Science Policy For All

Because science policy affects everyone.

Breast cancer screening: How do we maximize benefit while minimizing harm?

leave a comment »

By: Catherine Lerro, Ph.D., M.P.H.

Image by Bruno Glätsch from Pixabay 

Breast cancer is the most commonly diagnosed tumor in US women, and the second leading cause of cancer death in women with an estimated 268,600 diagnoses and 41,760 deaths predicted for 2019. Despite these seemingly sobering numbers, mortality due to breast cancer has declined over the past several decades. Today, women diagnosed with early stage disease are about 99% as likely to be alive five years after their diagnosis as cancer-free women. These declines in cancer death have been largely attributed to both improvements in treatment and successful implementation of mammography (breast x-ray) screening programs, considered a hallmark of preventative cancer care. Some researchers estimate that upward of 380,000 breast cancer deaths have been averted since 1989 due to mammography and improved breast cancer treatment. In fact, the Affordable Care Act has provisions to ensure that women with private health insurance, public health insurance (e.g. Medicare, Medicaid), or health insurance purchased through a state exchange are covered for breast cancer screening. 

The idea behind mammographic screening is that breast cancers diagnosed at an early stage are more likely to respond well to treatment, preventing cancer-related death. While not all cancers have population-wide screening programs, breast cancer is a good candidate for screening. First, breast cancer is common enough to warrant subjecting women to a mammogram at regular intervals during a defined period of known risk. If a disease is very rare, it is likely not a good candidate for population-wide screening because the costs would outweigh the potential benefit. Second, there must be a good test available that is both sensitive and specific. In other words, the test should detect as many true cases as possible, while minimizing the number of patients with false-positives that require more invasive testing such as a biopsy. Finally, there must be some benefit to detecting disease early. For breast cancer, women with early stage disease may be more easily treated and have better prognosis compared to women with distant-stage disease.

Currently, mammograms are recommended for much of the adult female population in the US over the age of 50. Many different organizations release breast cancer screening guidelines on a regular basis including (but not limited to) the US Preventive Task Force, the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American College of Radiology. While the recommendations share some similarities, there are important differences and no one guideline is universally accepted. For example, for women ages 50-74, the US Preventative Task Force recommend biennial mammograms, while the American College of Radiology recommends yearly mammograms. These differences may arise from the data used to develop the guidelines and how the data are valued. For example, the US Preventive Task Force counts mortality reduction as the soul benefit of mammography and considers potential risks such as false-positive tests. The American College of Radiology considers other mammography benefits outside of morality reduction such as less aggressive treatment for early stage cancers. The American College of Radiology also have recently amended their guidelines to consider race, with the option to screen African American women, who are at greater risk of more aggressive breast cancers, starting at younger ages at the discretion of both the patient and physician. 

Understanding how and if breast cancer screening guidelines are integrated into clinical practice is a murkier area still. In recent years, most major guidelines recommend less routine screening and have endorsed a more individualized approach that involves discussion of the benefits and harms of screening and incorporates patient preferences and beliefs, especially for younger women. However, studies have found that despite these changes in recommendations, breast cancer screening in practice in the US has changed very little. This may be driven by US health system traits, such as fee-for-service payment systems and concerns about litigation. Furthermore, both clinicians and patients may overestimate the benefits and underestimate the harms of mammography, particularly for younger women.

The benefits of diagnosing breast cancer early cannot be overstated, as response to treatment and survival depends greatly on stage at diagnosis. However, the potential harms of screening are often overlooked. Of course, there are economic costs incurred for any wide-scale screening program. Just as importantly, we should seriously consider the physical and emotional costs of overdiagnosis and overtreatment. A 2018 report in the Journal of the American Medical Association found that for every 10,000 women screened for breast cancer, more than half under the age of 60 will experience a false positive test result. Almost 10% of women will undergo at least one unnecessary biopsy. Additionally, the authors demonstrated that through screening more women were potentially overdiagnosed (cancers diagnosed and treated that would have never become clinically evident) than deaths were averted. There may be psychological consequences to false positive test results, including both short-term and long-term anxiety. Unnecessary biopsy and overdiagnosis could potentially have long-term physical health consequences that would otherwise be avoided. 

