Breaking News
July 20, 2018 - Study compares outpatient antibiotic prescribing with traditional medical, retail clinic settings
July 20, 2018 - Immediate Monitoring With ECG Patch Ups A-Fib Diagnosis Rate
July 20, 2018 - Scientists seek to better protect the eye from glaucoma
July 20, 2018 - Football training could improve bone mineral density in prostate cancer patients
July 20, 2018 - Single genetic change in gut bacteria can lead to obesity
July 20, 2018 - Research uncovers new target for therapeutic intervention in breast cancer
July 20, 2018 - WFN to highlight clean air for brain health on World Brain Day 2018
July 20, 2018 - Health Highlights: July 17, 2018
July 20, 2018 - Mom’s marijuana winds up in breast milk
July 20, 2018 - Black men could be healthier if seen by black physicians, new research suggests
July 20, 2018 - Alcoholics have persistent difficulties with emotional communication after long-term abstinence
July 19, 2018 - Researchers unravel how ALL invades the central nervous system
July 19, 2018 - Mother’s microbiome determines offspring’s risk of developing autism
July 19, 2018 - Refining standards of maternal-fetal care
July 19, 2018 - Stitching single cells together any which way you want to
July 19, 2018 - Study identifies RNA molecules that regulate male hormones in prostate cancer
July 19, 2018 - New machine-learning model shows promise in predicting undiagnosed dementia
July 19, 2018 - Sleep supports antioxidant processes, study suggests
July 19, 2018 - MiRagen Therapeutics Announces Initiation of Phase 2 Clinical Trial of MRG-201
July 19, 2018 - Unique brain ‘fingerprint’ can predict drug effectiveness
July 19, 2018 - Life on the border: Struggling to survive in Jordan
July 19, 2018 - CT scans may raise brain tumor risk
July 19, 2018 - Moderate alcohol intake linked with improved male fertility
July 19, 2018 - Alcohol-related cirrhosis mortality on the rise among young adults
July 19, 2018 - Study uncovers new protein complex that shields broken DNA ends
July 19, 2018 - Regular sunscreen use protects young people from melanoma
July 19, 2018 - Using non-invasive brain recordings to characterize activity in deep structures
July 19, 2018 - Mediterranean diet could influence academic performance through effects on sleep quality
July 19, 2018 - Woman’s pregnancy history may be linked to Alzheimer’s disease risk
July 19, 2018 - Study calls for new gold standard in research to treat non-alcoholic steatohepatitis
July 19, 2018 - Cancer patients receiving anti-PD-1 therapies may experience delayed skin reactions
July 19, 2018 - Scientists study adverse effects of carbon, silicon nanotubes and carbon nanofibers
July 19, 2018 - Keck Hospital of USC receives Magnet recognition for excellence in nursing
July 19, 2018 - Scientists identify hidden signals in RNAs that control protein synthesis
July 19, 2018 - Quadrivalent HPV Vaccine Not Tied to Spontaneous Abortion
July 19, 2018 - FDA OKs first drug made to reduce excessive sweating
July 19, 2018 - New Finnish study compares surgical treatment of shoulder impingement syndrome to placebo surgery
July 19, 2018 - New findings do no support caffeine as effective appetite suppressant or weight-loss aid
July 19, 2018 - Kite collaborates with Gadeta to develop novel gamma delta TCR therapies for various cancers
July 19, 2018 - Study evaluates Neoteryx’s VAMS technology for monitoring HbA1c levels of diabetic children
July 19, 2018 - New clinical trial examines use of adrenaline to treat cardiac arrests
July 19, 2018 - Early surgical intervention may improve outcomes for patients with mitral valve disease
July 19, 2018 - Prolonged preoperative opioid use linked to adverse outcomes after total knee and hip arthroplasty
July 19, 2018 - Biophysicists use infrared sensor as new method for drug discovery
July 19, 2018 - Rat study shows negative effects of perinatal exposure to phthalates
July 19, 2018 - Children with disabilities endure long waits for life-changing medical equipment
July 19, 2018 - Ways to stay safe while camping and hiking
July 19, 2018 - People with HIV twice as likely to suffer from heart disease
July 19, 2018 - On-the-Job Stress Relief – Drugs.com MedNews
July 19, 2018 - Compounds found in green tea and wine may block formation of toxic metabolites
July 19, 2018 - Gene regulator associated with protein pileup in exfoliation glaucoma
July 19, 2018 - Trump administration summons immigrant infants
July 19, 2018 - FDA grants approval for first breast cancer drug through ‘Real-Time Oncology Review’
July 19, 2018 - Five tips for men seeking plastic surgery
July 19, 2018 - Researchers discover the reasons why some people get dizzy when hearing certain sounds
July 19, 2018 - Research project investigates snake venom treatment as antibiotic alternative for eye infections
July 19, 2018 - Melanoma could soon be detected using a blood test
July 19, 2018 - Exposure to bright light may have big impact on sleep-related behavior in children
July 19, 2018 - Deleting single gene in gut bacteria affects metabolism, reduces weight gain in mice
July 19, 2018 - New proteomics studies help gain more insights into Alzheimer’s, cancer and listeriosis
July 19, 2018 - Study finds major discrepancies in prescription drug labeling pregnancy information across four countries
July 19, 2018 - Cellectar’s CLR 131 Receives FDA Orphan Drug Designation for Treatment of Ewing’s Sarcoma
July 19, 2018 - Watching the immune system in action reveals what happens when things goes wrong
July 19, 2018 - Increasing blood sugar levels improves memory and performance in older adults
July 19, 2018 - Connection between self-regulation and obesity appears to be different for girls and boys
July 19, 2018 - Researchers develop new, less destructive method for whitening teeth
July 19, 2018 - Revving up innate control of viral infection requires a three-cell ignition
July 19, 2018 - Inaccurate direct-to-consumer raw genetic data can harm patients, new research suggests
July 19, 2018 - Weight loss surgery is effective under the right situations
July 19, 2018 - BioTek awarded patent for autofocus feature on microplate reader
July 19, 2018 - Low-carb diets reduce stiffness of arteries in women and promote weight loss in men
July 19, 2018 - New review examines cannabinoids’ potential for direct treatment of cancer
July 19, 2018 - Allergic responses may help protect the skin against cancer, research suggests
July 19, 2018 - Inappropriate Prescribing of Abx High in Urgent Care Centers
July 19, 2018 - Many at risk for HIV despite lifesaving pill
July 19, 2018 - Tips for doctors and parents on the harms of marijuana use for teens
July 18, 2018 - Researchers detect presence of IgE antibodies after kidney transplantation
July 18, 2018 - New technique allows researchers to create large scale, personalized bone grafts
July 18, 2018 - Smoking May Boost Atrial Fibrillation Risk
July 18, 2018 - Genome editing method targets AIDS virus
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