The Mayo Clinic reported: Ibid.
That matched the findings of a study that would be published in 2012 suggesting that patients taking Aricept would perform cognitively better: Robert Howard et al., “Donepezil and Memantine for Moderate-to-Severe Alzheimer’s Disease,” New England Journal of Medicine, March 8, 2012.
When Cole answered the phone: Author’s interview with Cole Hornstein, February 13, 2014.
FOURTEEN: THE RISE AND FALL OF GOLDEN BOY
his office nickname was Golden Boy: Author’s interview with Susan Molchan, February 6, 2014.
He won NIMH’s Exemplary Psychiatrist Award: Biography of Trey Sunderland, MD, provided by the NIH Clinical Center for an event titled “Alzheimer’s Disease: Advances and Hope” on September 16, 2003.
But there was another side to the Golden Boy: Author’s interview with Susan Molchan, February 6, 2014.
To NIMH director Thomas Insel, the NIH was “Camelot”: Congressional testimony of Thomas Insel, “Human Tissue Samples: NIH Research Policies and Practices,” Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, US House of Representatives, 109th Congress, June 14, 2006, serial no. 109–119.
though theoretically there were boundaries to safeguard against any conflict of interest: Testimony of Thomas Insel, “Human Tissue Samples.”
“The NIH is supposed to be above all that”: Author’s interview with Susan Molchan, February 6, 2014.
At the same time, a lot of government scientists were consulting for private companies: Testimony of Thomas Insel, “Human Tissue Samples.”
Since Aricept’s introduction: Katie Thomas, “Drug Dosage Was Approved Despite Warning,” New York Times, March 22, 2012.
Cognex would be discontinued: Mona Mehta, Abdu Adem, and Marwan Sabbagh, “New Acetylcholinesterase Inhibitors for Alzheimer’s Disease,” International Journal of Alzheimer’s Disease, November 7, 2011.
Looking to further the progress they’d just made with Aricept: Staff report written by the Majority and Minority Committee Staff of the House Committee on Energy and Commerce for the use of the Subcommittee on Oversight and Investigations in preparation for its hearing, “Human Tissue Samples: NIH Research Policies and Practices,” June 13–14, 2006.
“the experience, and knowledge, and access to samples that would make this project possible”: Testimony of David Friedman to the Subcommittee on Oversight and Investigations.
In total, Sunderland sent thirty-two hundred or so vials of plasma and spinal fluid to Pfizer: Ibid.
Pfizer wanted those vials to help develop drugs that would target the disease in its earliest stages: Testimony of David Friedman to the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, June 14, 2006.
In April 2003, the storied Journal of the American Medical Association published some of their results: Trey Sunderland et al., “Decreased β-Amyloid1-42 and Increased Tau Levels in Cerebrospinal Fluid of Patients With Alzheimer Disease,” Journal of the American Medical Association, April 23, 2003.
But the company also used Sunderland to promote Aricept: Willman, “$508,050 from Pfizer” (see chap. 10, n. 11).
under which he was paid $25,000 per year as a consultant: Staff report written by the Majority and Minority Committee Staff of the House Committee on Energy and Commerce for the use of the Subcommittee on Oversight and Investigations.
All told, he earned roughly $500,000 from his five-year private arrangement: Ibid.
Of that amount, Sunderland failed to disclose about $300,000 to his bosses: David Willman, “Illicit payments from Pfizer Cost NIH Researcher $300,000,” Los Angeles Times, December 23, 2006; John T. Papavasiliou, Deputy Director, Maryland State Board of Physicians, Final Decision and Order, March 30, 2009, Case Number 2007-0392.
From 1999 to June 2004, he took the show on the road: Willman, “$508,050 from Pfizer.”
Molchan was a graduate: Author’s interview with Susan Molchan, February 6, 2014.
Molchan embarked on a study that tested whether lithium—an element sometimes used to treat mania—might help prevent tau proteins from becoming toxic: Author’s interview with Susan Molchan, March 3, 2014.
However, Molchan took more fluid than was typical, with the intent of storing some for future research: Staff report written by the Majority and Minority Committee Staff of the House Committee on Energy and Commerce for the use of the Subcommittee on Oversight and Investigations.
Molchan began to think that her studies got less support: Author’s interview with Susan Molchan, February 6, 2014.
Sunderland promised to support her for a tenure-track position: Author’s interview with Susan Molchan, February 6, 2014.
