Science Policy For All

Because science policy affects everyone.

Posts Tagged ‘drug policy

The Trans-Pacific Partnership and its Impact on Pharmaceutical Affordability

leave a comment »

By: Shakira M. Nelson, PhD, MPH

        For many, the Trans-Pacific Partnership (TPP) was a point of great debate during the 2016 Presidential primaries and election. As a simplified explanation, the TPP is a free-trade agreement involving the United States, Canada, Australia, Japan, New Zealand, Mexico, Chile, Peru, Brunei, Malaysia, Singapore and Vietnam, intended to “level the trading playing field” through the elimination of tariffs and other laws that create trade barriers. In its final form, the TPP would impact up to one-third of world trade and 40% of the global gross domestic product. Many who debated the ramifications of the TPP did so in the context of foreign policy interests. Although aligned with foreign policy, a major part of the TPP deals with intellectual property protection, and pharmaceutical drug development. If implemented, the effects of the TPP could greatly diminish public access to affordable medicines, both domestically and internationally. Moreover, the stronghold the TPP places on intellectual property could limit the development and marketing of less expensive options.

Intellectual property can be divided into two categories: industrial property and copyright. Patents, trademarks, and industrial design fall under industrial property. Patent development is a large part of scientists’ work, seen as almost a necessity to incentivizing innovation. Many argue that, without the ability to patent inventions and significant findings, scientists would not be able to generate profits used to sustain research and development; within the pharmaceutical industry, patents are the proverbial bread-and-butter. When in place, patents create a stronghold around the release of new chemical drugs, which prevents competition by generic brands. The standard length of time of a patent for a chemical drug is 20 years, which starts from the time the drug is invented.

Many new medicines under development today fall under the category of ‘biologics’. As the name suggests, biologics are treatments made from biological sources, and are very different from chemical drugs. Created to treat a multitude of diseases, including Ebola and cancer, biological sources include vaccines, anti-toxins, proteins, and monoclonal antibodies. Given their structural complexity compared to traditional drugs, and use of recombinant DNA technology, biologics are more difficult, and costlier to make. Moreover, manufacturers have a greater burden in ensuring product consistency, quality, and purity over time. This is done through certifying that the manufacturing process remains the same over time. Because of this, it is estimated that the price to manufacture biologics cost on average more than 22 times the price of chemical drugs. Current laws state that generic biologic development, known as biosimilars, cannot be approved until 12 years after the branded product has been approved – this is known as an exclusivity period. This was enacted under the Biologics Price Competition and Innovation Act of 2009, by the Food & Drug Administration (FDA).

The challenge with current policies is establishing a period-of-time that balances the need for companies to generate profits and cash flows, which will incentive them to conduct more research and compensate them for the extensive manufacturing processes, with the need to provide greater access through launching generic drugs and biosimilars. The trouble with the proposed policies of the TPP agreement is that they seem to embolden the pharmaceutical companies by introducing changes that would prevent competition from generics and biosimilars for longer periods of time than the current basic terms. The implications of this are far-reaching, as it may lead to a significant increase in the current costs of pharmaceutical drugs and biologics, hindering the health of the patients who rely upon these treatments.

Critics of the current system of patent length and biologic exclusivity periods fear that rather than incentivizing innovation, companies are being rewarded through their ability to charge higher amounts for drugs without the fear of competition on the market. Health policy experts concur, identifying policies such as the Hatch-Waxman Act of 1984 in allowing for the creation of drug monopolies, and “going too far in compensating the pharmaceutical industry at the public’s expense”. A report released in 2009 by the Federal Trade Commission stated that biosimilar development was more difficult to achieve than traditional generic drugs. For example, development requires comparisons to the original biologic, to prove efficacy and equivalence. Biosimilars must share the same mechanism of action, with no clinically significant differences in terms of safety or potency for the approved condition of use. The steps necessary to achieve this are significant, and therefore imposing a 12-year exclusivity period on biologics may be unnecessary. US Congressmen have pushed to compromise, floating an amendment to the TPP that would lower the exclusivity period to 8 years. However, critics and patients who rely upon drug competition to lower market prices, have protested this amendment stating that costs of new drugs and biologics are too high, and 8 years is too long of a length of time to wait for affordable generics and biosimilars to come on to the market.

