With a deadline looming, California’s health exchange and a major insurer pressed Republican leaders in Washington to clear up confusion over their commitment to key provisions of the Affordable Care Act.
Health insurers participating in the Covered California exchange for individuals and families must submit initial rates for 2018 on Monday. Peter Lee, the exchange’s executive director, warned in a conference call Thursday that rates could jump by more than 40 percent if the Trump administration and Republican-led Congress walk away from crucial elements of the health law.
In the meantime, House Republicans are looking to revive their Obamacare replacement bill and rally more support among moderate lawmakers in hopes of holding a vote soon.
In addition to Covered California, the chief executive of Molina Healthcare, a Long Beach-based insurer, implored Congress and the Trump administration on Thursday to act quickly to stabilize the exchange markets.
At issue are the continued federal funding of subsidies that reduce low-income consumers’ deductibles and copays and the enforcement of the individual mandate to purchase health coverage or pay a penalty.
Premiums in Covered California plans could increase by 42 percent, on average, if those subsidies aren’t funded and the mandate isn’t enforced, according to an analysis released Thursday by the exchange. Covered California has about 1.3 million customers.
Lee said it is imperative for leaders in Washington to clear up the uncertainty to avoid damaging insurance markets nationwide and hurting consumers. He said statements this week by the Trump administration that it would continue funding the cost-sharing subsidies haven’t specifically addressed whether that applies to all of 2017 or 2018.
“Health plans need to know now what are the rules of the road,” Lee said. “Insurers are considering their participation in the face of unprecedented uncertainty.”
Much of the debate this week in Washington has centered on House Republicans amending their Obamacare replacement bill, the American Health Care Act. But Lee said addressing the current market rules should be a priority ahead of crafting broader legislation.
Lee declined to comment on the latest legislative proposal from House Republicans, but he noted it still faces a long road ahead in Congress before it would win approval. “Health plans need to submit bids for today’s reality. Policymakers need to address that reality,” Lee said.
In a letter to House Speaker Paul Ryan and other congressional leaders, Molina Healthcare CEO J. Mario Molina said the cost-sharing reduction subsidies are essential for making coverage affordable for many consumers. Those subsidies cover out-of-pocket costs for exchange customers with incomes below 250 percent of the federal poverty level. They are separate from the tax credits that subsidize premium costs.
Without that federal funding, Molina wrote, “we will have no choice but to send a notice of default informing the government that we are dropping our contracts for their failure to pay premiums and seek to withdraw from the marketplace immediately.”
Molina said his company currently serves more than 1 million people through insurance exchanges in California and several other states. Molina had nearly 69,000 enrollees in Covered California as of December, state data show.
Anthem, California’s largest for-profit health insurer and a key player on exchanges nationally, issued a similar warning this week. During an earnings conference call on Wednesday, Anthem CEO Joseph Swedish said the insurer may exit some state exchanges or resubmit for higher rates if the fate of the cost-sharing subsidies isn’t resolved by early June.
Anthem has more than 310,000 customers in the California exchange, or nearly 25 percent of the market. Rival Blue Shield of California is the leader in state enrollment with 389,480, or 31 percent market share.
Republican leaders in Congress say they will address these concerns and move quickly to aid consumers by replacing the ACA with a plan that will reduce premiums and expand options for coverage.
The health law “is collapsing,” Ryan said at a news conference Thursday. “The American health care system in the individual market is in peril right now. We have a moral obligation to prevent people from getting hurt, to stop the damage from being continued.”
Many conservative Republicans oppose the Trump administration’s decision to continue to pay the cost-sharing subsidies, calling the subsidies unconstitutional because they lack congressional approval. House Republicans successfully sued to block the payments, but a judge put the ruling on hold while the Obama administration appealed the case. It’s not yet clear how President Donald Trump will handle that appeal.
Amid this political uncertainty, California Insurance Commissioner Dave Jones told insurers this week they could submit two sets of rate filings on Monday for their exchange business. One filing would reflect continued funding of cost-sharing subsidies and enforcement of the individual mandate. A separate filing could assume the opposite.
“In light of all the actions taken by the Trump administration and House leadership to undermine the ACA, I expect that health insurers will consider filing significant rate increases for 2018,” Jones wrote in a bulletin to insurers this week.
