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FDA Approves Vaccine That Covers More HPV Strains

Tue, Dec 16, 2014

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Source: webmd.com
Author: E J Mundell, HealthDay Reporter
 

WEDNESDAY, Dec. 10, 2014 (HealthDay News) — The U.S. Food and Drug Administration last Wednesday approved a new vaccine with expanded protection against the human papillomavirus (HPV), by far the leading cause of cervical and certain other cancers.

The agency said that Gardasil 9 can shield users against nine strains of the virus, compared to the four strains covered by Gardasil, the Merck & Co. vaccine approved in 2006. Merck also makes Gardasil 9.

“Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers,” the FDA said in an agency news release.

“Vaccination is a critical public health measure for lowering the risk of most cervical, genital and anal cancers caused by HPV,” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “The approval of Gardasil 9 provides broader protection against HPV-related cancers.”

The U.S. Centers for Disease Control and Prevention currently recommends the HPV vaccine for boys and girls at age 11 or 12, so they are protected before being exposed to the sexually transmitted virus. One other HPV vaccine, Cervarix, was also approved by the FDA in 2009. Cervarix is made by GlaxoSmithKline and protects against two HPV strains strongly linked to cancer, HPV 16 and 18.

According to the FDA, the approval of Gardasil 9 was based on a clinical trial involving more than 14,000 girls and women aged 16 to 26 who were not infected with HPV at the start of the trial. Participants were given either Gardasil or Gardasil 9.

“Gardasil 9 was determined to be 97 percent effective in preventing cervical, vulvar and vaginal cancers caused by the five additional HPV types [31, 33, 45, 52, and 58],” the FDA said. “In addition, Gardasil 9 is as effective as Gardasil for the prevention of diseases caused by the four shared HPV types (6, 11, 16 and 18).”

For younger people — boys and girls aged 9 through 15 — Garadsil 9 was determined to be effective from measurements of immune-system antibody responses to the vaccine, the FDA explained. “Based on these results, the vaccine is expected to have similar effectiveness when used in this younger age group,” the agency said.

In terms of safety, the FDA said that the most common adverse effects were injection site pain, swelling, redness and headaches.

Like Gardasil, Gardasil 9 is administered as three separate shots, with the second and third doses given two and six months after the first one, respectively.

This year, about 12,360 new cases of invasive cervical cancer will be diagnosed, and about 4,020 women will die from the disease, according to the American Cancer Society.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
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Doctors Trying To Remind Americans That The HPV Vaccine Isn’t All About Sex

Fri, Dec 12, 2014

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Source: thinkprogress.org
Author: Tara Culp-Ressler

 

Dr. Ronald A. DePinho is on a mission.

 
DePinho, who’s been a cancer researcher for decades and currently serves as the president of the University of Texas MD Anderson Cancer Center, wants to reframe the national conversation about the HPV vaccine to drive home a fundamental point.

 
“It’s important to appreciate that this is a cancer vaccine. A cancer vaccine!” DePinho said in an interview with ThinkProgress. “It’s a dream come true that we’ve converted knowledge into something that can actually save lives and avoid getting cancer in the first place. It’s really what we have been hoping for, and now we have it.”
Since the introduction of the HPV vaccine in 2006, the rate of human papillomavirus in teenage girls has plummeted. And the research in this field continues to advance. On Thursday, the Food and Drug Administration approved an updated version of the Gardasil vaccine that protects against nine strains of the cancer-causing virus — more than twice as many as the 2006 version, which covered just four strains.

 
According to DePinho, that’s a really significant advance for cancer care. He doesn’t want it to get lost in the ongoing controversy about HPV vaccination, a round of shots that some parents still worry is unsafe or inappropriate for their kids.
There’s a persistent myth, for instance, that giving teen girls the shots will spur them to become more “promiscuous” because they know they’ll be protected from a sexually transmitted infection. Large scientific studies have debunked the notion that there’s any link between the HPV vaccine and sexual activity, but inoculation rates still lag behind in some of the Southern states that are wary to provide teens with preventative tools to protect their sexual health.
In general, HPV vaccination rates in the U.S. are still much too low, hovering around 30 percent. Public health professionals are aiming to increase those rates dramatically, to at least 80 percent — closer to the percentage of people who get vaccinated against the virus in other developed countries.

 
To accomplish that, the health professionals who have dedicated their lives to treating HPV-related cancers want to move the conversation away from sexuality altogether. Instead of framing Gardasil as vaccine that protects against an STD — which might give some Americans the impression that they don’t need to worry about it — they want to present it as a vaccine that protects against cancer.

 
“It doesn’t seem like it makes sense to see it in terms of a vaccine for a sexually transmitted disease necessarily,” Dr. Erich Sturgis, an expert in head and throat cancer who works as the program director for the MD Anderson Oropharynx Program, said in an interview with ThinkProgress. “Most of us will have an HPV infection at some point in our lifetime and we’ll never know it.”
Nearly all sexually active Americans get HPV at some point in their lives, according to the Centers for Disease Control and Prevention. An estimated 80 percent of people are infected at some point, and most never realize it because the infection resolves itself on its own. But certain strains of the virus go on to cause cervical, vulvar, anal, penile, and oropharyngeal cancers.

