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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. 

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/

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May 9, 2019 at 4:23 pm

Science Policy Around the Web – April 12, 2019

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By: Saurav Seshadri, PhD

Photo by Elijah Hiett on Unsplash

With Vertex, NHS back at the pricing table, CF advocates ratchet up the pressure

petition demanding coverage of the cystic fibrosis (CF) drug Orkambi in the UK has now garnered over 100,000 signatures, and must therefore be considered by Parliament for debate.  The milestone is the latest development in the struggle between Orkambi maker Vertex Pharmaceuticals and the British government, which began soon after Orkambi was approved in 2015.  The main point of contention is the price of the drug.  The UK’s National Institute for Health and Care Excellence (NICE) has refused to recommend Orkambi at Vertex’s asking price of £104,000 ($136,000) per patient per year, but Vertex has rejected the UK’s offer of £500 million for 5 years’ access, leaving both parties at an impasse.

The UK is not the first country to clash with Vertex over pricing. Several health agencies have refused to pay for Orkambi on the grounds that it is only marginally effective; some now face lawsuits, as programs like Medicaid are required to provide available drugs for qualifying patients.  While Orkambi is not as effective as Vertex’s first drug Kalydeco, it can be prescribed to more patients (up to 50% of those with CF).  Life expectancy for patients with CF is less than 40 years, and many patients are children, so even small improvements can be life-changing.  However, as with the multiple sclerosis drug Ocrevus, NICE seems unlikely to relent; on the contrary, UK Health Minister Matt Hancock recently accused Vertex of ‘hold[ing] the NHS to ransom’ and ‘profiteering’.  

For its part, Vertex is unlikely to compromise on the price of its best-selling drug, which brought in $1.26 billion in 2018.  CEO Jeffrey Leiden insists that this revenue is critical to the company’s continued investment in CF research.  Ironically, this stance may be pushing the UK closer to a measure that would jeopardize all future medical R&D efforts: invoking ‘Crown’ use, which allows the government to sell a patent without the consent of its owner. While the idea has gained support among some British lawmakers, and has been used in the past (to make Pfizer-owned antibiotic tetracycline available in the 1960s), it would face legal challenges that could render it ineffective.  But with public pressure mounting, especially after Vertex recently admitted to destroying almost 8,000 packs of Orkambi amid the standoff, inaction may not be an option for much longer.

(Eric Sagonowsky, FiercePharma)


Why some low-income neighborhoods are better than others

A recent study, published in PNAS, builds upon a body of evidence that while race can influence upward mobility (with white children having a 4-fold higher chance of moving from the lowest to highest income brackets than their black peers), environmental factors also play a major role.  Previous work demonstrated that the neighborhood in which a child grows up has a large effect on their future success, with better outcomes for children raised in low-poverty neighborhoods, regardless of race.  However, black children are significantly less likely to live in such neighborhoods.  To combat racial inequality, it is critical to understand which aspects of poverty impact long-term socioeconomic progress. 

The new study is based on the Opportunity Atlas, and pulls together data from tax returns, Census surveys, police reports, prison admission records, and blood tests conducted by the health department. The data tracks a cohort of children born in 1978-1983 (age 31-37 in 2014), living in 754 Census tracts in Chicago.  The authors report that even after controlling for other variables, a large proportion of the racial disparity observed in adults can be explained by three factors: violence, incarceration, and lead exposure during adolescence.  Since these factors were highly correlated with each other, the authors combined them into a single ‘neighborhood harshness/toxicity’ factor; this variable proved to be a much stronger predictor of income, incarceration, and teen pregnancy than more traditional factors, such as poverty or college education rates.   

