Breaking News
July 17, 2018 - Researchers map family trees of cancer cells to understand how AML responds to new drug
July 17, 2018 - Mortality from heart failure remains higher in women than men
July 17, 2018 - Can-Fite BioPharma receives Australian and Chinese patents for new drug to treat erectile dysfunction
July 17, 2018 - AAP: Lawnmowers Pose Serious Injury Risk to Children
July 17, 2018 - Fewer U.S. kids are getting cavities
July 17, 2018 - Differences in brain’s reward circuit may explain social deficits in autism
July 17, 2018 - YCC researchers suggest promising treatment for two rare inherited cancer syndromes
July 17, 2018 - FAU and partners receive NIH research grant to shed light on sleep loss and metabolic disorders
July 17, 2018 - Advanced MRI technique predicts risk of disease progression in MS
July 17, 2018 - Health Tip: Microwave Safely – Drugs.com MedNews
July 17, 2018 - New target for treating heart failure identified
July 17, 2018 - Biodesign fellows simplify heart rhythm monitoring
July 17, 2018 - Study reveals new risk genes for allergic rhinitis
July 17, 2018 - Community college education can increase physician diversity and access to primary care
July 17, 2018 - Inflection Biosciences’ dual mechanism inhibitor shows promise as treatment for CLL
July 17, 2018 - Researchers uncover how cells invite corrupted proteins inside
July 17, 2018 - Studies show HORIBA’s new hematology analyzer improves POCT and care of oncology patients
July 17, 2018 - New website aims to make yoga safer for everyone
July 17, 2018 - Long-term survival worse for black survivors of in-hospital cardiac arrest
July 17, 2018 - Stanford data analyst’s childhood inspires his research: A Q&A
July 17, 2018 - Preventability of hospital readmissions changes over time, study reveals
July 17, 2018 - Nursing notes can help predict if ICU patients will survive
July 17, 2018 - Okayama University research could improve prognosis of diabetic kidney disease
July 17, 2018 - Researchers develop machine learning method to predict unknown gene functions of microbes
July 17, 2018 - Homogenous BTK occupancy assay used in tirabrutinib clinical studies
July 17, 2018 - Study identifies new genes linked to heart function and development
July 17, 2018 - NeuroTrauma Sciences and Henry Ford join hands to advance exosome technology
July 17, 2018 - Improved methods to measure enterococci concentrations in recreational water
July 17, 2018 - White adolescent boys experiencing early puberty have high risk for substance use
July 17, 2018 - Celgene and Acceleron Announce Luspatercept Achieved Primary and All Key Secondary Endpoints in Phase III ‘BELIEVE’ Study in Adults with Transfusion-Dependent Beta-Thalassemia
July 17, 2018 - Roots of leukemia reveal possibility of predicting people at risk
July 17, 2018 - Summer med program embraces low-income students’ potential
July 17, 2018 - New research lays foundation to create standards for RNA sequencing
July 17, 2018 - CRISPR/Cas9 gene editing can cause greater genetic damage than previously thought
July 17, 2018 - Democrats rally against threats to the ACA to block Trump’s Supreme Court nominee
July 17, 2018 - Staggering prices slow insurers’ coverage of CAR-T cancer therapy
July 17, 2018 - How proteins involved in neurodegeneration enter cells
July 17, 2018 - New super-resolution ‘nanoscope’ provides insight into progression of Alzheimer’s disease
July 17, 2018 - FDA Advisory Committee Endorses the Effectiveness and Safety of Single-Dose Tafenoquine for the Radical Cure of P. vivax Malaria
July 17, 2018 - Uncovering the evolutionary history of IBD-associated colorectal cancer
July 17, 2018 - Is nutrition research dependable? Stanford’s John Ioannidis weighs in
July 17, 2018 - New machine learning framework predicts effects of genetic mutations in ‘dark matter’ regions
July 17, 2018 - Plant-based products fail to have positive impact on blood pressure during clinical studies
July 17, 2018 - Electronic system to speed up facial pain diagnosis may improve quality of life and save money
July 17, 2018 - Study delves into the role played by Protein Kinase C in synaptic plasticity
July 17, 2018 - Women Often Unaware of Their Hospital’s Religious Affiliation
July 17, 2018 - New AASM guideline recommends use of actigraphy for sleep disorders
July 17, 2018 - CRISPR editing reduces repetitive behavior in mice with a form of autism
July 17, 2018 - Scientists use magnets to detect cancer
July 17, 2018 - Microfluidic chip to detect sepsis proves successful in clinical study
July 17, 2018 - Research provides better understanding of mechanisms underlying memory storage
July 17, 2018 - A Multi-Modal Approach for the Early Detection of Breast Cancer
July 17, 2018 - Mailing colorectal cancer tests to patients increases screening rates, report researchers
July 17, 2018 - Scientists find possible sources of medicinal and antimicrobial drugs
July 17, 2018 - Molecules formed when the body metabolizes omega-3 fatty acids may inhibit cancer
July 17, 2018 - Efficient communication between hospitals improves patient safety and reduces mortality
July 17, 2018 - Study highlights potential of fetal gene therapy to prevent lethal neurodegenerative disease
July 17, 2018 - For Americans, in Science They Trust
July 17, 2018 - Combating HIV/AIDS | NIH MedlinePlus the Magazine
July 17, 2018 - Study shows minorities widely underrepresented in autism diagnoses
July 17, 2018 - Multigene testing replacing BRCA tests for breast cancer risk | News Center
July 17, 2018 - Pre-clinical pilot study shows promising results of ‘concussion pill’
July 17, 2018 - Researchers reduce size of tumors in mice by artificially activating the brain’s reward system
July 17, 2018 - New study documents symptoms of people before they acquire multiple sclerosis
July 17, 2018 - Researchers discover why CRISPR gene editing sometimes fails
July 17, 2018 - New finding may hold key to better understand the complexities of neurological disorders
July 17, 2018 - The Current issue of “The view from here” is concerned with Novel Targets.
July 17, 2018 - Fighting the Flu with a Universal Vaccine
July 17, 2018 - Key social reward circuit in the brain impaired in kids with autism | News Center
July 17, 2018 - Insight into causes, types and treatment of aphasia
July 16, 2018 - Quark Pharmaceuticals, Inc Announces First Patient Dosed in Phase 3 Clinical Trial of QPI-1002 for Prevention of Acute Kidney Injury Following Cardiac Surgery
July 16, 2018 - NSAIDs shown to have causal role in cardiovascular risk of patients with osteoarthritis
July 16, 2018 - PET scan tracer predicts success of cancer ‘vaccine’ | News Center
July 16, 2018 - Parents struggle with what to do when their child has headache, shows study
July 16, 2018 - Outrageous or overblown? HHS announces another round of ACA navigator funding cuts
July 16, 2018 - Weight loss surgery may impact individual’s risk of developing cancer, shows study
July 16, 2018 - Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.
July 16, 2018 - Restoring epigenetic balance reinstates memory in flies with Alzheimer’s disease symptoms
July 16, 2018 - Magnetized wire could be used to detect cancer in people | News Center
July 16, 2018 - Non-surgical management found to be feasible option for penetrating kidney trauma
Drug Companies Make Eyedrops Too Big — And You Pay for the Waste

