Of the 14 COVIS-19 tests, only three delivered consistently reliable results. Even the best had some flaws

Coronavirus (Covid-19) antibody tests: Do you really want one? Think hard about it. Maybe not.

https://clearhealthcosts.com/blog/2020/05/coronavirus-covid-19-antibody-tests-do-you-really-want-one-think-hard-about-it-maybe-not/

Coronavirus testing: It has long been hard to get. Now suddenly in the New York area, tests are freely available.

The test will tell me truly if I have had coronavirus and am therefore immune, right? Or if I was exposed to the virus and magically skipped through, with few symptoms?

The expert opinions are in: Maybe. Maybe not.

We’ve been doing a lot of research about coronavirus (Covid-19), and particularly about testing. I live in the center of the pandemic. Also, I recently tested positive for coronavirus antibodies twice, and negative once, and I’ve been exploring what it means.

First: There are two kinds of tests. Both the respiratory test (nasal swab) and the antibody test have problems as far as accuracy. Beyond that, if the results are correct, experts disagree on what the results mean. If you have a positive respiratory test, that’s pretty clear: You’ve got it. But if you test negative, because of the high error rate, if you have with symptoms, most doctors will say you should still act like you have it.  With the antibody test, same problem: Positive probably means positive, but false positives are clearly possible.

I asked Donald G. McNeil Jr., the star New York Times reporter, who’s a friend from long ago: Is this good news? Am I immune?

He said: “I would NOT trust that antibody test. There are about 50 tests, none are validated yet and we know that some give false positives if you have antibodies to the common cold coronaviruses. Also, we don’t know what level of antibodies confers immunity. So although it’s potentially good news, I would not assume you are immune. Better tests are on the way.”

My negative test from CityMD followed two positive tests, one from the New York State Department of Health, see here, and one at Stony Brook University Medical Center, see here.

Here’s a negative test from Go Health urgent care, partnered with Northwell Health, from a friend.

The ‘immunity passport’ idea — not so fast

For a while, Gov. Andrew Cuomo of New York and others were talking about using antibody testing as a way to give people an “immunity passport.”

“At the time Cuomo talked up antibody testing, using the procedure to establish immunity was widely perceived as a possibility,” Anna Gronewold and Shannon Young wrote over at Politico on May 5. “But that ambition quickly turned to disappointment as the World Health Organization came out against such strategies, saying there is no evidence that antibodies give immunity. Something that seemed to have been a silver bullet was too good to be true. Cuomo stepped back.”

There are several issues: Does the test (and there are about 170 on the market, of varying degrees of usefulness) actually sense the presence of the actual coronavirus implicated in Covid-19? And does presence of those antibodies confirm immunity? Depends on who you listen to, but the smart money is on “Maybe.”

The situation is changing quickly, also.

On April 20, Anthony Fauci told “Good Morning America,” ‘“The problem is that these are tests that need to be validated and calibrated, and many of the tests out there don’t do that. So even though you hear about companies flooding the market with these antibody tests, a lot of them are not validated.

“There’s an assumption — a reasonable assumption — that when you have an antibody that you are protected against reinfection, but that has not been proven for this particular virus. It’s true for other viruses,” he said.”

Testing the tests

Then a team of scientists reported that they had tested the tests. “These tests are crucial to reopening the economy, but public health experts have raised urgent concerns about their quality,” The New York Times reported on April 24. “The new research, completed just days ago and posted online Friday, confirmed some of those fears: Of the 14 tests, only three delivered consistently reliable results. Even the best had some flaws.”

The scientists who started the test of the tests described the testing environment as “the Wild West.”

The FDA has given “emergency use authorization” to a number of tests, though the FDA’s “approval process” is deeply flawed. Dozens of other tests are being used, even without that light approval. The underlying scientific data on test performance is here. But remember, these are self-reported to the FDA and there hasn’t been enough time to really confirm performance.

What the doctors say

One of my friends asked her pediatrician about the tests; the pediatrician responded with this cautionary note from the Westchester, N.Y., county executive warning against using such testing to make personal decisions about exposure to coronavirus.

