Spinal-Cord Implants to Numb Pain Emerge as Alternative to Pills

For millions of Americans suffering from debilitating nerve pain, a once-overlooked option has emerged as an alternative to high doses of opioids: implanted medical devices using electricity to counteract pain signals the same way noise-canceling headphones work against sound. 

The approach, called neuromodulation, has been a godsend for Linda Landy, who was a 42-year-old runner when a foot surgery went awry in 2008. She was diagnosed with complex regional pain syndrome, a condition dubbed the suicide disease by doctors: The pain is so unrelenting that many people take their own lives.

Linda Landy and family

Last November, Landy underwent surgery to get an Abbott Laboratories device that stimulates the dorsal root ganglion, a spot in the spine that was the pain conduit for her damaged nerves. A year after getting her implant, called DRG, she’s cut back drastically on pain pills.

“The DRG doesn’t take the pain completely away, but it changes it into something I can live with,” said Landy, a mother of three in Fort Worth, Texas. She’s now now able to walk again and travel by plane without using a wheelchair. “It sounds minor, but it’s really huge.”

Crackdown on Opioids

Recent innovations from global device makers like Abbott to smaller specialists such as Nevro Corp. made the implants more powerful and effective. Combined with a national crackdown on narcotics and wanton pain pill prescriptions, they are spurring demand for implants.

The market may double to $4 billion in 10 years, up from about $1.8 billion in the U.S. and $500 million in Europe today, according to health-care research firm Decisions Resources Group.

“There was a big stigma around this when it first came out,” said Paul Desormeaux, a Decisions Resources analyst in Toronto. “The idea of sending an electrical signal through your nervous system was a little daunting, but as clinical data has come out and physicians have been able to prove its safety, there has been a big change in the general attitude.”

Read More: Millions Face Pain, Withdrawal as Opioid Prescriptions Plummet

At least 50 million adults in the U.S. suffer from chronic pain, according to the Centers for Disease Control and Prevention. Only a fraction of them would benefit from spinal-cord stimulation — about 3.6 million, according to Decisions Resources — but those are patients who are often given the highest doses of narcotics. They include people with nerve damage stemming from conditions like diabetic neuropathy and shingles, as well as surgeries.

“There is no question we are reducing the risk of opioid dependence by implanting these devices,” said Timothy Deer, president of the Spine and Nerve Centers of the Virginias in Charleston, West Virginia, a hotbed of the opioid epidemic. “If we get someone before they are placed on opioids, 95 percent of the time we can reduce their need to ever go on them.”

Studies show spinal-cord stimulators can reduce use of powerful pain drugs by 60 percent or more, said Deer, a clinical professor of anesthesiology.

Read More: Tangled Incentives Push Drugmakers Away From an Opioid Solution

Technology breakthroughs that are just now reaching patients came from a better understanding of how pain signals are transmitted within the spinal cord, the main thoroughfare between the command center in the brain and the body.

For some chronic pain patients, the spinal cord runs too efficiently, speeding signs of distress. Stimulators send their own pulses of electrical activity to offset or interrupt the pain zinging along the nerve fibers. They have been available for more than three decades, but until recently their invasive nature, potential safety risks and cost limited demand.

Market Leader Abbott

Illinois-based Abbott, with its $29 billion acquisition of St. Jude Medical this year, took the market lead with advances that allow it to target specific nerves and tailor the treatment. Nevro, of Redwood City, California, has rolled out improvement to its Senza system, a best-in-class approach that is safe while getting an MRI and operates without the tingling that often accompanies spinal-cord stimulation.

In the latest devices, which cost $30,000 or more, codes that are running the electrical pulses are more sophisticated. The frequency, rate and amplitude can be adjusted, often by the patients, which allows personalized therapy. 

The new implants are also smaller: The surgery is generally an outpatient procedure with minimal post-operative pain and a short recovery. They have longer battery life, reducing the need for replacement. And patients can try out a non-invasive version of the equipment before getting a permanent implant.

“This is really a defining moment in what we can do to impact the lives of people who suffer from chronic pain,” said Allen Burton, Abbott’s medical director of neuromodulation. “We can dampen the chronic pain signal and give patients their lives back.”

Medtronic Plc, which pioneered the technique but ceded the lead in recent years, is now working on next-generation devices. The company recently gained approval for the smallest pain-management implant, Intellis. In development are devices that can detect pain waves and adjust automatically, said Geoff Martha, executive vice president of Medtronic’s restorative therapies group.

“A self-correcting central nervous system — that’s the panacea. That’s the ultimate goal,” Martha said. “It could take a huge bite out of the opioid problem.”

    Read more: http://www.bloomberg.com/news/articles/2017-12-26/spinal-cord-implants-to-numb-pain-emerge-as-alternative-to-pills

    Sessions Ending Obama-Era Policy That Ushered In Legal Weed

    Attorney General Jeff Sessions is rescinding an Obama-era policy that helped states legalize recreational marijuana, throwing a wet blanket on the fledgling industry during what could have been a celebratory week.

