Pharmaceutical Company Pharmaceutical Company Control of the Control of the Information Information EnvironmentEnvironment

Adriane Fugh-Berman MDAdriane Fugh-Berman MDGeorgetown UniversityGeorgetown University

Institute for Teaching and Research on Institute for Teaching and Research on Women, Towson UniversityWomen, Towson University

March 9, 2007March 9, 2007

DrugsDrugs

Can save lives and improve Can save lives and improve health …when used health …when used appropriatelyappropriately

FDA approves drugs for FDA approves drugs for specific indications specific indications

Risks are balanced against Risks are balanced against benefits benefits

All drugs have risksAll drugs have risks

New drugs are more New drugs are more riskyrisky Over 25 years, 1 in 5 new Over 25 years, 1 in 5 new drugs was withdrawn or drugs was withdrawn or acquired a black box warningacquired a black box warning

Half of these changes Half of these changes occurred within two years of occurred within two years of approval approval Lasser et alLasser et al. JAMA 2002;287(17):2215. JAMA 2002;287(17):2215

Use of drugs by Use of drugs by elderselders More than 90% of persons More than 90% of persons ≥65 ≥65 years old used a least one years old used a least one medication per weekmedication per week

More than 40% used at least 5 More than 40% used at least 5 medications per weekmedications per week

12% used at least 10 medications 12% used at least 10 medications per weekper week

Kaufman DW. JAMA 2002;287:337Kaufman DW. JAMA 2002;287:337

Pharmaceutical company Pharmaceutical company promotionpromotion Encourages demand for the Encourages demand for the newest, most expensive drugsnewest, most expensive drugs

Most new drugs are me-too drugs, Most new drugs are me-too drugs, or combinations of old drugsor combinations of old drugs

New drugs are not necessarily New drugs are not necessarily betterbetter

In general, generic drugs are In general, generic drugs are safer than branded drugs simply safer than branded drugs simply because we know more about thembecause we know more about them

Pharma and EducationPharma and Education

Pharmaceutical companies fund Pharmaceutical companies fund many “educational” efforts many “educational” efforts

Disease awareness campaigns Disease awareness campaigns are meant to expand are meant to expand populations eligible for populations eligible for treatmenttreatment

Promotion ensures that the Promotion ensures that the newest, most expensive drugs newest, most expensive drugs are the best-known therapies are the best-known therapies

Drug CostsDrug Costs

In 2002, average expenses for Rx drugs $1,100 per person (75% higher than 1997)– average out-of-pocket expenses for prescription drugs were about 50% higher than in 1997 (CDC)

In 2004, $188.5 billion was spent on In 2004, $188.5 billion was spent on Rx drugs Rx drugs – Drug costs constitute 10.7% of health Drug costs constitute 10.7% of health care expenditures care expenditures (GAO)

ADR Frequency by Drug ADR Frequency by Drug UseUse

0

10

20

30

40

50

60

0-56-1011-1516-20Number of Number of

MedicationsMedications

Frequency

Frequency

(%)

(%)

May FE. Clin Pharmacol Ther 1977;22:322-8. Slide courtesy of Kaim Calis, NIH

The costs of The costs of promotionpromotion In 2000, total promotion In 2000, total promotion cost for Rx drugs was almost cost for Rx drugs was almost $16 billion$16 billion– About $5 billion spent on About $5 billion spent on detailingdetailing

For comparison, the 2007 NIH For comparison, the 2007 NIH budget is $29 billion budget is $29 billion

What drug reps costWhat drug reps cost

Between 1995 and 2005, the number of Between 1995 and 2005, the number of drug reps in the US increased from drug reps in the US increased from 38,000 to 100,000 38,000 to 100,000

Pharmaceutical companies spend Pharmaceutical companies spend $150,000 annually per primary care rep $150,000 annually per primary care rep and $330,000 per specialty rep*and $330,000 per specialty rep*

Average annual income for a drug rep Average annual income for a drug rep is $81,700 ($62,400 plus $19,300 is $81,700 ($62,400 plus $19,300 bonuses)**bonuses)**

*Med Ad News 2004;23(3):1; ** Pharm Exec 2005 (January)

Promoting the Promoting the profitableprofitable There are more than 10,000 There are more than 10,000 drugs in the US drugs in the US pharmaceutical marketpharmaceutical market

More than half of More than half of promotional expenditures are promotional expenditures are concentrated on the top-concentrated on the top-selling 50 drugsselling 50 drugsMa J et al. Clin Ther Ma J et al. Clin Ther

2003;25(5):1503-172003;25(5):1503-17

Docs vs. RealityDocs vs. Reality

Studies consistently show Studies consistently show that promotion increases that promotion increases prescribing *prescribing *

Studies consistently show Studies consistently show that physicians do not that physicians do not believe that promotion believe that promotion affects prescribing**affects prescribing***Chren MM et al. JAMA 1994 Mar 2;271(9):684-9; Lurie N et

al. J Gen Int Med 1990;5:240-243; Wazana A. JAMA 2000 Jan 19;283(3):373-80.**Sigworth SK et al. JAMA. 2001;286(9):1024-5.McKinney WP et al. JAMA 1990;264(13):1693-7.

