A Shameless Critique of

Pharmaceutical Advertising

By:Anthony Gonzalez, Chase Waddell, Michael Fimbres,

and Noah Oliver

Ad Campaigns

Pharmaceutical advertising is everywhere

Think about how many advertisements you have seen this week

How does this affect you?

What is Drug Advertising?

Any form of media that introduces a pharmaceutical to an audience

What Kinds of Advertising?

DTC

Direct To Consumer advertising.

TV, radio, newspaper, journals, billboards, internet advertising

DETAILING

Advertising to doctors & health professionals

Samples, pens, conferences, notepads, posters, etc.

Advertising GuidelinesFood and Drug Administration

Information must be accurate and not misleading Make claims only when supported by substantial

evidence Reflect a balance between risks and benefits Be consistent with FDA approved labeling Internet ads have no restrictions

http://www.asthma.com Not official legislation

Advertising GuidelinesPhRMA’s Guidelines Companies should submit all new direct-to-consumer television advertisements

to the FDA before releasing them for broadcast.

DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised.

DTC television and print advertising should be designed to achieve a balanced presentation of the benefits and risks associated with the advertised prescription medicine.  Specifically, risks and safety information in DTC television advertising should be presented in clear, understandable language, without distraction from the content, and in a manner that supports the responsible dialogue between patients and health care professionals.

Companies should spend an appropriate amount of time to educate health professionals about new medicines or new therapeutic indications before beginning the first direct-to-consumer advertising campaign.  In determining “an appropriate time,” companies should consider the importance of informing patients of the new medicine, the complexity of its risk-benefit profile, and health care professionals’ knowledge of the condition being treated.  Companies should continue to educate health care professionals as additional valid information about a new medicine is obtained from all reliable sources.

So Who Is Doing It?

PhRMA The Pharmaceutical

Research and Manufacturers of America

Trade organization

Who Is PhRMA? 3M Pharmaceuticals Abbott Amgen Inc. Amylin Pharmaceuticals, Inc. Astellas Pharma Inc. AstraZeneca LP Bayer Corporation Pharmaceuticals Di

vision Berlex Laboratories, Inc. Boehringer Ingelheim Pharmaceuticals

, Inc. Bristol-Myers Squibb Company Cephalon, Inc. Daiichi Pharmaceutical Corporation Genzyme Corporation GlaxoSmithKline Hoffmann-La Roche Inc. Johnson & Johnson

Eli Lilly and Company Merck & Co., Inc. Millennium Pharmaceuticals, Inc. Novartis Pharmaceuticals Corporation Organon USA Inc. Otsuka America, Inc. Pfizer Inc The Procter & Gamble Company Purdue Pharma L.P. sanofi-aventis Schering-Plough Corporation SCHWARZ PHARMA, INC. Sepracor, Inc. Serono, Inc. Solvay Pharmaceuticals, Inc. Valeant Pharmaceuticals International Wyeth Wyeth Research

PhRMA’s Purpose

PhRMA's mission is winning advocacy for public policies that encourage the discovery of life-saving and life enhancing new medicines for patients by pharmaceutical/biotechnology research companies.

To accomplish this mission, PhRMA is dedicated to achieving in Washington, D.C., the states and the world: 1. Broad patient access to safe and effective medicines through a

free market, without price controls; 2. Strong intellectual property incentives, and; 3. Transparent, efficient regulation and a free flow of information

to patients.

So How Big Are Drug Ads?

Questions Posed.• Do you think Budweiser is advertised more

then the leading drug?• $146 million in 2000

• How about Pepsi?• $125 million in 2000

• What about Nike’s entire advertising?• $78.2 million in 2000

• In 2000, Vioxx = $160 million www.theunadvertisedbrand.com

How Big Are Drug Ads?

May 2005 Wall Street Journal Reported: $4.5 billion dollars spent on advertising to consumers

(DTC) Only about 15% of total advertising “estimation”

Kaiser Family Foundation: 90% of Americans have heard or seen ads

Fortune 1000 2005: All 9 of the Fortune 500 pharmaceutical companies are in

PhRMA. 12 PhRMA companies are in the Fortune 1000 25% of PhRMA in Fortune 500, 33% in Fortune 1000

Where is the Free Stuff?

