Author Archives: Nawa Arsala

Federal Investigation on Potential Link Between Artificial Turf and Cancer

By: Nawa Arsala

After years of concern from athletes, their parents and coaches, a federal investigation on the potential link between artificial turfs and cancer has commenced. The Environmental Protection Agency, the Consumer Product Safety Commission and the Centers for Disease Control and Prevention will work together to research “whether crumb rubber, as part of an artificial turf field or as playground fill, is safe for their children to play on.”

Artificial turf, also known as synthetic turf, is a popular alternative to grass fields. It provides a consistent year-round, durable, all-weather playing surface with very low maintenance.  Crumb rubber, which is what is used in artificial turfs, is made from scrap car and truck tires that are ground up and recycled.

In a letter to President Obama, Senators Blumenthal and Nelson, asked for a comprehensive study of the correlation between the crumb rubber in cancer. The Senators cited extensive research from University of Washington soccer coach Amy Griffin. Her research found that 153 reported cancer cases involving athletes spent significant periods of time playing on crumb rubber turf.  Of those cases, 124 were soccer players, 85 of whom were goalies. Moreover, of the types of cancers, blood cancers like lymphoma and leukemia were the most diagnosed.

The investigation, known as the Federal Research Action Plan on Recycled Tire Crumb Used on Playing Fields and Playgrounds, will test different types of tire crumb and work with scientists to evaluate the potential cancer toxicity of various chemicals. The task force will meet with athletes, parents, coaches and industry representatives directly to get fire-hand perspectives on the potential exposures. According to the Synthetic Turf Council, “crumb rubber has been critically examined and studied since the late 1980’s. Science has proven it to be safe for children and people of all ages.”

Further, the task force hopes that by the end of 2016, a draft status report will identify the key constituents of concern, and an initial evaluation of potential cancer and non-cancer toxicity of key chemical constituents.

Although we have to wait until the end of the year for the federal hypothesis, there are many independent reports with plausible theories. One popular theory by chemical engineer Stewart D. Simonson, is that the increased cancers by athletes on artificial turf fields are due to “repeated electrostatic charge  buildup and electrical discharge due to triboelectric effects from the crumb rubber turf and  plastic blades of grass in contact with player’s skin and jerseys.” Further, as goalies have a higher incidence of cancer, it can be attributed to their repeated dives into the turf, which increases their electric charge due to an exchange of electrons between the grass and rubber fill material and the players.

As of late last year, more than 50 counties and cities in 17 states have reassessed their approach to crumb rubber turf. Montgomery County, Maryland, a suburb right outside Washington, banned new artificial turfs this year in a resolution for the “Use of Plant-Derived Materials for Infill in Artificial Turf.” Several surrounding counties, including Fairfax County, VA, have also enacted petitions to follow Montgomery County’s unanimous decision. Until these changes are made, many parents across the nation have chosen to not allow their children to play on artificial fields.

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Tragedy Strikes Clinical Trial

By: Nawa Arsala

A volunteer participating in a clinical trial in France died last week, while five more remain hospitalized in critical condition. On January 17th, the Portuguese company Bial conducting the trial issued a press release confirming the death of the volunteer at the University Hospital of Rennes, while the remaining five could be permanently disabled due to neurological damage.

The drug being tested, which has been referred to as BIA 10-2474, is a painkiller meant to treat anxiety and motor disorders. A major public health issuing plaguing the United States today is addiction to pain relief drugs, therefore, there is a great need for non-addictive drugs in this therapeutic area. Study-provided documents explained that the drug in development was for “the treatment of different medical conditions from anxiety to Parkinson’s disease, but also for the treatment of chronic pain of sclerosis, cancer, hypertension or the treatment of obesity.”

The drug was intended to work on the body’s endogenous cannabinoid system, which deals with pain. Simply put, the drug should have stimulated the same receptors as the active components of marijuana. Bial believes that the drug has the potential to reduce pain and anxiety, among other neurological conditions. Earlier reports said the drug was related to cannabis, but Bial maintains that it does not contain cannabis or cannabis extracts.

