Editorial: It's Hard to Believe!

Editor's Note: Much of the letter from Senator Charles Grassley to Wyeth's Chairman, President and CEO Bernard J. Poussot is printed below. With activities like this, the Wall Street fiasco, and the automakers' mess, we have a lot of work to do in trying to straighten things up and eliminate the greed, corruption, and dishonesty that is rampant in corporate-America. One thing that concerns me is whether or not Wyeth is the only company involved in this or are there others? The credibility of journal articles in health care has taken a hit with this revelation! How far does it go? What influence is exerted on other "scientific" literature? All the pharmaceutical-related entities have undergone credibility issues in recent years, including the FDA and the pharmaceutical industry. Maybe it's time for everyone to get "back to the basics" and focus on what you need to do and "do it right!" - Loyd V. Allen, Jr., Ph.D., R.Ph., Editor-in-Chief

Dear Mr. Poussot:

Over the last year, the Committee has been examining a practice used by drug companies referred to as "medical ghostwriting." I have been informed that this practice involves marketing and/or medical education companies that draft outlines and/or manuscripts of review articles, editorials, and/or research papers. This information is then presented to prominent doctors and scientists, particularly those affiliated with academic institutions, to review, edit and sign on as authors, whether or not they are intimately familiar with the underlying data and relevant documentation. In addition, it is not always apparent in the publication that individuals and companies other than the listed authors were deeply involved in the study and/or drafting of the final manuscript.

Articles published in medical journals are widely read by practitioners, and relied upon as being unbiased and scientific in nature. Concerns have been raised, however, that some medical literature may be subtle advertisements rather than publications of independent research. The information in these articles can have a significant impact on doctors' prescribing behavior and, in turn, on the American taxpayer, because the Medicare and Medicaid programs pay billions of dollars for prescription drugs. Thus, any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling.

It was recently alleged that Wyeth has been and may still be engaging in the practice of ghostwriting. Documents from recent lawsuits involving Wyeth's hormone therapy products have been provided to the Committee, in particular documents relating to articles published in the American Journal of Obstetrics and Gynecology, Obstetrics and Gynecology, and Primary Care Update for OB/GYNs. Based on a review of those 2 documents, it appears that Wyeth hired a medical communications and education company, DesignWrite Inc., to:

1. Draft manuscripts for reviews regarding the company's hormone therapy products and breast cancer risk; and
2. Seek academic investigators to sign on as the primary author(s).

Accordingly, I request that you provide the Committee with information regarding Wyeth's policies and procedures with respect to ghostwriting. In addition, I would appreciate a response to the following requests. In complying with this request, please respond by repeating the enumerated request, followed by the accompanying response; attach and identify all relevant documents or data by title and the number(s) to which they are responsive.

1. Please provide the Committee with a list of all scientific manuscripts or reports prepared by DesignWrite on behalf of Wyeth for the period of January 1, 1995 through the date of this letter. For each study, research paper or review article, please provide the following information:
   1. Title of study and/or report and/or review article;
   2. Brief description;
   3. Period of time for which the work was done;
   4. Author(s) who signed his/her name on to the study, research paper and/or review article;
   5. Payments¹ made to the author(s);
   6. Extent of involvement/participation of the author(s) in the drafting of the outline and/or final manuscript;
   7. Journal where study and/or article was published;
   8. A copy of the article;
   9. Total payments to DesignWrite for completed work;
   10. Name of any other third party(ies) that contributed or participated in the development of the study or article and payments made to the third party(ies); and
   11. A copy of the contract executed between Wyeth and DesignWrite.

¹ Payments include fees, honoraria, and any other transfers of value

2. Please provide all internal and external correspondence, communications and meeting minutes regarding each of the DesignWrite-prepared studies and/or articles identified in Wyeth's response to Request #1.

3. According to the documents received by the Committee, John Eden, MD, is the author listed on the article published in the American Journal of Obstetrics and Gynecology entitled, "Progestins and Breast Cancer." The final publication does not identify the original author of the article or mention any support that was provided by Wyeth. In addition, the publication acknowledges Karen Mittleman, PhD, and Stephen M. Parker, ELS, for their editorial assistance, but does not identify their affiliation.
   1. Please describe in detail the extent of Dr. Eden's involvement and/or participation in the development and drafting of the final manuscript.
      
      
   2. Please identify all individuals at DesignWrite and any other third party(ies) that contributed to the development and/or the initial and final drafts of the manuscript.
      
      
   3. Please provide the total amount of payments made to Dr. Eden, DesignWrite, and each individual who contributed either directly or indirectly to the drafting of the published article.
      
      
   4. According to the minutes from a "Strategic Publications Development Meeting" dated June 15, 2000, the following Wyeth employees participated in the meeting where Dr. Eden was suggested as the author for the "breast cancer paper questioning the role of progestins as a causative factor":
      
      
      1. Jamie Durocher;
      2. Mark Barbee;
      3. Steve Strickland;
      4. Stephanie Brown; and
      5. Alice Conti.

      Please provide their titles and role in the company. Please also identify any other individuals at Wyeth who were involved in the development and/or drafting and/or editing of the manuscript, including their title and role in the company.

   5. The documents also show that the initial draft of the manuscript was completed by Caron Pruiett. Please explain her affiliation with Wyeth and/or DesignWrite or any other entity.
      
