How Kentucky’s Members Of Congress Are Responding To The CBO’s Health Bill Score


Originally published on May 25, 2017 10:08 am

The Republican legislation that would repeal and replace the Affordable Care Act – also known as Obamacare – would reduce the federal deficit by $119 billion. But that would come at the expense of 23 million people who would not be able to afford health insurance over the next decade.

That’s according to a new analysis from the nonpartisan Congressional Budget Office released Wednesday.

In Kentucky, almost half a million people gained health insurance via the law — most of them through the state’s expansion of Medicaid to people making around $15,000.

What would the House GOP bill do?

The American Health Care Act would do away with subsidies for those who purchased health insurance plans via state-based and federal exchanges, and allow states to let insurers to once again deny insurance to people who are already sick or have had a lapse in coverage.

People without a health problem would be able to buy insurance based on their health. As a result, insurance for sick people would become even more expensive. The House Republican bill would also put in place tax credits for health insurance premiums based on age.

“If you start to make changes to make premiums more affordable, you get back to the original outline of the ACA,” said Sara Collins, vice president of health care coverage and access at research group The Commonwealth Fund.

One in six people in the U.S. would live in an area where there are no insurers left or premiums would be so high that it would be unaffordable, according to the CBO report.

What about the 10 Essential Health Benefits?

States could also apply to do away with the 10 essential health benefits that people are now required to have covered. That includes mental health treatment, maternity coverage, prescription drugs and doctor’s visits. Kentucky would likely be one of those states, as Gov. Matt Bevin has already asked to make some benefits in Medicaid harder to get.

That would result in premium decreases because insurance companies could pay for less. But since insurance companies would be able to charge based on age and health status, premiums wouldn’t decrease by much for older, sicker people.

What does this mean for Congress’ repeal and replace effort?

Because such a large number of people would become uninsured, the Senate will likely not use much of what the House version had. What might be similar is doing away with the Medicaid expansion program. But that will likely be a gradual tapering off, according to Mark Alderman, a Democratic campaign strategist.

As for the House bill: “It’s going absolutely nowhere,” according to Alderman. House Republicans have said as much.

What does this mean for Kentucky legislators who voted for the AHCA?

The Democratic Party in Kentucky will likely use Republican yes votes as ammunition during the next campaign season.

“This is about politics for my Republican colleagues, but it has life-or-death consequences for far too many Americans,” said U.S. Rep. John Yarmuth of Louisville. Yarmuth is also ranking member of the House Budget Committee.

While Republicans might say that a reduction of national debt is the responsible thing to do, it’s important to look at where that reduction comes from. Part is rolling back Medicaid expansion – that would save money.

But the bill also does away with a tax on people making more than $200,000 a year that helps pay for the expansion.

Fourth District U.S. Rep. Thomas Massie, a Republican who voted against the AHCA, had no comment. Three other Republicans from Kentucky — Reps. Andy Barr, James Comer, Brett Guthrie — did not respond to a request for comment.

U.S. Rep. Hal Rogers, a Republican who represents Kentucky’s 5th District, focused his comments on the CBO’s prediction that the bill would lower the deficit.

“As predicted, the CBO score confirms that the American Health Care Act moves the nation toward a more affordable health care system that lowers health insurance premiums and reduces the federal deficit by $119 billion,” Rogers said. “However, there is still work to do as the bill moves on to the U.S. Senate.”

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Dear Governor Bevin,


bird on hemp

 

Dear Governor Bevin,

I’m Audra Baker. My question is when are you plan on legalizing the use of marijuana for medicinal reasons?

I am the mother of 6 year old twins both with special needs. One with severe ADHD and the other non verbal autism.

I have done extensive research and have seen that cannabis oil has been proven to improve the symptoms of both these disorders. My family is considering moving to Colorado to be able to give my kids a better quality of life.

In addition to the health aspect of the legalization it will be an extreme boost to the economy.