For 2017, rates in Covered California rose by 13.2 percent, on average, statewide. The state exchange is one of the few that actively negotiates rates with insurers. Premiums for the next year usually are announced in July.
Categories: California Healthline, Cost and Quality, The Health Law
Tags: Insurers, Premiums, Subsidies, Trump Administration, U.S. Congress
California regulators are proposing a strict limit on a toxic man-made chemical that has contaminated water supplies throughout the state, particularly in its vast agricultural heartland.
California would be only the second state, after Hawaii, to establish a threshold for the former pesticide ingredient and industrial solvent known as TCP (1,2,3-trichloropropane) in drinking water. The chemical compound, identified in California as a human carcinogen, is no longer in wide use but has leached over the years into many wells and reservoirs.
The problem extends well beyond California and Hawaii, environmental advocates say, but the chemical is not regulated by the federal government. Citing federal data, the Environmental Working Group, a Washington, D.C.-based advocacy organization, says the chemical also has been detected in water supplies of a dozen other states, including New York, Pennsylvania and New Jersey, as well as Puerto Rico.
Once TCP gets into the groundwater, it “persists for centuries,” according to the EWG’s April report.
The California State Water Resources Control Board’s proposal would set the maximum allowable amount of TCP in public tap water at five parts per trillion — the lowest level that existing filtration systems can reliably detect and far lower than Hawaii’s.
It “is a top priority for the state water board,” said board spokesman Andrew DiLuccia.
TCP taints water systems serving nearly a million people from Sacramento to San Diego, according to the state water board. The compound is present at levels above the proposed limit in 562 wells, reservoirs and other sources belonging to 94 public water systems, according to 2016 data. Those numbers do not include private wells.
In California, the contamination exists in many urban areas, including in Los Angeles, San Bernardino and San Mateo counties. Though the source in those more populated regions is not known, the pollution is believed to come from industrial and hazardous waste sites.
“Los Angeles has quite a bit of contamination,” said Andria Ventura, toxics program manager for the environmental advocacy group Clean Water Action. “It’s hard for water providers to pinpoint where it came from.”
But California’s most serious and widespread TCP contamination is in the agricultural counties of the Central Valley, where the chemical was an ingredient in soil fumigants sold by the Shell Oil and Dow Chemical companies from at least the 1950s into the 1980s.
During that period, farmers who grew potatoes, sugar beets and other vegetables used the fumigants to kill tiny, soil-dwelling worms called nematodes. Dozens of municipalities and public water suppliers across the state have filed lawsuits against Shell and Dow, alleging that the companies knew — or should have known — that the TCP in their soil-fumigating pesticides would migrate into groundwater and pose a serious health hazard.
Shell and Dow have denied wrongdoing. Shell quit selling its product, known as D-D, in the mid-1980s. About the same time, Dow opted to reformulate its fumigant, known as Telone, after which TCP declined to “generally undetectable” levels, according to company spokesman Jarrod Erpelding. He declined to comment further, citing pending litigation.
Shell sent an email response: “The former Shell agricultural product, last manufactured more than 30 years ago, contained trace amounts of 1,2,3 trichloropropane (TCP). It was used to control microscopic worms that attacked crops causing millions of dollars a year of crop loss for farmers, and was approved for use by the U.S. government and the State of California.”
Environmental advocates say the adoption of a regulatory limit for TCP is a crucial step to help cash-strapped, rural water districts pay for the cleanup of their drinking water.
“It allows the districts when they go into court to be very specific and say to the judge, ‘We’re going to need exactly this amount of money to purchase this kind of system to meet the state standards,’” said Bill Walker, managing editor at the Environmental Working Group and co-author of its report on the role of Shell and Dow in California’s TCP drinking water problem.
“It doesn’t guarantee they’ll win,” he said, “but it increases their leverage.”
At a public hearing on April 19, water board members heard testimony and received written comments on the proposed limit. Now the board is reviewing the input it received and will likely vote on the plan by summer, DiLuccia said.
The regulation would require water utilities to test their supplies for TCP and remove it from any public drinking water source that exceeded the threshold, starting in 2018.
The proposed limit is more stringent than Hawaii’s because it is as close as California could get to meeting its stated “public health goal” for TCP set in 2009, officials say.
