The ache jolted me awake. It was barely daybreak, a misty February morning in 2023. My facet 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 observe him to a non-public space, the place he advised 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 had been hallmarks of a number of myeloma. “Most cancers,” he mentioned.
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 toes in addition to two damaged ribs and a compression fracture in my backbone. There is no such thing as a treatment.
I walked out of the ER searching for recent air. I sat on a steel bench and did what many sufferers do. I turned to Google. The primary hyperlink was a medical evaluate stating that the common lifespan of a newly recognized affected person was three to 5 years. My abdomen churned.
I quickly discovered that info was outdated. Most sufferers as we speak reside for much longer, largely on account of a drug with a horrific previous. It was a health care provider on the hospital who first advised me I’d doubtless take a thalidomide drug as a part of my therapy.
That couldn’t be doable, I advised him.
I knew the story of thalidomide, or at the least I believed I did. It represented one of many darkest chapters within the historical past of contemporary medication, having brought on 1000’s of extreme start defects after it was given to pregnant girls within the Nineteen Fifties and 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 by-product 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 complete gross sales of greater than $100 billion. It has prolonged tens of 1000’s of lives — together with my very own.
However Revlimid can be, I quickly discovered, terribly costly, costing practically $1,000 for every every 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 compelled into debt or just stopped taking the drug. The worth additionally helps gas our ballooning insurance coverage premiums.
For many years, I’ve reported on outrageous health care costs within the U.S. and the burden they place on sufferers. I’ve revealed the ways utilized by drug corporations to drive sales and hold the value of their merchandise excessive.
Even with my expertise, the price of Revlimid stood out. After I began taking the drug, I’d have a look at the graceful, cylindrical capsule in my hand and contemplate the actual 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 abnormal, orange-tinged plastic bottle, is similar worth as a brand new Nissan Versa.
I needed to understand how this drug got here to value a lot — and why the value retains going up. The worth of Revlimid has been hiked 26 instances 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 provide her dying husband an opportunity.
Tiny and Terrifying
Beth Wolmer’s story begins on a moon-splashed seashore within the Cayman Islands within the winter of 1995. She and her husband, Ira, had been holding arms 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.
They’d met by way of associates 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 medication. Beth was a lawyer on the high-powered agency Skadden Arps.
“We had an amazing life,” Beth advised me. “I particularly keep in mind coming house on the bus and pondering: ‘My life is simply excellent, excellent. I’m not going to vary 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 instances throughout the journey, turning into so intense that it introduced tears to his eyes.
When he acquired house, Ira made an appointment to determine what was incorrect. Imaging exams revealed a number of myeloma. The prognosis was grim. The couple was advised Ira had two years to reside.
Specialists really useful therapies that will solely present a quick reprieve. The couple searched for somebody who may provide one thing extra. That’s after they discovered Dr. Bart Barlogie in Little Rock, Arkansas.
I’ve by no means been extra petrified 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 Heart in Houston. In Texas, Barlogie had been annoyed by a medical tradition that he seen as too timid in its method to a number of myeloma.
He remembers engaged on a Sunday when a newly recognized 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 therapy.
The attending doctor later admonished him, Barlogie mentioned, saying, “Bart, we’ve to be taught to deal with myeloma gently.” Barlogie mentioned he thought to himself, “Fuck you.”
In Arkansas, Barlogie was in cost. He rapidly developed a status as a practitioner prepared to attempt something to struggle the deadly illness. Sufferers from all over the world — 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 advised them they’d come to the best place.
Now retired, Barlogie remembers being struck by Beth’s depth. He mentioned she advised him “you could do one thing” to assist Ira.
I met Barlogie at his house in Little Rock. We sat in his workplace, which is stuffed with images of the crimson Ducati motorbike he used to journey to work. An outdated license plate with the letters “MMCURED” sat on a shelf, reflecting his purpose to discover a treatment for a number of myeloma.
