The ache jolted me awake. It was barely daybreak, a misty February morning in 2023. My aspect felt as if I’d been stabbed.
I had been coping with ache for weeks — a bothersome ache that felt like a nasty runner’s cramp. However now it was so intense I needed to brace myself in opposition to the wall to face up.
A couple of hours after arriving on the emergency room, I heard my title. A health care provider requested me to comply with him to a personal space, the place he informed me a scan had uncovered one thing “regarding.”
There have been lesions, areas of bone destruction, on prime of each of my hip bones and on my sternum. These have been hallmarks of a number of myeloma. “Most cancers,” he stated.
A number of myeloma is a blood most cancers that ravages bone, leaving distinctive holes in its wake. Subsequent scans confirmed “innumerable lesions” from my neck to my ft in addition to two damaged ribs and a compression fracture in my backbone. There isn’t any treatment.
I walked out of the ER seeking contemporary air. I sat on a steel bench and did what many sufferers do. I turned to Google. The primary hyperlink was a medical assessment stating that the common lifespan of a newly identified affected person was three to 5 years. My abdomen churned.
I quickly discovered that info was outdated. Most sufferers at this time reside for much longer, largely as a consequence of a drug with a horrific previous. It was a health care provider on the hospital who first informed me I might probably take a thalidomide drug as a part of my remedy.
That couldn’t be potential, I informed him.
I knew the story of thalidomide, or at the very least I believed I did. It represented one of many darkest chapters within the historical past of recent drugs, having triggered 1000’s of extreme beginning defects after it was given to pregnant girls within the Nineteen Fifties and Nineteen Sixties. The drug was banned in a lot of the world, and the scandal gave rise to the modern-day U.S. Meals and Drug Administration.
It seems the drug as soon as relegated to a pharmaceutical graveyard had new life as a most cancers fighter.
That drug I take is named Revlimid. It’s a spinoff of thalidomide, a barely tweaked model of the mum or dad compound.
Revlimid is now one of many bestselling pharmaceutical merchandise of all time, with whole gross sales of greater than $100 billion. It has prolonged tens of 1000’s of lives — together with my very own.
However Revlimid can also be, I quickly discovered, terribly costly, costing practically $1,000 for every day by day tablet. (Though, I later found, a capsule prices simply 25 cents to make.)
That steep tab has put the drug’s lifesaving potential out of attain for some most cancers sufferers, who’ve been pressured into debt or just stopped taking the drug. The worth additionally helps gasoline our ballooning insurance coverage premiums.
For many years, I’ve reported on outrageous well being care prices within the U.S. and the burden they place on sufferers. I’ve revealed the techniques utilized by drug firms to drive gross sales and preserve the value of their merchandise excessive.
Even with my expertise, the price of Revlimid stood out. After I began taking the drug, I’d take a look at the graceful, cylindrical capsule in my hand and contemplate the very fact I used to be about to swallow one thing that prices about the identical as a brand new iPhone. A month’s provide, which arrives in an strange, orange-tinged plastic bottle, is similar worth as a brand new Nissan Versa.
I wished to know the way this drug got here to price a lot — and why the value retains going up. The worth of Revlimid has been hiked 26 occasions because it launched. A few of what occurred was reported on the time. However nobody has pieced collectively the total account of what the drugmaker Celgene did, how federal regulators did not rein it in and what the story reveals about unrestrained drug pricing in America.
What I found astonished even me.
My journey began with an indefatigable New York Metropolis lawyer on a quest to present her dying husband an opportunity.
Tiny and Terrifying
Beth Wolmer’s story begins on a moon-splashed seaside within the Cayman Islands within the winter of 1995. She and her husband, Ira, have been holding palms as they walked within the sand, having fun with a uncommon break from a busy life as mother and father to a 1-year-old daughter and demanding jobs as 30-something professionals in New York Metropolis.
That they had met by way of pals and clicked from the beginning. On Sunday mornings, they sat collectively for hours, sharing sections of the newspaper and consuming bagels. They deliberate journeys to Europe and outings to the Metropolitan Museum of Artwork.
Ira was an interventional heart specialist who adopted his father into drugs. Beth was a lawyer on the high-powered agency Skadden Arps.
“We had an awesome life,” Beth informed me. “I particularly keep in mind coming residence on the bus and considering: ‘My life is simply excellent, excellent. I’m not going to alter a factor.’”
As they walked that evening within the Caribbean, Ira felt a pointy ache in his cheekbone. The ache flared a number of extra occasions through the journey, turning into so intense that it introduced tears to his eyes.
When he obtained residence, Ira made an appointment to determine what was improper. Imaging checks revealed a number of myeloma. The prognosis was grim. The couple was informed Ira had two years to reside.