Though it is difficult to know how long the California cleanup might take, the cost of TCP testing and subsequent cleanup could reach nearly $500 million over 20 years, according to one water board estimate.
TCP contamination “disproportionately impacts poor communities and communities of color,” said Jenny Rempel, of Community Water Center, a Visalia, Calif.-based advocacy group. “This is a problem where the cost should not be borne by taxpayers.”
Todd E. Robins, a San Francisco attorney who is representing more than two dozen of the water suppliers that are suing Shell and Dow, argues that the companies included TCP in their worm-killing pesticides to get rid of the compound without having to pay for proper disposal. It was a byproduct of unrelated manufacturing processes and, according to the suits, played no role in killing the plant-damaging worms.
“The TCP that we find today in groundwater is the result of past use of soil fumigants that contained TCP as an unnecessary ingredient,” Robins said. “Instead of paying for disposal costs, they started getting farmers to pay for them.”
“The saddest part of the story,” Robins added, “is that the … actual active ingredient breaks down in the soil after a matter of days and has rarely been detected in anyone’s groundwater.”
One of the lawsuits filed by Robins, on behalf of the Del Rey Community Service District in Fresno County, says the companies knew they could remove or reduce the amount of TCP in their pesticides without compromising its effectiveness but failed to do so.
The complaint calls TCP a “hazardous waste” — a byproduct created in the manufacturing of a different chemical, allyl chloride, that Shell and Dow used to make plastics and other commercial products.
An internal Shell memo uncovered in Robins’ litigation cites $3.2 million in savings from “cost avoidance for disposal” related to the allyl chloride operations. The memo is dated Jan. 20, 1983 — a year before the company stopped producing the TCP-laced pesticide.
In addition to the pending cases, which also name distributors and marketers as defendants, Robins said he has settled eight cases against both Shell and Dow since 2010. He said he cannot disclose the amounts because of confidentiality agreements.
Last December, in a case tried by a different lawyer, a Fresno Superior Court jury awarded the city of Clovis $22 million against Shell to clean up its TCP-tainted drinking water.
In 2010, in a case brought by the city of Redlands, Shell won. The company argued that a nearby aerospace plant was the source of the toxin. Moreover, the wells in question were used for irrigation, and the jury didn’t believe they’d ever be used for drinking water.
As the lawsuits proceed, some California residents do what they can to protest the toxic chemicals in their water supply. Bartolo Chavez, 57, took time off his job in a juice packing house to testify at the recent hearing in Sacramento.
“We talk about the contaminants and the danger,” said Chavez, who has lived for 21 years in the Central Valley town of Arvin, Calif. “And [that] we’re exposed.”
He said he gets tokens from the water district to get free filtered water — not just because of TCP but because of other contaminants as well, such as arsenic and chromium-6.
“But the tokens aren’t enough,” Chavez said, speaking through a Spanish-language interpreter. “So in addition, we buy bottled water at Costco.”
Chavez and his wife, a hotel worker, pay about $50 a month for that water — a price they say they can ill afford. But leaving Arvin isn’t an option either, Chavez said.
“I have thought about moving, but it’s not so easy to find work in other places, especially when you’re older,” he said. “Our house is almost paid off, and to move would be to start over again, so it’s almost impossible.”
California Healthline Managing Editor Bernard Wolfson contributed to this report. This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
Using new gene-editing technology, researchers have rewired mouse stem cells to fight inflammation caused by arthritis and other chronic conditions. Such stem cells, known as SMART cells (Stem cells Modified for Autonomous Regenerative Therapy), develop into cartilage cells that produce a biologic anti-inflammatory drug that, ideally, will replace arthritic cartilage and simultaneously protect joints and other tissues from damage that occurs with chronic inflammation.
The cells were developed at Washington University School of Medicine in St. Louis and Shriners Hospitals for Children-St. Louis, in collaboration with investigators at Duke University and Cytex Therapeutics Inc., both in Durham, N.C. The researchers initially worked with skin cells taken from the tails of mice and converted those cells into stem cells. Then, using the gene-editing tool CRISPR in cells grown in culture, they removed a key gene in the inflammatory process and replaced it with a gene that releases a biologic drug that combats inflammation.
The research is available online April 27 in the journal Stem Cell Reports.
