oral cancer

This Is Why Your Drug Prescriptions Cost So Damn Much

Source: www.motherjones.com
Author: Stuart Silverstein



When the Republican-controlled Congress approved a landmark program in 2003 to help seniors buy prescription drugs, it slapped on an unusual restriction: The federal government was barred from negotiating cheaper prices for those medicines. Instead, the job of holding down costs was outsourced to the insurance companies delivering the subsidized new coverage, known as Medicare Part D.

The ban on government price bargaining, justified by supporters on free-market grounds, has been derided by critics as a giant gift to the drug industry. Democratic lawmakers began introducing bills to free the government to use its vast purchasing power to negotiate better deals even before former President George W. Bush signed the Part D law, known as the Medicare Modernization Act.

All those measures over the last 13 years have failed, almost always without ever even getting a hearing, much less being brought up for a vote. That’s happened even though surveys have shown broad public support for the idea. For example, a Kaiser Family Foundation poll found last year that 93 percent of Democrats and 74 percent of Republicans favor letting the government negotiate Part D prescription drug prices.

“I mean, how in the world can one explain that the government actually passed a law saying that you can’t negotiate prices?”

It seems an anomaly in a democracy that an idea that is immensely popular—and calculated to save money for seniors, people with disabilities, and taxpayers—gets no traction. But critics say it’s no mystery, given the enormous financial influence of the drug industry, which rivals the insurance industry as the top-spending lobbying machine in Washington. It has funneled $1.96 billion into lobbying in the nation’s capital since the beginning of 2003 and, in just 2015 and the first half of 2016, has spent the equivalent of $468,108 per member of Congress. The industry also is a major contributor to House and Senate campaigns.

“It’s Exhibit A in how crony capitalism works,” said Rep. Peter Welch (D-Vt.), who has sponsored or co-sponsored at least six bills since 2007 to allow Part D drug price negotiations. “I mean,” he added, “how in the world can one explain that the government actually passed a law saying that you can’t negotiate prices? Well, campaign contributions and lobbying obviously had a big part in making that upside-down outcome occur.”

Wendell Potter, co-author of a book about the influence of money in politics, Nation on the Take, likened the drug industry’s defiance of public opinion to the gun lobby’s success in fending off tougher federal firearms controls and the big banks’ ability to escape stronger regulation despite their role in the Great Recession.

“They are able to pretty much call the shots,” Potter said, referring to the drug industry along with its allies in the insurance industry. “It doesn’t matter what the public will is or what public opinion polls are showing. As long as we have a system that enables industries, big corporations, to spend pretty much whatever it takes to influence the elections and public policy, we’re going to wind up with this situation.”

While Part D is only one of the issues the drug industry pushes in Washington, it is a blockbuster program. According to a report from the trustees of the Medicare system, this year Part D is expected to spend $103 billion to serve an estimated 43 million Americans.

A paper released in August by Harvard Medical School researchers cited the size of the program and its lack of government negotiating clout as among the reasons why Americans pay the highest prices in the world for prescription drugs. A co-author of that paper, Ameet Sarpatwari, estimates that Part D accounts for nearly 30 percent of the nation’s spending on prescription drugs.

What’s more, Part D often pays far more for drugs than do Medicaid or the Veterans Health Administration—which, unlike Part D, mandate government measures to hold down prices. One report found that Part D pays 80 percent more for medicines than the VHA and 73 percent more than Medicaid. While researchers aren’t unanimous in their views, an array of experts have concluded that federal negotiating power—if backed up by other cost controls—would bring Part D drug costs more in line.

The drug industry and its allies acknowledge that, at least in the short term, federal intervention in the marketplace could bring lower drug prices. Yet the industry says such a step would also kill incentives to develop new medicines.

In addition, industry officials and many analysts say substantial cost reductions will come only if the Part D program refuses to pay for drugs that it considers overpriced, possibly reducing seniors’ access to some medicines. They point to the way the VHA strengthens its negotiating leverage by rejecting some expensive medicines. Instead, the veterans’ health care system limits its purchases to a list of approved drugs known as a formulary.

“If you want to have lower prices, you’re going to have fewer medicines,” said Kirsten Axelsen, a vice president at Pfizer, a pharmaceutical giant that leads all drug companies in spending on lobbying and political campaigns at the federal level.

It took intense maneuvering by the Bush White House and GOP leaders to get Part D through Congress in November 2003, when the House and the Senate were under Republican control. The measure came up for a vote in the House at 3 a.m. on the Saturday before Thanksgiving, as lawmakers were trying to finish business before the holiday. But when the bill appeared headed to a narrow defeat after the normal 15 minutes allowed for voting, Republican leaders kept the vote open for an extraordinary stretch of nearly three hours, described in a 2004 scholarly paper as by far the longest known roll-call vote in the history of the House.

With the help of pre-dawn phone calls from Bush and a custom-defying visit to the House floor by Tommy Thompson, then secretary of health and human services, enough members were coaxed to switch their votes to pass the bill, 220-215, shortly before 6 a.m.

Part D was conceived at a time when rapidly rising US drug costs were alarming seniors, prompting some to head to Canada and Mexico to buy medicines at dramatically lower prices. With the 2004 presidential election campaign coming up, Republican leaders saw “an opportunity to steal a long-standing issue from the Democrats,” said Thomas R. Oliver, a health policy expert at the University of Wisconsin-Madison and the lead author of the 2004 paper about the adoption of Part D.

Last year the drug industry retained 894 lobbyists to influence the 535 members of Congress, staffers, and regulators.

A key aim of Part D proponents, Oliver said, was to cover seniors “in a Republican, pro-market kind of way.” That meant including “as much private sector involvement as possible,” which led to insurance companies managing the program. At the same time, it excluded federal price controls, which were anathema to the drug industry.

