Overdosed America (51 page)

137
Air Force/Texas Coronary Atherosclerosis Prevention Study:
J. R. Downs, M. Clearfield, S. Weis, et al., “Primary Prevention of Acute Coronary Events with Lovastatin in Men and Women with Average Cholesterol Levels: Results of AFCAPS/TexCAPS,”
Journal of the American Medical Association
279:1615–1622, 1998.

138
At least 85 percent of the men in this study:
The first step: at least 85 percent of the men in the study had at least two major risk factors (all were over 45 years of age and 85 percent had an HDL cholesterol level of less than 40 mg/dL). The second step: the men in the study had an average age of 57, average total cholesterol of 221 mg/dL, average HDL cholesterol of 36 mg/dL, average systolic blood pressure of 138 mmHg. According to the Framingham Risk Score, these men had, on the average, a 16 percent risk of developing coronary heart disease over the next 10 years. Finally, all of the people in the study had LDL cholesterol levels of at least 130 mg/dL. The guidelines call for statin therapy in people with two or more major risk factors, a Framingham Risk Score of 10 percent or greater, and an LDL cholesterol of 130 mg/dL or higher (if the LDL cholesterol level does not respond to diet and exercise within three months).

138
“incremental cost per additional year:
NCEP Full Report, p. II-59.

139
statin therapy reduced risk for CHD in . . . women:
NCEP Full Report, p. II-3.

139
NCEP full report convincingly cites six references:
NCEP Full Report, p. II-5.

139
“There is no evidence from primary prevention trials:
J. M. E. Walsh and D. Grady, “Treatment of Hyperlipidemia in Women.”
Journal of the American Medical Association
274:1152–1158, 1995.

139
“Special Considerations for Cholesterol Management in Women (Ages 45–75)”:
NCEP Full Report, p. VIII-3.

140
“aggressive LDL-lowering therapy:
NCEP Full Report, p. II-32.

140
The table mentioned cites nine references:
NCEP Full Report, p. II-5.

141
average age was 51:
The Upjohn study was the only one that was difficult to find, having been completed in 1978, nine years before the first statin came on the market. S. B. Manuck, A. B. Mendelsohn, J. R. Kaplan, and S. H. Belle, “Cholesterol Reduction and Non-Illness Mortality: Meta-Analysis of Randomized Clinical Trials,”
British Medical Journal
322:11–15, 2001.

141
“The relationship between serum cholesterol:
NCEP Full Report, p. II-34.

141
total cholesterol is not significantly related to mortality:
Framingham Heart Study reported in 1993. See Kronmal, Cain, Ye, and Omenn, op. cit.

141
not even an increase in the risk of heart attack:
B. M. Psaty, C. D. Furberg, L. H. Kuller, et al., “Traditional Risk Factors and Subclinical Disease Measures as Predictors of First Myocardial Infarction in Older Adults: The Cardiovascular Health Study,”
Archives of Internal Medicine
159:1339–1347, 1999.

142
remains high in the elderly:
D. M. Lloyd-Jones, M. G. Larson, A. Beiser, and D. Levy, “Lifetime Risk of Developing Coronary Heart Disease,”
The Lancet
353:89–92, 1999.

142
average LDL cholesterol levels:
NCEP Full Report, p. II-39.

142
4S:
Scandinavian Simvastatin Survival Study Group, “Randomized Trial of Cholesterol Lowering in 444 Patients with Coronary Heart Disease: The Scandinavian Simvastatin Survival Study (4S),”
The Lancet
344(8934):1383–1389, 1994.

142
LIPID:
Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) Study Group, “Prevention of Cardiovascular Events and Death with Pravastatin in Patients with Coronary Heart Disease and a Broad Range of Initial Cholesterol Levels,”
New England Journal of Medicine
339:1349–1357, 1998.

142
CARE:
F. M. Sacks, M. A. Pfeffer, L. A. Moye, et al., “The Effect of Pravastatin on Coronary Events After Myocardial Infarction in Patients with Average Cholesterol Levels,”
New England Journal of Medicine
335(14):1001–1009, 1996.

143
4S:
Scandinavian Simvastatin Survival Study Group, op. cit.

143
CARE:
F. K. Welty, “Cardiovascular Disease and Dyslipidemia in Women,”
Archives of Internal Medicine
161(4):514–522, 2001.