Meetings:Meetings:Pharma controls CMEPharma controls CME In 2004, more than half of the $2 In 2004, more than half of the $2 billion dollars spent on CME came billion dollars spent on CME came from pharmaceutical manufacturers from pharmaceutical manufacturers

Medical Education and Medical Education and Communication Companies (MECs) Communication Companies (MECs) launder money for pharmalaunder money for pharma– 75% of their income is from firms that 75% of their income is from firms that manufacture FDA-regulated productsmanufacture FDA-regulated products

Medical schools are just as badMedical schools are just as bad– Pharma provides almost two thirds Pharma provides almost two thirds (63.8%) of CME income to medical (63.8%) of CME income to medical schools (ACCME) schools (ACCME)

Advertising in Advertising in medical journalsmedical journals

5 of 6 physician organizations 5 of 6 physician organizations raised at least 10% of annual raised at least 10% of annual revenue from advertising in revenue from advertising in affiliated medical journalsaffiliated medical journals

More than 95% of ads in JAMA are for More than 95% of ads in JAMA are for Rx drugsRx drugs

Pharma companies also purchase Pharma companies also purchase “sponsored” subscriptions “sponsored” subscriptions

And are the largest purchaser of And are the largest purchaser of reprintsreprintsFugh-Berman A, Alladin K, Chow J. PLoS Medicine 2006;3(6):e130

What about R&D costs?What about R&D costs?

Between 1970 and 2005, Between 1970 and 2005, research and development research and development accounted for between 8.5% accounted for between 8.5% and 17. 3% of salesand 17. 3% of sales (PhRMA (PhRMA Annual Membership survey 2006)Annual Membership survey 2006)

Pharma spends 3 times as Pharma spends 3 times as much on marketing as it much on marketing as it does on researchdoes on research

DTCADTCA

In the first half of 2006, In the first half of 2006, $2.47 billion was spent on $2.47 billion was spent on DTCA in the U.S.*DTCA in the U.S.*

Advertising leads to more Advertising leads to more requests for advertised requests for advertised medicines**medicines**

DTCA does not benefit DTCA does not benefit healthcare quality † healthcare quality † **Thomaselli R. Advertising Age, 77(43):8.Thomaselli R. Advertising Age, 77(43):8.**Mintzes et al. CMAJ 2003; 169(5): 405. **Mintzes et al. CMAJ 2003; 169(5): 405. ††Gilbody et al. Qual Saf Health Care Gilbody et al. Qual Saf Health Care 2005;14:246-250.2005;14:246-250.

Beware of websites Beware of websites and webpads…and webpads… Your doc’s website may be a Your doc’s website may be a present from Pharmapresent from Pharma– Information is collectedInformation is collected

Pharmaceutical company websites Pharmaceutical company websites can use information you submit can use information you submit to market products to youto market products to you

Filling out forms on a webpad Filling out forms on a webpad sends info back to sponsoring sends info back to sponsoring companycompany

Pharma knows youPharma knows you

About three fourths of About three fourths of pharmacies sell prescribing datapharmacies sell prescribing data

Insurers sell data as wellInsurers sell data as well The data is combined to The data is combined to reconstruct your medical historyreconstruct your medical history

Your name isn’t on this materialYour name isn’t on this material Why is this useful? Why is this useful?

Menopausal hormone Menopausal hormone therapytherapy Hormones have long been promoted Hormones have long been promoted for health promotion, disease for health promotion, disease prevention, and aging reversal prevention, and aging reversal

Hormones first used as anti-Hormones first used as anti-aging therapy in men in the late aging therapy in men in the late 19th century 19th century

““While not all women are affected by While not all women are affected by menopause to this extreme degree, no menopause to this extreme degree, no woman can be sure of escaping the woman can be sure of escaping the horror of this living decay.” horror of this living decay.”

“The mental depression typical of so many menopausal women can be avoided by early treatment and often alleviated even in obstinate cases. Difficult family situations can often be wholly remedied by estrogen therapy for the woman involved.”

Feminine Forever Feminine Forever Robert A Wilson MD, M Evans 1966/1968Robert A Wilson MD, M Evans 1966/1968

“Menopausal symptoms, such as weakening of the bones, dowager's hump, gastro-intestinal disorders, heart trouble, hardening of the arteries, atrophy of the breasts and sexual organs, disturbed vision, wrinkling of the skin, pains in the joints, etc, can be avoided by premenopausal therapy and often cured by post-menopausal therapy.”

