CreakyJoints Under Scrutiny for Ties to Drug Makers 

By Pat Anson, PNN Editor

Patient advocacy groups are coming under scrutiny again for their financial ties to drug companies. The latest is the Global Healthy Living Foundation (GHLF), a non-profit charity that created CreakyJoints, a website and social media platform that raises awareness about arthritis and other chronic illnesses. 

According to Bloomberg News reporter Ben Elgin, the foundation and CreakyJoints have long had a cozy relationship with Pfizer, Amgen, Johnson & Johnson and other corporate donors. Pfizer has donated nearly $1 million to the foundation over the past decade and one of its vice-presidents even serves on GHLF’s board of directors.

In a speech to drug makers in 2010, GHLF president Seth Ginsberg reportedly sought their donations -- while at the same time promising the companies “higher profits” and “sales rep participation in our programs.”

Ginsberg, who was diagnosed with spondyloarthritis as a teenager, co-founded GHLF in 1999 with marketing executive Louis Tharp.

In addition to CreakyJoints, GHLF has two other “grassroots” programs, Fail First Hurts and the 50-State Network, which advocate for healthcare policies that often align with the interests of its donors.  

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According to GHLF’s 2017 tax return, the foundation had over $5 million in annual revenue. Ginsberg was paid a salary of $384,000, while Tharp received $220,000 as Executive Director.  Nearly $300,000 was also paid to a for-profit marketing company established by the two men, although it’s unclear what the payment was for.

Bloomberg reported that GHLF’s tax returns “reflect errors and unexplained entries that have obscured the amounts of money flowing to its cofounders.”

“Are they operating in a way that is extremely transparent? It’s safe to say they’re not,” Brian Mittendorf, a professor of accounting at Ohio State University told Bloomberg. “From looking at their disclosures, you have no idea how closely they’re related to some of the entities it pays.”

At least one GHLF board member and several patient volunteers reportedly left the organization because they were troubled by its relationships with donors.

GHLF did not grant an interview to Bloomberg, but replied to questions in writing.

“The only time we engage in advocacy is when it helps patients. If it doesn’t help patients, we don’t do it,” the foundation said in a statement. “Our mission is to engage in patient-centered research, provide advocacy for access-to-care, and to support people living with chronic disease by providing a supportive environment and accessible education.”

In a related story, Bloomberg reported that several other recently formed non-profits – such as the U.S. Rural Health Network --  appear to be little more than front organizations for the pharmaceutical industry.

“There are a number of groups created by pharma companies that look and act like patient organizations, but they’re 100 percent funded by industry,” said Marc Boutin, chief executive officer of the National Health Council. “They sound and look like patient organizations, but they take positions that industry wants.”

Drug Companies Fined for Co-Pay Programs

Last week two drug companies agreed to pay $125 million in fines to settle allegations that they used charitable foundations as front organizations to bilk Medicare.

Amgen and Japanese drug maker Astellas Pharma paid the foundations to establish co-pay prescription drug programs for Medicare patients. Federal prosecutors say the programs were primarily designed not to help patients, but to illegally pay their co-pays for Astellas and Amgen products.

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Federal anti-kickback laws prohibit pharmaceutical companies from making any kind of payment to induce Medicare patients to purchase their drugs. The prohibition includes co-pays.

“The companies’ payments to the foundations were not ‘donations,’ but rather were kickbacks that undermined the structure of the Medicare program and illegally subsidized the high costs of the companies’ drugs at the expense of American taxpayers,” U.S. Attorney Andrew Lelling said in a statement.

“When pharmaceutical companies use foundations to create funds that are used improperly to subsidize the co-pays of only their own drugs, it violates the law and undercuts a key safeguard against rising drug costs,” said U.S. Assistant Attorney General Jody Hunt.

Last year, Pfizer paid nearly $24 million to settle allegations that it also used a co-pay program to pay Medicare for the company’s prescription drugs.

U.S. Pain Foundation Co-Pay

The U.S. Pain Foundation is under investigation by the U.S. Senate Finance Committee for a similar co-pay program established with Insys Therapeutics, a controversial Arizona drug company. Insys makes Subsys, an expensive and potent fentanyl spray blamed for hundreds of overdose deaths.

U.S. Pain received $2.5 million from Insys to launch the “Gain Against Pain” program, which ostensibly helped Medicare patients pay for drugs prescribed for breakthrough cancer pain. Critics say the program was primarily used to increase prescriptions for Subsys, which can cost $24,000 for just a four-day supply.

