Finalist: Staff of Bloomberg
Nominated Work
By Robert Langreth, Tanaz Meghjani and Rachael Dottle
The moment she heard that her mother, then 67, had advanced breast cancer, Stacie Dusetzina began hunting for potential treatments. A cancer policy researcher at Vanderbilt University, Dusetzina knew the go-to drug in many cases was Pfizer Inc.’s Ibrance. She learned it might cost her mother, who lived on a fixed income, around $10,000 out of pocket annually.
Medicare, required by law to cover cancer treatment, would have paid much of the rest of the cost. At the time, in 2020, the pill listed for a jaw-dropping $160,000 a year, rising more recently to $214,000.
Despite having a PhD in pharmaceutical science, Dusetzina couldn’t figure out whether swallowing those costs — potentially for years — would help her mom live any longer or any better. Her research showed that while the drug might shrink tumors, no clinical trials proved it would extend her mother’s life. At the time of her search, Ibrance had already been on the market for five years. “I could not find any satisfactory data where I could say this is worth the money,” said Dusetzina, whose mother ended up not using the drug because she had a less common type of cancer. “It was really frustrating.”
Ibrance is one of the biggest-selling drugs in a revolution that has made new treatments available to American cancer patients faster than ever before. Prodded by legislation backed by drugmakers that allowed the Food and Drug Administration to speed approvals, the regulator greenlit more than 200 cancer drugs over the past three decades. Cancer treatments generated at least $200 billion in worldwide sales for the pharmaceutical industry last year, turning the once-sleepy oncology business into a gold mine more than 10 times bigger than obesity drugs.
The profusion of new treatments is a source of hope for many patients. Some drugs are game-changers, especially new immune therapies that teach the body itself how to destroy cancer cells. But the downside of approving so many drugs with so few hurdles is now clear: Many don’t prolong life at all, or do so only modestly, with problematic side effects. Indeed, fewer than half of the cancer drugs approved since 2000 that Bloomberg News reviewed based on their FDA labels have ever been shown to extend patient survival for any of their approved uses. Even fewer have been shown to improve cancer-related symptoms or quality of life.
In the past decade alone, drugmakers have made more than $50 billion on cancer drugs that so far have demonstrated no survival benefit, Bloomberg’s analysis shows.
“There is a myth that these cancer drugs are saving enormous numbers of lives,” says Richard Sullivan, a professor of cancer and global health at King’s College London. “It is not true.”
Trials are still underway that, according to the companies, could one day prove their drugs extend lives. Some treatments for rare cancers have kept patients in remission for years, even when they don’t have formal data from controlled survival trials. The genuine successes have helped many thousands of cancer patients live longer. The American Cancer Society says US cancer death rates have plummeted 34% since peaking in 1991, thanks to early detection, advances in medicines and a decline in smoking. Immunotherapies revolutionized treatment of melanoma, while also extending survival more modestly in cancers of the lung and other organs. Drugs that block specific overactive proteins have improved the outlook for certain types of breast cancer, leukemia and myeloma.
Still, an analysis in JAMA Oncology of a subset of major solid tumors estimated that four out of five cancer deaths averted from 1975 to 2020 were due to improved screening and preventive health measures, not new treatments. Survival rates remain relatively low for some types of advanced cancer, including advanced colon cancer — the second-biggest killer — and cancers of the pancreas and ovaries.
Advanced cancer generally can’t be cured, and the new medicines haven’t changed that. They’re still often used in combination with toxic chemotherapy and radiation, at a staggering cost: Bloomberg’s analysis found the median initial price of a new cancer drug has quadrupled after inflation since the early 2000s to about $25,000 a month in recent years. Meanwhile, a forthcoming study from Columbia University researcher Tito Fojo measured how long the average new drug treating the disease improves survival: about three months.
Sullivan says his patients assume every freshly licensed drug is “fantastic” — and “when you tell them that is not the case, they get super upset.”
The rise of what some doctors now call the “cancer industrial complex” is in part a familiar story of a captured regulator that draws much of its funding from the industry it’s supposed to monitor. In exchange for drug companies and medical device makers paying fees that now bring in almost half of the FDA’s $7 billion annual budget, Congress effectively has handed them ever-more ways to shorten testing and get priority treatment from agency reviewers.
This new cancer capitalism, though, is also a little-known tale of scientific gamesmanship. An empire of drugs grew out of the companies’ ability to exploit one specific marker: a measure of tumor growth known as “progression-free survival.” An obscure term used primarily by doctors until a standardized definition appeared in an academic journal in 2000, it’s since become a common justification for the FDA’s expedited approval of treatments. Researchers assumed that if a drug delayed the growth of tumors, it would also extend life. Recent studies have found the link is not so clearcut, and even one of the originators of the measure calls it arbitrary.
Yet demonstrating a 10-month improvement on this metric turned Pfizer’s Ibrance into a blockbuster. One thing it’s never been proven to do: prolong women’s lives. Ibrance was the top-selling drug in the Bloomberg survey that fell short on this measure, long considered the gold standard of clinical trials. Notably, a 2022 study showed no statistically meaningful improvement in survival for more than 600 women who were initially diagnosed with advanced breast cancer, the drug’s main use. Women would have to read deep into the fine print on page 19 of the label to find this out.
“It’s incredibly confusing for patients and their families to know what they’re signing up for,” says Vanderbilt’s Dusetzina.
Drug companies enhanced the groundswell for new treatments by working with patient advocacy groups, led by sympathetic spokespeople: cancer sufferers. The companies help fund the groups’ budgets, sponsor their conferences and sometimes pay members to consult on studies. Hospitals, for their part, share in the markups for administering the drugs and also get paid for bringing patients to trials.
Sometimes it did. Often, it didn’t. A review in the European Journal of Cancer found that two-thirds of drug trials aiming to slow progression of solid tumors were deemed successful from 1999 to 2015. This turned out to be a surprisingly poor predictor of whether patients live longer — which happened in only 38% of those cases.
The manufacturers got an additional fast track with Congressional approval of another category known as “breakthrough therapy” drugs. The concept came from Friends of Cancer Research, a group founded by Ellen Sigal, a real estate developer with a Russian literature PhD whose sister had died of cancer. She co-authored a column for The Hill with a former FDA commissioner in April 2012, calling for the “breakthrough” designation for agents that looked promising early in testing.
The effort came at a time of particularly high enthusiasm for cancer drugs, after multiple medicines had bolstered survival in advanced melanoma, previously considered one of the toughest to treat.
Sigal’s group hosts regular roundtables bringing together companies and regulators; Pazdur is a frequent speaker at its events. About 64% of its $6.8 million in funding last year came from drug and biotech companies including Pfizer, Sanofi and Amgen Inc., according to Friends. “The challenges we aim to address arise and evolve due to the rapid pace of scientific progress,” a spokesperson says. “That is the source of our agenda and the projects which we take on, not directives from industry or any one party. No matter the topic we strive toward evidence-based solutions.”
The law Congress passed in 2012 required the FDA to consider requests for the new “breakthrough” designation within 60 days and to work with the sponsor on a trial design that would be “as efficient as practicable… such as by minimizing the number of patients.” The law also endorsed the concept of using short-term clinical data as the basis for expedited approvals. In the decade through 2020, 85% of the drugs granted accelerated approval treated cancer, many premised on preventing tumor growth.
It became a shortcut to a financial, not a medical, blockbuster that rewards investors faster, says Christopher Booth, an oncologist at Queen’s University in Ontario. “The bar is lower,” he says. “You just need to show that you can delay tumor growth by literally eight weeks without having the patient live any longer or feeling better. And that’s a multi-billion-dollar drug right there.”
In the program’s first full year, the FDA got more than 90 applications for the new breakthrough designation. Among them was a drug from Pfizer called palbociclib.
Researchers from the University of California at Los Angeles had been investigating a Pfizer compound, PD-0332991, in the lab since the mid-2000s. Now better known by its brand name, Ibrance, palbociclib appeared to target specific proteins, CDK4 and CDK6, that can become overactive and lead to the development of the most common type of advanced breast cancer. After a clinical trial at UCLA on 12 women, four had significant responses.
The researchers embarked on a Phase 2 trial of the drug that eventually included 165 patients. The FDA granted breakthrough status in April 2013 after initial results showed it significantly delayed the growth of tumors in combination with a standard hormone treatment.
Reviews with an agency team followed, as mandated by the new law. Some staffers pointed out that the pivotal study was small, according to meeting minutes later made public. They noted that it was hard to draw conclusions because a portion of the trial studied only women with certain genetic alterations. Pfizer hoped to get approval to use the drug more widely.
That May, a team from the FDA gathered with Pfizer executives in a conference room in Silver Spring, Maryland. An agency reviewer called the initial results encouraging and said it looked forward to seeing more comprehensive Phase 3 data, recalls Mace Rothenberg, then head of development for Pfizer’s oncology unit. That could add years. Then, he remembers, Pazdur’s voice boomed in from a loudspeaker on the ceiling: “I am not so sure I agree with that.”
The oncology chief hadn’t spoken until that point, but argued the trial challenges could be overcome. “We knew we had some traction,” Rothenberg recalls.
Pazdur’s wife, Mary, who’d worked at MD Anderson as an oncology nurse, was at the time herself suffering from ovarian cancer. That, and the new law, had helped motivate him: “I have been on a jihad to streamline the review process and get things out the door faster,” as he later told one interviewer.
Pfizer formally submitted its application the next year. The company was slated to defend the drug before an external panel of advisers for a vote the FDA suggested could take place in February 2015. Rothenberg says he assigned staffers to prepare hundreds of slides for potential use during the meeting. Then, late in 2014, Pazdur called and told him the agency had decided against the panel.
The drug won accelerated approval in the same month the advisory panel would’ve met. One condition was that Pfizer follow up with the results of its larger trial, including overall survival data by November 2020.
Ibrance was an almost immediate hit for Pfizer. It beat competing medicines from Novartis AG and Eli Lilly & Co. to the market by two years. At an investment conference in New York in February 2015, Lazard’s Stephen Sands congratulated its chief executive officer, Ian Read, on winning such rapid approval with preliminary results. “That was unexpected by the marketplace, I think everybody was surprised,” he said.
“We started delivering product the day of the launch,” Albert Bourla, who was then running Pfizer’s oncology and vaccines business, told investors a month later. “Our reps were trained immediately after the approval and we had increased our salesforce the year before, so they were ready.”
In October, Pfizer reported that quarterly growth in oncology revenues had reached 54%, driven by Ibrance, Analysts on earnings calls showered executives with compliments — “great launch” — over the next year as doctors issued tens of thousands of prescriptions.
Pazdur, too, won praise. In the five years following passage of the breakthrough law, the FDA approved almost 50 new cancer drugs, more than it had in the previous decade. Pazdur earned a new public profile: Fortune in 2015 put him on the magazine’s list of the “World’s 50 Greatest Leaders” for his work in getting more cancer medications to market. (Pope Francis and Apple Inc. leader Tim Cook were among the others.) In November that year, Pazdur’s wife died.
Ibrance sales topped $2.1 billion in 2016, and the FDA granted additional approval that year for use in women who had failed other treatments. After a larger trial confirmed the initial results showing delayed tumor growth, the FDA converted its accelerated approval to a full blessing in 2017.
Bourla was elevated to CEO in 2019. The next year, Ibrance sales reached $5.4 billion, making it one of the company’s top three products and accounting for 13% of revenue.
One Pfizer deliverable wasn’t forthcoming: The overall survival data it had originally promised to submit to the FDA by November of that year.
