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Sgt. Robert Rose Jr. (Ret.) on why he filed a $350 million lawsuit against the VA
Posted on March 8, 2019 by Pharmaciststeve
The US Food and Drug Administration (FDA) Is Requesting Input From The Public On The Re-Scheduling of Cannabis, aka (Marijuana) Delta 9, THC and CBDs. The Comment Period Ends 11:59 14 March 2019
Posted on March 8, 2019 by Pharmaciststeve
The US Food and Drug Administration (FDA) Is Requesting Input From The Public On The Re-Scheduling of Cannabis, aka (Marijuana) Delta 9, THC and CBDs. The Comment Period Ends 11:59 14 March 2019
Summary
The Food and Drug Administration (FDA or Agency) is providing interested persons with the opportunity to submit comments about the World Health Organization (WHO) recommendations to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States’ position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, March 18-22, 2019. This notice is issued under the Controlled Substances Act (CSA).
Dates
Submit either electronic or written comments on the notice by March 14, 2019. The short time period for the submission of comments is needed to ensure that the U.S. Department of Health and Human Services (HHS) may, in a timely fashion, carry out the required action and be responsive to the United Nations.
Addresses
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 14, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.”
This notification reflects the recommendation from the 41st WHO Expert Committee for Drug Dependence (ECDD), which met in November 2018. In the Federal Register of October 10, 2018 (83 FR 50938), FDA announced the WHO ECDD review and invited interested persons to submit information for WHO’s consideration.
The following recommendations regarding the review of cannabis and cannabis-related substances are as follows:
Recommendation 5.1: The Committee recommended that Cannabis and Cannabis Resin be deleted from Schedule IV of the 1961 Single Convention on Narcotic Drugs.
Recommendation 5.2.1: The Committee recommended that dronabinol and its stereoisomers (delta- 9-tetrahydrocannabinol) be added to Schedule I of the 1961 Single Convention on Narcotic Drugs.
Recommendation 5.3.1: The Committee recommended that tetrahydrocannabinol (understood to refer to the six isomers currently listed in Schedule I of the 1971 Convention on Psychotropic Substances) be added to Schedule I of the 1961 Single Convention on Narcotic Drugs, subject to the Commission’s adoption of the recommendation to add dronabinol (delta-9-tetrahydrocannabinol) to the 1961 Single Convention on Narcotic Drugs in Schedule I.
Recommendation 5.4: The Committee recommended deleting Extracts and Tinctures of Cannabis from Schedule I of the 1961 Single Convention on Narcotic Drugs.
Recommendation 5.5: The Committee recommended that a footnote be added to Schedule I of the 1961 Single Convention on Narcotic Drugs to read: “Preparations containing predominantly cannabidiol and not more than 0.2 percent of delta-9-tetrahydrocannabinol are not under international control.
Recommendation 5.6: The Committee recommended that preparations containing delta-9-tetrahydrocannabinol (dronabinol), produced either by chemical synthesis or as a preparation of cannabis, that are compounded as pharmaceutical preparations with one or more other ingredients and in such a way that delta-9-tetrahydrocannabinol (dronabinol) cannot be recovered by readily available means or in a yield which would constitute a risk to public health, be added to Schedule III of the 1961 Convention on Narcotic Drugs.
It is now time for ACTION to #ENDtheMADNESS
Here is your opportunity to make a difference. The short timeline is restrictive but we must deal with it. If you want to change it takes action.
Remember;
If You Do NOTHING, NOTHING will Be Done!
Filed under: General Problems | 1 Comment »
stage 4 pancreatic cancer has a < 5% 5 yr survival rate
Posted on March 7, 2019 by Pharmaciststeve
He has stage 4 pancreatic cancer and this is the insanity they put him through here !!! As someone called the police claiming to have “Smelt” Marijuana in his hospital room, He didn’t have any marijuana and had taken THC oil in a capsule while outside. And his doctors were aware of it
Nolan’s Tribe of Warriors Against Cancer
stage 4 pancreatic cancer has a < 5% 5 yr survival rate
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More than 1,000 accidental drug intoxication deaths in Connecticut in 2018
Posted on March 7, 2019 by Pharmaciststeve
More than 1,000 accidental drug intoxication deaths in Connecticut in 2018
(WTNH) – More than 1,000 people died from accidental drug intoxication in 2018.