 
Without the HPV vaccine, men in particular are put at risk of developing neck and throat cancers. Unlike cervical cancers, which can be detected with regular Pap smears, there’s no way to screen men.

 

Sturgis treats mostly middle aged male patients, and he estimated that about 60 percent of the cancers he deals with are caused by HPV. He said it’s important to increase the rates of vaccination among both girls and boys because it will be another 30 to 40 years before today’s kids hit the point when these type of throat cancers may start displaying themselves.
“To let your kids potentially suffer later in life is just a tragedy. That’s really the message here,” he said.

 
Both cancer doctors are optimistic that once more parents are educated about what’s at stake, they’ll start vaccinating their kids at higher rates. There’s a big information gap — one recent study found that 70 percent of U.S. adults didn’t realize the HPV vaccine has any connection to cancer whatsoever — that they believe can be corrected with more investment from primary care doctors who are on the front lines of recommending the shots.

 
“It’s really about empowering parents and health care professionals, and making them recognize that this is a childcare responsibility and a priority for all of us,” DePinho said. “It begins with interviews like this and just having the media getting this information out there.”

 
“Doctors are probably not as good at messaging to the public as we could be. We need some help,” Sturgis agreed.

 

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
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Revolutionary new approach uses advanced technology to remove head and neck cancer tumors

Thu, Dec 11, 2014

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Source: www.news-medical.net
Author: staff

In a groundbreaking new study, UCLA researchers have for the first time advanced a surgical technique performed with the help of a robot to successfully access a previously-unreachable area of the head and neck.

This pioneering method can now be used safely and efficiently in patients to remove tumors that many times were previously thought to be inoperable, or necessitated the use of highly-invasive surgical techniques in combination with chemotherapy or radiation therapy.

Developed by Dr. Abie Mendelsohn, UCLA Jonsson Comprehensive Cancer Center member and director of head and neck robotic surgery at UCLA, this new approach provides the surgical community with a leading-edge technology roadmap to treat patients who had little or no hope of living cancer-free lives.

“This is a revolutionary new approach that uses highly advanced technology to reach the deepest areas of the head and neck,” said Mendelsohn, lead author of the study. “Patients can now be treated in a manner equivalent to that of a straightforward dental procedure and go back to leading normal, healthy lives in a matter of days with few or even no side effects.”

A New Approach to Saving Lives
The parapharyngeal space is pyramid-shaped area that lies near the base of the human skull and connects several deep compartments of the head and neck. It is lined with many large blood vessels, nerves and complex facial muscles, making access to the space via traditional surgical options often impossible or highly invasive.

Current surgical techniques can necessitate external incisions be made to the patient’s neck, or the splitting of their jaw bone or areas close to the voice box. Chemotherapy and radiation therapy are also often required, further complicating recovery and potentially putting patients at risk for serious (or even lethal) side effects.

Approved by the U.S. Food & Drug Administration in 2009, Trans Oral Robotic Surgery (or TORS) utilizes the Da Vinci robotic surgical system, the state-of-the-art technology that was developed at UCLA by the specialized surgical program for the head and neck. TORS uses a minimally invasive procedure in which a surgical robot, under the full control of a specially trained physician, operates with a three-dimensional, high-definition video camera and robotic arms.

These miniature “arms” can navigate through the small, tight and delicate areas of the mouth without the need for external incisions. A retraction system allows the surgeon to see the entire surgical area at once. While working from an operating console just steps away from the patient’s bed, every movement of the surgeon’s wrists and fingers are transformed into movement of the surgical instruments.

Currently, Mendelsohn’s new procedure largely benefits patients with tumors located in the throat near the tonsils and tongue, but it continues to be adapted and expanded in scope and impact.

“We are tremendously excited about the possibilities for the surgical community with this new advancement of TORS,” said Mendelsohn. “Now patients have options they never had before, and we can even develop potential applications for the procedure beyond the surface of the head and neck.”

The study was published online ahead of print in the journal Head & Neck

David Alpern: One Patient’s Story
In 2012, David Alpern received devastating news. He was diagnosed with throat cancer, and the treatment options given to him by his doctors sound worse than the disease.

“They described a procedure where your face is split in half and it’s basically reconstructive surgery. I was completely freaked out,” said Alpern, a husband and father of two.

After careful examination and imaging by Dr. Abie Mendelsohn at UCLA, the doctor determined David was a perfect candidate for TORS. The husband and father of two was soon up and about in a matter of days following the procedure. Like the over 100 similar TORS surgeries performed with Dr. Mendelsohn at the controls, David’s tumor was removed and he’s now completely cancer free.

