Transcript Why Should We Even Care?

A Shameless Critique of
Pharmaceutical Advertising
By:
Anthony Gonzalez, Chase Waddell, Michael Fimbres,
and Noah Oliver
Ad Campaigns
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Pharmaceutical advertising is everywhere
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Think about how many advertisements you
have seen this week
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How does this affect you?
What is Drug Advertising?
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Any form of media that introduces a
pharmaceutical to an audience
What Kinds of Advertising?
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DTC
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DETAILING
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Direct To Consumer
advertising.
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Advertising to doctors &
health professionals
Samples, pens,
conferences, notepads,
posters, etc.
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TV, radio, newspaper,
journals, billboards,
internet advertising
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Advertising Guidelines
Food and Drug Administration
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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 Guidelines
PhRMA’s Guidelines
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Companies should submit all new direct-to-consumer television
advertisements to the FDA before releasing them for broadcast.
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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.
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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.
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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?
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PhRMA
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The Pharmaceutical
Research and
Manufacturers of
America
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Trade organization
Who Is PhRMA?
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3M Pharmaceuticals
Abbott
Amgen Inc.
Amylin Pharmaceuticals, Inc.
Astellas Pharma Inc.
AstraZeneca LP
Bayer Corporation Pharmaceuticals
Division
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
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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
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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.
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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.
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Do you think Budweiser is advertised more
then the leading drug?
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How about Pepsi?
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$125 million in 2000
What about Nike’s entire advertising?
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$146 million in 2000
$78.2 million in 2000
In 2000, Vioxx = $160 million
www.theunadvertisedbrand.com
How Big Are Drug Ads?
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May 2005 Wall Street Journal Reported:
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Kaiser Family Foundation:
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$4.5 billion dollars spent on advertising to consumers
(DTC)
Only about 15% of total advertising “estimation”
90% of Americans have heard or seen ads
Fortune 1000 2005:
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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:
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Detailing accounts for 85% of the total advertising
budgets
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Which is about 25 Billion dollars
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50% of which is
The Details of Detailing
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Samples account for 50%
of the total expenditures of
detailing
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Doctors office and hospital
detailing ≈ 30%
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Medical Journals ≈ 3%
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Misc. ≈ 27%
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$7 billion to other things.
Conferences, etc.
Why Should We Even Care?
There be Dragons Here!
We Love Drugs!
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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
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1708: 1st Ad for Patent drug appears in Boston newspaper.
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1906: FDA established with Pure Food & Drugs Act
(response to rising addiction and horrible industry
practices…have we come far?)
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1938: Food, Drug and Cosmetic Act gives FDA authority
over labeling of drugs.
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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
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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
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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
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"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."
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Thomas Abrams in response to being asked what largest
misconception about DDMAC authority is. [3]
Fun Thoughts And Quirky
“Coincidences”
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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
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New campaigns required to submit for review, but no
enforcement power
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Can only send letters of warning
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After initial campaign, process is entirely voluntary
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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
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Where there is no enforcement, and big profits…one must
expect pirates
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2001: 10 American drug companies in Fortune 500 list
average profit margin of 18.5% of sales (now 15.8%) [2],[5]
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Median for all other 490 Companies was 3.3% of sales
(now 5.2%)
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2002: Net profit of 10 drug companies higher than all 490
companies combined
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CEO Bristol-Myers Squibb made $74,890,918 in 2001 with
additional $76,095,611 in stock options [2]
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That’s some serious booty!
Concerned Yet?
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As if profits aren’t large enough…
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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?
Loves America
Do you know how much more we pay?
Why?
Protects us from “terrorists.”
More Evil
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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 unresearched data to doctors?
Dorothy Hamill, doesn’t worry
about heart attacks on the ice.
Killing Diabetics
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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
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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
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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
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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!
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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]
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What is your doctor making his treatment choices
based on?
Frightening Encounters
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“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.”
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Author of “Hard Sell: the Evolution of Viagra Salesmen”
[13]
The World Just Keeps on Spinnin’ round,
While History Repeats…
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“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.”
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Marcia Angell, author of “The Truth about the Drug
Companies” [2]
Ad Consequences of Concern
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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
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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
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DTC causes consumers to ask for PhRMA drugs.
[18],[1]
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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
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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:
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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.
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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…”
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Marcia Angell, MD, New England Journal of Medicine
Consider This:
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How can something with
such a large conflict of
interest realistically promote
this?
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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
Meet Digger. He is the tiny yellow
fungus monster in Lamisil ads.
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In 2003, Digger infected a toenail,
after which a giant Lamisil tablet
appeared that rolled over Digger
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The FDA said this ad implied
"complete effectiveness for all or
most patients," when only 38% of
Lamisil patients in clinical trials were
cured.
DTC Advertising Study by the FDA
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In 2003, the FDA had found that DTC:
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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?
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Is acid reflux a disease?
Is ADD (Attention Deficit Disorder) a disease?
Is obesity a disease?
Is cancer a disease?
Credit the FDA
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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 popup as diseases.
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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
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Nexium is a drug for “acid
reflux disease.”
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Nexium is just as effective
as Prilosec, but Nexium is
7 times more expensive
(A “me-too” drug)
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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 doctorpatient 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
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Prices for the exact same drugs — made by the same
companies — are significantly lower in other countries, which
strictly control drug prices.
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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
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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
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From: “DOCTOR KNOWS BEST,”
To: “ITS MY DIME, I’LL ASK THE
QUESTIONS.”
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Roll of Advertising
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Aristocratic versus Egalitarianism
D-PR: MAIN POINTS
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Should the patient have a Legitimate
voice in their own healthcare? (Did you say
Autonomy?)
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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
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FDA Survey of 500 Physicians
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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
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Canadian Coalition says American ads are
Confusing. [2]
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Independent study of ads in ten US Magazines
from 1998-1999
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87% describe “benefit of medication in vague,
qualitative terms”.[2]
13% provided any evidence to support their claims.[2]
D-PR: DRUG CHOICE
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40% DTC budget spent on ten drugs
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Expensive
Long term
Large patient demographic
“me-too” drugs with safer/cheaper
predecessors
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Psychological and Neurological drugs
http://www.pharmacytimes.com/article.cfm?ID=338
D-PR: CONSUMER THOUGHTS
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FDA Consumer Survey
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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
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85% of total advertising budget goes to
detailing.[1]
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Abuses?
Detailing Regulation?
Samples?
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D-PR: Conclusions
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Effect of Both: Detailing and DTC
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Together move dialogue toward sales
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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,”
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Patient health always comes first!!
Questions?
Questions that Should Be
Considered
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Are DTC ads inducing consumers to press
their doctors for specific drugs?
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Are DTC ads appropriate to be directed at
children?
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Is the United States right to ban
pharmaceutical drugs from other countries?
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Are the ads leading to the inappropriate
clinical use of some drugs?
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Do DTC ads contain sufficient information on
the potential side effects of drugs?
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How much of the recent rise in drug spending
can be attributed to DTC advertising?
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Are doctors complying with such requests for
specific drugs?
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Are the ads driving consumers to desire
expensive new brand name drugs when less
expensive drugs might be better in some
cases?