This statistic comes from the Office of the Chief Medical Examiner.
According to the office, 948 of the 1017 deaths involved an opioid, while 760 involved fentanyl.
The total number of deaths marks a small drop from 2017, when 1,038 people from Connecticut died from accidental drug intoxication.
However, it is still a sharp increase from 2012 when that number was 357.
Below is a town-by-town list of accidental opioid overdose deaths in the state for 2018 using data from the Office of the Chief Medical Examiner.
| City or town | Number of people who died from accidental opioid overdose in city or town |
| Andover | N/A |
| Ansonia | 3 |
| Ashford | 1 |
| Avon | N/A |
| Barkhamsted | N/A |
| Beacon Falls | 1 |
| Berlin | 1 |
| Bethany | N/A |
| Bethel | 2 |
| Bethlehem | 1 |
| Bloomfield | 2 |
| Bolton | 1 |
| Bozrah | N/A |
| Branford | 9 |
| Bridgeport | 58 |
| Bridgewater | N/A |
| Bristol | 26 |
| Brookfield | N/A |
| Brooklyn | N/A |
| Burlington | 2 |
| Canaan | N/A |
| Canterbury | 1 |
| Canton | 2 |
| Chaplin | N/A |
| Cheshire | 1 |
| Chester | 1 |
| Clinton | 6 |
| Colchester | 4 |
| Colebrook | N/A |
| Columbia | 1 |
| Cornwall | N/A |
| Coventry | N/A |
| Cromwell | 2 |
| Danbury | 18 |
| Darien | N/A |
| Deep River | N/A |
| Derby | 10 |
| Durham | 1 |
| East Granby | N/A |
| East Haddam | N/A |
| East Hampton | 1 |
| East Hartford | 17 |
| East Haven | 4 |
| East Lyme | N/A |
| East Windsor | 2 |
| Eastford | 2 |
| Easton | N/A |
| Ellington | 2 |
| Enfield | 11 |
| Essex | 2 |
| Fairfield | N/A |
| Farmington | 3 |
| Franklin | N/A |
| Glastonbury | 2 |
| Goshen | 1 |
| Granby | N/A |
| Greenwich | 2 |
| Griswold | 1 |
| Groton | 9 |
| Guilford | 1 |
| Haddam | N/A |
| Hamden | 8 |
| Hampton | N/A |
| Hartford | 128 |
| Hartland | N/A |
| Harwinton | N/A |
| Hebron | 1 |
| Kent | N/A |
| Killingly | 1 |
| Killingworth | N/A |
| Lebanon | 1 |
| Ledyard | 1 |
| Lisbon | 1 |
| Litchfield | 1 |
| Lyme | N/A |
| Madison | 1 |
| Manchester | 23 |
| Mansfield | 1 |
| Marlborough | 3 |
| Meriden | 22 |
| Middlebury | 3 |
| Middlefield | N/A |
| Middletown | 17 |
| Milford | 11 |
| Monroe | 2 |
| Montville | N/A |
| Morris | N/A |
| Naugatuck | 7 |
| New Britain | 52 |
| New Canaan | 1 |
| New Fairfield | N/A |
| New Hartford | 2 |
| New Haven | 69 |
| New London | 22 |
| New Milford | 5 |
| Newington | 2 |
| Newtown | 1 |
| Norfolk | 1 |
| North Branford | N/A |
| North Canaan | N/A |
| North Haven | 2 |
| North Stonington | N/A |
| Norwalk | 10 |
| Norwich | 18 |
| Old Lyme | 2 |
| Old Saybrook | 2 |
| Orange | N/A |
| Oxford | N/A |
| Plainfield | 3 |
| Plainville | 2 |
| Plymouth | 1 |
| Pomfret | N/A |
| Portland | 4 |
| Preston | N/A |
| Prospect | N/A |
| Putnam | 5 |
| Redding | 1 |
| Ridgefield | 1 |
| Rocky Hill | 2 |
| Roxbury | N/A |
| Salem | 1 |
| Salisbury | N/A |
| Scotland | N/A |
| Seymour | 4 |
| Sharon | 1 |
| Shelton | N/A |
| Sherman | N/A |
| Simsbury | N/A |
| Somers | N/A |
| South Windsor | N/A |
| Southbury | 1 |
| Southington | 4 |
| Sprague | N/A |
| Stafford | 1 |
| Stamford | 13 |
| Sterling | 2 |
| Stonington | N/A |
| Stratford | 11 |
| Suffield | 1 |
| Thomaston | 2 |
| Thompson | N/A |
| Tolland | 3 |
| Torrington | 26 |
| Trumbull | 1 |
| Union | N/A |
| Vernon | 10 |
| Volluntown | N/A |
| Wallingford | 4 |
| Warren | N/A |
| Washington | N/A |
| Waterbury | 77 |
| Waterford | 1 |
| Watertown | 8 |
| West Hartford | 7 |
| West Haven | 5 |
| Westbrook | 2 |
| Weston | 1 |
| Westport | 1 |
| Wethersfield | 5 |
| Willington | 1 |
| Wilton | N/A |
| Winchester | N/A |
| Windham | N/A |
| Windsor Locks | 2 |
| Wolcott | 1 |
| Woodbridge | N/A |
