Selling Snake Oil: Direct-to Consumer Advertising

James G. Anderson, Ph.D.

Purdue University

Ask Your Doctor!One evening on CBS News

Condition Drug

Restless Leg Syndrome Requip

Heartburn

(Acid Reflux Disease)

Zantac

Allergies Nasonex

Hemorrhoids Preparation H

Pain Advil

Sleeplessness Ambien

Allergies Benadryl

Back Pain Thermacare

Medicalization

Defining a problem as a medical illness or a disorder requiring medical intervention to treat it.

Expansion of Medical Jurisdiction

Child birth Menopause Sexual Dysfunction Anxiety Childhood Behavior Heartburn or Indigestion Post Traumatic Stress Disorder Obesity Hair Loss Short Stature

Engines of Medicalization

Medical Profession Special Interest Groups Commercial and Market Interests

The Pharmaceutical Industry

Passage of the Food and Drug Modernization Act 1997 allows for a wider usage and promotion of off-label uses of drugs and facilitated direct-to-consumer advertising

Spending on direct-to-consumer advertising increased from $1.1 billion in 1997 to $4.5 billion in 2006.

The FDA sent only 15 warning letters to drug companies regarding ads in 2005 and 22 in 2006.

Sexual Dysfunction

In March 1998 the FDA approved Viagra as a treatment for erectile dysfunction (ED). “Ask your doctor if Viagra is right for you.”

Sales were sensational! The first year 3 million men were treated with Viagra translating into $1.5 billion in sales. By 2003, 6 million men were taking Viagra and sales rose to $1.7 billion

Sexual Dysfunction

With the introduction of Levitra and Cialis the drug industry estimates the potential market for these drugs to be 30 million men in the U.S. alone.

The drug industry has expanded the notion of ED and has begun to encourage the use of these drugs as an enhancement to sexual pleasure and relationships.

Anxiety

Prozac was introduced in 1987 as an antidepressant. Paxil was approved by the FDA in 1996 to treat “Social Anxiety Disorder (SAD)” and “Generalized Anxiety Disorder (GAD)”

Marketing diseases and then selling drugs to treat them is now common. The tag line is “Imagine being Allergic to People.”

Paxil is now the prescription drug that is number six in sales amounting to $2.1 billion in 2001.

Children’s Behavior Problems

Children’s problems constitute a growing market for psychotropic drugs.

Ritalin in particular is being prescribed to treat attention deficit hyperactivity disorder (ADHD).

Spending on behavior drugs for children and adolescents rose 77% from 2000 to 2003.

These drugs are now the fastest growing type of medication taken by children eclipsing aqntibiotics and asthma treatment.

Short Stature

Synthetic human growth hormone became available in 1985 to treat a rare hormonal disorder.

Genentech began to market the off-label use of their drug, Protropin, for children who were short but had no growth hormone deficiency.

This market has grown since the FDA approved the use of Eli Lilly’s drug, Humatrope, for use with short-statured children in the lowest 1.2% of the population.

The Future

A private market for enhancements for children exists.

Biotechnology companies will work to increase the size of this market.

The promotion and use of biomedical enhancements will increase medicalization of human problems.

The New Drug Epidemic

2.1 million teenagers are abusing prescription drugs that they obtain from other teens and adults (e.g., Adderall, Ritalin, Oxicontin)

The Human Body

Cosmetic surgery from tummy tucks to liposuction to nose jobs to breast augmentation have become big medical business.

Between 1960 and 1990 there were 2 million women who received silicone breast implants. In 2003 alone, 280,401 breast augmentations were performed in the U.S.

Overall 8.3 million Americans had cosmetic medical procedures in 2003, a 20% increase from the previous year and a 277% increase since 1997.

Tummy Tuck

Price ListSurgery With Airfare Without Airfare

Breast Augmentation

$5,000-4,500 $4,500-4,000

Breast Reduction $4,750 $4,250

Liposuction

(3 area)

$4,500 $4,000

Tummy Tuck $5,500 $5,000

Blepharoplasty $3,800 $3,300

Nose Surgery $4,500 $4,000

Obesity

The number of gastric bypass surgeries in the U.S. has risen from 20,000 in 1965 to a projected 144,000 in 2004.

Bypass operations are becoming an increasingly common way to treat problems of overweight. The recent Medicare policy shift declaring obesity as a disease will further expand the number of procedures performed.

Lapband

Hawking other Health Productscaveat emptor!

Diet products Herbal products Hearing Aids Wheel chairs

Power Chair Jazzy 1170

Arguments for DTC Advertising DTCA serves an important physician and

patient education function that raises their awareness of new conditions leading to greater detection, diagnosis, and treatment

Patients are empowered to seek the best available treatment for their conditions

In some instances, the patient may be better informed than their physician

DTCA stimulates the patient to discuss their condition and treatment with their physician

DTCA is free speech and is protected by the U.S. Constitution

Arguments for DTC Advertising

DTCA stimulates the patient to discuss their condition and treatment with their physician

DTCA is free speech and is protected by the U.S. Constitution

Arguments against DTC Advertising DTCA raises health care costs by stimulating

consumers to demand more expensive new drugs and products (e.g.. Celebrex at $188/mo. vs. ibuprofen at $18/mo.)

Pressure from patients erodes physicians’ authority and may lead to inappropriate prescribing

Ads may be misleading and promote inappropriate use. Education should not be left primarily to private companies promoting their products.

Arguments against DTC Advertising The FDA should require a waiting period of two

years from the time a drug is approved until the drug can be promoted throuugh DTCA

Advertising leads to early heavy use of new drugs before their long term safety has been ascertained (e.g., VIOXX,HRT)

Among the 10 drugs most heavily advertised to consumers, many are deemed less essential medications by the WHO.

Concerns

Pharmaceutical and biotechnology companies are having an increasing impact on what is considered normal or pathological. This is worrisome since these companies are primarily responsible to their shareholders and not to their patients. Shareholder desires are frequently at odds with patients' needs.

The U.S. health care system has been reshaped from an enterprise focused on the health of the people to just another market place like fast food prducts, automobiles, etc.

Engines that Drive Medicalization

Biotechnology Consumers Managed Care