Drug Companies Make Eyedrops Too Big — And You Pay for the Waste

image_pdfDownload PDFimage_print

If you’ve ever put in an eyedrop, some of it has almost certainly spilled onto your eyelid or cheek.

The good news is the mess doesn’t necessarily mean you missed. The bad news is that medicine you wiped off your face is wasted by design — and it’s well-known to the drug companies that make the drops.

Eyedrops overflow our eyes because drug companies make the typical drop — from pricey glaucoma drugs to a cheap bottle of Visine — larger than a human eye can hold. Some are so large that if they were pills, every time you swallowed one, you’d toss another in the garbage.

The waste frustrates glaucoma experts like Dr. Alan Robin, whose patients struggle to make pricey bottles of drops last. He has urged drug companies to move to smaller drops — to no avail.

“They had no interest in people, their pocketbooks or what the cost of drugs meant,” said Robin, a Baltimore ophthalmologist, researcher and adjunct professor at the University of Michigan Medical School.

ProPublica has been documenting the many ways healthcare dollars are being wasted. We’ve shown how hospitals throw out brand new supplies, nursing homes flush tons of unexpired medication and drug companies concoct costly combinations of cheap medication. Recently we described how arbitrary drug expiration dates cause us to toss safe and potent medicine.

Often, large swaths of the medical and pharmaceutical communities know about this waste — even about solutions to it — but do nothing. Those who end up paying the bill, in one way or another, are consumers.

