Saturday, 21 June 2008

An Open Letter to Sen. Grassley Re: Withholding of Paxil Adverse Events Information

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June 21, 2008

Sen. Chuck Grassley
135 Hart Senate Bldg.
Washington, DC
20510-1501
via email

Dear Senator Grassley:

Regarding the June 21, 2008 article in my local newspaper, the Philadelphia Inquirer, entitled “Glaxo’s Paxil faces scrutiny on the Hill” (http://www.philly.com/philly/business/20624784.html), I note your concerns that Glaxo/GSK may have withheld Paxil adverse events information on suicidal behavior from regulators.

As a physician and medical information science specialist, I feel obligated to express an even broader concern based on my personal experiences and that of my colleagues.

One way for a pharmaceutical company to “withhold” or suppress adverse information is to not have the information to begin with.

One way to not have such information, or to have less information, is via capricously denying hiring of specialists who could help better identify, uncover, and produce this information. In effect, one can hide information by evading or avoiding ever discovering the information through talent management (or mismanagement, as the case may be).

The Institute of Medicine of the National Academies of Science, after careful consideration, formally recommended that pharmaceutical companies engage Medical Infomatics experts in drug adverse event surveillance:

Informatics experts should track progress on the national health-information infrastructure, look for opportunities to gather information about drug safety and efficacy after approval, coordinate partnerships with external groups to study the use of electronic health records for [drug] adverse event surveillance, participate in FDA’s already strong role in setting national standards and track the development of tools for data analysis in industry and academe, and encourage the incorporation of the tools into FDA practice where appropriate.

(From "The Future of Drug Safety: Promoting and Protecting the Health of the Public”, Committee on the Assessment of the US Drug Safety System, Alina Baciu, Kathleen Stratton, Sheila P. Burke, Editors, Board on Population Health and Public Health Practice (BPH), Institute of Medicine, 2006)

I am such a specialist, and yet just a few short years ago, after my role as chief of scientific information at Merck Research Labs, I was turned down flat -- even for an interview – by GSK for an Informatics Director position, on what I believed was indeed capricious and unusual grounds.

With my expertise and experience in information technology for collection, analyis and management of biomedical information, including identification of adverse events, and coming with strong recommendation from GSK’s own retained recruiters in the UK who had identified me as a candidate for this very role, I was stunned when GSK refused even to talk to me.

My credentials were summarily dismissed. Attached below are the details of this event ("Case Example On Pharma Hiring Practices"), a case study I use in my graduate teaching of medical informatics.

I have experienced similar responses towards similar roles from numerous other pharmas as well, as have a number of my colleagues.

These incidents raise the following question: could such hiring practices be part of a systematic pattern designed to impair the comprehensive uncovering of adverse events information?

My suggestion is that you should investigate not only possible withholding of data from regulators, but also pharmaceutical hiring patterns that could in effect obstruct or suppress the detection and production of drug adverse events information.

Sincerely,

S. Silversteien
MedInformaticsMD
Healthcare Renewal Blog

-----------------------------------------

Case example on pharma's hiring practices:


In July 2004 I received an unsolicited email about a new job opening from a prestigious British recruiting firm (“headhunter”) retained by GSK, Armstrong Craven Ltd. It referred to a cheminformatics position I'd once applied to (and never heard back about), and sought me out for a converstation about a new role: Director of Medical Informatics (text of letter here).

I set up a phone interview with the recruiter, who called me from the UK a short while later. We spoke for over an hour about the Director of Medical Informatics role. As a result of our detailed conversation, the recruiter felt I was highly qualified for the position. As a further check, he emailed me a GSK document that described the position in great detail.

With extensive medical informatics training and experience in both hospitals and pharma, having been Director of Scientific Information Resources and of
The Merck Index at Merck Research Labs, I must have seemed to him well qualified for the job description. That JD included items such as identifying, prioritizing and partnering on projects where Medical Informatics can deliver business impact, and developing both strategic (long term) collaborations that will have a sustained impact as well as short term efforts that will impact high-priority R&D projects. The full job description can be seen here.

Finally, the job was described as reporting at a high level but not to an M.D. It reported to the Vice President of Informatics & Knowledge Management who apparently authored the description, a Ph.D. The recruiter told me he would speak with the hiring team and present my credentials to them ASAP. He fully expected at least a follow up interview.

Unfortunately, this was not to occur.

I received a call back from the recruiting firm several days later to tell me that GSK had no interest in my background, and the Ph.D. hiring manager did not wish to speak to me at all. When I inquired why, I was told he was looking for someone with “an extensive computer science background to write algorithms to solve business problems.”

Needless to say, I was rather disappointed by this response. The Armstrong Craven response raises a number of important questions:

  • Was it typical at GSK for a hiring manager to read a resume that came from its own retained recruiter and, on the basis of secondhand knowledge from the recruiter and line items on a piece of paper, make a decision not to even talk to the recommended candidate – or even meet in person, since that candidate lived perhaps fifteen miles from one of the sites the hiring manager frequented? Is this above-board, state-of-the-art talent management in an industry as critical and under such societal mistrust as pharma?
  • Was there anything in my resume with regard to my training and experience in biomedical computing science and in healthcare suggesting I could not write such algorithms to solve biomedical business problems?
  • How was the prejudicial decision that algorithms needed to be written by a Medical Informatics specialist made? Who set this as a strategic objective? Why was it done by someone with no apparent Medical Informatics credentials?
  • Is the best use of a medical informatics specialist to write algorithms (i.e., do programming), or is it to create and direct the writing of algorithms, separating the high-level biomedical cognitive tasks form the lower ones (i.e., programming)? See example of this issue here.
  • Why do we have computer-oriented VP's lacking medical credentials evaluating resumes of those who do?
  • Did the lack of medical credentials and experience prevent proper understanding of critical line items on my resume?
  • Were other potentially valuable Medical Informatics candidates turned away on similar reasoning?

This was not my first encounter with GSK / SKB. I had also had fruitless discussions with SKB in the 1996-8 timeframe, while I was Director of Clinical Informatics at Christiana Care. In February 2000 as well, a senior recruiter had contacted me, interviewed me in person after a phone discussion and then enthusiastically tried to sell my background to GSK discovery scientists. He was quite puzzled that they expressed no interest.

In conclusion, I wonder if pharma really "gets it" regarding Medical Informatics. Many of my observations indicate the industry does not. That the IOM needs to call pharma's attention to a specialty field whose professional education is largely NIH-sponsored is quite revealing.

One also wonders if such hiring practices impair companies’ abilities to monitor the safety of their drugs, and if Avandia’s, Paxil’s and other drug’s safety issues would have been detected earlier if, as the Institute of Medicine (IOM) suggests, more Medical Informatics professionals were involved in drug adverse events surveillance, and in roles beyond "writing computer algorithms to solve business problems.


I do not know if this letter will be read or taken seriously. It does express highly personal views and anecdotal evidence regarding a possible blindness in pharma to modern information science thinking, perhaps willful, towards formally trained Medical Informatics specialists. However, I believe one should not attempt to fix symptoms of problem(s) without doing a thorough diagnostic of the problem(s).

It is not hard to conjecture that pharma management might fear critical thinking professionals in a field whose major purpose might be described as enhancing transparency in medicine through dual, formal expertise in medicine and biomedical information science.

To illustrate that this talent mismanagement phenomenon is not limited to one company, see here and here. Finally, even when such talent is brought in, it can be misutilized.

-- SS



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