The impact of decreasing the length of time it takes for biosimilars to come onto the market can be seen with Neupogen, a leukemia drug that was first approved by the FDA in 1991. Delivered via injection, Neupogen costs patients $3,000 for 10 injections. With injections needed daily, this drug could carry a price tag of well over $100,000 per year. It wasn’t until recently, however, that the first biosimilar was approved on the US market. The biosimilar, Zarxio, was approved as a leukemia drug and is priced at more than $1000 less than Neupogen. This pricing has the potential to decrease the yearly costs of this drug from $100,000 with Neupogen to $55,000-$75,000. Further evidence of these financial savings was provided by the Rand Corporation, which predicted a savings of over $44 billion over 10 years with an increased approval of biosimilars, for patients who rely upon these specific cancer treatments.

Internationally, the policies of the TPP also have far reaching effects on the availability and costs of pharmaceuticals. The 12-year exclusivity period would be imposed upon the other countries involved in the TPP, where currently for some, such as Brunei, there is no current exclusivity protection. By imposing the 12-year period, global competition could become restricted. Additionally, the TPP proposes other key patent protections that play a bigger role on the international market. One protection, known as evergreening, allows drug companies to request patent extensions for new uses of old drugs. The immediate effect of this is an extension of monopolies on drug sales for minor reasons. The second protection allows pharmaceutical companies to request patent extensions if it takes “more than 5 years for an application to be granted or rejected.” Advocacy groups fear that the price of drugs would undermine the efforts of health initiatives, such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria. These initiatives rely upon price competition to manage costs, with the availability of cheap generics helping drive costs down.

Although the current administration has ended the USA’s association with the Trans-Pacific Partnership, it is important to note that other countries may try to implement some of the policies, affecting the availability and affordability of drug treatments. To decrease this burden, the US could work to assist in negotiating exceptions for the poorer and smaller countries, to help them meet any challenges they may come up against. Within the US itself, it is important for policies, laws and any future trade agreements to be modified, with more of a focus on the affordability and regulation of drugs and biologics. Imposing price controls may offer a modest benefit, but may not be a long-term solution. A focus on lowering the patent length for new drugs and biologics can be an immediate step. Although the push back from pharmaceutical lobbyists will be substantial, alleviating the financial burden on families afflicted with cancer and diseases should be the focus.

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

Science Policy Around the Web – March 7, 2017

leave a comment »

By: Allison Dennis, BS

Synthetic opiates

Opioid Crisis

Keeping up With the Synthetic Opioids

At the center of the opioid crisis is an ever-expanding class of would-be-regulated drugs, exploited for their ability to produce morphine-like effects. Opioids, including morphine, heroin, and oxycodone interact with the opioid receptors found on the surface of our nerve cells to trigger feelings of euphoria, and block pain. Unfortunately, these substances can adversely affect the respiratory rhythm generating area of the central nervous system, resulting in respiratory depression, effectively disrupting the body’s instincts to breathe.

In 2013, the U.S. Drug Enforcement Agency began to detect in confiscated supplies of heroin the synthetic compound, Fentanyl, which is 50 to 100 times more potent and carries a much higher risk of respiratory depression. The supply was traced to illicit online pharmacies in China, prompting Chinese officials to implement an export ban on fentanyl. Just as medical drug makers audition new compounds through structure-based drug design, illicit drug makers quickly modified the structure of fentanyl to produce furanyl fentanyl, temporarily circumventing the ban. This was followed by the production of the elephant tranquilizer, carfentanil. As of March 1, 2017, China has placed a ban on the sale and manufacture of these compounds along with acrylfentanyl and valeryl fentanyl.

However the dynamic that has emerged is a global game of whack-a-mole. Cutting off the global supply of fentanyl-derived compounds will require negotiations with individual governments to cooperate in their ban. Willing chemists in Mexico may already be setting up to fill the gap left by the ban in China. As each substance is entering the U.S. Drug Enforcement Agency’s radar, the list of designer fentanyls is expanding. The rotating portfolio of synthetic opioids has left local law-enforcement and coroners stumped as to how to test for drugs not-yet-known to their screens, leaving a critical lag in identifying local suppliers. (Eric Niler, Wired Magazine)

Influenza

Keeping up with the Neuraminidases

The H7N9 strain of bird flu may be gaining ground as a global threat to human health. On Monday, the U.S. Department of Agriculture confirmed the presence of a highly pathogenic H7 avian influenza strain in a flock of chickens in Lincoln County, Tennessee. The agency is hurrying to establish the neuraminidase protein type, or “n-type” of the virus. In combination with the H7 hemagglutinin type, an N9 would consign this virus to the class of influenza the WHO has described as “definitely one of the most lethal influenza viruses we have seen so far.”