“Our goal is to package the rewired stem cells as a vaccine for arthritis, which would deliver an anti-inflammatory drug to an arthritic joint but only when it is needed,” said Farshid Guilak, PhD, the paper’s senior author and a professor of orthopedic surgery at Washington University School of Medicine. “To do this, we needed to create a ‘smart’ cell.”
Many current drugs used to treat arthritis -; including Enbrel, Humira and Remicade -; attack an inflammation-promoting molecule called tumor necrosis factor-alpha (TNF-alpha). But the problem with these drugs is that they are given systemically rather than targeted to joints. As a result, they interfere with the immune system throughout the body and can make patients susceptible to side effects such as infections.
“We want to use our gene-editing technology as a way to deliver targeted therapy in response to localized inflammation in a joint, as opposed to current drug therapies that can interfere with the inflammatory response through the entire body,” said Guilak, also a professor of developmental biology and of biomedical engineering and co-director of Washington University’s Center of Regenerative Medicine. “If this strategy proves to be successful, the engineered cells only would block inflammation when inflammatory signals are released, such as during an arthritic flare in that joint.”
As part of the study, Guilak and his colleagues grew mouse stem cells in a test tube and then used CRISPR technology to replace a critical mediator of inflammation with a TNF-alpha inhibitor.
“Exploiting tools from synthetic biology, we found we could re-code the program that stem cells use to orchestrate their response to inflammation,” said Jonathan Brunger, PhD, the paper’s first author and a postdoctoral fellow in cellular and molecular pharmacology at the University of California, San Francisco.
Over the course of a few days, the team directed the modified stem cells to grow into cartilage cells and produce cartilage tissue. Further experiments by the team showed that the engineered cartilage was protected from inflammation.
“We hijacked an inflammatory pathway to create cells that produced a protective drug,” Brunger said.
The researchers also encoded the stem/cartilage cells with genes that made the cells light up when responding to inflammation, so the scientists easily could determine when the cells were responding. Recently, Guilak’s team has begun testing the engineered stem cells in mouse models of rheumatoid arthritis and other inflammatory diseases.
If the work can be replicated in animals and then developed into a clinical therapy, the engineered cells or cartilage grown from stem cells would respond to inflammation by releasing a biologic drug -; the TNF-alpha inhibitor -; that would protect the synthetic cartilage cells that Guilak’s team created and the natural cartilage cells in specific joints.
“When these cells see TNF-alpha, they rapidly activate a therapy that reduces inflammation,” Guilak explained. “We believe this strategy also may work for other systems that depend on a feedback loop. In diabetes, for example, it’s possible we could make stem cells that would sense glucose and turn on insulin in response. We are using pluripotent stem cells, so we can make them into any cell type, and with CRISPR, we can remove or insert genes that have the potential to treat many types of disorders.”
With an eye toward further applications of this approach, Brunger added, “The ability to build living tissues from ‘smart’ stem cells that precisely respond to their environment opens up exciting possibilities for investigation in regenerative medicine.”
A research team from iMM Lisboa led by Luís Graça has found a cellular mechanism that underlies the development of autoimmune diseases.
The immune system is responsible for our body’s defense against infections. However, an inefficient and uncontrolled defense can lead to certain lesions and result in autoimmunity.
The study, published in Nature Communications, builds on previous observations from the same team who found that a specific type of cells regulate antibody production. They hypothesized there was probably a marked division of tasks between different cells of the immune system: those that help the production of antibodies (T follicular helper) and those that stop the production of antibodies against our own tissues (T follicular regulatory). The team developed experimental methodologies which allowed them to identify the molecular targets that lead to the formation of antibodies in both helper and regulatory cells.
The development of autoantibodies is one of the key factors for the development of several autoimmune diseases, such as lupus or rheumatoid arthritis.
As such, to be able to identify the specific cells that regulate the production of antibodies and that suppress the actions of the immune system may lead to the development of novel forms of diagnostic or treatment, including more efficient vaccines.
Using CRISPR technology, a team of researchers rewired stem cells’ genetic circuits to produce an anti-inflammatory arthritis drug when the cells encounter inflammation. The technique eventually could act as a vaccine for arthritis and other chronic conditions. Visit the Source Site
A drug combination that could help thousands of children with arthritis has been discovered by a team of researchers. Children and adolescents with Juvenile Idiopathic Arthritis (JIA) are likely to develop uveitis, a condition that causes inflammation in the middle layer of the eye. The drug combination discovery will help preventing them from serious complications, including blindness. Visit the Source Site
Citing budget-busting drug costs, a California lawmaker wants state health programs to band together to negotiate better prices with drug companies.