My husband and I are both from KY and don’t want to leave but as a parent knowing there is an all natural medical alternative to the harsh drugs given to children I am doing my kids an injustice by staying.

I know we are not alone in the fight for legalization of medical marijuana. There are hundreds of ailments that can be drastically helped by its benefits. Millions of Kentuckians are suffering.
It seems the general assembly has come to an end again without any advancing of any marijuana bill at all to arrive on your desk. We as Kentuckians can’t wait indefinitely on the legislative branch to help our quality of life. Merely discussing this in Frankfort is just not enough. We need action. You have an incredible power like no other governor of KY has before. You have the ability to change and save lives. And change history in our state.

President Trump is a deal maker. So am I. SO is KENTUCKY. Let’s all work together and make this happen. So many other states are taking advantage of the increased tax dollars to improve schools, roads and commerce. JOBS will be created in so many of the poor counties of KY like those affected by factories closing and farming almost becoming obsolete. There are so many positive reasons.
Let’s all work together to make this happen. I don’t want to move to Colorado but it will soon be a necessity.
Thank you for reading this and I hope to hear from you soon.

God bless you and God bless Kentucky

Sincerely, Audra Baker

In chaotic scene, Rand Paul demands to see the House GOP’s Obamacare repeal bill


By Lauren Fox and Phil Mattingly, CNN

Updated 3:25 PM ET, Thu March 2, 2017

Rand Paul 3.2.17

Senator demands to see ‘secret’ Obamacare bill 01:59

Story highlights
  • Some House Republicans were being granted a chance to review an Obamacare repeal draft
  • GOP leadership has taken a new level of caution with their Obamacare legislation

(CNN)  Kentucky Republican Sen. Rand Paul marched to the House side of the Capitol Thursday morning, knocked on a locked door and demanded to see a copy of the House’s bill to repeal and replace the Affordable Care Act, which he believed was being kept under lock and key.

Aides in the room told the senator — before dozens of reporters in a crowded hallway — that there was no bill to see. In fact, it wasn’t the room where GOP members of the Energy and Commerce Committee were told to meet with staff to review the current draft of their bill at all. But that did little to dissuade Paul, openly critical to the House Republican leadership’s preferred path on the process, from making his underlying point.

“This should be an open and transparent process,” Paul said. “This is being presented as if it were a national secret, as if this was a plot to invade another country, as if this were national security. That’s wrong.”

    Paul ventured to the House Thursday afternoon after reports surfaced that House Republicans on the Energy and Commerce Committee were being granted an opportunity to review the current draft of the Obamacare repeal legislation and ask questions behind closed doors.

    Opposed to the House legislation’s principles, Paul said he wanted to see the bill himself even though he didn’t serve on the committee.

    “I’m not allowed to read the working product so I can comment on it?” he said.

    Outside the small House office, the chaotic scene continued with a handful of Democrats demanding they, too, see the legislation, which aides continued to say was not even in the room. Two Democrats on the Energy and Commerce Committee and House Minority Whip Steny Hoyer, a Democrat from Maryland, asked aides if the bill was ready, only to be rebuffed.

    “I want to see the bill. I want to read the bill,” New York Democrat Paul Tonko said, noting that as far as he knew, Republicans were still planning to move forward with a markup on the legislation next week.

    At one point, the GOP staff allowed Hoyer, Rep. Joe Kennedy and a dozen or so reporters into the room to inspect it themselves. It was, in fact, bill-less.

    Hoyer proceeded to hold an impromptu news conference near a bust of President Abraham Lincoln a few feet away from the misidentified room. He then held an imaginary conversation with the 16th president about what Hoyer said was the poor state of the Republican Party.

    Rep. Greg Walden, the chairman of the Energy and Commerce Committee, downplayed perceptions of secrecy in a statement Thursday.

    “Reports that the Energy and Commerce Committee is doing anything other than the regular process of keeping its members up to speed on latest developments in its jurisdictions are false. Simply put, Energy and Commerce majority members and staff are continuing to discuss and refine draft legislative language on issues under our committee’s jurisdiction.”

