3/23/2015 Vying for Market Share, Companies Heavily Promote ‘Me Too’ Drugs ­ ProPublica

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Vying for Market Share, Companies Heavily Promote ‘Me Too’DrugsOur comprehensive analysis of drug company spending on doctors in the last five months of 2013 shows the most­promoted productstypically were not cures, breakthroughs or top sellers.

by and ProPublica, Jan. 7, 2015, 3 p.m.

Charles Ornstein Ryann Grochowski Jones

(David Sleight/ProPublica)

This story was co­published with the New York Times' .The Upshot

For more than five decades, the blood thinner Coumadin was the only option for millionsof patients at risk for life­threatening blood clots. But now, a furious battle is underwayamong the makers of three newer competitors for the prescription pads of doctors acrossthe country.

The manufacturers of these drugs —, and — have

been wooing physicians in part bypaying for meals, promotionalspeeches, consulting gigs andeducational gifts. In the last fivemonths of 2013, the companies spentnearly $19.4 million on doctors andteaching hospitals, according toProPublica's analysis of federal datareleased last fall.

Pradaxa Xarelto Eliquis

The information, from a databaseknown as Open Payments, gives thefirst comprehensive look at how much

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Běģįňňįňģ įň 2014, țħě fěđěřǻŀ ģǿvěřňměňțmǻňđǻțěđ țħǻț pħǻřmǻčěųțįčǻŀ ǻňđ měđįčǻŀđěvįčě mǻňųfǻčțųřěřș pųbŀįčŀỳ řěpǿřț țħěįřpǻỳměňțș țǿ đǿčțǿřș ǻňđ țěǻčħįňģħǿșpįțǻŀș. Ųșě țħįș țǿǿŀ țǿ șěǻřčħ fǿř ǻčǿmpǻňỳ, đřųģ ǿř đěvįčě — ǻňđ čǿmpǻřě įțțǿ ǻňǿțħěř. Ěxpŀǿřě țħě ǻpp

Dollars for DoctorsHow Industry Money Reaches Physicians

3/23/2015 Vying for Market Share, Companies Heavily Promote ‘Me Too’ Drugs ­ ProPublica

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money drug and device companies havespent working with doctors. What itshows is that the drugs mostaggressively promoted to doctorstypically aren't cures or even bigmedical breakthroughs. Some are topsellers, but most are not.

Instead, they are newer drugs thatmanufacturers hope will gain afoothold, sometimes after failing tomeet Wall Street's early expectations.

"They may have some unique niche inthe market, but they are fairlyredundant with other therapies that arealready available," said Dr. JosephRoss, an associate professor ofmedicine and public health at YaleUniversity School of Medicine. "Manyof these, you could call me­too drugs."

In almost all cases, older, cheaperproducts are available to treat the same conditions. Companies typically try todifferentiate the new drugs by claiming they are easier to use; carry fewer side effects;work faster than competitors; or have medical advantages.

The makers of Pradaxa, Xarelto and Eliquis, for example, say their drugs are at least aseffective as Coumadin for certain conditions but do not require routine blood tests orlimitations on what patients can eat. (Patients taking Coumadin, also known as warfarin,shouldn't eat grapefruit or cranberries and have to limit green leafy vegetables in theirdiet.)

Officials at the Centers for Medicare and Medicaid Services, which administers OpenPayments, and the Pharmaceutical Research and Manufacturers of America, the drugindustry trade group, said they had not analyzed the data in order to rank spending bydrug.

When told of ProPublica's analysis, John Murphy, PhRMA's assistant general counsel,said drug makers' spending should be seen not only as a marketing strategy, but also as away of ensuring the best treatment options for patients. "On paper, a drug may not looklike it is monumentally better than another drug, but to an individual patient, it mightbe," Mr. Murphy said.

According to ProPublica's analysis, , a diabetes medication made by NovoNordisk, was the drug associated with the most payments to doctors, by dollar amount.The company spent more than $9 million on physician interactions related to Victoza inthe last five months of 2013, excluding research payments and royalties, which relatemore to drug development than marketing. (ProPublica that lets you lookup any drug, device or company and compare it with any other.)

Victoza

created a tool

Victoza, through a once­a­day injection, helps lower blood sugar among diabetics, butresearchers and advocacy groups have said drugs of its class carry an increased risk ofthyroid cancer and pancreatitis. Dr. Todd Hobbs, chief medical officer of Novo Nordiskin North America, said the company's spending reflected Victoza's newness and the needto address such safety concerns.

"We just received a huge amount ofinterest and questions and need foreducation," Hobbs said, referringto inquiries by health careprofessionals, particularly primarycare doctors. "You see the fruits ofthat in this report."

(Ŀěňǻ Ģřǿěģěř, Řỳǻňň Ģřǿčħǿẅșķį Jǿňěș,Čħǻřŀěș Ǿřňșțěįň ǻňđ Mįķě Țįģǻș, PřǿPųbŀįčǻ)

20 Đřųģș Țħǻț Čǿmpǻňįěș Ǻřě Pǻỳįňģ țħě Mǿșț țǿ Přǿmǿțě

Below is a list of drugs for which companies spent the most on interactions with physicians and teachinghospitals in the last five months of 2013. These totals exclude royalty payments and research, which arerelated to drug development. FDA alerts and warnings may relate to a product’s side effects or concernsabout its marketing.

Drug Year Use General FDA Alerts &

3/23/2015 Vying for Market Share, Companies Heavily Promote ‘Me Too’ Drugs ­ ProPublica

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Eliquis, the anticoagulant jointlymarketed by Bristol­Myers Squibband Pfizer, ranked second in itslink to spending on physicians,with nearly $8 million, ouranalysis showed. In a statement,the companies said their spendinghelps ensure physiciansunderstand the appropriate use ofEliquis. Because the drug isprescribed by physicians indifferent specialties, the statementsaid, "it is critical to have a speakerprogram that adequately providesrobust education to thesephysicians."