At one local Westchester medical group, a friend seeking to schedule a test heard from the nurse, “They will do it but the nurse told him that it is not reliable, as her husband and in-laws had the virus and she was exposed to it and not one of them tested positive for antibodies.”

Another friend had a test at CityMD in New York, after she had a serious bout of respiratory illness. The test came back negative — and she said a friend in the medical profession ridiculed her for seeking a test.

So, after a long time when no one could get tested, now every doctor’s office and a number of national labs have begun to offer these tests. See details here.  But at many of these medical offices, the offer comes with a warning.

It’s logical to ask: why is my medical group offering the test if it does not tell me anything? Why are reputable companies like Quest and Labcorp, national testing giants, offering the test if it isn’t accurate?

The results are not clear or definitive

Most have language about how the results are not clear.

CityMD: “Serum Antibody IgG (Blood Test): Regardless of your results, you should continue to exercise universal precautions such as social distancing, quarantining, frequent hand washing, wearing of a mask or face cloth in public, and other CDC guideline recommendations. Remember, COVID-19 is a new infection, and it is unclear if a positive antibody definitively offers immunity.” CityMD uses the Abbott test. In New York City, testing is free.

Labcorp says: “Your test results may help identify if you were exposed to the virus that causes COVID-19 and, if so, whether or not your body has developed antibodies. Although having antibodies usually gives immunity from further infection, there is not enough evidence at this time to suggest that people who have antibodies against SARS-CoV-2, the virus that causes COVID-19, are protected against future infections from the virus. Results from this test also will not provide information on whether you can spread the virus to others and is not used as a basis for diagnosis.” It also notes that false positives are possible.

Why do so many people want tests if the results are not actionable?

People want certainty, especially here in New York in pandemic central.   Also, the nationwide test shortage has meant that people want tests more than ever — a respiratory test or an antibody test.

My thoughts when I got a positive test included: “Yay, I’m home free! I will volunteer for all the trials I can volunteer for, and share my antibodies and genes with anybody!”

But I’m not immune. Also, there’s that one negative test …

According to human nature, we lust for the test — conveniently skipping by the fact that the test seems at this point to be 1) not reliable, whatever test it is, and 2) not proof of immunity.

So why get this test? Why not focus on the things we know are working: Stay home. Wear a mask. Wash hands. Be careful until you know things have changed.

Questions you might have

Should I get a test? Ask your doctor.

No really, should I? What are your reasons for wanting a test? If you want a certain answer about whether you had it or have it, you might not get that. If you’re asking to be given permission to leave self-isolation, do not use these tests for that purpose.

I hear there are two kinds of test — one for active infection and one for the presence of antibodies, which suggests immunities. Can you explain?  The one for active infection is usually done with a swab stuck into your nose or elsewhere in the respiratory tract, and the resulting sample is tested at a lab. Another kind of testing is now being done, serological (blood) testing for the presence of antibodies to the virus.

My work needs me to have a test. What should I do? Ask them why — the truth is that these tests do have errors. Better ones may be on the way. In any case, most scientists will say you should not base your personal behavior on these tests. Also ask your employer what test they need — the one for active infection, or the one for antibodies. Also ask: Will you pay? How do you want me to show you the results? Can you give me written, detailed instructions? Many workplaces have a hard time understanding these subtleties.

I need to have a test to get my sick pay for the days off I took for what I believe to have been coronavirus. My employer requires this before I can get my pay. See above on employers.

I need to get tested to know if I can go see my elderly mom (immunocompromised brother) etc. What should I do? Again, these tests are not going to prove that you are immune or not able to give the virus to someone else. The tests are not that reliable. Remember, the virus can be passed on not just through breathing but also by taking virus particles from, say, a doorknob and delivering them with your mom’s groceries. Stay safe.