DETAILING: Detailing accounts for 85% of the total advertising

budgets

Which is about 25 Billion dollars

50% of which is

The Details of Detailing Samples account for 50%

of the total expenditures of detailing

Doctors office and hospital

detailing ≈ 30%

Medical Journals ≈ 3%

Misc. ≈ 27%

$7 billion to other things.

Conferences, etc.

Why Should We Even Care?

There be Dragons Here!

We Love Drugs!

World pharmaceuticals sales totaled more than $550,000,000,000 in 2005

US share was $235.4 billion That’s 43%! US population ~300 million Europe pop. alone ~720 million Wait a minute… DTC is now only legal in the US

Look Mom, Narcotics!

Brief History of Regulations: Old Timer Days 1708: 1st Ad for Patent drug appears in Boston newspaper.

1906: FDA established with Pure Food & Drugs Act (response to rising addiction and horrible industry practices…have we come far?)

1938: Food, Drug and Cosmetic Act gives FDA authority over labeling of drugs.

1962: Kefauver-Harris drug amendment gives control of promotions for drugs to FDA instead of FTC. [1]

Brief History of Regulations:It Gets Nasty In Our Lifetimes 1960-1980: Drug Sales Static 1981: Drug industry begins pressuring FDA to allow

advertising to consumers Regan Administration Pro-Business Bayh-Dole Act (NIH Grant Findings Patentable) Hatch-Waxman Act (patent life extension) 1985: FDA approves DTC under current regs…the lobbyist

score a victory 1980-2000: Drug Sales Tripled 8 yrs, 1980; 14 yrs, 2000 Still, in 1997 industry claims regulations too strict; they are

relaxed

FDA-DDMAC

Division of Drug Marketing, Advertising, and Communications

Headed by Thomas Abrams Former Marketing and Sales Manager at

Merck 35 staffers (overworked) Average 53,000 promotional items per year 6 per employee per day. [3]

DDMAC Incapable of Monitoring Industry "We get complaints from consumers and physicians

who call us up and say, ‘Tom, how can you allow that TV ad to be on?’ … They're flabbergasted when we say, 'We didn't approve it before it went on TV.' Often, we're seeing it at the same time as the American public. DDMAC has limited resources and we use our limited resources as effectively as we can to do our job."

Thomas Abrams in response to being asked what largest misconception about DDMAC authority is. [3]

Fun Thoughts And Quirky “Coincidences”

Former Merck marketing manager is making calls on Fed regulation of drug company marketing.

Former Republican Representative Billy Tauzin (now president of PhRMA) is heading the drug company pressure group

So the government is in industry, and the industry is in government. Hmm…they should have lunch!

Tauzin was on both the subcommitee for health, and for commerce, trade and consumer protection.

This is by far not the only case of conflicting interests in government. Just one of the most lucrative.

Compliance with DDMAC Reg’s Voluntary New campaigns required to submit for review, but

no enforcement power

Can only send letters of warning

After initial campaign, process is entirely voluntary

There is almost no governmental oversight [1], [3], [4]

But Don’t Worry!

Who’s Needs Fed Intervention Anyway?

High Stakes and the Watchman is Asleep

Where there is no enforcement, and big profits…one must expect pirates

2001: 10 American drug companies in Fortune 500 list average profit margin of 18.5% of sales (now 15.8%) [2],[5]

Median for all other 490 Companies was 3.3% of sales (now 5.2%)

2002: Net profit of 10 drug companies higher than all 490 companies combined

CEO Bristol-Myers Squibb made $74,890,918 in 2001 with additional $76,095,611 in stock options [2]

That’s some serious booty!

Concerned Yet?

As if profits aren’t large enough… In 2005 PhPRM approved, then abandoned, a plan to pay

$100,000 to have a book written about terrorists who kill unsuspecting American consumers by poisoning imported Canadian drugs. [6]

Cheaper to re-import drugs rather than pay high prices here, PhRMA wanted their money back. [2]

Remember how much of the world’s drugs we consume? Do you know how much more we pay? Why?