Its competitors had already raced ahead with additional studies of their own, even though they’d entered the market later. The Eli Lilly drug proved in a 2019 study to prolong survival in breast cancer patients who had failed other therapies. Two years later, the Novartis product showed it prolonged survival a full year when used as an initial treatment for advanced cancer — Ibrance’s biggest use. Finally, in 2022, Pfizer reported the results of its large trial of 666 women: There was no survival benefit for initial treatment.
A Pfizer spokesperson says the results took longer than planned because patients in the trial lived longer than anticipated, even those in the control group. Its trials were aimed at slowing progression and thus “not optimized” to detect a difference in survival, which can be hard to measure due to post-trial therapies and patient dropout, the spokesperson adds. The company presented a real-world analysis of 9,000 patients at a breast cancer conference late last year that found no statistical difference in survival rates among the drugs. (A Novartis spokesperson says that study had “design limitations” and its findings shouldn’t be used to directly compare the drugs.) Ibrance “remains a standard of care first-line treatment” that gives women with incurable cancer “more time without their disease worsening” and can delay the need for chemotherapy, the Pfizer spokesperson said.
Doctors are divided over what to make of the contrasting results.
ulie Gralow, chief medical officer of the American Society of Clinical Oncology, considers Ibrance’s lack of survival data an “anomaly” that doesn’t reflect real-world practice. Gralow has found that Ibrance generally has fewer side effects than its competitors. “Getting promising drugs to patients sooner, particularly those who have run out of other options, is important,” she says. Others argue that the survival results reflect subtle but real differences that become apparent over time. Matthew Goetz, an oncologist at the Mayo Clinic in Rochester, Minnesota, says the benefits from Ibrance seem to fade more quickly than its competitors; he favors the other medicines.
Pazdur is convinced the FDA’s approach is correct. Borrowing a line from a Black Eyed Peas song, he says critics who focus on survival data are “so 2000 and late.” He suggests a number of reasons why companies commonly struggle to prove their drugs prolong life. Some treatments target rare types of cancer where there are few patients to study. In other cases, patients are living so much longer that confirming survival gains can take years. Some of them drop out of studies if they end up in a control group for an extended period of time.
For the patients, an effective drug means “I might be able to make a graduation” or “I may be able to make a wedding,” Pazdur says. “We’re working to get safe and effective therapies out to patients in the most expeditious fashion here.” He adds that in about 15% of cases, followup studies have failed to confirm the benefits of drugs approved early and the agency has pushed for their removal. “We interpret that as a reasonable figure if you’re taking the appropriate degree of risk,” he says.
In the view of a growing number of cancer specialists, the trouble with this approach is that too many mediocre drugs stay on the market for years as companies drag their feet in producing the evidence that might prove whether they actually work.
Booth, the Queen’s University doctor, helped found a group called Common Sense Oncology in 2023 that’s pushing for a return to higher standards in clinical trials. It’s drawn members from Canada, the US, India, Japan, Australia, the UK, Israel, Ghana, Rwanda and Brazil.
These doctors agree that new drugs give patients hope — it’s just that it sometimes turns out to be false hope. In the meantime, drug companies generate billions.
Takeda Pharmaceutical Co., for example, won approval for the $4,450-a-pill multiple myeloma treatment Ninlaro in 2015 after a trial showed it delayed the growth of bone marrow cancer by six months. Multiple follow-up studies failed to show Ninlaro extends patients’ lives. It also can cause severe diarrhea. Since that early trial, though, Takeda has made more than $4 billion by touting the pill as the “first and only” medication in its class that allows patients to avoid a trip to an infusion center.
Aaron Goodman, a hematologist at the University of California at San Diego, calls the pill “an expensive laxative” that diverts patients from other myeloma drugs that do have proven survival advantages. “Any time someone is getting this drug, they could be getting something else,” he says. A Takeda spokesperson called the drug an “important treatment option” that offers patients an all-pill regimen, if not a survivability benefit.
The other concern for cancer drugs is quantity. A study by Mark Ratain, a University of Chicago cancer researcher, identified dozens of cancer pills sold at unnecessarily high doses or frequencies, adding to cost and side effects. “The thirst for profits and revenues is harming patients at this point,” Ratain says.
Most mid-stage melanoma patients fare just as well with two doses of immunotherapy treatment prior to surgery, compared with the usual regimen of nearly a year of drugs such as Opdivo from Bristol Myers Squibb Co. after surgery, according to results published in the New England Journal of Medicine last year. Preliminary findings in the Netherlands suggested that lower dosing of Merck & Co.’s Keytruda was also effective at keeping lung cancer patients alive for a year. And in a 1,000-patient-study published in Nature, researchers at the Netherlands Cancer Institute showed that advanced breast cancer patients could safely postpone taking drugs such as Ibrance for more than a year without any difference in long-term progression, reducing side effects and saving millions.
The conflicting evidence often leaves patients and their families questioning everything. Crystal Vaagen, a children’s book writer in Fargo, North Dakota, says her mother was diagnosed with advanced breast cancer in July 2021 at age 74. Her mom was put on Ibrance three months later after a 20-minute appointment during which no other treatment choices were mentioned. Doctors didn’t tell her about the Novartis drug, says Vaagen, who went to all her mother’s appointments. Her mom remained on the drug until April 2024, when her tumors began spreading and she switched to chemotherapy. She died from a bloodstream infection, a possible chemotherapy complication.
Ibrance “did okay for her,” Vaagen says. But she wishes they had been told that other drugs had more proven life-extending benefits. “If I would have known there are different medicines out there, I would have fought a little harder,” she says. “I would have said, ‘Maybe we ought to switch, is there a way of doing that?’ But as a patient you are expected to know nothing.’’
Costs, meanwhile, radiate across the health system. An analysis of Medicare found that annual spending on oncology drugs more than doubled in the four years ending in 2020, to $53.9 billion. By comparison, Trump’s Health and Human Services Department has said it would save taxpayers $1.8 billion a year by reducing its workforce to 62,000 from 82,000.
One of FDA commissioner Makary’s first major hires, UC San Francisco cancer doctor Vinay Prasad, is a critic of the overuse of expedited approvals who has questioned the lack of survival evidence for some cancer drugs. As head of the FDA’s Center for Biologics Evaluation and Research, he won’t oversee most cancer treatments, which remain in Pazdur’s division. But he may have the commissioner’s ear.
Ibrance has now brought in more than $40 billion for Pfizer, a decade after the drug hit the market on the strength of a trial of tumor growth in 165 patients. Sales have slipped recently, though. Ibrance was among 15 drugs selected by Medicare this year for price negotiations under a 2022 law that capped out-of-pocket prescription costs at $2,000.
Bourla, the Pfizer chief executive, has recently touted a new breast cancer treatment that targets a similar protein. Derived from a Pfizer compound known as PF-07220060, this one is called atirmociclib.
Early trials show an encouraging ability to shrink tumors.
With assistance from: Fiona Rutherford, Damian Garde Jade Khatib and Sam Hornblower
Edited by: Peter Robison, Cynthia Koons and David Ingold
Methodology
Drugs listed as shown to prolong life have statistically significant survival benefit in FDA label or were under review as of April 1, 2025. Prices shown are 30-day prices at or near the time of initial approval. For single-dose drugs, total price is shown. For weight or body-surface-area based drugs, dosages for 75 kg or 1.75 m2 adults are used; pediatric drug prices are based on age. Prices are rounded up to nearest single dose vial. Prices for multiweek cycles are prorated to create an exact 30 day price.
Searing pain, pus-filled infections and dying tissue: The BioZorb device tormented patients. Its maker kept complaints from the public.
By Anna Edney and Tanaz Meghjani
In the two years following her breast cancer surgery, not a day went by when Mary Munney Griffiths wasn’t in pain. It was different from the burning she felt in her chest during eight weeks of radiation. This was a new sharp, shooting sensation that woke her up at night and stopped her cold in the grocery store.
She worried her cancer had returned, but tests said otherwise. When she finally got a surgeon to operate two years later, the doctor removed 24 plastic shards from her breast.
They were remnants of a medical device called BioZorb, which Griffiths’ physician had implanted to help maintain the shape of her breast. Instead of dissolving within about a year, as intended, it had broken into pieces.
“I’m always worried that there’s more in there,” said the 64-year-old retired administrative assistant in an interview near her home in Syracuse, New York.
Hundreds of patients have had similar experiences – or worse, according to a Bloomberg review of a US Food and Drug Administration database of complaints. They reported searing pain, pus-filled infections and dying breast tissue that they attributed to the device. To alleviate their discomfort, some chose to get mastectomies, losing breasts that — even through radiation and chemotherapy — they might have otherwise kept.
Much of this was kept from the public. Between 2015 and 2022, hundreds of complaints from patients, doctors and others were sent to BioZorb’s makers. The vast majority were only disclosed to the FDA years later, despite a legal requirement that the company submit them within 30 days. Hologic Inc., the device’s maker, received hundreds more complaints after a series of lawsuits starting in 2022.
Hologic didn’t comment on why it didn’t share early reports sooner.
In 2024, the company pulled BioZorb from the market, with the FDA warning it “may cause serious injuries or death.” The agency warned the device caused “adverse events,” including infections, device erosion and other complications, some of which required additional medical treatment. No deaths were reported, it said.
Still, many of the 90,000 breast cancer patients that have had the device implanted continue to live with it in their bodies. And the regulatory system that put it on the market — and kept it there — remains in place.
“The standards are lax and can be manipulated by expert lawyers and creative manufacturers,” said David Simon, an associate law professor at Northeastern University who co-leads the Amy J. Reed Collaborative for Medical Device Safety. “In a variety of cases, devices are cleared and implanted in humans without ever having been tested on humans.”
Hologic said in an emailed statement that “clinical evidence demonstrates that BioZorb is safe and effective.” The company said it’s committed to meeting the highest standards of patient safety and is working with the FDA to address the agency’s questions. Hologic will face the first trial concerning the device early next year.
Due to the sheer number of people diagnosed annually with breast cancer, treating the disease is a big money-maker. Hologic’s breast health business brings in $1.5 billion annually through a mix of devices and screening and diagnostic tools, like mammography machines.
Medical devices are a particularly appealing revenue stream, in part, because of how easy they are to get to market compared to drugs. The agency doesn’t typically require clinical trials for “moderate risk” devices, a category that includes 99% of all medical devices cleared for sale in the US.
This system has existed since 1976, when the FDA created its modern device regulation process. Since then, thousands of products have entered the US market with no human testing. There’s little oversight once they’re widely available, too.
“It’s become the default way to get devices to market because it’s so much easier and less expensive,” Simon said.
In an emailed statement, the FDA said “patient safety is of the highest priority” and that once a device is approved the agency uses “a multifaceted approach” to ensure the safety and effectiveness of devices.
BioZorb was the brainchild of plastic surgeon and inventor Gail Lebovic. Now 68, Lebovic has said her interest in breast cancer began after a family friend died from the disease while she was in medical school at George Washington University in the 1980s. She decided to go into the then-nascent field of oncoplastics, a surgical subspecialty for helping breast-cancer patients maintain the shape of their breasts.
While in training, she started coming up with ideas for new products. Her earliest creations included the MammoPad, a thin cushion meant to make mammograms less painful — which she eventually sold to Hologic for $70 million — and the Expand-a-Band Breast Binder, a bra designed to help with swelling and bruising after surgery.
Around the time she sold MammoPad, she came up with BioZorb: a round plastic coil that doctors could place where they'd removed a tumor. The thinking was that eventually, tissue would grow around the device and the plastic would dissolve. Instead of leaving an empty crater, the breast would heal practically whole.
