Michigan Disability Resistance

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The state of the world looks a little different through the eyes of the sick. Porochista Khakpour would know — she’s been sick most her life, and never really knew it. Rather, she knew she was sick, but the root cause remained unidentified for almost 10 years, during which time she blamed her ever-weakening state of mind and body on the drugs she was using and abusing, the alcohol, her poor romantic choices. Who knew she should, all this time, be blaming her endless hospital visits on one of the most obtrusive unobtrusive creatures there could be: a tick.

In 2015, Khakpour was diagnosed with late-stage Lyme disease. This diagnosis was both a relief and a sentencing. There is no cure for Lyme. Most cases go undiagnosed. What irony that Khakpour would wield in her defense the argument that out of so many cases of suspected Lyme disease, hers was one of the few that was actually found and diagnosable. And yet, finally, with the diagnosis came the admission. The truth. A debilitating one, at that. “i’m getting more and more ill very fast,” she said in a heartbreaking email of scattered words on the screen, lowercased i’s, and misspelled words. “i’m scared [. …] i’m not totally sure what i’m asking [. …] i didn’t want you to feel the burden.”

http://bit.ly/2tnawH4

As Commissioner Gottlieb recently explained and we detailed last week in our 2017 annual report to Congress on drug shortages, the FDA does everything possible within our statutory authority to help address drug shortages. For example, using a range of available tools, the FDA’s Center for Drug Evaluation and Research worked with manufacturers to prevent 145 drug shortages in 2017. Still, there were 39 new shortages that occurred during 2017, and although this number is far lower than the peak of 251 new shortages in 2011, we recognize that many of these shortages have been for critical drug products and that they are having a tangible impact on patients.

IV fluid shortage

The 2017 hurricane season devastated Puerto Rico and impacted many of the drug and device manufacturers on the island. Among them was Baxter Healthcare Corporation. Baxter is a major manufacturer of sodium chloride-based (saline) and dextrose-based fluids for IV infusion, which, for example, are critical for mixing drugs for use in health care settings and are also used to keep patients hydrated. While IV fluids were in short supply before the hurricane and the FDA had been working with various manufacturers since 2014 to help improve the supply and address rising demand, the hurricanes compounded the pre-existing shortage situation leading to significant challenges in care across the country. After the hurricanes, the FDA quickly began working in partnership with Baxter and other manufacturers to consider ways to get ahead of the inevitable and significant impact on the existing shortage situation. With the support of other manufacturers, and after careful evaluation of the inspection history of specific manufacturing sites around the world, we worked with manufacturers to temporarily import IV fluids approved in other countries. We also expedited review of product applications from other manufacturers that would help with the shortage and add capacity to this market.

But even though the FDA quickly took these and other important steps, in the months following the hurricanes, many hospitals throughout the U.S. and abroad experienced serious shortfalls of these essential products. A particularly challenging flu season added to the concerns with IV fluid availability. The products’ scarcity forced health care professionals and facilities to use less desirable alternative therapies – for example, in some instances it required them to manually “push” drugs to patients through syringes instead of an IV drip, stretching already thin resources for medical staff at the bedside of patients.

After much work and a great deal of collaboration with a wide range of stakeholders, these IV fluid shortages are beginning to improve. Baxter is now producing at significantly higher levels. Other companies, including ICU Medical, B. Braun Medical, Laboratorios Grifols and Fresenius Kabi, are also producing critically-needed saline, many of which received expedited FDA reviews of their applications and supplements to add capacity and additional supply. In addition, six different manufacturing sites continue to temporarily import saline, which is helping to meet patient needs until the shortage completely resolves and approved IV fluid products can meet all demand.

http://bit.ly/2KbMGVk

Knock, knock.”

“Who’s there?”

“HIPAA.”

“HIPAA, who?”

“I’m sorry, but I cannot disclose that.”

Clinicians and patients alike will laugh at this, but behind the laughter are anger and frustration. The Health Insurance Portability and Accountability Act (HIPAA), a law created to protect patients, has borne with it serious obstacles to effective care. How did this happen? What went wrong on the road to protecting privacy?