Sunderland informally diagnosed her as paranoid and depressed, while another woman was ordered to see a psychiatrist: Author’s interview with Susan Molchan, February 6, 2014; complaint in the Equal Employment Opportunity Commission (EEOC) case of Susan Molchan.
she filed a sex discrimination claim that was dismissed: EEOC decision in the case of Susan Molchan v. Donna E. Shalala, Appeal No. 01982167, October 29, 1998.
she was alerted to a lithium study requiring spinal fluid similar to the archive she’d left behind at NIMH: Staff report written by the Majority and Minority Committee Staff of the House Committee on Energy and Commerce for use of the Subcommittee on Oversight and Investigations.
“Now, I understand we didn’t need a whole lot”: Testimony of Susan Molchan to the Subcommittee on Oversight and Investigations, June 13, 2006.
But when she asked what happened to the rest, Sunderland appeared to hedge: Ibid.
True, at the time, the NIH’s policies for tracking its human tissue samples were erratic: Testimony of Thomas Insel, “Human Tissue Samples.”
However, for Molchan this atmosphere of carelessness didn’t explain away Sunderland’s vagueness about the vials: Testimony of Susan Molchan to the Subcommittee on Oversight and Investigations.
she contacted the inspector general and the Department of Health and Human Services: Prepared statement of Ed Whitfield, chairman, Subcommittee on Oversight and Investigations, June 13, 2006.
“Not disclosing over $500,000 [sic] in income”: Staff report written by the Majority and Minority Committee Staff of the House Committee on Energy and Commerce.
“I thought of Dr. Sunderland as one of the people who had made tremendous contributions”: Testimony of Thomas Insel, “Human Tissue Samples.”
“What little information that we have gotten, some of it appears to be misleading or intentionally inaccurate”: Response by US Representative Joe Barton to Thomas Insel, Subcommittee on Oversight and Investigations hearing, June 14, 2006.
Insel pointed out that the ethics case had been referred to the Department of Justice: Testimony of Thomas Insel, “Human Tissue Samples.”
“We made a referral”: Ibid.
Barton was sympathetic, but only to a point: Response of US Representative Joe Barton to Thomas Insel, Subcommittee on Oversight and Investigations hearing, June 14, 2006.
Trey Sunderland pleaded guilty: “NIH Scientist Sunderland Pleads Guilty to Conflict-of-Interest Charge,” FDA News, December 12, 2006; David Willman, “Illicit Payments from Pfizer Cost NIH Researcher $300,000,” Los Angeles Times, December 23, 2006.
“This process has humbled me”: David Willman, “Illicit payments from Pfizer.”
Despite her protests against his use of her samples, Molchan remained sympathetic to her former boss on a personal level: Author’s interview with Susan Molchan, February 6, 2014.
His medical license was revoked in Maryland in 2009 and in New York in 2011: John T. Papavasiliou, Deputy Director, Maryland State Board of Physicians, Final Decision and Order, March 30, 2009, Case Number 2007-0392; Kendrick A. Sears, Chair, State Board for Professional Medical Conduct, New York State Department of Health, Consent order BPMC: 11-10, January 11, 2011.
“He has not convinced the Board”: John T. Papavasiliou, D
eputy Director, Maryland State Board of Physicians, Board Decision and Order on Petition for Reinstatement, Case Number 2007-0392, December 20, 2010.
One, who joined the research because his own father had died with Alzheimer’s: Willman, “Illicit payments from Pfizer.”
Julie Noonan Lawson was deeply saddened: Author’s interview with Julie Noonan Lawson, February 12, 2014.
At the time of the investigation, a scientist in Sunderland’s position: Testimony of Thomas Insel, “Human Tissue Samples.”
But what bothered Lawson the most: Author’s interview with Julie Noonan Lawson, February 12, 2014.
The information and samples he collected were warehoused, and over time, some of them were lost: Author’s interview with Marilyn Albert, February 21, 2014.
Albert was awarded $1.5 million: Ibid.
In return, she received: Ibid.
Karla, who was devastated: Author’s email exchange with Karla Hornstein, December 6, 2012.
One of the most poignant losses in the Sunderland affair: Author’s interview with Julie Noonan Lawson, February 12, 2014.
Marilyn Albert tried to help: Author’s interview with Marilyn Albert, February 21, 2014.
Documentation was important to Marilyn Albert: Ibid.
FIFTEEN: FAVORITE SON
Debbie Thompson, Brian’s high-school girlfriend: Author’s interview with Debbie Ness, April 10, 2014.
