December 2015 Newsletter

Recent Project News

  • On November 19th, Dr. Fugh-Berman was quoted in the Mashable article "Doctors are trying to ban pharmaceutical ads that drive up drug costs" discussing "disease branding," wherein drug companies create science-y names for everyday problems – like dubbing heartburn "gastroesophageal reflux disease" to promote Nexium and Prilosec.
  • Dr. Fugh-Berman's article in the National Women's Health Network's Women's Health Activist describes a study that found, again, that menopausal hormone therapy failed to benefit measures of cardiovascular health and cognition.
  • 227 prescriptions! That's how many flibanserin (Addyi) prescriptions were sold in the first 3 weeks the drug was on the market. That's a vanishingly small number (Viagra, in contrast, sold half a million prescriptions in its first month on the market). Just goes to show that those hordes of women clamoring for this pill were a fiction dreamed up by Addyi's marketers. And that PharmedOut, the National Women's Health Network, and the New View Campaign effectively educated prescribers and women that Addyi had questionable benefits and real risks – including sudden prolonged unconsciousness and severe drops in blood pressure.

Dr. Fugh-Berman promoting the National Women's Health Network's
"Pass on Addyi or Pass Out" campaign
at the Network's annual gala.

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December's PharmedOut Fodder:

Doctors Speak Out on DTC Advertising

In November, physicians at a meeting of the American Medical Association (AMA) voted in support of a ban of direct-to-consumer (DTC) drug advertising. AMA Board Chair-elect Patrice A. Harris said the vote "reflects concerns among physicians about the negative impact of commercially-driven promotions, and the role that marketing costs play in fueling escalating drug prices ... direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate."

DTC drug advertising is only allowed in two countries: New Zealand, since 1981, and the United States, since 1997. Although some print ads appeared in U.S. publications before then, FDA's new guidelines in 1997 effectively allowed for broadcasted pharmaceutical ads by implementing an “adequate provision” standard for risk information.

According to market research firm Kantar Media, television ads make up the majority of drug advertising ($2.8 billion out of $4.5 billion spent in 2014). Expenditures had dipped since 2006's peak of $5.4 billion, but 2014 represents the highest spend since that year.

It is essential to note that while the AMA is taking issue with DTC advertising, targeting the public through television, radio, and mainstream publications, Pharma spends much more on marketing to physicians — $24 billion in 2012. This has been primarily done through detailing (drug rep visits and promotions), free samples to physicians, and educational and promotional meetings. A relatively smaller fraction of $90 million was spent on print ads in medical journals.

Still, DTC advertising reaches a vast population and leads to major ROI. Online advertising has been most lucrative, with data showing a 5:1 ROI in past years. And the average American television viewer is said to watch up to nine drug ads a day, totaling 16 hours per year. A 2015 survey by Treato, a pharma analytics firm, found that 21% of respondents said they talk to a doctor about a drug or treatment after watching a TV ad, and an additional 5.8% suggest the treatment to someone else.

What is the likely outcome from the AMA vote? Thus far, pharmaceutical companies have successfully deflected calls for restrictions on marketing by citing their right to free commercial speech. One of the arguments made by DTC advertising proponents is that the ads promote provider-patient dialogue and strengthen their relationship. But ads are often inaccurate and may encourage overprescribing

A DTC advertising ban would require Congressional action. AMA certainly may have the clout needed to make a difference as the #2 lobbyist to Congress this year.

To avoid the Constitutionality argument of a full-out ban, more regulation may be a logical intermediate step. Rep. Jarrold Nadler (D-NY) introduced the Say No To Drug Ads Act, most recently in 2013, which would have amended the IRS Code to prevent drug companies from claiming tax deductions for the cost of DTC ads. Perhaps with the momentum of the AMA announcement and hopefully, their support, Rep. Nadler or another member of Congress will reintroduce this common-sense piece of legislation.

Check This Out!

Healthcare Triage is a YouTube channel series hosted by Aaron Carroll MD, of Indiana University Department of Pediatrics. In addition to producing videos on generics vs. brand name drugs, he explains healthcare policy, medical research, and answers other questions you may have about medicine, health, and healthcare.

News Round-Up

(For more, follow @Pharmed_Out on Twitter!)

November 30

Johnson & Johnson faces Oregon lawsuit over ‘phantom recall’ of Motrin by Ed Silverman (Stat Pharmalot)

November 24

Four in 10 say they know someone who has been addicted to prescription painkillers by Lenny Bernstein (Washington Post)

FDA Panel: BioMarin Muscular Dystrophy Drug Trials Didn’t Prove Effectiveness by Thomas M. Burton (Wall Street Journal)

November 23

F.D.A. Targets Inaccurate Medical Tests, Citing Dangers and Costs by Robert Pear (New York Times)

Risk of Off-Label Uses for Prescription Drugs by Sumathi Reddy (Wall Street Journal)

Bill for speeding drug approvals would have been costly for Alzheimer’s by Ed Silverman (Stat Pharmalot)

November 22

Pfizer and Allergan Reach $150 Billion Merger Deal by Michael J. de la Merced (New York Times)

November 20

Specialty drugs now cost more than the median household income by Carolyn Y. Johnson (Washington Post)

Novartis Admits To Valeant-like Pharmacy Scheme in $390 Million Settlement by Jen Wieczner (Fortune) 

November 19

The 21st Century Cures Act could be a harmful step backward by Susan F. Wood and Diana Zuckerman (Washington Post)

November 18

Doctors' Proposed Ban of Drug Ads Goes After Top Magazine Ad Category by Nathalie Tadena (Wall Street Journal)

November 17

AMA Calls for Ban on Direct to Consumer Advertising of Prescription Drugs and Medical Devices by AMA (press release)

The Female Libido Pill Is No Viagra by Anna Edney and Laura Colby (Bloomberg)

Companies ranked by drug trial transparency by AllTrials (press release)

November 16

Blacklisting Icahn: How Some Drug Companies Keep Out Activists by Miles Weiss (Bloomberg)

FDA nominee Robert Califf must prove his independence from industry by Ed Silverman (Stat Pharmalot)

It's payers vs. pharma and vice versa as Washington targets drug prices by Tracy Staton (FiercePharma)

November 14

Brand Name Placebos Are More Effective than Generic Placebos. For Real. by Healthcare Triage (video)

November 12

Drugmakers Kept One-Third of Trial Results Secret, Study Finds by Doni Bloomfield (Bloomberg)

Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012 by Jennifer E. Miller, David Korn, and Joseph S. Ross (BMJ)

November 11

Veterans drop hundreds of empty pill bottles in front of the White House by Perry Stein (Washington Post)

November 10

Meet the CEO waging war against 'absurd' drug prices (CNN Money)

November 9

Common Antibiotics Cause Arrhythmias, Death And Everything Else by Judy Stone (Forbes)

Payers: Forget specialty drug costs—generic prices are crushing our budgets, too by Nicole Gray (BioPhrma Dive)

Canadian Federal Scientists Can Now "Speak Freely" To The Media by Josh L. Davis (IFL Science)

November 6

Some Older Patients Are Treated Not Wisely, but Too Much by Paula Span (New York Times)

November 4

Senate launches investigation into drug pricing at ‘pharma bro’ company Turing, three others by Ariana Eunjung Cha (Washington Post)

November 3

Prescription Drug Use on the Rise as United States Gets Fatter by Melissa Bailey (Stat)

November 1

'60 Minutes' Blames The Pharmaceutical Industry For America's Heroin Epidemic by Matthew Herper (Forbes)

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