Former U.S. Pain CEO Paul Gileno initially defended the co-pay program, saying the money from Insys “does not influence our values,” but later resigned over allegations that he misappropriated $2 million from his own charity.

The Gain Against Pain program was subsequently shutdown in August 2018 and U.S. Pain said it would no longer accept funding from Insys.

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Sen. Ron Wyden (D-OR), the ranking member of the Senate Finance Committee, sent a lengthy letter last December to U.S. Pain interim CEO Nicole Hemmenway asking a series of questions about the Insys co-pay program. According to the senator’s office, Wyden has still not gotten a full response.  

“The U.S. Pain Foundation has yet to provide a substantial amount of the information that Senator Wyden requested in his letter. Staff is in communication with the organization in order to get to the bottom of the organization’s financial relationship with pharmaceutical manufacturers, including Insys, and its compliance with applicable federal laws,” a Wyden spokesperson said in a statement to PNN.

A federal jury in Boston is currently in its third week of deliberations in a criminal case against Insys founder John Kapoor and four former executives of the company, who are accused of bribing doctors to boost sales of Subsys. 

U.S. Pain also remains under investigation by the Connecticut Attorney General’s office for financial irregularities that led to Gileno’s resignation.

Migraine Costly to Workers and Employers

By Steve Weakley

Most employees who suffer from chronic migraine headaches miss nearly a full week of work (4.6 days) due to migraines each month, according to a large new online survey.

Amgen and Novartis surveyed over 11,000 migraine sufferers in 31 countries to demonstrate how painful and costly the condition can be for both workers and employers.  The My Migraine Voice survey included people who had four or more migraine days a month.

Eighty percent of the survey takers in the U.S. said their employers knew about their migraines, but only 21 percent said their bosses offered support and understanding. Nearly two-thirds (63%) said migraines impaired their work performance and many felt judged by co-workers as a result.

"From being afraid to speak up about their disease at work in fear of losing their jobs, to feeling judged by colleagues, the stigma around migraine in the workplace is an ongoing issue that the migraine community faces daily," said Mary Franklin, executive director of the National Headache Foundation, in a press release.

"The findings from the My Migraine Voice survey shed light on the true impact of migraine at work, and showcase the urgent need for employers and employees to change the dialogue around migraine."

According to one estimate, U.S. employers lose about $11 billion a year in missed work and lost productivity because of migraines.

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Amgen and Novartis presented the survey findings at the 60th annual meeting of the American Headache Society in San Francisco, to help stir up interest in their new injectable migraine drug, Aimovig (erenumab). The FDA recently approved the monthly self-injected drug for the prevention of migraine in adults.

Aimovig uses human antibodies to target brain receptors that are thought to trigger migraines. Three clinical trials demonstrated that the drug reduced the number of migraine days for sufferers by an average of 2.5 days per month.

One obstacle in getting people to try Aimovig is its price. Amgen say the drug will cost about $6,900 a year, or $575 for each monthly dose. Amgen holds the sales rights for Aimovig in the United States, Canada and Japan, while Novartis will sell the drug in Europe and the rest of the world.

Amgen is offering a migraine management program to several large U.S. employers. The program consists of an educational program as well as a research study to document the impact of migraine on worker absenteeism, presenteeism, healthcare utilization and costs. The wellness portion of the program includes webinars, email and website tips, and a  mobile app to track migraine symptoms.

FDA Approves Injectable Migraine Drug

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a monthly self-injected drug for the prevention of migraine in adults.

Aimovig (erenumab) is the first FDA-approved migraine treatment in a new class of drugs – known as fully human monoclonal antibodies -- that target receptors in the brain where migraines are thought to originate. It blocks the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks.

"The FDA approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine," said Sean Harper, MD, executive vice president of Research and Development for Amgen, which shares the licensing rights to Aimovig with Novartis.

The effectiveness of Aimovig for the prevention of migraine was evaluated in three clinical trials, which found that patients experienced one to 2.5 fewer migraine days per month compared to those who took a placebo. The most common side effects were irritation at the injection site and constipation. 

Like many specialized drugs used to treat chronic conditions, Aimovig comes with a hefty price tag. Amgen says the drug will cost about $6,900 a year, or $575 for each monthly dose.

Out-of-pocket costs will vary for patients depending on their insurance. Amgen has a co-pay program for Aimovig that could reduce the cost to as little as $5 per month for eligible patients.

