her co-conspirators used chemists, including Dagnesses, to manipulate the blood samples drawn from Midway’s patients before the blood was sent to a laboratory for analysis. In her plea, Del Cueto admitted to ordering that patients at Midway receive medications to treat thrombocytopenia despite knowing that the laboratory results had been falsified and the patients did not actually have any such condition.

Midway was not the only clinic where Del Cueto purported to treat HIV patients with injection and infusion therapies. In her plea, Del Cueto admitted that she engaged in substantially similar fraudulent conduct at Diagnostic Medical Center Inc. (Diagnostic), another Miami-area infusion clinic. At Diagnostic, Del Cueto admitted that she and her co-conspirators also billed the Medicare program for HIV injection and infusion services that she knew were medically unnecessary and, in some instances, never actually provided. At the two clinics, Del Cueto admitted to causing the submission of approximately $9.5 million in fraudulent claims to Medicare.

Dagnesses admitted that he would obtain vials of blood drawn from Midway’s patients and place those vials in a blood centrifuge. After rotating the blood in the centrifuge for approximately 15 minutes, the blood would separate into its component parts, enabling Dagnesses to extract the platelets from the sample. Dagnesses would then return the adulterated blood to his co-conspirators at Midway, who would send it to a laboratory for testing. Dagnesses admitted that he was generally usually paid $1,000 for every vial of blood that he tainted for his co-conspirators at Midway. Dagnesses admitted he was aware that the purpose of tainting the blood was to obtain false laboratory reports for Midway’s medical files, which would make it appear that the medications allegedly provided at Midway were medically necessary, when in fact they were not necessary.

The case is being prosecuted by Trial Attorneys John K. Neal and Anthony Burba of the Criminal Division’s Fraud Section. The case is being investigated by the FBI and the Department of Health and Human Services-Office of Inspector General. The case was brought as part of the Medicare Fraud Strike Force, supervised by Deputy Chief Kirk Ogrosky of the Criminal Division’s Fraud Section and U.S. Attorney Acosta of the Southern District of Florida. Since the inception of MFSF operations, federal prosecutors have indicted 106 cases with 196 defendants in Miami and Los Angeles. Collectively, these defendants fraudulently billed the Medicare program for more than $577 million.

Coast IRB has urged authorities to investigate and prosecute the perpetrators whose actual identities remain unknown. Several felony fraud violations and potential RICO may have been committed. “We are informing the media in the hopes of alerting those who might otherwise become study subjects that this appears to be a fraudulent trial,” said Coast IRB CEO Daniel Dueber. “We are also doing so because we want other institutional review boards to learn of our experience and avoid review of this trial pending the result of federal and state investigations”.

Coast IRB discovered the evidence in a routine audit of the trial. Coast IRB discovered that credentials for the principal investigator were forged and that neither the principal investigator nor the medical director was licensed in Virginia. The Department of Health Professions from whence the forged license was allegedly issued reported no record of granting license to the person involved, no record of the license number listed on the forged credentials, and no issuance of licenses in the history of the Commonwealth in the format presented by the study sponsor. Coast IRB further discovered through on-site visit the address for the clinical trial organization where testing was presumably taking place, was in fact a strip mall. A 510(k) FDA number given for the medical device did not exist in FDA’s records.

Coast IRB is one of the largest independently owned IRB’s. Its mission is to protect the rights and welfare of subjects in clinical trials by providing ethical and thorough review. It is located in Colorado Springs, Colorado.