Liquid medication is squandered every day. Beyond eyedrops, liquid cancer drugs are frequently packaged in oversized single-use vials that contain more of the drug than most patients need. This guarantees that a quantity of life-saving medication is tossed — and its cost tacked onto patients’ bills.

“Why are they putting the providers in a position where we have so much waste and it’s costing everybody money?” said Lorraine Holzapfel, an administrator at Marin Cancer Care in California who has analyzed the cost of wasted cancer drugs. “We are in a time when we are trying to cut medical costs.”

Both eyedrops and cancer drugs are sold by volume, and we spend billions of dollars every year on them. Chemotherapy drugs can run thousands of dollars per infusion. Crucial eye medications to treat conditions like glaucoma may cost hundreds of dollars for a small bottle that only lasts a month, making the waste of even a drop a problem for low-income patients.

Gregory Matthews said there have been times when he’s run out of his $295 bottle of Azopt, a glaucoma medication, with a few days remaining before his refill and he’s blamed himself. “You feel like you’re doing something that’s going to cause your blindness and it’s because of you,” said Matthews, 63, a teacher from Baltimore.

Last year, drug companies brought in about $3.4 billion in the U.S. alone on drops for dry eyes and glaucoma drops, according to the research firm Market Scope.

With both eyedrops and cancer drugs, pharmaceutical companies have done research showing that it’s possible to waste less — and save consumers money. Some of that research has been around for decades.

Robin, for example, consulted in the early 1990s with Alcon Laboratories, one of the world’s largest eye-care companies, when its researchers developed a so-called microdrop. Patients, he said, were able to safely and effectively deliver the tiny drops, with nothing wasted. But instead of being a breakthrough, the innovation, he said, became a case study in how business interests trump patient needs.

In the early 1990s, Bill York recalled his bosses at Alcon coming to him with a pressing request. Patients were complaining that some of the company’s drops caused stinging and burning in their eyes. Could he find a fix?

York, head of the research lab at the company’s Fort Worth, Texas, headquarters, knew one way to ease the irritation: Make the drops smaller. The size of eyedrops isn’t regulated, he said recently. Some are over 50 microliters, more than twice what the eye can hold.

When drops are too big, the overflow runs down the face or drains into the body through the ducts in the corner of the eye, he said. This explains why you sometimes get the sensation of “tasting” your eyedrop — it’s entered your sinuses.

“If it spills out, it’s just wasted,” said York, who has a doctorate in pharmaceutical chemistry and is now retired. “It’s not doing any good.”

So his team created a 16-microliter drop — a microdrop — that was about a half to a third of the size of most drops on the market today, he said. They used a standard bottle with a latex dropper tip that wouldn’t cause injury if it touched the eye. Then they recruited 29 glaucoma patients to test the tiny drops. Glaucoma, a leading cause of blindness in the United States, is characterized by increased pressure in the eye, which can damage the optic nerve. Daily use of medicated eyedrops preserves sight by reducing the pressure.

The patients tried different formulations of the same medication in both micro- and regular drops, which were about twice as large, for a week at a time. The researchers tracked the patients’ eye pressure and side effects, such as burning, stinging, itching, and dryness.

Their results were conclusive: Microdrops worked as well as larger drops to lower eye pressure. They also reduced some of the uncomfortable side effects of larger drops. And all the patients preferred using them.

York and two of his Alcon colleagues published their results in 1992 in the American Journal of Ophthalmology. Robin, who consulted on the research, was the principal investigator.

“The microdrop delivery system worked,” York said recently. The drop “was manufacturable. It reduced stinging and the amount of drug needed to produce the same biologic effect. Excess drug draining out of the eye would be significantly reduced.”

But his innovative solution ground to a halt when it came to getting it on the market.

Back in the early 1990s, Jerry Cagle was the head of product development at Alcon. Cagle, who has a doctorate in microbiology, retired in 2008 after 32 years at the company. He said the microdrop project failed because it raised too many questions — all of them about profits.

First, would competitors in the cutthroat eye-care business undermine the project? One time, Cagle recalled, Alcon wrapped one of its bottles in foil to reduce evaporation, extending the life of the product. A competing company started a rumor that Alcon’s drops needed the foil because they were toxic. Alcon had to remove the foil.

“No good deed goes unpunished,” Cagle said.

Second, if Alcon reduced the drop size on this product, would they have to do the same on the company’s other eyedrop products?

And maybe most crucially, how would the microdrop affect sales? Microdrops, Cagle recalled, had “the potential to increase the use-life of a bottle by a factor of two,” which could cut sales in half. But if they raised the price on the bottle to recover revenue, Cagle said, “then what’s a competitor going to say? ‘Look at Alcon’s product. It’s twice as expensive as ours.'”

