PharmedOut Newsletter, July 2014

Recent Project News

  • On June 2nd, Dr. Fugh-Berman was interviewed for Al Jazeera, again regarding flibanserin (the "female Viagra") and whether FDA's refusal to approve it was due to gender bias toward women.
  • On June 10th, Dr. Fugh-Berman was quoted in ChemistryWorld's story on recent off-label marketing settlements with Pfizer and GlaxoSmithKline. She explained some of the ways pharmaceutical companies use off-label marketing, and said that because it is profitable, fines are simply incorporated "into the cost of doing business."
  • On June 14th, Dr. Fugh-Berman was quoted in this New York Times article on Botox, Allergan's "multipurpose blockbuster" and "marquee" drug. Allergan began "a kind of frequent-buyer program" offering rebates to doctors, but “incentivizing physicians to use a paralytic drug for a cosmetic condition is not advancing patient care," said Dr. Fugh-Berman.
  • We will miss Dr. Arnold Relman, an eloquent and influential critic of industry involvement in health care. Dr. Relman came to several PharmedOut conferences and was an inspiring presence to medical students and physicians. May his ideas live on!
  • PharmedOut's Resource of the Month: Did you know PharmedOut is on Facebook? "Like" us and get access to news and linked up with other advocates!
June's PharmedOut Fodder: What's In A Word?

Glowing language, even if it isn't exactly accurate, is often used when trying to sell a product. Dr. Oz was in the news this month for being slammed at a Senate hearing for using words like "miracle" and "magic" to describe green coffee bean extract, forskolin flower, and other “natural” weight loss products. Oz admitted these words were hyperbole, but implied they are important to motivating his audience. Many took issue with the fact that a trusted doctor was saying these things.

About that word “natural”. An article in USA Today notes that the word "natural" has a very positive connotation to consumers. A Consumer Reports survey found that "two-thirds of Americans think the word ... on the label of a packaged or processed food means it contains no artificial ingredients, pesticides or genetically engineered organisms." As USA Today explains, "under federal labeling rules, the word natural means absolutely nothing" — certainly not that the product is healthy or better for you.

It’s understandable why marketers favor words with expansively positive connotations, but why would a regulatory agency follow suit?  On June 13th, PharmedOut attended the "What Evidence is Essential for New Medical Products? Implications for Patients and Health Policy" conference sponsored by the American Association for the Advancement of Science, Brigham and Women’s Hospital/Harvard Medical School, and the National Center for Health Research. A presentation by Lisa Schwartz and Steven Woloshin of Dartmouth Medical School focused on marketing language; namely, the word "breakthrough". "Breakthrough" is used frequently not only in product promotion, but also in the FDA's own press releases. The word “breakthrough” may imply a product is innovative or superior; a more accurate view, the presenters said, is that benefits are uncertain when something is new.

Many consumers associate physicians and the FDA with specialized knowledge about drug safety. PharmedOut advises patients to do their own research, trust only healthcare providers who trust evidence, and edit out hyperbole when we hear it.


News Round-Up 
(for more, please follow @pharmed_out on Twitter!)

May 28: MarketWatch: "Trimel Receives FDA Approval for Natesto(TM) Nasal Gel to Treat Men with Low Testosterone"

June: Reader's Digest Magazine: "What Medication Do Most Men Not Need?" (adapted from this February 3, 2014 New York Times article)

June 2: Reuters: "Pfizer to pay $325 million in Neurontin settlement"

June 3: Fear and Loathing in Bioethics blog: "The Medtronic scandal that refuses to disappear

June 3: Huffington Post: "Shooting Stars, Hot Flashes and Feeling Sexy"

June 4: Medical Marketing & Media: "FDA and off-label uses: a balancing act"

June 4: State of California Department of Justice: "Attorney General Kamala D. Harris Secures $105 Million Multistate Settlement with GlaxoSmithKline

June 5: Medical Marketing & Media: "Study: sales rep limits reduce off-label prescriptions

June 5: CityIndex: "GSK agrees mis-promoting settlement"

June 6: WSJ Pharmalot: "A Case of Mistaken Identity? Glaxo Faces a Lawsuit Over Generic Liability"

June 9: NPR: "More And More, Young Women Are Being Diagnosed With ADHD"

June 9: NPR: "Taking Statins May Make People Less Physically Active"

June 10: WSJ Pharmalot: "Free Speech or Bribes? Feds Wrestle With Allergan Over Advice Given Docs

June 10: Bloomberg: "Italy to Fund Unapproved Use of Roche Drug to Cut Costs

June 10: AP: "Federal Views Diverge On Proper Use of Painkillers"

June 10: WSJ Pharmalot: "How Many? Novartis Says 10,000 Side Effect Cases Were Never Filed"

June 12: BMJ: "EMA policy on transparency is 'strikingly' similar to deal struck with drug company, say experts"

June 13: MarketWatch: "Baron and Budd Announces $177 Million Settlement for Seven States Against Avandia Manufacturer GlaxoSmithKline"

June 17: AP: "$1,000-A-Pill Sovaldi Jolts US Health Care System"

June 17: USA Today: "66% of consumers wrongly think "natural" means something"

June 18: The Atlantic: "Senators to Dr. Oz: Stop Promising Weight-Loss Miracles"

June 19: U.S. Food and Drug Administration: "FDA adding general warning to testosterone products about potential for venous blood clots"

June 20: ProPublica: "Medicare Billing Outliers Often Have Disciplinary Problems, Too"

June 21: The New York Times: "Dr. Arnold Relman, 91, Journal Editor and Health System Critic, Dies"

June 23: The Washington Post Wonkblog: "A reminder that not everyone loves more transparency for health-care prices"

June 23: NPR: "Pharmaceutical Companies Accuse Hospitals Of Misusing Discounts"

June 23: BBC: "Erin Brockovich calls for end to Bayer's Essure"

June 26: WSJ Pharmalot: "Lawmakers ask White House to Review FDA Rule for Generic Label Changes"


Check These Out!

July 18 & 19 – International Conference on Diabetes in Washington, D.C.

At the Physicians Committee for Responsible Medicine's International Conference on Diabetes, experts will share their latest insights on the causes of diabetes, the role of nutrition, and priorities for research. Continuing education credits are available for health care professionals; poster abstracts are also welcome. PharmedOut newsletter readers will receive a special rate of $50 off standard registration.

Make the "Prescriber Promise" to refuse pharmaceutical industry gifts, turn away drug reps at your office, and avoid participating in industry-funded events and research. Then proudly display our No Drug Reps certificate, available for download here.  


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