That these elements impair social mobility is perhaps not surprising, as exposure to both violence in the community and high levels of lead have both been linked to cognitive impairment. But the magnitude of the effect is striking: for example, according to their model, toxicity exposure could account for 60% of the difference in incarceration rates between black and white men in their sample, and a 10% increase in teen births among black women.  While the authors acknowledge they cannot establish causality, they conclude that ‘Chicago’s residential segregation is disproportionately exposing its black children to neighborhoods that are hazardous to their development’.  Recently elected mayor Lori Lightfoot ran on a platform that includes stopping violence, expanding affordable housing, and ‘investing in our neighborhoods’.  Insight into the mechanisms that perpetuate inequality can only enhance these policies’ power to improve the trajectories of vulnerable kids.      

(Sujata Gupta, Science News


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April 12, 2019 at 5:21 pm

Science Policy Around the Web – February 26, 2019

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By: Mary Weston, Ph.D.

Source: Wikimedia

A Century-Old Debate Over Science Patents Is Repeating Itself Today

In 1923, after the economic devastation of World War I, the Italian senator Francesco Ruffini wanted to bolster scientific research by giving scientists ownership of their discoveries. His scheme would have awarded scientists a patent of sorts on the laws of nature they found. Although he had reasonable scientific support and the backing of the newly formed League of Nations, ultimately scientists around the world strongly rejected the plan for various reasons. Recent proposed changes to scientific discovery patent law possess a striking similarity to these events and proposals nearly 100 years ago.

Ruffini, desiring to increase scientific research, argued that scientists should be able to receive “scientific property” for a discovery, similar to patents awarded for inventions. He cited the example of “Hertzian waves” (i.e. radio waves) as something that resulted in many valuable products. The proposal was a large deviation from the existing law, where patents could only be assigned for inventions – artificial things made by humans, like machines – but not for discoveries of the natural world. Ruffini “was clear that scientific property would not prevent all uses of a natural law. But only practical commercial applications”.

In 2017, the American Intellectual Property Law Association (AIPLA) and the American Bar Association’s Intellectual Property Section (ABA’s IP) both submitted proposals to change current laws (Amendment 35, Section 101) and allow for patents on scientific discoveries. Motivation for change stems from recent Supreme Court decisions regarding patents for medical techniques (use of the BRCA1/2 gene for detecting breast cancer and a blood diagnostic test to fine-tune autoimmune disease treatments). Currently legislators, specifically Senators Thom Tillis and Chris Coons, are revisiting these guidelines and roundtables were held in both January and February of this year. 

The demise of the previous 1920s proposal was due to details in implementation, very similar to the problems current proposals face today. These include how to:

  • attribute scientific property when there are many contributors to one discovery (i.e. who “discovered” electricity? Benjamin Franklin? George Ohm?). 
  • deal with unexpected liability, potentially requiring some sort of scientific property insurance scheme. 
  • deal with the scope of some scientific discoveries, possibly being so large that it leads to tremendous and costly amounts of ligation. 
  • write the patents with the specificity required without being too vague and/or speculative. 

Edward S. Rogers, a Chicago lawyer who assisted Ruffini with his proposals in the 1920s, ultimately warned against it in 1931, saying that while the plan was appealing, “the whole scheme seems impractical.”

If changes to the patent law are to occur, the same issues that prevented change nearly 100 years ago will need to be solved – a daunting and challenging task.

(Charles DuanSlate

Japanese Spacecraft Successfully Snags Sample of Asteroid Ryugu

The Hayabusa2, a Japanese asteroid-sampling spacecraft, just successfully retrieved surface pieces from Ryugu, a 3000-foot wide asteroid. To obtain the sample, the probe fired a 0.2 ounce tantalum “bullet” into the boulder-covered surface at close range, and then collected disturbed particles using a “sampling horn” located on the underside of the machine. 

The Japanese Space Agency (JAXA) launched the Haybusa2, Japanese for Peregrine Falcon, in December 2014. They told CNN that even reaching the asteroid, 180 million miles from earth, is the “equivalent of hitting a 2.4-inch target from 12,400 miles away”. Upon arrival, the probe circled the small asteroid for 1.5 years collecting data. Then, last September, two probes were successfully released to image and document the asteroid surface. 