My son tested positive on the respiratory test this spring, but now he needs a negative test to volunteer. What should I do? I believe in this scenario, the volunteer organization is looking for a swab or nasal test to confirm that he has no active viruses in his system. Confirm with the volunteer organization, and ask them for detailed, specific instructions in writing. (The nasal test also has a lot of errors.)

My son tested positive this spring, and now he wants to give plasma. What should I do? I believe in this scenario, the organization is looking for presence of antibodies to confirm that he had exposure to the virus in the past. Confirm with the organization, and ask them for detailed, specific instructions. Also, here’s a list of plasma donation and other studies. If you sign up, they’ll get in touch if you fit their criteria.

My doctor said the test was approved by the FDA. Doesn’t that make his test the best? The FDA approval process has been sorely lacking. Read here.  The underlying scientific data on test performance is here.  But remember, these are self-reported to the FDA and there hasn’t been enough time to really confirm performance.

My doctor’s office is offering the test, so isn’t that safe? It depends on what you think of as safe. Again, the results are unreliable, and most doctors will tell you that you should not use the test results to make decisions about where to go and what to do.

My doctor’s offering the test, but his nurse said don’t get it. What should I do? Think carefully about what you expect to gain from a test. Remember, they’re not all that accurate, and results shouldn’t be used to govern personal behavior — a positive antibody test is not a free pass to leave isolation.

I never tested positive but I know I had it. Should I get tested? We’re not doctors. But since we know a little about the reliability of the tests, we suggest that you think carefully about why you want to get tested.

I want one of these “immunity passport” things I’m reading about, certifying that I had it and I’m now safe. What should I do? The “immunity passport” idea has been discarded. First, the tests aren’t that accurate, and second, even if they do confirm that you have antibodies, no one knows whether those antibodies will protect you from another infection.

Some tests are better than others, I hear. I want the best one. What is it? There are a lot of people out there selling tests that have not been authorized by the FDA. Scammers will find ways to scam people. What’s the best one? The science is still out on this one, but Michael Osterholm, a well-respected scientist who runs a center studying pandemics at the University of Minnesota, said he thinks the best one is being used by Mount Sinai Medical Center in New York City. It’s a two-step process, he said. The Mount Sinai test is not commercially available; scientists there are using that test to qualify potential donors for a convalescent plasma trial.

Wait, there’s an at-home test! Why shouldn’t I use that? At this point the FDA has not authorized any at-home tests. There are a lot of people trying to make money on coronavirus testing, so you should be cautious. For example, LetsGetChecked.com is promising an at-home test. They don’t have one now. They just raised a ton of money, $71 million to be exact. Would you choose them to test you? Why?

 

If it’s not about testing, what is it about? Scientists say testing is an important element of dealing with the pandemic. But other important elements should not be disregarded: Tracing the contacts of infected people, social distancing, hand-washing, mask-wearing, responsible conduct in general.

 

Kolodny: has been an absolute champion for American families in continuing to fight against very powerful interests

Flattery credits Kolodny with helping survivors deal with the devastating effects of their loss. “He has been an absolute champion for American families in continuing to fight against very powerful interests

https://www.brandeis.edu/magazine/2018/spring/featured-stories/opioid.html

In 2003, as a new employee in New York City’s health department, having just completed a psychiatry residency at Mount Sinai, Andrew Kolodny was given a singular charge: Reduce the city’s drug-overdose deaths.

The size of the task felt overwhelming. “How can a psychiatrist in Lower Manhattan prevent somebody from doing too much heroin in the South Bronx?” Kolodny says. “It seemed sort of impossible.”

Still, he was game to try. Buprenorphine, a milder, safer alternative to methadone, then the standard opioid-addiction treatment, had recently come on the market. He started visiting medical clinics across the city to persuade physicians to use buprenorphine to treat heroin-addicted patients. “They’d look at me like I was crazy,” he says. “They said, ‘Why would we want to treat addicts? Why would we want them coming into our office?’”