| Woodbury | N/A |
| Woodstock | 1 |
Filed under: General Problems | 3 Comments »
research found actually the smaller independent pharmacies really consistently offered cheaper options for the same medications
Posted on March 7, 2019 by Pharmaciststeve
The price of the same prescription drug can vary by hundreds or even thousands of dollars, depending on where you buy it, according to a new report by the U.S. Public Interest Research Group which surveyed hundreds of pharmacies and found large price differences for identical medications.
Nearly one in four Americans struggle to pay for their medications and this year already, more than 250 prescription drugs have seen price hikes averaging 6 percent, according to an analysis by RX Savings Solutions.
Adam Garber is the consumer watchdog for the U.S. PIRG. The group surveyed more than 250 pharmacies across the country for the cash prices of common medications, the price someone pays if they don’t have insurance or are under-insured and do not qualify for coupons or savings programs sometimes offered by drug manufacturers.
“These real price variations we’re seeing have huge health consequences for Americans,” Garber told CBS News’ Anna Werner. “These prices are often how they determine how much insurers are going to pay for the drugs … it sort of sets the whole pricing scheme up.”
The study found consumers could save anywhere from $100 to $5,400 a year just by price shopping. In Ohio, they found the same inhaler being sold for $11.99 at one pharmacy and $1,136 at a different pharmacy. In North Carolina, a generic medicine to lower cholesterol could cost $7 or $393 depending on where it was purchased.
“You expect like when you go to the bigger pharmacy you’ll get a better deal, but our research found actually the smaller independent pharmacies really consistently offered cheaper options for the same medications,” Garber said.
Like 30 million other Americans with diabetes, Brianna Hamilton needs insulin to stay alive. Last year, she says she paid $60 for a 90-day supply of NovoLog pens, the brand of insulin she uses. But then her insurance coverage changed this year.
“Anytime I eat anything, even with a small amount of sugar in it, I have to take insulin or my blood sugar goes really high, I could end up in a coma and I could be dead,” Hamilton said. “I showed up at the pharmacy to pay for my 90-day supply and it was $1,400.”
Hamilton said the two types of insulin she uses as well as supplies, like needles and testing strips, will now cost her $1,000 per month, even with a coupon from the manufacturer until she hits her new insurance plan’s $3,000 deductible.
“It’s one of those things where I try to do everything right financially. You know, get my degree, get a good job and I still … If I don’t like cut back on a lot of stuff, I could be homeless. Or dead without my insulin and that’s not fair,” Hamilton said.
Stephen Schondelmeyer, a professor of pharmaceutical economics at the University of Minnesota, said, “At all levels of the marketplace from the manufacturer to the wholesaler, to the retailer, and then to the insurer and the pharmacy benefit manager, they all kind of hide the prices and don’t like to make their prices transparent or known to anyone.”
The National Association of Chain Drug Stores told us in a statement that cash transactions only account for eight percent of prescriptions written and “these prices vary according to many factors, including: the exact time when the drugs were purchased from the supplier; fluctuations in product supply and thus pharmacies’ costs; and other factors throughout the entire supply chain.”