The goal of this exploration journey is to better understand the early history and evolution of the solar system. Ryugu is a C-type asteroid, the category that ~75% of known asteroids falls into, and is thought to contain water and other organic materials. One theory suggests that much of earth’s water and organic compounds may have been delivered by asteroids and comets. This will be the first time scientists have visited and collected samples from this type of asteroid and evaluation of its composition may “clarify interactions between the building blocks of Earth and the evolution of its oceans and life,” JAXA described

JAXA is planning two additional sampling expeditions in the next couple of weeks. This second mission will collect additional surface material. The third will use a copper projectile to create a surface crater in order to obtain samples from beneath the asteroid’s surface, which has been weathered by deep-space radiation. The Haybusa2 will depart the asteroid in December 2019 and should arrive back to earth in December 2020.

(Mike WallSpace.com)

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March 1, 2019 at 12:58 pm

Science Policy Around the Web – February 26, 2019

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By: Jennifer Patterson-West, Ph.D.

Source: Ellsworth Airforce Base

Scientists Release Controversial Genetically Modified Mosquitoes In High-Security Lab

Malaria is a parasitic disease that affects more than 200 million people each year.  Symptoms can range from mild to severe, and include high fever, chills, and flu-like symptoms.  These symptoms are more dangerous to children under the age of 5, which account for 77% of related deaths.

The life cycle of malaria requires two hosts: humans and female Anopheles mosquitoes.  It is important to note that not all species of Anopheles mosquitoes are good vectors, in fact, only 30-40 of the approximately 430 species transmit malaria in nature. The life cycle of malaria is also dependent on additional environmental factors including ambient temperature and humidity. Together these factors account for the geographic distribution of malaria. Although malaria is found more than 100 countries, transmission is most prevalent in Sub-Saharan Africa and in parts of Oceania including Papua New Guinea. 

In the past decade, major gains have been made to control the disease in developing nations thanks to increased funding. Current preventative measures include insecticide-treated netsindoor residual spraying, and intermittent preventative treatment for individuals at increased risk including pregnant women and infants.

In early February, a high-security laboratory in Terni, Italy launched a study to evaluate a new powerful weapon against the mosquito vector.  This new weapon is a genetically modified mosquitothat can spread a genetic mutation lethal to its own species. Researchers targeted the gene “doublesex” to producing female mosquitos that are sterile and have mouths resembling male mosquitos, which are unable to bite.  

The goal is to dramatically crash or reduce the local population of the main species of malaria spreading mosquitoes, Anopheles gambiae. To increase heritability of the mutation, researchers utilized CRISPR technology to engineer a “gene drive” into the genetically modified species. Gene drive inheritance ensures that nearly all progeny inherits the mutation.

Despite the need for new methods for reducing malaria, activists and other scientists warn that the technology can have unforeseen effects on the environment.  The environmental group, Friends of the Earth, is part of international coalition protesting the use of these new genetically modified organisms. Jim Thomas of the ETC group, has noted concern that gene drive technologies can also be used to develop biological weapons.  

To reduce the risk associated with releasing the gene-drive mosquitoes, the project plans years of additional study that will methodically and cautiously evaluate the mosquitoes and their potential environmental impacts with close consultation from other scientists, government officials, and local residents in Africa.

(Rob Stein, NPR)

With one manufacturer and little money to be made, supplies of a critical cancer drug are dwindling

Bacillus Calmette-Guerin (BCG) is a potent immunotherapy for the treatment of fast-growing bladder cancer.  BCG was initially used in 1921 as a tuberculosis vaccine.  In the 1970s, BCG was shown to stimulate the immune system to attack tumor cells when administered through a catheter into the bladder of cancer patients. Since then, BCG has become a potent treatment for intermediate and high-risk non-muscle invasive (NMI) urothelial cancer (UC) of the bladder.

Bladder cancer is the nation’s sixth most prevalent cancer with approximately 80,000 new cases each year.  About 20% of these patients are diagnosed with a type of bladder cancer that can be treated with BCG.  Although BCG doesn’t work for all eligible patients, the response rate is more than 70%.