Today, the program remains subject to the pervasive influence of the drug industry. An analysis by FairWarning, based on spending data provided by the Center for Responsive Politics, a nonprofit and nonpartisan research group, has found:

— There are far more lobbyists in Washington working for drug manufacturers and wholesalers than there are members of Congress. Last year the industry retained 894 lobbyists to influence the 535 members of Congress, along with staffers and regulators. From 2007 through 2009, there were more than two drug industry lobbyists for every member of Congress.

— For each of the last 13 years, more than 60 percent of the industry’s drug lobbyists have been “revolvers”—that is, lobbyists who previously served in Congress or who worked as congressional aides or in other government jobs. That raises suspicions that lawmakers and regulators will go easy on the industry to avoid jeopardizing their chances of landing lucrative lobbying work after they leave office.

Probably the most notorious example was the Louisiana Republican Billy Tauzin. He helped shape the Part D legislation while serving as chairman of the House Energy and Commerce Committee. In January 2005, just days after he retired from the House, he became the drug industry’s top lobbyist as president of a powerful trade group, the Pharmaceutical Research and Manufacturers of America, or PhRMA. He remained in that job—which reportedly paid him $2 million a year—until 2010.

“It was pretty blatant but an accurate reflection of the way pharma plays the game, through campaign contributions and, in Billy’s case, way more than that,” said US Rep. Jan Schakowsky, an Illinois Democrat who has been a leading proponent of government price negotiations.

— Since January 2003, drug manufacturers and wholesalers have given $147.5 million in federal political contributions to presidential and congressional candidates, party committees, leadership PACs and other political advocacy groups. Of the total, 62 percent has gone to Republican or conservative causes.

Over the period, four Republican lawmakers from the 2015-16 Congress received more than $1 million in contributions from drug companies. (One of them, former House Speaker John Boehner, R-Ohio, resigned last October.) In all, 518 members of the current Congress—every member of the Senate and more than 95 percent of the House—have received drug industry money since 2003.

Pfizer said that since the beginning of 2003 through the middle of this year it has spent, at the federal level, $145.9 million on lobbying as well as $12.2 million on political contributions through its PACs. In a written statement, the company said, “Our political contributions are led by two guiding principles—preserve and further the incentives for innovation, and protect and expand access for the patients we serve.”

— The big money goes to top congressional leaders as well as chairs and other members of key committees and subcommittees.

The House Energy and Commerce Health Subcommittee, repeatedly a graveyard for Part D price negotiation bills, underscores the pattern. The 16 Republican members have received an average of $340,219 since the beginning of 2003.

The drug industry “knows that you really only need, in many cases, just a small number of influential members to do their bidding. That’s why you see contributions flowing to committee chairs, regardless of who is in power. They flow to Democrats as well as Republicans,” Potter said.

Proponents of negotiations say some economic and political currents may turn the tide in their favor. The main factor: After years of relatively modest price rises for prescription drugs, cost increases have begun to escalate. That’s partly because of expensive new treatments for illnesses such as hepatitis C.

According to Medicare officials, Part D payments are expected to rise 6 percent annually over the coming decade per enrollee, up from only 2.5 percent annually over the last nine years. Already, cost increases are “putting wicked pressure on our hospitals, on our seniors, and on our state governments,” Welch said.

At the same time, both major presidential candidates, Hillary Clinton and Donald Trump, have called for Medicare drug price negotiation. So have doctor groups such as the American College of Physicians and an alliance of more than 100 oncologists, many nationally known, who last year garnered headlines with their plea for Medicare negotiations and other measures to fight skyrocketing costs for cancer drugs.

PhRMA, the trade group, wouldn’t comment for this story on lobbying or campaign spending. In a written statement, however, PhRMA spokeswoman Allyson Funk said, “There is significant price negotiation that already occurs within the Medicare prescription drug program.” Pointing to the private companies that run the program, Funk added, “Large, powerful purchasers negotiate discounts and rebates directly with manufacturers, saving money for both beneficiaries and taxpayers.”

Funk also pointed to skeptical assessments by the Congressional Budget Office about the potential additional savings from federal negotiations. Repeatedly—including in letters in 2004 and 2007—the CBO has said government officials likely could extract only modest savings, at best. The office’s reasoning is that costs already would be held down by bargaining pressure from insurance firms and by drug manufacturers’ fear of bad publicity if they are viewed as jacking up prices too high.

But many analysts, particularly amid recent controversies over skyrocketing costs for essential drugs and EpiPen injection devices, scoff at those CBO conclusions. They fault the CBO for not taking into account other price controls, such as those used by Medicaid and the VHA, that likely would be coupled with price negotiation.

“You would want Medicare to have the option to say, ‘Okay, this is our price, and you’re going to take it. And if you don’t take it, we’re not buying it.'”

What CBO officials “seem to be assuming is that Congress would change the law in a really foolish way,” said Dean Baker, a liberal think tank economist who has studied the Part D program. “It seems to me that if you got Congress to change the law, you would want Medicare to have the option to say, ‘Okay, this is our price, and you’re going to take it. And if you don’t take it, we’re not buying it.”

In fact, related bills proposed during the current Congress by two Illinois Democrats—Schakowsky and Richard J. Durbin, the Senate minority whip—go beyond requiring drug price negotiations. They both provide for federal officials to adopt “strategies similar to those used by other Federal purchasers of prescription drugs, and other strategies…to reduce the purchase cost of covered part D drugs.”

The potential to reduce prices is underscored by a 2015 paper by Carleton University of Ottawa, Canada, and the US advocacy group Public Citizen. It found that Medicare Part D on average pays 73 percent more than Medicaid and 80 percent more than the VHA for the same brand-name drugs. The VHA’s success in holding down costs helped inspire a measure on California’s November ballot, Proposition 61, that would restrict most state-run health programs from paying any more for prescription drugs than the veterans agency does.

