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Paul Merrell

The frightening promise of self-tracking pills | The Verge - 0 views

  • Some morning in the future, you take a pill — maybe something for depression or cholesterol. You take it every morning. Buried inside the pill is a sand-sized grain, one millimeter square and a third of a millimeter thick, made from copper, magnesium, and silicon. When the pill reaches your stomach, your stomach acids form a circuit with the copper and magnesium, powering up a microchip. Soon, the entire contraption will dissolve, but in the five minutes before that happens, the chip taps out a steady rhythm of electrical pulses, barely audible over the body's background hum. The signal travels as far as a patch stuck to your skin near the navel, which verifies the signal, then transmits it wirelessly to your smartphone, which passes it along to your doctor. There's now a verifiable record that the pill reached your stomach.
  • This is the vision of Proteus, a new drug-device accepted for review by the Food and Drug Administration last month. The company says it's the first in a new generation of smart drugs, a new source of data for patients and doctors alike. But bioethicists worry that the same data could be used to control patients, infringing on the intensely personal right to refuse medication and giving insurers new power over patients’ lives. As the device moves closer to market, it raises a serious question: Is tracking medicine worth the risk?
  • But not everyone's convinced that the ability to track pills will be good news for patients. The right to refuse treatment is an important, fragile principle in health care. Many are worried that tracking whether a pill is being consumed will be the first step towards punishing patients that don't comply. While doctors can’t force a patient to take a pill, court orders frequently mandate treatments involving specific drug regimens.
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  • Patient's biggest protection are medical privacy laws like HIPAA, which prevent medical data from being shared with anyone outside the hospital system. That would stop your boss or your parents from using Proteus to make sure you haven't fallen behind on your anti-anxiety medication. But those laws won't keep data out of the hands of healthcare providers, and Caplan is concerned the pill could also be used to enforce compliance. Insurers might offer a discounted rate on tracked pills, then hit patients with a $100 co-pay for every treatment they miss. It's not as oppressive as a court order, but the end result would be similar.
  • NYU bioethicist Arthur Caplan says he can imagine a judge using Proteus to enforce medication as part of a sentence: miss a pill, and your parole is revoked. "The temptation in the legal system to say, 'I can monitor you and make sure you're not a threat' is going to be huge," Caplan says. "Maybe that's good, maybe it's bad, but it's a different world than saying I consent to taking these pills." Those court orders are rare at the moment, since there’s no way to ensure a patient is taking medication outside of a controlled treatment facility — but as pill-tracking becomes easier, those measures could become much more common. That's particularly likely given the way Proteus is entering the market. The device's first partnership bundles it with Abilify, a powerful antipsychotic most commonly used to treat mood disorders, schizophrenia, and Tourette's. The most common effects are improved concentration and decreased hallucinations, but it comes with extreme side effects like increased suicide risk and a lower seizure threshold. It's most often prescribed in cases of severe mental illness, often in psychiatric institutions or as part of a court-mandated treatment program — exactly the scenarios bioethicists like Caplan are most worried about.
  • Still, those concerns are unlikely to keep Proteus out of the hands of doctors. The upcoming FDA approval will focus largely on safety and efficacy, leaving the larger ethical challenges to be solved after the drug is released to doctors and patients at large. With the technology available, it will be up to the courts to decide when it’s legal and ethical to use it. As far as Proteus is concerned, the power of the technology outweighs the risks. "There are challenges with bringing digital into any sector," a company representative said. "The reason to embrace the challenge in health care is because the need is so great."
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    Let's not forget that because Congress recently decided to revive Patriot Act sect. 215, the FBI is authorized to gather medical records for foreign intelligence and anti-terrorism purposes and according to ex-NSA chief scientist William Binney, the NSA in fact collects medical records and makes them available to law enforcement agencies without a warrant or court order.  http://motherboard.vice.com/read/i-toured-stasi-hq-with-nsa-whistleblowers  One judge has found that statute unconstitutional and may rule in the next few days. A court of appeals has found that the statute did not authorize bulk collection of telephone metadata records. An Oregon federal judge ruled that the DEA cannot obtain prescription records (in part because they are medical records) without an individualized search warrant, specifically ruling against the bulk collection argument. Maybe someday someone in federal government will get a clue that medical records are not one of the "haystacks" the NSA is permitted to create.  Involuntary medical treatment is another giant legal hairball. See https://en.wikipedia.org/wiki/Involuntary_treatment   
Paul Merrell