Alcon would also have to get Food and Drug Administration approval. Company-funded studies would need to prove to the agency that the smaller drop was just as effective as a larger drop.

So the project was killed, Cagle recalled, doomed by the cost of bringing the microdrops to market, combined with the risks of whether they would sell.

“I’m a believer in small drops, don’t get me wrong,” Cagle said. “If this had been an innovation we thought would have increased Alcon’s sales, I think it would be in the marketplace today.”

Novartis, which now owns Alcon, did not want to talk about the microdrop study. When asked about the drop size, a spokesperson said the drops include a “margin of safety” to ensure patients get enough of the drug in their eyes.

Robin recalled a different response back in the 1990s when he urged Alcon executives to pursue the microdrop. It was, he said, like asking your wife if you could leave town for your anniversary or her birthday.

“It was a dead issue,” Robin said. “They would say, ‘It’s not profitable. We’re going to sell less drugs.’ Very simple. Bottom line.”

Twenty-five years later things haven’t changed. Those in the eye industry — doctors, pharmaceutical officials, researchers — know that eyedrops are much larger than the eye can hold.

But there’s little focus on the waste. Dr. Michael Repka, spokesman for the American Academy of Ophthalmology, said the drops have been larger than the eye’s capacity for the three decades he’s been in practice. While the focus has been on drop administration and ensuring patients can get refills, he said, the industry should be looking at drop size.

You might think the FDA would intercede, but the agency’s mission is the safety and efficacy of drugs, not prices or indirect costs due to waste.

Since Alcon’s mothballed research in the early 1990s, other studies have similarly found that most drops on the market are larger than necessary. A 2006 study published in the Journal of Ocular Pharmacology and Therapeutics, for example, said 15 microliter drops are as effective as large drops. “Smaller drops would be preferable to minimize systemic exposure and spilled or wasted medicine,” the study said.

That study, like Alcon’s, was the work of an eyedrop maker. Two of its authors worked for the pharmaceutical giant Allergan, which also funded the study. Eleven years later, Allergan still doesn’t make any drops that are 15 microliters or smaller. The company declined to comment.

Another study published in May in the journal BMC Ophthalmology said “a significant portion of an eyedrop is wasted.”

Internal drug company documents and depositions unearthed in a recent court case in Illinois also suggest that companies have long known their eyedrops are bigger than human eyes can absorb.

A 2002 Bausch & Lomb memo said dropper tips “deliver drops which exceed that of which the physiology of the eye can retain.” In a 2014 deposition, the company’s executive director of research and development said the pharmaceutical giant had no “procedure related to the development of what a drop size should be.”

A 2011 Pfizer memo said: “The drop size is not a medical dosing issue because the human eye can only absorb 7 (microliters) of fluid.” Common drop sizes are between 25 and 56 microliters, the memo added.

And in a 2014 deposition, a principal scientist from Allergan acknowledged that the company studied glaucoma drops of 5, 10, 15, 20 and 30 microliters in size and found no statistically significant difference in the ability of the drops to reduce eye pressure.

None of the drug companies wanted to discuss these documents or why they haven’t pursued a smaller drop.

Even a drug industry consultant, Gary Novack, said it would be ideal to have a smaller drop with a higher concentration of medicine. But Novack, a pharmacology expert who helps companies shepherd products to market, does not believe reducing the size of drops would lower healthcare costs. The drug companies, he said, would “acclimate,” raising prices by charging by dose instead of volume.

“People would price it per day or per month. It would work for a while but in the end the prices, I think, would adjust,” Novack said.

That may sound cynical, but what happened with cancer drugs suggests Novack’s probably right.

More than a decade ago, Genentech got a powerful new drug, Herceptin, approved for breast cancer. The drug, which helped slow the spread of the cancer, came in shareable vials so little of it would be wasted. This was no small issue since every milligram costs about $9 and each of a patient’s regular infusions can run more than $3,000.

Herceptin became a blockbuster. In 2016, U.S. sales were about $2.5 billion.

Then, this May, Genentech announced it would stop making the 440-mg shareable vials of the drug and would replace them with 150-mg single-use vials. The switch would make the supply chain more reliable because single-use vials are used worldwide, the company wrote in a statement.