Despite the established potency of BCG, there is a critical national shortage.  Supplies of BCG have been erratic since 2011, when the United States Food and Drug Administration (FDA) promptly shut down the Sanofi manufacturing lab after a failed inspection.  After continued regulatory issues, Sanofi stopped production of BCG in 2016. Merck is now the only manufacturer of BCG for the Unite States and European markets.

Merck has acknowledged short supplies and indicated that they are currently working at capacity.  Tyrone Brewer, the vice president of global oncology marketing at Merck, has indicated that the company intends to continue producing BCG for “the foreseeable future.”

During shortages, chemotherapies, such as mitomycin, can be used as alternative therapies.  However, they have lower efficacy and a higher price tag than BCG. During the 2014 BCG shortage, the cost of mitomycin increased by 99% further exacerbating the financial burden of these alternative therapies. 

In response to erratic supply of BCG, the Southwest Oncology Group has launched a clinical trial (S1602) to compare the TICE BCG strain currently used in the United States to the Tokyo Strain.  The FDA will consider the results of this trial as critical information for approving the Tokyo strain for use in the United States. 

In the meantime, urologists have begun to divide dosages into thirds to prolong supplies.  However, a recent literature review indicated that a large scale, well-designed, prospective study is need to establish a standard dose and maintenance instillation for reducing recurrence rate since the efficacy of lower dosage is unclear from existing data.

The University of Utah Drug information Service reported that in 2015 approximately 265 generic drugs were in short supply in the United States.  Of potentially greater concern than the current shortage of BCG are generic drugs that can have immediate life and death consequences. For instance, a retrospective study of the norepinephrine shortage in 2011 indicated a 10% higher mortality rate during hospitalization when the alternative vasopressor, phenylephrine was used.

A recent perspective from Davies et al. argues that current policy efforts have not sufficiently prevented supply disruptions of important generic drugs.  A major consideration for dealing with generic drug shortages are the unintended consequences of current policies. For instance, the 2003 Medicare Modernization Act, which sought to protect consumers by limiting the cost increase for generic drugs to 6% above the Medicare average sale price (ASP). This restriction may not provide manufactures with sufficient proficient to invest in production facilities.  

Further compounded these issues is the fact that manufacturers face few negative consequences during shortages, whereas an excess in supply cuts in to profit margins. To provide additional incentive for maintaining reliable supplies of generic-drugs, Davies et al. suggested that the FDA prioritize the review of future generic-drug applications from companies that “maintain generic drug production without quality-control problems”.  In November, the FDA issued a news release about efforts to address drug shortages, which included remedying the underlying problems when a shortage arise within their current authorities.  In today’s political climate, any policy reform or expanse to FDA’s authority to mitigate future shortages and provide incentives for the production of generic medications will require cross-party support. 

(Meghana Keshavan, STAT news)

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February 26, 2019 at 1:44 pm

Science Policy Around the Web – April 10, 2018

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By: Allison Dennis B.S.

Linkpost_20180410

source: pixabay

Mental Health

Many People Taking Antidepressants Discover They Cannot Quit

15 million American adults have taken antidepressants for a period longer than five years, in spite of the fact that these drugs were originally approved for short-term treatment, lasting less than nine months. Many doctors agree that a lifetime prescription may be necessary for the treatment of some patients. However, many are concerned that some patients may simply be accepting long-term use of antidepressants when faced with the challenge of stopping.

Surveys have shown that choosing to stop long-term medications is not a straightforward process with many patients reporting withdrawal effects. Some antidepressants take weeks to break down and leave the body, and their absence can induce feelings of anxiety, insomnia, nausea, “brain zaps,” and even depression itself. Antidepressants are one of the most frequently prescribed therapeutics by physicians, yet the drugs’ labels do not outline how to end a prescription safely. Patients may have to turn to online resources, including  The Withdrawal Project, which provides a community based approach to provide support, but whose writers are self-described as “laypeople who have direct personal experience or who have supported someone else in the process of reducing or tapering off psychiatric medication,” but are not medical professionals.