First detected in China in 2013, the H7N9 strain has been the source of yearly epidemics of human infections. These infections are characterized by severe respiratory illness, which has lead to death in 40% of cases. Over 5 flu seasons, 1222 human cases of H7N9 flu have been confirmed. Most infections have been tied to direct exposure to poultry where the avian strain circulates, indicating that the virus is not currently suited for sustained person-to-person spread. However, the ability of these viruses to recombine, gaining new specificities, keeps public health officials watchful.

Following the first reports of H7N9 infections in humans in 2013, the U.S. Department of Health and Human Services amassed a 12 million-dose stockpile of H7N9 specific vaccines. However, the strains selected as the seeds for these vaccines may not adequately protect against the particular H7N9 virus circulating now.  The U.S. CDC is currently evaluating the need to update its vaccine stockpiles in addition to recommending inclusion of H7N9 in next year’s seasonal flu vaccine. Many researchers are hoping to circumvent these concerns with the development of a universal vaccine, protective against all known flu strains. (Helen Branswell, STATnews)

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

Written by sciencepolicyforall

March 7, 2017 at 9:02 am

Science Policy Around the Web – February 10, 2017

leave a comment »

By: Saurav Seshadri, PhD

Source: pixabay

Sleep

The Purpose of Sleep? To Forget, Scientists Say

Humans spend approximately one third of their lifetime sleeping, yet the purpose of sleep is still largely unknown. A pair of recent studies in the journal Science suggest that a key function of sleep is to give the brain a chance to rewire itself, specifically by cutting down connections between neurons, which naturally scale up during wakefulness, and especially during learning.

In one paper, researchers used 3D electron microscopy to measure the sizes of these connections, called synapses, in mouse brain slices. They found that sleep produced a significant decrease in the size of synapses. Interestingly, this effect was more pronounced in smaller synapses, which were likely strengthened by general information processing while awake, than large ones (~20% of synapses), which may encode more well-established memories. In the other, researchers used two-photon imaging in live mice to observe sleep-induced changes in synapses. They found a similar decrease in synaptic strength, and went on to identify the signaling pathway that caused this effect; blocking this pathway prevented a normal reduction in the scope and magnitude of a learned behavioral response.

These findings underscore the importance of sleep, especially for memory consolidation involved with learning. Studies like these can have far-reaching effects on the public’s perception of sleep, influencing individual habits as well as policy related to education. For example, they suggest that prioritizing sleep when setting school start times (an issue currently under debate in Montgomery County schools) could improve students’ lesson retention and ultimately their test performance. They also point to important cellular and molecular processes that take place during sleep, which could help explain how existing sleep aids adversely affect brain functioning and memory (a public health concern), and ultimately lead to the development of better drugs. (Carl Zimmer, The New York Times)

Drug Policy

Massive Price Hike for Lifesaving Opioid Overdose Antidote

Increased public exposure to the epidemic of opioid abuse, which continues to intensify in the US, has made it increasingly influential in politics, possibly including the recent presidential election.  A crucial tool for communities at the forefront of this public health crisis is naloxone, which can reverse potentially fatal symptoms associated with overdose. The Evzio naloxone auto-injector, produced by Kaleo, is one of two such products approved by the FDA. Kaleo has recently come under fire for increasing the price of Evzio from $690 to $4,500.

Kaleo cites several justifications for the price hike. Firstly, they offer coupons to patients whose insurance doesn’t cover Evzio. Second, they argue that large insurance companies and government agencies (such as the Veterans Health Administration, which sees a high rate of opioid use) can negotiate prices, while other organizations are currently well funded (thanks to public concern) to absorb the increase. Thirdly, they are expanding their donation supply to allow smaller groups to apply for free devices. However, experts say that the increase is not justified by production costs, and some organizations have been forced to switch to alternative drugs.

News of the decision arrives at a time when the public is particularly sensitive to drug pricing, and have made their concern clear to lawmakers. Negotiation with drug companies over prices has been a prominent campaign issue in recent elections. Public outcry following similar moves by investor Martin Shkreli and Mylan led to hearings by a special congressional committee. Soon after the last election, a bill that would have allowed patients to import cheaper drugs from Canada became a high-profile occasion for posturing in the Senate, where it failed despite overwhelming public support. These stories highlight the often antagonistic relationships between the American public, its government, and the pharmaceutical industry, and illustrate how disruptive drug pricing can directly affect policy. (Shefali Luthra, Scientific American)

Scientists in Politics

Geneticist Launches Bid for US Senate; while Empiricists Around the Country Will March for Science

Donald Trump’s agenda of self-serving lies and denial of evidence has led to unprecedented levels of engagement and activism across the country. The scientific community has been especially impacted by Trump’s brand of broad, allegedly populist anti-intellectualism. Thus, although the empirical facts uncovered by scientific research are inherently apolitical and should be treated as such, scientists are beginning to mobilize to oppose the Trump administration in several ways.