    The Justice Department will reverse the so-called Cole and Ogden memos that set out guardrails for federal prosecution of cannabis and allowed legalized marijuana to flourish in states across the U.S., according to two senior agency officials. U.S. attorneys in states where pot is legal will now be able prosecute cases where they see fit, according to the officials, who requested anonymity discussing internal policy.

    Shares of pot companies plunged as news of the policy change surfaced, though many began to rebound after investors weighed the potential impact.

    The change comes at a high point for the weed industry. California, the biggest U.S. state and sixth-largest economy in the world, launched its legal marketplace on Jan. 1. Sales in California alone are expected to reach $3.7 billion in 2018, according to estimates from BDS Analytics. 

    Seven other states and the District of Columbia have also legalized cannabis for adult use. Twenty-one additional states have voted to allow the plant to be used for medicinal purposes. The market is expected to skyrocket from $6 billion in 2016 to $50 billion by 2026, according to Cowen & Co.

    Sessions, a Republican from Alabama, has long been opposed to marijuana, equating it with heroin. But this is the first action he’s taken that deviates significantly from the Obama administration. Many in the industry said the news is unsurprising but disappointing.

    “While dismantling the industry will prove impossible, the move by Sessions will sow more seeds of uncertainty in an industry that already has its fair share of risks and unknowns,” said Chris Walsh, vice president of Marijuana Business Daily. “Businesses could be in for a bumpy ride amid this uncertainty, and we certainly could see some types of regional crackdowns or delays in upcoming medical or recreational cannabis markets.”

    Shares Plummet

    The Bloomberg Intelligence Global Cannabis Competitive Peers Index dropped as much as 24 percent after the Associated Press first reported the Justice Department plan. Most companies in that group are small. Still, there are a few big names that could be hit by the changing policy. 

    Constellation Brands Inc., which sells Corona beer and Svedka vodka in the U.S., got involved in the cannabis industry in October when it acquired a minority investment in Canopy Growth, a Canadian marijuana company. Scotts Miracle-Gro Co. has also made its way into the Green Rush. It fell as much as 5.7 percent after the news, the biggest intraday drop since May. 

    A tightening of enforcement also would be felt in Canada, where the cannabis industry has blossomed. Ontario’s Canopy Growth fell as much as 19 percent to C$29.06 in Toronto, while Aphria Inc. plunged as much as 23 percent to C$16.59. ETFMG Alternative Harvest ETF, the first pure-play pot ETF to be listed in the U.S., dropped as much as 9.7 percent, the biggest intraday decline since May.

    Fear and Doubt

    Sessions’s policy may cause investors to think twice before putting their money into the Green Rush, according to Adrian Sedlin, founder of Canndescent, a marijuana cultivation and branded-flower company.

    “Fear, uncertainty and doubt will rip through our industry like a California wildfire because of this,” he said. “Whatever happens longterm, this will retard and limit capital flows into the industry for the foreseeable future.”

    The move is likely to sow confusion among consumers and state officials, and may spark a backlash if state-approved retailers are prosecuted. Sixty-four percent of the U.S. population now wants to make pot legal, according to a Gallup poll released in October.

    But it’s too late to stop the industry from growing, said Laura Bianchi, a partner and director of cannabis, business and corporate transactions and estate planning at Rose Law Group in Scottsdale, Arizona.

    “To undo this industry would be like closing Pandora’s box once it’s been opened,” she said. “It would be a Herculean effort that would undermine another Republican cornerstone, which is the importance of states’ rights.”

    Senators React

    Senator Cory Gardner, a Republican from Colorado, where marijuana is legal, said in a tweet that Sessions’s move contradicts what he told the senator before his confirmation.

    “I am prepared to take all steps necessary, including holding DOJ nominees, until the Attorney General lives up to the commitment he made to me,” Gardner said.

    Senator Kirsten Gillibrand, a New York Democrat, said Sessions’s actions are an affront to medical patients who need to use the plant as medicine. 

    “Parents should be able to give their sick kids the medicine they need without having to fear that they will be prosecuted,” she said in a statement. “This is about public health, and it’s about reforming our broken criminal justice system that throws too many minorities in prison for completely nonviolent offenses.”

    Still, the federal policy change may not actually hurt business much at all. Entrepreneurs starting marijuana businesses have already been working under risky circumstances. The plant has remained federally illegal, meaning most large companies — including banks — have shied away. Instead, the business has relied on state regulators, many of whom previously said they would defend the industry through any federal crackdown. 

    “We’re not overly concerned that a change in DOJ policy around cannabis will be meaningfully disruptive to legal adult use cannabis states, given the vocal support offered by these state-level AG’s,” said Vivien Azer, a Cowen & Co. analyst who covers the industry.