Feminine Forever,p 159

 

JAMA July 1, 1968; 205(1):8

In the last 20 years In the last 20 years HT has been promoted HT has been promoted for: for: YouthfulnessYouthfulness Osteoporosis prevention and Osteoporosis prevention and treatmenttreatment

Cardiovascular disease Cardiovascular disease preventionprevention

Prevention of dementiaPrevention of dementia Prevention and treatment of Prevention and treatment of incontinenceincontinence

Mood disordersMood disorders

In RCTs…In RCTs…

HT has not benefitedHT has not benefited– MoodMood– IncontinenceIncontinence– CVDCVD– DementiaDementia

HT does benefitHT does benefit– Hot flashesHot flashes– Vaginal drynessVaginal dryness– Fracture riskFracture risk

Bidil: Race-based Bidil: Race-based medicinemedicine Two older drugs: hydralazine Two older drugs: hydralazine and isosorbide nitrateand isosorbide nitrate

1986 Vasodilator Heart 1986 Vasodilator Heart Failure Trial (VHeFT1) showed Failure Trial (VHeFT1) showed H/IN to be slightly better H/IN to be slightly better than placebothan placebo

1991 VHeFt2 showed that an 1991 VHeFt2 showed that an ACE inhibitor was superiorACE inhibitor was superior

Sifting old dataSifting old data

Reanalysis of VHefT2 showed Reanalysis of VHefT2 showed a benefit of H/IN for some a benefit of H/IN for some African Americans African Americans

2004: African American Heart 2004: African American Heart Failure Trial (AHEFT) showed Failure Trial (AHEFT) showed that adding H/IN to standard that adding H/IN to standard therapy for CHF improved therapy for CHF improved outcomesoutcomes

Is Bidil better?Is Bidil better?

No study designed to look at No study designed to look at outcomes in African-American outcomes in African-American patients has compared Bidil patients has compared Bidil directly with standard therapy directly with standard therapy for CHFfor CHF

AHRQ metaanalysis of 3 RCT found AHRQ metaanalysis of 3 RCT found no difference in mortality no difference in mortality between African Americans and between African Americans and Caucasians using ACE inhibitorsCaucasians using ACE inhibitors

Bidil sets a bad Bidil sets a bad precedentprecedent Promotion of Bidil as African-Promotion of Bidil as African-American drug may cause docs to American drug may cause docs to prescribe it alone…prescribe it alone…

And avoid it in others who might And avoid it in others who might benefitbenefit

There is more variability within a There is more variability within a racial/ethnic population than racial/ethnic population than between populationsbetween populations

Data-dredging of failed studies may Data-dredging of failed studies may now be expectednow be expected

Disease-mongeringDisease-mongering

Diseases have been invented Diseases have been invented or their incidence or or their incidence or importance exaggeratedimportance exaggerated

Risk factors have been Risk factors have been turned into diseases turned into diseases

There are more well people There are more well people than there are sick peoplethan there are sick people

Recommended BooksRecommended Books

Abramson, John. Overdo$ed AmericaAbramson, John. Overdo$ed AmericaAngell, Marcia. The truth about the Angell, Marcia. The truth about the drug companiesdrug companiesAvorn, Jerry. Powerful medicinesAvorn, Jerry. Powerful medicinesDavid, Healy. Let them eat ProzacDavid, Healy. Let them eat ProzacDavid, Healy. The antidepressant era David, Healy. The antidepressant era Elliott, Carl. Better than wellElliott, Carl. Better than wellGoozner, Merrill. The $800 million pillGoozner, Merrill. The $800 million pillKassirer, Jerome P. On the takeKassirer, Jerome P. On the takeMoynihan, Ray. Selling SicknessMoynihan, Ray. Selling SicknessMundy, Alicia. Dispensing with the Mundy, Alicia. Dispensing with the truthtruthReidy, Jamie. Hard SellReidy, Jamie. Hard SellWashburn, Jennifer. University, IncWashburn, Jennifer. University, Inc

OrganizationsOrganizations No Free Lunch nofreelunch.org No Free Lunch nofreelunch.org Healthy Skepticism healthyskepticism.orgHealthy Skepticism healthyskepticism.org Health Care Renewal hcrenewal.blogspot.comHealth Care Renewal hcrenewal.blogspot.com National Women’s Health Network National Women’s Health Network women’shealthnetwork.orgwomen’shealthnetwork.org

Our Bodies Ourselves ourbodiesourselves.orgOur Bodies Ourselves ourbodiesourselves.org GoozNews gooznews.comGoozNews gooznews.com PharmaWatch PharmaWatch pharmawatch.blogspot.com Center for Science in the Public Interest Integrity Center for Science in the Public Interest Integrity in Science Project Integrityinscience.orgin Science Project Integrityinscience.org

American Medical Student Association amsa.org American Medical Student Association amsa.org Health Action International haiweb.orgHealth Action International haiweb.org

PharmedOut.orgPharmedOut.org

Funded by the Attorney Funded by the Attorney General Prescriber and General Prescriber and Consumer Education Grant Consumer Education Grant ProgramProgram

News, resources, film clips, News, resources, film clips, slideshows, pharma-free CME, slideshows, pharma-free CME, and eventually modules on and eventually modules on pharmaceutical promotion pharmaceutical promotion