One essential path to policy change is increased representation. With that in mind, evolutionary biologist Dr. Michael Eisen, an HHMI-funded investigator at UC Berkeley and co-founder of the People’s Library of Science (PLOS), recently announced his candidacy for the US Senate in 2018. Dr. Eisen’s platform seems to center on bringing a scientific perspective to Senate proceedings, and working towards comprehensive yet practical solutions to issues such as climate change. More of Dr. Eisen’s views can be found on his twitter feed and blog.

Protests are another way for individuals to make their voices heard by policy makers. The March for Science, which currently has over 350,000 followers on Facebook, will be an opportunity for ‘scientists and science enthusiasts’ to both call for and demonstrate support for the scientific community, and promote solidarity between science and the public. The main march will be held on April 22nd, 2017 in Washington D.C.; satellite marches are scheduled in over 100 additional cities. Organizers hope to maintain the momentum gained by January’s Women’s Marches, which saw historic attendance. (Sara Reardon, Nature News; Lindizi Wessel, ScienceInsider)

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

Science Policy Around the Web – December 23, 2016

leave a comment »

By: Joel Adu-Brimpong, BS

Source: Flickr, by Ben Gordon, under Creative Commons

Public Health

Looking Beyond Flint

All eyes turned to the city of Flint, Michigan as it burst onto the national scene after reports revealed that children were being exposed to dangerously high levels of lead in their drinking waters. Although shocking, a recent study shows that the Flint narrative is no abnormality. “In fact, it doesn’t even rank among the most dangerous lead hotspots in America,” states Reuters, an international news agency and investigative body that conducted the study.

In this Reuters report, it was discovered that almost 3000 areas in the country had at least twice the lead poisoning rates of the infamous Michigan city, with much less press coverage. In some areas, such as Baltimore, Cleveland and Philadelphia, areas with multigenerational lead poisoning, about 40 to 50 percent of children had elevated levels of lead. Nationwide estimates by the Centers for Disease Control and Prevention (CDC) purport that approximately 2.5 percent of small children, children between ages one and five, present highest levels.

For this study, Reuters obtained lead poisoning data from state health departments and the CDC. But rather than peruse and detail state or county-level data, Reuters pursued more granular results; testing for lead poisoning at the neighborhood-level. Altogether, Reuters observed 2,606 census tracts, or small county subdivisions, and 278 zip codes across the country with at least twice the prevalence rate of lead poisoning as Flint. It was noted that while poverty remains an integral predictor of lead poisoning, victims span the American tapestry of rich and poor, urban and rural and black and white.

Federal aid to assist states in lead poisoning management is quite limited. After the Flint debacle, Congress delivered $170 million in aid to Flint. However, the budget allocated to the CDC to assist states in lead poisoning control is only a fraction of the Flint package. With the 21st Century Cures Act set to withdraw approximately 3.5 billion from the Prevention and Public Health Fund, a fund established under Obamacare, and a pervasive political rhetoric regarding the repeal of Obamacare, lead poisoning may return to its obscure position in the public sphere. (M.B. Pell and Joshua Schneyer, Reuters)

Drug Policy

When Drug Prices Rise, Americans Turn Outward?

A recent study revealed that 70 percent of Americans take at least one prescription drug a day. And if you are among this group, or care for someone on medication, you are most likely aware that drug prices have been rising. In fact, a 2015 poll by the Kaiser Family Foundation (KFF) found that roughly 80 percent of Americans deemed costs of prescription drugs ‘unreasonable.’ A report by the IMS Institute for Healthcare Informatics earlier this year indicated that, after accounting for estimated reimbursements, net medication spending for the 2015 year was roughly $310 billion. So what happens when drug prices exceed affordability in the U.S.?

