By Ben Hirschler
LONDON (Reuters) - Americans are paying way over the odds for some modern cancer drugs, with pharmaceutical companies charging up to 600 times what the medicines cost to make, according to an independent academic study.
The United States also pays more than double the price charged in Europe for these drugs - so-called tyrosine kinase inhibitors (TKIs), a potent class of cancer pills with fewer side effects than chemotherapy.
The analysis by pharmacologist Andrew Hill of Britain's University of Liverpool, who will present his findings at the Sept. 25-29 European Cancer Congress in Vienna, is likely to fuel a growing storm over U.S. drug costs.
Democratic presidential candidate Hillary Clinton's declared aim to lower the cost of prescription drugs by ending what her campaign describes as "excessive profiteering" triggered a sell-off in drug stocks this week.
Hill told Reuters he had shared his work on the cost of producing TKIs with the World Health Organization (WHO), which is keen to add such treatments to its list of medicines deemed essential for a basic healthcare system. WHO officials have used the findings in determining that the drugs can be made at low cost, he said.
The first such TKI was added to the WHO's latest draft Essential Medicines List earlier this year.
Several widely-used TKIs are expected to become available as generics within the next five years, as patents expire. Hill calculated that large-scale production could achieve treatment prices in the range of $159 to $4,022 per person a year, against current U.S. prices of around $75,000 to over $100,000.
"It shows there is a lot of scope for prices to come down," he said. "There has to be some middle ground between the prices that companies are charging, which may not even be cost-effective by the standards set by some healthcare authorities, and the actual production cost."
RESEARCH COSTS
Drug companies argue that they need to make decent profits to pay for the billions of dollars needed for drug research. Many companies also have extensive low-cost or even free access schemes for patients who cannot afford their medicines.
But the high prices charged for modern drugs is generating increasing push-back from healthcare providers, patients and some doctors.
Hill used Indian government data on the cost of pharmaceutical ingredients and allowed for a 50-percent profit margin - but no money for investment in research - to work out the costs of producing certain drugs.
On this basis, he found that Novartis' leukaemia drug Glivec actually cost $159 for a year's treatment, against the $106,000 charged in the United States.
Roche's Tarceva for lung cancer cost $236, against a U.S. price of $79,000, and Novartis' Tykerb cost $4,000 against a price of $74,000.
In all these cases the U.S. cost was far above that charged in certain western European countries, where Glivec costs approximately $29,000-35,000, Tarceva $26,000-29,000 and Tykerb around $35,000, Hill reported.
Roche declined to comment. Novartis said it had no immediate response.
The issue is not unique to cancer drugs. Earlier this month, for example, Amgen launched its new injectable cholesterol drug Repatha in Europe at around half the U.S. price.
"Why should the U.S. bear this huge burden cost? It is not as if the GDP of the United States is so much higher than that of European counties, but they just seem to pay these big premiums," Hill said.
The future pricing of TKIs could also have major implications for developing countries, Hill believes, since mass production could open the way to widespread cancer treatment in the same way that cheap generic drugs helped fight HIV/AIDS.
(Editing by Pravin Char)
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My son Teddy was diagnosed August 13, 2010 at the age of 16 months with high-risk, stage 3 neuroblastoma. He was being treated at Kaiser, in Oakland, California.
Sadly, he passed away on December 13, 2012.
You can follow his story on our Caring Bridge page. -- Clarence Berger-Greer
This is a picture of my son Jake when he was battling stage 3 high-risk neuroblastoma. He was 5 years old when he was diagnosed. He endured 16 months of a horrible, aggressive therapy: six rounds of chemo, stem cell harvesting, tumor resection, high dose chemo/stem cell rescue, radiation and five rounds of immunotherapy. It was the hardest thing we have ever gone through.
