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A Shameless Critique of Pharmaceutical Advertising By: Anthony Gonzalez, Chase Waddell, Michael Fimbres, and Noah Olive

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?.

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A Shameless Critique of Pharmaceutical Advertising By: Anthony Gonzalez, Chase Waddell, Michael Fimbres, and Noah Olive

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  1. A Shameless Critique of Pharmaceutical Advertising By: Anthony Gonzalez, Chase Waddell, Michael Fimbres, and Noah Oliver

  2. Ad Campaigns • Pharmaceutical advertising is everywhere • Think about how many advertisements you have seen this week • How does this affect you?

  3. What is Drug Advertising? • Any form of media that introduces a pharmaceutical to an audience

  4. DTC Direct To Consumer advertising. TV, radio, newspaper, journals, billboards, internet advertising DETAILING Advertising to doctors & health professionals Samples, pens, conferences, notepads, posters, etc. What Kinds of Advertising?

  5. Advertising Guidelines Food 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

  6. Advertising Guidelines PhRMA’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.

  7. So Who Is Doing It? • PhRMA • The Pharmaceutical Research and Manufacturers of America • Trade organization

  8. 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 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 Who Is PhRMA?

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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.

  14. There be Dragons Here! Why Should We Even Care?

  15. 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!

  16. 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]

  17. 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

  18. 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]

  19. 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]

  20. 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.

  21. 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]

  22. But Don’t Worry! Who’s Needs Fed Intervention Anyway?

  23. 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!

  24. 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? Loves America Protects us from “terrorists.”

  25. 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.

  26. 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!

  27. 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?

  28. 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]

  29. 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?

  30. 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]

  31. 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?

  32. 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]

  33. 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]

  34. 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

  35. 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.

  36. 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]

  37. 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]

  38. 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] A Poignant Finish to Get You Patriots Looking:

  39. What Are Some Ethical Considerations That Should Be Made?

  40. ad·ver·tisev. 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. What is it to Advertise?(from dictionary.com)

  41. 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

  42. 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.

  43. 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.

  44. 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)

  45. 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.

  46. What is a Disease? • Is acid reflux a disease? • Is ADD (Attention Deficit Disorder) a disease? • Is obesity a disease? • Is cancer a disease?

  47. 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.

  48. 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

  49. Why should someone need a guide to go see the doctor? How is the doctor-patient relationship being affected by DTC? From the Nexium Website:

  50. How Can This Be Ethical?

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