The Government Accountability Office (GAO) issued its final report(PDF) on the OCI this week and it is clear that accountability is the magic word. Specifically, the Office of Criminal Investigations lacks accountability to the FDA itself! Senior FDA officials never hear about OCI investigations unless the director of the department decides to share it. Can you imagine telling your boss “none of your business” if she asks about the specifics of a project you are working on? You would be undoubtedly be fired. Yet this is what the Office of Criminal Investigations can say to the FDA. According to the report, the FDA doesn’t have any requirements that the OCI report any specific information about their current investigations. On top of that, the FDA has an internal investigations unit called the Office of Internal Affairs (OIA). The OIA is an office within the OCI that investigates FDA employee misconduct. The OIA is not required to report specific information to OCI or any other FDA senior-level office. In addition, there is no process in place to ensure compliance with policies that guide investigations. In other words, the Office of Criminal Investigations and Office of Internal Affairs operates with little accountability to the FDA…let alone the American people.

The FDA responded to the report in a letter(PDF) to Senator Grassley (R-Iowa). The FDA’s letter highlighted reforms to deal with the shortcomings pointed out in the GAO report. The FDA highlights successful prosecutions since the start of the Office of Criminal Investigations in 1992. Well, its great to throw counterfeit drug makers and people who send contaminated products out into the market but what about the corporate officials responsible for hiding key safety data? The FDA plans to increase the use of misdemeanor* prosecutions to punish those officials. Of greater importance is the FDA’s commitment to develop procedures to disqualify certain clinical trial investigators from participating in the drug approval process. This is something that will be addressed in a post sometime in the near future but its important to mention that the FDA does not conduct its own studies. The FDA relies mostly on clinical trial data from the drug company to prove that the company’s drug is safe and effective. Disqualifying certain clinical trial investigators from submitting data is, in my opinion, one of the most important reforms that the FDA can make.

*misdemeanors are those crimes generally punished with fines.

**Repost from www.MarkSadaka.com

• renal impairment, including failure
• hepatic impairment, including failure
• gastrointestinal hemorrhage

In some reported cases, these reactions were fatal. These reactions were more frequently observed in patients with advanced age, high risk myelodysplastic syndromes, underlying renal or hepatic impairment or low platelet counts. Exjade therapy requires close patient monitoring, including measurement of serum creatinine and/or creatinine clearance as specified in the PI and serum transaminases and bilirubin as specified in the PI.

Click here to see the “Dear Healthcare Professional Letter”

Use: Automated peritoneal dialysis (PD) systems are prescription medical devices used to treat pediatric and adult patients with kidney failure.
In PD, a soft tube called a catheter is used to fill the abdomen with a cleansing liquid called dialysis solution. The walls of the abdominal cavity are lined with a membrane called the peritoneum, which allows waste products and extra fluid to pass from the blood into the dialysis solution. These wastes and fluid then leave the body when the dialysis solution is drained. Several fill – drain cycles are typically needed during a treatment. Automated PD systems, like the HomeChoice systems, can be programmed to deliver and remove several cycles of doctor-prescribed amounts of dialysis solution.
HomeChoice systems are used in conjunction with Baxter’s single use disposable tubing sets and bags of dialysis solutions.
The HomeChoice PRO model also has a small electronic data card, called a PRO card, which stores information from the nurse or doctor and automatically sets up the system for the patient.
Recalling Firm:
Baxter Healthcare Corporation
One Baxter Way
Deerfield, IL 60015
Reason for Recall: Baxter is conducting a recall of the HomeChoice and HomeChoice PRO because of reports of serious injuries and at least one death associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity. IIPV can cause serious breathing and heart problems that can result in serious injury or death.
Public Contact: If you need assistance with your HomeChoice or HomeChoice PRO, call the Baxter Customer Service line, available 24 hours and day, 7 days a week at 1-800-553-6898.
FDA District: Chicago
FDA Comments:
Although Baxter is not removing the HomeChoice and HomeChoice PRO from the market, clinicians should weigh the risks and benefits to continued use of these devices by their patients versus other forms of dialysis therapy. Clinicians should also review the prescription settings for patients who continue to use these devices.