Specialists really useful remedies that may solely present a short reprieve. The couple searched for somebody who might provide one thing extra. That’s after they discovered Dr. Bart Barlogie in Little Rock, Arkansas.
I’ve by no means been extra frightened of a partner of a affected person than I used to be of her.
Barlogie had been recruited to the College of Arkansas for Medical Sciences from the extra prestigious MD Anderson Most cancers Middle in Houston. In Texas, Barlogie had been annoyed by a medical tradition that he considered as too timid in its strategy to a number of myeloma.
He remembers engaged on a Sunday when a newly identified affected person was admitted to the hospital. With few choices, Barlogie determined to place the affected person on a taxing, four-drug chemotherapy cocktail used for lymphoma sufferers. It didn’t work. The affected person died from a sepsis an infection, a identified complication of the remedy.
The attending doctor later admonished him, Barlogie stated, saying, “Bart, we’ve to study to deal with myeloma gently.” Barlogie stated he thought to himself, “Fuck you.”
In Arkansas, Barlogie was in cost. He shortly developed a popularity as a practitioner keen to attempt something to combat the deadly illness. Sufferers from around the globe — together with the actor Roy Scheider from the film “Jaws” — flocked to his clinic.
Beth and Ira heard Barlogie earlier than they noticed him. The cowboy boots he’d taken to donning since his time in Houston clacked down the linoleum hallway flooring. A brief, slight man, Barlogie had a booming voice with a German accent. He wore leather-based jackets and spherical, red-framed glasses on his bald head.
When he strode into the examination room, he hugged Beth and Ira and informed them that they had come to the suitable place.
Now retired, Barlogie remembers being struck by Beth’s depth. He stated she informed him “it’s essential to do one thing” to assist Ira.
I met Barlogie at his residence in Little Rock. We sat in his workplace, which is stuffed with images of the crimson Ducati bike he used to experience to work. An outdated license plate with the letters “MMCURED” sat on a shelf, reflecting his objective to discover a treatment for a number of myeloma.
When Beth and Ira discovered him, Barlogie informed me, he had been having some success with a novel strategy that put sufferers by way of two stem cell transplants just a few months aside, which he known as a tandem stem cell transplant. With a transplant, a affected person is bombarded with high-dose chemotherapy to kill the cancerous plasma cells. The affected person is then infused with wholesome stem cells that journey to the bone marrow.
The extreme chemotherapy may be grueling and poses a small danger of demise.
Ira underwent three transplants. Every time, he relapsed. By the autumn of 1997, after two years of remedy, Ira’s thick black hair was gone. He was losing a few pounds. Then he had a stroke. His kidneys failed and required dialysis. He developed pneumonia and needed to be intubated.
Beth was decided to maintain him alive lengthy sufficient for his or her toddler daughter to recollect him. With {a photograph} of Ira smiling with their child as motivation, she utilized her lawyer’s tenacity to the case. She pored over medical journals and peppered oncologists with questions on why what they have been making an attempt wasn’t working or quizzing them a couple of promising examine. When docs informed her there was nothing extra they might do for her husband, she refused to simply accept it.
“She is a tiny individual, however she is terrifying,” stated Dr. David Siegel, a part of the workforce that handled Ira in Arkansas. “I’ve by no means been extra frightened of a partner of a affected person than I used to be of her.” He meant it as a praise.
By late fall in 1997, Ira was dying and Beth was determined.
A researcher informed her in regards to the work of Dr. Judah Folkman, a surgeon and researcher at Boston Kids’s Hospital. Folkman believed the expansion of cancerous tumors might be stunted by ravenous them of a provide of recent blood vessels.
“Thank You, God”
Folkman was a workaholic who, when he wasn’t within the working room or the analysis lab, was touring internationally to advertise his novel idea of find out how to assault most cancers. Friends had ridiculed his thought since he first proposed it within the Nineteen Seventies. The prevailing perception on the time was that tumors didn’t want a brand new blood provide to develop.
A younger researcher in his lab, an ophthalmologist named Robert D’Amato, was at work on the highest query Folkman had posed. Might they give you a drug, in tablet kind, that blocks the expansion of recent blood vessels?
Folkman has since died, however it wasn’t tough for me to trace down D’Amato. He nonetheless works at Boston Kids’s Hospital, the place he has his personal lab and holds the Judah Folkman Chair in Surgical procedure. Now in his early 60s, D’Amato has a youthful power and speaks in a fast, matter-of-fact clip.
D’Amato informed me that he had got down to discover current medication that block blood vessel progress. He began by considering of his personal physique and negative effects brought on by sure medication. A drug that causes hair loss is perhaps the results of the blood provide to hair follicles being shut off, for instance. However this train wasn’t producing any viable candidates.