Protects us from “terrorists.”

Loves America

More Evil

Merck initially spent $100 million annually when originally released Vioxx for promotion [7]

Possibly contributed to 27,000 heart attack deaths Warnings given before initial release of drug, with

researches specifically asking for more trials [8] As of yesterday, lawsuits are climbing all over

country [9]

Were the drug representatives emphasizing that un-researched data to doctors?

Dorothy Hamill, doesn’t worry about heart attacks on the ice.

Killing Diabetics

2000: Johnson & Johnson subsidiary LifeScan plead guilty to marketing faulty blood glucose monitors

Agreed to pay $60 million in fines Company concealed over 2,700 complaints from

customers from Feds 1998: Feds raid corporate headquarters Company aware of defect prior to marketing 61 hospitalized [10]

So easy, even a child can kill themselves by relying on it!

Endangering Children

TRICARE users from USAF had their children (4,000) vaccinated with diluted antigens.

“Unnamed pediatric supplier” for government admitted to knowing of the fraud.

66% of children were not properly immunized against Hep-B. [11]

Profit motive?

Philisophical Question:

What are you informed about with respect to your healthcare, and what do you believe?

Are these drug advertisements increasing your knowledge base, personally?

The families in the USAF did not believe investigators when 1st informed of faulty vaccinations, prompted testing for immunity [11]

Money Laundering Dr.’s and PhRMA TAP pharmaceuticals distributed free samples of

Lupron to doctors through representatives [11], [2]

Rep’s instructed to encourage doctors to charge for the free samples…and they did

Laundered kickbacks through detailing structure. TAP admitted guilt and paid $854 million in 2000 Fraud carried across private sector and military

health providers. TRICARE federal investigators key in detecting fraud structure. [11]

FDA?

Screw the Poor and Old, Daddy Needs a New Escalade Of the top 100 Federal False Claim Act

settlements, drug companies took 9 (From $14 – $875 million settlements.)

TAP, Abbott Labs, AstraZeneca, Bayer (2x), GlaxoSmithKline, Pfizer, Johnson & Johnson (2X)

Hospitals defrauded the federal government most

Oil companies came in 3rd. Qui tam (15-30% of settlements.) Fed’s solution

to lack of regulation. [12]

Those Drug Rep’s Have Such Nice…Sales Figures!

Spirited Sales Leaders, rep recruiters Attempts to require a science degree for reps shot

down Norvartis lawsuit claiming rep was encouraged to

use sexual favors to increase sales 12 out of 13 female reps report sexual harassment

[13]

What is your doctor making his treatment choices based on?

Frightening Encounters

“In an interview, Mr. Reidy remembered a sales call with the "all-time most attractive, coolest woman in the history of drug repdom." At first, he said, the doctor "gave ten reasons not to use one of our drugs." But, Mr. Reidy added: "She gave a little hair toss and a tug on his sleeve and said, 'Come on, doctor, I need the scrips.' He said, 'O.K., how do I dose that thing?' I could never reach out and touch a female physician that way.” Author of “Hard Sell: the Evolution of Viagra Salesmen”

[13]

The World Just Keeps on Spinnin’ round, While History Repeats…

“The industry is also being hit with a tidal wave of of government investigations and civil and criminal lawsuits. The litany of charges includes illegally overcharging Medicaid and Medicare, paying kickbacks to doctors, engaging in anticompetitive practices, colluding with generic companies to keep generic drugs off the market, illegally promoting drugs of unapproved uses, engaging in misleading direct-to-consumer advertising, and, of course, covering up evidence.” Marcia Angell, author of “The Truth about the Drug

Companies” [2]

Ad Consequences of Concern

Rising drug prices Decreased innovation (profit motive) Lack of proper testing (profit motive) Decreased scientific authority Narrowed treatment options International spill over

Rising Drug Prices Due to Ad

PhRMA says no. Economists say yes. This is so convoluted and scattered that I

won’t insult your intelligence with subjecting you to the painfully enormous body of lies.