IIPV may result in serious injury or death from conditions including but not limited to: abdominal wall and/or diaphragmatic hernias, hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function, pericardial effusion, and peritonitis.

Children and non-verbal patients may be at increased risk because of their smaller size or inability to communicate. Increased monitoring of these patients is recommended.

Other vulnerable populations include critically ill patients and patients with pulmonary and hemodynamic instability.
Patients and caregivers should watch for the potential signs of IIPV. If patients or caregivers notice any of the signs of IIPV, stop the device, initiate manual drain, and contact your doctor immediately. Please refer to the Baxter press release, for a list of signs and symptoms of IIPV and more specific instructions for what to do if symptoms appear.

Any adverse reactions experienced with the use of this product or quality problems should be reported to the Baxter Renal Division at 1-888-736-2543, prompt 3 (Corporate Product Surveillance), and the FDA’s MedWatch Program by phone at 1-800-FDA-l088.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The following is the joint press release issued by Senators Max Baucus(D) and Chuck Grassley(R):

United States Senate
Committee on Finance
Washington, D.C.

For Immediate Release Saturday, February 20, 2010

Baucus, Grassley Release Finance Committee Report on Diabetes Drug Avandia, Express Concern About FDA’s Role in Protecting Patients in Ongoing Avandia Study

WASHINGTON – Senator Max Baucus, Chairman of the Committee on Finance, and Senator Chuck Grassley, Ranking Member, today released a committee report based on a two- year inquiry of the diabetes drug Avandia. The senators also asked the Food and Drug Administration to describe what steps the agency has taken to protect patients in an ongoing Avandia clinical trial, and why the study is allowed to continue, given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. In 2008, FDA officials called the clinical trial, as then-designed, “unethical and exploitative” of patients.

“There’s a real problem when FDA’s office that reviews drugs that are on the market is an unequal player in drug safety efforts,” Grassley said. “It doesn’t make any sense to have these experts, who study drugs after they have been on the market for several years, under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision. The Avandia case may be the most alarming example of the problem with this set-up. Both the FDA and Congress need to take every step possible to establish independence for post-market surveillance. The Institute of Medicine has made recommendations. It’s a matter of sound science and public safety.”

“Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust,” Baucus said. “We will continue watching closely and working with the FDA to make sure patients and doctors are aware of the risks associated with Avandia and all drugs so they can make safe and informed decisions when choosing their medicines.”

The committee report explores when the Avandia manufacturer, GlaxoSmithKline, became aware of heart attack risks associated with the drug, whether the company sufficiently warned patients and the FDA of the dangers, and steps the company apparently took to create doubt regarding negative findings about the drug.

The report was developed over the last two years by committee investigators who reviewed more than 250,000 pages of documents provided by GlaxoSmithKline, the FDA, and several research institutes. Committee investigators also conducted numerous interviews and phone calls with GlaxoSmithKline, the FDA and anonymous whistleblowers. The report can be found at finance.senate.gov.

Baucus and Grassley directed the report over concerns that Avandia and other high- profile drugs such as Vioxx put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks. In 2007, Congress enacted legislation giving the FDA some new tools to better protect patients from harm caused by drugs that are brought to market without sufficient safety oversight or consumer warnings. However, the legislation did not fix a fundamental problem at the FDA — the imbalance between the office responsible for monitoring the safety of drugs after approval and the office that puts drugs on the market in the first place.

The FDA has overlooked or overridden safety concerns cited by its own officials, as appears to be the case with the ongoing Avandia study. The text of the Baucus-Grassley letter to the FDA on the Avandia study follows here.

February 18, 2010

The Honorable Margaret A. Hamburg, MD 
Commissioner 
U.S. Food and Drug Administration 
White Oak Building 1 
10903 New Hampshire Avenue 
Silver Spring, MD 20993

Dear Commissioner Hamburg:

As senior members of the United States Senate and Chairman and Ranking Member of the Committee on Finance (Committee), we have a duty under the Constitution to conduct oversight into the actions of executive branch agencies, including the Food and Drug Administration (FDA). In this capacity, we must ensure that FDA properly fulfill their mission to advance the public’s welfare, safeguard the nation’s drug supply, and protect patients participating in clinical trials.