The benefits of antidepressants in the treatment of depression is undeniable, leaving government regulators cautious about limiting their availability. Antidepressant manufacturers appear unwilling to dive into research characterizing the discontinuation syndrome experienced when patients try to stop, feeling their efforts to demonstrate the drugs are safe and effective is sufficient. Academic and clinical researchers have occasionally tackled the issue, but few studies have looked at the barriers facing open-ended antidepressant prescription holders.

(Benedict Carey and Robert Gebeloff, The New York Times)

Alzheimer’s Disease

Scientists Push Plan To Change How Researchers Define Alzheimer’s

Currently, the 5.7 million Americans living with Alzheimer’s are identified through a panel of symptoms including memory problems or fuzzy thinking. However these symptoms are the product of biological changes scientists feel may be an earlier and more accurate marker of disease. On the biological level, Alzheimer’s can be characterized by the accumulation of several characteristic structures in brain tissue including, plaques, abnormal clusters of protein that accumulate between nerve cells, tangles, twisted fibers that form inside dying cells, and the build up of glial cells, which ordinarily work to clear debris from the brain. It is unclear if these changes are driving the widespread disconnection and destruction of neurons exhibited in the parts of the brain involved in memory and later in those responsible for language and reasoning in the brains of Alzheimer’s patients or just a byproduct of a yet-to-be-discovered process.

A work group formed by collaborators at the National Institute on Aging and the Alzheimer’s Association are putting forward a research framework which defines Alzheimer’s by the progression of a panel of risk factors, including neuropathology, tangles, plaques, and neurodegeneration. By allowing these biomarkers to fall along a continuum, the group is accommodating the observation that the exhibition of these traits can vary widely between individuals and may not always co-occur with symptoms. Yet the framework is intended to “create a common language with which the research community can test hypotheses about the interactions between Alzheimer’s Disease pathologic processes.”

Although much of the research is preliminary, specialized brain scans and tests of spinal fluid are already being designed to identify these biomarkers directly. The biomarkers included on the continuum can be observed 20-30 years prior to symptoms, fostering the hope that early interventions could be implemented to slow disease progression or even prevent it in the first place.

(Jon Hamilton, NPR)

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April 11, 2018 at 6:11 pm

Science Policy Around the Web – March 27, 2018

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By: Patrick Wright, Ph.D

20180327_Linkpost

source: pxhere

Right to Try Drug Access

Why Can’t Dying Patients Get the Drugs They Want?

The United States House of Representatives passed “Right to Try” legislation last week (HR 5247, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018”), which allows terminally ill patients access to experimental drugs that are only required to have completed Phase 1 of a clinical trial, bypassing approval of the Food and Drug Administration (FDA). These patients are those with life-threatening illnesses who have exhausted approved treatment options and are not eligible to participate in a clinical trial (e.g. due to not meeting inclusion criteria) designed to evaluate the desired drug. However, this access still requires cooperation and permission from the drug companies themselves. Hesitation on the side of these companies can be rooted in the potential risk of jeopardizing ongoing clinical trials and the long process of bringing a drug to market. Furthermore, drug companies often do not have a sufficient extra supply of a product to provide to patients. The logistics of granting access could slow efforts to get the drug approved. Opponents of this legislation cite patient safety concerns and the failure to address the fundamental issue of pharmaceutical company denial of access as the most significant problems that still must be addressed.

Some companies acknowledge the importance of FDA oversight and would continue to seek FDA permission even if a Right-to-Try bill becomes law. Dr. Joanne Waldstreicher, the Chief Medical Officer of Johnson & Johnson, said “In our view, the FDA plays a really important role.” It has “information that we don’t have necessarily; they see safety and efficacy information on products that may be similar.” The legislation includes language that could potentially encourage companies to participate, including preventing the FDA from considering the experiences of patients using the drug when approving drugs. The FDA itself already approves 99 percent of applications to its expanded access program for access to investigational drugs for patients facing serious illnesses.