After giving it some thought, D’Amato realized he had myopically narrowed his search. What a couple of girl’s physique? There have been medication that stopped menstrual cycles. Then there have been medication that triggered beginning defects in pregnant girls. In each of these instances, it was potential the drug was inhibiting blood vessel progress. He got here up with an inventory of 10 medication. On the prime of the record was one with a devastating historical past: thalidomide.
Starting within the Nineteen Fifties, pregnant girls in Europe, Australia and different international locations have been regularly prescribed thalidomide as a remedy for morning illness and to assist them sleep. The drug was regarded as innocent and in Germany was bought over-the-counter. An commercial for thalidomide in the UK claimed it might “be given with full security to pregnant girls and nursing moms with out adversarial impact on mom or little one.”
They have been improper.
The drug was finally linked to beginning defects in additional than 10,000 infants. These infants have been born with out limbs or with shortened limbs, malformed palms, disfigured faces and injury to inside organs. Almost half died inside months of being born.
By the early Nineteen Sixties, the drug was broadly banned, thought of a shameful chapter within the historical past of prescription drugs. It was by no means bought within the U.S. because of the unwavering objections of a resolute reviewer on the FDA named Frances Oldham Kelsey. The shut name, nonetheless, prompted Congress to require extra rigorous security and efficacy knowledge from drug producers and empower the FDA to observe the trade extra intently.
D’Amato theorized that the thalidomide beginning defects have been the results of the drug stopping the expansion of recent blood vessels that the fetus must develop. He walked me by way of his experiments: He cracked a fertilized rooster egg on a glass petri dish and positioned thalidomide on the floor. After two days, if no blood vessels develop on the embryo, a halo ought to seem across the thalidomide pattern, displaying the drug labored. It didn’t.
Folkman informed D’Amato to maneuver on. However D’Amato couldn’t shake the disappointing outcomes. He did extra analysis and realized thalidomide must first be damaged down within the physique to affect people. He bought metabolites of thalidomide, repeated the take a look at and this time discovered a halo across the pattern.
He stored experimenting and in 1994 printed a paper discovering that thalidomide had “clear implications” for treating tumors.
So when Beth known as three years later, Folkman informed her they need to attempt it.
Barlogie informed me he didn’t assume it will work. Beth stated she needed to persuade him to attempt it.
Barlogie agreed to check it on Ira and two different sufferers who have been out of remedy choices in early December.
I wished him alive endlessly.
The drug didn’t work for Ira. Beth stated simply earlier than he died, Ira sat up in mattress, kissed her and smiled. It was March 10, 1998. He was 38.
After years of frantically trying to find something that may assist, the finality of his demise was tough to simply accept, she stated. “I wished him alive endlessly.”
It’s unclear what occurred with the second affected person. The third affected person, nonetheless, began to get higher.
His title was Jimmy. Little extra is thought about him besides that he was a affected person of one other oncologist on the hospital, Dr. Seema Singhal, and close to demise earlier than he began the drug. “I informed him it’d work, however on the very least it will assist him sleep,” Singhal stated. Shortly after Jimmy took his first dose of thalidomide, Singhal left for a trip.
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When she returned two weeks later, her mailbox was stuffed with lab outcomes for Jimmy. He was nonetheless alive. She sat right down to double-check the outcomes, which confirmed declining quantities of a most cancers marker. “For half-hour, I used to be the one individual on the planet who knew this labored,” she stated.
Singhal walked right down to Barlogie’s workplace to present him the information. “He took me by the hand, opened a window and shouted, ‘Thanks, God,’” she stated.
“Violent Arguments”
Phrase of Jimmy’s beautiful restoration in Arkansas shortly made its technique to the places of work of Celgene Corp., situated in a small company park in a rural patch of northern New Jersey.
The corporate had simply wrapped up a brutal year-end accounting, which confirmed losses of $27 million on income of simply $1.1 million. Cash was so tight that executives engaged in what one in every of them known as “violent arguments” over whether or not to cost staff for espresso.
Celgene had acquired the rights to thalidomide patents held by researchers at Rockefeller College in 1992. The corporate, which was new to prescription drugs, deliberate to make use of the expertise of acquiring FDA approval for thalidomide to develop different medication.
“It wasn’t meant to be a blockbuster,” stated Sol Barer, who began on the firm in 1987 and later turned CEO.
When Celgene introduced plans to develop the disgraced drug for brand new makes use of, the one analyst following the corporate on Wall Road dropped protection and informed Celgene officers they didn’t know what they have been doing.
The corporate thought the biggest market can be as a remedy for AIDS sufferers experiencing harmful weight reduction. To win approval of the drug, nonetheless, Celgene chosen a use that was already in apply in components of the world for a small group of sufferers.
In July 1998, the FDA accredited thalidomide for the remedy of a painful complication of leprosy. It was a momentous choice, coming just some a long time after the drug triggered a lot hurt.