Assemblymember David Chiu (D-San Francisco) has introduced a bill that would strengthen intra-agency collaboration on drug cost-saving strategies. Lawmakers will consider the bill at an Assembly Health Committee hearing on Tuesday.
“Californians and Americans are frustrated with the lack of progress around drug prices,” Chiu said, citing the uproar over EpiPen and hepatitis C medications.
He said state agencies should pool their efforts “so that we can leverage that consumer power and get the best deal for our money.”
While the proposed California Drug Costs Reduction Act does not mandate that various California health programs such as Medi-Cal or Covered California purchase drugs together, it would require administrators of those programs and 17 other state agencies to convene twice a year to strategize about ways to keep costs down.
Through the California Pharmaceutical Collaborative (CPC), state officials would consider a uniform state drug formulary and look at paying for drugs based on the value they bring to the health system.
A pharmaceutical collaborative by that name already exists within the California Department of General Services and purchases drugs for state prisons, hospitals and universities. This bill would expand on those efforts.
Chiu says it’s unclear what the current program is doing, and if it has been successful in bringing down drug costs. The 2002 legislation that created the collaborative required only a few agencies to participate, and only one report back to the legislature in 2005.
A 2005 report from the California State Auditor suggested the Department of General Services could do more to bring down pharmaceutical costs for California.
A more recent analysis from the nonpartisan Legislative Analyst’s Office showed spending by the Department of General Services has increased at a relatively high rate — about 20 percent annually between 2012 and 2016, although that trend may have been skewed by the release of high-cost hepatitis C drugs during that time.
“I haven’t had transparency about the work that’s happened,” Chiu said. During a February 2017 California legislative hearing about drug prices, the lawmaker expressed frustration about not being able to get information about the workings of the CPC.
Chiu’s bill would require annual reports from the pharmaceutical collaborative, which the lawmaker says would ensure more accountability.
A spokesman with the Department of General Services, Brian Ferguson, wrote in a statement that it has been meeting “regularly” to create a “roadmap” to cut drug costs.
The proposal so far has no registered opposition. Priscilla VanderVeer, a spokeswoman with the drug company trade association Pharmaceutical Research and Manufacturers of America (PhRMA) had no comment on the proposal.
Other states such as Massachusetts have bulk purchasing programs for drugs, according to the National Academy for State Health Policy. And Oregon and Washington have joined together to create a bulk purchasing program. It is one of five multi-state pharmaceutical programs in the country, according to the National Conference of State Legislatures.
About a third of Californians have health care coverage through Medi-Cal alone. Together with Covered California, and the California Public Employees’ Retirement System (CalPERS), these agencies insure more than 16 million people.
Experts say the diverse ways state programs pay for drugs would make it hard to implement an across-the-board prescription drug purchasing system in California.
Ben Johnson, fiscal and policy analyst with the Legislative Analyst’s Office said that the Medi-Cal program has different rules for payment and coverage than the state’s prison system. Medi-Cal is also entitled to deep drug discounts that other state agencies don’t receive.
“A lot of work would have to be done to be able to actually harmonize and create a uniform system of drug procurement in the state,” Johnson said. His agency does not take positions on legislation.
Advocates for AIDS patients and retired people support the bill. The California Public Interest Research Group (CALPIRG), which sponsored the initial legislation to create the collaborative in 2002, supports the current proposal as well. In a letter to the bill’s author, the group said the measure would provide “additional tools and direction” and increase accountability on the state government’s actions to reduce drug prices.
This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.
Categories: California Healthline, Pharmaceuticals
After Michael Uvanni’s older brother, James, was diagnosed with a deadly form of skin cancer, it seemed as if everyone told the family what they wanted to hear: Have hope. You can beat this, and we are here to help.
The brothers met with doctors at a half-dozen of the country’s best hospitals, all with impressive credentials that inspired confidence.