To get it on the market, she co-founded a company called Focal Therapeutics and started the process of getting FDA clearance. The agency’s 510(k) program governs the sale of devices deemed “moderate-risk.” It doesn’t require clinical trials or lengthy applications. Instead, device-makers have to show their product is similar to something the FDA already approved.
BioZorb’s application listed three “substantially equivalent” products. They were all markers, pieces of metal implanted in people’s breasts that imaging machines can detect to mark where cancer once was.
The device also had a plastic orb-shaped coil that was intended to dissolve as the breast healed. While other medical devices like stents use a similar material, those are made of thin strands that form a netting. In BioZorb’s case, the plastic was as thick as an iPhone cord.
With that application, the FDA allowed BioZorb to come to the US market as a marker in 2012.
When Focal started selling BioZorb it wasn’t just as a marker, according to two people who worked for the company. The device was pitched as something that would help women's breast tissue grow back in a more aesthetically pleasing way before dissolving. Multiple surgeons said they were told it was for cosmetic purposes, too.
The FDA doesn’t allow companies to market their devices for anything other than their approved use.
Lebovic declined to comment on BioZorb’s FDA application or its marketing.
Concerns emerged from some patients and doctors using the device about a year after BioZorb hit the market. Around then, Sarah Blair, a surgical oncologist in San Diego, implanted the device in six patients. Half complained of pain. She said she called Focal to complain.
“They were like, ‘It should dissolve,’” she said about her call with the company. “And I was like, ‘It’s not dissolving.’” She said she couldn’t get the answers she needed, so she stopped using the device.
Lebovic didn’t respond to questions about surgeons who called Focal to complain.
Another surgeon, who asked not to be identified because their employer didn’t authorize them to speak said they were so disturbed after a BioZorb they implanted began poking through a woman’s breast that they stopped using the device. Then, they said they told another surgeon set to operate on a family member who had been diagnosed with breast cancer that there was “no f–king way” they could use BioZorb on her.
For any FDA-approved products, the agency requires companies to submit complaints they receive that “reasonably” could be linked to them. Over BioZorb’s first seven years on the market, Focal received more than 100 reports from patients, doctors and others that rose to that level, according to the FDA’s database. Focal only submitted one of those within 30 days, as required by law.
Lebovic didn’t address questions about the company’s process for sharing complaints with the FDA.
In 2018, Hologic paid $125 million to buy Focal. After the sale, Lebovic told GW’s alumni magazine how gratifying it was to see the device in the world.
“When you become an entrepreneur and invent something that improves patient care, now you can impact millions of women all at once,” she said in the piece.
Soon after the purchase, Hologic started receiving complaints about BioZorb. One woman said she felt like she had bugs crawling under her skin, another said her breast turned black and was leaking blood and fluid. Many said they wished they had never had the device implanted in the first place. The company only sent a handful of the complaints to the FDA over the next few years.
Meanwhile, doctors kept inserting BioZorb into their patients, including Griffiths.
Griffiths said her surgeon made the decision to get BioZorb an easy one. As she was preparing to have her tumor removed, the doctor said BioZorb would help her keep her breast’s shape. Placing it wouldn’t even require a second surgery: the surgeon could implant it when she removed the cancer.
Griffiths trusted her doctor, and still doesn’t blame her for what happened. “She’s wonderful,” Griffiths said. “We had a very good rapport.”
The pain began immediately. When it didn’t go away after a few months, Griffiths said she asked her doctor to take BioZorb out. She said her physician told her to wait, that it would dissolve within about a year. She couldn’t wear a bra or seatbelt without wincing. Two years later, the surgeon finally relented. Griffiths said even the surgeon couldn’t believe what she ended up pulling out of Griffiths’ chest.
“You’re supposed to trust your doctor,” Griffiths said. But she’s since learned “doctors aren’t gods. They’re getting told things, too — by companies.”
Griffiths’ doctor didn’t respond to requests for comment.
As complaints to the company mounted, Hologic continued to promote BioZorb. In 2022, Nimmi Kapoor, a breast surgical oncologist with UCLA Health, attended a company-sponsored course that promoted BioZorb’s cosmetic benefits. She used it a couple times after that, but abandoned it after determining it wasn’t much better than manipulating breast tissue to get the same effect.
“It’s not unsurprising to me that it didn’t always absorb,” she said in an interview, comparing the device’s material to a plastic toy.
It was only during legal proceedings that Hologic started releasing batches of complaints to the FDA. More than 50 came in a two-day span starting in September 2023. Hundreds more would follow over the next two years.
This influx of reports apparently caught the FDA’s attention. In February 2024, the agency released a “safety communication,” telling doctors to warn patients there might be a risk of serious complications with BioZorb and advising them to monitor those who’ve had it implanted.
Hologic, meanwhile, told some investors not to worry.
Chief Operating Officer Essex Mitchell referred to the issues with BioZorb as “more of an administrative recall,” he said on a July 2024 call with industry analysts. The med-tech firm simply needed to update some of the language on its packaging, he said.
“We are still selling our product, feel great about it, and are working through that,” Mitchell said.
The next day, FDA inspectors showed up at Hologic’s headquarters in Marlborough, Massachusetts, according to a letter the FDA sent Hologic in December. Inspectors combed through the company’s files related to BioZorb. They found Hologic didn’t have sufficient data or “verification testing” to prove the device would dissolve, the letter said. There were other missing pieces too, according to the FDA’s letter, like a lack of evidence the company had properly guided surgeons as to how deeply to implant the device or how to use it on different body types.
Hologic took BioZorb off the market shortly after the visit.
On a call with investors Hologic Chief Financial Officer Karleen Oberton called the impact of BioZorb “de minimis,” she said. “It was a revenue line item that was less than $10 million in ’24.” Hologic’s total sales for its 2024 financial year were more than $4 billion.
The FDA is continuing to monitor the situation. Hologic hasn’t “appropriately evaluated” when the device would be expected to dissolve, how radiation may interact with it and whether it could interfere with detecting any future cancer, according to the FDA’s warning letter. All of this is necessary, the FDA said, to determine whether some women may still need to have the device taken out.
The company told the FDA it has no plans to further study BioZorb, according to the agency’s December letter. A Hologic spokesperson said the company is working with the FDA to address its concerns in a comprehensive and timely manner.
“Their response was like ‘We made a mistake and we’re trying to quickly wipe our hands,’ but it didn’t really show concern for the patients,” said Vinay Rathi, a physician and health policy researcher who has studied medical device regulation at Ohio State University Wexner Medical Center. “It’s like: ‘We can exit this product line, but without surgery, you can’t.’”
Meanwhile, the FDA has received more complaints, bringing the total number to 549 as of Aug. 29.
Getting the shards of BioZorb removed hasn’t solved all of Griffiths’ problems.
Her breast doesn’t look like it used to, the skin where the BioZorb once was has hardened, leaving a large lump behind. “Looking at myself in the mirror, I can’t stand it,” she said.
Her annual mammogram revealed an abnormality where BioZorb used to be. The results of a two-hour biopsy came back negative for cancer, but she fears that the lump left behind by BioZorb — or perhaps a shard of the device — will constantly cause doctors to question whether the cancer has come back.
She’s also still in pain and now considering a mastectomy.
Doctors are experimenting with using lower doses of blockbuster cancer drugs. It could help hundreds of thousands of people — if pharmaceutical companies would allow it.
By Robert Langreth
Three hours inland from Chennai, India, traffic crawls on a half-finished road past rice fields and cow crossings until it reaches a newer complex of neat white buildings. Among them is the cancer wing of a hospital founded over a century ago by American missionaries.
By morning, the line of people waiting to be seen at Christian Medical College Vellore’s Ranipet Campus snakes from the parking lot to the front door. In a basement treatment room one day in May, several of those who’ve made it inside sit in beds getting an intravenous drip of a Bristol Myers Squibb Co. drug called Opdivo or a competing Merck & Co. drug, Keytruda. A single infusion might cost at least $7,000 at the standard dose in the US, and a year’s treatment more than $200,000. Here, by financial necessity, most of the patients are getting as little as one-sixth of that.
The remarkable thing is that the radically low doses may also be effective at keeping cancer sufferers alive, doctors here and in other hospitals across India say. The science isn’t settled, but hospitals in Israel, France, the Netherlands, Canada and the UK are all testing or implementing more modest dose reductions. A small trial in the US also found some benefits. The consequences could be dramatic, expanding access to cancer treatment in poor countries and bending the curve of skyrocketing drug prices in the developed world. Smaller doses could also help limit the serious side effects many patients endure, from diarrhea to thyroid problems.
A broad reevaluation of dosing has the potential to benefit hundreds of thousands of people in developing countries who otherwise wouldn’t be able to afford the drugs. One obstacle has stood in the way: the drugmakers themselves. Paid per dose, they stand to lose billions of dollars if doctors prescribe less medicine to their patients. Bristol declined to assist doctors conducting trials of lower-dose Opdivo in India, doctors say there; they ended up getting the medication from other sources, such as charities.
Merck went so far as to eliminate smaller vials of Keytruda, effectively requiring hospitals to use more than might be needed. Used to treat melanoma and many other forms of cancer, Keytruda is now the best-selling drug of any kind in the world, with $29.5 billion in sales last year.
Doctors seeking to challenge the status quo have notched only a few successes. In Israel, it took a bruising two-year fight before the health ministry in 2022 approved a plan by the country’s largest health insurer to use smaller “weight-based” doses of Keytruda for lung cancer patients.
Daniel Goldstein, a doctor who helped lead the insurer’s effort, says he was ambushed at one meeting by Merck executives who accused him of promoting an unproven treatment. He suspected Merck’s influence in the opposition arising from some doctors and patient groups. The response was all the more surprising, he says, because the company itself had initially sold the medication in the same weight-based amount before switching to a fixed dose as much as 25% higher for the average patient.
Officials at Merck, Goldstein says, don’t want lower dosing to become commonplace and have “done everything they possibly can to try to crush it.” Now an oncologist at the Center for Cancer Economics at the Rabin Medical Center in Israel, he estimates that weight-based dosing might cut Keytruda’s sales by $6 billion or $7 billion a year, a quarter of the drug’s total.
Merck says in a statement that the dosing regimen for Keytruda, approved by the Food and Drug Administration, is “based upon wide-ranging preclinical data and extensive clinical evidence.” The company declined to answer questions about the dispute in Israel.
Bristol says its dosages are determined in “a collaborative and rigorous process” with health authorities and are “based on robust evidence from multiple phases of clinical trials across tumor types.” Some studies, it adds, have shown that shortening treatment or lessening doses can lead to worse outcomes. One, examining lung cancer patients, suggested that taking Opdivo beyond a year led to improved results.
A cancer-drug revolution over the last 15 years has helped many thousands of people live longer, with immunotherapies like Opdivo and Keytruda among those proven to work the best. The drugs bind onto white blood cells to trigger an immune response from the body itself against tumors. Once seen as a backwater for drug companies, cancer is now a prime money maker for many of them, generating more than $200 billion in worldwide sales last year alone.
The financial windfall is in part due to the drugmakers’ ability to find ever more ways to administer their drugs early in treatment, for long periods of time, and in relatively high amounts – sometimes even in the face of their own evidence.
In early trials of Keytruda, Merck’s own pharmacologists found no clinical advantage to doses even five-fold higher than the original amount, based on weight. Later, as it began testing the generally higher fixed dosage, it said the change would be more convenient for doctors and nurses. It eventually removed all mention of the original dose from the adult dosing instructions.