“I try not to get too cocky or excited that I beat cancer, but I think I did,” said David. “There are no side effects at this point. My hopes are just to watch my kids grow up and enjoy my family and my life.”

Source: UCLA’s Jonsson Comprehensive Cancer Center

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Government anti-smoking campaign cost just $480 per quitter, study finds

Thu, Dec 11, 2014

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Source: www.washingtonpost.com
Author: Lenny Bernstein

At $48 million, the first government mass media campaign to convince cigarette smokers to quit would seem a pricey luxury, especially since that sum purchased just three months of television ads from March through June of 2o12. But a new study of its cost effectiveness, released Wednesday, determined that it cost just $480 for each smoker who quit and $393 per year of life saved.

The graphic videos featured pleas from former smokers who had suffered amputated limbs, oral and throat cancer, paralysis, lung damage, strokes, and heart attacks. One of the most haunting showed Terrie Hall, a 52-year-old North Carolina woman whose larynx was removed after she was diagnosed with throat cancer. In the ad, she spoke with the help of an artificial voice box. Hall later died.

The campaign and the analysis were both conducted by the Centers for Disease Control and Prevention, but Saul Shiffman, a University of Pittsburgh psychology professor who has spent decades studying smoking habits, said there is no doubt it was a tremendous bargain for the public and, especially, the smokers who quit or added years to their lives. One standard used in studying such interventions considers them cost effective at $50,000 per year of life gained–more than 100 times the cost of the campaigns.

Medical interventions, such as heart and lung surgery commonly needed by long-term smokers are much more expensive than that, Shiffman noted. The money spent on the campaign “would pale next to the money we spend for medical treatment for smokers who otherwise are going to have a heart attack and lung cancer,” he said.

CDC Director Thomas Frieden said the campaign is “an example of an investment that saves lives and money. Most smokers want to quit. Tips show that people can, and can save literally tens of thousands of lives, and has done so at a cost vastly lower than the cost of most other health interventions.”

Shiffman and Tim McAfee, director of the CDC’s Office on Smoking and Health, noted that the tobacco industry spends about $8 billion annually to promote its products. Funding for the campaign, which continued in subsequent years, comes from the Affordable Care Act.

A previous study of the effort determined that more than 100,000 people gave up smoking for six months or more, considered permanent abstinence for the purposes of the research. Another 100,000 quit for shorter periods of time and 1.6 million tried to quit after seeing the ads.

The data was derived by surveying a group of several thousand smokers before and after the ad campaign, McAfee said. About 89 percent said they had seen the ads.

The shocking nature of the campaign was designed to reach smokers, who already know that the habit is likely to sicken and kill them. They told researchers “we don’t want to die early , but we’ve kind of absorbed that message. We don’t want to suffer and we don’t want our families to suffer,” McAfee said.

“What they told us [was you] need to show us in a way that we can understand or believe what the consequences of us continuing to smoke are,” he said. A positive message was included at the end of the ads to highlight the fact that even smokers who quit late in life improve their health and gain quality of life, he said.

Despite declines in smoking rates, about 42 million people in the United States, 18 percent of the population, still smoke. The habit remains the single most preventable cause of death and disease in this country, the study noted.

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Vigilant Biosciences, Inc. marks significant milestone with ISO certification

Thu, Dec 11, 2014

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Source: www.prnewswire.com
Author: press release

Vigilant Biosciences, Inc. (“Vigilant”), an oncology company specializing in point-of-care and lab-based products that aid in the early detection and intervention of cancer, today announced that it has received ISO 13485:2003 certification, an internationally recognized quality standard for medical devices.

The ISO 13485:2003 certification covers the design, development, production, sales and service of Vigilant’s OncAlert oral cancer-specific risk assessment products. This certification demonstrates that Vigilant has successfully implemented a quality management system that conforms to the worldwide standard for medical device and diagnostic manufacturing.

For Vigilant, the certification marks a pathway to achieving a CE Mark for sale of its products in the European Union, and additional regulatory approvals needed for commercialization of its products worldwide.

“Obtaining ISO certification is a significant step forward for Vigilant as we continue our efforts to bring our oral cancer risk assessment kit to market,” said Matthew Kim, founder and chief executive officer of Vigilant Biosciences, Inc. “As thousands continue to be diagnosed with oral cancer every year, we are committed to providing a simple, specific and cost-effective way to aid in the detection of the disease in its earliest stages. This accomplishment will help us to achieve that goal.”

The Vigilant oral cancer risk assessment kit is formulated to detect proteins specific to oral cancer captured by an oral rinse. The test can be applied to every adult at risk, with particular emphasis on tobacco users, those who consume alcohol, and people with human papillomavirus (HPV) – collectively representing a $3.9 billion United States market and $10.2 billion worldwide market. In a 300 patient study, the largest oral cancer study of its kind, the kit demonstrated the ability to detect tumors early and across a racially and ethnically diverse population.