Update on Iran Sanctions Legislation « LobeLog - 0 views

  • The sponsors of the latest Kirk-Menendez Iran sanctions bill appear determined to move the legislation as quickly as possible, although it has yet to be formally introduced. Of course, both Obama and visiting British Prime Minister David Cameron came out strongly against any sanctions legislation during their joint press appearance at the White House Friday, warning that approval risked sabotaging not only the ongoing negotiations, but also unity among the P5+1 (U.S., U.K, France, Russia, China plus Germany) themselves. In olden times one would have expected most Republicans to take seriously what a British prime minister–especially one from Winston Churchill’s Conservative Party–has to say about a foreign policy issue of mutual interest. But the combination of their real hatred for Obama and purported love for Israel (and especially for the campaign funds from wealthy Republican Jewish Coalition donors like Sheldon Adelson) is likely to supersede the historic “special relationship” extolled by Churchill himself. In any event, the best and most up-to-date summary of where things stand was provided in the weekly Legislative Round-Up by Lara Friedman of Americans for Peace Now (APN), lengthy excerpts of which are reproduced below with permission. (APN legislative round-ups are an excellent source for tracking what’s happening on Capitol Hill on Middle East policy.) Note that there are two parts to her account: the first is regarding an AIPAC draft that circulated earlier this week (and Lara’s analysis of that legislation); the second, an updated version circulated at week’s end apparently in the hope of securing more Democratic support, as well as Lara’s analysis of that draft.
  • Updated analysis of Kirk-Menendez text (as of 3pm, 1/16) In some annoying corollary to Murphy’s Law, shortly after posting analysis of the draft text of the new Kirk-Menendez sanctions bill (in which it was noted that the text should not be considered final or authoritative), a newer draft of the bill began circulating (underscoring the oddness of AIPAC circulating a “summary” of the bill while it was/is apparently still being tweaked).  Bearing in mind that this new text should still not be considered final or authoritative, the following are some observations about this newer text:
  • Existing sanctions don’t snap back, but additional sanctions relief remains elusive: This newer text repeats language in the earlier draft to the effect that while following an agreement (and required notification to Congress) the President may not waive any sanctions on Iran until Congress has had time to review the deal and the Administration’s plans to verify Iranian compliance. The newer version includes language – completely absent in the earlier draft – stipulating that this ban on waiving sanctions does not apply to sanctions previously waived under the JPOA. Notably, the updated version of the bill still stipulates that the Congressional review period during which the President is barred from waiving any new sanctions must last “30 days of continuous session of Congress,” and defines “continuous session” as not including periods where Congress is in recess for more than 3 days.  What does this mean? Looking at the House Calendar for 2105 and counting the days, it means that if the President sends the details of a deal and the required “verification assessment” to Congress on July 5, no new sanctions may be waived until at least November 13.
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  • Automatic new sanctions if no agreement or further delay: Like the earlier version, this text stipulates that new sanctions would automatically be imposed, escalating over a period of months, in the event that  the Presidents fails to send to Congress the details of a comprehensive deal reached with Iran and the required “verification assessment” by July 5. This appears to apply even in the case of an additional extension or the sides agreeing to a period to iron out the details of implementation of an agreement.  It also stipulates that in the event that the President fails to send to Congress the details of a comprehensive deal reached with Iran and the required “verification assessment” by July 5, any sanctions previously waived by the President under the JPOA will automatically snap back on.
  • Laying out far-reaching parameters for a deal: Like in the previous version, the Sense of Congress included in the bill is, by definition, non-binding. It nonetheless sends a strong statement of Congressional intent. And this Sense of Congress, like the previous version, sends a statement of hardline red lines in order for any deal to be acceptable to Congress (and the lengthy review period imposed by this bill clearly implies that Congress will be reviewing any agreement to determine if it meets its standards – and implies that if it does not meet its standards, there will be concrete consequences). Promising that sanctions will continue, regardless of a deal. While, like in the previous version, the Sense of Congress is by definition non-binding, it nonetheless sends a strong statement of Congressional intent. And this Sense of Congress once again makes clear that even if there is a deal that verifiably addresses U.S. concerns about Iran’s nuclear program, Congress will seek to continue to impose far-reaching sanctions against Iran for other reasons.
  • Planting the seeds for a deal to far apart:  The key provisions of this updated version of the bill, even amended, are a clear poison pill for any agreement.  In effect, this bill undermines negotiations and weakens U.S. negotiators. Rather than offering more sanctions relief to Iran in exchange for a deal, it prohibits it, and establishes a 4-month period during which the President is explicitly deprived of any authority to deliver anything to Iran beyond what was already delivered during negotiations. Assuming Iran would agree to a deal under such circumstances – which is doubtful – this bill sets into motion a dynamic in which Iranian opponents of a diplomacy will have an easy time arguing against the deal, and in which mischief-makers in Congress will have ample time to push ahead with new legislation rejecting a deal or putting new conditions on its implementation and limitations on sanctions relief. And given the Sense of Congress in this bill – which makes the case for continued Iran sanctions even after a nuclear deal, it is not a stretch to imagine that members of Congress would adopt such an approach during this 4 month waiting period.
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    Remember that the Israeli-firsters goal is not actually do do anything about Iranian nuclear weapons: there are none. There goal is to shoot down the negotiations and for the U.S. to bomb Iran back into the Stone Age.
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