How do we improve mammography screening in the US, maximizing the benefits while minimizing the risks? What is clear is that there is no simple solution. In a health system that largely favors more testing at potential cost to patients, institutional changes in how health insurance reimburses clinicians for care should consider looking beyond fee-for-service models. The newest breast cancer screening guidelines also favor individualized approaches, prioritizing screening among high-risk women and educating patients about the potential benefits and harms of screening with full consideration of their own medical history and preferences. Clinicians may consider tools that utilize detailed patient information to assess an individual patient’s risk of breast cancer, as well as tools soliciting patient preferences that support shared decision-making. Finally, it is important that all women requiring regular mammograms have access to breast cancer screening and high-quality treatment regardless of age, race, geographic location, or socioeconomic status, in order to minimize disparities in stage at diagnosis and breast cancer survival. 

Have an interesting science policy link? Share it in the comments!

Advertisements

Written by sciencepolicyforall

May 15, 2019 at 11:30 am

Posted in Essays

Tagged with , , ,

Science Policy Around the Web – May 14th, 2019

leave a comment »

By: Mary Weston, Ph.D.

Source: Pixabay

Rural areas drive increases in global obesity

While past studies have found that the increase in global obesity is largely driven by urban regions, a newly published paper argues that this rise is actually being led by those in rural areas. 

Global increases in BMI (body mass index) have been observed for decades, but no one had evaluated differences in urban and rural regions on a large-scale across many countries. The new Nature study evaluated BMI values in 200 countries from 1985-2017, finding that rural areas are responsible for more than 55% of the global rise in the average BMI and more than 80% of the rise in some low- and middle-income countries (LMICs). 

Previous theories argued that urbanization caused rising BMI largely because of the availability of cheap, ultra-processed foods, a lifestyle that provides more transportation options, and greater access to non-physical leisure activities (smartphones, cable television). In contrast, rural areas were thought more likely to consume more local produce, have less access to ultra-processed and packaged food, and participate in high energy expending activities. However, rural areas, even in LMICs, have now begun to resemble urban areas because of access to ultra-processed foods and cheap mechanized devices that reduce transport and farming energy expenditure.

Obesity results in higher health care costs, lower life expectancy, and reduced quality of life. Thus, prevention strategies are vital but currently, most preventative measures are targeted towards urban areas. Given this new data, funding priorities and strategies need to adjust to address this growing issue. 

(Barry M. Popkin, Nature)

After outcry, USDA will no longer require scientists to label research as ‘preliminary’

After protests, the US Department of Agriculture (USDA) has stopped requiring their staff scientists to label all published peer-reviewed research as “preliminary.” Released last week, the revised USDA guidelines now require the following language when disclaimers are necessary: “The findings and conclusions in this [publication/presentation/blog/report] are those of the author(s) and should not be construed to represent any official USDA or U.S. Government determination or policy.” Not all publications will be obliged to contain this statement. 

Previous USDA guidelines, implemented last July, required publications to carry the label: “The findings and conclusions in this preliminary publication have not been formally disseminated by the [USDA] and should not be construed to represent any agency determination or policy.”  This disclaimer caused concern over claims that it was confusing and possibly misleading. Scientific publications are peer-reviewed (evaluated by professionals in the field for quality and accuracy) and considered completed work, not preliminary. Some among the scientific community feared the disclaimer might reduce the impact of the published research conclusions or be used to diminish findings that conflict with views of the current administration. 

While reaction towards the disclaimer change has been generally positive, some non-USDA researchers are still concerned that the latest guidelines have the potential to jeopardize scientific integrity. The new guidelines say that the USDA can request “corrections” or “changes” to research papers if they pertain to a “prominent issue,” a significant scientific advancement, or could influence trade/policy decisions. Rebecca Boehm, an economist at the Union of Concerned Scientists, stated that “removing ‘preliminary’ from the disclaimer is a step in the right direction, but there still may be unnecessary obstacles preventing agency researchers from publishing their work in peer-reviewed journals.” 

(Ben Guarino, Washington Post)

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

May 14, 2019 at 4:56 pm

Science Policy Around the Web – May 10th, 2019

leave a comment »

By: Caroline Duncombe

Image by Steve Buissinne from Pixabay 

Drug prices will soon appear in many TV Ads

When watching an advertisement for a prescription drug on the television, a new addition will be added to that long list of side-effects: the product’s cost. On Wednesday, the health and human services secretary, Alex Azar, announced that the Trump administration will require pharmaceutical companies to state the priceof prescriptions in television advertisements in “legible” text, similar to the current standard of side effects. This policy will only apply to drugs whose whole-sale-price exceeds $35 per month.