According to the World Health Organization, there are over 600,000 new cases of head and neck cancer and 300,000 deaths each year worldwide. In the United States, more than 54,000 individuals will be diagnosed with head and neck cancers in 2014, with 13,500 deaths from the disease. Historically the death rate associated with this cancer is particularly high due to late-stage diagnosis and intervention. Early diagnosis of oral cancer results in a cure rate of up to 90 percent.

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Study suggests that experience counts when it comes to head and neck cancer treatments

Tue, Dec 9, 2014

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Source: medicalxpress.com
Author: staff
 

When it comes to specialized cancer surgery, it’s generally true that the more experienced the surgeon, the better the outcome. The same might hold true for radiation therapy used to treat head and neck cancer, according to a new study led by researchers Evan Wuthrick, MD, assistant professor of radiation oncology at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), and Maura Gillison, MD, PhD, professor of internal medicine and epidemiology at the OSUCCC – James.

Published in the Journal of Clinical Oncology with an accompanying editorial, the study compared survival and other outcomes in 470 patients treated with radiation therapy at 101 treatment centers through a clinical trial held from 2002 to 2005. The trial was sponsored by the National Cancer Institute and organized by the Radiation Therapy Oncology Group (RTOG).

The findings indicated that patients treated at the less-experienced centers were more likely to have cancer recurrence (62 percent versus 42 percent at five years) and had poorer overall survival compared with those at the highly-experienced centers (51 percent versus 69 percent five-year survival, respectively).

“Our findings suggest that institutional experience strongly influences outcomes in patients treated with radiation therapy for head and neck cancer,” says Wuthrick, the paper’s first author. “They indicate that patients do better when treated at centers where more of these procedures are performed versus centers that do fewer.”

Radiation therapy for head and neck cancer requires complex treatment planning that can vary considerably between institutions and physicians. In addition, significant short-term and long-term side effects can occur that require management by a carefully coordinated multidisciplinary care team. National Comprehensive Cancer Network guidelines recommend that head and neck cancer patients receive treatment at experienced centers, but whether provider experience affects outcomes was previously unknown.

Wuthrick, Gillison and their colleagues used participation in previous RTOG head and neck cancer clinical trials as a surrogate for experience. They identified 88 low-accruing centers that enrolled an average of four patients yearly to the trials, and 13 high-accruing centers that enrolled an average of 65 patients annually. Next, the researchers compared outcomes based on whether patients were treated at the high-accruing (more experienced) or low-accruing (less experienced) centers.

The study’s key findings include:

  • Five-year local recurrence rates were higher among patients treated at less experienced centers versus more experienced centers (36 percent and 21 percent, respectively);
  • The radiation therapy plan was more likely to deviate from protocol at less experienced centers (18 percent versus 6 percent);
  • Treatment at low-accruing centers was associated with a 91-percent increased risk of death and an 89-percent increase in progression or death when compared with high-accruing centers.

Institutional elements not assessed by the study that can also influence outcomes included use of a tumor board, the number of colleagues and their years of practice, and ancillary services such as speech and swallowing therapy, dietetic and nutritional support, and specialized nursing.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
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Green Day Guitarist Jason White Diagnosed with Tonsil Cancer

Mon, Dec 8, 2014

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Source: billboard.com
Author: Jocelyn Vena

Send Green Day your well wishes.  The band confirmed on Dec. 5 that guitarist Jason White was recently diagnosed with tonsil cancer.

The band shared the news with their fans on their official website.

“We have some news to report regarding our brother Jason White, and wanted you to hear it from us before word spread. Jason recently underwent a routine tonsillectomy, and his doctors discovered a treatable form of tonsil cancer,” the statement reads. Rolling Stone first posted the statement. “Thankfully they caught it early and he should make a full and speedy recovery. Please join us in sending him love and positive healing vibes during this time.”

The 41-year-old has been playing with Green Day since the late 90′s, serving as the band’s touring guitarist. In 2012, with the release of ¡Uno!¡Dos! and ¡Tre! he officially became a full-time member of the legendary punk band. He has also worked with lead singer Billie Joe Armstrong on the side project Pinhead Gunpowder.

 
*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
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Antacids may improve head and neck cancer survival

Mon, Dec 8, 2014

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Source: www.webmd.com
Author: Robert Preidt

Using antacids to control acid reflux may improve head and neck cancer patients’ chances of survival, a new study suggests.

The researchers examined the effects that two types of antacids — proton pump inhibitors and histamine 2 blockers — had on head and neck cancer patients. More than two-thirds of the nearly 600 patients in the study took one or both types of the antacids after their cancer diagnosis.

Acid reflux — commonly known as heartburn — is a common side effect of chemotherapy or radiation treatment, according to the researchers. Proton pump inhibitors include drugs such as Prilosec, Nexium and Prevacid, while histamine 2 blockers include drugs such as Tagamet, Zantac and Pepcid.