The trial was run by the clinical research organization, Biotrial. Clinical research or contract research organizations, provide support and various services for pharmaceutical companies through various stages of drug development. In this case, the French company Biotrial ran the Phase I trial. In the European Union, this stage is the first time the drug is tested in humans. Generally during this stage, trials are conducted on healthy volunteers and are intended to see how the body responds to various dosages of the drug. As this trial began in July, it is likely this accident could have been a result of an increased dosage. This phase is not intended to test the effectiveness of the drug, but rather to see if there are any side effects. Phase II is intended to test for effectiveness, and Phase III increases the volunteer pool and compares the effectiveness to a placebo. In this case, 90 volunteers were given the drug. All of the volunteers were men, ranging from 28 to 49 years old. Further, there were an additional 38 volunteers who received placebo, which is considered highly unusual in a Phase 1 trial, since the purpose is to test safety, not effectiveness.

The trial has been suspended and the Paris prosecutor’s office has opened an investigation. The health minister of France Marisol Touraine said she has “no knowledge of a comparable event.” Bioethicists around the world have called into questions the consent of the volunteers.  The most vital aspect of human research is the ability for the volunteer to give informed consent. As many volunteers in clinical trials are compensated, many Phase I volunteers could be poor and easily exploited, as ascertained by bioethicist Carl Elliott.

The tragedy in Paris was truly unprecedented. With countless diseases vying for medications, the clinical trial process is vital for innovation. Although lives were lost in this instance, volunteers in clinical trials have saved innumerable of lives throughout history.

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Balancing a 5,455% Drug Price Increase with Innovation

By: Nawa Arsala

In a widely-criticized and controversial move, Martin Shkreli of Turing Pharmaceuticals increased the price of the drug Daraprim from $13.50 a tablet to $750. That is 5,455% more expensive than it was only two months ago. The seemingly overnight price increase has caused waves in the political arena, the pharmaceutical industry, and the financial market.

Daraprim is approved by the Food and Drug Administration to help prevent malaria and treat toxoplasmosis, an infection caused by a parasite. It is also used to prevent other kinds of infections, at the discretion of doctors. Although these uses are not explicitly included in Daraprim’s approved labeling by the FDA, doctors are able to prescribe as they see fit, which is known as off-label usage. Courts have deemed that off-label usage by doctors is permissible, and constitutes the practice of medicine. Some of these off-label uses include treating opportunistic infections of HIV. Moreover, Daraprim is also used on cancer patients on chemotherapy, whose immune systems are weakened and get infections. This can explain the outcry from patient advocates, claiming that Turing has raised the prices of a “cancer drug” or a “HIV drug.”

Martin Shkerli, CEO of Turing, has had a rocky and controversial history in the pharmaceutical industry. He began vilifying certain small drugmakers online, while simultaneously selling their stock short. This means that he’d profit if share prices fell. Many in the industry found this behavior as sneaky. In 2011, Shkreli founded the biotech firm Retrophin, which focused on medicines for rare, life-threatening diseases, and orphan drugs. Eventually, Shkreli was publically ousted and sued for arranging a series of backdoor deals using company cash and stock. Shkerli has since countersued demanding that Retrophin pay Shkreli more than $70 million reflecting company stock he’s owed and damage to his image as a businessman. 

In the case of Daraprim, Shkerli argues that the price is actually to the benefit of the patients in the long run because innovation is necessary. The Food & Drug Administration also tends to agree, granting market exclusivity to encourage innovation. Shkerli ascertains that only 2,000 people in the United States are prescribed Daraprim every year. Moreover, while many other life-saving drugs must be taken for life, Daraprim only needs to be taken for about six weeks. He believes this drastically reduces the cost for the drug because only one course is needed. Nonetheless, this could explain why there is currently no generic version, as there is not a substantial financial incentive to manufacture Daraprim to produce a drug that only needs one course, and for so few patients.

The pharmaceutical market has long been a hot-button political issue because it is where a free market economy and public health must agree. There is rising criticism over the cost of health care in general, and particularly drugs. With the upcoming presidential elections, many potential candidates are weighing in on Shkerli’s decision. Democratic presidential candidate Hillary Clinton said “price gouging like this in the specialty drug market is outrageous.” Vermont Senator Bernie Sanders took it a step further by sending a letter to Mr. Shkerli, requesting more information about the drug hike. Shkerli has yet to respond to the letter and Sanders believes he is “holding hostage the patients who rely on this lifesaving medication, as well as the hospitals that administer it, by charging unconscionable prices for a drug on which he has a monopoly just because he can.” Public outcry has called for antitrust laws to remedy the price increase. However, under U.S. antitrust law, a unilateral price increase, when done in agreement or not in response to competition, is almost never actionable.

