Overdosed America (52 page)

158
Daniel Troy, to be the FDA’s new chief counsel:
Michael, Kranish, “FDA Counsels Rise Embodies U.S. Shift,”
Boston Globe,
December 22, 2002.

158
the U.S. General Accounting Office (GAO):
U.S. General Accounting Office, “Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations,” October 2002. Viewed at http://www.gao.gov/new.items/d03177.pdf. Accessed January 7, 2003.

158
Special Investigations Division:
United States House of Representatives Committee on Government Reform—Minority Staff Special Investigations Division, January 2004. Accessed May 10, 2004, at http://www.house.gov/reform/min/pdfs_108_2/pdfs_inves/pdf_prescrip_drug_ad_enforcement_jan_29_rep.pdf.

159
Melody Petersen reported in the
New York Times
:
Melody Petersen, “Less Return in Marketing of Medicines, A Study Says,”
New York Times,
December 12, 2002.

159
reaching $3.2 billion:
Scott Hensky, “As Drug Ad Spending Rises: A Look at Four Campaigns,”
Wall Street Journal,
February 9, 2004.

159
drug industry profit margins have skyrocketed:
“Pharmaceutical Industry Ranks as Most Profitable Industry—Again,”
Public Citizen,
April 18, 2002.

159
American senior citizens have been taking bus rides:
David Gross, “Prescription Drug Prices in Canada: What Are the Lessons for the United States?” AARP, 2003. Viewed at http://www.aarp.org/international/Articles/a2003-07-11-ia-perspectives.html. Accessed October 7, 2003.

160
$350 million to $650 million worth of drugs:
Scott Hensley, “Drug Companies Cry ‘Danger’ over Imports,”
Wall Street Journal,
September 22, 2003.

160
FDA Commissioner Mark McLellan announced a new initiative:
“FDA Announces Initiative to Heighten Battle Against Counterfeit Drugs,”
FDA News,
July 16, 2003.

160
“Fakes in the Medicine Chest”:
Leila Abboud, Anne Wilde Matthews, and Heather Won Tesoriero, “Fakes in the Medicine Chest,”
Wall Street Journal,
September 22, 2003.

160
“Drug Companies Cry ‘Danger’ Over Imports”:
Hensley, op. cit.

161
New York Times
editorial:
“The Safety of Imported Drugs (Editorial),”
New York Times,
September 20, 2003.

161
The
New England Journal of Medicine
published a report in 2001:
G. R. Bernard, J.-L. Vincent, P.-F. Laterre, et al., “Efficacy and Safety of Recombinant Human Activated Protein C for Severe Sepsis,”
New England Journal of Medicine
344:699–709, 2001.

161
Xigris was “relatively cost-effective:
B. J. Braden, H. Lee, C. J. Doig, D. Johnson, C. Donaldson, “An Economic Evaluation of Activated Protein C Treatment for Severe Sepsis,”
New England Journal of Medicine
347:993–1000, 2001.

161
future of Xigris (and Eli Lilly) seemed bright:
David Shook, “A Shock to Lilly’s System?”
BusinessWeek online,
March 7, 2002.

161
less than a quarter of that:
Eli Lilly and Company Second Quarter Financial Review, July 24, 2003.

162
only one had been well enough:
“FDA Clinical Review, Drotrecogin Alfa (Activated), Xigris Approved: November 21, 2001.” Viewed at http://www.fda.gov/cder/biologics/review/droteli112101r1p2.pdf. Accessed on February 26, 2004.

162
the ultimate outcomes of the hospitalized patients:
Ibid.

162
PR firm developed a strategy:
Antonio Regaldo, “To Sell Pricey Drug, Eli Lilly Fuels a Debate Over Rationing,”
Wall Street Journal,
September 18, 2003.

162
charged with developing “national guidelines:
Liz Kowalczyk, “Rationing of Medical Care Under Study: Doctors Seeking Plan as Costs Soar,”
Boston Globe,
September 14, 2003.

163
manufacturer of the antidepressant Paxil, hired a PR firm:
Brendan I. Koerner, “Disorders Made to Order,”
Mother Jones,
July–August 2002. Viewed at http://www.motherjones.com/magazine/JA02/disorders.html. Accessed October 7, 2003.