The marketplace for leprosy was tiny, however what occurred with Jimmy in Arkansas modified every little thing for the corporate.
Blocked Exits
The Arkansas docs had been busy since first testing thalidomide on Ira Wolmer, Jimmy and the opposite affected person. They shortly obtained approval to conduct a bigger experiment funded by a grant from the U.S. Nationwide Institutes of Well being. Now, in December 1998, they have been able to share their preliminary findings on the annual assembly of the American Society of Hematology.
It had been three a long time since a brand new remedy for a number of myeloma had been accredited, and there was a buzz among the many oncologists gathered in Miami Seashore for the convention. So many docs crowded into the room for the presentation that the fireplace marshal needed to intervene a number of occasions to clear exit methods. Phrase had already unfold amongst a number of myeloma specialists about Jimmy. Now, the assembled docs wished to know whether or not it had been a fluke or a discovery that may basically change how they practiced.
Singhal was tasked with presenting the information. It was an enormous stage for the 32-year-old physician, who had solely been training within the U.S. for 2 years.
It fully modified the remedy panorama.
The 89 sufferers within the examine have been high-risk instances who had undergone prior remedy. They have been sufferers who, like Ira, had run out of choices. Now, after thalidomide remedy, one-third had declines in myeloma exercise.
These have been beautiful numbers, in contrast to something seen earlier than within the remedy of a number of myeloma. When Singhal completed, the room erupted in applause.
“It fully modified the remedy panorama,” she stated.
I wasn’t in a position to monitor down Jimmy, however I’ve a way of how he might need felt when he realized the remedy was working.
After my preliminary emergency room go to, it took time to substantiate my prognosis and do some further testing. Whereas I waited, the ache worsened. Painkillers barely made a dent. All I might image was this most cancers consuming away at my bones, doing extra injury on daily basis.
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Some sufferers wait months for care. I used to be fortunate sufficient to fulfill my oncologist inside weeks. He had a script for Revlimid able to go, a part of a routine of 4 medication I might take as customary induction remedy, and I used to be in a position to begin it inside days.
The preliminary dose of Revlimid price $18,255 for a month’s provide, and my insurance coverage lined the associated fee.
Inside a month, my blood checks confirmed a large drop in a key most cancers indicator.
My ache progressively subsided too. By the top of April, I wrote in my journal that the ache was a 3 or 4 as an alternative of the same old 9 or 10. “It doesn’t damage to get off the bed anymore,” I wrote.
A Piggy Financial institution
The invention in Arkansas made thalidomide, which Celgene bought as Thalomid, an instantaneous hit.
In consequence, Celgene’s income elevated practically sevenfold to $26.2 million within the yr after the Miami presentation. It bought its thalidomide drugs for $7.50 every.
From these modest beginnings, Celgene took a barely altered model of that tablet and turned it into one of many bestselling and costliest pharmaceuticals in historical past. Celgene’s success with Thalomid was the results of outstanding luck, a case the place the heavy lifting of discovery and preliminary testing had already been carried out, by Beth Wolmer, D’Amato, Barlogie, Singhal and others.
The event of the drug that may turn out to be Revlimid took me deep into the confounding, sharp-elbowed world of drug patents, which ostensibly defend drugmakers, permitting them to recoup the large investments they made in growing a brand new product. Celgene drew on patent regulation, a drug security system and even affected person help applications to protect the exclusivity of its prized drug and the large income it generated.
These techniques, detailed in reams of court docket filings, allowed Celgene to deal with Revlimid like a piggy financial institution, tapping it every time it wished.
There was a standard inside theme at Celgene that most cancers sufferers have been keen to pay nearly any quantity Celgene charged.
Amid the early success of Thalomid, Celgene recognized two potential threats: One was apparent. Thaldiomide triggered beginning defects, a looming danger that would lead to it being pulled from the market.
The opposite was that Celgene held restricted patents on the drug. Patents are unique authorized rights to innovations, and researchers file them on practically each facet of drug improvement as quickly as they will, locking up every little thing from particular units of elements to the way in which the drug is used and administered. The extra strong patents an organization has, the longer it might probably beat back rivals.
Thalidomide was an outdated drug and Celgene’s patents didn’t cowl the energetic ingredient, leaving it open to competitors. The patents it did have, protecting gadgets such because the optimum dosages and its use in treating explicit ailments, have been thought of weaker and open to a court docket problem. If Celgene might create a brand new model of thalidomide — ideally one which didn’t trigger beginning defects — the corporate might search extra and stronger patents that may prolong past these of the unique drug.
So researchers at Celgene examined analogs of thalidomide, that are medication which have an identical impact however are completely different from the mum or dad compound in minor methods, resembling having one much less oxygen atom. The analogs are additionally stronger than the unique, which means they will obtain an identical impact at decrease doses.