When Beth and Ira discovered him, Barlogie advised me, he had been having some success with a novel method that put sufferers by way of two stem cell transplants a couple of months aside, which he referred to 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 will be grueling and poses a small danger of dying.
Ira underwent three transplants. Every time, he relapsed. By the autumn of 1997, after two years of therapy, Ira’s thick black hair was gone. He was shedding weight. 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 had been making an attempt wasn’t working or quizzing them a few promising examine. When docs advised her there was nothing extra they may do for her husband, she refused to just accept it.
“She is a tiny individual, however she is terrifying,” mentioned Dr. David Siegel, a part of the workforce that handled Ira in Arkansas. “I’ve by no means been extra petrified 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 advised her in regards to the work of Dr. Judah Folkman, a surgeon and researcher at Boston Youngsters’s Hospital. Folkman believed the expansion of cancerous tumors could possibly 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 principle of the way to assault most cancers. Friends had ridiculed his thought since he first proposed it within the 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, but it surely wasn’t tough for me to trace down D’Amato. He nonetheless works at Boston Youngsters’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 vitality and speaks in a fast, matter-of-fact clip.
D’Amato advised me that he had got down to discover present medicine that block blood vessel progress. He began by pondering of his personal physique and unwanted side effects attributable to sure medicine. A drug that causes hair loss could be 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 few girl’s physique? There have been medicine that stopped menstrual cycles. Then there have been medicine that brought on start defects in pregnant girls. In each of these circumstances, it was doable the drug was inhibiting blood vessel progress. He got here up with an inventory of 10 medicine. On the prime of the listing was one with a devastating historical past: thalidomide.
Starting within the Nineteen Fifties, pregnant girls in Europe, Australia and different international locations had been steadily prescribed thalidomide as a therapy 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 may “be given with full security to pregnant girls and nursing moms with out antagonistic impact on mom or baby.”
They had been incorrect.
The drug was ultimately linked to start defects in additional than 10,000 infants. These infants had been born with out limbs or with shortened limbs, malformed arms, disfigured faces and harm to inner organs. Almost half died inside months of being born.
By the early Sixties, the drug was extensively banned, thought-about a shameful chapter within the historical past of prescribed 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, nevertheless, prompted Congress to require extra rigorous security and efficacy information from drug producers and empower the FDA to watch the trade extra carefully.
D’Amato theorized that the thalidomide start defects had 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 hen 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, exhibiting the drug labored. It didn’t.
Folkman advised 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 impact 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 referred to as three years later, Folkman advised her they need to attempt it.
Barlogie advised me he didn’t suppose it might work. Beth mentioned she needed to persuade him to attempt it.
Barlogie agreed to check it on Ira and two different sufferers who had been out of therapy choices in early December.
I needed him alive endlessly.
The drug didn’t work for Ira. Beth mentioned 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 looking for something that will assist, the finality of his dying was tough to just accept, she mentioned. “I needed him alive endlessly.”
It’s unclear what occurred with the second affected person. The third affected person, nevertheless, began to get higher.
His title was Jimmy. Little extra is understood about him besides that he was a affected person of one other oncologist on the hospital, Dr. Seema Singhal, and close to dying earlier than he began the drug. “I advised him it would work, however on the very least it might assist him sleep,” Singhal mentioned. 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 filled 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 earth who knew this labored,” she mentioned.
Singhal walked right down to Barlogie’s workplace to provide him the information. “He took me by the hand, opened a window and shouted, ‘Thanks, God,’” she mentioned.
“Violent Arguments”
Phrase of Jimmy’s beautiful restoration in Arkansas rapidly made its strategy to the places of work of Celgene Corp., positioned 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 considered one of them referred to as “violent arguments” over whether or not to cost workers for espresso.
Celgene had acquired the rights to thalidomide patents held by researchers at Rockefeller College in 1992. The corporate, which was new to prescribed drugs, deliberate to make use of the expertise of acquiring FDA approval for thalidomide to develop different medicine.