164
CRP, can predict . . . a person’s risk of developing cardiovascular disease:
P. M. Ridker, R. Nader, L. Rose, et al., “Comparison of C-Reactive Protein and Low-Density Lipoprotein Cholesterol Levels in the Prediction of First Cardiovascular Events,”
New England Journal of Medicine
347:1557–1565, 2002.

164
the
Boston Globe
:
Anne Barnard, “Boston Researchers Call Protein Test Best Gauge of Heart-Disease Risk,”
Boston Globe,
November 14, 2002.

164
the
New York Times
:
Denise Grady, “Study Says a Protein May Be Better Than Cholesterol in Predicting Heart Disease Risk,”
New York Times,
November 14, 2002.

164
the
Washington Post
:
David Brown, “New Test for Risk of Heart Disease Study Shifts Focus from Cholesterol,”
Washington Post,
November 14, 2002.

164
Time
:
Alice Park, “Beyond Cholesterol: Inflammation Is Emerging as a Major Risk Factor—and Not Just in Heart Disease,”
Time,
November 25, 2002.

164
Newsweek
:
Anne Underwood, “In the News: A New Affair of the Heart,”
Newsweek,
November 25, 2002.

165
only slightly more than one (1.3) additional episode:
For a complete discussion of this issue see an article that I wrote about medical reporting for journalists: John Abramson, “Medical Reporting in a Highly Commercialized Environment,”
Nieman Reports,
Summer 2003. Viewed at http://www.nieman.harvard.edu/reports, 2003–2NRsummer/54-57V57N2.pdf. Accessed February 27, 2004. In the NEJM article’s absence of age- and risk factor–adjusted event-free survival rates, a reasonable approximation of the risk of the women with the highest 20 percent of CRP levels can be reconstructed from one of the graphs: The absolute risk of a cardiovascular event was 7 per 1000 for 20 percent of the women with the lowest CRP levels over the eight years of the study. Multiplying this by the adjusted relative risk of 2.3 for the 20 percent of women with highest CRP levels gives an approximate absolute risk of 16.1 per 1000 over eight years. The difference in absolute risk of developing cardiovascular disease between the women with the highest and lowest CRP levels is 16.1 minus 7, or about 9.1 per 1000 over an eight-year period.

165
less than one episode of cardiovascular disease:
The women with the highest CRP levels have about 2.3 cardiovascular events per 1000 each year, so a 40 percent reduction would mean 0.8 per 1000 fewer events per year.

166
207 medical news stories on television:
R. Moynihan, L. Bero, Ross-D. Degnan, et al., “Coverage by the News Media of the Benefits and Risks of Medications,”
New England Journal of Medicine
342:1645–1650, 2000.

166
Gloria Steinem:
Quoted in Barbara Seaman, “The Media and the Menopause Industry,” Fair.org, March–April 1997. Viewed at http://www.fair.org/extra/9703/hormone.html. Accessed November 24, 2003.

170
change the drain in his chest:
When the infection was not improving, I discussed Mr. Wilkins’s situation with a chest surgeon from one of the Boston teaching hospitals, an expert in the care of this kind of infection, wondering if there was perhaps a better treatment than our mutually tiresome modus operandi. The surgeon said that he could cut out the infected bone, but the risks would be significant and the recovery would be long. The discussion left me confident that we were doing the best that could be done. Conservative advice from a good surgeon, recommending less rather than more aggressive treatment, is almost always good advice.

171
five times more likely:
J. V. Tu, C. L. Pashos, C. D. Naylor, et al., “Use of Cardiac Procedures and Outcomes in Elderly Patients with Myocardial Infarction in the United States and Canada,”
New England Medical Journal
336(21):1500–1505, 1997.

171
75 percent higher per person:
“Health at a Glance,” op. cit. p. 59.

171
between Texas and New York state:
E. Guadagnoli, P. J. Hauptman, J. Z. Ayanian, et al., “Variation in the Use of Cardiac Procedures After Acute Myocardial Infarction,”
New England Medical Journal
333:573–578, 1995.

172
1998, more than half of our heart attack patients:
D. M. Cutler and M. McClellan, “Is Technological Change in Medicine Worth It?”
Health Affairs
20(5):11–29, 2001.

