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Saturday, January 26, 2019

Cost savings, disruption threat pushing more providers into home dialysis


In an era when just about every medical treatment that can be done at home is moving in that direction, only about 12% of patients receiving kidney dialysis do so at home, despite it being cheaper and research showing it’s just as safe.
There are a host of reasons why. Most people cite physicians’ lack of training on home dialysis and their resulting reluctance to suggest it. Sometimes patients themselves are too sick or overwhelmed to take on that task.
But experts in the field say there’s another major factor at play: money. More than 80% of the nearly 6,500 dialysis facilities nationally are owned by two for-profit companies, DaVita and Fresenius Medical Care. Providers aim to see a return on the money spent building and staffing those dialysis clinics, which some say means keeping patients in those dialysis chairs.
“An empty chair is kind of like an empty seat on an airplane,” said Dr. Brent Miller, professor of medicine and clinical chief of nephrology at Indiana University. “If we were just looking at this not as people and not as healthcare but just as a business like an airline, our goal would be to fill all those slots.”
On the contrary, the country’s biggest dialysis providers insist they’re all-in when it comes to home dialysis, and reject the notion that their own reluctance has contributed to the slow uptake. DaVita said it wants to bump its home dialysis patients from about 13% of dialysis patients currently to 25% by 2025. And Fresenius said it wants to go from 12% currently to 25% of dialysis patients receiving some home therapy by 2022. Fresenius is even looking to buy home dialysis devicemaker NxStage for $2 billion.
One potential driver of companies’ apparent enthusiasm for home treatment might be CVS Health’s announcement last year that it plans to disrupt kidney care by expanding home dialysis, identifying kidney disease earlier and developing new home hemodialysis technology. CVS hasn’t released many details, but Dr. Harry Jacobson, a nephrologist and co-founder of the investment firm TriStar Health Partners, described it as a “breakthrough.” He declined to share more detail because of a confidentiality agreement with the company.
“It’s disruptive and it’s my opinion that it will be a real catalyst for increasing home hemodialysis,” he said.
Academics like Miller and Dr. Thomas Golper, a professor of medicine at Vanderbilt University, said they welcomed the innovation, but know traditional providers are nervous.
“That’s the 800-pound gorilla,” Golper said. “There’s a lot of people who are very nervous about that.”
CVS plans to launch a clinical trial to study the safety and efficacy of its new technology ahead of a planned Food and Drug Administration submission, a company spokeswoman wrote in an email. The device is intended to make home hemodialysis simpler and safer, and to facilitate longer, more frequent treatments.
“We expect to provide more information on the device, and our associated activities throughout this year,” she wrote.
Whatever the reason, the percentage of patients with prevalent end-stage renal disease who receive the treatment at home has grown only slightly, from 11.3% in 2013 to 11.8% in 2016, according to the U.S. Renal Data System, which publishes information about end-stage renal disease treatment.