    Leadership has taken a new level of caution with Obamacare repeal and replace reconciliation drafts after a leaked version of the bill in progress was circulated to news outlets last week.

    House aides told CNN that the review process was simply part of regular procedure of giving their members an opportunity to review the current draft and ask committee staff questions. The committee — along with a second panel responsible for the repeal legislation — is tentatively shooting to consider their respective pieces of legislation as soon as next week.

    The leaked draft — which aides say was outdated — drew condemnations from conservatives who pledged to oppose any final bill and set off a new round of internal divisions that threatened to endanger the repeal process before it even gets off the ground.

    CONTINUE READING AND TO VIDEO…

    Morgellons Disease Scientifically Proven to Occur in Dogs


    Charles E. Holman Morgellons Disease Foundation Announces Collaborative Study Linking Skin Condition to Canine Lyme Disease

    The finding of skin lesions similar to Morgellons disease, first in cattle and now in dogs, confirms that the skin disease is not a delusion, as some have maintained. Marianne Middelveen

    AUSTIN, TX (PRWEB) OCTOBER XX, 2016 (PRWEB) (PRWEB) December 07, 2016

    Man’s best friend may help solve another mystery. A new study entitled “Canine Filamentous Dermatitis Associated with Borrelia Infection” reveals that a condition similar to human Morgellons disease can occur in dogs. The study was published in the prestigious Journal of Veterinary Science & Medical Diagnosis.

    Morgellons disease is an unusual skin condition associated with Lyme disease in humans. It is characterized by skin lesions containing unusual multicolored fibers and symptoms such as fatigue, joint and muscle pain and neurological problems that are typical of Lyme disease. Similar skin lesions have previously been reported in bovine digital dermatitis, an infectious disease of cattle.

    The dog study was partially funded by the Charles E. Holman Morgellons Disease Foundation (CEHMDF) and was conducted by an international team of researchers, including Calgary microbiologist Marianne Middelveen, San Francisco Internist Dr. Raphael Stricker, molecular biologists Dr. Eva Sapi and Dr. Jennie Burke, and Calgary veterinarians Dr. Gheorghe Rotaru and Dr. Jody McMurray.

    The dogs in the study presented with unusual fiber-containing skin lesions that lacked other explanations and that failed to respond to non-antibiotic treatments. “Generally-speaking, the fibers we have seen are teal and pink,” explains Dr. Rotaru.“Dogs are hairy, so fibers can be hard to see. Fortunately the fibers fluoresce under UV light, so we have used that diagnostic tool to identify dogs with the skin condition.”

    Analysis performed by five different laboratories detected the corkscrew-shaped agent of Lyme disease, Borrelia burgdorferi, in canine skin tissue by special staining and DNA analysis. Culture studies showed that the Lyme bacteria in skin were alive. Further analysis of the canine skin fibers showed that they were made of the same proteins as human Morgellons disease fibers.

    Most of the owners of the study dogs were healthy and were not familiar with Morgellons disease or Lyme disease; however, two of the owners also had Morgellons disease. “In those cases, we do not have evidence of contact transmission from human to animal or animal to human,” says Dr. Stricker, “it may be that both owner and dog were exposed to the same disease vector.”

    “The finding of skin lesions similar to Morgellons disease, first in cattle and now in dogs, confirms that the skin disease is not a delusion, as some have maintained,” said Ms. Middelveen. “We need to learn much more about this mysterious skin condition.”

    About the Charles E. Holman Morgellons Disease Foundation:
    The Charles E. Holman Morgellons Disease Foundation based in Austin, TX, is a 501(c) (3) nonprofit organization committed to advocacy and philanthropy in the battle against Morgellons. Director, Cindy Casey-Holman, RN, leads the foundation, named for her husband, Charles E. Holman, a pioneer in the fight against MD. The CEHMDF is the recognized authority and primary funding source for Morgellons Disease medical-scientific research. There are neither grants, nor any other public or private funding to support research for Morgellons. Donations are tax deductible in the US. To learn more about Morgellons disease go to http://www.MorgellonsDisease.org

    SOURCE LINK

    RELATED:

    Has KY been infected with “Morgellons Disease”, or is there another type parasite that is being seen in the area?