Celgene was not alone in its efforts. D’Amato was additionally learning thalidomide analogs and submitting patents on their use, which he and Boston Kids’s Hospital licensed to a Celgene competitor, EntreMed Inc.
With dueling patents, the businesses sued one another in 2002.
Celgene was newly flush with money from rising gross sales of thalidomide. EntreMed, alternatively, was burning by way of cash because it targeted most of its sources on growing different medication found in Folkman’s lab.
In December of 2002, the businesses settled.
Celgene agreed to pay Boston Kids’s Hospital royalties from future gross sales of Revlimid. In change, the hospital and D’Amato licensed their patents of thalidomide analogs to Celgene. Celgene additionally agreed to pay EntreMed $27 million.
For Celgene, the combat with EntreMed was a invaluable expertise. It discovered that competitors may be neutralized.
The Rise of Revlimid
Celgene had stored the value of Thalomid low when it was initially meant for AIDS sufferers, CEO John Jackson informed buyers in 2004, as the corporate “didn’t need enormous numbers of individuals demonstrating in entrance” of its workplace.
That wasn’t an issue with most cancers sufferers. There was “loads of room for very substantial will increase” within the worth of the drug now, Jackson informed buyers.
It’s time for us to take Jimbo to the wooden shed.
Simply two days earlier, Celgene had hiked the value of Thalomid to $47 a tablet.
“There was a standard inside theme at Celgene that most cancers sufferers have been keen to pay nearly any quantity Celgene charged,” wrote David Schmidt, a former nationwide account supervisor on the firm, in a whistleblower lawsuit he filed after his employment was terminated in 2008. The lawsuit was voluntarily dismissed by Schmidt. (Jackson didn’t reply to requests for remark; Schmidt declined to speak to me.)
When Celgene launched Revlimid in December of 2005, it set the preliminary worth at $55,000 a yr, or $218 a tablet, which was about double what analysts anticipated.
Seven months later, when the FDA accredited the drug for a number of myeloma, the value jumped to $70,560 a yr, or $280 a tablet.
The fee to fabricate every Revlimid tablet, in the meantime, was 25 cents. I discovered a deposition marked “extremely confidential” by which a prime Celgene government testified that the associated fee began at 1 / 4 and by no means modified.
Even on Wall Road, which cheered greater pricing, the preliminary price of Revlimid prompted concern amongst analysts who tracked the corporate that such aggressive maneuvering would trigger insurers to push again. Within the U.S., that is among the solely actual checks on the value of pharmaceuticals.
That concern turned out to be unfounded, and Celgene would repeatedly take a look at the bounds of how excessive it might go.
On the similar time, Celgene labored to mute any criticism of Revlimid.
In 2005, Celgene acquired experiences that Los Angeles oncologist Dr. James Berenson was “bashing” Revlimid in shows sponsored by affected person teams.
In a single e-mail, a senior firm official stated, “it’s time for us to take Jimbo to the wooden shed.” The corporate mentioned a variety of choices for coping with the physician, from taking authorized motion to arranging a sit-down with Celgene’s chief government.
In the end, the corporate seems to have selected a friendlier plan of action. Berenson turned a frequent paid speaker and guide for the corporate, with funds totaling at the very least $333,000, in response to Celgene disclosures. Berenson declined to remark.
He wasn’t the one physician the corporate befriended. Fee data present that between 2013 and 2018, Celgene paid docs $11 million for talking engagements and consulting work associated to Revlimid. At one level, Celgene rented a set on the Houston Astros baseball stadium to throw a celebration for the whole a number of myeloma division on the MD Anderson Most cancers Middle, in response to court docket testimony. The middle stated it was unable to confirm any of these particulars.
They remind me of an octopus with many, many tentacles, and on the finish of every tentacle is a wad of money.
Celgene went on to unfold its largess throughout the a number of myeloma world. It funded affected person teams, sponsored medical conferences and contracted with prestigious educational medical facilities.
“They remind me of an octopus with many, many tentacles, and on the finish of every tentacle is a wad of money,” stated David Mitchell, a former Washington, D.C., communications government who launched a nonprofit group to combat for decrease costs after he was identified with a number of myeloma. “All people depends on the cash.” Mitchell stated his group, Sufferers For Inexpensive Medication, doesn’t settle for donations from any entity that income from the event or distribution of prescription drugs.
On the similar time it showered docs and affected person teams with cash, Celgene was shutting Beth Wolmer out. She informed me that John Jackson, the CEO on the time, had promised her a paid board seat on the firm as a method of compensating her for her position within the discovery earlier than the corporate lower off communication.