      Read more: http://www.bloomberg.com/news/articles/2018-01-04/sessions-said-to-kill-obama-policy-that-ushered-in-legal-weed

      It’s no longer felony to knowingly infect others with HIV in California

      Knowingly exposing others to HIV without disclosing your status is no longer a felony in California—which is being heralded as a victory for sex workers’ rights activists and LGBTQ organizations for easing the stigma in being HIV-positive.

      Senate Bill 239 was signed by Gov. Jerry Brown (D) on Friday, after it was passed early last month. Starting Jan. 1, 2018, exposing another person to HIV without their knowledge or consent is a misdemeanor crime punishable by up to six months in county jail. Previously, doing so was a felony with up to eight years in prison if charged and convicted.

      According to the Washington Post, arrests under the former law were rarely handed down to people who maliciously infected others with HIV. Instead, sex workers facing a solicitation conviction were regularly charged with infecting others with HIV during mandatory testing.

      “If you are a sex worker and you solicit someone and you’re HIV positive, you’re guilty of a felony before any contact occurs,” co-sponsor and state Sen. Scott Wiener (D) said, the Post reports. “These laws are so draconian that you can be convicted of a felony and sent to state prison even if you engage in behavior that creates zero risk of HIV infection.”

      The bill’s changes stem partly from ongoing research: The Center for Disease Control recently declared that people on HIV medication can’t transmit the virus through sex.

      “The most effective way to reduce HIV infections is to destigmatize HIV,” Wiener said, CNN reports. “To make people comfortable talking about their infection, get tested, get into treatment.”

      Republicans aren’t happy about the law, with conservatives in both the state government and right-wing media harshly condemning its passing. National Review’s Wesley J. Smith called California “radical” and “accepting of dysfunctional and anti-social behavior.”

      “To knowingly decide that one’s own desires matter more than the right of a partner to decide yes or no to potentially risky behavior, or to potentially risk the blood supply, deserves more than a slap on the wrist,” Smith wrote. “Leave it to California to make a declining and decadent culture even more declining and decadent.”

      Meanwhile, for LGBTQ rights group, the bill’s signing is a huge victory across the state. Equality California praised the law as a step forward in fighting discrimination against people with HIV.

      “This is an important bill that modernizes California’s HIV laws,” Equality California executive director Rick Zbur said to CNN. “It will really advance public health and reduce stigma and discrimination that people living with HIV have suffered.”

      H/T the Washington Post

      Read more: https://www.dailydot.com/irl/california-hiv-misdemeanor/

      Trump Officials Dispute the Benefits of Birth Control to Justify Rules

      When the Trump administration elected to stop requiring many employers to offer birth-control coverage in their health plans, it devoted nine of its new rule’s 163 pages to questioning the links between contraception and preventing unplanned pregnancies.

      In the rule released Friday, officials attacked a 2011 report that recommended mandatory birth-control coverage to help women avoid unintended pregnancies. That report, requested by the Department of Health and Human Services, was done by the National Academies of Sciences, Engineering and Medicine — then the Institute of Medicine — an expert group that serves as the nation’s scientific adviser.

      “The rates of, and reasons for, unintended pregnancy are notoriously difficult to measure,” according to the Trump administration’s interim final rule. “In particular, association and causality can be hard to disentangle.”

      Multiple studies have found that access or use of contraception reduced unintended pregnancies. 

      Claims in the report that link increased contraceptive use by unmarried women and teens to decreases in unintended pregnancies “rely on association rather than causation,” according to the rule. The rule references another study that found increased access to contraception decreased teen pregnancies short-term but led to an increase in the long run.

      “We know that safe contraception — and contraception is incredibly safe — leads to a reduction in pregnancies,” said Michele Bratcher Goodwin, director of the Center for Biotechnology and Global Health Policy at the University of California, Irvine, School of Law. “This has been data that we’ve had for decades.”

      Riskier Behavior

      The rules were released as part of a broader package of protections for religious freedom that the administration announced Friday.

      The government also said imposing a coverage mandate could “affect risky sexual behavior in a negative way” though it didn’t point to any particular studies to support its point. A 2014 study by the Washington University School of Medicine in St. Louis found providing no-cost contraception did not lead to riskier sexual behavior.

      The rule asserts that positive health effects associated with birth control “might also be partially offset by an association with negative health effects.” The rule connects the claim of negative health effects to a call by the National Institutes of Health in 2013 for the development of new contraceptives that stated current options can have “many undesirable side effects.” 

      The rule also describes an Agency for Healthcare Research and Quality review that found oral contraceptives increased users’ risk of breast cancer and vascular events, making the drugs’ use in preventing ovarian cancer uncertain.

      Federal officials used all of these assertions to determine the government “need not take a position on these empirical questions.”

      “Our review is sufficient to lead us to conclude that significantly more uncertainty and ambiguity exists in the record than the Departments previously acknowledged.”

        Read more: http://www.bloomberg.com/news/articles/2017-10-06/trump-officials-dispute-birth-control-benefits-to-justify-rules