Two studies by the inspector general of health and human services that compared drug expenditures under the Part D and Medicaid programs also concluded that Part D pays far more for the same medicines. The more recent inspector general study, released in April 2015, examined spending and rebates on 200 brand-name drugs. It found that, after taking rebates into account, Medicaid, which provides health care for low-income families with children, paid less than half of what Part D did for 110 of the drugs. Part D, on the other hand, paid less than Medicaid for only 5 of 200 drugs.

Those findings provide evidence that “the current reliance on private insurers that negotiate drug prices isn’t working that well,” said Edwin Park, vice president for health policy at the Center on Budget and Policy Priorities, a Washington think tank.

Five Democrats who are leading opponents of the status quo—US Representatives Welch, Schakowsky, and Elijah E. Cummings of Maryland, along with Sens. Durbin and Amy Klobuchar of Minnesota—each have introduced price negotiation bills (HR 3061, HR 3261, HR 3513, S 31 and S 1884) during the current, 114th Congress. All the measures have stalled in committee.

Schakowsky, a House Democratic chief deputy whip, said under Republican control in her chamber, “I think it is virtually impossible for this to ever go to hearings and markups.”

Take, for example, the bill that Welch introduced in the House on July 14, 2015. Within a week, it was referred to two health subcommittees, where it has sat ever since.

The closest Welch ever came to success was in 2007. He was among 198 co-sponsors—all but one, Democrats—of a bill introduced by then-US Rep. John D. Dingell of Michigan. It was approved by the House but then blocked by Republicans from being taken up in the Senate.

“There’s a lot of industry opposition…It doesn’t mean, however, that industry is all-powerful.”

 Lawmakers on committees where Part D bills ordinarily go—the Finance Committee in the Senate, and the Energy and Commerce Committee as well as the Ways and Means Committee in the House—tend to be well funded by the drug industry.

For instance, Sen. Richard Burr (R-N.C.), who sits on the Finance Committee, has received more money from the industry since 2003 than anyone else currently in Congress, $1.3 million. Close behind is Senate Finance Chairman Orrin Hatch, (R-Utah), who has gotten $1.18 million. (The other members of the million-dollar club are Rep. Fred Upton (R-Mich.), House Energy and Commerce chairman, at $1 million, and former House Speaker Boehner, at $1.21 million.)

Burr also is the Senate leader so far in the 2015-16 political cycle, collecting $229,710 from the drug industry. In the House in the current cycle, John Shimkus (R-Ill.), a member of the Energy and Commerce health subcommittee, has snagged $189,000, trailing only Republican Majority Leader Kevin McCarthy ($292,550) and House Speaker Paul Ryan ($273,195). A Burr spokeswoman declined to comment. Hatch and Shimkus did not respond to repeated requests for comment.

Amid the EpiPen controversy and growing concerns about prescription drug prices, Park sees signs that more lawmakers are willing to buck industry opposition to government price negotiation. “There’s a lot of industry opposition. This would affect their bottom line,” Park said. “It doesn’t mean, however, that industry is all-powerful.”

But Baker, co-director of the Center for Economic and Policy Research in Washington, was skeptical about the prospects for reform. “I think it’s pretty clear what you’re seeing is, there’s an industry group that stands to lose a lot of money, and they’re basically using all of the political power they can to make sure that it doesn’t happen.”

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

October, 2016|Oral Cancer News|

Cancer-Preventing Vaccines Given To Less Than Half Of US Kids

Source: www.houstonpublicmedia.org
Author: Carrie Feibel

U.S. regulators approved a vaccine to protect against the human papilloma virus (HPV) in 2006, but cancer experts say misconceptions and stigma continue to hamper acceptance by both doctors and parents.

Eighty percent of Americans are exposed to the human papilloma virus in their lifetimes. Some strains of HPV can cause genital warts, but most people experience no symptoms and clear the virus from their systems within a year or two. But for an unlucky minority, the virus causes damage that, years later, leads to cervical cancer, throat cancer, and other types.

Researchers at MD Anderson are frustrated that ten years after the first vaccine arrived on the market, only 42 percent of U.S. girls, and 28 percent of boys, are getting the three-shot series.

The series can be given to girls and boys between the ages of 9 and 26, but the immune response is strongest at younger ages, before sexual activity begins.

n 2007, then-Texas governor Rick Perry proposed making the HPV vaccine mandatory for all preteen girls.  At the time, the vaccine was only approved and marketed for girls.

Dr. Lois Ramondetta, a cervical cancer specialist at MD Anderson, remembers the outcry.

“A lot of people felt that was the right idea, but the wrong way to go about it. Nobody really likes being told what to do, especially in Texas,” Ramondetta said. “I think there was a lot of backlash.”

Eventually, the legislature rejected Perry’s plan, even though it included an opt-out provision. Ramondetta said too many politicians focused on the fact that HPV is sexually transmitted. That had the unfortunate effect of skewing the conversation away from health care and into debates about morality and sexuality. She said the best and most accurate way to discuss the vaccine is to describe it as something that can prevent illness and death.

“I try to remove the whole concept of sexuality,” Ramondetta said. “When you’re talking about an infection that infects 80 percent of people, you’re really talking about something that is part of the human condition. Kind of like, it’s important to wash your hands because staph and strep are on all of us.”

Today, only Virginia, Rhode Island and Washington, D.C. mandate HPV vaccines.

“Our vaccination rates are really terrible right now,” Ramondetta said.

In Texas, only 41 percent of girls get all three of the required shots, and only 24 percent of boys.


Kara Million of League City finds those numbers upsetting.  Million survived two rounds of treatment for cervical cancer.