    Lawmaker says top issue for constituents is marijuana; oncologist advocates for safe access


    02/12/2017 12:39 PM

    Far and away the largest number of phone calls from constituents of Rep. Jason Nemes, R-Louisville, are in support of marijuana legalization, and he says he’s heard plenty of other lawmakers also getting the calls.

    Nemes recently published online what voters are calling him about, and in a phone interview with Pure Politics he said the calls on marijuana come in three forms: advocating for medical marijuana in pill form, medical marijuana that can be smoked and full-scale state legalization of the federally illegal drug.

    “I’m getting contacted on all three of those areas, I don’t know where I am on it, but the Kentucky Medical Association tells me there’s no studies that show that it’s effective,” Nemes said in a phone interview on Wednesday.

    Dr. Don Stacy, a board certified radiation oncologist who works in the Kentucky and Indiana areas, said there’s a reason there’s no studies proving effectiveness — studies have not been allowed to take place.

    “It’s one of those things where we can’t provide randomized phase three studies in cannabis without making it legal — that is the gold standard for any sort of medicine,” Stacy said. “We have a variety of studies of that nature from other countries of course, but American physicians are very particular about American data. The database we have now is plenty enough to say we shouldn’t be arresting patients for trying to help themselves.”

    Stacy said he became interested in marijuana after he noticed some of his patients were doing better with treatment than similar patients. In reviewing their records and through private discussions with the patients, he learned “a significant portion” of those doing better were the patients using marijuana.

    “I was surprised by that,” he said. “I’ve always been a skeptic of alternative medicines, but then I began to research the data. I was impressed with the data.”

    Dr. Stacy said he’s had some particular patients who showed minor or moderate improvements or side effects, but patients who had to stop treatment because the toxicity of the treatment was so severe. The patients who had to stop treatment tried marijuana, and then they were able to complete their treatments showing “dramatic differences,” Stacy said.

    Because of the improvements in patients, Stacy is advocating for safe and legal access to the drug.

    Twenty-eight states and the District of Columbia allow access to medical marijuana in different forms. Through those states allowing access, Stacy said several show improvements outside of overall medical care.

    In states that have legalized medical marijuana the suicide rate has dropped by 10 percent among males 18 to 40, he said.

    “It says when people have serious medical or behavioral issues — if you cannot find the treatment that helps you then some people decide to end their lives, and cannabis apparently prevents a certain portion of people from doing that.”

    Stacy said that there is also a 10 percent decrease in physicians prescribing narcotics in medical marijuana states. The effect of that, Stacy said is a 25 percent decrease in overdose deaths linked to narcotics in states with medical cannabis laws. With the level of heroin and opiate abuse in Kentucky, he said there would be positive effects seen here too.

    “I think that one-quarter of the people who will overdose and die of narcotics in this state in this year would be alive if we had a medical cannabis law.”

    CONTINUE READING…

    The Next Big Brain Cancer Drug Could Come from Marijuana


    Sy Mukherjee

    9:44 PM Central

    Image result for marijuana

    GW Pharmaceuticals (gwph, +2.63%) is already well on its way to winning the first-ever U.S. approval for a cannabis-derived therapy. But an early trial suggests that these treatments could also be an effective way to fight one of most devastating forms of brain cancers: glioblastoma multiforme.

    The U.K.-based company unveiled preliminary data Tuesday from a mid-stage study on an experimental drug combining cannabidiol and THC, the “high” producing element of marijuana. Results so far show that the drug boosted brain cancer patients’ median survival rates by about six months compared to a placebo. Typically, this type of cancer ravages the brain and (on average) leaves 70% of patients dead within two years of being diagnosed.

