All three profit from promoting this position. Goozner peddles his wares via book sales, lectures, etc. And Lurie and Wolfe have co-authored something called Worst Pills, Best Pillsm which ,I kid you not , was once offered as a the perfect holiday gift.
"All three have or had direct influence on the FDA's decisions on medicines and establishing the risk-benefit tolerance of the agency. Gooz and Wolfe were or are on FDA advisory committees. Lurie is now in the FDA's Office of Policy in Peggy Hamburg's shop.
Lurie, a physician, will be the third person with ties to Public Citizen to be engaged by the FDA. Sidney Wolfe, former head of Public Citizen's Health Research Group and editor of Worst Pills, Best Pills (http://worstpills.org/; Nat. Biotechnol. 26, 149, 2008) has been a member of the FDA Drug Safety and Risk Management Advisory Committee since 2008. Also Joshua Sharfstein, the FDA's current principal deputy commissioner, has early ties to Public Citizen from an internship in 1992. Before joining the FDA, Sharfstein developed a reputation as a reformer and an industry critic through his advocacy work in the field of HIV/AIDS and his efforts to limit marketing of pediatric cold remedies."
No conflict or coverage thereof?
Only sweet sounds are heard about their appointments:
“It can't hurt to have smart people—who may be a little controversial—in government. People [in government] can go into this deep inertia of making only small, incremental movement...you can take [Lurie's] energy and his desire to improve the process to help move things forward.”
Which brings me to the comments of Wolfe and Goozner and the manufactured hit job they help lead against another smart, controversial person, Scott Gottlieb, who is a real doctor who sees real patients, unlike Wolfe or Goozner.
Here's what Goozner said about Scott's appointment to Alicia Mundy, who is now the go to source for those inside FDA seeking to make life miserable for Janet Woodcock, John Jenkins and others:
"I've never heard of anything like this," said Merrill Goozner, a director at the liberal Center for Science in the Public Interest.
"If he's had dealings regarding companies whose products are up for review at the agency, it strikes me as a potential conflict of interest. You want a barrier between the regulated and the regulators. It's fundamental," Goozner said.
What about intellectual bias? Note how the Gooz cut himself yards of slack, with Mundy giving him room to do so. I guess neither knew or cared about the FDA's equally strict restriction on using one's position to skew or bias proceedings to fit a particular, uh, narrative. Or book sales. Or continued existence as Project Director at certain advocacy groups...Or whatever:
But intellectual bias is a big problem. Bigger than financial conflicts because, as Aaron Wildavsky observed in Risk and Culture, the adherents of organizations that individuals such as Lurie, Goozner, Wolfe and Alicia Mundy have worked for and work for need enemies, corporate enemies to unify and motive a base sharing a deep cultural bias about the inherent dangers of technology. To suggest this bias does not exist or is an articulation of objective reality is to cede control of the political and social institutions that regulate all human activity to the aforementioned since their goal is not this regulation or that, but to "break the stranglehold which they consider such interests have on society." tinyurl.com/33vyzj5
All the more reason that the FDA in it's small way has sought to put a leash on such totalitarian behavior:
"Within the Center for Drug Evaluation and Research, there are provisions stating that members participating on advisory panels should be free from intellectual bias. According to the FDA document, the appearance of intellectual bias is an issue if the member is identified as a "primary advocate" or is "so strongly associated with a position on a matter" that concerns could be raised about his or her impartiality and objectivity.
Also, intellectual bias may exist if "statements of record have been made by that member concerning an issue to be considered by the committee that draw conclusions or strongly appear to draw conclusions to a degree that would appear, to informed experts, to preclude an impartial and objective evaluation of information on that matter presented to the committee." These statements could be taken from legal cases, other regulatory agencies, or even from the media.
As Jenkins told heartwire last week, members are welcome to bring differing perspectives and to ask tough questions, "But at the same time, we want the committee members to come to the table with an open mind, so they can give us advice based on the data, the presentations, and the discussions that are held at the committee meeting itself."
www.theheart.org/article/943511.do
And finally here is Lurie essentially shooting himself in the foot by acknowleding that financial "conflicts" are easily spotted whereas intellectual bias can be disguised as just scientific disagreement:
"Frequently, one hears that there are both financial and intellectual conflicts of interest; somehow this argument is offered as evidence to downplay the importance of the financial conflicts. While intellectual conflicts are important, they can readily be distinguished from financial ones. Financial conflicts of interest are extrinsic to the scientific endeavor, whereas intellectual conflict is the very way science moves forward. Financial conflicts can occur at variable levels – some people have them, some people don’t – and they can be quantified, whereas intellectual conflicts are ubiquitous and not susceptible to quantification in the same way. Moreover, in the context of debate on an advisory committee, for example, it is unlikely that the financial conflict information will naturally emerge, whereas it is likely that any relevant intellectual one will. There are relatively straight-forward methods to alleviate financial conflicts, whereas it’s not nearly as clear how one should approach intellectual conflicts. Finally, our legal system has long recognized the distinctions between the two.
brodyhooked.blogspot.com/2008_03_01_archive.html
Indeed, it has. The intellectual bias is much more problematic:
"Two of these definitions are: an individual has a COI when there is a conflict between his/her private or institutional interest and his/her official duties in a position of responsibility or trust; or, an individual is in conflict if he/she owes a duty of loyalty or responsibility to two distinct entities or individuals, both of which are likely to be affected by the scientific activity in which the individual is engaged. The term "interest" can refer to a financial (i.e., employer, employee, consultant, stockholder, investor, etc.) or a non-financial interest/relationship (i.e., family member, mentor, mentee, professional colleague, co-author, etc.). Most existing COI policies address financial but not non-financial conflicts of interest; however, non-financial conflicts of interest are equally common and important, and they warrant, and will likely receive, more attention and a higher degree of scrutiny in the future."
toxsci.oxfordjournals.org/cgi/content/full/87/1/11