A poll by KFF last month found eight percent of survey respondents, or roughly 19 million adults in the U.S., had or knew someone in their household who had imported a drug at some point. Drug prices when obtained outside the country (i.e., Canada, Mexico, etc.) may be half the sticker price in the U.S., or even cheaper. This finding comes on the heels of recent spikes in prescription drug prices such as that of Daraprim, a life-saving drug often prescribed for AIDS patients, Cycloserine, a drug used to treat tuberculosis, Epipen, an injection device for patients with severe allergies, and others which have caused national outrage.

Although illegal for Americans, in most instances, to import drugs into the U.S. for personal use due to safety and effectiveness concerns, experts contend that eight percent is a conservative number. Some respondents may be reluctant to report violations of the law or are uncomfortable with talking about daily struggles with drug affordability. Demographics of individuals who imported prescription drugs ranged from young adults in college to elderly retirees, with prescription drugs imported spanning treatments for chronic and acute conditions.

Earlier this week, Senate Democrats sent a letter to Donald Trump urging the President-elect to effect bipartisan support to curb rising drug prices. But with no assurances in sight to curtail the epidemic of rising drug costs, will even more Americans turn outward in order to meet their prescription needs? If so, how might this affect the quality of circulating drugs and medication adherence practices? (Rachel Bluth, Kaiser Health News)

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

Written by sciencepolicyforall

December 23, 2016 at 9:00 am

Science Policy Around the Web – November 22, 2016

leave a comment »

By: Rachel Smallwood, PhD

Photo source: pixabay

Federal Research Funding

US R&D Spending at All-Time High, Federal Share Reaches Record Low

Recently released data from the National Science Foundation (NSF) showed trending increases in scientific research funding in the US across the past several years. Estimates of the total funding for 2015 put the value at an all-time high for research and development (R&D) funding for any country in a single year. In 2009, President Obama stated a goal to devote 3% of the USA’s gross domestic product (GDP) to research, and we have been making slow progress to that point; in 2015, 2.78% of the GDP went to research. Businesses accounted for the largest portion of overall scientific funding, contributing 69% of the funds. The second largest contributor was the federal government; however, it had the lowest percentage share of the total since the NSF started tracking funding in 1953, and the actual dollar amount contributed has been declining since 2011. Therefore, although the overall percentage of GDP going to research is increasing, that increase is driven by businesses, whereas the GDP percentage contributed by the federal government has dropped to almost 0.6%.

When taking a closer look at types of research, the federal government is the largest funding source for basic science research, covering 45% of the total. However, businesses make up the majority of the funding for applied research (52% in 2014) and experimental development (82% in 2014). This disproportionality in funding types combined with the decreases in federal research spending are concerning for the basic science field. There is more competition for less money, and this concern is compounded by uncertainty and questions about President-Elect Trump’s position on and plans for scientific funding. Aside from a couple of issues, primarily concerning climate change and the environment, he has said very little about science and research. Many scientists, institutions, and concerned citizens will be watching closely to see how science policy develops under Trump’s administration and its effects on federal spending and beyond. (Mike Henry, American Institute of Physics)

Biomedical Research

‘Minibrains’ Could Help Drug Discovery for Zika and for Alzheimer’s

A group of researchers at Johns Hopkins University (JHU) is working on a promising tool for evaluating disease and drug effects in humans without actually using humans for the tests. ‘Minibrains’ are clusters of human cells that originated as skin cells, reprogrammed to an earlier stage of development, and then forced to differentiate into human neural cells. They mimic the human brain as far as cell types and connections, but will never be anywhere near as large as a human brain and can never learn or become conscious.

A presentation earlier this year at the American Association for the Advancement of Science conference showcased the potential utility for minibrains. A large majority of drugs that are tested in animals fail when introduced in humans. Minibrains provide a way to test these drugs in human tissue at a much earlier stage – saving time, money, and animal testing – without risking harm to humans. Minibrains to test for biocompatibility can be made from skin cells of healthy humans, but skin cells from people with diseases or genetic traits can also be used to study disease effects.

A presentation at the Society for Neuroscience conference this month demonstrated one such disease – Zika. The minibrains’ growth is similar to fetal brain growth during early pregnancy. Using the minibrains, Dr. Hongjun Song’s team at JHU was able to see how the Zika virus affected the cells; the affected minibrains were much smaller than normal, a result that appears analogous to the microcephaly observed in infants whose mothers were infected with Zika during the first trimester.

