US Sen. Grassley Demands Teen Screen Pharma Connections

United States Senate
Committee on Finance
Washington, DC 20510=6200

December 7, 2009
Via Electronic Transmission
Laurie Flynn
Executive Director
TeenScreen National Center for Mental Health Checkups at Columbia University
1775 Broadway, Suite 610
New York, NY 10019

Dear Ms. Flynn:
The United States Senate Committee on Finance (Committee) has jurisdiction
over the Medicare and Medicaid programs and, accordingly, a responsibility to
the more than 100 million Americans who receive health care coverage under
these programs. As Ranking Member of the Committee, I have a duty to protect
the health of Medicare and Medicaid beneficiaries and safeguard taxpayer
dollars authorized by Congress for these programs.

For the last three years, the Committee has been looking into various aspects
of the pharmaceutical industry, including consulting arrangements, and industry
funding for Continuing Medical Education (CME). My inquiry was spurred, in
part by press accounts documenting the lack of transparency in the relationships
between the pharmaceutical industry and nonprofit organizations. For instance,
in April 2008, The Wall Street Journal reported that industry representatives,
including ten major drug companies, formed a coalition to promote looser
restrictions on off-label marketing.

1 The coalition asked the National Alliance on Mental Illness (NAMI) to speak in favor
of this issue.

On October 6th of this year, I sent letters to all fifty state chapters of NAMI
asking them to disclose income from pharmaceutical companies. In that letter, I
explained that NAMI National receives almost two-thirds of its funding from the
drug industry.

2 I learned recently that a few days after I sent those letters, one
of the founders of NAMI and member of the NAMI National Board of Directors
emailed his resignation, stating that he was shocked at NAMI’s reliance on
pharmaceutical industry funding. In particular he said: “This financial dependency
presents a number of problems.”

[ATTACHMENT]
1 Alicia Mundy, “Off-Label Use of Drugs Gets a Push --- Big Pharma Lobbies
Washington to Relax Rules on Marketing,” The Wall Street Journal, April 18, 2008.
2 Gardiner Harris, “Drug Makers Are Advocacy Group’s Biggest Donors,” New York
Times, October 21, 2009.


In response to my concerns, NAMI began to disclose publicly on its website, any
amount of funding exceeding $5,000 that it received from pharmaceutical companies
and other foundations. This decision in favor of transparency by NAMI is encouraging.

In April of this year, the Institute of Medicine issued a report endorsing
transparency and stating that protections against conflicts can be established without
inhibiting productive relationships between medicine and industry to improve medical
knowledge and care. I am hoping you can assist me in this effort by providing additional
insights into these relationships as well as any changes in transparency that your
organization may be planning for in the future. Operating with transparency sends a
message that there is nothing to hide.

Accordingly, I would appreciate an accounting of industry funding that
pharmaceutical, medical device companies, foundations established by these companies
or the insurance industry have provided to the TeenScreen National Center for Mental
Health Checkups at Columbia University (TeenScreen) (The term “industry funding”
means any transfer of value, including but not limited to grants, donations, and
sponsorship for meetings or programs, etc.) This request covers the period of January
2006 to the present.

Because reporting practices vary widely from one charitable organization to
another, I would appreciate you also placing this income into a chart, detailing annual
amounts of industry funding. For each year, please provide the following information
for

TeenScreen:
1) Year;
2) Name of company;
3) Amount of funding; and
4) Reason(s) that the funding was provided.

In addition, please explain TeenScreen’s policies for accepting industry funding
and the disclosure requirements of your top executives and board members by
answering the following questions. For each question, please respond by first
repeating the enumerated question followed by the appropriate answer. Again,
this request covers the period of January 2006 to the present:

1) Please describe the policies for accepting industry funding and whether or not
TeenScreen allows companies to place restrictions or provide guidance on how
funding will be spent.

2) If TeenScreen allows companies to place restrictions on industry funding, then
please explain all restrictions and/or guidance for each transfer of value from
industry. For every transfer of value with a restriction, please provide the
following information: year of transfer, name of company, and restriction placed
on funding.
3

3) Please explain what policies, if any that TeenScreen plans to adopt to ensure
transparency of funding in order to provide a greater public trust in the
independence of your organization.

4) Please explain your policies on disclosure of outside income by your top
executives and board members.

5) Please provide the disclosures of outside income filed with your organizations by
your top executives and board members.