Michael Uvanni was in awe when he visited the University of Texas MD Anderson Cancer Center in Houston, one of the world’s most respected cancer hospitals. It was like seeing the Grand Canyon, said Uvanni, 66, of Rome, N.Y. “You never get used to the size and scope.”
Even the MD Anderson logo on buses and buildings — with “Cancer” crossed out in red, above the words “Making cancer history” — made the family’s battle seem winnable.
“I thought they were going to save him,” said Uvanni, an interior designer.
Patients and families are bombarded with the news that the country is winning the war against cancer. The news media hypes research results to attract readers. Drug companies promise “a chance to live longer” to boost sales. Hospitals woo paying customers with ads that appeal to patients’ fears and hopes.
“I’m starting to hear more and more that we are better than I think we really are,” said Dr. Otis Brawley, chief medical officer at the American Cancer Society. “We’re starting to believe our own bullshit.”
The consequences are real — and they can be deadly. Patients and their families have bought into treatments that either don’t work, cost a fortune or cause life-threatening side effects.
“We have a lot of patients who spend their families into bankruptcy getting a hyped therapy that [many] know is worthless,” Brawley said. Some choose a medicine that “has a lot of hype around it and unfortunately lose their chance for a cure.”
Although scientists have made important strides in recent years, and many early-stage cancers can now be cured, most of those with advanced cancer eventually die of their disease.
For Uvanni, hope gave way to crushing disappointment when his brother’s health declined and he died from metastatic melanoma in 2014.
“You get your hopes up, and then you are dropped off the edge of a cliff,” said Uvanni. “That’s the worst thing in the world.”
Caregivers like Uvanni can suffer prolonged grief and guilt if their loved ones are riddled with side effects and don’t survive as long as the family expected, noted Holly Prigerson, co-director of the Center for Research on End-of-Life Care at Weill Cornell Medical College.
For decades, researchers have rolled out new cancer therapies with great fanfare, announcing that science has at last found a key to ending one of the world’s great plagues, said Dr. Vinay Prasad, an assistant professor of medicine at Oregon Health & Science University. When such efforts fail to live up to expectations, the cancer world simply moves on to the next big idea.
Hyping early scientific results — based on lab tests or animal studies — can attract investors that allow researchers to continue their work. Positive results can lead biotech firms to be bought out by larger drug companies.
“It’s in the interest of almost every stakeholder in the health system to be optimistic about these therapies,” said Dr. Walid Gellad, co-director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
Uvanni says his brother may have gotten more time from the many drugs he tried during his illness but that his quality of life was mostly terrible. (Mike Roy for KHN)
Of course, there is plenty of money to be made.
The U.S. spent nearly $88 billion treating cancer in 2014, with patients paying nearly $4 billion out-of-pocket, according to the American Cancer Society Cancer Action Network. Spending on cancer, a disease that most afflicts the aging, is predicted to soar as people live longer.
“While many people are trying to make patients’ lives healthier and longer and better, there are others that are exploiting their vulnerability,” said Dr. Leonard Saltz, chief of the gastrointestinal oncology service at New York’s Memorial Sloan Kettering Cancer Center.
Others argue that the excitement about cancer research is justified. A spokeswoman for the Pharmaceutical Research and Manufacturers of America, an industry group, said cancer patients have good reason for optimism.
“We continue to see great strides in identifying the genetic mutations and related factors that can drive the seemingly random formation of abnormal cells in cancer,” spokeswoman Holly Campbell said in a statement. “In the last decade, we’ve seen a number of scientific advances transform the landscape of many cancers.”
Promises To Cure Abound
Even the country’s top scientists sometimes get carried away.
In 1998, Nobel laureate James Watson — who co-discovered the structure of DNA — told The New York Times that scientists would “cure cancer in two years” using drugs that block tumor blood supplies. At that time, the drugs had succeeded only in mice.
In 2003, the director of the National Cancer Institute, Dr. Andrew von Eschenbach, announced a goal of “eliminating suffering and death due to cancer by 2015” by better understanding tumor genetics.
Last year, when President Barack Obama announced the Cancer Moonshot, which aims to accelerate and better coordinate research, he said, “Let’s make America the country that cures cancer once and for all.”
In a recent interview, von Eschenbach acknowledged he didn’t communicate his goal well.