“It wasn’t meant to be a blockbuster,” mentioned Sol Barer, who began on the firm in 1987 and later grew to become CEO.
When Celgene introduced plans to develop the disgraced drug for brand new makes use of, the one analyst following the corporate on Wall Avenue dropped protection and advised Celgene officers they didn’t know what they had been doing.
The corporate thought the most important market could be as a therapy for AIDS sufferers experiencing harmful weight reduction. To win approval of the drug, nevertheless, Celgene chosen a use that was already in observe in elements of the world for a small group of sufferers.
In July 1998, the FDA accredited thalidomide for the therapy of a painful complication of leprosy. It was a momentous determination, coming just some many years after the drug brought on a lot hurt.
The marketplace for leprosy was tiny, however what occurred with Jimmy in Arkansas modified every 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 rapidly acquired approval to conduct a bigger experiment funded by a grant from the U.S. Nationwide Institutes of Well being. Now, in December 1998, they had been able to share their preliminary findings on the annual assembly of the American Society of Hematology.
It had been three many years 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 instances to clear exit methods. Phrase had already unfold amongst a number of myeloma specialists about Jimmy. Now, the assembled docs needed to know whether or not it had been a fluke or a discovery that will basically change how they practiced.
Singhal was tasked with presenting the info. It was a giant stage for the 32-year-old physician, who had solely been training within the U.S. for 2 years.
It utterly modified the therapy panorama.
The 89 sufferers within the examine had been high-risk circumstances who had undergone prior therapy. They had been sufferers who, like Ira, had run out of choices. Now, after thalidomide therapy, one-third had declines in myeloma exercise.
These had been beautiful numbers, not like something seen earlier than within the therapy of a number of myeloma. When Singhal completed, the room erupted in applause.
“It utterly modified the therapy panorama,” she mentioned.
I wasn’t capable of observe down Jimmy, however I’ve a way of how he might need felt when he realized the therapy was working.
After my preliminary emergency room go to, it took time to verify my analysis and do some extra testing. Whereas I waited, the ache worsened. Painkillers barely made a dent. All I may image was this most cancers consuming away at my bones, doing extra harm daily.
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Some sufferers wait months for care. I used to be fortunate sufficient to satisfy my oncologist inside weeks. He had a script for Revlimid able to go, a part of a routine of 4 medicine I’d take as customary induction remedy, and I used to be capable of begin it inside days.
The preliminary dose of Revlimid value $18,255 for a month’s provide, and my insurance coverage coated the price.
Inside a month, my blood exams confirmed an enormous drop in a key most cancers indicator.
My ache steadily subsided too. By the tip 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 harm to get away from bed anymore,” I wrote.
A Piggy Financial institution
The invention in Arkansas made thalidomide, which Celgene bought as Thalomid, an on the spot hit.
Because of this, Celgene’s income elevated practically sevenfold to $26.2 million within the 12 months after the Miami presentation. It bought its thalidomide capsules 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 success, a case the place the heavy lifting of discovery and preliminary testing had already been completed, by Beth Wolmer, D’Amato, Barlogie, Singhal and others.
The event of the drug that will turn into Revlimid took me deep into the confounding, sharp-elbowed world of drug patents, which ostensibly defend drugmakers, permitting them to recoup the huge investments they made in growing a brand new product. Celgene drew on patent legislation, a drug security system and even affected person help packages to protect the exclusivity of its prized drug and the huge income it generated.
These ways, detailed in reams of courtroom filings, allowed Celgene to deal with Revlimid like a piggy financial institution, tapping it each time it needed.
There was a typical inner theme at Celgene that most cancers sufferers had been prepared to pay nearly any quantity Celgene charged.
