Evelyn Pringle February 2008
Sheldon Bradshaw stepped in to replace the pharmaceutical industry's inside guy, Daniel Troy, in the Office of Chief Counsel at the FDA in April 2005, and the Bush Administration's steadfast protection of the industry did not miss a beat.
On September 20, 2005, an article by Lily Henning entitled, "Is FDA's New Chief Counsel a Change in Name Only?" appeared in the Legal Times and reported that despite Mr Troy's return to the private sector, "his controversial legal policies remain in force at the agency."
"Like Troy," she wrote, "Bradshaw offers one-on-one meetings with the companies regulated by the agency, has kept low the number of warnings issued to companies violating regulations, and, perhaps most notably, has continued to intervene on behalf of drug companies in private civil lawsuits."
Ms Henning reported that Mr Bradshaw also continued the "open-door policy" that Mr Troy initiated, in meeting with drug and medical-device companies in "courtesy visits."
"Over the summer," she stated, "Bradshaw's visitors included Pfizer General Counsel Jeffrey Kindler, lawyers from Covington & Burling, Alston & Bird and other firms."
Mr Bradshaw left his post as a principal deputy assistant attorney general at the Department of Justice to become Chief Counsel and both he and Mr Troy were part of the Bush Administration's advance legal teams in 2001, according to Ms Henning.
Taking up the torch for his predecessor's preemption invention, in September 2005, Mr Bradshaw, and 9 other Bush Administration attorneys filed a brief in support of Pfizer, in the case of Kallas v Pfizer, telling the court to throw out a lawsuit filed by the parents of a teen age girl who committed suicide while taking the SSRI antidepressant, Zoloft.
Shyra Kallas was only 15-years-old when she went to a doctor for treatment of warts and came home with an off-label prescription for Zoloft, which was not FDA approved to treat children or adolescents with warts or any other ailment in October 2002.
In the brief, Mr Bradshaw claimed that the FDA would not have allowed Pfizer to add a warning about the risk of suicide with Zoloft and would have considered any such warning to be "false and misleading," an argument inserted in the FDA's first preemption brief by Mr Troy, at the request of Pfizer attorney, Malcolm Wheeler, in September 2002.
Houston attorney, Andy Vickery, handled the Kallas lawsuit, and the case was settled before any decision was reached on the preemption motion, but Mr Vickery points out that none of antidepressant makers ever asked the FDA if they could add a warning and therefore, the argument that the FDA would have rejected a request is pure speculation.
Prior to the Bush Administration, state consumer protection laws have always provided a legal remedy for citizens injured by pharmaceutical products when a company failed to warn about a risk. "Preemption completely divests the states of the rights and the role that they have had for years, and puts the foxes firmly in charge of the henhouse," according to Mr Vickery.
The King & Spalding law firm also represents pharmaceutical companies in preemption cases and judging by it's web site, the firm is another nesting place for the alumni of Mr Troy and Mr Bradshaw, with members that include 5 attorneys who served in the Chief Counsel's Office and one from the FDA's Center for Drug Evaluation and Research.
"The members of King & Spalding’s Government Advocacy & Public Policy Team utilize our experience and long-standing relationships with key members of the House, Senate, and the Bush Administration, to help clients effectively manage their interactions with the federal government," the site reports.
King openly states that the firm's "Special Matters and Government Investigations Group includes more than a dozen former federal prosecutors, congressional investigators and other enforcement officials".
"Many of our attorneys served in key positions within the U.S. Department of Justice (DOJ), other regulatory enforcement agencies, and Congressional investigative committees," the firm states. The site reports hiring Dan Donovan in January 2007, who is described as "managing congressional investigations and oversight hearings in the U.S. Senate for the past eight years."
King attorney, Mark Brown, who served as an Associate Chief Counsel at the FDA during the first Bush Administration, argued preemption on behalf of GlaxoSmithKline in O'Neal v SmithKline Beecham d/b/a GlaxoSmithKline, a case involving the Paxil-induced suicide of a 13-year-old boy, before federal Judge Frank Damrell, in the Eastern District of California, on January 21, 2008.
It's worth mentioning that in his last few years at the FDA, immediately before hooking up King, Mr Brown was the agency’s chief litigator in medical device enforcement actions, and represented the government against device makers.
The California-based law firm of Baum, Hedlund, Aristei & Goldman represents the plaintiffs in O'Neal, and senior trial attorney Ronald Goldman argued the case on behalf of the child's surviving family members.