“We all fall into that trap,” said von Eschenbach, now a senior fellow at the Milken Institute, a health and public policy think tank. “We’re offering what we have, but making it appear that it’s more than what it is.”
It’s easy to see how patients’ hopes are raised, said Timothy Turnham, former executive director at the Melanoma Research Foundation, an advocacy group. Researchers are frequently overly enthusiastic about early discoveries that have little chance of leading to a new drug.
“There is a disconnect between what researchers think is statistically significant and what is really significant for patients,” Turnham said. “Patients hear ‘progress,’ and they think that means they’re going to be cured.”
A Marketing Blitz
Uvanni said his brother’s experience was nothing like the sunny images in TV commercials, in which smiling cancer patients hug their grandchildren, hike in the mountains and lead dance classes.
A TV commercial for the Bristol-Myers Squibb drug Opdivo projects the words “a chance to live longer” on the side of skyscrapers, as a captivated crowd looks on. In much smaller type, a footnote reveals that lung cancer patients taking Opdivo lived just 3.2 months longer than others.
(Screenshot of Opdivo TV Commercial)
(Screenshot of Opdivo TV Commercial)
A TV ad for Merck’s Keytruda features reassuring images of a smiling, healthy patient hugging her family — not fighting for breath or struggling to walk. Although the commercial notes that the people in the ad are portrayed by actors, the commercial claims the drug provides “a chance for a longer life. It’s Tru.”
“Your heart sinks when you see those ads,” Uvanni said. Seeing the family depicted in the ad, he said “makes you wonder if they’re going down the same path that we did.”
The Keytruda ad notes that 71 percent of patients given the drug were alive “at the time of patient follow-up,” compared with 58 percent of those who received chemotherapy. The ad doesn’t mention that the “time of follow-up” was 11 months.
(Screenshot of Keytruda TV Commercial)
“It’s not false; it’s just incomplete,” said pharmacist Harold DeMonaco, a visiting scientist at the Massachusetts Institute of Technology in Boston. “They don’t give patients or the patients’ family enough information to make a reasonable decision.”
In an interview, Merck senior vice president Jill DeSimone said that the company aims to be responsible with its advertising, noting that the Keytruda ad reminds patients to talk to their doctors. “The physician is the ultimate decider on treatment,” DeSimone said.
In a statement, Bristol-Myers’ senior vice president Teresa Bitetti said that Opdivo ads play “an important role in educating patients about new treatment options and fostering informed conversations between patients and their doctors.”
Hospitals also have drawn criticism for overstating their success in treating cancer. In 1996, Cancer Treatment Centers of America, a for-profit chain, settled allegations from the Federal Trade Commission that “they made false and unsubstantiated claims in advertising and promoting their cancer treatments.”
The company’s current commercials — dozens of which are featured on their website — boast of offering “genomic testing” and “precision cancer treatment.”
The commercials don’t tell patients that these tests — which aim to pair cancer patients with drugs that target the specific mutations in their tumors — are rarely successful, Prasad said. In clinical trials, these tests have matched only 6.4 percent of patients with a drug, according to Prasad’s 2016 article in Nature. Because these drugs only manage to shrink a fraction of tumors, Prasad estimates that just 1.5 percent of patients actually benefit from precision oncology.
In a statement, Cancer Treatment Centers of America said, “We use national media to help educate cancer patients and their families about the latest diagnostic tools and treatment options. … All of our advertising undergoes meticulous review for clinical accuracy as well as legal approval to ensure we tell our story in an informative and responsible manner, and in compliance with federal guidelines.”
Spending on ads for hospitals that treat cancer soared 220 percent from $54 million in 2005 to $173 million in 2014, according to a 2016 article in JAMA Internal Medicine. Ads for Cancer Treatment Centers of America accounted for nearly 60 percent of all total cancer center advertising.
For more than a decade, the Food and Drug Administration approved no new treatments for metastatic melanoma. Patients typically died within a year of diagnosis.
Since 2011, however, the FDA has approved 11 new treatments, including several immunotherapies, which aim to harness the immune system to fight cancer. Last year, doctors leading a clinical trial announced that the median survival of patients taking the drug Keytruda had grown to two years. Forty percent of patients were alive three years later, according to the clinical trial, presented at the American Society of Clinical Oncology.
Researchers have tested immunotherapies against a variety of tumors, leading to approvals in lung cancer, kidney cancer, bladder cancer and others.