“It’s not a huge groundswell,” said Mark Stephens, owner of Prima Health Analytics, a Weymouth, Mass.-based firm that researches and shares data on the treatment of chronic diseases.
Medicare pays for the vast majority of patients who receive dialysis treatment, a population that represented less than 1% of Medicare-eligible patients in 2016 but more than 7% of total fee-for-service claims that year, or $35.4 billion, according to the U.S. Renal Data System, or USRDS.
Since 2011, Medicare has bundled its payments for end-stage renal disease patients, so the payment providers receive is the same whether patients receive dialysis in facilities or at home.
Home dialysis can generate a better margin, however, because it’s cheaper for providers to deliver. Medicare cost report data filed by dialysis providers show it costs providers an average of $256 to deliver a single in-center hemodialysis treatment in 2017, according to Prima Health Analytics. It cost them roughly $215 to deliver a home dialysis treatment that year. The average staff hours allocated to a home dialysis treatment is about one hour versus 2.5 hours in a facility, Prima’s data show.
“That is clearly very profitable for providers,” said Dr. Joel Glickman, a professor of clinical medicine at the University of Pennsylvania and director of its home dialysis program.
Kent Thiry, CEO of dialysis giant DaVita, called home dialysis “very capital-efficient growth because we don’t have to build another clinic,” speaking at the J.P. Morgan Healthcare Conference in San Francisco in early January.
In an interview, DaVita executives emphasized patient enthusiasm and increased awareness as their rationale for heightening their efforts around home dialysis.
Tad Stahel, group vice president of DaVita Kidney Care’s home dialysis and hospital services group, played down the cost factor, noting that the company still provides the supplies and medications for patients who choose home dialysis, as well as the nurse who supports the patient.
Stahel and Dr. Martin Schreiber, DaVita Kidney Care’s chief medical officer for home dialysis, flatly rejected the notion that the company didn’t get into home dialysis sooner because of the need to fill dialysis centers. Schreiber said therapy decisions are always made based on the patient’s ability to do home dialysis.
“You make the decision based on the clinical value,” he said.
Schreiber blamed the slow uptake on both a lack of physician training on home dialysis and staffing to train patients on home dialysis, as well as patients’ economic issues, such as not having transportation to training sites or a large enough home to be able to perform home dialysis. Stahel said home dialysis supply shortages have also played a role.
Peritoneal dialysis works by sending cleansing fluid through a catheter into the abdomen that filters waste products from the blood. After a certain amount of time, the fluid and waste products flow back out of the abdomen and are discarded. With hemodialysis, a machine uses a filter to clean the blood. A small proportion of hemodialysis treatments are currently done at home.
Nonetheless, Schreiber said he thinks the slow growth in home dialysis is about to change, especially with the development of telehealth, which helps patients feel less isolated.
“I think as we move forward into the millennial generation, you’re going to see more and more people who want to monitor their diseases at home rather than going to a dialysis facility,” he said.
Asked whether financial incentives have slowed the transition to home dialysis, Fresenius Medical Care’s Dr. Frank Maddux said his company is committed to offering patients the treatment modality that best suits their lifestyle and care needs.
Significant progress has been made over the past decade with respect to having the right technologies, policies and social conditions that are now “finally aligning” to help Fresenius achieve its home dialysis goal, said Maddux, the company’s chief medical officer and executive vice president of clinical affairs.
Both DaVita and Fresenius said new remote communication technologies are helping the transition toward home dialysis.
“Back in the early days, patients were really just on their own,” Maddux said. “We had very little visibility of what was happening during their treatment.”
That’s part of what drove Fresenius’ interest in NxStage, Maddux said. The company has a user-friendly machine and connected health device that supports patients on home hemodialysis, he said.
Some physicians said part of the reason for the slow uptick in home dialysis is that dialysis patients are increasingly sicker and less able to perform the treatments at home. Research has shown home dialysis patients tend to be healthier compared to their in-center counterparts.
For his part, Vanderbilt University’s Golper said he believes the biggest reason home dialysis hasn’t caught on more is a lack of physician education. He said not enough academic programs are training nephrologists to teach patients to perform home dialysis.
Miller agreed and said the country’s top nephrology training programs by and large are not proficient in training providers on home hemodialysis. And while other industries are quick to provide continuing education, he hasn’t seen it in this area.
Golper said he’s also skeptical that DaVita and Fresenius are truly making the necessary investments in home dialysis to make it work. He has offered faculty support for both companies’ home dialysis providers, but neither has accepted.
The CMS launched an accountable care demonstration for end-stage renal disease in 2015 that experts say may encourage more dialysis providers to use home dialysis. As of 2017, there were nearly 40 participating organizations, and that’s expected to grow once the program progresses. Fresenius has the largest presence, with 24 organizations, and the company said it decreased patients’ hospitalization rate by almost 9% and saved more than $43 million in the program’s first year.
Indiana University’s Miller said he thinks a big reason more providers are turning to home dialysis is because they’re recognizing that their current model, which relies on expensive buildings, lots of nurses and transportation, is unsustainable.
“I think they’re a little bit afraid of the sustainability of their current business model,” he said.

American Well rolls out acute care telehealth cart for specialty access


  • American Well on Tuesday launched a new acute care telehealth cart to connect patients and care teams to remote specialists.
  • The American Well 760 Cart is designed for health systems performing telemedicine via the company’s software or an existing Cisco infrastructure.
  • Features include a touch panel and 20x zoom to increase image clarity, as well as the new Cisco Plus Codec. The FDA-registered Class I cart also offers round-the-clock device monitoring with automated alerts and remote device management.