But cancer doctors, pharmacists and administrators immediately seized on the trouble with the change. The dosage of such drugs is based on body weight, so while some patients would have no wasted medicine, others would end up billed for medicine that would have to be thrown away.

The announcement lit up an internet discussion group for pharmacists who work in cancer centers.

“I’m assuming since it will now be a single dose vial that we’ll have to bill for the waste?” wrote James Meier, a pharmacist at Hays Medical Center in Hays, Kansas.

“Yes you will bill for the waste,” replied another pharmacist.

This “sets all of us back in our efforts to reduce waste in our facilities,” wrote a pharmacist in Montana.

Payers will now have to spend millions of dollars “for a drug that’s literally going in the trash can,” Meier said in an interview following up on his comments.

Some pharmacists speculated that there’s a financial reason for the change. “Biosimilar” drugs — those that are almost an exact copy — are expected to compete with Herceptin, which could cut into Genentech’s profits.

In a statement, the company said the “change has been in the works for several years and required significant time and investment to achieve.”

When Marin Cancer Care administrator Holzapfel heard about the switch she decided to estimate how much it would cost. She calculated use for the clinic’s 37 Herceptin patients in the first five months of the year, when they could share the larger 440-mg vials. Then she analyzed how much they would have wasted with the new 150-mg single-use vials.

The average patient used 340 mg per infusion, she said. That would require three of the 150-mg single-use vials, resulting in 110 mg of waste per infusion. Each milligram costs the clinic $9, so that’s an average of almost $1,000 of drugs wasted per infusion, she said.

Individual patients would have to pay for more or less waste depending on their body size. Two of the Marin patients would have been billed for more than $10,000 in medicine they didn’t use over the course of their infusions, Holzapfel’s analysis showed. One would have been billed for more than $18,000 in wasted chemotherapy drugs.

Holzapfel was appalled and fired off an email to her colleagues: “Is this in the best interest of the patient?” she wrote. “How can they be allowed to change a drug from multi-use vials to single dose only? Is there scientific justification for this?”

Her analysis is a small sample, but it showed the change to single-use vials would waste 16% of all the Herceptin used at the facility. Apply that rate nationally and it would total about $401 million in wasted Herceptin in a year, based on 2016 numbers.

Given the high cost of cancer drugs, the thought of needlessly throwing any away outrages cancer researchers like Dr. Peter Bach.

It’s “evil” to pass along the cost of this enforced waste to patients, said Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in New York.

Bach led a study in 2016 that calculated the waste associated with the top 20 cancer drugs packaged in single-use vials. It estimated that 10% of the medication gets wasted at a cost of $1.8 billion a year.

A cancer diagnosis doubles the risk of bankruptcy in the United States, and paying for wasted drugs adds to the cost borne by patients, Bach said. “It’s a business, and in the middle of this are people dying of cancer.”

It isn’t hard to find patients who are paying the cost of this waste without knowing it.

David Zinke, 67, lamented on Facebook that he couldn’t afford the $185 per month drops his doctor had just prescribed.

He was shocked to hear about microdrops. He always thought “a drop was a drop.” Zinke said he was getting by on his Social Security plus what he made by selling fudge and driving for Uber in Tucson, Arizona, clearing about $1,500 a month. His budget doesn’t cover the brand-name drug his doctor prescribed, so every day he uses three less expensive bottles of drops.

“If we could deliver it in a smaller and more appropriate way,” he said, “then that little bottle of 2.5 mL would last me two months instead of one.”

In Baltimore, Matthews, the teacher who fears running out of his drops, carefully puts a single drop of Azopt into each eye twice a day to preserve his remaining eyesight. His glaucoma has left him almost completely blind in one eye, and partially blind in the other.

The drops allow him to continue to work as a teacher and watch his beloved Baltimore Orioles. Azopt is made by Alcon. Matthews has good insurance so he doesn’t pay the $295 sticker price, but he can’t get a refill until a certain date, so it’s critical not to waste a single drop.

But Matthews told me, no matter how hard he tries, the drug gets wasted. Each drop is more like a milky “gob,” he said that collects in the corner of his eye. “Sometimes I feel like I’m wiping half of it out,” he said.

As he talked about the size of eyedrops, Matthews grew more irritated. “This whole blind thing takes some getting used to,” he said. “If the maker of the medicine isn’t really looking out for me, that bothers me.”

This story first appeared on Propublica and was co-published with NPR‘s Shots blog.

2017-10-21T09:00:00-0400

Tagged with:

About author

Related Articles