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The company says Aimovig will be available to patients within one week.

"Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success," said Stewart  Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School. "Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy – with a discontinuation rate of two percent due to adverse events – and experienced sustained migraine prevention."

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraine than men.

About one-third of migraine sufferers can predict the onset of a migraine because it is preceded by an aura – a sensory or visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision. People with migraine tend to have recurring attacks, triggered by stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet.

Amgen and Novartis expect Aimovig to be approved in the European Union in the next few months. Amgen holds the sales rights for Aimovig in the United States, Canada and Japan, while Novartis will sell the drug in Europe and the rest of the world.

New Hope for Hard-to-Treat Migraine Patients

Amgen and Novartis have announced promising results from a Phase III clinical trial of an injectable new migraine drug called Aimovig (erenumab).

In a study of 246 patients with episodic migraine, significantly more patients injected with Aimovig had at least a 50 percent reduction in the number of monthly migraine days compared to a placebo. The study was the first of its kind to include hard-to-treat patients who have tried and failed at least two other migraine medications due to lack of efficacy or intolerable side effects.

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"We've purposely designed a clinical program for Aimovig that examined a broad spectrum of migraine patients, ranging from those who have never tried a preventive treatment to patients who have tried and failed such treatments," said Sean Harper, MD, executive vice president of Research and Development at Amgen.

"These data in patients with multiple treatment failures, who are not only considered difficult to treat but also have few options available, add to the consistent body of evidence for Aimovig.”

Aimovig belongs to a new class of medication – known as fully human monoclonal antibodies -- that target and block receptors in the brain where migraines are thought to originate. It is designed to be administered once a month with a self-injection device for migraine prevention.

"The results add to the consistent body of evidence for erenumab (Aimovig) across the full spectrum of migraine patients, from those trying preventive medication for the first time through to those who have failed multiple therapies and have been suffering for years,” said Danny Bar-Zohar, Global Head of Neuroscience Development for Novartis.

“We look forward to making erenumab, the first targeted preventive option specifically designed for migraine, available to patients as soon as possible."

Amgen and Novartis expect the Food and Drug Administration to make a decision on Aimovig in May. The two companies will share sales rights to Aimovig in the U.S. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize it in Europe and the rest of world.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

About half of people living with migraine are undiagnosed. Current medications to prevent migraines have been repurposed from other medical conditions, and are often associated with poor results.

Amgen Biologic Drug Approved by FDA

By Pat Anson, Editor

A new biologic drug may soon be available for rheumatoid arthritis patients and others who suffer from autoimmune diseases – if they can afford it and if the drug clears a patent challenge.

The Food and Drug Administration has approved Amgen’s Amjevita as a biosimilar to Humira for the treatment of rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and severe plaque psoriasis. 

“Approval of Amjevita is an exciting accomplishment as it marks a new chapter in Amgen’s story of being a leader in biotechnology. In addition, Amjevita holds the potential to offer patients with chronic inflammatory diseases an additional treatment option,” said Sean Harper, M.D., executive vice president of Research and Development at Amgen.

Amjevita is Amgen’s first approved biosimilar and the fourth to receive regulatory approval in the U.S.

“The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

A biosimilar is nearly identical to an already-approved biological drug and there is no clinically meaningful difference in terms of their safety, purity and potency. Unlike generic drugs, however, biosimilars are not considered interchangeable with their branded counterparts – and are not given the generic label.

Zarxio was the first biosimilar product approved by the FDA as a version of Neupogen. The second was Inflectra, a biosimilar to Remicade. Last month the FDA approved Erelzi as a biosimilar to Enbrel.

Biologic products are generally derived from a living organism and can come from many sources, including humans and animals. They help inhibit the joint damage caused by rheumatoid arthritis, a chronic disease in which the body’s own immune system attacks joint tissues, causing pain, inflammation and bone erosion.

Injectable biologic drugs often work well in controlling RA and other autoimmune diseases, but can lose their effectiveness over time. They are also notoriously expensive, with some of the newer drugs costing $20,000 annually. A study last year found that Medicare patients paid an average of $835 in out-of-pocket costs every month to obtain them.

Last year Humira generated sales of more than $8 billion for drug maker AbbVie. In anticipation of Amjevita being approved by the FDA, AbbVie filed a lawsuit against Amgen last month, alleging that Amjevita infringes on 61 of its patents for Humira.