Other presentations at the meeting showcased work from several research groups that are already using minibrains to study diseases and disorders including brain cancer, Down syndrome, and Rett syndrome, and plans are underway to utilize it in autism, schizophrenia, and Alzheimer’s disease. Though there might be a bit of an acceptance curve with the general public, minibrains potentially offer an avenue of testing that is a better representation of actual human cell behavior and response, is safer and more affordable, and reduces the need for animal testing. (Jon Hamilton, NPR)

Health Policy

A Twist on ‘Involuntary Commitment’: Some Heroin Users Request It

The opioid addiction epidemic has become a significant healthcare crisis in the United States. Just last week the US Surgeon General announced plans to target addiction and substance abuse. He also stated the desire for a change in perception of addiction – it is a medical condition rather than a moral or character flaw. Earlier this year, the Centers for Disease Control published guidelines that address opioid prescribing practices for chronic pain, strongly urging physicians to exhaust non-pharmacologic options before utilizing opioids. In response to the rising concern over prescription opioid abuse, steps have been taken to reduce prescriptions and access. This has resulted in many turning to heroin – which is usually a cheaper alternative anyway – to get their opioid fix.

One of the first steps in treatment and recovery for addiction and dependence is detoxing. However, opioids are highly addictive and many people struggle with the temptation to relapse. Additionally, many of the programs designed to help with the initial detox have long wait lists, are expensive, and may not be covered by insurance, further deterring those with addiction and dependence from getting the help they need. These factors have caused many to start turning to their states, asking to be voluntarily committed to a program on the basis that they are a danger to themselves or others because of their substance abuse. This is currently an option in 38 states. These programs can be held in either privately-run institutions or in state prisons. However, this practice is controversial because if the person’s insurance does not cover their stay, it falls to tax payers to foot the bill. While this is unpopular with some, advocates say the civil commitment laws are important options while there may be no other immediate ways for an individual to get help. (Karen Brown, NPR)

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

Written by sciencepolicyforall

November 22, 2016 at 9:00 am

Drug policy changes: Marijuana legalization and its therapeutic potential

leave a comment »

By: Kseniya Golovnina, PhD

Source: Flickr, under Creative Commons

On November 8th 2016, nine states voted on legalizing recreational and medical marijuana (Cannabis L.). All US presidential candidates supported relaxing current restrictions on marijuana use. Since 2011, more than 50% of Americans consistently show positive attitudes towards legalizing marijuana. It is estimated that marijuana industry tax revenues for federal, state and local governments could total up to $28 billion. In addition to tax revenues, the non-profit advocacy group the Drug Policy Alliance highlights that marijuana legalization will reduce harm to young people and people of color, create new jobs, save money on law enforcement, and promote development of tests for drug impairment.

One of the challenges in marijuana regulation is how it is generally perceived—either as a drug or as a harmless recreation. On the one hand, it is a central component of the long standing ‘war on drugs’ that is a primary part of US law enforcement. According to the legal system, marijuana remains classified as a Schedule I substance under the Comprehensive Drug Abuse Prevention and Control Act of 1970, along with heroin. On the other, prominent thinkers argue that it is a drug of choice, without a known lethal case, which helps produce serenity and insight, and should be regulated as alcohol and tobacco. Recent policy shifts will strike a new balance between these views.

While prohibited at the Federal level, marijuana decriminalization laws have been passed in several states by lawmakers, and often through public ballot measures. In 25 states, Cannabis is legal for medical use and in 5 states, for recreational use. Out of the 9 states that voted on Nov 8, only Arizona hasn’t supported marijuana initiatives. In 2013, the Obama administration clarified Federal marijuana enforcement to deemphasize some criminal behavior, and remain in harmony with new and evolving state laws. The US Congress is acting as well, with a petition introduced (the CARERS Act) intended to remove conflicts between state and federal laws.

Marijuana in science

Shown clearly by these recent political trends, the public attitude has been shifting rapidly, and legalization appears to be only an issue of time. From a scientific point of view, legalization of Cannabis will open the door for robust federally approved research on marijuana’s therapeutic value. The reasonable scientific question now is whether and to what degree Cannabis can be a real new frontier of therapeutics?

Marijuana chemical science started from the identification of THC (delta-9-tetrahydrocannabinol) as the main active ingredient. Today, more than 460 chemicals are known to be Cannabis ingredients, more than 60 of which are grouped under the name cannabinoids. In the early 1990s, cannabinoid (CB) receptors were discovered and cloned. Cannabinoids, along with their receptors, make up the endocannabinoid (EC) system, which participates in the regulation of neurotransmission. Surprisingly, a number of chocolate-derived chemicals can activate the human cannabinoid system, both directly and indirectly, suggesting that chocolate and marijuana can have overlapping effects. The identification of natural agonists anandamide and 2-arachidonylglycerol, which also act on CB receptors, has stimulated interest in the medical uses of Cannabis. On PubMed the number of publications with the term “cannabis” has increased from 71 in 1990 to 1195 in 2016, revealing both the unexpected Cannabis therapeutic horizons and warnings about its effect on adolescent brain.