We recently released a report raising concerns about Avandia, a diabetes drug made by GlaxoSmithKline (GSK). We began this inquiry after the New England Journal of Medicine published a study in May 2007 warning of the possible cardiovascular risk of Avandia.

Our report was based on a review of hundreds of thousands of pages of internal GSK documents and concluded:

The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public…. Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk.

In 2007, the FDA asked GSK to perform a cardiovascular safety trial, called TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation), to compare Avandia to other diabetes treatments such as ACTOS (piolglitazone). According to clinicaltrials.gov, the TIDE trial is currently recruiting patients. [ATTACHMENT A]

In response to several document requests made to the FDA, we received and reviewed an analysis conducted by two FDA safety officials. It is our understanding that this analysis, conducted in October 2008, reviewed all available studies comparing rosiglitazone (Avandia) to pioglitazone (ACTOS). The analysis by these FDA officials raise some alarms. For instance, they wrote:

[T]here is no evidence that rosiglitazone confers any unique health benefits over pioglitazone while there is strong evidence that rosiglitazone confers an increased risk of [heart attacks] and heart failure compared to pioglitazone. [ATTACHMENT B]

Even more alarming, they concluded that “any proposed head-to-head trial of rosiglitazone vs. pioglitazone would be unethical and exploitative.”

Two days after releasing this analysis, one of these same safety officers reviewed the protocol for the TIDE trial. This safety officer wrote that because of cardiovascular concerns with Avandia “the safety of the study itself cannot be assured, and is not acceptable.” [ATTACHMENT C]

After reading these documents, we would like to know what steps the FDA has taken to protect patients in the TIDE trial, and why this trial is allowed to continue. We would also like to know if the Office for Human Research Protection (OHRP) was notified about the safety concerns of the TIDE trial identified by the FDA. Further, we were alarmed to learn that the warnings from these safety officers do not appear to be addressed in the consent form that was handed out to patients that were enrolled in the study. [ATTACHMENT D]

We look forward to hearing from you by no later than March 4, 2010. Sincerely,

Max Baucus Chairman

Chuck Grassley Ranking Member

*Repost from www.MarkSadaka.com

I sat down on Saturday morning with my coffee and New York Times and right on the front page was an article that should have shocked me but didn’t. The article on the front page described a “fierce debate within the [FDA]” concerning whether or not the prescription drug Avandia is safe. For those of you that don’t know, Avandia is a drug used to treat type 2 diabetes by lowering the amount of sugar in the blood. According to the article, there seems to be some sort of civil war within the FDA where one faction wants to recall Avandia and another that thinks the drug should remain on the market.

Type 2 diabetics already have an increased risk of developing cardiovascular disease. Avandia received black box warnings about the increased risk of heart attack 8 years after it was approved in 1999. That is 8 years of type 2 diabetics suffering from deadly heart attacks that may have been prevented if they never received Avandia. The question is why would the FDA allow this drug to remain on the market when it increases the risk of heart attack in an already susceptible population? Nobody seems to know the answer to this question. Avandia is not unique and, as the New York Times article reports, there is a drug within the same family called Actos that seems to have better safety record.

Is there any good news from this? Yes. The good news is that because of this controversy doctors started to abandon the product. I am sure that more people will stop using Avandia after this article on the front page of the New York Times. The bad news is that more people will die while the FDA engages in a “fierce debate” with itself. More bungling from an agency charged with keeping us all safe from the bottom line interests of large corporations.

*This is a repost from Mark Sadaka’s blog (www.MarkSadaka.com)

* Influend Cold and Cough, 24 Tablets, Product Code/ Lot # 800074
* Influend Severe Cold & Flu, 24 Tablets, Product Code/Lot# 800075
* Influend JR. Cold & Cough, 4 oz. bottle, Product Code/Lot# 800076
* Influend JR. Severe Cold & Flu, 4 oz. bottle, Product Code/Lot# 800077

While no illnesses have been reported to date, ION Labs, Inc. has ceased distribution of these products until further notice.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Please return the product for a full refund to the address below.

ION Labs, Inc.
115th Ave. N.
Clearwater, Fl. 33760

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at the MedWatch website at www.fda.gov/medwatch

Consumers who have questions about the above recall may contact ION Labs Customer Service at 1-877-990-4466 and ask for the Quality Director at Ext. (212). Hours of operation are M-F from 8 a.m. to 5 p.m. EDT.