Because of that pending court case, a spokesperson for Amgen told PNN the company would be unable to provide a launch date for Amjevita or a projected price for the drug.

The most serious side effects of Amjevita are infections and malignancies. The drug will have a "Boxed Warning" to alert healthcare providers and patients about an increased risk of serious infections leading to hospitalization or death. The warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including Humira (adalimumab) products.

Experimental Drug Reduces Migraine Days by Half

Pat Anson, Editor

An experimental injectable drug reduces the number of migraine days by 50 percent or more in patients who suffer from chronic migraine, according to the results of a new study released by drug makers Amgen and Novartis.

The Phase II study of AMG 334 -- also known as erenumab – involved 667 patients who suffered an average of about 18 migraine days per month.  A reduction of 50% or more in monthly migraine days was observed in four out of ten patients taking a 140 mg dose of erenumab. Patients taking a 70 mg dose had a 40% reduction in migraine days compared to a placebo drug. 

Significant improvements were also noted in quality of life, headache impact, disability, and pain interference compared to the placebo.

“Chronic migraine patients lose more than half of their life to migraines with 15 or more headache days a month, facing intolerable pain and physical impairment,” said Stewart Tepper, MD, a professor of neurology at the Geisel School of Medicine at Dartmouth. “As a neurologist, these findings are exciting because they demonstrate that erenumab could serve as an important new therapy option for reducing the burden of this often-disabling disease.”

Erenumab is not an opiate and falls under a newer class of medications – known as fully human monoclonal antibodies -- that target receptors in the brain where migraines are thought to originate.

“Erenumab is specifically designed to prevent migraine by blocking a receptor that is believed to have a critical role in mediating the incapacitating pain of migraine,” said Sean Harper, MD, executive vice president of Research and Development at Amgen, which is co-developing the drug with Novartis.

“The results from this global chronic migraine study are exciting because they support the efficacy of erenumab for a patient population that has had few therapeutic options.”

Results from two Phase III studies of erenumab for episodic migraine are expected later this year. If positive results are achieved, that could lead to a new drug application with the Food and Drug Administration.

"This is an exciting time in the treatment of chronic migraine, which has a profound impact on the lives of those who suffer from the disease," said Vasant Narasimhan, Global Head of Drug Development and Chief Medical Officer for Novartis. "These important data further support the efficacy of AMG 334 in patients who currently have limited therapeutic options."

Under its agreement with Novartis, Amgen holds sales rights for erenumab in the United States, Canada and Japan, while Novartis would sell the drug in Europe and the rest of the world.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

New Treatments Offer Hope to Migraine Sufferers

By Pat Anson, Editor

Findings from several new clinical studies could pave the way for new treatments that could someday prevent and lessen the severity of migraines.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. Although there are many treatment options available, most migraine sufferers are not fully satisfied with their effectiveness.

Teva Pharmaceuticals (NYSE: TEVA) is developing a new injectable drug – called TEV-48125 – that is designed to be injected monthly in chronic migraine sufferers who have headaches at least 15 days per month.

"Chronic migraine affects about 1 percent of all adults, yet less than 5 percent of those people receive a correct diagnosis and appropriate treatment," said study author Marcelo Bigal, MD, of Teva Pharmaceuticals. "Most people who receive preventive medication for chronic migraine stop using them, and one reason for that is the drugs can take a long time to become effective.”

In findings published online in the journal Neurology, Bigal reported that TEV-48125 was effective in reducing the length of headaches three to seven days after the first injection. The drug contains an antibody that blocks the calcitonin gene-related peptide that plays a role in migraine pain.

Teva’s Phase II study involved 261 people with chronic migraine who were divided into three groups; one group received a monthly shot for three months with a low dose of TEV-48125, the second group received a high dose and the third group received a placebo shot. Participants then used an electronic diary to record the number and length of their headaches.

After one week, the average number of headache hours went down by 2.9 hours for people taking the placebo, 9.1 hours for people taking the low dose of TEV-48125 and 11.4 hours for those taking the high dose.

After two weeks, the number of days with moderate or severe headaches, fell by 0.8 days for patients getting the placebo, 1.3 days for the low dose and 1.5 days for the high dose of TEV-48125.

“If these results can be confirmed with larger studies, this could be exciting for people with migraine," said Bigal.

Amgen Injectable Migraine Drug

Amgen (NASDAQ: AMGN) and Novaratis (NYSE: NVS) are also developing a monthly injectable drug --- called erenumab – which contains an antibody that blocks a peptide receptor that is believed to transmit migraine pain signals.