Companies have significant influence over dosing decisions in part because they run their own trials. In charge of determining the questions to be answered, they have little incentive to study, in effect, how to make less money.
The FDA last year issued new guidance recommending more randomized testing of various doses in cancer drug studies. Still, the agency relies on the manufacturers to submit their own supporting data and only has the authority to force labeling changes for marketed drugs based on new safety information. “FDA will continue to use golden standard science in its evaluation of drugs and appropriate dosing,” a spokesperson says.
The more-is-better approach is in part a legacy of oncology’s reliance on toxic chemotherapy, given in maximum tolerated doses. But modern targeted drugs work more subtly, and the response can vary considerably among individuals. Some patients in the US have discovered serendipitously that they can get by with less, after experiencing side effects that forced a change. That’s led to benefits that aren’t captured in most trials – like fewer trips to the hospital and more time with loved ones.
James Davie, 69, runs a biotech company near Seattle and thought he was going to die when he was diagnosed with melanoma that had spread to his brain and both lungs in June 2020. After starting Opdivo that fall, his tumor quickly shrank 80%. But the side effects, including severe colon inflammation, were so intolerable that he stopped taking it after four doses.
His oncologist at Fred Hutchinson Cancer Center, Shailender Bhatia, had him resume treatment at one-tenth of the normal dose, and later cut the frequency to every three months instead of once a month. The tumors have continued to shrink, and he’s no longer in agony. The improvised regimen, Davie says, “made all the difference in the world.” He got his last dose in August and is now off treatment.
Bhatia says doctors are “hungry” for more studies proving that doses can be spread out safely – but the companies are “never gonna sponsor” them.
Merck and Bristol were two of the first drugmakers to spot the potential of new immunotherapies early last decade, prompted by the realization that the targeted treatments might work on a variety of different cancers. Tumors grow, in part, by turning the immune system off. They contain proteins that latch onto what are known as PD-1 receptors, which act as crucial checkpoints in the system. The drugs blanket the receptors to spur the immune system against tumor cells.
Bristol reported promising early results from testing of its first PD-1 drug in 2010. Less than a year later, Merck began its own tests of a PD-1 treatment called pembrolizumab. “Really just incredibly exciting results, which we have never seen before in oncology, where patients are living and basically getting complete responses to these drugs,” Ken Frazier, then Merck’s chief executive, said at a conference in 2013.
As it sought the initial approval for melanoma, Merck combined the typical three phases of testing into one large trial. That allowed it to beat Bristol to the market in September 2014 with a drug it dubbed Keytruda. Opdivo followed a few months later, first for melanoma and then for lung cancer patients. Keytruda also gained approval for lung cancer in 2015.
Dinesh de Alwis, a pharmacologist for Merck at the time, says researchers found no difference in efficacy when they compared two doses, one five times larger than the other, in early trials. As a result, the company selected the lower dose it had tested for its initial approval: 2 milligrams per kilogram of body weight, given every three weeks. The average patient in one study weighed a bit above 75 kg. That meant the treatment might come to 150 mg for many patients. Merck originally sold the drug in 50 mg vials, so a typical person might require three vials.
Bristol’s initial studies of Opdivo showed that even tiny doses were enough to blanket the receptors responsible for immune response. Doses as little as 3% of the amount eventually approved dramatically shrank melanoma tumors. Low doses were also effective in kidney cancers. But in patients with lung cancer, tumor shrinkage was pronounced at higher dosage levels. The company chose to move forward with a dose of 3 mg per kilogram every two weeks across treatments, in part due to the better response in lung cancer.
Both drugmakers soon began considering moving to fixed dosages for all patients. Roger Perlmutter, who ran Merck’s research lab, told investors on a quarterly earnings call in April 2015 that there was nothing wrong with the dosage approved months earlier. “Our data are persuasive,” he said, “that 2 milligrams per kilogram given every three weeks is as efficacious as higher doses across all tumor types studied.” But Perlmutter said using a fixed amount would “simplify dosing for the vast majority of patients.”
In 2016, Bristol did so by multiplying the weight-based-dose – 3 mg per kilogram – by the average weight in its trials to come up with a 240 mg flat dose that it now sells, in vials as small as 40 mg.
Merck, though, did something different. That same year, it sought approval for Keytruda for a new broader use in lung cancer at a flat dose of 200 mg, based on a new trial it had done. The dose was higher than the 150 mg that a typical 75-kilogram patient would have been given previously. Subsequent approvals in other cancers, and most follow-up trials, were based on the new flat dose. This same guidance was eventually added to the label across treatments, except for children and those weighing less than 40 kilograms.
De Alwis, the former Merck pharmacologist, says the fixed dose is simpler for nurses to administer and reduces the risk of a dosing error. He rejects the idea that financial considerations played into the decision. He says the company chose the dose of 200 mg “to make sure all patients at the very highest weight ranges were covered.” De Alwis left Merck in 2022 and now works at a biotech startup company.
An FDA spokesperson says the agency’s approval of flat dosing for each drug was informed by clinical data provided by the applicants showing the change was unlikely to compromise safety or efficacy.
Even before the new flat dosing was approved, researchers at Memorial Sloan Kettering Cancer Center reported in 2016 that Merck had already stopped selling the 50 mg vials in the US and introduced a new 100 mg vial. That made it difficult for any doctor who wanted to use the often lower weight-based dosing without throwing away large amounts of the drug. The financial difference was considerable. It meant that the typical person would now have to use two 100 mg vials. The Memorial researchers estimated this would boost Keytruda’s US sales by 12% through additional waste.
The change caught the attention of Goldstein, the doctor in Israel. “In effect, it was a price hike,” he says. Goldstein, 45, had grown up in the UK, where the country’s pride in a nationalized health system – and struggle to maintain it – convinced him that healthcare spending isn’t an infinite resource. After attending the University of Leeds, Goldstein did a medical residency in New York and moved on to an oncology fellowship at Emory University in Atlanta from 2012 to 2015. He watched in frustration as multiple colon cancer drugs came to market with high prices despite marginal improvements in patient survival.
“Bored of shouting into the wind,” as he puts it, he latched onto Keytruda. A 2017 study he and several colleagues published in the Journal of the National Cancer Institute proposed restoring the drug’s original dosing for lung cancer. He calculated it would save $825 million per year in the US alone.
By then working at the Rabin Medical Center near Tel Aviv, Goldstein heard from someone at Merck who invited him to present his findings at the company’s local offices in Israel. He gave a 45-minute lecture to about 20 people. The smaller vial size was then still available in Israel, and he remembers asking the Merck officials not to discontinue it, as the company had in the US. They listened and asked a few questions, as he recalls it. The next day he got a polite WhatsApp message thanking him for his time.
At the medical center, Goldstein talked to fellow doctors about switching back to weight-based dosing for the drug. Many of them privately agreed there was no difference, he says, but were nervous about implementing the change on their own, since the previous dose was no longer on the official label. Colleagues told him it would be better if there was an official guideline.
Goldstein brought up the idea with officials at Clalit Health Services, a health insurer that covers 5 million in Israel. He says Merck got wind of their discussions ahead of a big annual conference in Chicago of the American Society of Clinical Oncology in 2019 and arranged for him to talk to representatives of the company in a private meeting room.
There by himself, Goldstein walked into a roomful of Merck executives and researchers. He says they told him weight-based dosing could be dangerous and might be less effective – at odds with its earlier statement on the matter. “It felt like an ambush,” Goldstein says. An email invitation he received shows that eight people from Merck were invited, including two vice presidents involved in cancer research and the senior vice president in charge of cancer research. (He doesn’t remember which of them actually attended.)
Goldstein continued talking to Clalit about making the change. He took an official role at the insurer as medical manager of drug and technology policies in 2021, while also remaining at the medical center. That year, the insurer invited public comment on its proposal for weight-based dosing.
The response was furious. The Knesset, Israel’s parliament, held a hearing after newspaper stories accused the insurer of risking patients’ lives. The Israeli Lung Cancer Foundation was among those opposed to the change. “This is a matter of life and death. You can’t play around,” testified Shani Shilo, co-founder of the nonprofit patient advocacy group. It lists Merck and Bristol among several drug company sponsors. In an interview, Shilo says the companies had nothing to do with the group’s opposition. “The doctors on our board said we have to fight this, this is not okay,” she says. One of those board members, an oncologist named Nir Peled, testified that the change would leave doctors in an untenable position merely to save a few bucks. “This puts doctors in a legal, regulatory and ethical predicament,” he said. Peled had earlier collaborated with Merck researchers on a study that suggested the fixed and weight-based doses produced similar effects in the body. In an email, Peled says “the wish for cost reduction is important” but it “should not interfere with any clinical decisions.”
Ultimately, Israel’s health ministry decided in favor of the change for lung cancer patients in March 2022. Goldstein remembers thinking it was only the first domino. But when Clalit sought to make similar dosing changes for other types of cancer the next year, he says, it faced more resistance. Exhausted by the fight, Goldstein left his role there earlier this year to return to academia.
A Clalit spokesperson declined to comment, other than to forward a statement from a health ministry committee that said the insurer had “full medical justification” for making the dosing change across all approved indications. The ministry, though, never made a final decision allowing the insurer to do so. In an emailed statement to Bloomberg, the health ministry said that after extensive discussions, it decided at this stage not to expand use of the lower dosage to other types of cancer.
Goldstein suspects the dispute has limited his career prospects. “I’m considered a troublemaker,” he says. “Some people view me as a pariah.”
Tata Memorial Hospital in central Mumbai is one of the busiest cancer centers in India, registering 50,000 new cancer patients each year. Late into one evening in May, patients crowd the waiting room, some camped out on the stairwell and others on mats on the floor. Guards sometimes sweep by to usher people out of crowded hallways.
Cancer rates in India are less than one-third those in the US, but they’ve been rising as the population ages and middle-class lifestyles bring more desk work and processed foods. In absolute terms, the country has far more cancer deaths: some 900,000 people a year, up from 700,000 a decade previously – more than the 600,000 in the US.
Top doctors at Tata fly to international conferences to stay abreast of the latest treatments. They routinely test all lung cancer patients using the latest DNA scanning technology. But few people in India have access to comprehensive health insurance, and the hospital estimates only a small fraction of its patients can afford the $200,000-a-year personalized drugs that those tests suggest might work for them.
So about seven years ago, oncologist Kumar Prabhash and his colleagues at Tata did something radical: They began a trial testing Bristol’s Opdivo at 6% of the dose normally used in the US.
Prabhash says they informally asked Bristol to help fund the study – the primary cost of a trial is the medicine itself – but were politely turned down. Instead, the hospital got most of the 17 million rupees ($192,000) for the study from an Indian charity called Motivation for Excellence. The researchers’ original hope was to compare the effects of the much lower dose to the full dose. They didn’t have the money, so the trial compares the low dose with patients getting chemotherapy.
The results were astonishing. After a year of treatment, more than twice as many people with advanced head and neck cancer who got low-dose Opdivo plus chemo were still alive compared with chemotherapy alone. It was one of the first controlled trials to show that even tiny doses of immunotherapy drugs could produce life-prolonging results. It doesn’t prove they’re as effective, but the results have motivated doctors across India to pursue similar strategies.