April 2, 2009

The Honorable Barack H. Obama
President of the United States
1600 Pennsylvania Avenue NW
Washington, DC 20500

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

It’s not news that the Federal regulatory agency we the people depend on to provide us with SAFE food and drugs is in shambles. A group of dedicated middle and lower echelon government employees will most likely take the blame for policies that have resulted from the revolving door used by upper level management sell-out/collusion with the pharmaceutical industry.

I can only relate a personal experience to substantiate the above accusation. In 1982, the FDA, with influence from George H.W. Bush (Reagan’s vice president) and Dan Quayle (later to be Bush I’s VP)—both with ties to Indianapolis-based Eli Lilly and Company—was encouraged/instructed to fast-track rDNA synthetic ‘human’ insulin. [This was before the term ‘fast track’ entered the FDA lexicon.]

rDNA human insulin was the FIRST biotech drug ever approved. As such—with no guidelines to navigate an emerging industry—one would have expected that the Agency would have sought to err on the side of safety and demand MORE rather than LESS rigorous standards for approval. With Dr. Henry I. Miller, M.S., M.D. (now of the Hoover Institution) serving as the biotechnology industry’s “inside man”, the product—again, THE FIRST OF ITS KIND—garnered approval in a period of less than six months, far short of the usual 18-month process which was typical at that time. A good deal of shenanigans and string-pulling which occurred has remained well hidden. Miller, the most vociferous proponent for approval, initially met with a number of well-founded objections and roadblocks from other concerned scientists, including his own boss. As a second-banana in the hierarchy, his advocacy alone could not guarantee approval. However, by merely biding his time and waiting for his boss to go on vacation, he successfully circumvented the roadblocks, ignoring the objections, re-defined himself as the resident biotech expert (paving the way for his future career outside of public service), and achieved the industry’s goal.

Miller actually achieved more than the industry could have hoped. He used existing rules to gain approval for the product under the ‘small molecule’ guidelines; and when beneficial, used the absence of rules, to insulate the product from yet-to-be-codified but more stringent regulations to follow. A genius? Perhaps, but in my opinion, a very evil genius. (Remember, also, that all this occurred during the Reagan era where industry innovation and economic expansion were given dominance over bureaucratic safeguards that had long served public interests.)

As a diabetic of 26 years (at that time), the new insulin—Humulin®—was of little interest to me because the natural analog insulins were already providing me very good control and what I considered an acceptable quality-of-life. In fact, only about 5% of diabetics experienced problems (ranging from mild itching of injection sites not unlike those some users of Lantus® experience today to more severe) with the 27 insulin varieties that populated the marketplace. All these insulins were derived from pork or beef abattoir pancreatic tissue.

For that 5% who experienced problems, rDNA insulin provided an opportunity to try a synthetic product, heralded as HUMAN insulin. The talking point/selling point used to encourage its use was: “Why would anyone want to take anything BUT human insulin?”

Eli Lilly embarked on an aggressive campaign to change the dynamics of the insulin market. Doctors were encouraged (bribed or coerced) to switch patients to the new HUMAN product. Charitable advocates (ADA and JDRF) experienced increased advertising revenues which, in turn, helped influence their position regarding the product. Still, by the end of the decade, the desired goal of switching all patients to rDNA human insulin was not attained. But, when one essentially OWNS the market, there were a number of other tactics available.

In 1993, Eli Lilly began removing the standard animal (natural) insulins from the marketplace. Influence (political or financial or both) was used to encourage the government and the FDA to imply that a threat of BSE and other animal-borne diseases existed in natural insulins. Omitted from any discussion of BSE/animal-borne diseases was the fact that rDNA Human insulin production began with a media culture with even more suspect animal tissue components. In other words, beef and pork pancreases—properly prepared—have little to no chance of contamination. After several crystallizations, the insulin in a natural analog batch is more pure than in rDNA products.

The ultimate insult to diabetics came from Dr. Loren Grossman, VP of Lilly-Canada, speaking before a HealthCanada committee. His admission that “not all diabetics can take human rDNA insulin” was followed by a corporate decision to remove ALL natural insulins from the U.S. marketplace. This statement and subsequent corporate actions reveals disdain, disregard or utter contempt for diabetics whose very lives depended on continued availability of natural insulins.