Compared to patients who didn’t take antacids, those who took proton pump inhibitors had a 45 percent lower risk of death, according to the researchers. They also found that those who took histamine 2 blockers had a 33 percent lower risk of death.

The study is published in the December issue of the journal Cancer Prevention Research.

“We had suspicions that these medications somehow had a favorable impact on patient outcomes. This led us to review our large cohort of patients and screen them for common medications, focusing on antacids. In fact, our study did show that people taking antacids are doing better,” study author Dr. Silvana Papagerakis, research assistant professor of otolaryngology–head and neck surgery at the University of Michigan Medical School, said in a university news release.

It’s not clear why antacids may improve survival. But, the researchers have started looking for answers to that question.

“Currently, patients might be on and off of this medication according to their symptoms of acid reflux. We believe this medication can also be beneficial at stopping cancer progression. Perhaps longer duration of treatments may have significant effect in terms of outcome survival,” Papagerakis said.

“What this study makes clear is these medications may be more beneficial to the patients than just controlling side effects,” Papagerakis added.

The researchers also want to investigate if the use of antacids by people with reflux disease or with precancerous lesions might reduce their risk of developing head and neck cancer.

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Red wine: Cancer causing or cancer protective? Researchers say both

Mon, Dec 8, 2014

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Source: www.inquisitr.com
Author: staff

People who drink red wine have the lowest incidence of cancer caused by alcohol, and researchers think they know why that is. A new study published in the medical journal Advances in Experimental Medicine and Biology explains that while alcohol has cancer causing effects, red wine offers an anti-cancer quality that most other forms of alcohol do not offer. The study was completed by researchers at the University of Colorado Cancer Center.

red-wine-cancer-665x385

When people first begin to metabolize alcohol, it is converted to acetyl aldehyde, a known carcinogen.

“With enough alcohol, the body can get behind and end up with a backlog of acetyl aldehyde,” Dr. Robert Sclafani, the author of the paper, said. As he looked at epidemiological studies of head and neck cancer, he noted that alcohol is a major factor. He explained that when he separated the data into the type of alcohol, it was clear that people who drank red wine seemed to be more protected from cancer.

“In red wine, there’s something that’s blocking the cancer-causing effect of alcohol,” Sclafani said. Sclafani believed the resveratrol found in the skin of the grapes used to make red wine removes the most damaged cells from wine drinkers’ bodies. The most heavily damaged cells are also the cells most likely to turn cancerous, according to Medical News Today.

“Alcohol bombards your genes,” Sclafani explained. “Your body has ways to repair this damage, but with enough alcohol eventually some damage isn’t fixed. That’s why excessive alcohol use is a factor in head and neck cancer. Now, resveratrol challenges these cells – the ones with unrepaired DNA damage are killed, so they can’t go on to cause cancer. Alcohol damages cells and resveratrol kills damaged cells.”

According to the press release, research into another disease was integral to the research about red wine’s complicated relationship with cancer. Fanconi anemia is a rare genetic disorder which makes it so that these patients are not able to repair DNA as well as the general population. Without being able to make repairs, damaged DNA accumulates in the body, so these patients are very susceptible to head and neck cancer and leukemias, according to the press release about red wine and cancer.

“We learn a lot from genetic disorders because you can put a finger on a gene and say, hey, we know what that does,” Sclafani said, explaining that a genetic cancer-accelerator in Fanconi anemia patients is the same cancer causing mechanism in alcohol-related cancers; partially metabolized alcohol. For red wine drinkers, Sclafani explained, the ability to flush out damaged cells with the help of resveratrol might just be a life saver!

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This drug treatment costs $84,000 and the US health-care system can’t make it any more affordable

Wed, Dec 3, 2014

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Source: vox.com
Author: Sarah Kliff 

 

The first thing Philip Mason noticed was the hair loss. The 73-year-old retiree, a former computer programmer, began shedding hair from his arms, legs, everywhere on his body. “It just all came right off,” he said.

After the hair loss came weight loss; Mason dropped from 150 to 125 pounds. He felt weak and sick. Mason, who is blind and already used a white cane to get around, began having falls. He switched to a walker for more stability.

Mason went to the doctor and discovered he had Hepatitis C. He had contracted the disease through sex with an ex-boyfriend. And when he received his diagnosis three years ago, the prognosis wasn’t good. He already had renal insufficiency, a chronic condition in which the kidneys become increasingly weak and unable to process urine. After the diagnosis of Hepatitis C, which weakens liver function, Mason’s doctor recommended a transplant.

Mason declined. “I told my doctor I was already old, and worried about what my quality of life would be like after the transplant,” he said.

“I wish I could say I was optimistic that the future would be different, and prices would moderate”

So Mason lived with his Hepatitis C, the hair loss, the weight loss, the walker, and the falls, until this past February. That’s when his doctor at the Whitman Walker Clinic in Washington, DC, asked if he wanted to try a new Hepatitis C drug called Sovaldi. It had just come on the market a few months earlier. In initial trials, Sovaldi used with another medication cured at least 94 percent of Hepatitis C cases during a 12-week treatment course.