Having reliable access to specialists could be especially beneficial for smaller and rural hospitals and clinics, where patients might otherwise have to travel long distances to get the specialty care they need. Typical use cases for the 760 Cart, according to American Well, include telestroke, ICU consults and telepsychiatry.
Telehealth can increase healthcare access and quality, but the degree to which that occurs varies with settings and uses. An Agency for Healthcare Research and Quality report found success with virtual care in areas like remote ICU consultations, which can help reduce deaths and length of stay. Specialty telehealth can also cut time patients spend in emergency rooms and improve outcomes in outpatient care.
There is less evidence that telehealth reduces length of inpatient stay and cost or that remote ICUs reduce overall hospital length of stay, according to the report. And there’s little (if any) evidence that outpatient telehealth increases patient satisfaction.
Meanwhile, a recent KLAS Research survey found that no telehealth vendor is meeting all of customers’ virtual needs. KLAS asked healthcare leaders how they fared with nine telehealth vendors, including American Well, Intouch Health and MDLive. None of the vendors equally satisfied organization’s three primary concerns — virtual care clinics, telespecialty consults and on-demand visits.
The report pointed to scalability issues and the ability to support multiple visit types. Companies seeking “all-purpose” status are doing so through internal development and/or acquisitions.
American Well boosted its acute care capabilities with last year’s purchase of Avizia. The deal gave American Well access to comprehensive acute care capability, including hospital cart lineup and customized workflows for more than 40 specialties. At the time of the purchase, American Well said the merger would create an enterprise system of services ranging from urgent care to chronic disease management, acute care and post-acute care.
The company has also partnered with Philips to embed telehealth services in a range of products, and with Anthem and Samsung Electronics America to bring 24/7 telehealth services to consumers. The latter allows people with an Anthem-affiliated health plan and the latest Samsung Health app on their Samsung Galaxy device to access American Well’s LiveHealth Online to video chat with a provider. Consumers can also use the app to consult with experts in a range of subspecialties.

CMS approves 8th state for Medicaid work requirement


  • CMS on Friday approved Medicaid work requirements for Arizona, which will be the eight state to put the enrollment restrictions in place.
  • The state’s Arizona Health Care Cost Containment System Worksprogram will require people to have a job, get employment training or participate in community service to be eligible for Medicaid. The requirement is expected to start in 2020.
  • The Section 1115 Medicaid demonstration project will exempt federally recognized tribe members from the requirement.

Proponents of Medicaid work requirements see the policy as a way to get people to work and reduce the size and cost of the program. States have increasingly sought ways to bend the Medicaid cost curve.
A recent HHS Office of the Actuary report projected Medicaid expenditures to grow at an average annual rate of 5.7% over the next decade. That’s faster than the gross domestic product. Fitch Ratings said last year that rising Medicaid costs may force state and local communities to cut spending on other programs, such as education and public safety.
Instead, some states are looking to restrict who has access to Medicaid.
The Arizona work requirement will require people between 19 and 49 to “engage in qualifying community engagement activities for at least 80 hours per month and report monthly that they are meeting the community engagement requirements.”
The state will exempt pregnant woman, beneficiaries who are medically frail and those in active treatment for substance use disorder.
The work requirement is expected to impact about 120,000 Arizonans.
CMS Administrator Seema Verma said the waiver gives states the flexibility to tailor a program to fit their needs. Republican Gov. Doug Ducey said in a statement the requirement will improve health outcomes and employment opportunities.
Arizona’s waiver follows other states’ work requirements, which were celebrated by conservatives and derided by liberals. Kentucky was the firstto receive a work requirement Medicaid waiver, but a federal judgerejected the rule. Kentucky proposed a similar second work requirement plan and CMS approved that option. However, that rule is being challenged in court as well.
Arkansas also received a work requirement, but Verma said she will review the impact of the change after more than 12,000 people lost Medicaid coverage.
Those wrinkles haven’t stopped other states from exploring work requirements. CMS is reviewing similar requirements for another eight states: Alabama, Mississippi, Ohio, Oklahoma, South Dakota, Tennessee, Utah and Virginia.