It also says surveys like U.S. PIRG’s don’t take into account “widely prevalent savings programs” made available to patients who pay cash. But Schondelmeyer said big chains take advantage of their name recognition and “charge higher prices typically than your medications would cost at the local independent pharmacy.”
Brianna Hamilton said her family will cut back more and possibly move until her deductible kicks in.
In response to growing concerns, Eli Lilly announced on Monday it will start selling a cheaper, generic insulin. Novo Nordisk, the company that makes the brand of insulin Hamilton uses, told CBS News they “want to find additional solutions that address access and affordability” of their medications.
Some tips for getting the best price on your medications include calling multiple pharmacies, both large and small, to compare costs and asking for prices with insurance as well as cash prices. It’s also important to consult with your doctor about generic options and check out websites that do cost comparisons with drugs.
In a statement to CBS News, B. Douglas Hoey, the CEO of the National Community Pharmacists Association, said, “We really can’t speculate why certain large chains are significantly more expensive, but community pharmacies answer to citizens on Main Street, not shareholders on Wall Street.”
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Doctors and insurers are using federal guidelines as cover to turn away patients, experts tell the C.D.C. and Congress.
Posted on March 7, 2019 by Pharmaciststeve
Doctors and insurers are using federal guidelines as cover to turn away patients, experts tell the C.D.C. and Congress.
www.nytimes.com/2019/03/06/health/opioids-pain-cdc-guidelines.html#commentsContainer
Three years ago this month, as alarms about the over-prescription of opioid painkillers were sounding across the country, the federal government issued course-correcting guidelines for primary care doctors. Prescriptions have fallen notably since then, and the Trump administration is pushing for them to drop by another third by 2021.
But in a letter to be sent to the Centers for Disease Control and Prevention on Wednesday, more than 300 medical experts, including three former White House drug czars, contend that the guidelines are harming one group of vulnerable patients: those with severe chronic pain, who may have been taking high doses of opioids for years without becoming addicted. They say the guidelines are being used as cover by insurers to deny reimbursement and by doctors to turn patients away. As a result, they say, patients who could benefit from the medications are being thrown into withdrawal and suffering renewed pain and a diminished quality of life, even to the point of suicide.
The letter writers form an uneasy alliance spanning differing positions on opioids — professors of addiction medicine as well as pain specialists, some patient representatives who have taken money from the pharmaceutical industry, and the former drug czars, from the Obama, Clinton and Nixon administrations.
Michael Botticelli, who served as the drug czar under President Obama and now leads the Grayken Center for Addiction at Boston Medical Center, said he signed the letter because “there has been enough anecdotal evidence to raise the alarm bells” about the misuse of the guidelines leading to pain patients losing effective treatment.
“The C.D.C. really does need a rigorous evaluation of this because we don’t know how big the problem is,” he said. “Minimally, we need some level of clarification on appropriate use of the guidelines.”
Specifically, the letter asks the C.D.C. to emphatically state that treatment decisions for these patients be left to their doctors.
“It is imperative that health care professionals and administrators realize that the guideline does not endorse mandated involuntary dose reduction or discontinuation,” the group wrote in the letter, which it also sent to members of relevant congressional committees.
A spokeswoman for the C.D.C., Julie Eschelbach, said the guidelines “do not endorse mandated or abrupt dose reduction or discontinuation.” She added that the agency has several studies underway to examine the guidelines’ impact, and has published a “pocket guide” for doctors on tapering.
The guidelines are nonbinding, but many of them have become enshrined in state regulations. Therefore, said Dr. Stefan G. Kertesz, an author of the letter who teaches addiction medicine at the University of Alabama at Birmingham, “it’s normal to say from the top: ‘This needs a clarification because we don’t want people hurt.’”
Others say the problem lies not with the guidelines, which urge non-opioid therapies as the first-line treatment for chronic pain, but with their misapplication.
“What the guidelines are being blamed for versus what they actually recommend are two different things,” said Dr. Thomas R. Frieden, who ran the C.D.C. when the guidelines were developed.
