Saturday, June 21, 2008

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

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

4 comments:

Anonymous said...

Scot--

Great letter . . . let us hear if you are contacted regarding your concerns.

Melody

Anonymous said...

Scot, you state 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).


I enjoyed your article. Let me dream a bit: wouldn’t it nice if a change of paradigm were in the offing, and concerned physicians who might actually care about patients instead of corporate bottom lines are given a seat at the table. If Grassley et al. were indeed looking out for all Americans—including all patients—he could hire you for analysis, consulting, and DIRECTION.

These two paragraphs are so on-point for the insulin issue about which I have previously contacted you. I spent a great deal of time going over the NDA that Lilly submitted to FDA to garner approval for rDNA insulin. The adverse events (particularly hypoglycemia and hypoglycemia unawareness) were marginalized. And though FDA required a 24-month post-marketing study/evaluation, I can find no indication that this was ever performed. As you state so well, suppression can work quite well by merely NOT doing the work . . . which, I believe, is the case with rDNA insulin.

I’ve acknowledged that I’m a bit of a conspiracist . . . but will qualify this with the fact I don’t believe the original intent was a broad-based conspiracy. I believe the results have been a matter of evolution . . . a roadmap, if you will, of what works, what doesn’t . . . and how to avoid the ‘doesn’t work’ pathway.

The trials that supported Lilly’s application were exceedingly small. And conveniently, Lilly found a way to include T1 and T2 patients, as though these individuals actually had the SAME disease. This muddying of the waters benefited them, and seems to have slipped through FDA without comment. They used an exceedingly low bar (reduction of blood glucose level . . . and no SERIOUS (life-threatening) adverse events).

As one rDNA insulin-like product reaches patent expiration, they are ready with a new formulation—always the latest and greatest. They also begin to admit the shortcomings of the patent-expiring/expired product to inflate the value/importance of the new product. If (or when) this does not garner them adequate market share, the roadmap was laid down long ago with ‘human’ insulin . . .take the ‘old stuff’ off the market (after all, the old stuff is OUR stuff, and we control what does and doesn’t get produced). I have spent a great deal of time over the last 7-8 years trying to find a listener, fighter, advocate. I’ve written to legislators, agency heads, advocacy groups, law firms, journalists, media investigators. When the landscape changes (after a federal election), I start over. No one will take a look back because, as you say, they do not have (nor do they want) the information to begin with. Except for the bG-lowering metric (and non-carcinogenicity study—long-term seems to be 6 months?), no COMPARISONS between natural and genetically-engineered products were conducted. Since Lilly removed their products from the U.S. market, there is no reason for scientists, doctors, researchers to now find a source for natural products and actually DO comparison studies. I truly feel that such studies (unless spun by top-notch PR spinmeisters) would reveal the lies and fraud that has been perpetrated on insulin-dependent diabetics for more than 2 decades; that they have literally been FORCED to use an inferior, more-dangerous product while being told it is better, safer, etc.

There are some who claim that the technological advances (pumps, meters, strips, frequent A1c’s, CBGM’s, etc.) have all improved the quality of life for insulin-dependent diabetics; but many who make these claims, themselves, have no basis for comparison . . . they never used the ‘old’ stuff; have no experience of surviving sans monitor; many have never experienced the true warning signals the human body provides when in danger.

I hope you hear from Grassley; it would be heartening to think that anyone in our government is actually looking out for American citizens instead of American corporations. I’ll be watching HC Renewal to see if you receive a response.



Melody

MedInformaticsMD said...

let us hear if you are contacted regarding your concerns.

I put the chance at 1 in 10^6.

Anonymous said...

The following are thoughts regarding pharma companies insistence on hiring those pesky and possibly unnecessary drug reps, yet the premise is the same, as the seek all who will not question thier future employer:

Are Drug Reps Really Necessary?

One of the main functions of pharmaceutical representatives is to provide free samples to doctor’s offices presently instead of authentic persuasion, and these samples in themselves cost billions to the pharmaceutical industry. Yet arguably, samples are the most influential tool in influencing the prescribing habit of a health care provider. Let me be clear on that point: Its samples, not a representative, who may be the top influencer of prescribing habits.
Yet considering that drug promotion cost overall is approaching 20 billion a year, combined with about 5 billion spent on drug reps themselves, what if there is another way for doctors to get free drug samples, which is what they desire for their patients to initiate various treatment regimens? What if prescribers could with great elation avoid drug reps entirely?
There is, actually, a way to do this, but it is limited. With some select, smaller pharma companies, doctors have the ability to order samples by printing order forms on line for certain medications through certain web sites associated with the manufacturers of these samples. Some examples are such medications that can be ordered in this way are keflex, extendryl, and allerx. Possibly several more can or are available to prescribers in this way. Others, however, cannot be acquired by this method.
So in some situations, a doctor can go on line, print off a sample order form, fax it into a designated fax number after completion of the form, and the samples are shipped directly to the doctor’s office with some products thanks to their manufacturers who provide this avenue. There is no review of the doctors’ prescribing habits by the drug rep. And no embellishments stated by reps actually sounds pretty good for any medical community.
Usually, this system is available for those smaller companies with very small sales forces to compensate for what may be vacant territories, but can be applied to any pharmaceutical company who, upon discretion, could implement such a system.
Now, why is this not done more often? Apparently, it is legal to obtain samples in this manner. If samples are the number one influencer of prescribing habits, why spend all the money on reps to deliver samples personally? It’s worth exploring, possibly, since the drug rep profession has evolved into those who become UPS in a nice suit.
Think of the money that could be saved if more pharma companies offered samples to doctors in this manner. Furthermore, additional benefits with this ideal system are that there is no interruption of the doctor’s practice. And again, there is no risk of bias presented to the doctor by a rep, as they would avoid contact with reps if they order samples through this way- to have the samples directly to be shipped to their office.
When samples are shipped to doctors’ offices in this manner, prescribing information of the particular med is included with the samples shipped. Doctors can order and utilize samples according to their discretion, and would be free of interference from the marketing elements of pharmaceutical corporations. Patients benefit when this occurs.
Considering the high costs associated with the pharmaceutical industry, having samples shipped directly to doctor’s offices should be utilized more than it is presently- regardless of the size of the pharmaceutical company.
Something to think about as one ponders cost savings regarding this issue.

“The new source of power is not money in the hands of a few but information in the hands of many.”
---- John Naisbitt

Dan Abshear

Author’s note: What has been written has been based upon information and belief.