Diabetes costs escalation since 2012, mostly from insulin price hikes


  • The cost of covering someone with diabetes has skyrocketed this decade while use only rose modestly, according to a new report by the nonprofit research Health Care Cost Institute.
  • The average cost of managing Type 1 diabetes in employer-sponsored health insurance plans rose from $12,467 in 2012 to almost $18,500 in 2016. The group said 47% of that increase came from higher insulin prices.
  • The per-person cost for insulin increased from $2,900 in 2012 to $5,700 in 2016 — driven almost entirely by point-of-sale price increases. The analysis did not look at rebates or out-of-pocket costs for patients.

Diabetes is a major health cost driver, and prevalence is only expected to increase as 86 million Americans adults are estimated to have prediabetes.
Now, the cost of insulin is rising and patients could be faced with sacrificing their insulin for other necessities. Forgoing insulin would make their health worse, which will only increase healthcare costs. The American Diabetes Association said costs associated with the more than 30 million people with diabetes in the U.S. are more than double those without diabetes and estimates that diagnosed diabetes costs the U.S. $327 billion annually.
CMS is testing demonstration projects to bend the cost curve, but rising insulin prices could be another trend that makes it hard to keep healthcare costs under control.
For the HCCI study, researchers looked at health insurance claims from between 13,800 and 16,200 people with Type 1 diabetes in employer-sponsored plans. The disease affects about 1.5 million Americans.
Every insulin product increased in cost between 2012 and 2016. The median price increased by 92% in that period, according to the report.
Insulin cost growth exceeded other costs, including non-insulin prescriptions, inpatient and outpatient care.
The authors said the findings are consistent with anecdotes of patients not being able to afford insulin. Niall Brennan, CEO of HCCI, said it’s difficult to square the increases with the fact that the drug hasn’t really changed.
“We are frequently told that high drug prices are justifiable in order to promote innovative new cures, but the cost of insulin — a longstanding therapy that 1.25 million Americans with type 1 diabetes rely on to live — has nearly doubled in the last five years, despite very little change in the underlying product,” Brennan said in a statement.
The research found that shortages or increased need weren’t to blame for the price increase. HCCI said insulin use went up just 3% over the period. Insulin delivery methods are changing, though. Syringes remain the most common method (53% of insulin used in 2016), but that usage declined from 61% in 2012. Meanwhile, prefilled insulin pens are becoming more common, having increased from 38% of usage in 2012 to 46% in 2016.

Medicaid advisory panel calls for phasing in DSH allotment cuts


  •  The Medicaid and Children’s Health Insurance Program Payment and Access Commission voted Thursday to recommend staggering reductions in payments to disproportionate share hospitals and changing the current methodology for allocating spending.
  • MACPAC approved of the measures 16-1 and plans to recommend them to Congress in the federal Medicaid advisory committee’s annual report later this year. The changes are projected to save the government anywhere from $1 billion to $5 billion over the next decade.
  • The $12 billion allocated in Medicare for disproportionate share payments is meant to offset the financial pressure on hospitals that serve larger populations of low-income patients. The current formula hasn’t been tweaked since 1992.