“Even if you had a chance that your kid could have any kind of cancer, and you could have given them two shots or three shots for it? To me, it’s a no-brainer,” Million said.

Million always got regular Pap tests. But she missed one appointment during a busy time following the birth of her second child. When she went back, it had been only 15 months since her last Pap test. But the doctor found cervical cancer, and it had already progressed to stage 3.

“That was a huge surprise,” Million recalled.

Million had chemotherapy and radiation at MD Anderson. But a year later the cancer returned.

The next step was surgery, a radical procedure called a total pelvic exenteration.

Million and her husband looked it up online.

“When I was reading it, I was just, like, ‘this is so barbaric, there is no way they are still doing this in this day and age,’” Million said. “‘For certain, in 2010 we have better surgeries to do than this.’”

But there weren’t better surgeries. This was her only option.

“I had a total hysterectomy; they pulled all the reproductive system out,” she explained. “They take your bladder out, they take part of your rectum, they take part of your colon, they take your vagina, all of that in your pelvic area comes out.”

The surgery took 13 hours, and left her with a permanent colostomy bag and urostomy bag.

“At that point, with two kids at that age – I think they were one-and-a-half and three – there’s no option. I’m a mom, so I’m going to do whatever it takes so they can have their mom.”

Most women survive cervical cancer if it’s caught early enough. But Million’s cancer was diagnosed at a later stage, where only a third of women make it past five years. She has already made it past that five-year anniversary, and she’s not wasting any time.

She now volunteers as a peer counselor at MD Anderson to other cervical cancer patients, and she urges parents to vaccinate their kids.

“If most of cervical cancer is caused by HPV, and now we have something that can help prevent what I went through, and what my friends went through, and the friends that I lost?” Million says, “I don’t understand why people don’t line up at the door to get their kids vaccinated for it.”

But Dr. Ramondetta said parents can’t consent to the vaccination if pediatricians or family doctors don’t offer it. And they’re not offering it nearly enough, she said.

Some doctors don’t know how to broach the topic, fearing it will lead to a difficult conversation about sexual behavior. Some mistakenly think boys don’t need it, although they do – not only to protect their partners from HPV, but to protect themselves against oropharyngeal and anal cancers, which are also caused by HPV.  Ramondetta added that some doctors incorrectly assume that giving the vaccine will promote promiscuity.

Ramondetta says extensive research actually shows it doesn’t.

“There should be this understanding of an ethical responsibility. That this is part of cancer screening and prevention, just like recommending mammograms and colonoscopies.”

In Texas, only 41 percent of girls get all three of the required shots, and only 24 percent of boys.

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

September, 2016|Oral Cancer News|

Expert Asserts Pembrolizumab to Play Important Role in Head and Neck Cancer Treatment

Source: www.targetedonc.com
Author: Laura Panjwani


The FDA approval of pembrolizumab (Keytruda) as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in August 2016 was extremely significant for this patient population, which previously had limited options following progression on a platinum-based chemotherapy.

The approval was based on the phase Ib KEYNOTE-012 study, which demonstrated that pembrolizumab had an overall response rate (ORR) of 18% and a stable disease rate of 17% in patients with recurrent/metastatic HNSCC.

Several other studies are further evaluating the immunotherapy agent in HNSCC.Preliminary results of the phase II KEYNOTE-055 study—which included 92 evaluable patients who received pembrolizumab after failing platinum and cetuximab therapies—were presented at the 2016 ASCO Annual Meeting.

In an interview with Targeted Oncology, lead study author Joshua M. Bauml, MD, an assistant professor of Medicine, Hospital of the University of Pennsylvania and the Veteran’s Administration Medical Center, discusses the impact of pembrolizumab’s success in HNSCC, the results of the KEYNOTE-055 study, and what he sees on the horizon for the PD-1 inhibitor in this field.

TARGETED ONCOLOGY: What role do you envision pembrolizumab having in this patient population?

Baumi: It is going to play a critical role in head and neck cancer. The other agents that are available have limited efficacy, and are associated with significant toxicities. This is a clear improvement for our patient population with limited options.

TARGETED ONCOLOGY: What were the key takeaways from KEYNOTE-055? Baumi: Patients with recurrent/metastatic head and neck cancer that is refractory to both platinum-based therapy and cetuximab (Erbitux) really have very few options. The historical reference population we usually use is patients treated with methotrexate, which has a response rate of 5% and an overall survival (OS) of only about 6 months. There is a really great need for this. For pembrolizumab, which is an anti–PD-L1 agent, there is biologic rationale to think that it would be active in this patient population. PD-L1 and PD-L2 are unregulated in head and neck cancer.

What KEYNOTE-055 did is really try and create a homogenous patient population. Rather than a large phase I study, here are patients all who have failed both platinum-based therapy and cetuximab. We have really identified the sickest patient population.

What we are able to show in this study was that the drug was well tolerated and it has a response rate of 17% to 18%, which compares favorably for the 5% seen with the prior data with methotrexate. The OS rate was 8 months, which again compares very favorably to the 6 months seen with methotrexate. This was true, even though 85% of patients had received at least 2 prior treatments for head and neck cancer.

TARGETED ONCOLOGY: What did this study tell us about the safety of pembrolizumab in head and neck cancer?

Baumi: The rate of grade 3 through 5 treatment-related adverse events was 12% in our study. Nearly all of the side effects are what you would expect with pembrolizumab; those have been reported in multiple other studies. There was 1 treatment-related death due to pneumonitis, which is a rare side effect of this class of drugs.

Outside of that, it was a really well-tolerated agent. The fact that if you compared grade 3 through 5 toxicities of 12% with cytotoxic chemotherapy, this is a very well-tolerated agent.

TARGETED ONCOLOGY: How common is it for patients to fail both platinum-based therapy and cetuximab?