Wolmer sued Celgene in federal court docket in 2009, in search of $300 million or extra for alleged misappropriation of her thought and what she termed the “unjust enrichment” of Celgene.
Celgene stated it by no means promised to compensate Wolmer. The corporate additionally recommended she vastly inflated her position within the discovery and, in any occasion, waited too lengthy to take authorized motion.
In 2010, a decide granted Celgene’s movement for abstract judgment within the case, agreeing that the statute of limitations had expired whereas on the similar time expressing “admiration” for Wolmer’s “contribution to the battle in opposition to this horrible illness.”
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Wolmer has remarried and adjusted her title to Jacobson. She stays upset about the way in which she was handled by Celgene. “There was no ambiguity about who discovered the aim of this drug, and I’m thrilled that it’s serving to so many individuals,” she stated. “Why they handled me that method? I don’t know.”
The Generic Risk
After the FDA accredited Revlimid in late 2005, it additionally granted Celgene one thing else: seven years of market exclusivity as a result of the drug treats a uncommon illness. In these seven years, Celgene raised the value of the drug 9 occasions, rising the value per tablet by 82% to $397 in 2012.
The corporate additionally fended off challengers by claiming its patents protected the drug from competitors till 2027.
However by 2010 generic makers have been already engaged on copies of the drug, getting ready to problem these patents and enter the market earlier. A authorities evaluation has discovered that generics usually decrease the value of name title medication by a median of 85% after only one yr.
Celgene was properly conscious of the hazard generics posed and warned in a 2012 monetary submitting that their entry into the market might have a “materials adversarial impact” on its funds. At that time, Revlimid gross sales made up 70% of the corporate’s income.
Celgene wanted one other transfer.
The drug nonetheless posed a danger of beginning defects just like the mum or dad compound. In approving the drug, the FDA had mandated a strict security program to regulate its prescription and distribution.
Celgene realized early on that this may be a device to thwart competitors. An inside firm presentation on the time famous that the protection program might make it “harder for generic firms to entry” thalidomide for testing.
Generic drug makers are required by the FDA to check their model in opposition to the model title drug, so they should purchase small quantities of Revlimid from the corporate.
By 2012, at the very least six generic makers had requested to buy Revlimid for testing. In each case, Celgene refused.
Federal regulators took discover. The FDA had warned Celgene that it couldn’t use the protection program “to dam or delay approval” of generic rivals. Now, it gave the impression to be doing simply that.
The Federal Commerce Fee, which enforces antitrust legal guidelines, had been investigating Celgene for years and in June of 2012 notified the corporate it was poised to take motion.
In a beforehand unreported letter, the FTC stated that its employees had really useful submitting a authorized criticism in opposition to the corporate for refusing to promote to rivals, thereby retaining them out of {the marketplace}.
The fee’s endurance is carrying skinny.
In its letter, the FTC famous that whereas Celgene refused to promote its medication to potential rivals, it routinely offered Revlimid to different third events around the globe, together with researchers and universities learning the drug.
Then, in August of 2012, the FDA directed Celgene to promote a small quantity of Revlimid to a generic competitor.
With each federal companies bearing down on Celgene, a closed-door assembly was held at FDA headquarters on the finish of August. The FTC despatched 5 attorneys, and 11 FDA staffers attended. Celgene confirmed up with a big contingent that included in-house attorneys and out of doors counsel.
Celgene began by denying it was utilizing the protection program to dam generics, in response to minutes of the assembly. (The minutes have been filed in a court docket case in opposition to Celgene, and it’s unclear in the event that they have been ready by the companies or the corporate.) Citing the specter of beginning defects, the corporate stated that it had reliable security considerations about promoting Revlimid to generic firms and that it wanted to guard its funding within the drug.
Jane Axelrad, an affiliate director for the FDA, informed Celgene that it was elevating security considerations as a result of “the corporate doesn’t need generics available on the market,” in response to the minutes. She declined to remark.
The assembly ended with no decision. The FDA had no method of implementing its directive to Celgene. The FTC employees, nonetheless, was nonetheless decided to behave. The company had spent greater than two years investigating Celgene. It employed specialists, deposed Celgene officers and obtained inside firm paperwork.
The employees drafted a criticism alleging the corporate engaged in unfair actions to keep up a monopoly, hoping both that it will push the corporate to conform to promote to rivals to keep away from authorized motion or that Celgene can be pressured to take action by the courts, in response to an individual acquainted with the company’s stance.
“The fee’s endurance is carrying skinny,” FTC official Richard Feinstein wrote to the corporate’s lawyer in February 2013. “We have now reached some extent the place the employees could also be instructed within the very close to future to start litigation.” (Feinstein didn’t reply to emails in search of a remark.)
Celgene appeared to relent, telling the FTC that it will promote to generic makers, so long as the FDA accredited their security plan. In July, the FDA accredited the protection protocols of generic maker Mylan.