Policymakers have been concerned about the accuracy of calculating DSH and how the payments are targeted to certain states and certain types of hospitals.
The Affordable Care Act legislated DSH cuts because Medicaid expansion was supposed to cover more Americans, which would sharply lower hospitals’ uncompensated care costs and give their margins some relief.
Congress delayed the cuts before they were slated to start in 2014, and they’ve been procrastinating on them ever since. In an early 2018 spending bill, lawmakers authorized a one-year delay — and hospitals are bumping up against that deadline.
Congress has until Sept. 30 to decide what, if anything, to do about the DSH program. The cuts are slated to start in October, the start of federal fiscal year 2020.
Under current law, DSH payments are expected to be cut by $4 billion then and $8 billion a year through FY 2021-2025. MACPAC, however, recommends phasing in the cuts more gradually: $2 billion in FY 2020, $4 billion in FY 2021, $6 billion in FY 2022 and $8 billion a year in FY 2023-2029.
That measure received strong support from MACPAC, with multiple members voicing their approval of the suggestion, which should mitigate disruption for DSH hospitals and allow states some breathing room for adjusting other Medicaid hospital payment policies.
The second prong of MACPAC’s proposal is meant to minimize the amount of reductions in DSH funds currently being paid out to providers. As the reductions are being phased in, they would first affect the states that, historically, have been receiving more federal funds than they’ve been spending in the program.
In FY 2016, $1.2 billion in federal DSH allotments were unspent, MACPAC analyst Robert Nelb said. So this section of the recommendation would go far in trimming the fat.
However, another draft recommendation around the calculus of allocation proved a sticking point with one member of the advisory committee. The third draft recommendation suggests HHS tie DSH payments to the number of non-elderly, low-income individuals in a state, instead of the uninsured population.
Commissioner Darin Gordon, the one dissenting vote not to recommend the measures, didn’t support this idea, citing his preference for the rebasing factor being tied to the number of uninsured people in the state.
“I do believe the uninsured rate, which does have a strong correlation to uncompensated care, I think that is something that is fundamental,” he said at Thursday’s meeting.
Gordon’s rationale was that in the aggregate, non-expansion states would do worse under the third draft recommendation than under current law.
This concern, of potential spillover effects for states that expanded Medicaid from the policy choices of states that elected not to following2012’s Supreme Court decision, resonated with the committee.
“In a program by statute defined to have a limited pool [of money], the moment you say we’re only going to look at that state’s decisions, you have a negative effect on others,” commissioner Alan Weil said.
The American Hospital Association and America’s Essential Hospitals both sent representatives to MACPAC’s meeting voicing their wariness of changes to the DSH program and to advocate against the ACA Medicaid DSH allotment reductions altogether.
“This crucial funding stream will essentially be gutted,” said AEH senior policy analyst Zina Gontscharow, who also noted the funding stream as is doesn’t cover all uncompensated care costs hospitals take on.
AHA continues to urge Congress to push back the cuts until more Americans are insured, executive VP Thomas Nickels wrote in a letter to MACPAC. He also voiced his concern over the proposed restructuring of the allotment methodology, alleging it could end up shifting larger sums of money around than the reduction alone.
Squabbling over DSH is all the rage right now — the nation’s highest court has even gotten involved. Oral arguments began in the U.S. Supreme Court earlier this month in a case over whether CMS needed stakeholder comment before changing the formula used to calculate DSH payments.
And in December, Florida Republican Sen. Marco Rubio proposed tweaking the funding formula so a state’s allotment is tied to its population of adults below the poverty level.
There’s huge variation in DSH payments depending on where you are in the country. Florida, under current law, receives one of the lowest allotments.
States that receive the lion’s share of DSH funding will face the biggest cuts if they go into effect, including Alabama, New York and South Carolina.

Fewer Americans see doctors in their offices: CDC


  • Americans made an estimated 883.7 million visits to physician offices in 2016, down from 990.8 million in 2015, according to new data from the Centers for Disease Control and Prevention.
  • That translates to about 278 office-based visits per 100 people, compared with 313 the prior year. More women than men visited a doctor, while infants and older adults outpaced rates for those aged 1 to 64.
  • Private insurance was the chief source of payment for 54% of all office-based physician visits, followed by Medicare (26%), Medicaid (15%) and no insurance (3%).

The new figures come as value-based payment is shifting more care in outpatient settings, but options like telehealth and retail clinics are eating into some traditional office-based encounters.
A recent study in JAMA found annual telehealth visits among commercially insured consumers jumped 52% a year from 2005 to 2014 and a whopping 261% from 2015 to 2017. Many of those are encounters that would otherwise likely have occurred in a physician’s office, urgent care or emergency room.
Patients who use telehealth services tend to be younger, disproportionately female and looking for easy, timesaving ways to connect with doctors or other healthcare professionals.
Regardless of how people access care, they want providers who are readily available and convenient to use. According to NRC Health’s 2019 Healthcare Consumer Trends Report, patients’ positive feelings about their provider didn’t override concerns about support staff, wait times and billing and insurance, even when they held their provider in high regard. Of more than 223,000 surveyed, 51% said access and convenience are their key reasons for choosing a provider.
According to the CDC, 86% of adults and 96% of children had a usual place they received healthcare in 2016, in most cases a doctor’s office.
Chronic conditions were the No. 1 reason people visited the doctor’s office, accounting for 37% of all encounters. Next were “new problems” (27%), preventive care (23%), injuries (7%) and pre- or postoperative care (6%).
Nearly half (48%) of all office-based visits involved an examination or screening. Other services provided included laboratory tests (29%), education and counseling (22%), imaging (14%) and procedures (14%). Comparatively, children outpaced adults for preventive visits, while adults accounted for more visits involving imaging services.
When it comes to payment, private insurance was the primary source for 63% of children and 71% of people aged 18 to 64. However, roughly a third (32%) of children relied on Medicaid. Among adults over 64, Medicare was the primary payment source (82%), with only 14% listing private health insurance.
The report is based on the National Center for Health Statistics’ National Ambulatory Medical Care Survey and covers doctors providing direct patient care in office-based practices. It excludes doctors working in community health centers.