Amid the early success of Thalomid, Celgene recognized two potential threats: One was apparent. Thaldiomide brought on start defects, a looming danger that might end in 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 growth as quickly as they’ll, locking up every thing from particular units of elements to the best way the drug is used and administered. The extra sturdy patents an organization has, the longer it could probably keep at bay rivals.
Thalidomide was an outdated drug and Celgene’s patents didn’t cowl the lively ingredient, leaving it open to competitors. The patents it did have, protecting gadgets such because the optimum dosages and its use in treating explicit illnesses, had been thought-about weaker and open to a courtroom problem. If Celgene may create a brand new model of thalidomide — ideally one which didn’t trigger start defects — the corporate may search extra and stronger patents that will prolong past these of the unique drug.
So researchers at Celgene examined analogs of thalidomide, that are medicine which have the same impact however are totally different from the mum or dad compound in minor methods, akin to having one much less oxygen atom. The analogs are additionally stronger than the unique, that means they’ll obtain the same impact at decrease doses.
Celgene was not alone in its efforts. D’Amato was additionally finding out thalidomide analogs and submitting patents on their use, which he and Boston Youngsters’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 centered most of its assets on growing different medicine found in Folkman’s lab.
In December of 2002, the businesses settled.
Celgene agreed to pay Boston Youngsters’s Hospital royalties from future gross sales of Revlimid. In alternate, the hospital and D’Amato licensed their patents of thalidomide analogs to Celgene. Celgene additionally agreed to pay EntreMed $27 million.
For Celgene, the struggle with EntreMed was a useful expertise. It discovered that competitors will be neutralized.
The Rise of Revlimid
Celgene had stored the value of Thalomid low when it was initially supposed for AIDS sufferers, CEO John Jackson advised traders in 2004, as the corporate “didn’t need big 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 advised traders.
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 typical inner theme at Celgene that most cancers sufferers had been prepared 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 12 months, 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 12 months, or $280 a tablet.
The fee to fabricate every Revlimid tablet, in the meantime, was 25 cents. I discovered a deposition marked “extremely confidential” through which a prime Celgene govt testified that the price began at 1 / 4 and by no means modified.
Even on Wall Avenue, which cheered greater pricing, the preliminary value 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 without doubt one of 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 may go.
On the identical 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 displays sponsored by affected person teams.
In a single e-mail, a senior firm official mentioned, “it’s time for us to take Jimbo to the wooden shed.” The corporate mentioned a spread of choices for coping with the physician, from taking authorized motion to arranging a sit-down with Celgene’s chief govt.
In the end, the corporate seems to have selected a friendlier plan of action. Berenson grew to become a frequent paid speaker and marketing consultant for the corporate, with funds totaling at the least $333,000, based on Celgene disclosures. Berenson declined to remark.
He wasn’t the one physician the corporate befriended. Cost 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 collection on the Houston Astros baseball stadium to throw a celebration for all the a number of myeloma division on the MD Anderson Most cancers Heart, based on courtroom testimony. The middle mentioned 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,” mentioned David Mitchell, a former Washington, D.C., communications govt who launched a nonprofit group to struggle for decrease costs after he was recognized with a number of myeloma. “Everyone depends on the cash.” Mitchell mentioned his group, Sufferers For Inexpensive Medicine, doesn’t settle for donations from any entity that earnings from the event or distribution of prescribed drugs.
On the identical time it showered docs and affected person teams with cash, Celgene was shutting Beth Wolmer out. She advised me that John Jackson, the CEO on the time, had promised her a paid board seat on the firm as a means of compensating her for her function within the discovery earlier than the corporate minimize off communication.
Wolmer sued Celgene in federal courtroom 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 mentioned it by no means promised to compensate Wolmer. The corporate additionally urged she significantly inflated her function 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 identical 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 disillusioned about the best way 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 mentioned. “Why they handled me that means? 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 instances, 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 had been already engaged on copies of the drug, making ready to problem these patents and enter the market earlier. A authorities evaluation has discovered that generics usually decrease the value of brand name title medicine by a median of 85% after only one 12 months.