Baumi: Any patient who has recurrent or metastatic head and neck cancer is going to go through these agents if they survive long enough to get them. Basically, we know that these are the limited tools in our toolbox. We have platinum, we have cetuximab, and then we are really out of options. Many patients have received cetuximab in the locally advanced setting and so we have already lost one of our active treatments. This affects a lot of people.

TARGETED ONCOLOGY: What is next for pembrolizumab in head and neck cancer?

Baumi: There are currently phase III studies evaluating pembrolizumab in head and neck cancer both in combination with and versus traditional cytotoxic chemotherapy to see if we can move up the treatment earlier for patients. The key difference between pembrolizumab and cytotoxics is beyond the improved safety profile. However, we have durable responses; 75% of those patients who responded are still responding to this day. That is really not something that we see.

TARGETED ONCOLOGY: What are the biggest questions that remain regarding the treatment of patients with metastatic head and neck cancer?

Baumi: One of the key questions that relates to immunotherapy—and this covers all tumors—is trying to identify who the 20% of patients are that will respond. Eighty percent of our patients are not responding to our therapies.

Identifying a biomarker to enrich this patient population is very critical. Right now, I would not select patients for pembrolizumab by virtue of PD-L1 status because there were responses in the PD-L1–negative cohorts.

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

September, 2016|Oral Cancer News|

Expert says Nivolumab Poised to Change Standard of Care in SCCHN

Source: www.onclive.com
Author: Laura Panjwani


Nivolumab (Opdivo) is a game-changing agent for the treatment of patients with squamous cell carcinoma of the head and neck (SCCHN), according to Robert L. Ferris, MD, PhD.

“Recent findings have shown us that this agent is really the new standard-of-care option for all platinum-refractory patients with head and neck cancer,” says Ferris, vice chair for Clinical Operations, associate director for Translational Research, and co-leader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute. “This is regardless of whether patients are PD-L1–positive or negative or whether they are HPV-positive or negative.”

The PD-L1 inhibitor received a priority review designation by the FDA in July 2016 based on the CheckMate-141 study, which demonstrated a median overall survival (OS) with nivolumab of 7.5 months compared with 5.1 months with investigator’s choice of therapy (HR, 0.70; 95% CI, 0.51-0.96; P = .0101) in patients with recurrent or metastatic SCCHN.

The objective response rate (ORR) was 13.3% with nivolumab and 5.8% for investigator’s choice. The FDA is scheduled to make a decision on the application for the PD-1 inhibitor by November 11, 2016, as part of the Prescription Drug User Fee Act.

Ferris was the lead author on an analysis that further evaluated preliminary data from CheckMate-141, which was presented at the 2016 ASCO Annual Meeting. In an interview with OncLive, he discusses the findings of this study, potential biomarkers for nivolumab, and questions that remain regarding the use of the immunotherapy in SCCHN.

OncLive: What were the updated findings from CheckMate-141 presented at ASCO?

Ferris: The data that were presented at the 2016 ASCO Annual Meeting were further evaluations and follow-up on some preliminary data—originally presented at the 2016 AACR Annual Meeting—that listed the OS results.

At ASCO, we recapped the primary endpoint of OS as an important endpoint for immunotherapies because response rate and progression-free survival may not be as accurate. Ultimately, the FDA and people at large want OS. In this study, OS was 36% at 1 year in the nivolumab-treated arm and 16.6% in the comparator arm, which was investigator’s choice of single-agent chemotherapy, consisting of methotrexate, docetaxel, or cetuximab. In this phase III randomized trial, nivolumab was given in a 2:1 randomization: 240 patients received nivolumab and 120 received investigator’s choice.

Also at ASCO, we presented further evaluations consisting of what the regimens are in the comparator arm. There was about 20% each of docetaxel and methotrexate and 12% of cetuximab. Approximately 60% of the patients had prior cetuximab exposure and we stratified by cetuximab as a prior therapy. We also demonstrated the ORR, which was 13.3% in the nivolumab-treated arm versus 5.8% in the investigator’s choice arm.

Therefore, there was an improvement in overall response, but the difference seemed more modest than the OS benefit—which was a doubling—with 20% more patients alive at 1 year. This reinforces the concept that perhaps response rate may not be the best endpoint. Progression-free survival (PFS) was double at 6 months, with about 20% in the nivolumab arm versus about 9.9% in the investigator’s choice arm. The median PFS was not different, but the 6-month PFS was twice as high. The time to response was about 2 months in each arm at the first assessment.

Your analysis also looked at biomarkers. Can you discuss these findings and their significance?

The p16 or HPV-positive group had a better hazard ratio for OS than the overall study population. The hazard ratio was .73 for the overall population, using a preplanned interim analysis. With the HPV-positive group, we had a hazard ratio of .55 and the HPV-negative group had a hazard ratio of .99. It is still favoring the nivolumab-treated patients but, with the curves separated earlier in the HPV-positive group, one could see the improvement with nivolumab at about 1 to 2 months. It took 7 or 8 months with the HPV-negative group to show a separation of the curves in favor of nivolumab.

We looked at PD-L1 levels, and PD-L1—using a 1% or above level—had an improvement in the PD-L1–positive patients in favor of nivolumab in terms of OS and ORR. When we looked at 5% and 10% thresholds of PD-L1, the OS did not seem to improve. Therefore, in all levels above 1%, the OS was similarly beneficial over the PD-L1 less-than-1% group. However, essentially all levels of PD-L1–positivity and PD-L1–negativity still favored nivolumab, but the benefit was more when its levels were greater than 1%.

We could combine HPV status with PD-L1 status and look at subsets; however, essentially every subset benefited, whether it was PD-L1–negative or positive. This indicates that, in this group of patients, who progress within 6 months of platinum-based therapy, that no current systemic therapeutic options benefit patients as well as nivolumab.