Mr Bradshaw and his army of 9 attorneys' also filed a brief supporting Glaxo in this case, with the same old "false and misleading" argument.
Since 1999, Baum Hedlund has handled a number of lawsuits against Pfizer including the high profile case of comedian Phil Hartman and his wife, who was on Zoloft, when she shot her husband first and then herself while their children slept in another room, and a case featured in Fortune Magazine, filed on behalf of Kim Witczak, whose 39-year-old husband committed suicide while taking Zoloft.
During Zoloft litigation, Baum Hedlund soundly defeated the FDA's bogus "false and misleading" arguments with four federal courts and one state court in 2005, holding that preemption did not apply where the plaintiffs claimed that Pfizer should have provided a stronger warning suicidality. In the July 20, 2005 Witczak ruling, federal judge James Rosenbaum stated:
"It is obvious that state failure-to-warn laws do not pressure manufacturers to include false or invalid warnings. Instead, they give drug manufacturers every incentive to warn of real, known risks as soon as they are discovered -- even before any FDA action."
In response to Pfizer's argument that it should not be exposed to 51 separate tort-law regimes, the court stated: "If Congress intends to create a class of protected businesses, it has the means and ability to do so. The Court finds no proof that it has done so here."
In Baum Hedlund's latest Paxil case, on January 30, 2008, Judge Damrell dismissed the lawsuit but the family is expected to request a reconsideration of the ruling.
The only Paxil case ever make it to jury, involved a man who in 1998, shot his daughter, granddaughter, wife, and then himself, 2 days after ingesting Paxil. Andy Vickery tried the case and after weighing the testimony of the world famous psychiatrist and pharmacologist, Dr David Healy, against Glaxo's expert quack, John Mann, who received more than $30 million in research funding from drug makers in the 10 years prior to the trial, in 2001 the jury found that Paxil was the cause of the tragedy and hit Glaxo with a verdict of more than $6 million.
And yet, on November 24, 2004, when the first black box was added to antidepressants warning parents about an increased risk of suicide with children, Dr John Mann told the New York Times, "It would be ludicrous to think that antidepressants could actually contribute to suicide in the United States in any kind of significant way."
In May 2006, a federal judge in Pennsylvania was the first to use the Bush Administration's preemption policy to throw out a Paxil suicide case in Colacicco v Apotex. Joseph Colacicco sued Glaxo, and the maker of generic Paxil, when his wife committed suicide 21 days after she was prescribed the drug for mild depression.
Mr Bradshaw signed off on the government's brief in this case as well, along with 9 other government attorneys, to once again try and defeat a lone citizen already battling 2 drug giants. The plaintiff's attorneys include Derek Braslow, Harris Pogust, Robert Wilkey, and T Matthew Leckman from the Pennsylvania firm of Pogust Braslow & Millrood.
The Colacicco case is currently awaiting a decision in the 3rd Circuit Court of appeals.
The Bush Administration's backing of Glaxo in private litigation is directly at odds with efforts by state and federal officials to put a stop to Glaxo's peddling of the useless Paxil to kids while concealing the drug's risk of suicide.
In August 2004, Glaxo paid $2.5 million to settle fraud charges brought by New York State Attorney General Eliot Spitzer alleging the company hid Paxil studies that "not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo."
According to Mr Spitzer's complaint, because it's studies failed to demonstrate efficacy and indicated a possible increased risk of suicidal thinking and acts for these youth:
"GSK sought to limit physicians' access to only the most favorable aspects of the data from these studies. To accomplish this, GSK embarked on a campaign both to suppress and, conceal negative information concerning the drug and to misrepresent the data it did reveal concerning the drug's efficacy and safety."
It should be pointed out in every article written on this subject, that for nearly all the studies that claim SSRIs work with kids and do not cause suicide, the same academic quacks appear as investigators and authors. The list of names includes but is not limited to, Dr John Mann, Dr Graham Emslie, Dr Martin Keller, Dr Karen Wagner, Dr Frederick Goodwin, Dr Neal Ryan, Dr Charles Nemeroff, Dr David Dunner, Dr Andrew Leon, Dr John March, Dr David Shaffer, Dr John Rush, Dr Mark Olfson, and Dr Robert Gibbons.
A report showing that Glaxo knew about Paxil's 8-fold increased suicide risk from clinical trials conducted as far back as 1989, was submitted to the court in the Baum Hedlund O'Neal case, by the plaintiff's expert, Dr Joseph Glenmullen, a psychiatrist and instructor at Harvard, but was sealed under a court order when it was filed in June 2007.