Celgene was effectively conscious of the hazard generics posed and warned in a 2012 monetary submitting that their entry into the market may have a “materials antagonistic 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 start defects just like the mum or dad compound. In approving the drug, the FDA had mandated a strict security program to manage its prescription and distribution.
Celgene realized early on that this may be a software to thwart competitors. An inner firm presentation on the time famous that the protection program may make it “harder for generic corporations 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 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 seemed 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 mentioned that its workers had really useful submitting a authorized grievance in opposition to the corporate for refusing to promote to rivals, thereby maintaining them out of {the marketplace}.
The fee’s persistence is sporting skinny.
In its letter, the FTC famous that whereas Celgene refused to promote its medicine to potential rivals, it routinely offered Revlimid to different third events all over the world, together with researchers and universities finding out 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 businesses 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 outdoors counsel.
Celgene began by denying it was utilizing the protection program to dam generics, based on minutes of the assembly. (The minutes had been filed in a courtroom case in opposition to Celgene, and it’s unclear in the event that they had been ready by the businesses or the corporate.) Citing the specter of start defects, the corporate mentioned that it had authentic security considerations about promoting Revlimid to generic corporations and that it wanted to guard its funding within the drug.
Jane Axelrad, an affiliate director for the FDA, advised Celgene that it was elevating security considerations as a result of “the corporate doesn’t need generics available on the market,” based on the minutes. She declined to remark.
The assembly ended and not using a decision. The FDA had no means of imposing its directive to Celgene. The FTC workers, nevertheless, was nonetheless decided to behave. The company had spent greater than two years investigating Celgene. It employed specialists, deposed Celgene officers and obtained inner firm paperwork.
The workers drafted a grievance alleging the corporate engaged in unfair actions to take care of a monopoly, hoping both that it might push the corporate to conform to promote to rivals to keep away from authorized motion or that Celgene could be compelled to take action by the courts, based on an individual aware of the company’s stance.
“The fee’s persistence is sporting skinny,” FTC official Richard Feinstein wrote to the corporate’s lawyer in February 2013. “Now we have reached a degree the place the workers could also be instructed within the very close to future to begin litigation.” (Feinstein didn’t reply to emails in search of a remark.)
Celgene appeared to relent, telling the FTC that it might 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, advised me that Celgene’s promise to cooperate, even when it didn’t end in 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, looking back, he mentioned 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 medicine for testing, the corporate continued to lift the value of Revlimid.
They may elevate their worth any time they needed to.
On a Saturday morning in early March of 2014, Celgene President Mark Alles despatched an inner 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 authentic alternative out there to us to enhance our Q1 efficiency,” he wrote. However the one thought he proposed was a well-known one: elevate the value of the drug.
Alles mentioned he needed a gathering the next Monday to debate an instantaneous 4% worth improve, adopted by one other improve of three% originally of September.
The corporate carried out 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 12 months to $5 billion. Alles didn’t reply to my requests for remark.
“They may elevate their worth any time they needed to,” mentioned Francis Brown, a former gross sales govt on the firm, in a 2015 deposition. I wasn’t capable of 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 may convey a generic to market, Celgene agreed, however not for seven extra years — in March 2022. Even then, the generic could be restricted to lower than 10% of the whole marketplace for Revlimid within the first 12 months, 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 unattainable to duplicate.
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 completed so many instances previously, Celgene tapped Revlimid to attempt to mitigate the harm. The day it introduced the failure of the Crohn’s drug, it quietly raised the value of Revlimid by 9%.
By the tip of the 12 months, Celgene had cumulatively raised the price 20% to $662 a tablet, the most important one-year improve within the drug’s historical past.
That made Revlimid the costliest Medicare drug that 12 months, with the federal government insurance coverage program spending $3.3 billion to offer it to 37,459 sufferers.