With regard to these findings, what are you most excited about?

Head and neck cancer is a difficult disease. Until recently, we didn’t know the impact of this enrichment for HPV-positive virus-induced subsets and we didn’t know if this was an immune responsive cancer. Clearly, it is. We have all of the hallmarks that we have seen for a bright future—based on the melanoma data—and a series of other cancers indicating response rates in the 15% to 20% range, suggesting that we now have a platform of the PD-1 pathway to combine with other checkpoints and to integrate earlier in disease with radiation and chemotherapy.

We have a demonstration of head and neck cancer as an immune-responsive cancer. We are beginning to get an idea of the biomarkers and starting to be able to segment patients who will benefit. Now, we have a large comparative trial with an OS endpoint and tissue to look at biomarkers to try and understand what the best future combinations will be.

What are some questions that you still hope to answer regarding nivolumab in head and neck cancer?

We have to get down deeper into the nonresponders. We should acknowledge that the majority of patients neither had a response nor benefited. Understanding who is more likely to benefit is useful, but we also need to understand the levels of alternative checkpoint receptors or other biomarkers of resistance.

We have sequential lymphocyte specimens from the peripheral blood, tissues, and serum so those are intensively under evaluation. There are interferon gamma signatures that have risen from the melanoma checkpoint field that will certainty be applied, as well.

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

August, 2016|Oral Cancer News|

Henry Schein Donates Medical Supplies In Support of Free Oral Cancer Screening Events throughout the United States

Source: www.mysocialgoodnews.com
Author: Api Potter

Company’s Donation to Support 77 Screening Events in 2016 and 2017 by the Oral Cancer Foundation

Press Release – MELVILLE, N.Y., July 25, 2016 – Henry Schein, Inc. (Nasdaq: HSIC) announced today that it is donating more than $10,000 in medical supplies to the Oral Cancer Foundation (OCF) in support of 77 free oral cancer screening events being held throughout the United States in 2016 and 2017. Each OCF-hosted event aims to boost awareness of the disease and increase early detection.

The Company’s donation of gauze, tongue depressors, and disposable dental mirrors, facemasks, and gloves is an initiative of Henry Schein Cares, the Company’s global corporate social responsibility program, and continues the Company’s support of OCF’s screening events. OCF hosts the events in a range of locations, including pharmacy parking lots, health fairs, farmer’s markets, colleges, and OCF Walk/Run for Awareness events.

“The health of our mouths greatly impacts our ability to eat and drink, communicate thoughts and ideas, and express feelings for loved ones,” said Brian Hill, Founder of the Oral Cancer Foundation. “When cancer affects our mouths, it does more than take away these everyday functions, it too often takes our lives. Our screening events are designed to identify signs of oral cancer before it ever gets that far, and we thank Henry Schein for this generous donation and its continued support of oral cancer awareness and early detection efforts.”

The donation comes at a time when nearly 500,000 people worldwide are diagnosed annually with oral and oropharyngeal cancer, according to data from the International Agency for Research on Cancer’s Globocan 2000 database and the World Health Organization’s Mortality Database. Of that number, between one-third and one-half lose their lives annually while many more suffer from the complications of treatment. Despite the easy accessibility to these body sites by health care providers and the overall impact early detection can have on a person’s overall health, more than two-thirds of these patients are diagnosed in advanced stages where the cancer has already spread to regional lymph nodes or beyond.

“Regular oral cancer screening events raise awareness and enhance early detection and prevention efforts, which are critical to reducing the disease’s incidence and impact,” said Steven W. Kess, Vice President of Global Professional Relations at Henry Schein. “Oral cancer is a stark reminder of the vital importance of good oral health in relation to a person’s overall health, and that’s why Henry Schein is pleased to support the Oral Cancer Foundation.”

Henry Schein’s donation continues the Company’s long-standing commitment to exploring ways of reducing the disease’s global impact. Earlier this year, the Henry Schein Cares Foundation, Inc.—an independent 501(c)(3) organization founded by the Company to foster, support, and promote dental, medical, and animal health by helping to increase access to care in communities around the world—funded the Global Oral Cancer Forum. The Forum gathered many of the world’s foremost experts on oral cancer, as well as clinicians, scientists, epidemiologists, activists, public health experts, nonprofit organizations, government agencies, and other stakeholders who are working to understand how to reduce the global oral cancer burden.

About Henry Schein Cares

Henry Schein Cares stands on four pillars: engaging Team Schein Members to reach their potential, ensuring accountability by extending ethical business practices to all levels within Henry Schein, promoting environmental sustainability, and expanding access to health care for underserved and at-risk communities around the world. Health care activities supported by Henry Schein Cares focus on three main areas: advancing wellness, building capacity in the delivery of health care services, and assisting in emergency preparedness and relief.

Firmly rooted in a deep commitment to social responsibility and the concept of enlightened self-interest championed by Benjamin Franklin, the philosophy behind Henry Schein Cares is a vision of “doing well by doing good.” Through the work of Henry Schein Cares to enhance access to care for those in need, the Company believes that it is furthering its long-term success. “Helping Health Happen Blog” is a platform for health care professionals to share their volunteer experiences delivering assistance to those in need globally. To read more about how Henry Schein Cares is making a difference, please visit our blog: www.helpinghealthhappen.org.

About Henry Schein, Inc.

Henry Schein, Inc. (Nasdaq: HSIC) is the world’s largest provider of health care products and services to office-based dental, animal health and medical practitioners. The Company also serves dental laboratories, government and institutional health care clinics, and other alternate care sites. A Fortune 500® Company and a member of the S&P 500® and the Nasdaq 100® indexes, Henry Schein employs nearly 19,000 Team Schein Members and serves more than one million customers.

