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