Vijay Patil, a doctor who first experimented with low-dose immunotherapies at Tata, later moved to a private institute and began using them in patients with earlier-stage operable cases. In his exam room in Mumbai, Patil traces his fingers along a 10-centimeter tumor bulging from the neck of Hemant Champanekar, 46, a chauffeur who makes about $200 a month driving for a wealthy client. Champanekar says he tried to ignore it at first, worried about affording treatment. “We have to think about the family’s future, children’s education, we need to look after the house, we need to pay rent,” he says.
Patil enrolled Champanekar into a new study, where patients could get the medication for free. After the first low dose, his pain started to subside and he could move his neck better. By June, and two more small doses, the tumor had shrunk about 80%. Champanekar went in a month later for surgery to try to remove all of it. He’ll still need chemo and radiation to minimize chances of a relapse, but Patil is optimistic about his odds. So is Champanekar’s 19-year-old son, Pawan, who shared a photo of his father beaming with family.
At Christian Medical College Vellore, the hospital system three hours from Chennai with a line of people outside, a spotless but undecorated basement treatment room contains refrigerators full of medicines, including 40 mg vials of Opdivo. They give patients a single vial, one-sixth of the US dose, or even split it in half and give them 20 mg, saving the rest in the refrigerator. Recently, the hospital has also started using a newer PD1 drug called toripalimab, sold in India by Dr. Reddy’s Laboratories Ltd. under license from a Chinese company.
“With immunotherapy, I am living, I am alive still,” 66-year-old lung cancer patient Chinnappan S says, shortly after finishing an infusion. A recently retired accountant for a small parochial school, he says he couldn’t possibly have afforded full-dose immunotherapy on his salary of $300 a month.
Ashish Singh, head of the rapidly expanding medical oncology department, started Chinnappan on low-dose Keytruda in 2023 after his tumor came back in both lungs following chemotherapy. Singh was able to obtain charitable funding for just four 50 mg doses – the amount in a single US dose. Even that small amount, he says, caused a dramatic shrinkage in his tumors. When they came back this year, Singh put Chinnappan on low doses of toripalimab, leading to a partial remission.
Singh, 44, says he hasn’t noticed any obvious difference in the tumor shrinkage or rates of remission between patients getting the high dose and those getting a tiny fraction of the listed dose. He would like to do formal trials to prove that low doses work just as well. He even approached local Bristol and Merck representatives to propose various studies of reduced doses – and was turned down. “They say if you do a trial you have to use the approved dose,” he says.
A Merck spokesperson says the company has already done extensive clinical testing, and “we would be concerned that empiric reductions in dose or duration might compromise efficacy.” A Bristol spokesperson says it encourages healthcare providers to “refer to the most current prescribing information” and adds that it has sponsored more than 300 studies of the drug, including some involving lessening the dose. India, the spokesperson says, is part of a Bristol program called Aspire that seeks to broaden access to new medicines in low- and middle-income countries
Another Vellore patient, 17-year-old PG Shrinidhi, is in remission after receiving just one-twelfth the cumulative Opdivo dose she might have been given in the US. A high school senior, she wants to become an astrophysicist. At age 14 she developed swelling in her neck, then a severe cough. Doctors at first blamed a thyroid problem and finally diagnosed her with advanced Hodgkin’s lymphoma. “I am just grateful,” Shrinidhi says. “There are so many people like me who have been diagnosed but don’t have any facility to get such treatments.”
The teenager received the drug after her doctor, Anu Korula, got a grant from the government of India for a trial that examines using ultra-low doses of Opdivo to treat lymphoma in combination with chemotherapy. “It is a struggle to get the money to do the studies,” says Korula, visibly frustrated, in her windowless office. “It is a struggle to get them published.”
Tata, the hospital in Mumbai that pioneered low-dose treatments, does have funding for another trial, says its director, CS Pramesh. This one will test how well patients with operable esophageal cancer do with a short course of low-dose Opdivo before surgery compared with not using it at all. In informal conversation, according to Pramesh, Bristol hasn’t expressed interest in funding it so far. “They said this wasn’t a research priority for them,” he says, before offering his own explanation. “It would cut into their market,” he says with a laugh.
For now, that market remains buoyant. Opdivo generated about $2.6 billion in second-quarter sales for Bristol, the top-selling drug in what the company calls its “growth portfolio.” A decade after it won approval, Keytruda is Merck’s biggest single product, with second-quarter sales of $8 billion, thanks in part to its dominant position in lung cancer, the biggest cancer killer.
But India isn’t the only place experimenting with using less.
Researchers in France, the UK and the Netherlands are all pursuing various studies that examine whether doses can be spread out or given in smaller amounts. The Netherlands Cancer Institute, for instance, plans to lead a trial in 1,000 patients to see if some early-stage breast cancer can be treated with Keytruda before surgery instead of the usual regimen both before and after surgery, potentially sparing them months of infusion visits. More than 20 Dutch hospitals are already using weight-based dosing of Keytruda for lung cancer, and one study estimated they used 22% less with no difference in outcomes for patients.
Gabe Sonke, the institute’s head of medical oncology, faults the manufacturers for skipping or ignoring research that might have benefited patients earlier. “We’re doing studies that we shouldn’t have needed to be doing,” he says. “It should have been done right in the first place.”
In Seattle, where the biotech executive James Davie was treated after his melanoma diagnosis, his doctor Bhatia co-authored a University of Washington study of 23 advanced skin cancer patients. The study found that after starting with standard dosing, most did well with less frequent doses of Keytruda and Opdivo and it saved about $70,000 per patient. Skeptical of getting funds for similar work in the US, Bhatia says the team next plans to study the approach for patients in Uganda with a variety of cancers.
Almost two-thirds of cancers are in developing countries. Making smaller doses available more widely could save billions of dollars and benefit hundreds of thousands of people who otherwise wouldn’t have access to them, says Prabhash, the Tata doctor who conducted the early trials in India, where households often rely on a single income. “These cancer patients, if they become sick, it doesn’t only affect the patient, it affects the whole family,” he says.
Updating its list of essential medicines this month, the World Health Organization added several new uses of Keytruda and endorsed the use of weight-based dosing to improve access. It said ultra-low doses like those in India “could be a viable strategy” pending further research. A group of cancer experts advising the health group had said in January that “clinical evidence supporting dose reduction” for immunotherapies “is rapidly growing.” They said the idea has “the merit of being immediately implementable” and called it “noteworthy” that the initial trials in melanoma and lung cancer used weight-based dosing.
In those initial trials a decade ago, Merck had cited “persuasive” evidence that weight-based doses were effective across cancer types. In its own letter to the health organization earlier this year, though, the company said reduced intensity treatments were “not appropriate.” The data on ultra-low doses like those used in India, it added, were “not conclusive” and based on small studies with potential for bias.
The company said it’s working on other ways to get drugs to developing countries.
With assistance from: Tanaz Meghjani
Physicians stand to earn big money when signing up patients for drug trials. And lately, some of those trials have been producing dubious science.
By Caleb Melby and Robert Langreth
The future of cancer drug research just might be in Omaha, Nebraska, between a Panda Express and a Mattress Firm.
Here, in an otherwise unremarkable storefront, a little-known clinic called XCancer has become one of the most trusted research partners of pharmaceutical companies seeking to test experimental prostate cancer medicines. XCancer and its sole physician, Luke Nordquist, have participated in more than 200 trials over 15 years, and played a leading role in testing Novartis AG’s widely advertised blockbuster, Pluvicto.
A big draw is speed: Nordquist says he can open a trial in as little as two weeks, unlike big academic research centers that take several months because of layers of management and lengthy internal review protocols. “They come to me first,” Nordquist says of the drugmakers.
The Omaha clinic is emblematic of a larger shift. Increasingly, privately owned clinics like Nordquist’s are the engine room of a fast-growing, lucrative and, for many patients, little-understood business. So many trials for so many cancer drugs are now underway — 2,400 recently compared with 400 in 2000 — that drug companies by one estimate spend $80 billion a year on clinical trials in oncology.
Patients are the customer for all these new treatments — but they’re also the product.
Drug trials offer people with cancer hope and free medicine, and open routes to new profits for pharma companies. But the flood of money is also creating incentives for doctors to sign up patients for unproven treatments and at times bending traditional research norms.
Clinical trials involve elaborate protocols meant to set out objective criteria for comparison. In recent years, many trials are “loading the dice” by comparing their new treatments to inferior options or excluding some of the most potent existing treatments, says Ian Tannock, a University of Toronto emeritus professor who pioneered new chemotherapy drugs to treat advanced prostate cancer.
The gambit has a name – the “straw man” control group.
“When you are putting a $100 million bet down, you want to maximize the chance you will see a benefit,” says Christopher Sweeney, an oncologist at the University of Adelaide.
As the boom in therapies runs headlong into a finite universe of patients, the rewards for clinics have soared. Drug companies can pay $250,000 or more per patient in major oncology trials, says Tim Opler, managing director of global health care at Stifel Financial Corp. Less than a decade ago, one study estimated, the average was less than half that.
Disclosure rules haven’t kept pace with the new financial realities. While drug companies have long courted doctors with consulting fees and other payments – which are disclosed – gaps remain when it comes to clinical trials. Doctors have no legal obligation to inform patients when their clinics receive compensation for enrolling them in trials, and several participants around the US told Bloomberg News that their doctors, in fact, didn’t. They’re not the only ones flying blind. Two oncologists who have reviewed drugs for the Food and Drug Administration say they were alarmed to learn such payments had become a major source of revenue for many clinics and hospitals.
While there’s a popular belief that each new experimental drug must be better than the last, the alignment of researchers and pharmaceutical companies hasn’t reliably produced ground-breaking therapies. Fewer than half of the cancer drugs approved since 2000 have been proven to prolong people’s lives, a Bloomberg analysis found. Some studies show the average cancer trial might add weeks to patients’ lives, often with serious side effects.
Dan Odorisio, a youth basketball coach and former drummer in Omaha-area bands, sought out XCancer following his prostate cancer diagnosis a decade ago. After years of traditional therapies overseen by Nordquist, Odorisio’s cancer metastasized. He tried Pluvicto soon after it was approved, then enrolled in trials for two experimental drugs from AstraZeneca Plc.
Nordquist often goes by Dr. Luke online, where he’s posted photos of his fiancee (an XCancer front desk secretary turned company president) and son (head of an XCancer-branded racing team). He also shares photos of his patients. In a post to LinkedIn, Nordquist lauded Odorisio’s “willingness and courage” and included a photo of his patient. A medal hangs around his neck that says, “1st in World, XCancer.”
Contacted after reporters saw the post, Odorisio said he didn’t recall any discussion with the doctor about the clinic getting paid for the work. Two former XCancer clinicians who regularly participated in visits say they couldn’t recall Nordquist telling patients about the center’s trial compensation. Nordquist says he discusses it with “every patient that goes on a trial.”
Odorisio’s prostate-specific antigen levels, a cancer marker, spiked during each trial, indicating his condition had actually worsened. He volunteered to share his medical records with Bloomberg. “I lost time,” he said in August, holding back tears. “In my mind, I lost a year of stopping my cancer.”
Nordquist learned his trade at one of the world’s premier cancer institutions, Memorial Sloan Kettering Cancer Center in New York. He’d landed a plum oncology fellowship there but says he found the bureaucracy of a major research hospital stifling. “I’d rather be a landscaper,” Nordquist says.
A group practice in Omaha was equally unfulfilling. Most patients, he realized, have no way of determining if one doctor is better than another. “Having a clinical trial that another center doesn’t have is a marketable difference,” he says.
Trials are a “win, win, win, win,” he says. Patients get access to new therapies for free, pharmaceutical companies get fast and accurate trial results, his small business gets income and society gets more drugs faster. “I’m your guy in the trenches,” Nordquist says he tells drug sponsors.