Treatment would not be invasive like a liver transplant. He would just need to take Sovaldi and one other medication once a day for three months. Mason agreed.

Sovaldi worked better than Mason had hoped. His hair began to grow back. Within three weeks of finishing treatment, he gave up his walker — and his Hepatitis C was gone. “I keep thinking it’s going to come back,” Mason said. “But each time they test me, it’s undetectable.”

What Mason didn’t know: the pills he took typically cost $1,000 each. His entire course of treatment has a an $84,000 sticker price that his health insurer, public assistance programs, and the drug manufacturer itself all chipped in to cover.

Mason didn’t know that the yellow pill he took daily, and its price, were the subject of a massive fight in the healthcare system and one of the biggest policy debates of the year.

The way the pharmaceutical industry developed, priced, and sold Sovaldi is an instructive study in how the American healthcare system allows drugs to become expensive — an incredible, unprecedented, and $1,000-per-pill type of expensive that the country has never seen before.

The story of Sovaldi shows the American health care system is incapable of fighting back against these prices. The people who buy drugs — mostly private health plans and public insurance programs — are too fragmented to demand lower prices.

“I wish I could say I was optimistic that the future would be different, and prices would moderate,” said Jeff Meyers, chief executive of the Medicaid Health Plans Association, which represents the private insurance companies that states use to manage their Medicaid programs. “But I suspect that’s not the case. What the companies have learned from the Sovaldi experience is that there are precious few ways for us to manage costs.”

How Sovaldi came to be

The $1,000 Sovaldi pill — before it had a price tag, or a name, or had caused a national controversy — had a code name: PSI-7977.

PSI-7977 was a molecule developed in the mid-2000s and owned by Pharmasset, a small biotechnology company based in Atlanta. The firm had a library of hundreds and hundreds of molecules, all tiny investments they tested in laboratories. They wanted to figure out which one could unlock new secrets about how to treat autoimmune diseases like AIDS and Hepatitis C.

Hepatitis C looked like a particularly lucrative market. There are at least 130 million infections worldwide. Left untreated, chronic Hepatitis C ravages the liver, causing the organ to fail or cancer to develop. It kills an estimated 350,000 people worldwide each year and, in 2007, Hepatitis C deaths surpassed those from AIDS

Hepatitis C treatments did exist before PS-7977, but they often had terrible side effects. Half of all patients used an injectable drug known as interferon. It works by mimicking the immune system’s response to infection, pushing the body to produce more of the cells that fight off the disease. Patients on interferon regimens regularly experience fever, chills, and aches while taking the medication — which doesn’t cure the disease, just continues to treat it. Pharmasset wanted to build a molecule that could do better.

Most molecules in Pharmasset’s library — like any of its competitors’ collections — fail. They exist solely in pharmaceutical companies’ storehouses, never to see the light of a pharmacy shelf. “At a big pharma company, you can end up screening potentially several million molecules to see which one is viable,” said Michael Sofia, who worked extensively on PS-7977 in the mid-2000s.

The firm recognized, in what its founder Raymond Schinazi describes as “a collision of science and serendipity,” that PS-7977 might not be the typical failure.  PSI-7977 turned out to be really great at stopping the Hepatitis C virus from reproducing in a way that other drugs never had.

It “turned out to be a very potent and very selective inhibitor of the Hepatitis C virus,” Sofia said. “That’s why it continued into development.”

“In terms of the American patient, you’re just paying double or more the price for no more health gain”

Initial trials showed never-before-seen cure rates for Hepatitis C, upwards of 90 percent of patients treated. That quickly made PS-7977  the envy of the pharmaceutical world. Pharmasset found itself in the middle of a bidding war, with large drug makers looking to buy the small biotech company and its valuable molecule. Gilead, one of the country’s largest pharmaceutical companies, won. In 2011, it paid $11.4 billion for Pharmasset — and, most importantly, for that single, special molecule.

“There was a big competition to buy Pharmasset,” said Stefan Zezeum, a prominent Hepatitis C researcher at J.W. Goethe University Hospital in Frankfurt, Germany. “Everybody wanted to buy them, but only Gilead was willing to give them $11.4 billion. Everyone said that Gilead was crazy then, that they were going to go bankrupt.”

Gilead was about do something almost as crazy as buying Pharmasset: last December, it announced it would be charging about $1,000 for each single yellow pill. That adds up to $84,000 for a 12-week course of treatment — more when combined with other medications. That’s how Gilead would earn that $11.4 billion back, and more — and, in the process, become the center of the $2.7 trillion health care industry’s most vicious fight in years.

How drug pricing works differently in other countries

Nexium is a bright, purple pill that treats heartburn. In 2013, it was the second best-selling drug in the United States, after Abilify, an anti-depressant manufactured by Otsuka. Americans spent $6.2 billion buying Nexium prescriptions in 2013 alone.