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

I look forward to hearing from you by no later than December 21, 2009. All
documents responsive to this request should be sent electronically in PDF format
to Brian_Downey@finance-rep.senate.gov. If you have any questions, please do
not hesitate to contact Paul Thacker or Brian Downey of my Committee staff at
(202) 224-4515.

Sincerely,
Charles E. Grassley
Ranking Member
Attachment

Kin sue Harvard over son's suicide - Allege neglect in health services' drug prescription

Boston Globe
Shelley Murphy
December 4, 2009
Harvard sophomore John Edwards was studying to become a doctor and training for the Boston Marathon in June 2007 when he sought help at the university’s Health Services because he could not study for as many hours as some of his friends.

A nurse practitioner prescribed a drug to treat attention deficit hyperactivity disorder, a condition the overachieving Edwards had never been diagnosed with. Later, she prescribed two powerful antidepressants, Prozac and Wellbutrin, when he began complaining of anxiety, depression, and other side effects. Meanwhile, he was taking a fourth drug for acne, Accutane, that has been linked to suicidal thoughts.

“The Wellbutrin is having the effect that we were seeking . . . but unfortunately I feel like it has canceled out the anxiety-reducing effects of the fluoxetine [Prozac], as recently I’ve been pretty nervous,’’ Edwards wrote in a Nov. 27, 2007, e-mail to the nurse practitioner, Marianne Cannon. “Let me know if I should schedule to come in and meet with you soon, or if I should change the med plan.’’

Cannon replied that she was concerned and told Edwards to schedule an appointment with her. Two days later, Edwards, 19, of Wellesley committed suicide in a bathroom at Harvard Medical School by suffocating himself with a plastic bag.

His father, John B. Edwards II of Wellesley, filed a suit Wednesday in Middlesex Superior Court alleging gross negligence by Cannon; Dr. Georgia Ede, who was the doctor who supervised her; and Harvard College, for causing his son’s wrongful death

Harvard released a statement yesterday, saying, “We understand how difficult it must be for John Edwards’ family to cope with such a tragic loss, but we are confident that the care he received at Harvard University Health Services was thorough and appropriate and he was monitored closely by its physicians and allied health specialists.’’

Lisa G. Arrowood, a Boston attorney who represents Edwards, said, “We’re alleging that the supervising physician in this case did not do her job, which was to supervise the nurse who didn’t have medical training that a physician has. She was writing prescriptions for powerful drugs that were inappropriate in this combination and are associated with an increase of suicide.’’
The US Food and Drug Administration has warned that anyone taking Accutane, Prozac, or Wellbutrin should be monitored closely for suicidal thoughts.

“If a college such as Harvard cannot properly care for somebody like Johnny, I think it’s very concerning who can,’’ Edwards’s father said. “They are leaders in medicine and psychiatry, and it’s just astounding that at a school such as Harvard that something like this could happen.’’
Edwards was class president and valedictorian of Wellesley High School class of 2006 and played on the school’s championship tennis team. His father said he was an A student at Harvard and was conducting stem cell research at Harvard Medical School.

He said he “thought it was bizarre’’ when his son told him he had been prescribed medication for attention deficit disorder, because “he never had an attention issue.’’

The suit accuses Cannon of prescribing Adderall, an amphetamine, which caused Edwards to have chest pains and anxiety, then several months later prescribing Prozac and then Wellbutrin, even though Edwards told her he had taken Prozac when he was younger and experienced “out-of-control feelings.’’

Edwards said his son was upset by a break-up with a girlfriend two months earlier, but there was no indication he contemplated taking his own life. He was training for the marathon and had created a Harvard College Marathon Challenge Web page, with a goal of raising $2,000 for two charities. “In six months, I hope to cross the finish line of the Boston Marathon,’’ Edwards wrote.
His father said he last saw him when he dropped him off at his dorm two days after Thanksgiving. “He seemed to be in a good mood,’’ Edwards said. “I gave him a kiss on the head and hugged him. He hugged me. I told him I loved him and left. He seemed to be fine.’’
Edwards said his son, a guitarist, was planning to perform “High and Dry’’ by Radiohead with a friend at a talent show the night after his death. The show was canceled because of the suicide, then held three months later. His only sister, Julia, now 16, learned the song and played it in his memory.

Edwards said he always hated to run, but after his son’s death he started training and ran the Boston Marathon this year.

“I put some of Johnny’s ashes in my back pocket,’’ Edwards said, his voice cracking. “Together we ran the marathon.’’

Shelley Murphy can be reached at shmurphy@globe.com.
© Copyright 2009 The New York Times Company