He started what was then the Urology Cancer Center in 2010. Trials became the unique selling point of the new venture, later renamed XCancer. At first, he scheduled appointments with patients from the unfinished basement of his house.
After starting with three employees, Nordquist now has more than 60. They manage both a research arm that works with drug companies on trials and a routine practice that sees 450 prostate cancer patients and 25 to 50 with other types of urologic cancer each month. He’s still the only physician. “I don't have a lot of people telling me what to do here,” he says. Three nurse practitioners who report to him also see patients.
“No other oncologist in the U.S. has access to as many innovative clinical trials for prostate cancer than Dr. Luke and his XCancer Omaha research team,” the clinic’s website advertises. For patients facing a grim prognosis, the appeal is obvious: “More hope, more time,” it says.
Nordquist doesn’t disclose the company’s annual sales, but its success has helped fund a Cessna 441 aircraft painted in blue and gold stripes, branded XCancer Air; sponsorship of XCancer Motorsports, the car racing team helmed by his son; and, for charity, a residential complex for cancer patients near a hospital in Tanzania. A 2023 divorce settlement showed Nordquist had an annual personal income of $2 million. “As the only owner, you take the risks and hope for rewards,” he says.
Thanks in part to research funding, Nordquist adds, he’s never sent a patient to collections or had one file for bankruptcy due to medical debts.
Other investors see opportunity in clinical trials. The drug distributor McKesson Corp. in 2022 combined its cancer research unit with Sarah Cannon Research Institute, a Nashville-based researcher. McKesson has said the venture had a role in 70% of adult oncology drug approvals last year by the FDA; it brings together more than 1,300 physicians at 200 locations in 20 US states. In February, McKesson’s chief executive described the company’s oncology division as “one of the central growth pillars for the business.” In a recent investor slide, the company noted that cancer clinical research had a “higher margin” than its main drug distribution business.
As recently as the 1990s, most cancer trials were federally funded, says Joseph Unger, a health services researcher at Fred Hutchinson Cancer Center in Seattle. Drug companies now provide most of the money and direction. Annual enrollment in industry-sponsored cancer trials more than doubled to almost 120,000 patients in the five years through 2022, compared with a decade before that, Unger and colleagues found in a 2024 study. Enrollment in federally funded trials was largely unchanged at around 15,000 patients a year, a gap that’s only likely to grow with the Trump administration’s cuts to federal support for research.
From late February to August, the National Institutes of Health terminated grant funding for 118 cancer trials, representing 1 in 37 oncology trials it sponsored, according to an analysis by Harvard Medical School researchers. Such terminations had been rare.
Private investment has brought important new treatments. But industry sponsors typically aren’t interested in some kinds of studies, according to Unger. Among them: testing combinations of old drugs from competing companies, finding out which medicines work better than surgery or radiation, lowering the dose — or not using a drug at all. “A lot of questions that would be of interest to patients may be going unanswered,” Unger says.
rials are attractive to medical centers in part because they get paid for every step, from office visits to administering drugs to research-related scans. It isn’t just privately owned clinics benefiting from the largesse. Industry payments related to cancer drugs at 51 US cancer centers, such as MD Anderson in Houston and City of Hope near Los Angeles, doubled from $482 million in 2014 to $972 million in 2021, one study found.
The money can send researchers’ stars rising. They work with drug companies to help design studies, then announce the results in prestigious journals or conference keynotes. The research is monitored at each center by an institutional review board, typically a group of medical professionals and local community members who are supposed to make sure people aren’t being harmed and the trials are pursuing a valid scientific question. Once the design parameters proposed by the lead scientists are set, any number of physicians can raise their hands to enroll patients in the trials.
Over the past decade, an increasing number of cancer studies have come under fire from prominent academics. Perhaps the most scathing critic is Vinay Prasad, now chief medical and scientific officer at the FDA. Before he was picked for the job in May, he was a UC San Francisco hematologist-oncologist known for skewering what he saw as flawed cancer trials. He did so in a 2020 book called Malignant, research papers and YouTube videos in which he sometimes let expletives fly about “sh-tty” or “absolutely worthless” work. The trial that led to Pluvicto’s approval was among his targets. (An FDA spokesperson said Prasad and other officials were unavailable to comment.)
In one 2024 video, dressed in a faded tie-dyed T-shirt, he deemed oncology “deeply broken,” with doctors and researchers captured by the manufacturers. “It is really the love of money that is driving this whole field,” he said. “What’s best for patients is so far on the back burner that people have forgotten it entirely.” When the textbooks are written years from now, he added, many oncology trials “are going to look so unethical.”
One basic way many trials manipulate results, Prasad and other critics say, is through the choice of treatment given to patients in the control group. Trials are often designed to give patients the “least possible treatment that will not bring an outcry,” says Bishal Gyawali, an oncologist at Queen’s University in Canada.
“The companies will do everything they can to make their drugs look better,” agrees Tannock, the University of Toronto professor.
In some cases, patients in the control group who’ve already failed one type of therapy are switched to another similar type that is also unlikely to work. Prasad and colleagues found in one 2019 paper that 16 of 96 cancer drugs approved from 2013 to mid-2018 were based on trials with control groups that either gave inferior drugs or excluded some proven options. For patients, it means their care might be worse than if they hadn’t signed up for a trial.
In other instances, patients are denied chemotherapy. This was one of Prasad’s objections to the key Pluvicto trial. In a paper with researchers from Switzerland and Texas, he wrote that the clinical investigators had concocted “bizarre rationales” to justify giving patients in the control group another androgen-inhibiting drug while denying them access to additional chemotherapy. The paper did not dispute that Pluvicto, approved in 2022, was “highly active.”
The trial patients who got Pluvicto lived an average of four months longer than those in the chemo-free control arm. Novartis says the research was designed “to reflect real-world practice and protect patient safety” and the resulting drug “offers patients the chance to delay chemotherapy and live longer without their disease progressing.”
While the chair of the trial’s scientific committee was at Memorial Sloan Kettering, 46 of the 861 patients were enrolled at XCancer in Omaha, according to Nordquist. That’s more than any other site, he says, and more than quadruple the average of other sites, federal records show. “I’m not smart enough to help design these,” Nordquist says of the concerns raised about the trial. “I run them and I run them well.” Novartis declined to comment on trial enrollment. It bought the small company developing Pluvicto in 2018, after the trial was underway.
Memorial Sloan Kettering oncologist Michael Morris, the trial’s scientific committee chair, wrote in an email that while some studies have inappropriate control arms, this “was just not one of those studies.” He said the trial was designed for the most advanced prostate cancer patients, and most do not get further chemotherapy after one type fails, either by choice or because they are no longer fit to receive it.
The New York hospital is projected to enroll 5,000 patients in clinical trials this year. That’s a 25% decline from 2023, despite increased demand for patients, because highly targeted trials make it harder to identify eligible people, according to Paul Sabbatini, the hospital’s senior vice president for clinical research.
It takes the hospital 150 days on average to open a study, faster than the 175-day average for its peers, he says.
Considering the increased demand, it’s crucial that smaller community centers begin enrolling patients to help fill it, Sabbatini says. Memorial Sloan Kettering is trying to bring them into the fold with a “decentralized” system where those clinics would work in collaboration with the hospital, and under the purview of its review systems.
How best to share the financial incentives involved in those trials is still an open question, he says. Guidelines published by the American Medical Association aren’t legally binding but say compensation should be at “fair market value,” and that the “nature and source of funding” should be disclosed to prospective participants.
Sabbatini says Memorial Sloan Kettering investigators disclose if they have an ownership stake or have received consulting or other payments that might pose conflicts. But when it comes to fees paid to the hospital itself for enrolling patients in studies, disclosure is limited to letting patients know which drug companies are sponsoring the trial, he says.
A similar approach might present ethical risks at a for-profit center, Sabbatini says. “As these trials move into these sites, how is the patient informed of that?” he asks. “How is the patient informed about the financial conflicts of interest or what is driving the offering of this trial? The more transparency the better.”
At XCancer, Nordquist himself pitches patients on clinical trials. New patients get a generous amount of time with him, two to three hours. About 20 minutes is devoted to “dispelling a lot of the myths and misconceptions” about research, a conversation he never skips because “it puts a seed there,” he says, “and then every time they come in, we’re always discussing research so it builds on that seed.” Some 30% of his patients eventually enroll, higher than the 7.1% trial participation rate among cancer patients nationwide.
A South Dakota native, he originally didn’t set out to become a doctor at all. Nordquist graduated with a pharmacy degree from Creighton University in Omaha in 1992, then moved to Oregon, but his new professional life derailed almost as soon as it started.
In December of that year, he took “a quantity of assorted merchandise and prescription drugs” from his employer, according to a 1993 disciplinary action obtained by Bloomberg. His license was suspended for 60 days and he was put on probation for two years, meaning he couldn’t act as a “pharmacist in charge.” The incident followed him back to Nebraska, where the board of pharmacy filed a reciprocal action against his license there. He went back to medical school at Creighton.
“It’s an ugly thing in your past when you’re 22 years old,” Nordquist says. He calls the episode a “bad judgment” that “has no bearing on XCancer operations or how I treat patients today.” He adds he disclosed the sanction while applying to schools and employers.
In the seven years through 2024, Nordquist’s companies have received at least $22 million in funding from pharmaceutical companies, federal data show.
Not all of that is profit. Clinical trial payments cover direct costs of administering trials, from the drugs themselves to the items needed to administer them. And then there’s the “overhead” – an amount that’s tacked on top to cover operating costs. This can also boost a clinic’s profit margin. The overhead charge at XCancer is 30% to 35% of the overall budget, according to Nordquist. That’s in line with other cancer centers, though Nordquist says one pharmaceutical founder told him his firm’s “value is better” because it can enroll patients so efficiently.
A large research staff and custom software for managing trial data is part of the reason. Former employees also point to an atmosphere much like a family company, where Nordquist gets the final say on important decisions, including what trials to open and what treatment regimens to offer. Enrolling patients into trials is a top priority.
Some key decision-makers are personally close to him. Stacy Moore, Nordquist’s fiancee, serves as president of the company and vice president of its research operations. For years, Nordquist’s brother Tim served as chief operating officer, in charge of finances and human resources. He’s now a Lutheran pastor. Nordquist says it is not uncommon to have family members on the staff of a small business and, as for Moore, “our professional conduct is exactly that, professional.”
At XCancer, Nordquist says, legal reviews have sometimes been completed in a single day. They might take months at research hospitals. Trials must also be approved by an independent review board – something that might add months more at a big hospital. Nordquist prefers professional, for-profit review board services. One used by XCancer, WCG, is owned by private equity firms and promotes that it will review studies deemed “minimal risk” to patients in one to two business days.
Each patient who enters XCancer is screened for trial eligibility, which can involve a long list of criteria, some of which are subject to judgment calls. When there’s gray area about whether a patient has failed other therapies that they’ve tried, Nordquist sometimes has leaned on the side of eligibility, according to three former employees, who asked for anonymity to avoid professional consequences. “The checks and balances system is sort of bypassed,” one says. Nordquist denies any focus on enrolling patients quickly. “Our focus is what is best for the patient,” he says. “We follow the protocol 100% without deviation.”
Described in his XCancer medical records as a delightful 71-year-old gentleman, Odorisio first started seeing Nordquist in 2015 and kept his prostate cancer at bay with the traditional methods: surgery, chemotherapy and hormone therapy drugs.