Experts in addiction medicine distinguish patients who need opioids for chronic pain from people addicted to the drugs: while some patients are physically dependent and will go into withdrawal if the drugs are withheld, the opioids help them function, despite severe pain.
“But just because you’re on a higher dose doesn’t mean you’re addicted,” said Dr. Daniel P. Alford, a professor who directs addiction medicine education at the Boston University School of Medicine, who signed the letter.
Addiction, he said, is “a behavioral maladaptation where the medication takes over their lives, and they continue to use despite negative consequences.”
The guidelines say doctors should discuss the costs of a high-dose regimen with pain patients and press for a prudent taper. They do not say those patients’ drugs should be summarily reduced. They advise doctors to prescribe opioids to new patients only for a short time, and with a daily dose below 90 morphine milligram equivalents. That recommendation has prompted many states and monitoring systems to impose a hard stop at that level for all patients except those with cancer or in end-of-life care.
“Who says that 90 is a magical threshold?” Dr. Alford asked. “There’s no good evidence. Yes, we should avoid escalating doses, but how do we treat people who are already on high doses?”
Dr. Frieden defended 90 M.M.E., as the measurement is known, as a responsible ceiling. “The death rates just go up exponentially,” he said, for people on very high doses of opioids.
Dr. Frieden said more doctors should be allowed to get federal permission to prescribe buprenorphine, a lower-risk opioid drug that can effectively manage opioid dependence while treating pain, as an alternative to more dangerous painkillers.
(Dr. Frieden was charged last summer with groping a woman; he pleaded not guilty and the case is still pending.)
The letter to the C.D.C. echoes a November resolution by the American Medical Association, which protested the “misapplication” of the guidelines “by pharmacists, health insurers, pharmacy benefit managers, legislatures, and governmental and private regulatory bodies in ways that prevent or limit access to opioid analgesia.”
A central question is how many patients have suffered from their doses being reduced or from being taken off opioids entirely. A report by the inspector general at the Department of Health and Human Services estimated that in 2016 about 500,000 beneficiaries of Medicare drug plans had been getting prescriptions of 120 M.M.E. or greater for three months or longer — a figure that doesn’t fully capture the current affected population.
Accompanying the experts’ letter are testimonials by hundreds of pain patients detailing struggles in the wake of the guidelines.
The opioid prescribing rate has been falling since 2012, but the amount prescribed per person is still about three times higher than it was in 1999, at the beginning of the addiction crisis, according to the C.D.C. While overdose deaths because of prescription opioids have begun leveling off, deaths from illicit fentanyl and its analogues increased by more than 45 percent in 2017 alone, a phenomenon that the letter writers attribute in part to the crackdown on pain pill prescriptions.
Dr. John Brooklyn, who runs two large addiction treatment programs in Vermont, gave one example. A 61-year-old patient, disabled by a back injury, had been functioning well for years on 225 M.M.E., he said. Invoking the guidelines, his pain doctor started cutting his dose by 40 milligrams a month.
“When he was at 120 M.M.E.,” said Dr. Brooklyn, “he was in such severe pain that he was buying opioids on the street. He barely ate, lost 40 pounds, couldn’t pay rent and then turned to cheap heroin. His doctor continued to reduce his dose and, at 30 M.M.E., the patient called our program.”
Dr. Brooklyn put the patient on methadone, a type of opioid approved to treat addiction as well as to manage chronic pain. “It was like watering a dehydrated plant,” he said.
Dr. Joanna L. Starrels, an associate professor of medicine at Albert Einstein College of Medicine and one of the experts who helped draft the C.D.C. guidelines, said chronic pain patients are an especially fragile group. “Some with severe persistent pain are barely getting by,” she said. “They are sometimes homebound, unable to work or fully participate in most of the rewarding aspects of life.” Their rates of depression are high, she said, and they have few reliable treatment alternatives.
Research that looks at the effect of dose reduction on such patients is in its infancy, she said.
In fact the guidelines include a plea for research to evaluate their efficacy.
That the guidelines have had widespread impact is not in question. While a handful of hospital systems and states had adopted opioid prescription limits before 2016, the number of institutions have since shot up.
In its annual survey of hospital-based pharmacies last year, the American Society of Health-System Pharmacists asked about opioid monitoring for the first time. In preliminary results, 41 percent said they had done so and some cited the C.D.C. guidelines.