Kolodny decided to open his own clinical practice in Manhattan, assuming he’d be treating addicted men from poor, predominantly minority neighborhoods. But a funny thing happened. Patients came to see him from as far away as New Jersey and New York’s Westchester County and Staten Island. They were mostly white and middle-class. And they were addicted to prescription painkillers such as oxycodone (OxyContin) and hydrocodone (Vicodin), not heroin.

“That was my first clue we had a really serious problem with prescription opioids,” Kolodny says today, sitting in his office at the Heller School for Social Policy and Management, where he is a senior scientist.

One of the first doctors to recognize what has become the deadliest drug epidemic in American history, Kolodny is now arguably the country’s most outspoken expert on a crisis that continues to grow. Opioids — including prescription drugs, heroin and the synthetic drug fentanyl — claimed more than 49,000 lives in 2016, according to data from the Centers for Disease Control and Prevention (CDC), up from 28,647 in 2014.

Over the past decade, Kolodny has broken ranks with many physicians by insisting the epidemic is not one of drug abuse but of addiction, borne of the overprescription of extremely addictive painkillers to patients suffering from back and nerve problems, and other kinds of chronic pain. His stance has put him at odds with pharmaceutical companies that manufacture opioids (as well as some pain-patient advocacy groups that receive funding from them), which claim problems with opioids are limited to people who abuse them.

But as the sheer magnitude of the opioid crisis swamps the nation’s medical system, and devastates families and communities alike, Kolodny’s warnings are finally being heeded.

Opioids in every medicine chest

When Kolodny arrived at Brandeis in December 2016, the Heller School’s Institute for Behavioral Health (IBH) already had a national reputation for opioid policy research. IBH director Connie Horgan believed Kolodny would lend a clinical perspective that would give greater urgency to the institute’s research, and made him co-director — alongside senior scientist Peter Kreiner — of IBH’s newly created Opioid Policy Research Collaborative (OPRC), which studies responses to the crisis.

More than 100 people attended the OPRC’s official launch celebration in mid-November. The HBO documentary “Warning: This Drug May Kill You” was screened, followed by a panel discussion moderated by Cynthia McFadden of NBC News and remarks from U.S. Representative Katherine Clark, from Massachusetts’ 5th District. The panel also included Marylou Sudders, Mass­achusetts secretary of health and human services, and Dr. Myechia Minter-Jordan, president and CEO of the Dimock Center, a Boston community health and human-services organization.

BAD MEDICINE: Audience members at the Opioid Policy Research Collaborative launch event watch the HBO documentary "Warning: This Drug May Kill You."

Following the event, President Ron Liebowitz and his wife, Jessica, hosted a dinner. U.S. Senator Edward Markey sent a video message viewed during the dinner. “I pledge my support for your work,” Markey said. “I believe the people here tonight can and will make a difference.”

When Kolodny’s not researching the most effective ways to prevent and treat addiction, he travels the country warning doctors’ groups, the media and policymakers about the crisis. “For years, nobody wanted to hear about it. Now everybody wants to hear about it at exactly the same time,” he sighs.

He’s become an unlikely celebrity. As he talks in his office at Heller, an NBC camera crew keeps interrupting him to line up shots — one crew member swivels around the table with a handheld camera; another shoots through the doorway with her iPhone. “It’s a little distracting,” Kolodny says good-naturedly as the cameraman aims up at him from a kneeling position on the floor. Wearing a puffy vest over his Oxford shirt, his hands awkwardly pushed into his pockets, Kolodny looks every bit the psychiatrist. He exudes a soft-spoken charisma, able to translate policy with passion.

Kolodny grew up on Long Island, where his father was a doctor and everyone assumed he would become one, too. “Jackie Mason used to joke that every Jewish kid’s supposed to be a doctor; or, if their brain doesn’t work too good, a lawyer; or, if their brain doesn’t work at all, an accountant,” he deadpans. After medical school, Kolodny was drawn to psychiatry. “I wasn’t really interested in sticking people with needles or cutting people. You could just talk to someone, which was nice.”