But we probably didn’t have to: while Americans pay an average of $215 for a Nexium prescription, the Dutch get the exact same purple pill for $23. In England, Nexium costs $42 and in Spain the price is $58.

There’s nothing different about the Nexium that we buy in the United States and the pills that the Dutch, British and Spanish take — except that, in the United States, we didn’t ask the manufacturers for a discount.

“It’s exactly the same product,” said Tom Sackville, chief executive of the International Federation of Health Plans. We spoke earlier this spring, when his group published an annual report comparing international health care prices. “In terms of the American patient, you’re just paying double or more the price for no more health gain.”

In Spain, the United Kingdom and the Netherlands, the government sits down with drug makers and haggles over how much they will pay. Each country uses different negotiating tactics. The United Kingdom, for example, runs its bargaining through the National Institute for Clinical Evaluation, typically known by its acronym, NICE.

NICE exists solely to decide at what point a new treatment is cost-effective: when it will save the health care system money, in the long run, by preventing further disease. NICE runs dozens of these analyses each year, on drugs and surgeries and scanning devices. And it uses its findings to tell medical manufacturers: this is the price our country will pay for your service. This is the point at which your new drug is worth buying.

NICE often finds itself at the center of controversy. If it declares a drug to not be worth its cost — tells breast cancer patients, for example, that the British system won’t cover a $39,000 new treatment — the recommendation can be met with fury. These are prescriptions that are typically too expensive for a patient to afford on their own; they need the government’s coverage approval. That’s the trade off inherent in asking a central agency to evaluate whether or not certain drugs are worth buying — some prescriptions won’t make the cut.

“How do we maintain insurance financing if everyone takes this approach? We end up sinking the ship”

The United States works differently. Federal law bars Medicare, the country’s largest insurance plan, from negotiating with drug makers. Once a pharmaceutical company sets its price, the government-run plan that insures 49 million seniors is required to accept it.

“For Medicare, the sky is really the limit,” said Jamie Love, who has studied drug pricing and directs the DC non-profit Knowledge Ecology International.

Other federal programs get certain discounts from drug makers. Federal law requires that Medicaid, the program that covers low-income Americans, gets a 23 percent discount off of all brand-name drugs’ sticker prices. Each state’s Medicaid program also has the authority to negotiate even lower prices. The Department of Veterans Affairs also negotiates drug prices, as do private health insurance plans.

There are thousands of private insurers, though, and they often have little clout to demand lower prices. Other countries are essentially buying in bulk — like shopping at Costco. The United States does the equivalent of going to the local grocery store — and paying more.

“We don’t have a NICE in the United States,” said Steven Pearson, founder and president of the Institute for Clinical and Economic Reviews, a non-profit that evaluates evidence on medical tests. “We have a system that says, ‘If it’s better, we have to provide this pill and you, the drug maker, get to name the price.’ It’s not a market. It’s a drug maker saying what they want.”

Gilead’s Sovaldi gamble

Gilead knew it had a potentially breakthrough drug on its hands when it acquired PharmAsset in late 2011. It spent two years finishing the research process, collecting the data that regulatory agencies would need to let its new product onto the market.

Gilead also had to settle on a price. When the sky is the limit in American drug pricing, it had to figure out how high it would go.

Pharmasset, in a December 2011 filing with the Securities and Exchange Commission, estimated that it would sell the drug for somewhere between $36,000 and $72,000. Those figures were, according to the filing, meant to be “ranges of possible deviations for each of the relevant commercializations.

Gilead had lots of options in setting its price. It could have stuck where Pharmasset was. Or it could have tried to recoup the $11.4 billion it spent acquiring Pharmasset. The drug company could have looked at what it spent on the drug — the purchase, the additional development costs, the marketing budget — and priced to earn more than that.

Gilead has repeatedly said it didn’t do any of this. “We he didn’t take those things into account,” Gilead’s chief executive officer John Martin said during an October appearance at the Brookings Institute, one of many think-tank gatherings where he’s been called on to defend Sovaldi’s price.

Gilead said that it looked around the market and got a sense of what its competitors were charging. They looked at what other Hepatitis C drug makers got away with, and chose something in that range.

“Our pricing analysis was looking at what was the cost of current other therapies,” Martin said.

That is how the $1,000 pill came to be. And that’s when Gilead had to wait and see: would the American health care system agree to buy it?

The debate over high drug prices

There’s an active debate among economists about the benefits and consequences of expensive drugs: whether $1,000 pills are the necessary rewards that keep the pharmaceutical world innovating — or just pure waste.

The argument against high drug prices is more intuitive: how does it make sense for the United States to pay $1,000 for a pill when billions of people elsewhere can buy it for less? It is unethical and unfair that some Hepatitis C patients in the United States would be unable to afford a drug that costs tens of thousands of dollars less in European countries. (NICE recommended that the United Kingdom buy the drug for British Hepatitis C patients at £34,000 — approximately $55,000. In provisional guidelines issued in August, NICE described the drug as “a clinically and cost-effective treatment.”)