By the end of 2016, seven states had passed legislation limiting opioid prescriptions; by October 2018, 33 states had enacted laws with some type of limit, guidance or requirement related to opioids, according to the National Conference of State Legislatures.
Aetna, one of the country’s largest health insurers, placed a limit of 90 M.M.E.s per day on its members last year based on the C.D.C. guidelines, said Ethan Slavin, a company spokesman. The stricter daily limits “are part of our efforts to help reduce the potential for misuse and diversion of the drugs,” he said, adding that prescribers who believe higher doses are needed can seek special permission by consulting with Aetna’s experts.
A study last year found that insurers overall were not doing enough to increase access to alternative pain treatments, including therapeutic massage, acupuncture and non-opioid drugs.
Dr. Anna Lembke, medical director of addiction medicine at Stanford, declined to sign the letter, saying the guidelines were sufficiently moderate.
The remedy to the problems detailed in the letter, she said, was to educate primary care doctors about how to provide “safe, compassionate, patient-centered tapers when medically indicated,” which can be a protracted, delicate process.
Dr. Kertesz acknowledged that tapering was a worthy goal. “But more typically what we are seeing,” he said, “are people who report non-consensual tapers.”
Correction:
An earlier version of this article misstated Dr. Thomas Frieden’s views on the C.D.C. guidelines for opioid prescriptions. He said higher doses greatly increase risk; he did not say they were not worth the risk.
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patients are receiving medicines from other countries, and which may be sub-potent, super-potent or counterfeit
Posted on March 7, 2019 by Pharmaciststeve
Clients shrug as FDA slams Canadian firm shipping cheap drugs to U.S.
The FDA has again lashed out at a Canadian company that it has been feuding with for more than a decade for helping U.S. consumers get drugs on the cheap. Its clients, however, are shrugging off the warning that the products they have been buying for years might not meet U.S. standards.
The FDA last week slapped a warning letter on CanaRx for hooking U..S. consumers up with Canadian pharmacies to buy at discounted prices drugs that range from cancer drug Gleevec to HIV drug Truvada.
While the agency acknowledged that the Canadian “first-class drug regulatory process” assures high-quality drugs that come from the country’s pharmacies, it said there is no guarantee drugs that come through Canadian websites have been vetted by Canadian regulators.
“Operations like CanaRx use their names to imply that patients are receiving medicines approved in Canada, when it’s likely that patients are receiving medicines from other countries, and which may be sub-potent, super-potent or counterfeit.,” the FDA said.
Consumers for years have crossed the border to buy drugs. In 2003 CanaRx was formed to provide mail-order service from Canada for public employee health plans in states that include Illinois, Vermont and Rhode Island and elsewhere.
An attorney for the company said the FDA has mischaracterized the CanaRx business model and operating protocols, and that it intends to continue to serve its U.S. clients.
One of those clients, Schenectady County, New York, defended the Canadian company that it has worked with for 15 years.
“This is a good program, and on the merits it looks lawful, and they are not doing the terrible things that the FDA is suggesting,” County Attorney Chris Gardner told Kaiser Health News.
He said about a quarter of the county’s 1,200 employees get their drugs from the Windsor, Ontario, company with no co-pays and that the program saved the county about $500,000 last year. He said the county will see how the situation plays out, but for now the program is being kept in place.
The FDA’s warning letter and announcement came after Florida Governor Ron DeSantis claimed he had President Trump’s backing to start a program to import drugs from Canada. Kaiser Health said that White House officials have chimed in since then that Florida would need approvals from state and federal officials to launch such a program.
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Jury finds Walmart wrongly fired Washington pharmacist who could not give injections
Posted on March 7, 2019 by Pharmaciststeve
A federal jury in Tacoma found Wednesday that Walmart wrongly fired a Western Washington pharmacist whose medical conditions kept her from giving injections.
The company should pay 63-year-old Lori Jacobs roughly $1 million for its violation of the Americans with Disabilities Act, the jurors in U.S. District Court decided.
The verdict came amid a national uproar about the company’s recent decision to get rid of its greeter positions, which greeters with physical disabilities worried would leave them without jobs.