This is what happens when business tries to argue with science, there is no objectivity or cooperation.

Start at Google, and you’ll see what I mean.

Double Edged Sword: Marketing Trap

DTC causes consumers to ask for PhRMA drugs. [18],[1]

Detailing convinces doctors to provide PhRMA drugs. [19]

This closed circle marketing approach is no accident.

In theory and empirically, it has proven quite profitable. [20]

The concern is that this bind keeps treatment options to a bare, and possibly inefficient minimum.

Research now suggests it also leads to inappropriate prescribing of at least COX-2 inhibitors. [21]

International Spill Over

EU had a 5 yr pilot project proposed, but rejected in 2003. [15]

Only US and New Zealand Allow DTC. New Zealand has had a moratorium on DTC

since 2004 due to lack of evidence for public good. Scheduled to ban DTC in 2006. [16],[18]

Canada is resisting, but US pressure is causing concern. [17]

Structure of NIH grants for R&D attracting foreign firms, possible decline in innovation on global scale. [2]

A Poignant Finish to Get You Patriots Looking:

Are you good Americans? Did you buy your Paxil? In Oct (that’s 1 month after Sep)

2001, GlaxoSmithKline (Brit Owned) launched a new ad campaign for Paxil.

“Millions suffer from chronic anxiety, millions could be helped by Paxil.”

Exclusively in the New York Times Magazine. [22]

What Are Some Ethical Considerations That Should Be Made?

What is it to Advertise?(from dictionary.com)

ad·ver·tise  v.

ad·ver·tised, ad·ver·tis·ing, ad·ver·tis·es v. tr.

To make public announcement of, especially to proclaim the qualities or advantages of (a product or business) so as to increase sales.

Drug Ads Have a Direct Conflict of Interest

“[T]o rely on the drug companies for unbiased evaluations of their products makes about as much sense as relying on beer companies to teach us about alcoholism…”

Marcia Angell, MD, New England Journal of Medicine

Consider This:

How can something with such a large conflict of interest realistically promote this?

Bottom line:There is no justification for DTC because consumers can’t obtain prescription drugs without a prescription

Artwork making fun of televangelist Peter Popoff. Popoff accurately stated home addresses and specific illnesses audience members. He said this was due to divine revelation, which many people believed.

Misuse of Advertising That is Initially “Overlooked” by the FDA In 2003, Digger infected a toenail,

after which a giant Lamisil tablet appeared that rolled over Digger

The FDA said this ad implied "complete effectiveness for all or most patients," when only 38% of Lamisil patients in clinical trials were cured.

Meet Digger. He is the tiny yellow fungus monster in Lamisil ads.

DTC Advertising Study by the FDA In 2003, the FDA had found that DTC:

Increases awareness of treatments Risks and benefits of prescription drugs are not equally

understood by patients Patients don’t read summary in print ads unless interested

in the advertised drug Patients still use doctors as the #1 source for information

about a drug or treatment Brand-specific requests made by patients are likely to be

accommodated Patient attitudes toward DTC are becoming less positive

over time (perhaps we all need Zoloft)

Ethics of the FDA

Taken from the FDA’s official website:

“Stated most simply, FDA's mission is to promote and protect the public health by helping

safe and effective products reach the market in a timely way,

to monitor products for continued safety after they are in use, and

to help the public get the accurate, science-based information needed to improve health.”

Yet, the FDA fails in many of these aspects solely by some of the current ads being advertised.

What is a Disease?

Is acid reflux a disease? Is ADD (Attention Deficit Disorder) a

disease? Is obesity a disease? Is cancer a disease?

Credit the FDA

Federal law states that any product (except a device) intended for the diagnosis, prevention, or cure of disease is subject to regulation as a drug. The FDA enforces this law.

Notice how conveniently more and more things pop-up as diseases. Acid reflux is now a disease. ADD is now a disease. Obesity is a now disease. Cancer is now a disease.

The Push for Drugs; Ads

Nexium is a drug for “acid reflux disease.”

