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Posts Tagged ‘drug enforcement

Science Policy Around the Web – August 11, 2017

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By: Saurav Seshadri, PhD

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source: FDA

Health information privacy

Finding the legal line between voluntary disclosure and doctor-patient confidentiality

The American Civil Liberties Union (ACLU) has suffered a setback in its efforts to protect private health information from what they see as unjust and unauthorized access by the government. Last week, a court in Utah ruled that federal agents are free to collect sensitive prescription records without a warrant. The concept of ‘third party doctrine’, which states that individuals lose their expectation of privacy when information is disclosed voluntarily (in this case, to a physician or pharmacist), played a key role in the court’s reasoning. This position contradicts common-sense expectations of doctor-patient confidentiality, as well as the spirit of the Health Information Privacy and Accountability Act of 1996 (HIPAA), which pledges that ‘your health information cannot be used for purposes not directly related to your care without your permission’.

The details of the case are as follows. Like almost every state, Utah monitors the prescription and distribution of controlled substances, ostensibly to prevent drug abuse and overdose, and archives this information in a database. Utah began requiring a probable cause warrant to access the database after an incident of police misconduct in 2015, but since then, DEA agents have been circumventing this rule by using administrative subpoenas to pull any record they feel is relevant to an investigation, without judicial oversight. When Utah stopped complying on the grounds that this practice violates state law and the Fourth Amendment, the DEA challenged the state in court and won.

The decision is disappointing, considering the ACLU won a similar suit in Oregon in 2014. However, there is hope that it may be revisited soon: United States vs. Carpenter will use the context of cell phone data to question the validity of the third party doctrine, which, if successful, would have clear implications for this case. Carpenter will be argued by the ACLU before the Supreme Court this fall.

(Brett Max Kaufman, ACLU)

 

International science policy

Indian scientists get their day to speak out

Though hundreds of international sites participated in the March for Science earlier this year, major cities in India were conspicuous by their absence. On Wednesday, a series of public demonstrations finally gave the Indian scientific community an opportunity to add their voices to this global movement. The marches, organized by the Breakthrough Science Society, saw modest but encouraging turnout, despite reports of scientists being instructed not to attend.

India is the largest source of immigrant scientists and engineers in the US, but it lags behind its regional peers in numbers of top-tier scientific publications. Part of the reason for this discrepancy is a lack of government support for scientific institutions and funding agencies. While the Indian Department of Science and Technology has received substantial boosts in funding in recent years, budgets are still far short what scientific department heads say they need. One of the march’s core demands was for the government to increase investment in R&D from ~0.8% to 3% of GDP, in line with other developed Asian countries.

The other main goal of the march was to counteract rising levels of pseudoscience and religious intolerance of science in Indian culture. Organizers point out that violent incidents motivated by superstition still occur regularly, and cite ‘confrontational chauvinism’ regarding science by high-ranking officials. While this toxic blend of anti-science sentiment and nationalism is not unique to India, the country is unusual in that its constitution explicitly includes developing a scientific temperament as a ‘Fundamental Duty’ of its citizens. Ultimately, as in the US, the extent to which such events will truly promote rational discourse and evidence-based policy remains to be seen.

(Sanjay Kumar, Science)

 

Marijuana legalization/Opioid crisis

Hands-off/Hands-on approaches to the war on drugs

Initial recommendations from two separate commissions on drug policy set up by the Trump administration have yielded unexpected results. First, the Task Force on Crime Reduction and Public Safety has urged officials to continue the Obama administration’s hands-off stance on enforcing federal anti-marijuana laws. This is a surprising outcome, considering the Task Force was created by Attorney General Jeff Sessions, and was expected to support a crackdown on state-level legalization: Sessions has blamed marijuana for increased violent crime, and recently notified several pot-tolerant states that they will face increased scrutiny from his Justice Department. Though the report’s suggestions are not binding and several methods to discourage legalization still exist (such as raiding dispensaries or suing state governments), given the overwhelming public support for legal marijuana and Sessions’ increasingly tenuous political position, it appears unlikely that any significant changes in enforcement policy are on the way.

The second report comes from the President’s Commission on Combating Drug Addiction and the Opioid Crisis. The death toll and burden to society of opioid addiction have increased dramatically in recent years, and the commission offers several constructive, bipartisan solutions that echo those advocated by public health and drug policy experts. However, Trump has already signaled his disinterest in these suggestions, ignoring the commission’s ‘urgent’ request to ‘declare a national emergency under either the Public Health Service Act or the Stafford Act‘ in order to divert more resources into fighting opioid abuse. Trump routinely exploited the opioid epidemic for political points while on the campaign trail, often using it to justify ‘tough-on-crime’ proposals such as a Mexican border wall, mandatory minimum sentencing, and property seizure. The report does not recommend any of these measures, instead encouraging expanded drug treatment under Medicaid, which would have been gutted by the GOP’s attempted repeal of the Affordable Care Act. Failure to effect change in opioid-afflicted communities, which strongly supported Trump in 2016, could be politically costly for him in 2020; but steadily climbing rates of addiction mean that this timeline would be too late for many.

(Daniel Politi, Slate, and Christopher Ingraham, The Washington Post)

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Written by sciencepolicyforall

August 11, 2017 at 5:54 pm

Science Policy Around the Web – March 7, 2017

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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)

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Written by sciencepolicyforall

March 7, 2017 at 9:02 am