A 2003 review on cannabinoids as potential anticancer agents reported, “cannabinoids have favorable drug-safety profiles and do not produce the generalized toxic effects of conventional chemotherapies.” Thirteen years later in 2016, cancer therapy using cannabinoids is still paradoxical but evident. In 2006, based on the analysis of 72 controlled studies evaluating the therapeutic effects of cannabinoids, it was shown that “cannabinoids present an interesting therapeutic potential as antiemetics, appetite stimulants in debilitating diseases (cancer and AIDS), analgesics, and in the treatment of multiple sclerosis, spinal cord injuries, Tourette’s syndrome, epilepsy and glaucoma”. A potential antipsychotic effect of cannabidiol was also reported in 2012. At the 2015 AAAS Annual Meeting, researcher Mark Ware from McGill University Health Centre in Montreal, Canada, reported, “it’s clear that the weight of evidence now is such that cannabinoids are analgesic drugs,” while also emphasized that more studies are needed to understand the best dosing and delivery methods for medical use.

A search on the website ClinicalTrials.gov, maintained by the National Institutes of Health shows 557 clinical trials with ‘known status’ for the term “cannabis” as of October 26, 2016. More than one hundred of them are open now. Topics for these studies relate to Cannabis abuse as well as new treatments for a variety of medical conditions such as schizophrenia, cancer, autoimmune diseases, epilepsy, musculoskeletal diseases, and others. For example, GW Pharmaceuticals Ltd. was conducting clinical trials with Nabiximols (trade name Sativex) to investigate its safety in treating cancer pain. However, out of ten cannabis-related drugs on the world market, only three (including Sativex) are approved for medical use in the US.

Legalization, public interest and scientific research on Cannabis has promoted regulatory agencies such as the Food and Drug Administration (FDA) to develop new policies and guidance. It is stated on the official FDA website that “the FDA supports researchers who conduct adequate and well-controlled clinical trials which may lead to the development of safe and effective marijuana products to treat medical conditions.” Non-profit US Pharmacopeial Convention (USP), a known leader in developing and controlling drug standards, has organized a Cannabis expert committee to develop USP Standards for medical Cannabis. Their aim is to control quality specifications for the Cannabis used in clinical studies.

While the frontier of science appears to be opening for Cannabis in the US, the regulatory regime will need to keep pace. As medical use legalization proliferates, there will be a strong, even urgent need to revamp regulation to accommodate and emphasize research and best uses. Until the regulations are properly developed there will be some uncomfortable unknowns from a public health perspective, leading to greater risks and missed benefits.

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

Written by sciencepolicyforall

November 14, 2016 at 9:00 am

Posted in Essays

Tagged with , ,

Science Policy Around the Web – November 6, 2015

leave a comment »

By: Sylvina Raver, Ph.D.

Photo source: pixabay.com

Education and Mental Health

Sesame Street’s new brand of autism education

There’s a new Muppet on the block: her name is Julia, she’s in preschool, and she has autism. Julia’s arrival on Sesame Street is part of a coordinated effort by the Sesame Workshop – the nonprofit organization behind the long-running educational children’s program – to reduce the stigma associated with autism and to normalize the disorder among preschool children. The initiative, called Sesame Street and Autism: See Amazing in All Children, is a web-based project with resources for parents that include videos aimed at educating kids ages 2-5 about their peers with autism, a storybook featuring Julia and her friends, and free daily routine cards that parents can use to teach their autistic children basic skills like teeth brushing.