Ultimately, after worldwide criticism, Shkreli promised to lower the price of the drug. To date, that lowered price remains unspecified. Ed Painter, a spokesperson for Turing Pharmaceuticals recently explained that more than half of Daraprim’s sales “continue to participate in federal and state programs such as Medicaid” and a drug discount program, that often lead to costs that are “as low as $1 per bottle.” Nonetheless, almost four weeks after Shkerli made this promise, the price remains the same. It is important to note that Turing is part of a growing trend of price increases in pharmaceuticals that include massive manufacturers such as Pfizer, Merck and Valaent. Shkerli’s latest response to the backlash was “there have been hundreds of companies that have raised [their drug prices] higher, and they’re not rolling back their prices, so why should we?”

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Pharmaceutical Company Preemptively Files Free Speech Suit Against The FDA

By: Nawa Arsala

Free speech is fundamental to the fabric of the United States. Americans fight for it zealously, regardless of the context, from political contributions to cartoon drawing contests. This battle has extended to the pharmaceutical industry. In an unconventional move, a small, Dublin-based pharmaceutical company, Amarin, filed suit against the Food & Drug Administration arguing that it has a constitutional right to share certain information about its product with doctors for unapproved uses.

The FDA approved Amarin’s drug Vascepa in 2012. It is a prescription form of fish oil that is used along with a low-fat and low-cholesterol diet, to lower high levels of triglycerides (fats) in adults, which is linked to heart disease. After the drug’s approval, Amarin requested permission to give doctors information regarding a study that showed Vascepa can reduce the triglyceride levels in less-severely affected patients, not just high-risk patients. The FDA ultimately rejected their request. Amarin’s issue is that many doctors already prescribe Vascepa to patients who do not have abnormally high triglyceride levels. The discretion of the physician to prescribe for an off-label use is perfectly legal and has been deemed the practice of medicine, which the FDA does not have jurisdiction to regulate. Manufacturers on the other hand, cannot promote for off-label uses.

Amarin wants to send doctors clinical trial data they described as “supportive but not conclusive research” that their drug could reduce the risk of heart disease in patients with less severe conditions than were initially approved for. The FDA denied Amarin’s request to share this information with doctors, and Amarin filed their suit. The FDA found that the “hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among” individuals with less severe symptoms, failed to be proven in clinical trials. Nonetheless, Amarin feels its First Amendment right is being infringed upon by not being able to share this use with doctors. Amarin has not been accused of wrong-doing by the FDA yet, but they are possibly the first pharmaceutical company to sue the FDA preemptively. This could be because dietary supplement forms of fish oil are legally permitted to make the same statement without such rigorous regulation by the FDA. However, there seems to be increased regulation of dietary supplements as well after several injuries have been reported using weight loss supplements.

In a private letter to physicians who are paid to speak on behalf of its company, Amarin writes, “if we receive a judgement in our favor, we will move rapidly to deliver to you additional Company-approved training and updated promotional speaker materials related to the court’s interpretation of free speech related to the ANCHOR results.” In reality, free speech is not as romantic as the founding fathers would have hoped, especially in closely regulated markets such as the pharmaceutical industry. Courts consider several factors in determine if the government is infringing on First Amendment rights including, whether a substantial governmental interest being asserted, whether the regulation directly advances that interest and whether it is not more extensive than necessary.

Amarin may look to a fairly recent case in which a pharmaceutical sales representative’s conviction was overturned because the information he shared was not false or misleading. As a matter of fact, Amarin’s attorney ascertains precisely that, that the clinical trial data is truthful and not misleading. The U.S. Department of Justice and State attorney generals have increasingly used the Federal False Claims Act as an enforcement mechanism against health care fraud. The government believes that by promoting off-label uses, the manufacturers caused pharmacies to falsely claim Medicaid payment for drugs in ways unapproved by the FDA. Amarin is at risk for violating the FCA if they proceed in sharing the data directly to the doctors.

Drugs have and continue to save countless lives. The FDA has the duty, through a rigorous preapproval process, to ensure drugs are safe and effective before they are on the market. However, it is the stance of Amarin, that since off-label usage is already so commonplace by physicians and legal, providing more information, rather than less, is safest for the patient to promote overall health and more informed decision-making by physicians.

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