Did I mention that rDNA insulin (and analogs) provide the perfect opportunity for the insulin cartel to provide an unending, and ever-changing supply of new, patented synthetic products for a vulnerable population? Did I mention that each newly-patented foreign hormone approved by the FDA will quickly—and more expensively—replace its predecessor as products go ‘off-patent.’ The money-stream is unending, as is the supply of human guinea pigs (diabetics). Astoundingly, the first-approved rDNA human insulin had no long-term follow-up reporting requirements. With such a precedent oversight by the FDA, we can expect that each new product will meet with the same lax, long-term safety oversight.

Having been receptive to new technology, I tried most of the new products and emerging protocols, up to and including pump therapy. In my opinion, sudden death, dead-in-bed syndrome, hypoglycemia unawareness, complications, and driver accidents are increasing BECAUSE money and influence-peddling by the pharmaceutical industry have been wildly successful.

The 5% of diabetics who NEEDED non-animal source insulins has been replaced by a similar group who NEED natural insulins. Additionally, 30-40% of the diabetic population might lead more “normal” lives, with better A1c’s as proof, had they been offered the option of using natural insulins. The insulin cartel, with both money and influence, do not want this information known. After more than two decades, we have yet to see the FDA, or other health-centered agencies (NIH, NIDDK, CDC) undertake comparative studies, so the truth remains hidden.

Insulin: A Voice for Choice by Dr. Arthur Teuscher (a world renowned endocrinologist) provides an eye-opening analysis of this saga, and is a cautionary tale of how an over-mighty pharmaceutical industry has, under the guise of progress, adversely influenced the best interests of those with diabetes. It should be required reading for all diabetics and their healthcare partners.

After hearing the mantra for years, I am growing tired of doctors, pharmacists, government representatives and the insulin cartel telling me to “get over it—that the new age protocols are here to stay.” Much like Dr. Grossman, they are essentially telling me it’s okay for me to NOT have an insulin that was on the market, that I prefer, that I need—just go ahead and die, just don’t tell anyone! Could it be that the insulin cartel (and diabusiness) is operating on the belief that UN-natural selection, for profit, is parallel to natural selection, where the weakest die anyway? To say this another way: genetic cleansing is okay as long as there is profit involved for the cartel.

ABOUT THE AUTHOR

Brent is scientist, advocate and author of a wonderful book called “Too Profitable to Cure” (available at www.tooprofitabletocure.com).

Brent Hoadley grew up in Vermont. After graduating from the University of Vermont, he obtained a Ph.D. in plant science from Kansas State University. At the age of 14, he was diagnosed with Type 1 diabetes. The impact of the disease, coupled with his scientific background, influenced both his career and avocation choices.

Living with diabetes for over 50 years, he has witnessed many changes in the treatment of the disease…but is distressed that the cure is no closer now than when he was diagnosed. From a not-unbiased viewpoint, he addresses the current state of healthcare for those who suffer from chronic diseases, and contends that profit, not humanitarianism, is driving American healthcare. As an entrepreneur/inventor, he is aware, and appreciates the profit motive that drives capitalism. However, he feels the bottom line should not be tainted with the smell of dead bodies. With Yankee pragmatism, he identifies culprits and urges activism as a countermeasure.

As a lawyer who subscribes to a “strict constructionist” reading of the U.S. Constitution, it’s a rare day when Chief Justice John Roberts, Justice Antonin Scalia and Justice Samuel Alito all three see a case before the U.S. Supreme Court differently than I do. Wednesday, March 4, 2009 was such a day, and I believe that the majority, comprising the remaining six justices, got it right. The Court, in Wyeth v. Levine, held that consumers who suffer adverse side effects of pharmaceuticals can sue the manufacturers in state courts, allege the inadequacy of the drugs’ warning labels, and recover damages, even if those labels have been approved at the federal level. In other words, the courts of each individual state retain the power to find warning labels inadequate to protect their citizens even after the labels are approved by the federal Food and Drug Administration (FDA) for use across the United States. I agree, for both Constitutional and practical reasons.