Jake is, to date, cancer-free and will be 9 years old this September. He has hearing loss due to chemo, he lost his fertility due to high-dose chemo, and he will be watched forever for late effects (heart damage and secondary cancers, to name a few). -- Lori Holmes
This is my daughter, Victoria. She is 5. When she was just 6months old she was diagnosed with AML (acute myeloid leukemia). She went through five rounds of high dose chemo, numerous surgeries, lumbar punctures, blood and platelet transfusions and so much more. We lived in the hospital for six months since her immune system was so compromised.
On October 14th of this year, she will celebrate five years cancer-free. This is a huge milestone for her since she was only given a 20 percent chance of making it this long. She just started kindergarten a week ago, and we couldn't be prouder! -- Heather Hernandez
This is our daughter Mackenzie Newsome. Mackenzie became an angel on March 5, 2013. An epithelioid sarcoma that she was diagnosed with on Feb. 28 2012 had taken its toll on Mackenzie's 4-year-old body.
Mackenzie believed herself to be Belle from "Beauty and the Beast" and would often refer to herself just so. Her father Mike, was always The Beast. A true Daddy's girl, Mac loved her dad more than anyone in the world.
Mac started showing symptoms shortly after her third birthday. It took seven months, four professional opinions and a whole lot of unnecessary pain to get a diagnosis. Mackenzie lived an incredible 370 days. Visiting Sesame Place, Disney World, The Maritime, Connecticut Science Center and her favorite -- the Boston Aquarium. Mac loved to take taxis, walk to the mall and go to Claire's Boutique for make up, cell phones and purses.
Mac expelled kindness. She often offered a kind word, a "God bless you" or would share a story with you. She was and always will be very special. -- Melissa Newsome
My son Jessen was diagnosed with stage 4 high-risk neuroblastoma on March 1, 2013 (it was three months before his third birthday). He went through six rounds of chemotherapy, five surgeries, a stem cell transplant, radiation treatments and antibody treatments.
During his course of treatment he ended up having a bowel obstruction caused by internal scarring from his tumor removal surgery. The obstruction occurred during a time that he had zero white counts, but they had no choice and he was rushed for an emergency surgery. He had an ostomy for a few weeks so that his intestines could heal enough to be reattached back inside of his body. He spent many days andnights in the hospital -- his longest consecutive stay was 59 days -- confined to just his hospital room because of his compromised immune system.
He finished his treatments in May of 2014, but he continues to have to go every few months for scans because the relapse rate is very high. He will continue to have scans for the rest of his life due to the possibility of relapse and also because of the possibility of secondary cancers from the treatments he received. His treating hospital is three-and-a-half hours away from where we live, so it's always a long trip to make.
Today he is a very happy 5-year-old who is fascinated by all things medical-related (and also tractors). He just started kindergarten and is loving it. When he was in treatment, he was not able to go to public places or be around people because of his compromised immune system, and he often asked if he could do "[fill in the blank]" when he was "all better"... he just wanted to be able to go to the grocery store with me again ... so I kept a list. I call it his "Live Life to the Full-List," and it is a never ending to-do list.
I wanted to make sure he got to do all of those things he wanted to when he was all better, and it is my goal to make sure he will always get to have as many amazing life experiences as possible. So far he has gone on a helicopter ride, rode in a hot air balloon, was the Grand Marshall in the lighted tractor parade in Calistoga, CA (he had seen the lighted tractor parade while watching the Travel Channel), heard his favorite songs live in concert ... and so much more.
He still has plenty more on his list and we will continue to add to it and complete as many things as we can! I am a single mom, so it is just him and me ... my dad (his grandpa) passed away from a nine month battle with leukemia just six months before Jessen was diagnosed with cancer ... so I definitely am making sure Jessen gets to live the most memorable life he possibly can! -- Melanie Whelchel
My 10-year-old is a nine-year cancer survivor! He was diagnosed with AT/RT, a rare brain tumor with a poor prognosis for infants -- less than five percent survival at the time he was diagnosed.