The Company offers a comprehensive selection of products and services, including value-added solutions for operating efficient practices and delivering high-quality care. Henry Schein operates through a centralized and automated distribution network, with a selection of more than 110,000 branded products and Henry Schein private-brand products in stock, as well as more than 150,000 additional products available as special-order items. The Company also offers its customers exclusive, innovative technology solutions, including practice management software and e-commerce solutions, as well as a broad range of financial services.

Headquartered in Melville, N.Y., Henry Schein has operations or affiliates in 33 countries. The Company’s sales reached a record $10.6 billion in 2015, and have grown at a compound annual rate of approximately 15 percent since Henry Schein became a public company in 1995. For more information, visit Henry Schein at www.henryschein.com, Facebook.com/HenrySchein and @HenrySchein on Twitter.

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

Knowledgeability, Attitude and Behavior of Primary Care Providers Towards Oral Cancer: a Pilot Study

Source: www.link.springer.com
Authors: Neel Shimpi, Aditi Bharatkumar, Monica Jethwani, Po-Huang Cyou, Ingrid Glurich, Jake Blamer, Amit Acharya


The objective of this study was to assess current knowledgeability, attitudes, and practice behaviors of primary care providers (PCPs) towards oral cancer screening. Applying a cross-sectional design, a 14-question survey was emailed to 307 PCPs practicing at a large, multi-specialty, rurally based healthcare system. Survey data were collected and managed using REDCap and analyzed applying descriptive statistics. A 20 % response rate (n = 61/307) was achieved for survey completion. Approximately 70 % of respondents were physicians, 16 % were nurse practitioners, and 13 % were physician assistants. Nearly 60 % of respondents were family medicine practitioners. Limited training surrounding oral cancer screening during medical training was reported by 64 %. Although 78 % of respondents reported never performing oral cancer screening on patients in their practice, >90 % answered knowledge-based questions correctly. Frequency rate for specialist referral for suspicious lesions by PCPs was 56 % “frequently”. Optimal periodicity for oral cancer screening on all patients selected by respondents was 61 % “annually”, 3 % “every 6 months”, 3 % “every visit”, 2 % “not at all”, and 31 % “unsure”. This study established a baseline surrounding current knowledgeability, practice patterns, and opinions of PCPs towards oral cancer screening at a single, large, regional healthcare system. In the absence of evidence-based support for population-based cancer screening, this study result suggests a need for better integration of oral cancer surveillance into the medical setting, supplemented by education and training with emphasis on assessment of high-risk patients to achieve early detection. Prospectively, larger studies are needed to validate these findings.

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

July, 2016|Oral Cancer News|

Rodeo Competitors Fight Smokeless Tobacco Use at Laramie Jubilee Days

Source: www.y95country.com
Author: Nick Learned

Cody Kiser and Carly Twisselman

Two professional rodeo contestants will ride exclusively for the Oral Cancer Foundation this weekend as part of Laramie Jubilee Days with a goal of preventing young fans from using smokeless tobacco.

Cody Kiser and Carly Twisselman each aim to show rodeo fans, particularly the younger ones, chewing or using other forms of smokeless tobacco isn’t what makes them who they are. They promote the Foundation’s campaign which uses the slogan “Be Smart. Don’t Start.”

Their approach is anything but confrontational or aggressive. Rather than encouraging people to quit, they hope to encourage young fans to never pick up the habit in the first place. And where some rely on statistics to make the point, Kiser and Twisselman take a different approach. Simply giving attention to young rodeo fans is a big part of getting their message across.

“Its not the facts that they’re going to take home,” Kiser says. “Everybody knows that tobacco’s bad; you can get cancer and you can die. But the biggest impact that I see is just acknowledging those kids or acknowledging those people in the audience that want to know more, and you can show them what you can do without tobacco.”

“I’m not out there to tell anybody how to live their life or preach to them about needing to quit,” Kiser says.

“It’s not our place to do that,” Twisselman says. “People most of the time aren’t going to listen when you tell them something like that anyway.”

The pair will be wearing Oral Cancer Foundation gear and handing out buttons, wristbands and bandanas bearing campaign messaging.

As they travel the rodeo circuit, Kiser and Twisselman each say they often see other riders use various types of smokeless tobacco such as chew and snuff.

“It’s very common,” says Kiser. “You see it everywhere.”

“One of my traveling partners, he started when he was in high school. He was just around it all the time,” says Kiser. “It was just the ‘cowboy’ thing to do, I guess.”

“A lot of people are very respectful about it,” Twisselman says. “They’ll see me in my shirt and be like ‘oh yeah, you represent the Oral Cancer Foundation’ and they’ll spit their chew out. I think that in itself is a positive side effect of it.”

“I think a large part of a lot of these cowboys is, it’s the cowboy thing to do, so they start doing it,” Kiser says. “And that’s where I want to step in and show the younger generation that you don’t have to chew to be a cowboy. You can be a cowboy athlete and not chew and treat your body as best you can, because what we do is very difficult and it’s hard on the body.”

“A lot of folks started when they young,” Kiser says. “And I’ve talked to guys who started chewing later in life and they can’t quit, or it’s hard for them. It’s a vicious thing.”

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

Rodeo outreach program fights oral cancer

Source: www.olivesoftware.com
Author: Stewart M. Green


Carly Twisselman, a spokesperson with the Oral Cancer Foundation’s rodeo outreach program, and her horse Chanel travel the Western rodeo circuit and talk with kids about the dangers of using spit tobacco. Photo by Stewart M. Green

Carly Twisselman brushed her horse Chanel outside a stall at the Norris-Penrose Event Center, home of the Pikes Peak or Bust Rodeo, which will roll into town July 13-16. “I’ve been rodeoing my whole life,” she said. “Now I do it at the professional level. This is my rookie year so I’m going really hard. I want to win the rookie title.”