143
LIPID:
Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) Study Group, op. cit.

144
The ALLHAT study:
The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group, “Major Outcomes in Moderately Hypercholesterolemic, Hypertensive Patients Randomized to Pravastatin vs Usual Care,”
Journal of the American Medical Association
288:2998–3007, 2002.

144
10,000 patients at high risk:
The study included people age 55 and older, with LDL cholesterol between 120 and 189 mg/dL, triglycerides lower than 350 mg/dL, who had hypertension and at least one other risk factor for coronary heart disease.

144
Wall Street Journal:
Ron Winslow and Scott Hensley, “Statin Study Yields Contrary Data,”
Wall Street Journal,
December 18, 2002. Many newspapers picked up the findings of the other part of the ALLHAT study, which showed that treatment of high blood pressure with inexpensive diuretics was as good as or better than treatment with much more expensive, newer drugs.

145
“Physicians might be tempted:
R. C. Pasternak, “The ALLHAT Lipid Lowering Trial: Less Is Less,”
Journal of the American Medical Association
288:3042–3044, 2002.

145
“financial disclosures”:
Dr Pasternak has served as a speaker for or on the speakers bureau for Merck, Merck/Schering-Plough, Kos, Pfizer, and Bristol-Myers Squibb/Sanofi; has served as a consultant to or on the advisory board for Merck, Pfizer Health Solutions, AstraZeneca, Kos, Johnson & Johnson–Merck, and Bristol-Myers Squibb/Sanofi; and has received a research grant from Merck-Medco.”

145
the PROSPER study:
J. Shepherd, G. J. Blauw, M. B. Murphy, et al., “Pravastatin in Elderly Individual at Risk of Vascular Disease (PROSPER): A Randomized Controlled Trial,”
The Lancet
360:1623–1630, 2002.

145 “
There is no evidence:
NCEP Full Report p. I–44.

145
“Carcinogenicity of Lipid-Lowering Drugs”:
Newman T. B., Hulley S. B., “Carcinogenicity of Lipid-Lowering Drugs,”
Journal of the American Medical Association,
275:55-60, 1996.

146
could take many years:
Bjerre L.M., LeLorier J., “Do Statins Cause Cancer? A Meta-Analysis of Large Randomized Clinical Trials,”
American Journal of Medicine,
: 110:716–723, 2001.

147
Dr. Scott Grundy:
Quoted in Thomas M. Burton and Chris Adams, “New Government Cholesterol Standards Would Triple Number of Prescriptions,”
Wall Street Journal,
May 16, 2001.

147
Dr. Walter Willett:
Naomi Aoki, “Drug Makers Influence Pondered Eye on U.S. Advice to Cut Cholesterol,”
Boston Globe,
May 31, 2001.

148
Morgan Stanley Dean Witter newsletter:
Jami Rubin and Andrew Baum, “Our Survey of the Statin Market Projects Strong Growth,”
Morgan Stanly Dean Witter U.S. Investment Perspectives,
March 21, 2001.

150
in 1981, the drug industry proposed:
M. S. Wilkes, R. A. Bell, and R. L. Kravitz, “Direct-to-Consumer Prescription Drug Advertising: Trends, Impact, and Implications,”
Health Affairs
19(2):110–128, 2000.

150
the FDA changed its rules:
U.S. General Accounting Office, “Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations,” October, 2002. p. 8.

151
nine prescription drug advertisements:
“Too Much Medicine?”
Post & Script,
Greater Glasgow Area Drug Percent Therapeutics Committee, Issue 20, July 2003.

151
increased 40-fold:
Richard Frank, Ernst R. Berndt, Julie Donohue, Arnold Epstein, and Meredith Rosenthal, “Trends in Direct-to-Consumer Advertising of Prescription Drugs,” Henry J. Kaiser Family Foundation, February 2002.

151
Christopher Lasch wrote in 1979:
Christoher Lasch,
The Culture of Narcissism: American Life in An Age of Diminishing Expectations,
New York: Warner Books, 1979, p. 137.

152
most heavily advertised prescription drug in the two years:
Frank, Berndt, Donohue, Epstein, and Rosenthal, op. cit.

152
advertising budget greater than that of Budweiser or Coca-Cola:
Jean K. Haddad, “The Pharmaceutical Industry’s Influence on Physician Behavior and Health Care Costs,”
San Francisco Medicine.
Viewed at http://www.sfms.org/sfm/sfm602a.htm. Accessed September 20, 2003.

