OVERDO$ED AMERICA

The Commercialization of American Medicine

Part II

American Medicine’s Perfect Storm• History: HMOs

• Patients become

Consumers

• Backlash

• The Diminishing Role of

Primary Care Doctors

• Drugging the Watchdogs

Drugging the Watchdogs

• FDA used to move at a “glacial pace” in the drug approval process

• 1992 PDUFA (Prescription Drug User Fee Act)

• Approval process drops from median of 20 month wait to average 6 months

• Number of new drugs approved doubles

Rezulin• FDA approves Rezulin despite concerns of

tendency to cause liver inflammation• Dr. John Gueriguan (19 year veteran of FDA)

objects and is removed from approval process• February 1997-Rezulin approved in U,S.• December 1997- Rezulin withdrawn in UK due to

liver toxicity• March 2000—U.S finally withdraws after

suspected 391 deaths and 400 cases liver failure

The Commercial Takeover of Medical Knowledge

• Prior to 1970 most funding was NIH– very few medical studies sponsored by Drug Companies

• Government money

began to dry up• Shift in funding to drug and biotech

industries– reaching 80% by 2002• Corporate funding ensures that research design

will be geared towards favorable product results

Trust in Peer Reviewed Journals

• Medical students are taught to trust research in respected peer-reviewed journals

• Journals enable MDs to keep current with new developments

• Who needs a defibrillator?

• Is there a monetary value on life?

• Studying the wrong population

• Aricept• Premature end to

study when results do not support your product

• As an example: Covera vs. Older cheaper drugs

Tinkering with Dosages

• Patent about to expire on Prilosec

• AstraZeneca made slight chemical change and doubled the dose

• Research question “was Nexium 40mg more effective than Prilosec 20mg

• Cost of Nexium- $4.90 per dose

• Cost of Prilosec—one eighth as much

Comparing Something with Nothing

• Post knee replacement study

• Two random groups

• One was given Oxycontin, the other was given a placebo

• Who would you guess got more relief?

The Snake and the Staff

• Free lunches & gifts• Trips to tropical

paradises• Drug advertising in

Medical Journals—• Conflict of interest?

Antidepressants

• Studies actually show that newer antidepressants are no more effective than older tricyclics such as Elavil

• In fact, they were only 10% more effective than placebos!

So ladies and gentlemen, throw away your Prozac!

CME Continuing Medical Education

• Required to maintain Medical Licenses• Drug Companies seek doctors who can

influence other doctors, often leaders in their field

• Much medical education now comes from Drug Companies in the form of “Lunch and Learn”

• Purdue Pharma gave one million to Massachusetts General in return for using a Purdue-designed curriculum.

Smoking Gun

• Link between cholesterol and

heart disease

• Actual study done correlates higher cholesterol with an increased risk of death from CHD only through age 60.

• The correlation does not extend beyond age 70

• Based on Framingham Study begun 1948

WOSCOPS Study

• Statin vs Placebo• 100 men would have to take Pravachol for two full years in order to prevent a single heart

attack @ a cost of $336,000 for the drugs alone• In order to prevent a single death, they would have to take it for five years.

Direct to Consumer Marketing

• 1985 FDA allowed DTC but with strict rules

• 1997 restrictions loosened only side effects and contraindications had to appear in the ad itself

• 1994-2000—the number of ads increase 40 fold

Selling Health and Happiness

• Can be achieved by using the right drugs

• Drugs are necessary for health and happiness

• Two out of five ads attempt to medicalize ordinary life issues

• Americans who have less education find drug ads more credible than those who have more education.

DTC

• Disempowers the doctor-patient relationship

• Increase in patient demands for specific drugs and tests

• Only New Zealand (pop 4 million) allows DTC.

• 2003 European Union continues to ban DTC

• DTC ads in U.S. $3.2 billion a year in 2003

The End

• Many thanks to Kyra Psaroudis without whose assistance this project would not have been possible.