Breaking News
February 20, 2018 - Lab-grown cerebellar cells may help explain how ASD develops at molecular level
February 20, 2018 - New Treatment Apalutamide (Erleada) Approved for Prostate Cancer That Resists Hormone Therapy
February 20, 2018 - Do You Really Need My Signature on That?
February 20, 2018 - HIV-1 genetic diversity is higher in vaginal tract than in blood during early infection
February 20, 2018 - Researchers aim to find out how PTSD affects decisions of police
February 20, 2018 - UH Cleveland Medical Center explores novel treatments for uterine fibroids
February 20, 2018 - Flu Vax Efficacy 25% Against Predominant H3N2 Strain So Far
February 20, 2018 - HIV screening most optimal at 25 years of age if no risk factors
February 20, 2018 - Loyola Medicine primary care physician offers advice to minimize risk of flu
February 20, 2018 - Safe sleep recommendations for parents that may help reduce child’s risk of SUID
February 20, 2018 - Why Do So Few Docs Have Buprenorphine Waivers?
February 20, 2018 - Low levels of alcohol good for the brain
February 20, 2018 - Experimental treatment improves invisible symptoms of a man with spinal cord injury
February 20, 2018 - Myriad’s EndoPredict offers better prediction of breast cancer recurrence, analysis shows
February 20, 2018 - Researchers identify fifteen genes that determine our facial features
February 20, 2018 - Morning Break: New Health IT Player; Luxturna No Bargain; Nuclear Freakout
February 20, 2018 - How does it compare? Hospice care at home, at assisted living facility, at nursing home
February 19, 2018 - Scientists develop water-soluble warped nanographene for bioimaging
February 19, 2018 - It’s Not Your Imagination: You’re Hungrier After Losing Weight
February 19, 2018 - Antihypertensive Use At Delivery Rising in Preeclampsia
February 19, 2018 - A centuries-old math equation used to solve a modern-day genetics challenge
February 19, 2018 - Liquid biopsies could be used as new predictive marker for metastatic TNBC
February 19, 2018 - Russian researchers develop new multi-layered biodegradable scaffolds
February 19, 2018 - Are ‘Vaccine Skeptics’ Responsible for Flu Deaths?
February 19, 2018 - Hidden genetic effects behind immune diseases may be missed, study suggests
February 19, 2018 - Emergency nurses experience regular verbal and physical abuse
February 19, 2018 - Study sheds light on biology that guides behavior across different stages of life
February 19, 2018 - Morning Break: Transgender Breast Feeding; Brazilian ‘Pro-Vaxxers’; Post-Stroke Exercise
February 19, 2018 - Meningitis vaccination strategy in Africa found to be effective, economical
February 19, 2018 - Researchers uncover how excess calcium may influence development of Parkinson’s disease
February 19, 2018 - Psoriasis drug also effective at reducing aortic inflammation
February 19, 2018 - Excess emissions can make serious contributions to air pollution, study shows
February 19, 2018 - Researchers reveal potential biological roots behind individuality
February 19, 2018 - Diabetes Drugs Differ on HF; School-Based Obesity Program Flop; Plaque Type in ACS
February 19, 2018 - Surgical infections linked to drug-resistant bugs, study suggests
February 19, 2018 - Poor awareness may hinder a child’s early dental care
February 19, 2018 - Research finds rising trend in incidence of merkel cell carcinoma
February 19, 2018 - Researchers uncover Ras protein’s role in uncontrolled cancer growth
February 19, 2018 - FDA Approves Apalutamide (Erleada) to Help Curb a Tough-to-Treat Prostate Cancer
February 19, 2018 - Educational Tool Boosts Cervical Length Screening