His real interest, however, lay in public health, which had captured his imagination as a kid when he read a book about epidemiologists fighting disease outbreaks. At New York City’s health department, he approached the outbreak of opioid addiction as a puzzle to be solved. The first clue surfaced in a 2006 study by CDC physician Len Paulozzi, which included a neat graph with two rising parallel lines — one the number of opioid painkillers prescribed by doctors, the other the number of deaths from opioid overdoses.

“That was sort of an aha moment for me,” Kolodny says. He naively assumed that, if the graph were true, the policy solution would be straightforward.

Yet almost as soon as Paulozzi’s report came out, pain organizations funded by pharmaceutical companies challenged it, placing the blame for the rising epidemic not on overprescribing doctors but on addicts and criminals who steal or divert legitimate opioid prescriptions to abuse them. The pain organizations argued a reduction in prescribing would penalize pain patients for the bad behavior of drug abusers. Federal agencies fell for this argument.

“Almost everything coming from the federal government was focused on ‘How do we keep kids from getting into grandma’s medicine chest?’” Kolodny says. “Nobody asked, ‘Why does every grandma now have opioids in her medicine chest?’”

Kolodny might have been persuaded by the pain groups if he hadn’t been seeing firsthand the impact of the drugs on patients, many of whom had been legitimately prescribed opioids for pain and were unable to stop taking them.

One opioid survivor, Betts Tully, was prescribed OxyContin in 2001 after two back operations. The medicine never completely eased her pain, so her doctor kept prescribing more — increasing her dosage from 20 mg to 280 mg over six months. Kolodny read about Tully’s ordeal in an Op-Ed she wrote for the Journal of the American Medical Association.

“I was no longer working or talking to friends and family,” she says. “All I did was stay in bed.” When she stopped taking the pills, withdrawal symptoms made her feel even worse. Because the drugs muddled her mind, she couldn’t see the problem clearly. It took an intervention by her daughter for her to get help, then two years of gradually reducing the prescription drug to get all the opiates out of her system.

Kolodny accompanied Tully and other patients to U.S. Food and Drug Administration meetings to advocate for tighter controls on the drug companies. Wherever he went, he found pharmaceutical company representatives with their own patients, begging policymakers not to take measures that could reduce what they said were needed pain medications.

An epidemic of overprescribing doctors

Purdue Pharma, which introduced OxyContin in 1995, aggressively marketed the drug, says Kolodny, deceiving doctors on the safety and effectiveness of its long-term use. (In February, Purdue announced it would no longer market opioid drugs to doctors.)

In 2010, to counter misinformation about opioids, Kolodny, other like-minded doctors, and patients founded Physicians for Responsible Opioid Prescribing (PROP). PROP exposed Big Pharma’s marketing efforts by publicizing how pain groups funded by pharmaceutical companies promoted aggressive prescribing as safe and effective.

Meanwhile, peer-reviewed studies were contradicting the safety and efficacy claims. Researchers found that, although opioids could be used to treat short periods of acute pain, pain patients on opioids did not do well over the long term.

In early 2014, actor Philip Seymour Hoffman died from an opioid overdose at age 46, spurring a public reckoning with the drugs’ prevalence. Even then, however, the federal government response was muted.

Kolodny compares President Barack Obama’s neglect of the opioid issue to Ronald Reagan’s lack of action on the AIDS crisis in the 1980s. “I don’t think the opioid crisis was on Obama’s radar,” Kolodny says. “He started to do the right things at the very end but never spoke about the problem publicly until his last year in office.”

Gradually, Kolodny shifted his focus from raising awareness of the crisis to researching how to fight it. “To bring the epidemic to an end, we have to prevent more people from getting addicted,” he says. “And, more than anything, that means cautious prescribing.”

In 2015, Kolodny used a grant and support from IBH to look at the prescription patterns of doctors in New York state, studying data from the state’s Prescription Drug Monitoring Program (PDMP), which tracks all opioid prescriptions.

Years earlier, Kreiner had established the Prescription Drug Monitoring Program Training and Technical Assistance Center to help improve state PDMPs through a combination of academic research and on-the-ground consultation with former PDMP administrators. In 2011, the CDC approached him about combining prescription data from multiple states.