    Click here to subscribe to Brainstorm Health Daily, our brand new newsletter about health innovations.

    “We believe that the signals of efficacy demonstrated in this study further reinforce the potential role of cannabinoids in the field of oncology and provide GW with the prospect of a new and distinct cannabinoid product candidate in the treatment of glioma,” GW CEO Justin Gover said in a statement.

    GW is already interpreting the results as a reason to expand its foray into cancer treatment. The company’s most advanced drug candidate, Epidiolex (for treatment of severe epilepsy related to a number of rare disorders), is closest to reaching the U.S. market. But the firm has staked out more far-reaching ambitions in an environment where cannabis-based products have been increasingly accepted.

    For one, Gover thinks that cannabidiol-based therapies show plenty of promise in behavioral disorders like schizophrenia, he told Fortune last year.

    Marijuana’s effect on cancer still isn’t all that clear. A big recent review by American scientists suggests the drug is effective for treating pain and nausea in cancer patients but doesn’t necessarily treat (or cause) cancer. However, GW’s drug isn’t just a bowl of weed to be smoked – it contains concentrated derivatives and is undergoing the kind of clinical testing that could provide insights hampered by U.S. policy towards studying cannabis.

    CONTINUE READING…

    http://fortune.com/2016/09/26/gw-pharmaceuticals-marijuana-therapy/

    Mother fighting to save daughter through medical marijuana


    marijuana

    By MELISSA REINERT

    The Kentucky Enquirer

    WILLIAMSTOWN, Ky.

    Tiffany Wigginton Carnal is in the fight of her life to save her daughter.

    Lyndi Carnal, 17, has Crohn’s Disease, an inflammatory bowel disease that causes inflammation of the lining of the digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. Lyndi was diagnosed when she was 14. Since that time, she and her mother have spent three Christmases, three New Year’s Days and countless other days at Cincinnati Children’s Hospital.

    The medications Lyndi has taken to control the Crohn’s and subsequent pain have negatively impacted her heart, kidneys and liver. Lyndi has also had her colon and rectum removed. The medications to control the pain keep Lyndi sedated and unable to function. One of her medications, Dilaudid, is a strong opiate that can be addictive.

    “These medications are making children drug addicts. Lyndi has gone through withdrawals,” Tiffany Carnal said. “Lyndi was once a cheerleader and a beauty pageant winner, she won all over the state. Now she is bed-ridden and not able to function. As a parent, I have to ask, ‘How can I help my child?’ ”

    The answer, according to Carnal, is illegal.

    “I started doing my own research and learned that medical marijuana can help children who have Crohn’s Disease,” she said. “However, this is illegal in our state.”

    The Carnals reside in Williamstown, Kentucky, where the use of marijuana, even for medical purposes is against the law. In 2016, Sen. Perry Clark introduced Senate Bill 13, a bill that would end marijuana prohibition for adults in the Commonwealth and create a regulated and taxed system. The legislature adjourned, however, without taking action on the bill. The bill — Cannabis Freedom Act — to legalize medical marijuana use in the state, will be presented to the legislature in 2017.

    Carnal has been busy writing and calling her state representatives to encourage passage of the bill.

    “I’m not at all for recreational use of marijuana, but there are facts that marijuana oil helps children with epilepsy, Crohn’s and cancer,” Carnal said.

    According to the Mayo Clinic, medical marijuana is marijuana used to treat disease or relieve symptoms. Marijuana is made from the dried leaves and buds of the Cannabis sativa plant. It can be smoked, inhaled or ingested in food or tea. Medical marijuana is also available as a pill or an oil.

    Also according to the Mayo Clinic, studies report that marijuana has possible benefits for several conditions. Crohn’s is on that list.