I can't even remember what life was like before he was diagnosed, it's all a dream. Cancer has always been in our lives and it always will be. -- Cyndi Yanke
My daughter Sadie was diagnosed with leukemia (ALL) at just 22 months old. She was in treatment for two-and-a-half years at Golisano Children's Hospital in Syracuse, NY and just finished in October. She is now a very happy and healthy 5-year-old getting ready to start kindergarten with her twin sister. -- Meghan Wilson
Our son Tyler was diagnosed three weeks ago with stage 4 neuroblastoma. He had been having stomach pains and losing some weight prior to the diagnosis, so we thought it was a food sensitivity or allergy. After a sleepless and painful night, we went to the ER, where the ultrasound and CT scan showed something abnormal. We were immediately transferred to the pediatric oncology hospital for Kaiser in Santa Clara, where after more tests and scans, it was confirmed that he has high-risk stage 4 neuroblastoma.
His tumors are quite large which makes him high risk, but he is unusual since the cancer is not in his bone marrow -- less than six percent of the neuroblastoma cases are like this.
Tyler is a fraternal twin, so this has been a huge life-changing event for us all, especially his twin brother, Alex. They have been together in every activity since birth, and now they will have separate lives. We are trying to navigate keeping Alex's life "normal" and dealing with Tyler's treatments. Tyler has had to take a break from the activities that he used to do, swimming and Brazilian jiu jitsu.
We finished our first round of chemo last week and have two weeks off until round two. The treatment protocol, if all goes well: rounds one and two of chemo (outpatient), stem cell harvest, rounds three through five of chemo (inpatient), surgery (might be two of them, due to tumor locations), round six of chemo (inpatient), stem cell transplant, radiation therapy, and lastly, immunotherapy. So we are in for the long battle of 12 to 18+ months.
Before he started chemo, we had a daytime dance party for family and friends since he cannot participate in large social events anymore. We had a great turnout of 150 people, and he had an awesome day. He has been a trooper. He likes maps, and we have asked for people to send him postcards from around the world. We've received over 300 postcards from all over in the past three weeks, ranging from Mongolia to the city we live in, as you see in the picture.
The kindness, generosity, and support of our friends, family and complete strangers is what has been sustaining us and healing our broken hearts. To say that our lives have turned upside down is an understatement, but we, along with all families affected by cancer, take it day by day, since we do not know what to expect anymore. -- Sylvia DeCourcey
At Kale's 4-month wellness checkup, his pediatrician noticed a Stigmas in his eyes. A "Stigmas" is a benign twitching in a baby's eyes that they grow out of. She wanted us to see a pediatric ophthalmologist, just to make sure nothing else was going on. So on March 3, we drove to Barrington, where the doctor found swelling of his optic nerves -- and with that our nightmare began.
The doctor explained that the swelling was due to either water in his brain or a tumor, and we should immediately go to the hospital. As parents, we felt fear swell up inside us as we drove up to Lutheran General Children's Hospital.
They took Kale for a CT scan, which showed water and a mass on his brain. An MRI and biopsy showed Kale had hydrocephalus and a stage 2 astrocytoma.
As parents, we just received the most heartbreaking news. Our sweet baby boy had an inoperable brain tumor which caused water build up on his brain.
During his biopsy, his neurosurgeon attempted to drain the fluid around the tumor with no luck. They went back in and put a shunt in to drain the water from his brain into his abdomen. However, the fluid wasn't draining, and they had to go back in and revise the shunt. Handing your baby over brings an unimaginable pain that my husband and I have become all too familiar with. Finally the shunt was working and we worked through the complications.
On March 16, Kale had his fourth surgery, this time to get his central line for chemo. That evening he received his first treatment and handled it well.
The next day, March 17, after two weeks in the hospital, we were able to take our baby home! Since then, his shunt had to be changed from a ventriculoperitoneal shunt, which drains into his belly, to a ventriculoatrial shunt, which drains into the atrium of his heart. He's had numerous procedures, weeks and weeks of hospital stays and weekly chemo treatments. His central line for chemo broke and was replaced with a chemo port.
Through it all, Kale remains the happiest baby in the world and captures the hearts of everyone he meets! We are blessed with a beautiful baby and will fight this evil thing until it's gone! He has taught us how to be Kale Strong! -- Chris and Kristie
My name is Lauren Hammersley, mother to fighter and survivor of stage 3 high-risk neuroblastoma, Hazel Hammersley!