Brain cancer’s empty pipeline


Brain tumours kill more people aged under 40 than any other cancer, yet there have been no new treatments for more than a decade. What’s more, there are still none in the pipeline. As part of pharmaphorum’s Listening to the Patient Voice series, we talk to the Brain Tumour Charity about tackling unmet need, redesigning clinical trials and the Tessa Jowell effect.
Despite huge advances in the way we treat and tackle cancer, the average five-year survival rate brain cancer is stuck at under 30%.
And that shows no signs of improving anytime soon. According to an Institute of Cancer Research report published in December, From Patent to Patient, there were no new indications for brain cancer treatments between 2000 and 2016.
Cameron Miller talks about brain tumours“That’s hugely concerning,” says Cameron Miller, head of policy and public affairs at the charity. “It means that as a community, not only are we behind the curve, but we are behind the curve with nothing new coming through.
“That’s not to say there isn’t hope and with our investment commitment of over £20m, we hope that this will change.”
Around 11,000 primary brain tumours are diagnosed in the UK each year, compared to around 55,000 cases of breast cancer or 47,000 prostate cancers.
Becky Birch, head of research at the advocacy group, explains that these are relatively small numbers, particularly when all the different brain tumour types were considered.
“One of the biggest problems we have is finding drugs that can cross the blood-brain barrier, but on top of that it’s just not an attractive space to develop drugs in,” she says.
“The small patient numbers mean it is generally not very profitable and that it is difficult to conduct trials that would move the basic science into the clinic. Randomised controlled trials are just not feasible in these small numbers with such short life expectancy.”
 Rethinking trials 
That’s not to say the quest for better treatments should be abandoned. Rather, researchers should think about collaborating and fundamentally rethink how they “do” trials.
Becky says: “It’s so expensive to get a drug to market, but when something fails, we need to try to understand why, not just throw the baby out with the bath water. Can we tweak failed compounds slightly to make them fit for purpose?
“We also need to develop better pre-clinical studies and models to make sure the drugs that are pushed forward into phase one and two trials are more likely to succeed. That’s far more cost effective and it will get treatments tested and to the patients quicker.”
Collaboration across countries would also help by increasing the overall number of people participating in a trial – something the charity is encouraging through its grant awards criteria.
 Adaptive design
It has also contributed funding for a new adaptive trial, designed to accelerate access to future drugs.
The Tessa Jowell BRAIN-MATRIX, named in honour of the late politician and campaigner, will allow new treatments to be added as soon as they are ready to be tested.
There is still a long way to go, explained Cameron, but patient advocacy was driving change.
“The incredible advocacy of Dame Tessa has driven the movement forward. She was able to utilise the patient voice and get the support of the Government behind the things we as a charity have been asking for.”
All stakeholders need to work together to tackle these huge unmet needs, from finding a cure to developing ways to help improve quality of life.
Understanding desperation
Cameron adds: “All parties need to listen carefully to one another, to fully appreciate the challenges.
“Patient groups need to listen to the pharmaceutical industry, pharma need to listen to patients. Once you can understand the problem in its entirety, then you can start to look for solutions.
Long term effects, such as the visual and cognitive problems caused by aggressive brain surgery as a child, can have a huge impact on quality of life. Many children who “recover” from low-grade tumours are never able to live independently as adults.
Ultimately, pharma has a lot to gain from listening to such concerns and working on ways to help, said Cameron.
“I don’t think a profit motive is a wholly bad thing. If something can benefit patients then it doesn’t matter if companies are gaining from it as well,” he said.
“What is important is advancing more and better treatments, whether they come from pharma, academic intuitions or third sector organisations.”
Sadly, there is currently nothing to shout about in terms of new brain tumour treatments, but that isn’t to say there isn’t hope, he adds.
“We just need to ensure that all groups work together to help us find the better treatments we so desperately need.”