Jacobs worked at Walmart’s Port Angeles and Sequim stores from 2007 until 2017 when she was let go, her lawsuit says.
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Want to Know If Someone Is Manipulating Data?
Posted on March 7, 2019 by Pharmaciststeve
Want to Know If Someone Is Manipulating Data?
Milton Packer describes how to distinguish science from magic
https://www.medpagetoday.com/blogs/revolutionandrevelation/78239
Every magician is master of deception, and we adore being deceived. How do magicians accomplish their illusions? The key to every magic trick is misdirection. If you tell the members of the audience to look at A, then they will not look at B. And it is B that makes the trick work.
That is why many magicians forbid cell phones during their performances. If you can take a video of the trick and play it back repeatedly, you might eventually be able to find out how the trick works. You can keep looking for B, even though the performer is doing everything to make sure that you are focused on A.
Why am I talking about magicians in a blog devoted to medicine?
Two weeks ago, I wrote a post about my experiences as a principal investigator in large-scale clinical trials. Several readers thought that my personal experiences did not represent the norm. Many thought that clinical trial data are commonly manipulated in order to put them in the best possible light. I had to acknowledge that their concerns were valid.
A respected friend suggested that I devote a post to describing how someone might manipulate data in order to make a negative trial look like a positive one. My challenge: how could I possibly describe it in a blog?
Soon the answer became obvious. Deception of the audience in presenting a clinical trial is based on the same strategy of misdirection that magicians use to make their performances work.
Believe it or not, there are dozens of possible forms of misdirection that are possible when presenting the results of a clinical trial. They could fill an entire book. But today, I am going to mention the two most important ones, which any reader or listener can look for.
First and most important is the trick of missingness. The best way to make data look better is to take out data that you do not like or not bother to collect it at all. If the presentation does not account for missing data, all sorts of mischief are possible.
Let us say that you have randomized 600 patients in a trial. According to the intention-to-treat principle that governs the integrity of clinical trials, you need to show data on 600 patients. But often, investigators will show you data on 550 patients, having taken 50 patients out of the analysis.
Clinical investigators can provide all sorts of reasons why the 50 patients are missing. They can say that the patients never returned for follow-up, or that they violated the protocol and were removed from the analysis. Investigators can get very creative in devising reasons that seem credible but are biased. They can even claim that the missingness does not matter if it affects both treatment groups equally, even though that is certainly not true.
The truth: Missingness is never random, and if it is large enough, it is always a source of bias. Did the patient not return for a repeat evaluation because they died or suffered a serious adverse effect? The investigator might not even know. The integrity of a clinical trial depends on the ability of an investigator to fully describe and account for all missing data. A strong investigator worries about missing data; a careless investigator ignores the problem.
When is missingness important? When the amount of missing data is a meaningful proportion of the size of the treatment effect. Example: if the treatment group had 25 fewer deaths than the control group, missing data in 15 patients is meaningful. If the treatment group had 200 fewer deaths than the control group, missing data in five patients is very unlikely to be relevant.
Second is the trick of not showing a planned analysis, or alternatively, showing an analysis that was not planned. In every clinical trial, the rules governing data analysis are written down in advance in a protocol and a formal statistical plan. These documents provide evidentiary proof that the investigators are planning to look at a very specific endpoint that is defined in a very specific way and analyzed in a very specific manner in a very specific sequence. These rules are defined before anyone has a chance to look at the data.
How do you know if the investigators followed their prespecified rules? You need to read the protocol and the statistical plan. And if you can, you need to look at the dates that these documents were filed in advance with regulatory agencies.
These documents might reveal that the investigators defined four endpoints in a very specific manner, and that they intended to analyze them in the following sequence: A, D, C, B.
So would you worry if the investigators only presented the results of A and C? Would you worry if they changed the definition of A after the fact? Would you worry if they analyzed C in a way that was not planned? And would you worry if the presenter told you to focus your attention on a new endpoint — let us called it E — which was never planned in advance at all?
You should worry under all these circumstances.
How can you tell if the investigators followed their plan faithfully? A few top-tier journals require that the investigators provide files of their protocol and a statistical plan at the time of initial peer-review, and they are published as online supplements to the paper reporting the main study results. Sadly, most journals do not have this requirement. And even when these documents are published, most readers do not bother to look at them.