The Right to Try campaign was initiated by the Goldwater Institute, a libertarian, free-market public policy research and litigation organization, and championed by Vice President Mike Pence. Currently, Right to Try legislation has been enacted by 38 states. Victor Riches, president and Chief Executive Officer of the Goldwater Institute said the passing of this bill “is a win for patients. Millions of Americans who have been told they are out of options and it’s time to get their affairs in order, are closer to having the opportunity for one last treatment, without having to get permission from the federal government first.”

In August 2017, the United States Senate unanimously also passed a Right to Try bill (S 204); notably, it was passed under pressure by Ron Johnson (R-WI) who threatened to hold up a five-year reauthorization of FDA user fee programs if he did not get a vote on the bill. However, the narrower House bill has key differences compared to the Senate version, with House Energy and Commerce Committee Chairman Greg Walden (R-OR), along with FDA Commissioner Scott Gottlieb and other interest groups, having specified additional provisions including limiting the types of patients who can access the pathway and giving the FDA more information regarding the use of the pathway. Because the House bill differs from the earlier Senate bill, the Senate must vote on this revised version. Last week, Senator Minority Leader Chuck Schumer (D-NY) blocked Ron Johnson’s attempt to secure unanimous consent in the Senate to pass the House version of the bill. Senator Schumer stated that the Senate had already passed its version and that he wanted to work on a compromise bill.

(Katie Thomas, The New York Times)

Animal Welfare

Congress Orders USDA to Restore Transparency, Completeness, to Animal Welfare Reports

The U.S. Department of Agriculture (USDA) blacked out a public database containing animal welfare inspection reports and records of enforcement actions that the USDA carried out against violations of the Animal Welfare Act in early 2017. The records were often later reposted after varying levels of redaction, eliciting resistance and objection from proponents of animal research and animal welfare activist groups. Last week, Congress released a report that accompanied the USDA’s 2018 spending bill. It stated that these redactions and the obfuscation in accessing USDA information on inspections and their subsequent enforcement violates previous congressional direction and that “the online searchable database should allow analysis and comparison of data and include all inspection reports, annual reports, and other documents related to enforcement of animal welfare laws.”

On the same day that the report was released, the Humane Society of the United States (HSUS) filed a lawsuit against the Animal and Plant Health Inspection Service (APHIS), the USDA entity responsible for conducting animal welfare inspections. HSUS had requested documentation (e.g. inspection reports) for three puppy breeding facilities (“puppy mills”) via the Freedom of Information Act (FOIA) and were, in response, provided reports by APHIS with significant contents redacted. The USDA’s FOIA office wrote that because the requested reports were about businesses that operated out of an individual’s private home, they could not be disclosed without that person’s consent. This is not the first lawsuit in response to the blackout that has been filed by animal welfare groups against the USDA. The Animal Legal Defense Fund as part of a coalition with other animal activist organizations (Stop Animal Exploitation Now, Companion Animal Protection Society, and Animal Folks) previously filed a lawsuit in February 2017 against the USDA’s handling of inspection report transparency and availability (Animal Legal Defense Fund v United States Department of Agriculture) that was dismissed by federal Judge William H. Orrick on the grounds that FOIA provides an “adequate, alternate remedy”. The coalition has since appealed the decision.

To explicitly describe the approach and process underlying the blackout and redactions, APHIS states on its website: “APHIS, during the past year, has conducted a comprehensive review of the information it posts on its website for the general public to view. To conduct the review, the entire agency search tool database, along with additional documents, was taken off line. As a result of this review, APHIS has removed certain personal information from APHIS’ website involving the Horse Protection Act and the Animal Welfare Act. APHIS recently reposted certain inspection reports and research facility annual reports that were determined to be appropriate for reposting.” It also states “The agency will continue to review records and determine which information is appropriate for reposting. Those seeking information from APHIS regarding inspection reports not currently posted to the website, regulatory correspondence, and enforcement related matters may submit FOIA requests for that information.”