Passed in 1996, HIPAA was not originally a privacy law at all. Its primary intent was to assure “portability”: continuity of health insurance coverage as individuals changed jobs. In fact, the privacy part of the law was very brief. Congress had been debating a Patients’ Bill of Rights for some time, which was to include privacy rights as well as the right to sue insurers for wrongful denial of coverage; but Congress failed to pass such legislation. This prompted the Department of Health and Human Services (HHS) to create the privacy regulations governing transfer of records (paper or electronic) containing personal health information (PHI), designed to ensure patient safety and prevent insurance companies from using that information to manipulate coverage.

The regulations that compose the HIPAA Privacy Rule are complex and voluminous. (The 2013 update alone, regarding electronic medical records and e-health, is 563 pages long.¹) However, these regulations coalesce around one simple rule: clinicians and health care organizations may not disclose PHI without patient permission unless that information is being used for treatment, payment, or health care operations. For these purposes, patient permission is assumed. In addition, organizations must release records to patients who ask for them and to HHS for enforcement purposes.

The myths abound. Every day, patients seeking second opinions or transferring to new clinicians experience treatment delays when wrongly conceived procedural hurdles prevent their physicians from talking to previous clinicians and obtaining timely access to test results and treatment histories. Family members seeking information about a loved one involved in a motor vehicle crash are wrongly told that HIPAA prevents even a confirmation of whether their family member is at that facility.

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Autopsy revised cause of death for nearly half, with many hidden overdoses.

Many reported sudden cardiac deaths (SCDs) can be attributed to non-sudden causes, with drug overdose and even other organ failures in the top five, according to a study probing the discrepancies between autopsy and SCD surveillance records reported to the medical examiner.

About 40% of such deaths reported from San Francisco County between February 1, 2011 and March 1, 2014 were not unforeseen and were noncardiac, and half were not even arrhythmic, according to a prospective autopsy analysis published in the June 19 issue of Circulation.

Only 55.8% turned out to be autopsy-defined sudden arrhythmic deaths, Zian Tseng, MD, MAS, a cardiac electrophysiologist at the University of California San Francisco, and colleagues reported.

"[T]hese data reflect the decreasing prevalence of coronary disease and increasing prevalence of nonischemic causes; therefore, further inroads into reducing the overall burden of sudden deathrequires investigation and earlier recognition of nonischemic and nonarrhythmic causes," they wrote.

"We can't assume that all sudden deaths are cardiac," Tseng said in an interview. "I think it's a wake up call for cardiologists overall to say that we can say that death is sudden, but we can't say that it's SCD."

The study's main findings applied to urban and suburban communities alike. On subgroup analysis, the leading causes of death were found to be coronary disease (32%), occult overdose (13.5%), cardiomyopathy (10%), cardiac hypertrophy (8%), and neurological causes (5.5%).

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For wheelchair users like me, who love fashion, ‘adaptive’ clothing has often been disappointingly dowdy. But Tommy Hilfiger and other high-end designers could change that.

After doing some custom work in the early 2000s for a client who was quadriplegic, Camilleri had her “eyes opened” to how existing clothing did not necessarily work for women using a wheelchair. For example, having a “seated frame” meant that many traditionally designed trousers rode down or dug into her client’s waist. At the time, “adaptive clothing” – clothes made with disabled people in mind – barely existed; when it did, it was not aimed at fashion-conscious young adults. “Most of what was out there were clothes for [older people] living in long-term care facilities,” Camilleri says. “I realised there was nothing for younger people. [I was] motivated to fill this void.”

In fact, Camilleri became so passionate about it that, in 2009, she released the revolutionary IZ collection, one of the world’s first fashion lines created for wheelchair users. Trousers do not ride down at the back or push on the wearer’s waist. Coats are cut so the customer can put them on while seated; they cover the thighs at the front, but reach only the seat of a person’s chair at the back, in order to avoid bunching.

Camilleri’s new range, IZ Adaptive, goes beyond the needs of wheelchair users to cater for those with a variety of disabilities. Trousers now come with horizontal pull-tabs at the side, waist and centre of the back, through which wearers with dexterity problems can slip their fingers to help them pull up the trousers without having to grip. They have elastic waists, too, negating the need for zips. Coats in the range have magnetic fastenings and pull-tabs on zippers.