By 2023, though, the cancer had traveled into his bones. He talked with the team at XCancer about Pluvicto. Odorisio knew Nordquist had been involved in Pluvicto’s approval. Ads for the drug are ubiquitous on TV and show middle-aged men driving golf balls, baking bread or laughing with their grandkids. Odorisio was told the patient response was “good,” he recalled. But his prostate-specific antigen levels quadrupled while on Pluvicto and after receiving five of his six doses, he stopped taking it. The XCancer records described a “mixed response.”
There were other drawbacks the ads hadn’t highlighted. Pluvicto uses a radioactive substance to target and destroy cancer cells, so he had to carry a card after treatments warning that he might give off small amounts of radiation. Not only could he not teach his grandkids to ride a bike, as a man in the ads does, he couldn’t be near them for several days after receiving a dose for fear of irradiating them. “I never asked the question ‘what is good?’ until we got pretty far into it,” Odorisio recalled. “I just felt like I made a mistake.”
The FDA in September called one of the recent ads for Pluvicto misleading, noting that only 49% of men saw their tumors shrink or disappear.
Novartis says there is “robust evidence” of the drug’s safety and efficacy and it is “committed to working with the FDA” to ensure the ads comply with the law. Nordquist says no drug is a cure and they all stop working at some point. “Research is the only way to move that forward,” he says.
Next, Odorisio eagerly signed up for two clinical trials, both experimental drugs from AstraZeneca Plc, with several months of chemotherapy in between.
Neither trial worked any better than Pluvicto did, and his PSA numbers soared again. Nordquist says Odorisio had a very resistant cancer and such responses are “unfortunately a reality in aggressive disease.” Nordquist says they would’ve been discussing hospice care if Odorisio hadn’t enrolled in the second trial. “He was adamant about trying this trial,” Nordquist says.
The cancer kept spreading. Beleaguered by new setbacks, Odorisio said in August he was still fighting. “I’m not at a point where I can say that I’ve had enough, I’ve got five grandkids,” he said, his voice cracking.
Clinical trials reimburse patients for costs like travel expenses, and he’d acquired a pre-paid debit card with a balance of about $1,600. “I’m not interested in the money,” he said. He hoped to use it to buy the XCancer staff lunch sometime. He never got the chance. On Sept. 26, Odorisio died.
Oversight of the clinical trial process essentially relies on self-policing. When it examines a new drug, the FDA requires investigators to report “disclosable conflicts,” such as an ownership stake in the pharmaceutical company that is trialing the drug. The compensation they get from enrolling patients is typically reported separately, to the Centers for Medicare & Medicaid Services. It generally only becomes public after a substantial lag, sometimes years. The upshot is that reviewers at the FDA have no real-time visibility into how the climbing per-patient pay rates might have affected the decisions of those conducting the trial.
Neither do patients, unless an institutional review board insists. Review boards, the agency wrote in guidance published in 2023, “have the final responsibility of determining whether subjects should be provided with information regarding the source of funding, funding arrangements or financial interests of parties involved.”
Increasingly, drug companies are looking overseas, to lower-cost trial sites in China and eastern Europe. Nordquist says an emissary from the United Arab Emirates even visited his Omaha clinic, curious how they too could play a bigger role in cancer research.
His business model is already expanding beyond Omaha. In exchange for 30% of revenue, Nordquist’s team is helping other community cancer clinics with trials; it will even upload data for them. He’s signed up clinics in Colorado, Louisiana and Alabama, with plans for many more.
Nordquist views this as public service. Community cancer centers have long struggled, with fewer business lines and lower insurance payouts than those of big hospitals. Many have closed or sold. Distributing the resources for trials across the country means more access to cancer care, in more places, for more patients. “I don’t see how this could be bad,” he says.
XCancer even launched a website for patients to find open trials and clinics that are offering them. The site recently showed Nordquist’s clinic participating in a dozen trials, backed by several companies. Novartis was listed as a platinum sponsor, in exchange for what Nordquist says is $100,000 a year.
He’s especially excited about a new therapy offered by an Australian startup called Clarity Pharmaceuticals. After Nordquist tested it on three patients, a Clarity press release quoted him as saying “I have not observed PSA responses like this after a single dose of any agent.”
A few months later, when XCancer became the first global site for the therapy’s latest trial, the holidays were fast approaching, and Nordquist promoted it with another photo. For this one, he donned a Santa hat and hopped in a sleigh.
Hundreds of hospitals across the US are marking up old cancer treatments — in some cases hundreds of times what Medicare pays.
By John Tozzi, Tanaz Meghjani and Mathieu Benhamou
Ida Martin’s first chemotherapy treatment at Rush University Medical Center cost her health plan $13,560. When she went down the street to a clinic for her next infusion three weeks later, the price dropped to $134.
“Same drug, different prices,” said Martin, a 62-year-old cook with colon cancer. The clinic was even still within the Rush system. “It’s ridiculous.”
Health spending in the US now tops $5 trillion a year with families and companies facing their steepest insurance premium hikes in years. Politicians often blame pharmaceutical companies, insurers, wasteful procedures and a bloated system too tangled to tame.
But beneath those familiar explanations lies a lesser known phenomenon. In the opaque world of hospital pricing, medical systems across the country are able to turn routine, decades-old cancer drugs into money-makers, marking up cheap chemotherapy drugs as if they’re pricey new treatments.
It’s a hidden toll that patients and their employers pay one infusion, and one inflated bill at a time. Hospitals are “taking advantage, basically, of a very sick population that’s undergoing lots of treatment,” said Ivana Krajcinovic, the vice president of health care delivery at Unite Here Health, Martin’s union health plan. “They do it because they can get away with it.”
Martin was on oxaliplatin, a more than 20-year-old cancer medicine long off its patent. Sanofi, the French company that first introduced it, barely makes money off it anymore. Medicare would pay about $35 for Martin’s dosage. Yet nearly 150 hospitals across the US are charging at least one insurer five times that — or more — according to a Bloomberg News analysis of data from Turquoise Health, a company working to bring transparency to health-care pricing. In some cases, like Martin’s, the markup is hundreds of times Medicare rates.
It’s not just one treatment or insurer. The analysis looked at over 1,700 hospitals, across eight generic cancer drugs and a group of major insurance companies. At 40% of those medical centers, they charged at least one insurer five times what Medicare pays, or more. That’s hundreds of cases across the country among various different insurers and various different drugs.
For these cancer drugs, the rate Medicare pays has dropped considerably over the last 15 years as generic alternatives have entered the market.
Medicare, the US federal government’s insurance plan for older Americans, pays a small markup on what it determines is the average sales price for a given drug. Often private insurers pay more than that. But, according to drug pricing experts, typically just a few times higher than Medicare rates, not the high multiples seen in the data set.
These findings are likely conservative. Turquoise Health limits its data, excluding commercial rates more than 10 times higher than Medicare rates. Unite Here Health has found multiple examples many times more than that, including Martin’s.
Charlie Jolie, a spokesperson for Rush, said the health system “strongly” rejects Unite Here Health’s assertion that it’s taking financial advantage of any patients.
Chemotherapy bills, he added, reflect more than just the price of the drug, including costs like specialized nurses and clinicians. This was the case for the higher price paid for Martin’s oxaliplatin at the hospital, Jolie said in an emailed statement, while overhead costs at the clinic where she got her later infusions are lower. Jolie added that this is a negotiated rate an insurer agrees to that helps “assure the best possible outcomes and affordability.”
Groups like Unite Here Health pay for health-care expenses but rely on outside insurance companies to negotiate rates with hospitals. Those agreed upon rates for any given drug or service often vary by insurer. Hospitals say their charges reflect the costs of acquiring the drugs and running complex medical centers that must serve everyone regardless of their ability to pay.
One New England Journal of Medicine study from 2024 found that hospitals routinely mark up drugs 2.5 to 3 times their estimated acquisition cost – substantially higher than doctors’ offices charge for the same medicines.
Critics say those factors might explain markups two to three times what Medicare pays, but not those that are five or 10, or in Martin’s case, more than 350 times higher. Unite Here Health believes that the most extreme instances it has found at various hospitals looks like price gouging, and has asked state regulators to investigate at least one instance in California.
“They can mark up the price of the drug whatever they want,” said Shawn Gremminger, the chief executive officer of the National Alliance of Healthcare Purchaser Coalitions, which represents employer groups.
Martin’s case was discovered by a small team working to find savings for the Unite Here Health insurance plan. The union’s health group covers about 230,000 people nationwide, hospitality workers in casinos, hotels and universities. It spends about $1.3 billion a year on health care. Krajcinovic said the fund aims to find quality care at the lowest price possible, since every dollar saved can go to members’ wages and pensions.
A group of five analysts assembled by the union plan scours claims looking for treatments with widely different prices. When they spot big variations, they try to get patients to go to the lower-cost option, as long as they believe they’ll get similar quality care.
“We're not changing their therapy in any way,” said Brian Cotter, the chief executive officer at Bright Spot Insights who works as a consultant with Unite Here Health. “It’s just switching where they get the therapy.” Cotter survived sarcoma as a child, and his wife is in treatment for the same disease right now – experiences that he said drive his determination to help people find more affordable care.
Ideally, they wouldn’t have to ask people to change providers at all. “These are cancer patients. They are very sick. They rely on their doctor’s judgement,” Krajcinovic said. She’d much rather see the higher prices come down.
Over the past few years, the group has found that hospitals are a hotspot for outsized markups of all kinds. In one case, the plan paid almost $90,000 for a series of oxaliplatin infusions from Salinas Valley Health in Monterey County, California. By Unite Here Health’s calculations, that’s more than 700 times what Medicare would’ve paid at the time.
When Krajcinovic asked the hospital about what she called an “extraordinary price discrepancy,” she said a representative told her that the health plan was only paying a small markup on the hospital’s acquisition price. They wouldn’t tell her what that cost was, only that it was comparable to other area hospitals’ rates, she said.
That didn’t seem believable to Krajcinovic: It was much more than Unite Here Health paid for oxaliplatin almost anywhere else in the country and far higher than listed charges at another local hospital. She also pointed out that Salinas Valley Health participates in a federal program for hospitals serving low-income patients that likely lets it purchase drugs at steep discounts.
Krajcinovic outlined all of this in a letter to the California Attorney General last year reviewed by Bloomberg News asking his office to investigate. A representative for the AG’s office declined to comment on any potential investigation and it has made no public indication that it’s pursuing a case.
Salinas Valley Health didn’t comment on the specifics of Krajcinovic’s account. A representative told Bloomberg News that it “understands why the historical charge for this medication raises concern” and that the previous price didn’t reflect the drug’s generic status. The hospital said it identified the pricing “discrepancy” during a leadership transition in late 2023 and responded by adjusting prices of medicines across its system, including lowering the standard charge for the cancer drug to $600 for 50 milligrams.
The acquisition cost ranges from $2 to $44 for 50 milligrams, Salinas Valley Health said; its pricing reflects the cost of staff, equipment and facilities. The hospital also said it loses money on many patients covered by government health programs, which influences how it negotiates with private insurers.
Salinas Valley Health’s public price list still shows the standard charge for oxaliplatin at $14,802 for 50 milligrams, as of the start of 2025. The hospital said the revised price will be posted in January.
For people with decent insurance coverage, the difference in price may not register — they pay a copay, whether the treatment costs the health plan $130 or $13,000. But those costs are eventually passed onto patients and workers. Unite Here Health calculated that markups on chemotherapy drugs specifically increased one of its plan’s per-member costs by almost $10 per month.