It appears that the language in the new Congressional report, part of the new omnibus spending bill that was just approved by Congress and President Donald Trump, has support among the animal welfare community. Cathy Liss, president of the Animal Welfare Institute, based out of Washington, D.C., stated “The Animal Welfare Institute applauds Congress for forcing USDA to lift its veil of secrecy.” Similarly, Kathleen Conlee, vice president for animal research at HSUS said she is “very pleased” with the report and that the “HSUS has been working closely with Members of Congress over the past year to address USDA’s outrageous purge and redaction of these vital documents.”

(Meredith Wadman, Science)

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Written by sciencepolicyforall

March 27, 2018 at 12:27 pm

Pharmaceutical Detailing: in the US the Details are Tied the Prescriber’s Name

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By: Allison Dennis B.S.

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Source: pixabay

While U.S. privacy laws protect patients from direct pharmaceutical marketing and shield their personal information from data mining, physicians are routinely identified based on their prescribing habits and targeted by pharmaceutical companies through personalized marketing campaigns. By their very nature, these campaigns aim to influence the behavior of prescribers. In other countries, including those protected by the European Union’s Data Protection Act, the personal identification of prescribers through medical data is strictly forbidden. However, in the U.S. these personalized campaigns are made possible by a robust pipeline of data sharing.

The pipeline begins with pharmacies, who routinely sell data derived from the vast volume of prescriptions they handle. While the prescribers’ names are usually redacted, IMS Health, a key health information organization in the pipeline, can easily use the American Medical Association (AMA)-licensed Physician Masterfile to reassociate physician ID numbers with the redacted names. The physician ID numbers are issued by the U.S. Drug Enforcement Administration (DEA) and are sold to AMA through a subscription service. IMS Health uses the prescription data to develop analytic tools for sale to pharmaceutical companies desperate to gain a marketing edge with individual prescribers. The tools consolidate the activity of nurse practitioners, dentists, chiropractors, and any professionals who can legally file a prescription. Marketers can use these tools to determine how much each named physician is prescribing, how that compares to other named physicians, what their specialty is, etc.

The data contained in the AMA’s Physician Masterfile is applicable for informing research and conducting surveys of practicing physicians, yet the need to identify physicians by name is usually not needed for public health research and enables prescriber manipulation.  The prescriber reports compiled by IMS Health enable pharmaceutical companies to take a data-driven approach to direct-to-physician advertising, a practice known as detailing. During a 17-month period between 2013 and 2015, pharmaceutical companies reported spending $3.5 billion in payments to physicians covering promotional speaking, consulting, meals, travel, and royalties. While many of the expenditures may be tied to legitimate collaborations between pharmaceutical companies and medical professionals, the U.S. Department of Health and Human Services warns that free samples, sham consulting agreements, subsidized trips, and industry-sponsored continuing education opportunities are all tools used by vendors to buy medically irrelevant loyalty. Indeed, physicians themselves seem conflicted over the significance of these relationships. When residents were asked if contact with pharmaceutical representatives influenced their prescribing practices, 61% believed they were unaffected. However, the same residents felt that only 16% of their peers were similarly immune to contact with pharmaceutical representatives.

Studies examining the role of detailing  have found it associated with higher prescribing frequency, higher costs, and lower prescribing quality, all with no contrasting favorable associations. Recent concerns over conflicts  of  interest arising from increased exposure of physicians to detailers led several academic medical centers to restrict sales visits and gift giving and implement enforcement mechanisms. Compared to hospitals with no detailing limitations, hospitals with limitations underwent an 8.7% relative decrease in the market share of detailed drugs and a 5.6% relative increase in the market share of non-detailed drugs. Overuse of brand-name drugs, which are most commonly associated with detailing, cost the US approximately $73 billion between 2010 and 2012, one-third of which was shouldered by patients. Advocates of the practice lament the lack of formal academic opportunities for physicians to learn about new drugs, believing the educational materials provided by pharmaceutical representatives fulfills a need.