    “It’s so frustrating that I can’t give my child a natural oil that could help her and not cause her other organs to fail or for her to be on a constant high,” Carnal said. “I can’t do that, but I can give her drugs that are killing her. There’s got to be a better way. There is. Things… the law… just have to change.”

    This last bout with complications from Crohn’s almost took Lyndi’s life. She has been at Children’s for two months and was recently taken off life support. She’s on the mend, but the road ahead will be tough. She’s looking at two more months at Children’s.

    “She has survived,” Carnal said. “She’s still here and for a reason. And that reason is not to spend her life in the hospital. Me? I’m going to fight to make sure she can get a natural treatment that will help her and not bring harm to her. That is my job as a parent.”

    Read more here: http://www.heraldonline.com/news/article126600394.html#storylink=cpy

    The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research (2017)


    THE NATIONAL ACADEMIES PRESS HAS RELEASED A NEW RESEARCH BOOK REGARDING THE HEALTH EFFECTS OF CANNABIS.  PLEASE USE LINK PROVIDED TO REVIEW.

     

    The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research

     

    Description

    Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk.

    However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively.

    Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agenda—outlining gaps in current knowledge and opportunities for providing additional insight into these issues—that summarizes and prioritizes pressing research needs.

    Topics

     

    CONCLUSIONS FOR: THERAPEUTIC EFFECTS
    There is conclusive or substantial evidence that cannabis or cannabinoids are effective:
    • For the treatment for chronic pain in adults (cannabis) (4-1)
    • Antiemetics in the treatment of chemotherapy-induced nausea and vomiting (oral cannabinoids) (4-3)
    • For improving patient-reported multiple sclerosis spasticity symptoms (oral cannabinoids) (4-7a)
    There is moderate evidence that cannabis or cannabinoids are effective for:
    • Improving short-term sleep outcomes in individuals with sleep disturbance associated with obstructive sleep apnea
    syndrome, fibromyalgia, chronic pain, and multiple sclerosis (cannabinoids, primarily nabiximols) (4-19)
    There is limited evidence that cannabis or cannabinoids are effective for:
    • Increasing appetite and decreasing weight loss associated with HIV/AIDS (cannabis and oral cannabinoids) (4-4a)
    • Improving clinician-measured multiple sclerosis spasticity symptoms (oral cannabinoids) (4-7a)
    • Improving symptoms of Tourette syndrome (THC capsules) (4-8)
    • Improving anxiety symptoms, as assessed by a public speaking test, in individuals with social anxiety disorders (cannabidiol)
    (4-17)
    • Improving symptoms of posttraumatic stress disorder (nabilone; one single, small fair-quality trial) (4-20)
    There is limited evidence of a statistical association between cannabinoids and:
    • Better outcomes (i.e., mortality, disability) after a traumatic brain injury or intracranial hemorrhage (4-15)
    There is limited evidence that cannabis or cannabinoids are ineffective for:
    • Improving symptoms associated with dementia (cannabinoids) (4-13)
    • Improving intraocular pressure associated with glaucoma (cannabinoids) (4-14)
    • Reducing depressive symptoms in individuals with chronic pain or multiple sclerosis (nabiximols, dronabinol, and nabilone)
    (4-18)

    PLEASE CONTINUE TO LINK HERE

    “Ten years from now, someone with a cancer diagnosis will be worse off with this bill. People will be exposed to more things that don’t work.”


    Drug-makers stand to benefit from act

    By Staff Reports

    1/6/17 8:19 PM

    Will patients benefit from the passage of the 21st Century Cures Act? After listening to politicians and reading the headlines, most people might think it’s the best thing ever to come along for patients.

    “A new day for medical research is on the horizon,” proclaimed Rep. Fred Upton, the outgoing chairman of the House Energy and Commerce Committee which had just won a major victory last week. “The House and the Senate have passed this bipartisan legislation which will ensure our health system can keep pace with incredible advances in science and technology,” Upton said in the GOP’s weekly radio address. “We needed to do better. And with 21st Century Cures, we will.”