            Such a change in policy has received substantial pushback from the drug industry. They claim that including the list price would confuse consumers who would potentially pay a different amount post-insurance (that is if you have insurance).  In addition, drug companies claim that such a requirement infringed on the companies’ First Amendment Rights. One of the driving forces behind the new policy change are the patient advocacy groups, who have pointed out that televised drug ads direct consumers to the higher priced medications.  The hope of such a policy is to potentially incentivize drug companies to lower their prices. Mr. Azar in a statement points out “If you’re ashamed of your drug prices, change your drug prices.” 

(Glenn Thrush and Katie Thomas, NYT)


Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

May 10, 2019 at 3:07 pm

Living in America with a chronic disease: Drug prices here and why they are so high.

leave a comment »

By: Mohor Sengupta Ph.D.

Image by Liz Masoner from Pixabay 

The USA has the highest average prices on drugs compared to all other developed nations across the globe. The average expenditure on drugs per person is around $1200 per year in the U.S., while it is roughly $750 in Canada, according to a 2014 survey. Let us look at a specific example. Nexium is a drug that helps reduce stomach acidity. It is manufactured by AstraZeneca in Sweden and sold to customers in the U.S., Canada, U.K., Australia, New Zealand, India and Turkey. The 40 mg pill costs $3.37 in Canada, $2.21 in the U.K., Australia and New Zealand, less than 37 cents in India and Turkey and $7.78 in the U.S. Specialty medicines, like those used for cancer can cost $10,000 a month in the U.S

Fred Smith, whom I interviewed recently, is a 26-year-old freelance musician and trumpet instructor. Shortly after his 26thbirthday, his health insurance coverage under his mother’s provider plan ended. He went on to buy his medical insurance from the private provider Blue Cross Blue Shield only to realize that he had to pay nine times the cost for each of two medicines, Vyvanse and Viibryd, and 18 times the cost for a third medicine, Adderall, compared to the amount paid while on his mother’s insurance. 

So why do Americans pay more for their medicines? 

  • Drug manufacturers in the U.S. can set the price of their products. 

While this is not the norm elsewhere in the world, federal law in the U.S. does not allow FDA or public insurance providers to negotiate drug prices with manufacturers. Medicare Part D is a 2003 legislation that prevents the nation’s largest single-payer health system from negotiating drug prices. Medicaid, which is the public healthcare program for people with limited income and resources, must cover all FDA-approved drugs, irrespective of the cost. However, drug makers must provide rebates to the government for drugs billed to Medicaid. In general, the biggest cost of medicines is borne by Medicare and private insurers. Private insurance providers do not usually negotiate prices with drug manufacturers. This is because middlemen or third-party pharmacy benefits managers that administer prescription drugs, such as CVS Health, receive payments from drug companies to shift market share in favor of these insurers. These deals also leave consumers with a limited choice. 

Drug makers in the U.S. not only set their own prices but they are also authorized to raise prices. Martin Shkreli became the “most hated man in America” overnight when he raised the price of a generic anti-parasitic drug Daraprim from $13.5 a pill to $750 a pill, a 5000% increase. Mr. Shkreli explained to critics that the hike was warranted because Daraprim is a highly specialized medicine and likened it to an Aston Martin previously sold at the price of a bicycle. He added that the profits from the price increase would go into improving the 62-year-old recipe of the drug. 

Deflazacort, a steroid used to treat Duchenne muscular dystrophy, is a generic compound that has been available worldwide for decades and costs $1000-$2000 per year. Yet, Illinois-based Marathon Pharmaceuticals acquired FDA approval to sell deflazacort under the brand-name Emflaza at $89,000 per year. 

Speaking of generic drugs, here is the next big reason for unaffordable brand-name medicines. 

  • Government-protected monopolies for certain drugs prevent cheaper generics from entering the market. 

The U.S. has a patent system that allows brand-name drug makers to retain exclusive selling rights for 20 years or more. Makers of drugs for rare diseases can also enjoy indefinite monopoly of sale. Moreover, these rare drug makers can extend their solo market dominance by making minor and non-therapeutic modifications to the patented product, like changing the dye component in the coating. They also often pay generic manufacturers to delay their products from entering the market. 

Additionally, FDA approval of generics following expiration of brand-name drug patents can be a long process; it can take up to 3-4 years for generic drug manufacturers to get FDA approval. It is estimated that prices of generic medicines fall to 55% of the brand-name medicine price once two generics enter the market and 33% of the brand-name cost when five generics become available. 

However, why would a brand-name manufacturer applying for a patent cite an unaffordable price to begin with?

  • Unjustified cost of research and development are cited by drug makers. 

It is generally agreed among critics that drug makers put an unjust price on their product citing the research that went into producing it. Because most of the R&D is funded by the National Institutes of Health via federal grants or by venture capital, the cost of research cited by the drug makers is above exaggeration. In reality, companies spend no more that 10-20 percent of their revenue on the research. 

Sofosbuvir was made by Michael Sofia, a scientist with a Princeton-based pharmaceutical company called Pharmasset. He even received the 2016 Lasker-DeBakey Clinical Medical Research Award for inventing it. Sofosbuvir is recommended for management of hepatitis C. After Gilead Sciences acquired Pharmasset for $11 billion in 2011, it applied to FDA for a new drug combining Sofosbuvir and Ribavirin, first made in 1972 by scientists at International Chemical and Nuclear Corporation (currently Canada-based Bausch Health Companies). Gilead priced their product at $84,000 for a single course of treatment in the U.S. The pricing caused a huge controversy when patients on Medicaid were denied the drug until becoming seriously ill. Moreover, generic licensing agreements to produce Sofosbuvir in 91 developing countries, which bear the burden of more than half the world population with hepatitis C, came under fire when Gilead asked for prices unaffordable by consumers in these countries. 

This brings us to the final cause of high drug prices. 

Doctors are often unaware that their prescriptions could be cheaper for their patients if they purchased two generic medicines instead of the brand-name prescription drug that is just a combination of the two. Vimovo, manufactured by Horizon Pharma, is a drug used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It is a combination of two generic medicines, naproxen (brand-name Aleve) and esomeprazole (brand-name Nexium). Naproxen is the anti-inflammatory component (NSAID) and esomeprazole is the aforementioned stomach-acidity reducer. It is added to the combination to reduce side effects of the NSAID. Whereas a month’s supply of Aleve and Nexium cost one patient $40, his insurance company was billed $3252 for the same supply of Vimovo. Moreover, not everyone who uses NSAIDs experiences stomach problems and do not need the additional esomeprazole component. 

Several Americans do not fill their prescriptions because they cannot afford to. Data show that 36 million Americans between the ages of 18 to 65 did not fill their prescriptions in 2016. Many resort to buying medicines online from foreign sellers or get them imported. Both routes are illegal and therefore we do not know the exact percentage of the population participating in these practices. 

I interviewed Tammy Connor, who regularly gets her medications from abroad. Tammy takes Synthroid, a brand-name drug, which is used to manage symptoms of hypothyroidism. She has been procuring it from Canada at 1/3rd its U.S. price for many years. In the middle of 2018, the U.S. began blocking drug purchases from Canada, preventing her from continuing this cost-saving practice. Eventually, she got a referral to a U.K.-based drug company called Medix Pharmacy, where she pays 1/3rd the amount that she would have to pay if she purchased Synthroid from the U.S. “Ironically, Medix gets its Synthroid supply from Canada”, Tammy said.

Big Pharma” is a major lobbying group in the U.S. This is a group of a few gigantic pharmaceutical companies which have together kept their profit margins rising amidst public outcry of drug unaffordability. Big Pharma also includes corporations that push overpriced drugs to customers. With their deep pockets, they can spend astronomical amounts on advertising and lobbying. 

Unaffordable prices of life-saving medicines cause many people to skip taking necessary medications, thanks to the Big Pharma. Now, more than ever, is the time that something was done about this. 

Recommended links: 

  1. http://money.com/money/4462919/prescription-drug-prices-too-high/
  2. https://jamanetwork.com/journals/jama/article-abstract/2545691
  3. https://www.cnbc.com/2017/05/10/americas-10-most-expensive-prescription-drugs.html
  4. https://www.renalandurologynews.com/home/news/almost-1-in-10-americans-cant-afford-medications-says-cdc/

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

May 9, 2019 at 4:23 pm

Science Policy Around the Web – May 7th, 2019

leave a comment »

By: Allison Cross Ph.D.

Source: Flickr

Shake-up at NIH: Term limits for important positions would open new opportunities for women, minorities

Beginning next year, the NIH will be setting into motion a new policy implementing 12-year term limits for lab and branch chiefs in the NIH intramural program.  Currently, of the 272 chiefs overseeing the NIH intramural program, almost 20% of them have served in their position 20 or more years and, of those, over 5% have held their position for over 30 years.  

Individuals serving as lab and branch chiefs oversee administrative matters, mentoring, and recruitment for several labs or groups at NIH. With the current lack of turnover in chief positions, many feel it is hard to move up to a leadership position within NIH.  The new policy intends to change this, and to increase diversity among NIH leaders.  It is noted that women currently hold 26% of cheif positions, which is comparable to the percentage of women who hold tenured track positions at NIH.  

With implementation of the new policy, as many as half of the currently serving chiefs will be replaced in the next 5 years. The new policy indicates that the positions which become vacant will be filled through “open and transparent processes”.  To increase diversity of those holding these leadership positions, it will be important for NIH to have a diverse field of candidates capable of filling these positions. To help build the pool of candidates, the NIH is relying on the recently launched Distinguished Scholars Program, a program aimed at reducing the barriers to the recruitment and success of tenure-track female and minority faculty.

While some see the policy change as an opportunity to increase diversity in NIH leadership, others feel the change will have little impact, and still others question if leaders doing stellar jobs should really be replaced.  The current term limit policy change intended to take place next year will only affect the midlevel leadership positions, however, these changes may spread to higher level leadership positions in the future.   

(Jocelyn Kaiser, Science)


Senator’s queries prompt NIH and NSF to clarify how they monitor foreign research ties

There has been a recent increase in concern among members of Congress that foreign governments are taking advantage of open nature of the nation’s research enterprise. These concerns prompted senator Chuck Grassley (R–IA), chair of the Senate Committee on Finance, to send letters to the NIH, NSF, and DOD asking each agency to explain the practices they have in place to root out any illegal behavior.

These letters contain several questions for each agency to answer including 1) how the agency conducts background checks before awarding a researcher or institute a grant, 2) how much money is being spent “to identify and investigate potential violations of the rules concerning foreign affiliations and financial support for an investigator’s research, and 3) the number of institutions under investigation by the agencies “for employing individuals who failed to disclose contributions from foreign governments”.

Congress has received responses to these letters from NIH and NSF and is still waiting on a reply from DOD. Though both agencies that responded to the letter failed to answer all the questions from Senator Grassley, they used their responses to highlight changes being made to their grant application processes.  

In response to the question regarding background checks for grantees, both NIH and NSF explained that the agencies do no perform background checks.  In the NIH’s response to Senator Grassley, they explained that, in the last year, they reminded grantee institutions about their responsibility to notify NIH if a grantee is found guilty of scientific misconduct. Notably, the NIH currently requires that grantees disclose all “foreign components” of their research. The NSF used their response to explain the development of a web-based discloser form where researchers are to list “all sources current and pending support”. In a recent change by the NSF, they now also require all those applying for NSF grants to disclose if their proposal requests money for a foreign organization and, if so, to justify what the foreign collaborator offers that cannot be done at a US-based institution.   

With the responses from NIH and NSF leaving many of Senator Grassley’s questions unanswered, it is expected that further inquiries from Congress will continue.  

(Jeffrey Mervis, Science) 


Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

May 7, 2019 at 4:15 pm

Science Policy Around the Web – May 3rd, 2019

leave a comment »

By: Allison Dennis B.S.

Image by Ashley Smith from Pixabay

A More Humane Livestock Industry, Brought to you by CRISPR

Innovations sparked by germline editing in livestock are poised to help farmers make rapid improvements in the care and treatment of their animals by helping overcome inefficiencies genetically. Livestock industries use animals specifically bred to maximize their use and often require or prefer animals of a particular gender. Male cattle produce more meat. Female cows produce milk. Female chickens lay eggs. Known as “the dirty secret” of the dairy industry, farmers under financial pressure may kill male calves soon after birth to avoid the costs of raising them further. Every year, 6 billion male chicks, which hold no economic value for egg production, are killed within a day of hatching. The egg industry is seeking to prevent this, and in June of 2016, the United Egg Producers, a group that represents more than 95% of egg production in the United States, stated their goal of “eliminating the culling of day old male chicks by 2020 or as soon as it is commercially available and economically feasible.”

Scientists are racing to offer these industries solutions by harnessing the power of the gene editing technology CRISPR to genetically engineer animals to break the 50-50 gender rule. Mark Tisard, a geneticist at the The Commonwealth Scientific and Industrial Research Organization, Australia’s national science agency, is using CRISPR to engineer male eggs to glow red under fluorescent light, allowing farmers to repurpose male eggs for vaccines or feed production before the chick has developed. Across the world, the startup eggXYt in Israel is taking a similar approach, making male eggs glow yellow. Alison Van Eenennaam, an animal geneticist at UC Davis, is exploring the possibility of using CRISPR to produce all male herds of beef cattle from the point of conception.

While pre-determining gender remains a major goal, gene-editing has already been used to introduce a gene for slick hair that helps cattle handle heat better in warm climates. Scientists have successfully used CRISPR to produce pigs that are resistant to the PRRS virus, which causes respiratory disease and reproductive failure, costing farmers in the United States half a billion dollars a year. 


The reception of these technologies in the United States remains unclear. Most recently, in January 2017, the FDA drafted rules that would put genetically altered animal products through the same safety and efficacy testing undertaken for new drugs. However, since then, the USDA has clarified that plants produced through genome editing will not be subject to additional regulation if they could conceivably been developed through traditional breeding methods. Those looking to harness the power of these types of genetic modifications for livestock are hoping to see this attitude expanded to animal products.

(Gregory Barber, Wired Magazine)

House Democrats move to resurrect Congress’s science advisory office

At the helm of American society is a group of appointed representatives racing to keep abreast of a deluge issues stemming from technological innovation. A draft of the 2020 Legislative Branch funding bill that was approved by its subcommittee on April 30th offers potential relief in the form of re-establishing the Office of Technology Assessment (OTA). The OTA was originally established in 1972 to provide congressional staff with deep and comprehensive analysis of technical issues to aid in the crafting of public policy, independent from lobbyists and activists. At that time, Anti-Ballistic Missiles and Super Sonic Travel were the technologies stirring up media frenzies. However, the OTA was eliminated in 1995 to reclaim $21 million for the congressional budget. The $3.9 billion dollar proposed budget for 2020 included only $6 million for its revival.

Currently, the Congressional Research Service (CRS) is tasked with keeping Congress informed on technical issues ranging from gene editing to artificial intelligence. In January 2019, recognizing the need for greater technical assistance, the US Government Accountability Office (GAO) established the Science, Technology Assessment, and Analytics team to conduct technology assessments and provide technical assistance directly to Congress. The proposed budget would support these efforts by providing CRS and the GAO an additional $24 million and $26 million respectively. However, some believe that there is still a need for the OTA in spite of these new teams. Representative Sean Casten testified to fund the OTA as he believes there is still a need to “fulfill the forward looking, deep-dive, technical assessments of new scientific and technological developments once provided by OTA.” Representative Mark Takano also expressed support, stating “In the ecosystem of legislative support organizations, OTA plays a unique role. No other entity has the capacity and expertise to provide in-depth and forward-looking analysis of complex, technical issues informed by an understanding of how Congress works.” 

Former Congressman Rush Holt similarly tried to revive the OTA in 2015, only asking for 2.5 million dollars, but his amendment was defeated 248 to164. The 2020 funding bill next heads to the full House Appropriations Committee for markup before representatives get a chance to vote.

(David Malakoff, Science)



Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

May 3, 2019 at 11:20 am

Keep your head in the game… or don’t: The link between football and brain injury

leave a comment »

By: Saroj Regmi, Ph.D.

Image by WikiImages from Pixabay 

American football is a team sport that enjoys wide popularity and an extensive fan following. For over 30 years it has reigned as the most popular sport in the US. In recent years, however, it has remained at the forefront of controversy due to growing concern over long term health effects.