Nonetheless, Celgene refused to promote.
Jon Leibowitz, who was the chairman of the FTC on the time, informed me that Celgene’s promise to cooperate, even when it didn’t lead to any gross sales to generic makers, lessened curiosity within the case amongst his fellow commissioners. Three of 5 commissioners must vote in favor of commencing litigation. Now, on reflection, he stated that “if we knew then what we all know now” in regards to the delays, “we actually would have introduced a case.”
The company would shut its case in 2017 with out taking any motion.
With would-be generic rivals sidelined by Celgene’s refusal to promote medication for testing, the corporate continued to boost the value of Revlimid.
They may increase their worth any time they wished to.
On a Saturday morning in early March of 2014, Celgene President Mark Alles despatched an inside e-mail complaining of disappointing first quarter Revlimid gross sales. Income from the star drug, which had surpassed $1 billion the earlier quarter, was down by about 1% — or $11.4 million.
“I’ve to think about each reliable alternative out there to us to enhance our Q1 efficiency,” he wrote. However the one thought he proposed was a well-known one: increase the value of the drug.
Alles stated he wished a gathering the next Monday to debate a direct 4% worth improve, adopted by one other improve of three% originally of September.
The corporate applied these hikes, together with a 3rd in December. It introduced the value of Revlimid to $9,854 a month, or $469 a tablet, and helped increase Revlimid gross sales for the yr to $5 billion. Alles didn’t reply to my requests for remark.
“They may increase their worth any time they wished to,” stated Francis Brown, a former gross sales government on the firm, in a 2015 deposition. I wasn’t in a position to attain Brown for remark.
Celgene discovered an answer to the generic menace when it struck a deal to settle a lawsuit introduced by generic maker NATCO Pharma in 2015. NATCO might deliver a generic to market, Celgene agreed, however not for seven extra years — in March 2022. Even then, the generic can be restricted to lower than 10% of the overall marketplace for Revlimid within the first yr, with gradual will increase after that.
The deal set the bar for offers with different rivals for restricted generic gross sales, and it ensured that limitless generic competitors — and decrease costs — wouldn’t arrive till 2026.
The delayed entry of generics could have been dangerous information for sufferers and well being care payors, however there was one constituency that was thrilled with the 2015 deal. Celgene’s inventory jumped practically 10% the day after it was introduced.
“Ridiculous,” “Ugly” and “Killer”
Revlimid turned out to be a unicorn for Celgene, a drug whose monetary success proved not possible to copy.
In October of 2017, Celgene introduced it was abandoning a once-promising effort to develop a drug for Crohn’s illness. Shares of Celgene declined by 11%.
Because it had carried out so many occasions up to now, Celgene tapped Revlimid to attempt to mitigate the injury. The day it introduced the failure of the Crohn’s drug, it quietly raised the value of Revlimid by 9%.
By the top of the yr, Celgene had cumulatively raised the associated fee 20% to $662 a tablet, the biggest one-year improve within the drug’s historical past.
That made Revlimid the costliest Medicare drug that yr, with the federal government insurance coverage program spending $3.3 billion to supply it to 37,459 sufferers.
At Celgene, the brash will increase triggered uncommon inside dissent. Betty Swartz, the corporate’s vice chairman of U.S. market entry, objected to the measures in a pricing assembly with the CEO, who on the time was Alles, and different prime executives. She stated her considerations have been swiftly dismissed, in response to a whistleblower lawsuit she filed and later dismissed.
“Why would you be afraid to take a rise on our merchandise?” she stated the CEO informed her. “What might be the worst factor that occurs … a tweet right here or there and dangerous press for a bit.” Swartz declined to remark.
The worth will increase added to the burden confronted by many sufferers. In on-line teams, sufferers use phrases like “ridiculous,” “ugly” and “killer” when speaking in regards to the monetary ache they’ve skilled associated to the excessive prices related to Revlimid. Some have taken out mortgages, raided retirement funds or in the reduction of on on a regular basis bills like groceries to pay for Revlimid. Others have discovered abroad suppliers who ship the drug for pennies on the greenback, though docs warning there’s no technique to assure high quality. Some simply resolve to not take the drug.
By rising the value of Revlimid, Celgene executives in a number of situations boosted their pay. That’s as a result of bonuses have been tied to assembly income and earnings targets. In some years, executives wouldn’t have hit these targets with out the Revlimid worth will increase, a congressional investigation later discovered.
In whole, Celgene paid a handful of prime executives a couple of half-billion {dollars} within the 12 years after Revlimid was accredited.
Robert Hugin, who labored as Celgene’s CEO after which government chairman, acquired $51 million in whole compensation from 2015 to 2017. Hugin retired in 2018 to launch an unsuccessful Senate bid.