In a Phase II study, 667 chronic migraine patients were injected with a placebo or two different doses (70 mg or 140 mg) of erenumab. At the start of the study, patients were experiencing about 18 migraine days per month.

Patients who received erenumab at either dose experienced an average 6.6-day reduction in migraine days, compared to a 4.2-day reduction in those who receive a placebo. Less than five percent of the  patients treated with erenumab had a side effect, such as injection site pain, upper respiratory tract infection and nausea.

Erenumab is currently under evaluation in several large global, randomized, double-blind, placebo-controlled trials to assess its safety and efficacy in migraine prevention. Amgen expects results from a Phase III study of erenumab in the second half of 2016. Depending on the findings, that could result in an early new drug application to the Food and Drug Administration.  

Clinical studies presented this week at the annual meeting of the American Headache Society also highlighted some promising new migraine treatments.

Alder BioPharmaceuticals presented data showing that a single injection of a drug called ALD403 reduces migraine for up to six months. In a recent Phase II study of patients with chronic migraine, ALD403 significantly reduced migraines by 75 percent in up to a third of patients. 

“A 75 percent reduction in migraine days for these patients means a reduction of 12 or more migraine days each month,” said Jeffrey T.L. Smith, MD, Senior Vice President at Alder. “This equates to giving patients back roughly two weeks of their lives after a single administration.”

Researchers at Montefiore Medical Center and Albert Einstein College of Medicine reported results from a placebo controlled study on the efficacy of ubrogepant in treating a single migraine attack. Patients who received ubrogepant reported a reduction in headache severity from severe or moderate to mild or none within two hours.

Ubrogepant is free of known cardiovascular risk and may provide an important treatment option for patients who suffer from cardiovascular disease. 

Migraine affect three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.

FDA Approves Migraine Drug for Children

By Pat Anson, Editor 

Millions of children who suffer from migraine headaches have a new treatment option -- an old drug that's already available to adults. 

The Food and Drug Administration approved Treximet for pediatric patients 12 years of age and older for the treatment of migraine with or without aura. Treximet is the first approved combination prescription drug for migraine to contain sumatriptan and naproxen, a non-steroidal anti-inflammatory drug (NSAID). Sumatriptan is a triptan that works in the brain by reducing vascular inflammation. 

About 20 percent of all pediatric patients 11 years and older suffer from migraine, but treatment options have been limited, compared to adults. 

“Until now, pediatric migraine sufferers have not had the same number of treatment options compared to adults to manage the potentially debilitating effects of acute migraine,” said Merle Lea Diamond, MD, president and managing director of the Diamond Headache Clinic and a consultant to Pernix Therapeutics (NASDAQ: PTX), which developed Treximet. Pernix expects Treximet to be available for pediatric patients in the third quarter of 2015.  

“As many as one out of five teens suffers from migraines, and their burden goes well beyond the pain, as migraines can also adversely affect their social growth and their efforts in school,” said Diamond. 

FDA approval came after a Phase III safety and efficacy study that found Treximet was significantly more effective than placebo in treating migraine in pediatric patients and has a safety profile similar to that of Treximet for adults. It comes with a black box warning of cardiovascular and gastrointestinal risks. 

The FDA approved Treximet for adults in 2008. The FDA set a priority review of Treximet for pediatric patients, in part, on the need for more treatment options for younger migraine sufferers.  

Amgen Migraine Drug 

Meanwhile, Amgen (NASDAQ: AMGN) announced the first results from a Phase II study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine.

The  company said the study met its primary goal of reducing monthly mean migraine days compared with placebo.  The data were presented at the International Headache Society in Valencia, Spain.

AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine by inhibiting a peptide receptor that is believed to transmit signals that can cause incapacitating pain.  

In the trial, 483 patients who averaged 8.7 migraine days per month prior to the study had their number of migraine days nearly cut in half by taking AMG 334.

"Migraine is a complicated, underdiagnosed neurological condition that has significant impact on the everyday activities of those who live with it, and for the millions of people around the world who are affected by this disease, significant unmet therapeutic need persists," said Sean Harper, MD, executive vice president, Research and Development at Amgen. "We are encouraged by these Phase 2 data, which further validate AMG 334 as a potential preventive treatment for episodic migraine."

Migraine is thought to affect a billion people worldwide and about 31 million Americans adults. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. About half of people living with migraine are undiagnosed.