The CDC was “a little blindsided by the intensity of the opioid problem,” Kreiner says. “A big part of that was the lack of timeliness of getting good data.”

Currently, Kreiner’s database contains data from 12 states. He’s used the information to develop a set of 43 measures of risky patient and prescriber behavior that could increase the risk of addiction.

As of now, 50 different state laboratories struggle with how to monitor and control opioid prescriptions. Some states have passed laws requiring doctors to check PDMP databases before writing a new prescription. Others have limited the number of days before a patient can get a refill. “People are trying things without really knowing what’s going to work,” Kolodny says.

“We have found no effect for even the most comprehensive laws on daily opioid dosage,” says Kreiner.

Perhaps that’s because states that limit the number of days before refills don’t specify limits on the dose, allowing patients to still get dangerous amounts. By drilling down deeper on the relevant data, the Prescription Drug Monitoring Program Training and Technical Assistance Center may be able to help states create more-effective laws.

‘It really is Kryptonite’

At the same time, states are investing in treatment for those already suffering from opioid addiction. “The genie is out of the bottle,” says Kolodny. “Doctors’ starting to prescribe cautiously doesn’t mean patients’ addictions are going to go away. It means building out a treatment system that doesn’t exist yet.”

Even before prescriptions began declining in 2011, young people were turning to the black market to buy heroin, often a cheaper alternative to OxyContin. In recent years, opioid overdose deaths among heroin users have risen rapidly. The heroin supply, which often has fentanyl mixed into it, has become more dangerous.

Although evidence shows the best treatment combines counseling with drugs like buprenorphine or methadone, abstinence-only programs predominate at treatment centers. “It’s easier for people who are addicted to buy heroin than it is to find a doctor who will treat their opioid addiction with buprenorphine,” Kolodny says.

The result is stories like Kevin Flattery’s. A member of an affluent Northern Virginia family, Flattery attended a Jesuit prep school, played varsity ice hockey and graduated from the University of Virginia ready to pursue a career as a screenwriter. Once in Hollywood, however, he began experiencing anxiety and depression. Remembering a long-ago treatment with opiates for a sports injury, he started self-medicating with OxyContin. “Like a lot of people, he seriously underestimated its addictive qualities,” his father, Don, says. “It really is Kryptonite.”

After Kevin became addicted, he sought help from his family, returning on a plane from LA in full withdrawal, suffering from fever sweats and looking like he hadn’t slept or eaten in days. His family was able to get him stabilized with buprenorphine and found a residential drug-treatment program to help him detox. The program advocated complete abstinence, releasing him clean after 30 days. Within another 30 days, he had relapsed and fatally overdosed. He was 26.

“We had to learn the hard way that opioid addiction is a chronic disease that affects brain circuitry and chemistry, and it takes a long time to rewire,” says Don Flattery, who is now, along with Kolodny, a committee member in FED UP!, an advocacy group pushing for an increased federal response to the opioid crisis.

Flattery credits Kolodny with helping survivors deal with the devastating effects of their loss. “He has been an absolute champion for American families in continuing to fight against very powerful interests,” Flattery says.

Others at Brandeis are also leaders in the fight. For the past 15 years, Connie Horgan and senior scientist Sharon Reif have examined medical coverage for treatments as part of a larger study on drug, alcohol and mental-health services. They have found that many health plans either neglect to include addiction-treatment drugs on their formularies or place them on the highest-cost tier. “If a medication isn’t on the formulary or you are going to have to pay out of pocket for it, you are not going to get access to it,” says Horgan.

Health insurers often have an attitude that “use of medication means you are not recovered from your addiction — or that it is just a substitute for heroin — which is far, far from the truth,” adds Mady Chalk, Heller PhD’80, an expert on the opioid crisis.

As awareness of the crisis has increased, a growing number of states are enacting policies to treat opioid addiction. “The more states look at their own data to make decisions, the better we’ll be able to address the opioid epidemic,” Chalk says.