There are four important things to remember about these documents.
- Investigators know that these documents will be closely scrutinized. Therefore, some might be tempted to specify an improper analysis in advance. Specifying something stupid in the statistical plan does not make it valid.
- Investigators should summarize the essence of these documents on a slide shown at the time of their presentation at a scientific meeting. It is one of their most important slides, but it is also the one that most people in the audience ignore. And all too often, it is missing entirely.
- If the drug or device is approved, the FDA is required to make its analyses available to the public. Therefore, it is possible to compare the analyses in a publication with the analyses performed by the FDA. For all prespecified analyses, these should look very similar to each other. The FDA analyses are particularly easy to access if the drug or device has been considered at a public advisory committee, since they are posted simultaneously on the FDA website.
- The statistical plan focuses only on the analyses that are relevant to demonstrating the intervention’s efficacy for a specific indication. Many secondary papers from a clinical trial describe analyses intended to learn about other effects of the intervention or about the disease itself. These analyses are not part of the regulatory approval process, and their findings should always be considered in the context of the totality of evidence in the medical literature. Some are hypothesis-generating; some confirm similar observations in other trials.
So in a nutshell, here are two simple rules.
First, are there missing data and is the degree of missingness meaningful?
Second, did the authors specify a valid analysis plan in advance and did they follow it?
If these two simple rules are not followed, you should wonder and worry. Does the presenter want me to focus on A, when I should be looking at B? If the presenters want to misdirect the audience, it is a really simple thing to do — especially in a presentation that lasts for only 10-15 minutes.
To be clear, these are not the only two tricks that people can play with the data from a clinical trial. But they cover a lot of ground.
Here is my most important point of all. Investigators who engage in misdirection may not actually be consciously trying to mislead people. Amazingly, they are often the ones who are being misled. All too often, investigators are susceptible to self-deception — especially if they do not know the rules of proper analysis and are inclined to find a way to show that the intervention works (even if it does not).
Misdirection is essential to the success of magicians. When done with perfection, it is a delight. The audience truly enjoys being fooled.
But when we are listening to the primary results of a trial or reading the publication of these results in a journal, we are not interested in entertainment or wishful thinking. We are interested in unbiased data and analyses. This is what makes science different from magic.
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We are NUMBER ONE !!!
Posted on March 7, 2019 by Pharmaciststeve
American deaths by alcohol, drugs, suicide broke record in 2017, study finds
Deaths due to alcohol, drugs and suicide in America reached a record 151,845 in 2017, new research has shown.
That number is more than double the figure from 1999 and was published Tuesday in an analysis by the Trust for America’s Health (TFAH) and Well Being Trust (WBT) using mortality data from the U.S. Centers for Disease Control and Prevention (CDC).
Overall, deaths by alcohol, drugs and suicide across the U.S. increased by 6 percent from 2016 to 2017, which is higher than the average annual increase of 4 percent since 1999.
The report also found that deaths by synthetic opioids increased by 45 percent from 2016 to 2017 and have increased ten-fold in the last 5 years.
More than 1,000 Americans died from synthetic opioid overdoses every two weeks in 2017, according to the report.
“Americans are now dying at a faster rate from overdoses involving synthetic opioids than they did from all drugs in 1999,” the study said.
Suicide-related deaths also rose 4 percent, the report found, marking the largest increase in rates of such deaths since the data first started being collected in 1999. Before that, suicide deaths increased on average by about 2 percent every year.
White men in rural areas remained the top demographic for suicide-related deaths, according to the study, though suicide rates for children and adolescents increased by 16 percent from 2016 to 2017.
The only states that decreased their rates of death from alcohol, drugs and suicide were Massachusetts, Oklahoma, Rhode Island, Utah and Wyoming, according to the study.
“We need a comprehensive approach with attention to the upstream root causes – like childhood trauma, poverty and discrimination —and the downstream life-saving efforts – like overdose reversal and access to treatment—and everything in between,” said John Auerbach, President and CEO of TFAH in a statement.
TFAH is a public health policy, research and advocacy organization and WBT is a 501(c)(3) charity focused on mental, social and spiritual health.
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