The report was unsealed in January 2008, and on February 6, 2008, Senator Charles Grassley (R-Iowa), on behalf of the Senate Finance Committee, sent a letter to Glaxo asking for an explanation of why the public was never properly informed of suicide risk associated with Paxil until May 2006 in a "Dear Doctor" letter which reported a "higher frequency of suicidal behavior" in patients on Paxil when compared to those on a placebo.
Preemption is not the only shield within the protection racket set up by Mr Troy and carried on by Mr Bradshaw at the FDA. A couple years ago, federal lawmakers investigated the drop in enforcement actions at the Chief Counsel's office, since Mr Troy began running the show and found an utter failure to police the pharmaceutical industry.
According to the July 2006, report, “Prescription for Harm: The Decline in FDA Enforcement Activity,” by the House Committee on Government Reform, under the Bush Administration, enforcement actions drastically declined during the same period in which the FDA most aggressively promoted the preemption policy.
The investigation found that the number of warning letters issued for violations of federal requirements had fallen by over 50%, to a 15-year low of 535 in 2005, down from 1,154 in 2000. Internal FDA documents also showed that in at least 138 cases in which agency field inspectors found violations, the FDA failed to take any action against the company.
The experts who were consulted for the investigation included Dr Jerry Avorn, Professor of Medicine at Harvard Medical School; Dr Michael Wilkes, Vice Dean of Medical Education at the University of California Davis School of Medicine; and Sammie Young, a former Director of Compliance in the FDA’s Bureau of Biologics, who worked at the agency for close to 30 years.
After reviewing the records, in a May 25, 2006 letter, Dr Avorn told the Committee, "In all of FDA's once-proud recent history, I cannot recall a time of greater concern about its work on the part of doctors, patients, and policy researchers."
"It is unlikely," he pointed out, "that the behavior of the regulated industries improved so much during these years to account for a reduction of 300 warning letters per year."
On June 10, 2006, Dr Wilkes stated in a letter to Rep Henry Waxman: The FDA "seems unable and unwilling to step in to protect the American public."
The FDA provided no records from the Chief Counsel, even though an investigation by the Special Investigations Division had credited a sudden decline in enforcement actions to a change in FDA policy issued by Mr Troy in September 2001, which required his approval of all warning letters and untitled letters before they were sent out.
Under the revised procedures, the Chief Counsel is required to “state in writing the reason for nonconcurrence” whenever it objects to an enforcement action, the report noted.
However, when the FDA was asked to explain why there were no records from Mr Troy's office, the agency said his office did not keep copies of the decisions or recommendations, or even a record of which files were reviewed.
On September 20, 2005, Lily Henning reported on actions taken by Mr Bradshaw in the Legal Times and wrote, "So far in 2005, 23 warning letters to advertisers and seven compliance letters regarding manufacturing or compliance problems have gone out."
"By contrast," she noted, "during the Clinton administration in 1999, 110 letters warning about illegal advertising claims were sent."
In any event, just like Mr Troy, Mr Bradshaw is now long gone, and according to Pharmalot's Ed Silverman on September 7, 2007: "There was no official announcement from the agency, at least not as far as we can tell, but Sheldon Bradshaw is joining Hunton & Williams, which has a significant pharmaceutical-industry practice and reps such companies as Pfizer."
However, the Hunton web site was more than happy to announce the arrival of it's employee with a bio that states: "As Chief Counsel, Mr. Bradshaw was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA’s senior leadership – including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers".
"In addition," it reads, "he oversaw FDA-related litigation and reviewed and approved every regulation and guidance promulgated by the FDA and every warning letter issued by the FDA."
The sites brags that Hunton served as statewide counsel for Merck in Vioxx cases and represented Lilly in Prozac cases all around the country and even brags about winning a lawsuit that alleged a client's product caused "complete deafness in a young child".
Probably most pertinent to Mr Bradshaw's area of expertise, Hunton claims to have "substantial experience in dealing with issues such as FDA preemption," and "off-label promotion".
The firm also says it handles consumer protection claims and investigations into business practices by attorneys general but does not mention cases by name. However, most of the cases filed on behalf of the states at the moment involve allegations that drug makers ripped off public health care programs by promoting drugs for off-label uses and injured consumers by concealing their side effects.
Mr Bradshaw's wealth of insider information gathered during his days as chief counsel, along with his direct line to all the Bush Administration attorneys he worked side by side with, will surely come in handy in this practice area of the firm.
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