The drug associated with the third­most payments to doctors was

, a different type of bloodthinner made by AstraZeneca thatvies for sales with Plavix, which isnow available generically. In anemail, AstraZeneca said it hadidentified Brilinta as one of its "keyplatforms for growth" andincreased speaker and researchspending on it. "Physicians are alsoindispensable partners in ourefforts to bring new medicines topatients," the company said.

Brilinta

ProPublica has tracked drugcompanies' payments to doctorssince 2009 through a searchabledatabase called . But this covers only 17 companies, most of which havebeen compelled to release this information under legal settlements with the government.It has no information from medical device makers.

Dollars for Docs

The list of most promoted drugs featured many recent arrivals: 14 of the top 20 wereapproved by the Food and Drug Administration since 2010. Some treat similarconditions, including diabetes, schizophrenia and chronic obstructive pulmonarydisease, so the competition among them is fierce. "They're fighting over the samedoctors, I guarantee you," said Rhonda Greenapple Simoff, founder of a consulting firmthat advises pharmaceutical companies in Bernardsville, N.J.

Largely absent from the top of the list were drugs that cure disease, such as a new class ofhepatitis C treatments, or those that significantly extend life, particularly for cancerpatients. If a drug is either the first to treat a disease or is much better than existingdrugs, said Dr. Sidney Wolfe, the founder and now senior adviser to Public Citizen'sHealth Research Group, "they 'sell themselves' on the merits of their unique benefits."

According to ProPublica's analysis, a few of the most heavily promoted drugs, including, which treats low sodium levels in the blood, have serious side effects that came

to light after their approval by the federal government. The manufacturers of severalothers, including , , , and , have been faulted bythe F.D.A. for improper promotion.

Samsca

Copaxone Latuda Xarelto Daliresp Humira

, approved in 2012 to treat cancer pain, ranked 23rd in spending on doctors. It's, or unapproved, uses; in November, The New York Times

reported that some of the doctors paid the most to promote the drug . In a statement to The Times, Insys Therapeutics, the drug's maker, said its

Subsysoften prescribed for off­label

had disciplinary orlegal troubles

Approved Payments* Warnings

Victoza 2010 Type 2 Diabetes $9.07M , Read Read

Eliquis 2012 Anti­clotting $7.99M

Brilinta 2011 Blood thinning drug $7.71M

Invokana 2013 Type 2 Diabetes $7.16M

Latuda 2010 Schizophrenia $7.03M Read

Xarelto 2011 Anti­clotting $6.93M Read

Humira 2002Arthritis, ankylosing spondylitis,Crohn disease

$5.58M Read

Tudorza 2012 COPD $5.31M

Daliresp 2011 COPD $5.2M Read

Abilify Maintena 2013 Schizophrenia $5M

Abilify 2002 Schizophrenia $4.77M Read

Linzess 2012Irritable bowel syndrome withconstipation, chronic idiopathicconstipation

$4.59M

Pradaxa 2010 Anti­clotting $4.43M Read

Tradjenta 2011 Type 2 Diabetes $4.17M , Read Read

Belviq 2012 Weight loss $4.14M

Copaxone 1996 Multiple sclerosis $4.01M Read

Samsca 2009Hyponatremia (low sodium levels inthe blood)

$3.89M Read

H.P. Acthar 1952Infantile spasms, multiple sclerosis,endocrine disorders, arthritis, lupus

$3.62M

Symbicort 2006 Asthma $3.5M Read

Aubagio 2012 Treats multiple sclerosis $3.37M

* Note: General Payment figures do not include royalties.Source: Centers for Medicare and Medicaid Services, Food and Drug Administration, ProPublica reporting

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marketing of Subsys was appropriate.

The medical device associated with the mostpayments to doctors was Intuitive Surgical's

, which thecompany has marketed as an effective, lessinvasive option for an array of procedures.Critics have complained that the device isneedlessly expensive and overused, and say ithas been

.

da Vinci surgical robot system

linked to patient complications anddeaths

Intuitive spent nearly $12.8 million onphysician interactions to promote the robotin the last five months of 2013, not includingroyalties and research. The spokeswomanPaige Bischoff said in an email that abouthalf of the company's outlays for educationand training were "pass through" spending:Surgeons or hospitals paid the company forservices, and the company, in turn, paiddoctors to provide them.

Dr. Robert Takla, an emergency roomphysician in the Detroit area, earned about$75,000 in the last five months of 2013 bydelivering promotional talks about several ofthe most heavily marketed anticoagulantsand blood thinners, particularly Brilinta,according to Open Payments.

He said he enjoys speaking on behalf ofcompanies and thinks he offers a differentperspective than cardiologists and internists — the usual prescribers of the drugs —because he treats complications of blood clots in the emergency room.

Dr. Takla said he reviews clinical studies before deciding to speak for a drug and turnscompanies down when he isn't impressed. He said he no longer spoke on behalf ofPradaxa because of what he characterized as public backlash against it, driven by a spateof lawsuits against its manufacturer, Boehringer­Ingelheim. (The company

to settle the suits.) He accepts fees to speak about Xarelto, a drughe has taken himself for a deep vein thrombosis.

agreed to pay$650 million last year

"It's a very fertile and very robust marketplace right now," he said of the anticoagulants.

News applications developer Mike Tigas contributed to this report.

Methodology: How we calculated company payments to doctors

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Some highly promoted newer drugs "are fairly redundant with other therapies that arealready available," said Dr. Joseph Ross, an associate professor of medicine and publichealth at Yale University School of Medicine. (Christopher Capozziello for The New YorkTimes)

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