Patient advocates say drug companies could significantly reduce their prices while running similar margins to other parts of the healthcare sector. Pharmaceutical companies have the largest profit margins in the healthcare industry, hovering just above 20 percent. That’s more than five times the margins that hospitals and health insurance plans typically run.

“How do we maintain insurance financing if everyone takes this pricing approach?,” said Rother, who leads the coalition protesting Sovaldi’s price. “We end up sinking the ship. We want innovation, but to continue loading these high drug benefits onto premiums, isn’t going to work.”

“This is an actual innovation, and that is something that they should get a reward for”

One particular challenge for the American health care system is fragmentation: insurers that pay for Sovaldi rarely recoup their spending on the drug, which, in the long run, does increase health.

But there’s another take on the higher drug prices, one that argues that large payouts in the form of big profits are the best way to encourage drug makers to innovate. Without the large profit margins, companies wouldn’t bother to chase the breakthrough cures — medications like Sovaldi.

Most new drugs that come out annually aren’t these type of breakthroughs, though. They are often tiny, incremental tweaks to existing treatments, like when AstraZeneca replaced Prilosec, its original blockbuster heartburn drug, with Nexium. Nexium didn’t offer much in the way of better outcomes, but it did give AstraZeneca an exclusive, brand-name product it could sell just as Prilosec’s patent expired.

“Pharmaceutical companies get criticized for lots of things like that,” Craig Garthwaite, a health economist at Northwestern University’s Kellogg School of Management, said. “This is an actual innovation, and that is something that they should get a reward for.”

The United States does pay more for drugs, but, Garthwaite and others argue, the end result is better drugs for the entire world.

The future of really expensive drugs

Gilead gained approval to sell Sovaldi in the United States on December 6, 2013. It was met with fierce protest from health insurers and state agencies, who quickly sized up the pill as a budget-buster.

Oregon and Illinois put strict limitations on which patients would receive the drug. Oregon, for example, limits access to those in late-stage liver disease. Illinois requires patients to meet a 25-item checklist before receiving a Sovaldi prescription. Most of the costs are borne by insurers, rather than patients, whose insurance typically shields them from the high price. Mason, for example, said he paid a mere $59 out-of-pocket during treatment.

Coalitions sprung up to denounce the high price. Congress launched an investigation into the issue in July. Sovaldi, Sens. Ron Wyden (D-Ore.) and Chuck Grassley (R-Iowa) said in a rare bipartisan press release, raises “serious questions about the extent to which the market for this drug is operating efficiently and rationally.”

All of these actions were meant to send a signal: it’s unacceptable for drug makers to price their products so high. Pharmaceutical companies will be made to answer for these actions.

It didn’t work: while Sovaldi became a poster child for pharmaceutical greed, it has brought Gilead and its shareholders a hefty profit. The drug “catapulted Gilead Sciences into the ranks of the top-selling pharmaceutical companies,” the Wall Street Journal reported this summer. Gilead has sold more than 280,000 Sovaldi prescriptions this year, according to a CitiGroup analysis. The company earned $3.5 billion in Sovaldi sales in 2014′s second quarter (sales fell to $2.8 billion the quarter after).

The lesson of the Sovaldi launch seems to be this: if drug companies are willing to take a little bit of heat, they can get away with high prices for drugs, especially those that deliver great results. That terrifies American health insurers, who fear a future where every large scientific breakthrough is accompanied with Sovaldi-esque prices.

Express Scripts, a pharmacy benefits management company, estimates that spending on specialty drugs like Sovaldi will grow another 18 percent in 2015 after similar growth rates this year and last.

Forecasters expect that Medicare spending on drugs will more than double over the next decade, from $79 billion in 2014 to $171.2 billion in 2023. At least some of that growth, this year’s Medicare Trustees Report said, will be due to “an increase in the use and price of speciality drugs.”

And much of that growth is rewarding big advancements in medicine, said Express Scripts chief medical officer Steve Miller. He’s anticipating the launch of new injectable drugs next year that could revolutionize the treatment of cholesterol — an equally impressive advancement to what Sovaldid did for Hepatitis C, with an equally steep price.

“There’s this new class of drugs out there for high cholesterol, injections that you give yourself every two to four weeks, that’s just extraordinary,” Miller said. “But here’s the scary part: there are 71 million people with high cholesterol. I love these drugs, they’re great, but they could increase drug spending by a full third. That’s just one drug.”

Mason knows that, for him, Sovaldi was incredible. But he also has friends, at an HIV support group he attends in Washington, who can’t access the drug because of the price. They don’t have health insurance coverage and it’s just too expensive.

“My experience is I feel much better and I’m much happier having taken the medication,” Mason said. “But let’s put it this way: I’m 73. I’m grateful to be alive now. But if there was some young child who could have used this money to keep them alive, I think it would have been better to spend the money on them.”

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

 

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