February 19, 2018 - Spider’s web inspires removable implant that may control type 1 diabetes
February 19, 2018 - Scientists develop fluorescent probe to identify cancer stem cells
February 19, 2018 - University Hospital of Santiago de Compostela participates in large pancreatic cancer study
February 19, 2018 - New blood test shows promise to revolutionize diagnosis of tick-borne diseases
February 19, 2018 - Report: Use, Not Price, Drives State Health Costs
February 19, 2018 - Emergency services crews often unprepared for diabetic crises
February 19, 2018 - Scientists in Sweden create DNA nanowires that offer hope for treatment of diseases
February 19, 2018 - ID Break: Clean Hands, Fewer Abx; $11 Million HIV Cure?; MenB Vax for Kids
February 19, 2018 - Patient exposure to X-rays depends on how dentists are paid
February 19, 2018 - Study reveals parents’ views toward children’s tanning bed use
February 19, 2018 - Shot may help reduce risk of shingles
February 19, 2018 - FDA approves first treatment to reduce risk of NSCLC progression
February 19, 2018 - FDA Expands Approval of Imfinzi (durvalumab) to Reduce the Risk of Non-Small Cell Lung Cancer Progressing
February 19, 2018 - D.C. Week: Congress Passes Spending Bill
February 19, 2018 - Heart-muscle patches made with human cells improve heart attack recovery
February 19, 2018 - FDA Approves First Blood Test to Detect Concussions
February 19, 2018 - Survival Bump in Bladder Cancer with Keytruda
February 18, 2018 - Scientists describe the mechanism of heart regeneration in the zebrafish
February 18, 2018 - Scientists uncover the structure of microtubule motor proteins
February 18, 2018 - Light-activated cancer drugs without toxic side effects are closer to becoming reality
February 18, 2018 - Pioneering research could provide novel insight into how genomic information is read
February 18, 2018 - Pearls From: David Putrino, PhD
February 18, 2018 - Researchers uncover how cancer stem cells drive triple-negative breast cancer
February 18, 2018 - Morning Break: Anti-Anti-Vaxxers; Private Piercings Prohibited; A Case for Pelvic Massage
February 18, 2018 - Lower-dose radiation effective, safe for HPV+ head and neck cancer after induction chemo
February 18, 2018 - Specialist residential service for adults with autism opens in Swansea
February 18, 2018 - FDA Moves to Limit Loperamide Doses per Package
February 18, 2018 - Alcohol use disorder – Genetics Home Reference
February 18, 2018 - Autism might be better detected using new two-minute questionnaire
February 18, 2018 - Hand hygiene-intervention practices may reduce risk of infection among nursing home patients
February 18, 2018 - Researchers develop most sophisticated mini-livers to date
February 18, 2018 - Obamacare Helped More Young Women Get Prenatal Care: Study
February 18, 2018 - School-Based Program Fails to Dent Kids’ Obesity
February 18, 2018 - Research compares neural activity in children with and without autism spectrum disorder
February 18, 2018 - Poor fitness levels increase the risk dementia, concludes study
February 18, 2018 - Risk Score May Reveal if Kids are Victims of Ill-Treatment
February 18, 2018 - Adding Folic Acid to Corn Masa Flour May Prevent Birth Defects
February 18, 2018 - Acute treatment suppresses posttraumatic arthritis in ankle injury
February 18, 2018 - A Role for Budesonide in Autoimmune Hepatitis?
February 18, 2018 - Lupus patients exhibit altered cell proteins, a discovery with potential implications for diagnostics
Why US consumers paid billions for drug deemed ineffective in other countries