The Constitutional rationale for my agreement with the majority in Wyeth v. Levine is rooted in my belief in states’ rights. Powers not specifically granted to the federal government by the Constitution are supposed to be reserved to the individual states, but over the past two centuries, the federal government has “progressively” usurped states’ rights in the name of regulating “interstate commerce,” which generally has been interpreted broadly enough to encompass just about anything the federal government has wanted to regulate. The regulation of interstate commerce is in fact one of the powers specifically assigned to the federal government in the Constitution, but in my view, states should be free to afford their citizens greater consumer protection than that which is provided by federal regulations, if they so choose. In other words, federal regulation should not preempt more restrictive pharmaceutical labeling standards at the state level.

The practical rationale for my agreement with the court’s ruling is rooted in my belief, as a psychologist, that I’m seeing psychotropic drugs in particular being prescribed to more and more Americans for more and more conditions and doing more harm than good in more and more cases. Lately, I’ve been writing and speaking a lot about the out-of-control hail of psychotropic pills pelting America’s children, and in my opinion, as both a lawyer and a psychologist, the only realistic hope of stemming that tide is a series of large jury verdicts across the country. That hope would’ve been diminished substantially had the Roberts-Scalia-Alito view prevailed in Wyeth v. Levine. The drug at the center of the Wyeth v. Levine ruling was not a psychotropic drug – it was the anti-nausea drug Phenergan, which caused an adult guitarist in Vermont to lose her arm after the drug was injected inadvertently into an artery instead of a vein, resulting in the onset of gangrene. Nevertheless, the same kinds of problems that I’ve identified with the marketing of psychotropic drugs for use in children – exaggerations of effectiveness, manipulations of the results of clinical trials, failures to disclose serious potential side-effects like suicidal ideation – are affecting adults with even greater frequency. For instance, it’s been widely reported that the maker of the antipsychotic Seroquel is alleged in recently-unsealed court documents to have minimized the risk of developing diabetes to adult patients taking that drug. Here again, I believe that the pharmaceutical industry’s highly-profitable practices can be modified by little else than money.

As I’ve consistently acknowledged, pharmaceutical companies aren’t 100% to blame. There are cultural factors in play as well, whereby consumers of psychotropic drugs bear some responsibility. Many self-absorbed adult Americans have bought into the cultural myth that they’re not only capable of but also entitled to complete, enduring happiness and are willing to turn to pharmaceuticals in their quest for that unrealistic utopia. Also, adults who are faced with mild to moderate psychological symptoms seem increasingly to want “quick fixes” for themselves as well as for their children in lieu of more time-and-effort-consuming treatment options like psychotherapy, consciously electing in many cases to mask symptoms medicinally rather than trying to learn to cope with and overcome them.

That notwithstanding, the major pharmaceutical companies are spending billions to market psychotropic drugs directly to adult consumers and for a seemingly ever-broadening range of symptoms. I recently saw a television commercial touting the psychotropic drug Abilify as a treatment for depression. Abilify, however, is primarily an antipsychotic, originally marketed to treat symptoms like hallucinations and delusions, not depression. In fact, after years of graduate training in psychology, including a year-long internship in the psychiatric ward of a hospital, followed by years of clinical practice, that commercial was the first I’d ever heard of using Abilify, or any drug in its class, as an antidepressant. But that didn’t stop the commercial from saying, “If an antidepressant alone isn’t enough… .” In fairness, I did some research and found that Abilify did get FDA approval at the end of 2007 for use as an adjunct (supplement) to treatment with conventional antidepressants, but here again, I think states should be free to enforce labeling standards tighter than the federal government’s (and by the way, that approval of Abilify for depression applied to adults only, not to kids, which of course doesn’t guarantee that some pediatricians won’t prescribe it anyway, “off-label”).

Shocking as it may be, when it comes to the regulation of pharmaceuticals, psychotropic and otherwise, the federal government doesn’t always get it right. That’s why it’s a good thing the Supreme Court did get it right in Wyeth v. Levine.

Brian Russell is a licensed psychologist, attorney at law and familiar national television pundit on psychological, legal and cultural issues. Email: drbrian@lawpsyc.com

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms.

Increased Risk of Digoxin Toxicity

The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase.