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Science Policy Around the Web August 27th, 2020

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By Mohor Sengupta, PhD

Image by skeeze from Pixabay 

Why Does California Have So Many Wildfires?

Yet another bout of wildfire season is raging in large forested swathes of California. Firefighters are struggling to bring to control 560 wildfires burning throughout the most populous state in the United States. A beloved redwood forest is directly under attack. The current fires are among the largest wildfires in the history of California. Brought about by lightening strikes, these fires have prompted evacuation orders for 48,000 people residing in Santa Cruz county. The ongoing and relentless pandemic has made evacuees wary of shelters where thousands are expected to stay put. So why are we seeing increasing wildfires in California? Ten largest fires in state records dating back to 1932 have occurred after 2000. Experts point to four basic reasons:

  1. Climate change

California gets most of its rainfall in the fall and winter months. That is when new vegetation springs to life. Over the hot and dry months of the summer, existing vegetation becomes dry, creating highly inflammable material waiting for a random spark, a lightening strike, or some thoughtless human activity, to turn into a smoldering mass that can quickly get out of hand. Gradual climate change has increased general summer temperatures by one to two degrees Fahrenheit, worsening the problem.  

  • Human activities

The Carr fire in 2018 started when sparks flew after a flattened truck tire scraped against the pavement. It was the sixth largest fire on record in California. Over the years people have also moved toward forested areas, which are called urban-wildland interface. Human activities, or results of human habitation, like downed power lines near forests, are a great recipe for fires. 

  • The method of controlling fires

Counterintuitive as it may seem, the long-existing strategy of firefighting that douses all burning vegetation might have caused the accumulation of more burnable material over the years! Experts say that had there been controlled burning, there would be lesser plants to start fires in the zones currently being affected by wildfires. The United States Forest Service has started using controlled burns in recent years to address this issue. 

  • Seasonal winds

A study has suggested that California has two fire seasons. One that is happening now, usually ranges from June through September and targets forested highlands. It is the wildfire season we are familiar with. A second, more devastating fire season is from October through April. That is caused by dry, hot winds, called Santa Ana winds, that blow from the Great Basin area into Southern California. These fires spread a lot faster and wreak havoc in urban areas. Since the last 20 years, this second fire season has caused 80 percent of the total economic damage caused by wildfires in California! 

(By Kendra Pierre-Louis and John Schwartz, The New York Times)

Written by sciencepolicyforall

August 27, 2020 at 2:32 pm

Science Policy Around the Web July 7th, 2020

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By Mohor Sengupta, PhD

Source: Pixabay

Unless it’s done carefully, the rise of telehealth could widen health disparities.

Among the many changes COVID-19 is set to bring to our society, the widespread practice of telehealth is one the most important. Although medical practitioners have been considering the benefits of telehealth for a while, the pandemic has pushed much of the medical community directly into practicing it, and telehealth has surged from 8% of Americans in December to 29% in May having used it. To the uninitiated, telehealth is a remote form of consultation with doctors by digital means. It foregoes in person visits to the clinic. Medical care, advice, clinician contact, interventions, reminders, monitoring and remote admissions are all possible via telehealth. 

In terms of the pandemic, keeping patients out of doctors’ offices and away from in-patient visits helps contain the spread of the coronavirus. Although insurance companies that are fully reimbursing for telehealth services say that they’ll do so only as long as the pandemic lasts, the need to socially distance might become a new normal, making telehealth a medical feature that might be here to stay. 

While the benefits for telehealth are obvious, it may have some unwanted consequences too. It is especially important to consider these if telehealth becomes a permanent feature of the healthcare landscape. Since telehealth implementation depends on information technology, the most basic thing needed for it to function properly is for the beneficiaries to have an internet connection. The pandemic has highlighted the fact that rural areas in the United States have struggled to keep up with regular classes without internet access. Even in urban areas, marginalized groups without adequate employment, health insurance and digital resources can face problems accessing the benefits of telehealth. 

Patients from these marginalized groups can fall into one of the several minority communities, including racial and ethnic minorities, socioeconomically disadvantaged individuals and those belonging to sexual and gender minority groups. Patients from these groups already face discrimination during in-person visits, which leads them to lose trust in healthcare systems. Telehealth may mean bigger challenges to them in navigating the system altogether. 

Part of the problem could be the absence of in-person conversation with the clinician or healthcare provider. Effective communication is key to both sides being on the same page about a medical advice. Minority populations already face cultural and linguistic barriers in healthcare. For many people who are not able to communicate in English, telehealth could be an impediment toward making their doctor fully cognizant of their needs, in the absence of in-person experience. 

On the part of the healthcare providers, it is important to keep the guards up against their implicit biases on race, ethnicity and educational status of the patient. A virtual environment might just be less conducive to such vigilance. 

Finally, telehealth uses algorithms to predict health patterns of people. With minority populations being underrepresent in studies and in clinical research, these predictive algorithms cannot fully account for the complex health behaviors and patterns among several different groups of people who don’t fall into the broad category which was used to come up with the algorithms in the first place.   

(Matthew Clair, Brian W. Clair, and Walter K. Clair, STAT)

Written by sciencepolicyforall

July 7, 2020 at 10:36 am

Science Policy Around the Web March 26th, 2020

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By Mohor Sengupta, PhD

Image by Miroslava Chrienova from Pixabay 

No, the coronavirus wasn’t made in a lab. A genetic analysis shows it’s from nature

When COVID-19 started raging across the globe, different theories surfaced about its origin. One was that the SARS-CoV-2 virus was genetically engineered and the other was that it might be a spill from a lab culture. Proximity of the Wuhan Institute of Virology to the wet market, to which the first COVID-19 case was traced, did not make things easier. However, a recent paper published in Nature Medicine has put to rest all unfounded theories about the origin of the virus. 

Scientists from Scripps Research Institute in La Jolla, CA, have studied the recently decoded RNA sequence of this virus and identified patches in the sequence unique to the novel coronavirus. This proves that the SARS-CoV-2 is not a result of genetic engineering, because the unique RNA sequence stretches don’t follow any previously known model or template that a human-made software would use for this purpose. The scientists then studied the virus structure in detail. 

The spike protein on the surface of the SARS-CoV-2 virus, which it uses to latch on to human cells, has a unique RNA-binding structure that is not found in the SARS virus. This structure is cleaved by a human protein, called furin. The cleavage of this unique RNA-binding structure by furin causes SARS-CoV-2 to attach tightly to human cells, making it highly contagious. 

The spike protein also has additional structures which bind to sugar molecules and protects the virus from being recognized by the human immune system. If the novel coronavirus was indeed an escaped organism from lab culture, it wouldn’t have evolved to shield itself from the host immune system, which is absent in lab viral cultures. 

ACE2, a protein on human cells bind with the SARS virus. Computer models had predicted that this binding would be weaker in the case of SARS-CoV-2, but to everyone’s surprise, ACE2 bound more strongly to the spike protein of SARS-CoV-2. The findings prove that the novel coronavirus is a product of natural selection, and not of human design or spillage of a lab culture. 

(Tina Hesman Saey, Science News)

Written by sciencepolicyforall

March 31, 2020 at 9:16 am

Science Policy Around the Web February 11th, 2020

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By Mohor Sengupta PhD

Image by Johannes Plenio from Pixabay 

One of Antarctica’s fastest-shrinking glaciers just lost an iceberg twice the size of Washington, D.C.

In October 2019, scientists from the European Union’s earth observation program, Copernicus, detected cracks in the Pine Island Glacier of Antarctica. Earlier this week, the cracks caved in and an iceberg the size of Washington, D.C., separated itself from the main glacier. 

Peeling off icebergs from a glacier, also called calving, is not uncommon. However, these occurrences have increased in frequency over the last decade. Glaciers like Pine Island are retreating inward because they are unable to keep up with calving and warmer waters surrounding them. 

Pine Island and its neighbor, Thwaites Glacier, are in the West Antarctic Ice Sheet. These glaciers have been consistently losing ice over the last several years. According to NASA, the two glaciers have enough mass to cause a 4 ft rise in the surrounding ocean levels if all of their ice melt away. 

Last week, a region of Antarctica close to the southern tip of South America reached a record high summer temperature of 65 degrees Fahrenheit (18.3oC). Rapidly warming oceans surrounding Antarctic ice shelves are a threat to their glaciers, according to scientists. The Arctic region is the fastest warming zone on the planet. Similar observations have not been made for Antarctica, but melting ice is indicative of profound changes in the climate and ecosystem of the region. 

 (Brandon Specktor, Live Science)

Written by sciencepolicyforall

February 11, 2020 at 3:26 pm

Science Policy Around the Web December 20th, 2019

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By Mohor Sengupta, PhD

Image by Eveline de Bruin from Pixabay 

Trump Administration Takes First Step to Allow Drug Imports From Canada

“For the first time in history, H.H.S. and the F.D.A. are open to importation as a means to lower drug prices,” Alex M. Azar II, secretary of HHS said recently. In a step unusual for the Trump administration, it has announced that import of drugs from Canada would be made possible. Despite vehement opposition from the pharmaceutical industry, and previously from even the FDA, the government is set to implement importing of drugs from outside the U.S., once the states have come up with individual proposals for approval by the federal government. 

The proposed implementation is still a long way off. The pharmaceutical industry’s main lobbying group, the Pharmaceutical Research and Manufacturers of America, are not happy with the recent turn of events. “At a time when there are pragmatic policy solutions being considered to lower costs for seniors at the pharmacy counter and increase competition in the market, it is disappointing the administration once again put politics over patients,” the group’s president and chief executive, Stephen J. Ubl, said in a statement.

Because a proposal such as this has never been implemented before, the Trump administration is unsure of the costs it would incur. Until the states submit their individual plans of how to go about implementing these imports, estimates of consumer or taxpayer savings cannot be made. However, it is amply clear that consumers of highly priced drugs will be happy with the move. In recent years, public outrage over high prices of prescription drugs has mounted steadily and lowering drug prices by importing them would meet a key campaign promise of the administration.

A 2003 law sets limits on the types of drugs that can be imported, and by that law, most of the expensive drugs, including insulin, biologics and injectable drugs, are excluded from this proposal.  

(By Katie Thomas, New York Times)

Written by sciencepolicyforall

December 20, 2019 at 3:57 pm

Science Policy Around the Web November 15th, 2019

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By Mohor Sengupta PhD

Image by David Mark from Pixabay

Rollout of Johnson & Johnson Ebola vaccine begins in Congo

To the African countries reeling with the second deadliest Ebola outbreak in history, two back-to-back launches of new vaccines may be a beacon of hope. On Tuesday this week, Merck’s vaccine Ervebo was pre-qualified by the WHO, meaning that it was declared safe for use. This occurred merely 48 hours after the European Commission granted conditional marketing authorization for the vaccine. The speed of this decision-making sheds light on the gravity of the situation at hand. 

The current outbreak in the Democratic Republic of Congo has killed more than 2,200 people. The previous Ebola outbreak, and the deadliest in living memory, rocked West Africa in 2013-16, claiming 11,300 lives. 

In addition to Ervebo, a new vaccine produced by Johnson & Johnson was approved yesterday. It passed several clinical trials, however it will now be tested for the first time in a real world setting in the village of Goma, on the Rwandan border with DRC. It will be administered to 50,000 people. 

The new vaccine by Johnson & Johnson is aimed at complementing Ervebo. While the later requires a single shot, the Johnson & Johnson vaccine will require two shots spaced at 8 weeks. Ervebo is being used as “ring-vaccination”, a strategy in which close contacts of Ebola-infected individuals will be vaccinated.  

(Reporting by Fiston Mahamba; Writing by Hereward Holland; Editing by Anna Pujol-Mazzini and Mark PotterReuters)

Written by sciencepolicyforall

November 15, 2019 at 4:35 pm

Science Policy Around the Web October 22nd, 2019

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By Mohor Sengupta PhD

Image by truthseeker08 from Pixabay 

What’s Behind The Research Funding Gap For Black Scientists?

A recently published study by a group of NIH investigators has found possible reasons for the funding gap that exists between grant proposals submitted by black and white researchers. This gap was first revealed in a report published in 2011 that found that black applicants to NIH grants were awarded funding at a significantly lower rate than white applicants to the same grant. These data prompted the NIH to investigate the grant funding process.

In this paper, the authors analyzed keywords in grant application topics and found that some topics were four times more likely to get funded than others. Broadly, topics dealing with the mechanistic basis of science on a micro-level, such as genetics, or cellular mechanisms were more likely to grab the attention of grant reviewers than grants involving population sciences and community-oriented research. Grants on these subjects are more commonly proposed by African American applicants. 

The authors find that black researchers tend to pursue studies on topics that are more connected with their communities. Such topics include health disparities research, which unfortunately don’t figure as priority in grant reviewers’ radar, possibly because they don’t see things through the same lens when evaluating proposals. This may be because the grant reviewers didn’t have similar life experiences while growing up as a person belonging to a minority community might have. In the present study, only 2.4% of grant reviewers was black. 

In the study, self-reported demographic data of applicants was not visible to grant reviewers. As a next step, the authors will investigate if applicant anonymity decreases the existing funding gap. 

(Emily Vaughn, NPR)

Marijuana and Vaping: Shadowy Past, Dangerous Present

A severe lung disease has been affecting users of e-cigarettes with marijuana. So far nearly 1500 people have become sick, and 33 have died of the mysterious disease. Residents of 49 states and the District of Columbia have reported the vaping-related illness. While the cause of the disease remains unknown, experts say that THC, the chemical in marijuana that makes people feel high, produces different components when burned in rolled joints versus when aerosolized in vaping devices. The latter may have unknown harmful chemicals. 

However in addition to THC, vaping oils contain additives, solvents and flavor enhancers. It is unclear which of these ingredients is the culprit, but vitamin E acetate is a likely candidate for the illness. The obscurity surrounding illness-causing vaping components in part exists because of restrictions imposed on cannabis research by the federal government. The reason behind this is the high abuse potential of cannabis, which classifies it as a controlled substance not available for research. 

This rule annoys scientists and industry experts alike. Lack of hard science and awareness among the vaping community is made worse by the many cheaper products freely available in black markets, both in states where vaping THC is illegal and legal. As counterfeit cartridges are much cheaper than the tested and taxed licensed products, these have many consumers. Vaping cartridges sold on the black market are not tested.

Considering the recent illnesses taking a toll on people who use e-cigarettes to smoke cannabis, the government should allow investigation into the chemical underpinnings of the disease. 

“I’m not able to take products we think are potentially harmful and do analysis. I can buy a vape device around the corner, but I can’t bring it into the lab and test it,” UCSF researcher on nicotine and vaping, Dr. Neal Benowitz said. Benowitz has sent a letter to the congress about the hugely popular and unstudied practice of vaping. 

(Matt Richtel, The New York Times)

Written by sciencepolicyforall

October 22, 2019 at 4:09 pm

Science Policy Around the Web August 20th, 2019

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By Mohor Sengupta PhD

Image by Ryan McGuire from Pixabay 

FDA makes new push for graphic warning labels on cigarettes

According to government records, the percentage of smokers in the U.S. has reduced from 40% of the population in the 1960’s to 14%. Despite this dramatic decrease, approximately 480,000 people in the U.S. die each year from diseases directly related to smoking. In an attempt to educate smokers about the dangerous medical consequences of smoking, in 2009 the FDA proposed 9 graphic labels to be printed on cigarette packets. However the FDA’s plan didn’t see the light of day when five tobacco companies challenged the FDA’s decision in court and in 2012 won on grounds of free speech. The judges who ruled in favor of the tobacco companies said that “[the images were] crafted to evoke a strong emotional response,” rather than educating consumers. 

The FDA then backed out saying that it will work on introducing new images and it was soon to announce new proposed labels. In 2016, a lawsuit was filed by health groups against the FDA for not proposing a new plan soon enough. Last Thursday, the FDA announced 13 new graphic labels to be displayed on cigarette packets that would show cancerous tumors, diseased lungs, and feet with amputated toes. The FDA’s tobacco director Mitch Zeller said that these new labels had been designed while keeping in mind the limited public awareness of lesser-known diseases caused by smoking. 

For 35 years, everything that the USA’s cigarette packets have told consumers about the harmfulness of smoking has been contained in a warning statement so tiny that it is missed by most consumers. Research has shown that graphic label inclusion on cigarette packets discourages smokers, and Canada was the first country to adopt this measure in 2000. 

Since then, more data have come to light identifying graphic images as an effect anti-smoking measure. A 2013 study showed that participants tended to respond to graphic labels rather than warning statements on cigarette packets. Another 2013 study estimated that if the FDA had adopted graphic labels in 2012, 5.3 to 8.6 million adults would have quit smoking in a year. They based their results on similar data from Canada where graphic labels are in use. 

It is anticipated that Big Tobacco will challenge the FDA’s move once again. Some of them are already citing the First Amendment as their defense. It is now time to see what is decided if the matter is taken to the courts once again. While thousands of people continue to die because of smoking habits in the USA, and graphic label inclusion on cigarette packets are repeatedly challenged by the tobacco industry, nearly 120 countries across the world have already adopted this measure and are reaping its benefits. 

(Matthew Perrone, STAT)

Experimental Ebola Drugs Saved Lives In Congo Outbreak

Ebola is raging in the Democratic Republic of Congo (DRC). However, a climate of distrust around Ebola clinics compounded with political upheavals in DRC has discouraged patients in the early stages of infection from leaving their community and seeking help in designated Ebola clinics. In this way, the virus has rapidly spread across communities and now threatens people outside of DRC as well. 

Despite these issues, efforts are underway to combat Ebola and develop more effective treatment strategies. A NIAID-funded study that compared four drugs against the Ebola virus recently concluded that two of them showed better results in combating the disease. The study, called ‘Pamoja Tulinde Maisha’ (PALM), is a randomized controlled trial of the four drugs and started on November 2018 as part of the emergency response in DRC.

The four investigational agents were Remdesivir, a commonly used antiviral drug, ZMapp, which showed effectiveness in previous Ebola outbreaks, REGN-EB3, developed by Regeneron and mAb114, a monoclonal antibody jointly developed by NIAID and INRB (in the DRC). 

Having reached a definite conclusion about the effectiveness of the four drugs, the PALM trial stopped earlier than originally scheduled. Preliminary results released on August 9, 2019 show only 30% of Ebola Virus Disease (EVD) patients treated with REGN-EB3 or mAb114 succumbed to the infection, compared to half of those treated with ZMapp or Remdesivir. When analysis was restricted to the relatively healthier patients receiving the more potent treatments, 6% and 11% died on REGN-EB3 and mAb114 treatment regimes respectively. 

With these preliminary results, patients on Remdesivir and ZMapp will now be switched to one of the more effective drugs based on their physician’s discretion. The study will continue to measure the effects of the two drugs from now on. The final analysis of the study data is likely to be made available later this year. 

(Richard Harris, NPR)


Written by sciencepolicyforall

August 20, 2019 at 4:56 pm

Science Policy Around the Web – July 12th, 2019

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By Mohor Sengupta, Ph.D.

Source: Maxpixel

CDC made a synthetic Ebola virus to test treatments. It worked

During the 2014-2016 Ebola outbreak in Guinea, West Africa, infectious samples containing the virus were shared by local government with international scientific communities. Using these materials, Dr. Gary Kobinger and his team developed and tested the efficacy of a monoclonal antibody vaccine at the Canadian National Laboratory. The same vaccine, ZMapp, and other therapies are currently being deployed in the most recent Ebola outbreak, which is the second largest outbreak so far. Beginning in ] 2018 in the Democratic Republic of Congo (DRC), this outbreak is still on the roll. Unfortunately, the Centers of Disease Control and Prevention (CDC) did not have any viral samples this time, meaning they were unable to test the efficacy of ZMapp and other drugs against the recent viral strain. 

Scientists at the CDC, led by Dr. Laura McMullan, constructed an artificial virus from the sequence of the current strain shared by DRC’s National Biomedical Research Institute (INRB). The group used the sequence data to perform reverse genetics and generate the authentic Ebola virus that’s currently infecting scores of people in Ituri and North Kivu provinces of DRC. 

“It takes a lot of resources and a lot of money and a lot of energy to make a cloned virus by reverse genetics. And it would be so much easier if somebody had just sent the isolate”, Dr. Thomas Geisbert, who is not involved in the work, said. 

The CDC group established the efficacy of current treatments (a drug called Remdesivir and the vaccine ZMapp) on the viral strain by using their artificial virus for all the tests. Their work was published Tuesday in the journal Lancet.

For all four Ebola outbreaks that the DRC has seen, healthcare authorities have not shared viral specimens with foreign Ebola researchers. Instead, the whole genome sequence was provided every time. With the whole genome sequence data, the Lancet paper noted that there are at least two Ebola strains in DRC that have independently crossed into the human population.  

Reasons for not sharing viral samples by DRC are not known but it is a roadblock to rapid and efficient treatments in affected geographical regions. McMullan said that shipping of samples across such large distances is often a logistical issue and requires permission from several authorities and coordination of many people. 

 (Helen Branswell, STAT)

Plastic Has A Big Carbon Footprint — But That Isn’t The Whole Story

We are all too familiar with ghastly images of dead whales with plastic-filled stomachs. These images are compounded by pictures of how much waste is generated, such as a picture of a twenty-story high mound of plastic trash in a developing country that appeared in a recent news article. While there is worldwide concern about how to eliminate use of plastics, there is very little discussion about the environmental impact of the materials that will replace plastic. 

Plastic has a high carbon footprint. In a recent report the Center for International Environmental Law (CIEL) has broken down the individual steps of greenhouse gas production, from the beginning of plastic production until it ends up incinerated as a waste. Manufactured from oil and natural gas, plastic production adds to carbon footprint right from its cradle when gases and oils leak into the environment. Subsequently, delivery of raw materials to the production sites further add to the burden. Being among the most energy intensive materials to produce, plastic production takes a heavy toll on energy, water and electricity. Finally, when plastics are incinerated, greenhouse gases end up in the environment. 

But what about the materials that commonly substitute for plastic, such as paper, compostable plastic, canvas or glass? What is their carbon footprint in production stages? Research by several independent groups has revealed that these materials leave an even larger carbon footprint during their production. Data have shown that polyethylene plastic bags not only used lesser fuel and energy throughout production, they also emitted fewer global-warming gases and left lesser mass of solid wastes, when compared with paper bags and with compostable plastic bags. Being more durable than other materials, use of polyethylene bags are more energy friendly than use of paper bags. 

Research done on behalf of the American Chemistry Council has shown that replacing plastic would eventually do more harm to the environment than their use. Finally, consumer habits count. If people don’t reuse plastics, then its advantages over paper cease to exist. Of course, the problem of permanent waste and global health consequences are issues that cannot be overlooked. The solution might lie in using plastics more wisely and re-using them as much as possible. 

(Christopher Joyce, NPR

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July 12, 2019 at 3:18 pm

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

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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. 

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Written by sciencepolicyforall

May 9, 2019 at 4:23 pm