Why US consumers paid billions for drug deemed ineffective in other countries

image_pdfDownload PDFimage_print
In a recently published article in JAMA IM, ‘A Clear-Eyed View of Restasis and Chronic Dry Eye Disease,’ Lisa Schwartz and Steven Woloshin, physician-researchers at The Dartmouth Institute for Health Policy and Clinical Practice, discuss why US consumers may have paid billions for a drug deemed ineffective in other countries. Credit: Dartmouth Institute

Why are Americans, both as patients and taxpayers, paying billions of dollars for a drug whose efficacy is so questionable that it’s not approved in the European Union, Australia or New Zealand? Restasis, a blockbuster drug sold by Allergan to treat chronic dry eye, has done $8.8 billion in U.S. sales between 2009 and 2015, including over $2.9 billion in public monies through Medicare Part D. Restasis and Allergan have been in the news lately due to the company’s novel legal strategy of transferring their patents on the drug to the Saint Regis Mohawk Tribe in order to stave off competition posed by generic drugs.

However, in a recently published article in JAMA IM, “A Clear-Eyed View of Restasis and Chronic Dry Eye Disease,” Lisa Schwartz and Steven Woloshin, physician-researchers at The Dartmouth Institute for Health Policy and Clinical Practice, argue that a more fundamental question we should be asking is: Does Restasis even work?

The FDA approved Restasis to increase tear production in 2003, after a 1999 application failed when reviewers and a unanimous FDA advisory committee concluded it did not meet efficacy criteria. Even though Restasis did not improve symptoms scores (compared to a placebo) when tested directly in the pivotal trials, the FDA accepted indirect evidence from the validation study in which, at six months, 15% vs. 5% of patients had a response with Restasis vs. placebo in a pooled analysis.

Meanwhile, regulatory agencies in other countries found the evidence of Restasis’s efficacy unconvincing. Australia’s regulatory agency found that the trials—the same ones submitted to the FDA—showed no convincing or sustained benefit to patients who had been treated with the drug. Although Canada approved Restasis for a narrower group of patients in 2010, its health technology assessment unit was unconvinced of the drug’s benefit and recommended Canada not pay for it. Schwartz and Woloshin’s research found that no Canadian provincial or federal drug plan currently does.

So why did Americans pay more than $1.5 billion a year in 2016 alone for a drug that potentially does so little, and to treat a condition that many would not even consider to be a disease? Schwartz and Woloshin point to the extensive marketing campaign to sell chronic dry eye (CDE) as a disease—and Restasis as the only viable treatment option. From 2016-2017, Allergan spent $645 million advertising Restasis, including its mydryeyes.com website. The website, Schwartz and Woloshin say, recasts the merely unpleasant experience of itching or watery eyes (often caused by allergies, weather, or other common irritants) as disease. Visitors to the site and to another Allergan website, Restasis.com, are also warned of potential health consequences of undiagnosed and/or untreated CDE disease.

Schwartz and Woloshin also note that both websites offer online help locating a doctor, though neither site discloses that participating doctors many have company ties. Allergan paid over $9 million to 24,152 U.S. doctors from 2013-2015, and the “find-a-doctor” feature includes seven of the top 10 payees.

“Disease awareness campaigns—like chronic dry eyes—are an effective way for companies to sell a disease to sell a drug,” Woloshin says. “But people shouldn’t assume that you even need a drug to treat symptoms—or that the advertised drug actually relieves the symptoms in the quizzes.”

Restasis might not have become such a blockbuster drug, Schwartz and Woloshin argue if consumers, doctors, and payers had easy access to independent drug information. While U.S. and foreign regulatory documents are valuable sources, they are often underutilized. Many doctors, they say, learn about new drugs not from regulatory documents but from company-sponsored promotional efforts. In addition, although regulators now produce more structured, readable documents, reviews for older drugs, such as Restasis, are often poorly organized, and missing information remains a problem. Reviews may be heavily redacted and some are never released. Unlike its counterparts in Europe and Australia, the FDA currently does not release reviews for drugs not approved (even when marketing applications are withdrawn prior to final regulatory action). Schwartz and Woloshin argue that they should.

“When you think of all the good that could have been done with the billions spent on Restasis in the U.S., it reminds us how high the stakes are for better independent information about how well drugs work,” Schwartz says.


Explore further:
Generic eye drops for seniors could save millions of dollars a year

More information:
A Clear-Eyed View of Restasis and Chronic Dry Eye Disease, DOI: 10.1001/jamainternmed.2017.7904 , https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2666792

Provided by:
Dartmouth College

Tagged with:

About author

Related Articles