152
New York Times Magazine
in 2001:
Stephen S. Hall, “Claritin and Schering-Plough: A Perfect Prescription for Profit,”
New York Times,
March 11, 2001.

153
Understanding how drug patents work:
For a complete discussion of drug patents and legal ploys, see Robin J. Strongin, “Hatch-Waxman, Generics, and Patents: Balancing Prescription Drug Innovation, Competition, and Affordibility,”
National Health Policy Forum,
June 21, 2002.

153
Schering-Plough was unsuccessful:
Reuters, “Schering-Plough Loses Claritin Patent Appeal,”
Forbes.com,
August 1, 2003.

153
take center stage in direct-to-consumer advertising was Vioxx:
Frank, Berndt, Donohue, Epstein, and Rosenthal, op. cit.

154
drugs that patients most frequently request:
“IMS Study: U.S. Physicians Responsive to Patient Requests for Brand-Name Drugs,”
IMSHealth.
Viewed at http://www.imshealth.com/ims/portal/front/articleC/0,2777,6599_3665_1003811,00.html. Accessed October 24, 2003.

154
ads provide an important educational service:
A. F. Holmer, “Direct-to-Consumer Prescription Advertising Builds Bridges Between Patients and Physicians,”
Journal of the American Medical Association
281:380–382, 1999.

154
only 13 percent of drug ads:
S. Woloshin, L. M. Schwartz, J. Tremmel, and H. G. Welch, “Direct-to-Consumer Advertisements for Prescription Drugs: What Are Americans Being Sold?”
The Lancet
358:1141–1146, 2001.

154
positive effects of lifestyle change:
M. S. Wilkes, R. A. Bell, and R. L. Kravitz, “Direct-to-Consumer Prescriptioni Drug Advertising: Trends, Impact, and Implications,”
Health Affairs
19(2):110–128, 2000.

154
Widespread public misconceptions:
Ibid.

155
drug companies capitalize on the public’s naïveté:
Woloshin, op. cit.

155
“We want to identify the emotions:
Quoted in Warren Ross, “Why Rubin-Ehrenthal Sticks Exclusively to DTC Accounts,”
Medical Marketing & Media,
1999. Viewed at http://www.cpsnet.com/reprints/1999/09/McCarren.pdf. Accessed October 14, 2003.

156
receive prescriptions for requested drugs 50 percent:
U.S. Food and Drug Administration, Center for Drug Evaluation and Research, “Attitudes and Behaviors Associated with Direct-to-Consumer Promotion of Prescription Drugs, Main Survey Results,” 1999. Viewed at http://www.fda.gov/cder/ddmac/dtctitle.htm. Accessed February 24, 2004.

156
prescribed requested drugs about three-quarters of the time:
B. Mintzes, M. L. Barer, R. L. Kravitz, et al., “Influence of Direct to Consumer Pharmaceutical Advertising and Patients’ Requests on Prescribing Decisions: Two-Site Cross-Sectional Survey,”
British Medical Journal
324:278–279, 2002.

156
prescribed requested drugs 80 percent of the time:
Phyllis Maguire, “How Direct-to-Consumer Advertising Is Putting the Squeeze on Physicians,”
ACP-ASIM Observer,
March 1999.

156
drug industry claims:
Holmer, op. cit.

156
four out of five family doctors:
M. S. Lipsky and C. A. Taylor, “The Opinions and Experiences of Family Physicians Regarding Direct-to-Consumer Advertising (Abstract),”
Journal of Family Practice
45:485, 1997.

157
media traditionally used to flog cars:
“Ads and Prescription Pads (Editorial),”
Canadian Medical Journal Association
169(5): 2003.

157
European Union voted in 2003:
R. Watson, “EU Health Ministers Reject Proposal for Limited Direct to Consumer Advertising,”
British Medical Journal
326:1284, 2003.

157
11 days after the 1997 rule change:
FDA Letter to Schering Corporation, August 19, 1997. Viewed at http://www.fda.gov/cder/warn/aug97/5738.pdf. Accessed February 26, 2004.

157
number of letters citing drug companies:
“Comments of Public Citizen,” Docket No. 02N-0209, October 28, 2002. Viewed at http://citizen.org/publications/release.cfm?ID= 7214. Accessed February 28, 2004. And FDA, “Center for Drug Evaluation and Research, Warning Letters and Untitled Letters to Pharmaceutical Companies, 2003.” Viewed at http://www.fda.gov/cder/warn/warn2003.htm. Accessed February 2, 2004.