Nexium is just as effective as Prilosec, but Nexium is 7 times more expensive (A “me-too” drug)

This is a direct result of advertising

The Purple Pill

From the Nexium Website:

Why should someone need a guide to go see the

doctor? How is the doctor-patient relationship being

affected by DTC?

How Can This Be Ethical?

Inflating Drug Costs

• 1990: Average prescription drug cost is $45.79

• 2000: Average prescription drug cost is $65.29

• Prices for retail drugs increased more than three times the inflation rate from 1998 to 2000

Influence of Other Countries

Prices for the exact same drugs — made by the same companies — are significantly lower in other countries, which strictly control drug prices.

U.S. Law: U.S. government officials have stated that individuals who order prescription drugs from Canada or other foreign sources (up to 90 day quantities) for their own use are not being pursued or prosecuted. However, it is technically not legal to order prescription drugs from abroad.

Some Interesting Facts About DTC Commercials….When talking about the side-effects, common

discouraging things include: the readability is more difficult between benefits

(sixth grade reading level) vs. side-effects (ninth grade reading level)

the location along with the size of print is made harder to see

the speed at which things are read is faster up-beat music and visuals usually compliment

Problems With DTC

It becomes more normal for someone to be on a prescription drug

Increases the “pill for everything” feel, promoting drugs over diet and exercise

Skews research priorities Drives up the cost of drugs Promotes newer drugs which are less safe Interferes with doctor-patient relationship

The Doctor-Patient Relationship (D-PR)

D-PR: OVERVIEW

From: “DOCTOR KNOWS BEST,” To: “ITS MY DIME, I’LL ASK THE QUESTIONS.”

Roll of Advertising Aristocratic versus Egalitarianism

D-PR: MAIN POINTS Should the patient have a Legitimate

voice in their own healthcare? (Did you say

Autonomy?) Roll of advertising

Does DTC improve health delivery?

D-PR: DTC MISSION “DTC communication about pharmaceutical products

enables consumers to take a hands-on interest in their own healthcare.”[5]

“DTC advertising not only informs consumers, it motivates them to contact their doctors, engage in thoughtful dialogue about health concerns, and receive appropriate treatment.”[5]

D-PR: Some Factoids

FDA Survey of 500 Physicians 73% said patient asked “thoughtful questions”

because he/she had seen a DTC medication ad.[4]

41% said “beneficial [because] it resulted in better discussion about treatment.” [4]

Results Positive?

D-PR: AD QUALITY

Canadian Coalition says American ads are Confusing. [2]

Independent study of ads in ten US Magazines from 1998-1999 87% describe “benefit of medication in vague,

qualitative terms”.[2]

13% provided any evidence to support their claims.[2]

D-PR: DRUG CHOICE

40% DTC budget spent on ten drugs Expensive Long term Large patient demographic “me-too” drugs with safer/cheaper predecessors

Psychological and Neurological drugs

http://www.pharmacytimes.com/article.cfm?ID=338

D-PR: CONSUMER THOUGHTS FDA Consumer Survey

58% said ads “make drug seem better than they are.” [4]

21% said ads “very clear.”[4]

–www.bcbst.com/.../docs/4_prescriptions.shtm

D-PR: DETALING

85% of total advertising budget goes to detailing.[1]

Abuses? Detailing Regulation? Samples?

D-PR: Conclusions

Effect of Both: Detailing and DTC Together move dialogue toward sales

The Pharmaceutical Four-Way Education good, but doctor still knows

best….or do they? Patient ≠ Consumer Autonomy (Who’s got the bag??) DTC Positive if executed “ethically,”

Patient health always comes first!!

Questions?

Questions that Should Be Considered

Are DTC ads inducing consumers to press their doctors for specific drugs?

Are DTC ads appropriate to be directed at children?

Is the United States right to ban pharmaceutical drugs from other countries?

Are the ads leading to the inappropriate clinical use of some drugs?

Do DTC ads contain sufficient information on the potential side effects of drugs?

How much of the recent rise in drug spending can be attributed to DTC advertising?

Are doctors complying with such requests for specific drugs?

Are the ads driving consumers to desire expensive new brand name drugs when less expensive drugs might be better in some cases?