You may remember my daughter Hazel from a story that went viral in July 2013. We put a "SEND PIZZA" sign in her hospital window one day, and the picture went around the world, resulting in over 200 pizzas being sent to Children's Hospital Los Angeles. The amount of support we received from the public was absolutely humbling and awe-inspiring, and I know that we could not have navigated our journey with childhood cancer as well without it!
After that story, Hazel still had to endure many more months of grueling treatment. She had several more rounds of chemotherapy; a massive, 9-hour-long tumor removal surgery; a stem cell transplant; radiation; and immunotherapy. The stem cell transplant process was especially difficult for our daughter, sending her to the ICU for three weeks and almost killing her. There were many days when we didn't know if she would make it to the next one.
After being heavily sedated, medicated and suffering for that time, she finally emerged from the ICU alive, but not entirely well. She had lost the ability to speak and walk and had to stay in the hospital six days a week for inpatient rehab. But through a miracle of God, our daughter has returned to her full state of functioning!
Now, a year off treatment, she looks, sounds, behaves and feels like a normal 4-year-old! Instead of days spent within the hospital walls, her days are spent playing with her four siblings, going to preschool (she just started last week! Such a great day!), taking dance lessons and just being a normal little girl. As a family, we now use her story as a platform to raise awareness for childhood cancer.
So again, thank you for joining the cause and helping us do better by our kids! -- Lauren Hammersley
This is Beydn (Bay-den) Gabriel Swink. Best big brother in the world to three brothers at his mom's and one brother and two sisters at his dad's. Military kid, lived in six states. Loved to read so he could travel the world. Planned his remission celebration trip to New York City (because we had been trying to get him there for most of his life), Chicago (he heard they had great pizza), and Las Vegas (he just wanted to see it). He never got to go.
Beydn fought T-cell acute lymphoblastic leukemia and won. But he never left the hospital because of an invasive fungal infection which has no treatment. Beydn was 10 years old when he died on February 22, 2014.
We, his family, are building a foundation in his name. We support research of the fungal infection that took him, literacy in his place of birth in North Carolina, and overall childhood cancer awareness. Because nothing can ever change that in four short months Beydn went from having a future to having a legacy, all because of childhood cancer. -- Joshua Swink
One of the things on Carson's bucket list was to hear the great George Strait LIVE! Funds were tight from his valiant three-year Carson vs cancer fight. So, I wrote King George a letter and before anyone could say "Jack Robinson," three tickets on the floor kicking off grand opening of Cowboy Stadium where King George was doing his amazing thing showed up!
Carson's warm smiled filled up his face every time he talked about that night and he kept this photo by his bed for the rest of his life. He died a few months later ... I loved that boy. -- Annette Leslie
My daughter Maylea Estridge. She passed away this year from DIPG at 7 years old. A deadly brainstem tumor. -- Morgan Styles
On June 23, 2013, at 8 months old, Sophie was diagnosed with a low-grade, optic pathway glioma brain tumor. My husband Josh and I were originally told that her only option would be a 13-month protocol of chemo in hopes to stop the development of the tumor. Since it is a slow-growing tumor, chemo was never meant to get rid of the tumor, and doctors told us if they saw even minimal shrinkage it would be considered a huge success.
After 13 months of chemo, Sophie’s brain tumor was about 85 to 90 percent gone, and a massive cyst that had formed was about 90 percent gone! We were told that chemo would also not get rid of the cyst. We were told that Sophie would go blind in her left eye and her right eye would likely be compromised. Because of the shrinkage we have seen, we have saved her vision ... After an eye exam her vision was reported to be, “That of a normal two year olds.” -- Tracy Ryan
I was diagnosed with rhabdomyosarcoma in October 1980, at four months old. After two years of experimental chemo and surgery, I went into remission and was cured. I've gone on to get married, have children and have taught for many years. -- Amanda L. Lynch