Brian was living in a trailer on the outskirts of Tioga: Author’s interview with Karla Hornstein, March 2, 2014.
Kassie found it ironic: Author’s interview with Kassie Rose, August 23, 2011.
In more advanced cases of dementia: “Traveling with Dementia,” Alzheimer’s Association, http://www.alz.org/care/alzheimers-dementia-and-traveling.asp.
Karla tried to interest the Oklahoma cousins: Author’s interviews with Karla Hornstein, January 23, 2012, and Sharon DeMoe, December 3, 2012.
“There’s only one family like the DeMoes”: Author’s interview with William Klunk, September 12, 2011.
At the local drive-in, family friend Kim Johnston: Author’s interview with Kim Johnston, April 7, 2014.
he forgot to let go of the fishing line and nearly lost a finger: Author’s interview with Karla Hornstein, August 17, 2011.
The answer came soon enough, in February 2008: Author’s interview with Karla Hornstein, March 2, 2014.
Brian’s son, Yancey, later got rid of the cat: Author’s interview with Kassie Rose, August 23, 2011.
When he discovered that he wasn’t free to leave, he became enraged at Karla: Author’s interview with Karla Hornstein, March 2, 2014.
“He [was] still part of my life because of my children”: Author’s interview with Christy Holm, July 2012.
On one visit, a friend left the building to light a cigarette: Author’s interview with Karla Hornstein, March 2, 2014.
“I made a choice to live my life as normally as possible and leave it up to God”: Author’s interview with Kassie Rose, April 16, 2009.
“You know, you’re just carrying that huge weight on your shoulders”: Author’s interview with Yancey DeMoe, September 2, 2012.
But families of Alzheimer’s patients often look for clues to their future: Kosik and Clegg, The Alzheimer’s Solution, p. 20 (see chap. 3, n. 3).
“Hey,” Brian said. “I know you”: Author’s interview with Yancey DeMoe.
“I kind of knew my secret was safe with him”: Author’s interview with Kassie Rose, August 23, 2011.
SIXTEEN: THE BAPTISTS AND THE TAUISTS
The human body produces the amyloid precursor protein (APP) in several organs: “APP: Amyloid Beta Precursor Protein,” Genetics Home Reference, US National Library of Medicine, reviewed May 2012, published May 10, 2016. https://ghr.nlm.nih.gov/gene/APP.
In Alzheimer’s patients, something goes awry in the process: Shenk, The Forgetting, pp. 143–145 (see chap. 1, n. 7).
In the amyloid-versus-tau debate, Paul Aisen: Author’s interview with Paul Aisen, November 26, 2013.
For years, he was fascinated with the earliest stages of Alzheimer’s: Ibid.
Allen Roses of Duke University, who was famous for his 1992 discovery of apolipoprotein (ApoE) gene variants: Shenk, The Forgetting, p. 153; Natalie Angier, “Scientists Propose Novel Explanation for Alzheimer’s,” New York Times, November 9, 1993; Turna Ray, “Do We All Have Alzheimer’s Completely Wrong? This Man Says Yes,” Public Radio International, May 3, 2015.
“I can go into any cemetery and find a tombstone over a dead person”: Author’s interview with Eric Reiman, October 2012; Robert Finn, “Neuroscience Meeting to Feature Feisty Debate on Alzheimer’s Etiology,” Scientist, October 16, 1995.
ApoE is a gene that codes a protein: Topic sheet, “Genetic Testing,” Alzheimer’s Association.
The theory says E2 and E3 bind to tau: Angier, “Scientists Propose Novel Explanation.”
In addition to not stabilizing tau, they say it also appears to promote the buildup of beta-amyloid: Troy T. Rohn, “Proteolytic Cleavage of Apolipoprotein E4 as the Keystone for the Heightened Risk Associated with Alzheimer’s Disease,” International Journal of Molecular Sciences, July 14, 2014; S. Ye, “Apolipoprotein (Apo) E4 Enhances Amyloid Beta Peptide Production in Cultured Neuronal Cells: Apoe Structure as a Potential Therapeutic Target,” Proceedings of the National Academy of Sciences of the United States of America, December 20, 2005.
Reiman frames the amyloid-versus-tau debate with a colorful analogy: Author’s interview with Eric Reiman.
In 1988, he joined the local Alzheimer’s Association chapter in Phoenix, Arizona: Ibid.
he read a story in the Wall Street Journal about the discovery of the ApoE connection: Ibid.