Summer is the busiest time of the year for cowgirls and cowboys. “We call it Cowboy Christmas, the 4th of July run,” she said. Twisselman and her travel partner have recently competed in Utah, Nevada, Arizona, New Mexico, and just drove up from Pecos, Texas, to Colorado Springs for qualifiers. “It’s a crazy time,” she said. “Lots of traveling, but lots of money to be won.”

Twisselman, a 30-year-old barrel racer, grew up on a ranch near San Luis Obispo on the central California coast. “My family’s been ranching there for seven generations,” she said. “I was on the back of a horse all the time. I was riding before I could walk.”

While growing up in the Western ranching and rodeo culture, Twisselman was aware of the widespread use of spit tobacco by cowboys. “I’ve been around it my whole life and seen a lot of things that were negative and I was affected by it.”

Rodeo and tobacco have a long history together. Starting in 1986, the U.S. Smokeless Tobacco Company sponsored the Professional Rodeo Cowboys Association until the association ended its partnership with tobacco advertisers in 2009. Tobacco use, however, still thrives with cowboys and spectators at rodeos.

In 2014, the Oral Cancer Foundation, a nonprofit organization that supports prevention, education and research of oral cancer, reached out to pro rodeo athletes to spread the word about the dangers of tobacco use, with Cody Kiser, a bareback bronc rider, as their first rodeo spokesperson. This past year they added Carly Twisselman to continue creating awareness in the rodeo community.

“Honestly, it was God that they came to me,” said Twisselman. “Their goal was to reach rodeo people, people in the Western culture and people that were horse lovers because tobacco is a huge problem in rodeo.” The foundation asked Twisselman to be a spokesperson and she gladly accepted. “It’s an amazing thing to represent such a great organization. I can take this rodeo platform where I’m in front of thousands of people and use it for good.” While the Oral Cancer Foundation wants to help adults with tobacco problems, its rodeo focus is on children. According to The Centers for Disease Control and Prevention, 9.9 percent of high school-age boys use spit tobacco nationwide, while 10.5 percent of men ages 18-25 use it. Usage is higher in rural states like Wyoming, Montana and West Virginia. A can of spit tobacco packs as much nicotine as 40 cigarettes, and a 30-minute chew is like smoking three cigarettes, making addiction to spit tobacco one of the hardest to break. Spit tobacco, including smokeless tobacco, dip, snuff, chew and chewing tobacco, can cause gum disease, tooth decay and oral cancer. Almost 50,000 people will be diagnosed with oral cancer in 2016.

“We aren’t telling people they should stop,” Twisselman said, “but we show people why it’s not good to use tobacco. If someone is chewing, I’m not going to go lecture them.”

Twisselman and Kiser focus on helping kids make positive choices about tobacco use. “Kids look up to us as idols and if they see us doing good and not chewing tobacco then maybe they won’t either,” Twisselman said. “Our message is: ‘Be Smart, Don’t Start.’”

Twisselman also attends junior rodeos where she hands out wristbands, bandanas, pins, and buttons. “Kids love the freebies,” she said. She also wears Oral Cancer Foundation logos on her competition shirts.

Surprisingly, some rodeo women chew tobacco. “It’s not the problem it is with the men,” Twisselman said, “but I do see it. I find it really repulsive. Sometimes women who chew will see me and say, “Oh, you work with oral cancer” and they’ll take their chew out and throw it away because they don’t want to be disrespectful to me.”

Twisselman said she and Kiser are making a difference, noting people are becoming more educated about the dangers of throat cancer from chewing tobacco and learning that it’s not a healthy habit. “We’ve only been doing this for a year now and we’re still getting our feet wet,” she said. “It’s hard to know if fewer kids are chewing now but I’m getting the word out and interacting with them. Because we take the time to talk with kids and give them the little gifts, it has a huge impact on them.”

To learn more about oral cancer and its prevention, medical research, education and for patient support, then visit oralcancer.org.

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

Rodeo rider partners with nonprofit group to fight smokeless tobacco use

Source: www.fox13now.com
Author: Rebecca Cade

SALT LAKE CITY — Oral cancer is becoming an epidemic in the U.S., and has been in the news in the last year with the loss of major league baseball hall-of-famer, Tony Gwynn, who died at 54 from smokeless tobacco use.

Rodeo has a historic tie to smokeless tobaccos, and Oral Cancer Foundation, has teamed up with Bareback Rider Cody Kiser to draw awareness to, and prevent, this growing epidemic where it thrives – the rodeo circuit.

Smokeless/spit tobacco is one of the historic causes of deadly oral cancers, and is more addictive than other forms of tobacco use.

The nonprofit is seeking to spread awareness of oral cancer and the dangers of starting terrible tobacco habits. While others are focused on getting users to quit, The Oral Cancer Foundation is reaching out to young people to not pick up the habit that they may see one of their rodeo “heroes” engage in.

Their message is simple, “Be Smart. Don’t Start.”

With the strong addictive powers of smokeless tobacco, the foundation and Kiser aim to engage fans early.

At the rodeos, Kiser will be solely wearing OCF logos and wording, while handing out buttons, wristbands and bandanas with the campaign messaging on them. The bareback rider hopes this will make him an alternative positive role-model for the adolescent age group whose minds are so easily molded.

“It’s something I’ve always been passionate about, so when I got into the partnership with OCF, it was no big deal to be able to say ‘I don’t smoke or chew, never have, and it’s easy not to,'” Kiser said.

Kiser added it all starts with kids.

“Most of these guys I ride with started smoking and chewing in sixth or seventh grade,” he said. “So, if we can get to those kids now, and tell them ‘you don’t have to do this to be cool or be a cowboy’ and show them what you can do without it.”

More information on the campaign can be found at www.oralcancer.org

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