172
United States does three and a half times as many coronary angioplasties and coronary artery bypass surgeries:
“Health at a Glance,” op. cit.

172
United States has the third-highest death rate from coronary heart disease:
National Institutes of Health, “Morbidity and Mortality: 2002 Chartbook on Cardiovascular, Lung, and Blood Diseases,” p. 36. Viewed at http://www.nhlbi.nih.gov/resources/docs/02_chtbk.pdf.

173
in-hospital death rate for heart attacks:
Ibid, p. 31.

173
experience a significant decrease in mental capacity:
M. F. Newman, J. L. Kirchner, Phillips- B. Bute, et al., “Longitudinal Assessment of Neurocognitive Function After Coronary-Artery Bypass Surgery,”
New England Medical Journal
344(6):395–402, 2001. Possibly there will be less cognitive impairment with cardiac surgery done without cardiopulmonary bypass (“off-pump”), but initial studies show the problem to be about the same both ways.

174
neonatology services varies widely:
D. C. Goodman, E. S. Fisher, G. A. Little, et al., “The Relation Between the Availability of Neonatal Intensive Care and Neonatal Mortality,”
New England Medical Journal
346:1538–1544, 2002.

174
almost twice as many neonatologists and neonatal intensive care beds:
The United States has twice as many neonatal intensive care and intermediate care beds as Canada, yet the neonatal mortality rate (death within the first 28 days of life) is 27 percent higher in the United States than Canada (4.7 versus 3.7 deaths per 1000 live births). The comparability of infant mortality statistics between countries has been questioned because of variations in the recording of very premature babies as not live births or as live births and neonatal deaths. Health statistics from Canada and the United States show the same number of infant deaths occurring in the first day of life, suggesting similar patterns of resuscitation of extremely premature babies, and therefore that the infant mortality rates of the two countries are measuring the same way.

174
United States has the highest infant mortality:
“Health at a Glance: OECD Indicators 200s, Organisation for Economic Co-Operation and Development, 2003.” International comparisons of infant mortality are unreliable because some countries are more likely to attempt to resuscitate very low birth-weight babies (thus counting them as infant deaths instead of fetal deaths). Canada and the United States have similar patterns of resuscitation, yet the U.S. infant mortality rate is 30 percent higher (6.9 versus 5.3 deaths per 1000 births).

175
the billions of dollars these procedures generated:
H. M. Krumholz, “Cardiac Procedures, Outcomes, and Accountability,”
New England Medical Journal
336:1521–1523, 1997.

175
A major study (VANQWISH):
R. A. Lange and L. D. Hillis, “Use and Overuse of Angiography and Revascularization for Acute Coronary Syndromes,”
New England Journal of Medicine
388: 1838–1839, 1998.

175
fees paid by Medicare:
Liz Kowalczyk, “Heart Stent’s New Promise May Be Costly for Hospitals,”
Boston Globe,
February 2, 2003.

176
“One important explanation is money:
K. Grumbach, “Specialists, Technology and Newborns—Too Much of a Good Thing,”
New England Medical Journal
346(20):1574–1575, 2002.

176
country to implement just such a program:
S. Perry and M. Thamer, “Medical Innovation and the Critical Role of Health Technology Assessment,”
Journal of the American Medical Association
282:1869–1872, 1999.

176
most recently by a federal commission in 1994:
Ibid.

177
not pleased with government-sponsored guidelines:
B. H. Gray, M. K. Gusmano, and S. R. Collins, “AHCPR and the Changing Politics of Health Services Research,”
Health Affairs Web Exclusive,
June 25, 2003.

177
explained the controversy about back surgery:
Reed Abelson and Melody Petersen, “An Operation to Ease Back Pain Bolsters the Bottom Line, Too,”
New York Times,
December 31, 2003. In a laminectomy, bone is removed from the vertebrae above and below the compressed nerve, to make room for it to traverse through the spinal column. In a spinal fusion, bone is similarly removed, then metal rods are fixed to the vertebrae by metal screws to help “fuse” the two vertebrae together to add stability.

177
allegedly making illegal kickbacks:
Reuters, “Company News: Inquiry into Possible Kickbacks at Medtronic Unit,
New York Times,
September 9, 2003.