In Chicago, Martin only learned about the price discrepancy between the hospital and the clinic from the union health plan. When a Unite Here Health caseworker told her she could avoid a $100 copay by going to the clinic down the street for treatment, where she wouldn’t pay at all, she was happy for the savings. “I would’ve been stuck with a bill,” she said.
Even with insurance, Martin has drained her savings paying for medical and other expenses while on leave from her hotel job, where she made about $27 an hour. Meanwhile, she saved the health plan more than $13,000 on each infusion, which is the equivalent of about three months wages for Martin.
Indeed, the union has had to choose between funding wage increases at the expense of higher health premiums, said Ken Blair, a president of his union local in Connecticut. “In order to get a decent raise we had to lower our health care,” he said. “The prices go up, the copays go up.”
But for the 68-year-old who has multiple myeloma, that means higher health-care costs for him. He owed about $4,000 last year for medical expenses that his insurance didn’t cover. His health plan had to pay almost seven times the Medicare rate for one of his drugs, bortezomib, a drug approved more than 20 years ago that has since gone generic.
A transparency push initiated by the first Trump administration mandated hospitals and insurers reveal prices that had long been kept hidden to keep these very costs in check. Despite the threat of fines, some hospitals have been slow to comply, and when they do the data is often unwieldy.
Even when the costs are out there for everyone to see, some hospitals don’t have much incentive to lower prices. “In certain markets, the providers have such a concentrated position, it’s hard to get a discount or to get lower rates for infused drugs,” said Mark Miller, executive vice president of health care at Arnold Ventures, a philanthropy that aims to lower health-care costs.
Having data is also just a starting point. Krajcinovic and her staff spend hours pouring through claims data to track down “surreal” prices, she said. It can take months to identify excess costs, and either negotiate better rates or encourage patients to switch to lower-cost providers. When Unite Here Health does finally manage to lower its costs in one place, it often discovers another markup elsewhere.
Krajcinovic describes it like a game of whack-a-mole. “It’s a constantly shifting target,” she said. “It’s exhausting.”
The impact on those suffering from cancer is likely to increase if federal health subsidies expire next year.
By Robert Langreth and Josyana Joshua
Jacqueline Trapp was paying down her mortgage and looking forward to early retirement when she got multiple myeloma a decade ago at the age of 50. She’s kept her disease mostly under control since then with a drug that lists for over $800 per pill, taken 21 days a month. It’s her finances that have deteriorated.
A former schoolteacher and real estate agent, Trapp had always been insured. In treating her cancer, she still racked up over $100,000 in out-of-pocket drug costs – not including her insurance premiums and the cost of other tests. To keep up with the bills, she and her husband sold a vintage truck he had painstakingly restored. They refinanced their house in Muskego, Wisconsin, and stopped going out to dinner and the theater. They even sold a nice dining room table set to raise $500.
“My choice has been pay it, or die,” Trapp said.
About 2 million Americans are diagnosed with cancer each year, and many face the same financial battle. It’s a particular burden for younger people not yet able to qualify for Medicare, saddling them with years of complex treatment and soaring prescription costs – even if they have insurance. A Bloomberg News investigation this year found that the median initial price of cancer drugs has quadrupled since 2000, to a staggering $25,000 a month.
Drugmakers, hospitals and doctors all benefit from what’s now sometimes called the “cancer industrial complex.” The US has an enviable infrastructure of gleaming cancer centers and no shortage of blockbuster treatments. A patchwork of government payment caps and charity programs help some patients cover the costs. For many, though, the price still soars far out of proportion to the benefits. And the fallout is only likely to grow if key federal subsidies for health insurance premiums expire next year.
The investigation found that many of the added expenses may not even be necessary. Fewer than half of the drugs approved since 2000 have ever been proven to prolong people’s lives, according to a Bloomberg analysis. Drugmakers have taken advantage of a fast-track approval process that allows new treatments into the market based on early research, and the Food and Drug Administration has been slow to force the withdrawal of those shown not to work.
Hospitals have marked up some types of chemotherapy drugs by 100-fold or more, the investigation found. Doctors participate in an $80-billion-a-year market for clinical trials in which cancer patients can generate $250,000 or more each in revenue. And drug companies have avoided testing lower doses of many treatments, even as evidence builds that some may work well with less cost and fewer visits to the infusion center.
In August, after the Bloomberg analysis was published, the FDA proposed tightening its approval standards by requiring drugmakers to more closely assess potential harmful side effects of new treatments and to gather more evidence of their long-term survival benefits. The drugmakers have said robust studies prove the new treatments’ effectiveness.
Even as US senators are locked in a stalemate over extending the federal health subsidies, members of both parties expressed frustration and called for legislation requiring the FDA to better police drugs after they’ve hit the market.
Senator Roger Marshall, a Kansas Republican who’s also a physician, said that while he admires the FDA’s expertise in advancing treatments, Congress should consider more funds for research that would confirm the “safety and efficacy” of drugs once people start taking them.
“I don’t know how good of a job we’re doing with follow-up and really collecting the data you’re wanting me to answer as the doctor,” Marshall said. “So we’re giving this new miracle drug, it’s $400,000 and we want to see its impact on the people it’s given to. Are they continuing prospective studies? Are they continuing retrospective studies? What are the side effects of those drugs?”
Marshall said he also supports a proposal for Medicare to pay hospitals a uniform amount for the same services, and co-sponsored a bill this year that would require providers to publish specific prices so that people can more easily compare them.
Cancer patients face high costs in part because many health insurance plans force them to shoulder some of the burden during periods of intense treatment after a diagnosis. When cancer hits, they may lose income just as they are slammed with numerous medical bills.
While the Affordable Care Act in 2025 restricts individual out-of-pocket costs to $9,200 a year for in-network care, some people end up with expenses that their insurer refuses to cover. Other costs aren’t reimbursed, such as travel to far-flung cancer centers for specialized treatment.
As part of the Inflation Reduction Act in 2022, Congress capped patient out-of-pocket costs at $2,000 in the Medicare prescription drug program. Trapp, who’s now a patient advocate for a non-profit group called Patients for Affordable Drugs, said that helped limit her own expenses once she qualified for Medicare through disability. But the cap only applies to drugs taken at home like pills and not other treatment for cancer patients, like chemotherapy or infusions.
A provision in the One Big Beautiful Bill Act passed this year would also exempt certain drugs from government price negotiations, which Senator Ron Wyden, a Democrat from Oregon, says might increase overall costs for seniors.
“Americans with cancer and their families are desperate for treatments that will get them on the road to recovery,” he said in a statement. “However, these treatments are increasingly unaffordable, and some are even brought to market without sufficient evidence of their effectiveness.”
Studies have long found that cancer poses particular financial risks. Cancer patients are nearly three times more likely to file for bankruptcy than similar people who don’t have cancer, a study by researchers in Washington state found in 2013. Those cancer patients who file for bankruptcy are 80% more likely to die than those patients who do not.
Recent evidence shows the problem persists, long after passage of the Affordable Care Act. Almost one in 10 cancer patients with private insurance coverage in Massachusetts experienced a significant drop in credit score after being diagnosed with cancer, researchers from Harvard Medical School reported at a conference in October. The more the credit score dropped, the more likely the person was to die, said Benjamin James, the Harvard Medical School associate professor who led the study.
He and his fellow researchers didn’t determine exactly why that was the case, but speculated that many patients got sicker because they couldn’t afford proper treatment. “It was a really shocking finding,” James said, adding that the situation is likely to be worse in other states with skimpier insurance coverage than Massachusetts.
Jacey Abbott of Stapleton, Alabama, was only 34 when she was diagnosed with breast cancer in 2019. The mother of three had every reason to be hopeful; her cancer was early-stage and treatable. After multiple surgeries that removed the tumor as well as both of her breasts, doctors gave her chemotherapy, followed by a standard cocktail of drugs to stop her ovaries from producing estrogen.
Abbott had insurance, which covered most of the treatment costs. Nonetheless, she built up $16,000 of medical debt. If the amount seemed manageable at first, it loomed much larger after she lost her job at a Domino’s Pizza restaurant. She extended the insurance and paid for it herself for two months but then stopped because it was too expensive, she said.
In 2021, with debts piling up, she declared bankruptcy. “I got to keep my car,” she said.
After acquiring Medicaid disability insurance, her treatments were covered for two years. But a paperwork snafu forced her off the plan. What looked to Abbott like an easily solvable documentation issue proved to be anything but. For eight months, she went uncovered by insurance. “I never got any reason why or anything like that,” Abbott said. “I just got a letter in the mail that said I didn't have it.”
Abbott wanted to pay out of pocket to continue treatment, but it just wasn’t possible. While one generic drug she was taking goes for around $40 a month, another essential brand-name treatment lists for more than $1,000 a month. By the time Abbott re-secured government coverage in July of last year, her cancer had spread to her liver, lungs and bones. It is no longer considered curable.
For cancer patients, the costs aren’t spread out evenly. They can be particularly heavy during the first year after diagnosis. Patients unlucky enough to get cancer in the middle of an insurance-plan year can get slammed with the full cost of multiple large deductibles within a relatively short period, while simultaneously losing their source of income because they are too sick to work.
Owen K.C. Stephens, a 55-year-old freelance game developer in Oklahoma City, required months of chemotherapy, then radiation, after he was diagnosed with colorectal cancer in early 2023. Unable to work, his income declined sharply. He quickly blew through his deductible and reached his out-of-pocket maximum under the “bronze” plan he had purchased.
Then, the insurance plan collapsed and was liquidated by state regulators. He had to join a new plan from scratch with a new deductible in September 2023, adding thousands more to his bill for the year. In January 2024, as he was getting radiation, another plan year started. He had to start over a third time with another big deductible.
Numerous procedures, doctor visits and drugs ended up not being fully covered for various reasons. Some doctors wound up being out of network. A hospital charged more for a procedure than the insurance plan was willing to pay, and he was too sick to fight with them. He had to pay $1,000 a year for a blood thinner because his new insurer didn’t cover it. Stephens turned to GoFundMe and managed to raise more than $100,000 to pay down the bills.
Even for people with insurance, the drugs are often so expensive that they’re skipping desperately needed treatments.
Jennifer Saura, a 49-year-old former Walgreens store supervisor in Immokalee, Florida, was diagnosed with breast cancer that had spread to her hip, knees and liver in April 2024, leaving her unable to walk or do her job. She needed six weeks in the hospital to repair a fractured hip followed by radiation to shrink the worst bone tumors. Despite being insured with standard “silver” plans under the Affordable Care Act, she quickly ran up close to $10,000 in medical debt to cover the various co-payments and deductibles.
Doctors put her on hormone therapy including Pfizer Inc.’s Ibrance along with a second drug to help keep the remaining tumors in check. But over the last 18 months, money has been so tight she had to skip infusions of a bone-preserving agent three times because she couldn’t afford the $75 copay. Other times she put off getting refills of Ibrance or painkillers to treat her bone pain because she didn’t have $5 left in her bank account for the copays.
Her car was repossessed in October after she fell behind in payments. She put off additional appointments because she had no way to get there. Her 20-year-old daughter, Audrey, started a GoFundMe, but the $815 it had raised through late December hasn’t come close to paying the bills.
Saura qualified for Medicaid in February. That eliminated most of her out-of-pocket costs, but she is months behind in paying the rent and is inundated with calls from debt collectors. “I am so far behind on everything,” she said. “It stresses me out not knowing if I’m going to be able to pay for my doctor’s visit or get my medicine.”
On Dec. 18, Saura got more bad news from her physician: The cancer has spread to her spine.