Such success has led doctors to label cancer immunotherapy as a “game changer.” Newspapers and magazines call it a “breakthrough.” And hospitals laud them as “a miracle in the making.”
Yet these treatments — which were initially assumed to be gentler than chemotherapy — can provoke fatal immune system attacks on the lungs, kidneys, heart and other organs.
And there are no approved immunotherapies for tumors of the breast, colon, prostate and pancreas.
Only about 10 percent of all cancer patients can expect to benefit from immunotherapy, Prasad said.
Uvanni’s brother — who tried immunotherapy, as well as a number of other approved and experimental treatments — survived 3½ years after his diagnosis. That might lead many oncologists to describe his story as a success.
Uvanni sees no reason to celebrate. He wanted more than short-term survival for his brother.
“I thought we were going to have a treatment where we’d at least have a good block of quality time,” Uvanni said.
But treatments meant to control the cancer only made him sick. Some caused flu-like symptoms, with fever, chills and shakes. Others left him nauseated, unable to eat or move his bowels. Others caused dangerous infections that sent him to the emergency room.
“I hope that if something like that happens to me,” Uvanni said, “I would be strong enough to say no to treatment.”
Categories: Cost and Quality, Health Industry, Mental Health, Pharmaceuticals
House Republicans were making headway in efforts to build support for a reworked plan to overhaul the U.S. healthcare system, but have not decided when to vote, House Speaker Paul Ryan said on Thursday.
Ryan spoke as Republican leaders scoured the U.S. Capitol in search of centrist Republican backing for the amended measure after it gained the approval on Wednesday of a group of hard-right Republican conservatives who had helped to sink the original version last month.
“We’re making very good progress,” Ryan told reporters at a news conference, saying the changes endorsed by conservative Freedom Caucus Republicans on Wednesday would also appeal to moderate Republicans.
The House could vote as early as this week on the legislation, aides said, meaning it could pass the House in time for President Donald Trump’s 100th day in office on Saturday.
It remained unclear whether the amended bill could attract the 216 votes needed to pass the House, given the united Democratic opposition. Its future is further clouded in the Senate.
“We’re going to go when we have the votes,” Ryan said.
Republicans in Congress have made repealing and replacing the Affordable Care Act, commonly known as Obamacare, a central campaign promise for seven years. Republican President Donald Trump made it a top campaign promise.
But House Republicans are not keen to repeat last month’s debacle, when their leaders acquiesced to Trump’s demand for a floor vote on the bill, only to unceremoniously yank the measure after determining it could not pass.
The Republican healthcare bill would replace Obamacare’s income-based tax credit with an age-based credit, roll back an expansion of the Medicaid government health insurance program for the poor and repeal most Obamacare taxes.
The nonpartisan Congressional Budget Office had estimated 24 million fewer people would have insurance under the original version.
The new amendment that has won over a number of conservatives, drafted by Representative Tom MacArthur, would allow states to seek federal waivers to opt out of some of the law’s provisions. That includes the highly popular provision mandating that insurers charge those with pre-existing conditions the same as healthy consumers, and that insurers cover so-called essential health benefits, such as maternity care.
Some centrists say the changes do not address their worries that the bill would hurt poor Americans in the Medicaid program. Others, including Republican Representative Dan Donovan of New York, said the loosening of protections for people with pre-existing medical conditions was a major problem.
“It’s going to cost people with pre-existing conditions even more money to have coverage … It’s something that we shouldn’t be doing,” Donovan said on CNN.
House Democrats on Thursday threatened to oppose a short-term government funding bill if the Republicans try to bring the healthcare bill to the floor this week.
Ryan brushed off this threat, even though Republicans are expected to need some Democratic votes to pass the funding bill.
House Democratic Leader Nancy Pelosi told reporters that Trump was making Republicans “walk the plank” on a healthcare bill that was “wildly unpopular.”
Ryan dismissed the idea that some Republican lawmakers’ House seats were at risk if they vote for the healthcare bill. “I think people’s seats are at risk if we don’t do what we said we would do” and repeal Obamacare, he said.
(Reporting by Susan Cornwell and Susan Heavey; Additional reporting by Amanda Becker and Will Dunham; Editing by Jeffrey Benkoe)