Glucose, the main sugar in the blood, is the primary fuel that the brain uses for energy: Chun-Ling Dai, “Role of O-GlcNAcylation in Tau Pathology and Cognitive Function,” Research Foundation for Mental Hygiene, Inc., at New York State Institute for Basic Research Staten Island, New York, 2015; Samuel Henderson, “Targeting Diminished Cerebral Glucose Metabolism for Alzheimer’s Disease,” Drug Discovery World, summer 2013.
although some researchers believe impaired glucose uptake helped to form the tau tangles: Ying Liu et al, “Decreased glucose transporters correlate to abnormal hyperphosphorylation of tau in Alzheimer disease,” ScienceDirect, January 2008.
Reiman thought he could look at a couple of hundred E4 carriers over two years: Author’s interview with Eric Reiman.
“Over half of family caregivers become clinically depressed”: Ibid.
which often does not fully cover the cost of patient care: Cynthia Ramnarace, “The High Cost of Caring for Alzheimer’s Patients,” AARP Bulletin, October 18, 2010.
they still wouldn’t win FDA approval solely on that basis: Author’s interview with Eric Reiman.
Recent medical history was littered with examples: Ibid.
The FDA has a system in place: Fact sheet, “Accelerated Approval,” US Food and Drug Administration, updated September 15, 2014.
A British colleague sitting next to Reiman: Author’s interview with Eric Reiman.
Already, there were hints that the government would be open to that kind of flexibility: Ibid.
At the University of Rochester, Tariot built: Author’s interview with Pierre Tariot, October 2012.
SEVENTEEN: EXPELLED FROM EDEN
Though the decision to know her results was terrifying: Author’s interview with Jennifer DeMoe, July 2012.
even so, Alzheimer’s was one topic they rarely discussed: Author’s interview with Sheryl Grammer, January 24, 2012.
Their mother, Sharon, worried privately: Author’s interview with Sharon Bratton DeMoe, December 3, 2012.
her grandfather Rob and aunt bluntly told her she was making a mistake: Author’s interview with Leah Klobucher, January 2, 2013; author’s interview with Robin Harvey, August 30, 2012.
He didn’t see the value of Leah burdening herself with the disease: Author�
�s interview with Jason Klobucher, January 2, 2013.
Her father, a Type I diabetic since childhood, agreed: Author’s interview with Reed Alexson, January 31, 2013.
Jessica, Steve and Lori’s oldest daughter, immediately made plans: Author’s interview with Jessica McIntyre, August 15, 2012.
Dean, the brother he’d always emulated most, sat Jamie down for a heart-to-heart talk: Author’s interviews with Dean DeMoe, Chelsey Determan, July 2012.
Though Jamie had been stunned, Karla thought he took the news surprisingly well: Author’s interview with Karla Hornstein.
“The generation of six”: Author’s interview with Bill Klunk, September 12, 2011.
Chelsey knew Jamie DeMoe by reputation: Author’s interview with Chelsey Determan, July 2012.
A surgeon reconstructed his face: Author’s interview with Karla Hornstein.
The next time he went to Pittsburgh for his research visit, his results showed his cognitive decline had worsened: HBO documentary, The Alzheimer’s Project: The Supplementary Series.
The days were long for Doug and Gail: Author’s interview with Gail DeMoe, August 24, 2011.
Like Gail, Gary searched for ways to occupy his friend: Author’s interview with Gary Anderson, October 20, 2015.
Since Karla held power of attorney for her brother: Author’s interview with Karla Hornstein.
She called Steve: Author’s interviews with Karla Hornstein, Steve McIntyre.
When they drove back home from Tioga, Deb would often suggest: Author’s interview with Deb DeMoe, March 16, 2012.
Dean asked his closest friend, Monte Olson, for the same favor: Author’s interview with Monte Olson.
but it is a fairly common one among Alzheimer’s patients: Russell Powell, “Is Preventive Suicide a Rational Response to a Presymptomatic Diagnosis of Dementia?” Journal of Medical Ethics 40, issue 8, August 2014, pp. 511–512; Kosik and Clegg, The Alzheimer’s Solution, pp. 195–197 (see chap. 3, n. 3).
tests predicting the likelihood of Alzheimer’s are so rarely permitted outside of research studies: “Alzheimer’s Disease Genetics Fact Sheet—Genetic Testing,” Alzheimer’s Disease Education and Referral Center, National Institute on Aging.
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