      
   6. Based on a review of the documents received by the Committee, it appears that Wyeth marketing employees are involved in discussions of the message and development of scientific manuscripts. According to a trial transcript dated January 26, 2007, Ms. Jeanne Marie Durocher, a Wyeth employee, was asked questions about the June 2000 meeting between Wyeth and DesignWrite. In response to a question whether Wyeth employees in attendance were all in the marketing department, Ms. Durocher stated, "That is correct and unusual." Accordingly, does Wyeth always and/or regularly include its marketing employees in the development of the message of an article for submission to a medical journal?

4. According to the documents received by the Committee, Lila E. Nachtigall, MD, is the author listed on the article published in Primary Care Update for OB/GYNs entitled, "Sex Hormone-Binding Globulin and Breast Cancer Risk." Again, the article acknowledges the editorial assistance of a Dr. Ann Contijoch, but does not identify her affiliation. Based on information provided to the Committee, Dr. Contijoch may have been the original author of the paper.

   1. According to a letter from Dr. Karen Mittleman to Dr. Nachtigall, it appears that Dr. Nachtigall was not involved in the manuscript until after it was drafted by DesignWrite. Please describe in detail the extent of the involvement/participation of Dr. Nachtigall in the development and/or drafting of the final manuscript.
      
      
   2. Please identify all individuals at DesignWrite and any other third party(ies) that contributed to the development and the initial and final drafts of the manuscript.
      
      
   3. Please provide the total amount of payments made to Dr. Nachtigall, DesignWrite, and each individual who contributed either directly or indirectly to the drafting of the published article.
      
      
   4. Please identify all individuals at Wyeth who were involved in the development and/or drafting and/or editing of the manuscript, including their title and role in the company.

5. According to the documents received by the Committee, Trudy L. Bush, PhD, Maura Whiteman, and Jodi A. Flaws, PhD, are the authors listed on the article published in Obstetrics and Gynecology entitled, "Hormone Replacement Therapy and Breast Cancer: A Qualitative Review." The published article reports that Dr. Bush received honoraria from Wyeth for speaking on this topic. It also acknowledges the assistance of Karen Mittleman, Laura Hirshfield, and Lynn Van Ruiten, but again does not identify their respective affiliations.

   1. Please describe in detail the extent of the involvement/participation of Dr. Bush, Ms. Whiteman, and Dr. Flaws in the development and/or drafting of the final manuscript.
      
      
   2. Please identify all individuals at DesignWrite and/or any other third party(ies) that contributed to the development and the initial and final drafts of the manuscript.
      
      
   3. Please provide the total amount of payments made to Dr. Bush, Ms. Whiteman, Dr. Flaws, DesignWrite, and all other individuals who contributed to the drafting of the published article.
      
      
   4. Please identify all individuals at Wyeth who were involved in the development and/or drafting and/or editing of the manuscript, including their title and role in the company.
      
      

6. Please provide the Committee with a list of all scientific manuscripts or reports prepared by each and every company (hereinafter "third party company"), other than DesignWrite, on behalf of Wyeth for any Wyeth human drug for the period of January 1, 2000 through the date of this letter. For each study, research paper or review article, please provide the following information:
   1. Title of study and/or report and/or review article;
   2. Brief description;
   3. Period of time for which the work was done;
   4. Author(s) who signed his/her name on to the study, research paper and/or review article;
   5. Payments made to the author(s);
   6. Extent of involvement/participation of the author(s) in the drafting of the outline and/or final manuscript;
   7. Journal where study and/or article was published;
   8. A copy of the article;
   9. Total payments to the third party company for completed work;
   10. Name of the third party company(ies) that contributed or participated in the development of the study or article and payments made to the company(ies); and
   11. A copy of the contract executed between Wyeth and the third party company(ies).

7. Please provide all internal and external correspondence, communications and meeting minutes regarding each of the company-prepared studies and/or articles identified in Wyeth's response to Request #6

In cooperating with the Committee's review, no documents, records, data, or other information related to these matters, either directly or indirectly, shall be destroyed, modified, removed, or otherwise made inaccessible to the Committee.

I look forward to hearing from you by no later than January 11, 2009. All documents responsive to this request should be sent electronically, on a disc, in searchable PDF format to Brian_Downey@finance-rep.senate.gov. If you have any questions, please do not hesitate to contact Angela Choy or Paul Thacker at (202) 224- 4515.

Sincerely,





Charles E. Grassley
Ranking Member Committee on Finance

The offices of the International Journal of Pharmaceutical Compounding will be closed on Thursday and Friday (December 25 and 26) so there will be no Newsletter on the 26th. IJPC wishes all a very Merry Christmas.

ANGELS EXPLAINED BY CHILDREN (From an e-mail received last week)

"I only know of two angels, Hark and Harold."
"Everybody's got it all wrong. Angels don't wear halos anymore. I forget why, but scientists are working on it."
"Angels don't eat, but they drink milk from Holy Cows!"
"My guardian angel helps me with math, but he's not much good at science."
"When an angel gets mad, he takes a deep breath and counts to ten. And when he lets out his breath, somewhere there's a tornado."
"Angels live in cloud houses made by God and his son, who's a very good carpenter."
"What I don't get about angels is why, when someone is in love, they shoot arrows at them."

Kind Words
A kind word this time of year goes a long way. We never know the hurts that are experienced by people that we see each day. Traveling a lot, I find it interesting to observe people that often tend to be quiet and not express themselves very much and, when in crowds they become more tense. However, a smile, a kind word, or a simple "thank you" is often all it takes to "break the ice" and everyone relaxes. Oh yes, and it's okay to say "Merry Christmas!"