The most tragic example of the potential harms of detailing targeting individual prescribers comes from the early days of the prescription opioid crisis. Purdue Pharma, the maker of OxyContin, used prescriber databases to identify the most frequent and least discriminate prescribers of opioids. Sales representatives, enticed by a bonus system that tracked their success according to upswings captured in the prescriber database, showered their target prescribers with gifts while systematically underrepresenting the risk of addiction and abuse from OxyContin. Recruitment into Purdue’s national speaker bureau and subsequent paid opportunities were further used to entice lukewarm and influential prescribers.

The last decade has seen several attempts to address the influence of detailing at the institutional, professional, and executive levels. Individual hospitals have begun limiting the access of physicians to vendors. The American Medical Student Association began issuing a conflict-of-interest scorecard, allowing all U.S. medical schools to track and assess their own detail-related policies, including those related to the limiting of gifts from the industry, industry-sponsored promotional speaking relationships, permitted accesses of pharmaceutical sales representatives, and overall enforcement and sanction of these policies. In 2016, 174 institutions participated. The AMA, which licenses the list of physician names used by health information organizations companies, has offered physicians the chance to block pharmaceutical representatives and their immediate supervisors from accessing their prescribing data. However, the Physician Data Restriction Program does not limit the ability of other employees at a pharmaceutical company to access prescribing data of doctors who have opted out. Physicians must renew their request to opt out every three years and are automatically added to the Masterfile upon entering medical school. Five years after the program’s introduction in 2006, just 4% of practicing physicians listed on the file had opted out.

In 2007, the state of Vermont outlawed the practice of selling prescription data for pharmaceutical marketing without prescriber consent. The law was quickly challenged by IMS Health, the Pharmaceutical Research and Manufacturers of America, and other data aggregators and eventually struck down by the U.S. Supreme Court. Vermont legislators held that detailing compromises clinical decision making and professionalism and increases health care costs and argued that the law was needed to protect vulnerable and unaware physicians. However, the Court held that speech in the aid of pharmaceutical marketing is protected under the First Amendment and could not be discriminately limited by Vermont law.

Congress made the first federal attempt to address the issue by enacting the Physician Payment Sunshine Act in 2010, which required companies participating in Medicare, Medicaid, and the State Children’s Health Insurance Program markets to track and collect their financial relationships with physicians and teaching hospitals. The transparency gained from the disclosures have allowed many researchers to systematically evaluate connections between conflicts of interests and prescribing behavior.

As policy makers and private watchdogs scramble to address the issues of detailing, the availability of physician names and prescription habits continues to facilitate the implementation of novel tactics. Limits on face time have pushed detailers to tap into the time physicians are spending online. When the names of prescribers are known, following and connecting with prescribers through social media accounts is straightforward. Companies like Peerin have emerged, which analyze prescriber Twitter conversations to learn whose conversations are most likely to be influential and which prescribers are connected. LinkedIn, Facebook, and Twitter all offer the ability to target a list of people by name or e-mail address for advertising. While all online drug ads are limited by the U.S. Food and Drug Administration, pharmaceutical companies are experimenting with the use of unbranded awareness campaigns to circumvent direct-to-consumer regulations.

While personalized prescriber marketing campaigns may be turning a new corner in the internet age, a simple opportunity exists at the federal level to de-personalize the practice of physician detailing. It is unclear the extent that the DEA stands to gain from selling physician ID subscriptions. However, in context of the downstream costs of the overuse of name-brand drugs this may be an appropriate loss. The U.S. Government’s central role in the reassociation of prescribers’ prescriptions could be directly addressed through systematic implementation of revised policy in order to preempt downstream prescriber manipulation.

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Written by sciencepolicyforall

November 9, 2017 at 10:41 pm