    Media headlines mirrored Upton’s victory declaration. Headlines like this from the Wall Street Journal, “House Passes Health Bill to Speed Drug Approvals, Boost Biomedical Research” seemed to say it all: faster drug approvals, more money for research, less pesky regulation.

    Or was there more to the story? Not everyone thinks the Cures Act will be wonderful for patients. But their voices were drowned out in the slick public relations campaign Upton’s committee waged over the past few years using some 200 or so patient advocacy organizations to push for the bill. Most of those groups have strong ties to the drug and medical device industry.

    A recent study by Dr. Vinay Prasad, an oncologist at Oregon Health Sciences University, found that three-quarters of 68 cancer advocacy groups he studied disclosed sponsorship from pharmaceutical companies. Some groups received money from as many as 16 or 17.

    Prasad told me, “Ten years from now, someone with a cancer diagnosis will be worse off with this bill. People will be exposed to more things that don’t work.” Prasad and others say the Cures Act actually lowers the regulatory standards for drugs and devices. It’s a step backward for patients.

    In a nutshell the Act turns current regulatory practice on its head.

    Randomized trials, the gold standard for medical research, may disappear if a drug company wants to sell a medicine for a different condition than the one it’s already approved for. Instead it can use “real world evidence” to show the drug also works for a new indication. Such “evidence” could be observational studies, which are less reliable than randomized trials, but are cheaper and take less time.

    The FDA can use patient experience to inform its regulatory decisions — information about the impact of a disease or related therapy on patients’ lives. The data can come from patients, family members, caregivers, patient advocacy organizations, disease research foundations and drug manufacturers.

    The agency can approve new drugs on the basis of data summaries rather than requiring the FDA to independently analyze study results for a new drug indication. Drug makers would have to submit all their data, but the FDA would not have to review it.

    And although the bill authorizes billions for new medical research at the National Institutes of Health (NIH), the funding is not guaranteed, and the NIH would have to fight Congress for the money.

    The Cures Act is the culmination of a 20-year effort by the drug industry and Beltway think tanks to loosen standards and permit new uses for drugs already approved in order to expand their markets. It can be traced back to the 1997 FDA Modernization Act, which was then — as the Cures Act is now — sold on the promise of getting cures to market faster. The 1997 law loosened regulatory standards and reduced the number of clinical trials needed for drug approval.

    Are the changes brought about by the earlier law a harbinger of what’s to come?

    The reporting by John Fauber and his colleagues at the Milwaukee Journal Sentinel offers a cautionary tale. In the past few years the paper has reported how drug and device makers have spent huge sums of money to sell drugs for conditions that were once thought to be part of everyday life.

    The reporters found that drug companies turned conditions such as overactive bladder, adult ADHD and premenstrual dysphoric disorder into medically treatable ailments. They reported that the latter was not even recognized as a mental disorder until 13 years after the first drug treatments were on the market. “Drugs used to treat the various medicalized conditions don’t work that well and often have side effects that are nearly as common as the benefit,” Fauber told me.

    Are we turning the calendar back to 1933 when a book called “100,000,000 Guinea Pigs” was published exposing the dangers of patent medicines? Federal oversight of drugs was pretty lax then, and patients died. It’s obvious drug makers will benefit from looser regulation. It remains to be seen whether patients will, too.

    Trudy Lieberman, a journalist for more than 40 years, is a contributing editor to the Columbia Journalism Review, where she blogs about health care and retirement at cjr.org. She can be reached at trudy.lieberman@gmail.com. This column was distributed by The Rural Health News Service.

    CONTINUE READING…

    “a puff is enough”


    Gary L. Wenk Ph.D.

    Gary L. Wenk Ph.D. Your Brain on Food

    Marijuana or Obesity: Which Is Worse?

    For the majority of people who read this blog, the answer will be obesity.