Even gross sales reps earned greater than $1 million a yr and have been rewarded with journeys to resorts such because the 4 Seasons in Maui. That pay is greater than two occasions what the common oncologist earns.
I linked with Hugin simply earlier than Christmas whereas he was driving. He was ardent in his protection of the pricing of Revlimid. He informed me the drug passes any cost-benefit evaluation due to its impression on a number of myeloma sufferers like myself. “Individuals acknowledge when you’ve got a breakthrough remedy and you’ve got a possibility to ship that, you need to ship that internationally,” he stated. “And I believe Revlimid is an instance of a product that ends as much as be a world lifesaver due to what it did.”
Hugin informed me that when Revlimid has limitless generic competitors, the value can be “cheaper than aspirin” and sufferers will profit from that low worth for a lot of a long time.
Celgene additionally cited the price of growing medication and its expansive analysis efforts as causes for the excessive price of Revlimid. Celgene stated it spent $800 million to develop Revlimid and spent a number of hundred million extra on further trials to check the usage of the drug in different cancers. These mixed figures symbolize about 2% to three% of Revlimid gross sales by way of 2018.
The drug didn’t get any higher. The most cancers sufferers didn’t get any higher. You simply obtained higher at making a living. You simply refined your abilities at worth gouging.
By the top of 2018, Celgene’s inventory was down 56% over the previous 15 months amid improvement failures. Regardless of the raft of dangerous information, Alles’ whole pay that yr elevated by $3 million to $16.2 million.
Celgene tried desperately to spice up its flagging inventory worth by shopping for again $6 billion of its personal shares that yr.
In the end, the buyback was not sufficient. Simply days into the brand new yr in 2019, Celgene introduced it had agreed to be acquired by Bristol Myers Squibb in a deal valued at $74 billion.
As a part of a severance settlement, prime Celgene executives stood to make thousands and thousands as soon as the deal closed. For Alles, that meant a possible estimated payday of $27.9 million.
Within the fall of 2020, Alles appeared earlier than the Home Oversight Committee, which was investigating the excessive price of pharmaceuticals. He stated pricing selections “mirrored our dedication to affected person entry, the worth of a drugs to sufferers and the well being care system, the continual effort to find new medicines and new makes use of for current medicines, and the necessity for monetary flexibility.”
When it got here time for questions, then-Rep. Katie Porter, D-Calif., quizzed Alles in rapid-fire model about Revlimid. Did the drug change as the value elevated? Did it work sooner? Have been there fewer negative effects? The drug was the identical, Alles responded.
“So, to recap right here,” Porter stated. “The drug didn’t get any higher. The most cancers sufferers didn’t get any higher. You simply obtained higher at making a living. You simply refined your abilities at worth gouging.”
The Drumbeat Continues
Excessive costs have penalties past particular person sufferers. Whereas there have been super developments within the remedy of my illness, there may be nonetheless no treatment. The specter of relapse hovers over each blood take a look at, each new ache or ache.
The day I discovered I used to be in remission, in November 2023, was bittersweet. I wrote on the time that I didn’t get to ring a bell — the normal signal {that a} most cancers affected person has completed remedy. As a substitute, my physician defined the following step: “upkeep” remedy.
This contains not solely persevering with Revlimid, however making month-to-month visits to my most cancers middle to get a shot of a bone-strengthening drug, have one other drug injected into my abdomen and blood drawn for lab checks.
“The go to,” I wrote that day, “solely strengthened the truth that I’m a affected person, and I at all times can be.”
For many of us, most cancers will return sooner or later after remedy. And for many sufferers, the medication finally cease working.
Revlimid can be tough to reside with. Some sufferers stop the drug after growing extreme gastrointestinal points, infections or liver issues. The drug additionally poses an elevated danger of stroke, coronary heart assault and secondary cancers.
These are the trade-offs for retaining a number of myeloma in examine.
In the meantime, the drumbeat of worth will increase continues below Bristol Myers Squibb, serving to the corporate usher in $48 billion in income from Revlimid because it bought Celgene. Bristol stated its pricing “displays the continued scientific profit Revlimid brings to sufferers, together with different financial elements.” The corporate stated it’s “dedicated to attaining unfettered affected person entry to our medicines” and offers some monetary assist for eligible sufferers. “Whereas BMS develops costs for its medicines, we don’t decide what sufferers can pay out of pocket.”
Final July, the price of my month-to-month Revlimid prescription elevated by 7% to $19,660.
Initially of this yr, my insurer switched me to generic Revlimid. I didn’t combat it, considering it will lead to a dramatic lower in what ProPublica’s well being plan pays for the drug.
It seems it isn’t a lot of a financial savings: The generic prices $17,349 a month.
Alec Glassford contributed analysis.