At Celgene, the brash will increase triggered uncommon inner dissent. Betty Swartz, the corporate’s vp 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 mentioned her considerations had been swiftly dismissed, based on a whistleblower lawsuit she filed and later dismissed.
“Why would you be afraid to take a rise on our merchandise?” she mentioned the CEO advised her. “What could possibly 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 reduce 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 strategy to assure high quality. Some simply resolve to not take the drug.
By rising the value of Revlimid, Celgene executives in a number of cases boosted their pay. That’s as a result of bonuses had 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 complete, Celgene paid a handful of prime executives a few half-billion {dollars} within the 12 years after Revlimid was accredited.
Robert Hugin, who labored as Celgene’s CEO after which govt chairman, acquired $51 million in complete 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 12 months and had been rewarded with journeys to resorts such because the 4 Seasons in Maui. That pay is greater than two instances what the common oncologist earns.
I related with Hugin simply earlier than Christmas whereas he was driving. He was ardent in his protection of the pricing of Revlimid. He advised me the drug passes any cost-benefit evaluation due to its influence on a number of myeloma sufferers like myself. “Folks acknowledge when you’ve gotten a breakthrough remedy and you’ve got a possibility to ship that, you need to ship that internationally,” he mentioned. “And I believe Revlimid is an instance of a product that ends as much as be a worldwide lifesaver due to what it did.”
Hugin advised me that when Revlimid has limitless generic competitors, the value will probably be “cheaper than aspirin” and sufferers will profit from that low worth for a lot of many years.
Celgene additionally cited the price of growing medicine and its expansive analysis efforts as causes for the excessive value of Revlimid. Celgene mentioned it spent $800 million to develop Revlimid and spent a number of hundred million extra on extra trials to review using the drug in different cancers. These mixed figures signify 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 acquired higher at creating wealth. You simply refined your abilities at worth gouging.
By the tip of 2018, Celgene’s inventory was down 56% over the previous 15 months amid growth failures. Regardless of the raft of dangerous information, Alles’ complete pay that 12 months 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 12 months.
In the end, the buyback was not sufficient. Simply days into the brand new 12 months 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 hundreds of 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 value of pharmaceuticals. He mentioned 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 present 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 type about Revlimid. Did the drug change as the value elevated? Did it work quicker? Had been there fewer unwanted side effects? The drug was the identical, Alles responded.
“So, to recap right here,” Porter mentioned. “The drug didn’t get any higher. The most cancers sufferers didn’t get any higher. You simply acquired higher at creating wealth. 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 therapy of my illness, there’s 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 standard signal {that a} most cancers affected person has completed therapy. As a substitute, my physician defined the following step: “upkeep” therapy.
This consists of not solely persevering with Revlimid, however making month-to-month visits to my most cancers heart to get a shot of a bone-strengthening drug, have one other drug injected into my abdomen and blood drawn for lab exams.
“The go to,” I wrote that day, “solely strengthened the truth that I’m a affected person, and I at all times will probably be.”
For many of us, most cancers will return sooner or later after therapy. And for many sufferers, the medicine ultimately cease working.
Revlimid will also 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 maintaining a number of myeloma in examine.
In the meantime, the drumbeat of worth will increase continues underneath Bristol Myers Squibb, serving to the corporate usher in $48 billion in income from Revlimid because it bought Celgene. Bristol mentioned its pricing “displays the continued scientific profit Revlimid brings to sufferers, together with different financial components.” The corporate mentioned it’s “dedicated to attaining unfettered affected person entry to our medicines” and gives some monetary help 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.
Firstly of this 12 months, my insurer switched me to generic Revlimid. I didn’t struggle it, pondering it might end in a dramatic lower in what ProPublica’s well being plan pays for the drug.
It seems it’s not a lot of a financial savings: The generic prices $17,349 a month.
Alec Glassford contributed analysis.