The safety of football was initially brought into question by a study in 2002 from  Dr. Bennet Omalu, a neuropathologist working in Pittsburgh. Dr. Omalu, whose efforts were portrayed in the popular movie Concussion starring Will Smith, discovered the link between chronic traumatic encephalopathy (CTE) and American football players. He performed an autopsy of former Pittsburgh Steelers player Mike Webster and established that CTE, a disease previously ascribed to boxers, also occurred in football players. Forensic analysis of Mike Webster’s brain, who struggled for years from mood disorders, depression, suicidal thoughts – symptoms associated with CTE – showed large accumulation of tau protein. Although the pathogenesis of CTE remains poorly understood, it is believed that clumping of the protein tau, also seen in Alzheimer’s patients, leads to death of brain cells. A series of publications have followed suit since 2002 and have included post-mortem analysis of the brains of some former NFL players including Terry Long, Justin Strzelczyk, Andre Waters and Tom McHale. From all these studies, the message is loud and clear: there is a strong link between tackle football and CTE.

With each new scientific report, the relationship between CTE and contact football became clearer. A recent study in the Journal of American Medical Association involving brains of  deceased people that played football at various levels, from high school to NFL, identified CTE in 87% of the players. Even more remarkably, it identified CTE in 99% of NFL players – a shocking number. In the study, the authors also argue that the disease risk and severity might be a result of age at first exposure to football and the duration of play as well as various other factors. This means that even limited exposure to contact football can significantly increase your chances of suffering from CTE. 

CTE, also referred to as “punch drunk syndrome”, as of yet is not treatable and research studies on the disease have been limited. Investigation of CTE pathogenesis is further complicated by the fact that a definitive diagnosis is only possible post mortem. Given the widespread impact of the disease, a recent push has been made by researchers to identify biomarkers of CTE in living patients. A recent collaborative study between the Concussion Neuroimaging Consortium and Orlando Health tested blood based biomarkers and were able to identify elevated levels of microRNAs in the blood of college football players. The report, published in Journal of Neurotrauma, demonstrated that these biomarkers were high in these players even prior to head injury for the season. This means that head injuries have a lasting effect and these biomarkers can identify head injuries incurred in previous seasons. Cognitive tests involving study participants demonstrated that the players who struggled with memory and balance had much higher levels of microRNAs than those who did not. Over the years, the researchers hope to use these microRNA biomarkers to identify at-risk athletes.

A recent report, published in The New England Journal of Medicine, has been a game changer in our understanding of CTE in NFL players. By taking brain scans of 26 former players at varying levels of symptoms associated with CTE, the study has taken an unbiased approach to analyze the severity of CTE in professional NFL players. The study used positron emission tomography (PET) scans to determine that NFL players had higher levels of abnormal tau protein in disease associated parts of the brain in comparison to men of similar age that had not played football. In contrast to some of the previous studies, the results of the report did not reveal a correlation between the severity of tau accumulation and the degree of cognitive issues associated with CTE. A correlation between tau accumulation and total years of playing football was seen. Therefore, while tau deposition can serve as a biomarker of CTE, levels of tau accumulation does not determine the severity of the disease. Interestingly, the study also found one former player that had levels of amyloid-beta deposition comparable to that of an Alzheimer’s patient. While the study provided a lot of answers, it also raised a wealth of different questions. It is still unclear whether tau accumulation is faster in people with repeated head trauma. Also, how the accumulation of tau leads to behavioral alterations associated with CTE remains a complete mystery.Although the report was careful to highlight that this imaging-based approach is still in its infancy and that it could take years to develop a proper diagnostic test for the disease, the results of the analysis are definitely encouraging. This is the first ever reported study to utilize tau imaging in living players. 

A major takeaway from these studies is that although CTE remains poorly characterized with symptoms ranging from forgetfulness to suicidal thoughts, it is almost invariably caused by concussions and head injuries resulting from contact football. What is terrifying is that CTE can occur not only in professional football players but also in high school students that play football. These reports bring into question the safety of the sport in its current state. With over a million high school students engaged in the sport, a radical rethinking of the game is required to make it a safe and fun activity that youngsters can partake in without risking their health. 

Recently, the Canadian league instituted a ban on full contact practices to reduce collision during practice. The league has also increased time between games so that the players are afforded a longer recovery time. Similar approaches have also been made by the Ivy League. There is also a need of policies to ensure that the general public is aware of the risks, particularly children and their parents. HEADS UP is one such program initiated by the CDC that provides online training course for health care providers and high school sports coaches. Efforts have also been made in recent years, at both state and federal levels to reduce concussion in the youth. Although not monumental, these efforts are an important step in the right direction.

Have an interesting science policy link? Share it in the comments!

Written by sciencepolicyforall

May 1, 2019 at 4:39 pm

Posted in Essays

Tagged with , ,