    Posted Jan 04, 2017

    Overall, the complete answer to this question depends upon knowing whether you inherited genes that predispose you to drug addiction or food addiction. Recent research has found evidence that these two addictions are closely related to each other. What differs, and what truly matters to most people, is the consequence to smoking too much marijuana or consuming too much food. Which is worse for your body and brain? For the majority of people the answer will be obesity, not marijuana. This is why.

    Obesity:

    During the past three decades an obesity epidemic has been responsible for a 77% increase in death rates. The accumulation of excess body fat has been clearly shown to accelerate the progression of many age-associated diseases such as cancer, arthritis, diabetes and dementia. Why? A few years ago it became clear that fat cells produce inflammation by releasing specialized proteins called cytokines. The more fat cells you have the more cytokines get released into your blood. Essentially, obesity is associated with chronic, low-grade, body-wide inflammation, insulin resistance and many of the same metabolic conditions that underlie the aging process itself. The cytokines are capable of inducing shrinkage of brain regions (primarily gray matter- where the neurons live) that are used in the process of learning new things and recalling memories

    One recent study examined the relationships between academic performance, cognitive functioning, and BMI among 2,519 young people.  BMI was inversely correlated with general mental ability even after controlling for demographics, lifestyle factors, and lipid profiles. Overall, obesity is implicated in lower performance on cognitive control tasks. The longer the inflammation is present, the more brain shrinkage occurs. Elderly obese people have more impaired learning and memory abilities than elderly thin people. Being obese at mid-life is also a strong predictor of dementia in later life. 

    Today, an overwhelming body of evidence across a wide spectrum of medical disciplines strongly argues that obesity accelerates the aging process, impairs overall cognitive function and, ultimately, is responsible for numerous processes that kill you.

    Marijuana:

    Studies suggest that adults (this argument does not apply to young people) who use low to moderate daily amounts of marijuana show no personality disturbances. During the past few years some sensational studies have been widely featured in the national press; one suggested that daily marijuana use might decreased IQ (Meier et al., PNAS, 2012), the other suggested that daily recreational use caused shrinkage of brain areas that are critical for learning, memory and emotional control (Gilman et al., 2014, J Neurosci). The report by Meier et al. was immediately challenged (Rogeberg, 2013, PNAS) for failing to take into account the confounding effect of socioeconomic status, a factor which has been shown to a significantly impact on IQ score. The results of the second study have now been confronted by a more recent publication (Weiland et al., 2015, J Neurosci) that clearly demonstrated that daily use of marijuana produced no significant changes in the size or shape of brain regions involved in the control of emotion or learning and memory. 

    Just last month another bit of nonsense derived from poor research methods was published and then debunked (see, https://www.leafly.com/news/health/does-marijuana-cause-alzheimers). Marijuana does not shrink the brain or predispose people to Alzheimer’s disease. Research in my laboratory (copies of publications can be obtained here: http://faculty.psy.ohio-state.edu/wenk/) has demonstrated that stimulating the brain’s marijuana receptors offer protection by reducing brain inflammation. Thus, later in life, marijuana might actually help your brain, rather than harm it. It takes very little marijuana to produce benefits in the older brain. My lab coined the motto “a puff is enough” because it appears as though only a single puff each day is necessary to produce significant benefit.

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    I often am asked by my students whether smoking marijuana makes it more likely that to develop schizophrenia. Forty years of research has led to the following answer: if you are not genetically vulnerable to schizophrenia then marijuana use will not induce it. It appears as though stimulating endogenous marijuana receptors may be able to unmask underlying symptoms of schizophrenia as well as other mental disorders, such as bipolar disorder, if you inherited the appropriate genes from your parents.

    Marijuana or Obesity?

    Given recent evidence, obese people and marijuana smokers face a challenging dilemma: do they feel genetically lucky? Each person will have a different answer to the question of “which is worse.”  The answer will be determined by the genetic cards you were dealt by your parents. 

    © Gary L. Wenk, Ph.D. Author of “Your Brain on Food,” 2nd Edition, 2015 (Oxford University Press)

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