The new initiative was created based on solid academic research thanks to input from multiple universities, professional organizations, and advocacy groups. The Sesame Workshop also worked to ensure that these resources included the viewpoints of individuals with autism. One in 68 children in the US is diagnosed with autism, which ensures that young kids are almost assured to interact with an autistic peer.  Despite the prevalence of the disorder, bullying is still extremely common. One recent study by the Interactive Autism Network found that 63 percent of children with autism have been bullied. The Sesame Street initiative aims to foster tolerance and acceptance with preschool age children in the hope of decreasing bullying among older children, in part by normalizing the features of autism, rather than by exaggerating how they may be disabling to children with the disorder. There’s plenty of room for optimism concerning the effectiveness of using Sesame Street as a platform for this type of education. A 2015 report from the National Bureau of Economic Research found that the program is “the largest and least-costly [early-childhood] intervention that’s ever been implemented” in the US. (Lauren McKenna, The Atlantic; Elizabeth Blair, NPR)

Drug Policy

In heroin crisis, white families seek gentler war on drugs

The nation’s long-running war on drugs has been defined by zero tolerance and stiff prison sentences. It emerged during a crack cocaine epidemic of the mid 1980’s that was primarily concentrated in poor, predominantly black, urban areas. In contrast, the heroin epidemic of the last decade is concentrated in white communities, many of which are suburban and middle-class. This demographic shift in drug use is starting to have profound consequences on how the drug war is being waged. Families who have lost loved ones to heroin are increasingly channeling their anger and grief into efforts to change the language surrounding addiction, and to urge politicians and government to treat drug use as a disease instead of a crime. For example, the derogatory term “junkie” is falling out of favor in lieu of softer and more understanding language. President Obama visited West Virginia recently, a mostly white state with staggering numbers of heroin overdose deaths, to discuss a new proposal to expand access for drug treatment and prevention programs. Presidential hopefuls from both parties have adopted a tone of compassion, rather than punishment: Hillary Clinton has been hosting forums on the issue in New Hampshire, and Jeb Bush is openly discussing his family’s experiences with drug addiction. In a dramatic shift, the Gloucester, Massachusetts police department is employing a new approach to heroin use that at least three dozen other departments have now adopted: users will no longer be arrested if they walk into a police station for help, even if they are in possession of heroin or its associated paraphernalia.

Many people welcome this shift as a needed course correction in light of our scientific understanding of the biology of addiction. However, some black scholars express frustration that similar calls for a more empathetic approach to drug addiction were not heard when they originated from the black community.  Kimberle Williams Crenshaw, a scholar of racial issues at Columbia and UCLA law schools, notes …”had this compassion existed for African-Americans caught up in addiction and the behaviors it produces, the devastating impact of mass incarceration upon entire communities would never have happened.” (Katherine Q. Seelye, The New York Times)

Microbiology

Create a global microbiome effort

In last weeks’ issue of Science magazine, a group of leading scientists in the US called for the creation of a Unified Microbiome Initiative (UMI) which would assemble researchers with representatives from private and public agencies and foundations to study the activities of the Earth’s microbial ecosystems. Nearly every organism and habitat on Earth hosts a unique population of microorganisms, known as its microbiome. These microbial communities are fundamental to nearly all aspects of life on Earth. For example, soil microbes drive the production of usable forms of crucial planetary elements like carbon and nitrogen, and their manipulation shows promise for reducing agricultural use of pesticides, fertilizers, and water use. Ocean microbes produce much of earth’s oxygen, and may be able to be engineered to remove gases from the Earth’s atmosphere that contribute to global warming. Emerging research has revealed the role played by microbes that live within our own bodies in driving overall health and shaping our behavior. This human microbiome is increasingly seen as a target for new drugs, and is an essential tool for precision medicine.

Despite the crucial functions that microorgansms play, and the spectacular promise that they show for addressing challenges to environmental and human health, scientists know very little about how microbes interact with each other, their environments, and their hosts. This is in large part due to an absence of tools currently available that would “enable a mechanistic, predictive, and actionable understanding of global microbiome processes.” Addressing these technical limitations are central to the proposed UMI. The team calling for its formation describes a need for enhanced multi-disciplinary collaboration between physical, life, and biomedical sciences; engineering, and computer science in order to implement hypothesis-driven approaches that can establish causal relationships between microorganisms and their environments.

A second – and equally important – aspect of a UMI involves the need for enhanced collaboration between researchers who study different microbiome populations. Boundaries between scientists who investigate various microorganism communities are artificial and are largely due to historical divides between scientific disciplines, rather than reflecting fundamental differences between microbes that colonize a human mouth or the ocean floor. Furthermore, microbe communities are not limited to national borders but are instead part of a global microbiome. Indeed, the journal Nature contains an accompanying call for the creation of an International Microbiome Initiative to provide universal insight into the microscopic organisms all around and within us. (Alivisatos et al., Science; Dubilier, McFall-Ngai, & Zhao, Nature; Ed Yong, The Atlantic)

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

Written by sciencepolicyforall

November 6, 2015 at 9:00 am