Despite the increasing awareness, Kolodny still gets criticism — sometimes from patients who take opioids and fear losing access to their medicine. A group of patients and a few doctors who lost their medical licenses for overprescribing opioids recently signed a letter addressed to President Liebowitz demanding Kolodny be fired. The university has no intention of firing Kolodny, says Horgan, who notes that IBH gets many letters that praise his work.

For his part, Kolodny expresses compassion for his critics. “I think of them as victims of our era of aggressive prescribing,” he says. “Many will have a hard time ever coming off opioids.” Nevertheless, “we need to prevent more pain patients from winding up in their shoes. Compassionate care for patients with pain isn’t jeopardized by more-cautious prescribing — it demands it.”

Though the tide of awareness has started to turn, the U.S. has a long way to go to solve the opioid-addiction epidemic. Unlike Obama, President Donald Trump hasn’t ignored the problem — in fact, he’s often spoken out publicly about the need to address it. When it comes to Trump’s record of action, however, Kolodny sums up his reaction in one word: “disappointed.”

The Trump administration’s declaration last fall that the opioid crisis is a public-health emergency is wholly inadequate, Kolodny says, since it came without any dedicated funds to fight the problem. Trump’s commission on the crisis issued its final report in November, punting the issue back to the states, with a call for Congress to issue an indeterminate amount of money in block grants.

“Trump certainly gets a better grade than Obama on speaking about the problem,” Kolodny says. “But there hasn’t been any action — none, zilch — from the administration. We don’t need another commission that issues recommendations. We need a plan, and we need funding that addresses the crisis.”

If one reads into what this article states… it is not clear if Brandeis is benefiting from what Kolodny is doing or Kolodny is riding on Brandeis’ coattails.  The fact that Kolodny is employed by Heller School’s Institute for Behavioral Health (IBH) at Brandeis University… would suggest that everyone involved with this project suggest that they knew that they were dealing with a mental health issue (addictive personality), but proceeded to proceed blaming various opiates. 

So Kolodny and Brandeis is “marketing” a medication for addiction that is a C-III and until 2014 Hydrocodone/Acetaminophen was a C-III. If one reads the DEA definition of what a C-II med is and what a C-III med is … they don’t vary all that much.  Substituting the dependency on one medication to another medication…can that really be labeled as a means to stop opiate abuse ?

Our Congress in 1999 declared that 2000-2009 was the “decade of pain” and the Joint Commission jumped on that law with “both feet” and declared that pain was a 5th vital sign and made pain management – especially in the hospitals that they accredited – a MAJOR STANDARD.  If a hospital failed meeting a major standard the hospital runs the risk of losing their ability to bill for services provided to Medicare & Medicaid pts.

While Purdue’s printed literature stated that Oxycontin was “less addicting” when prescribed to chronic pain pts and many studies validate that 98%+ of chronic pain pts prescribed routine dosing of any opiates WILL NOT BECOME ADDICTED.  Between Purdue’s marketing and the “decade of pain”.. may have contributed to some careless prescribing of opiates.

If one notices, there seems to be no mention that all of these people who were labeled as “addicts” weren’t already abusing/addicted to the two drugs -Nicotine and Alcohol – since we have some 30-40 million people abusing/addicted to both of these legal drugs.. why is there not some other stats on these opiate addicts/substance abusers on what other mental health addictive personality they may be involved in.

Has Kolodny and IBH had an intentional myopic viewpoint of the entire scope of the various substances that these people are using/abusing ?

Stimulus check — WHERE ARE YOU ?

The much-awaited documentary film—Pain Warriors– will be released on May 25th

Chronic Pain Documentary Set for Release in May

http://nationalpainreport.com/chronic-pain-documentary-set-for-release-in-may-8844122.html

The much-awaited documentary film—Pain Warriors– will be released on May 25th across Video on Demand Platforms, cable tv and other venues.

That’s the word from Tina Petrova of Visionary Films who says that Gravitas Ventures will distribute the film—a key relationship to getting more people to see the film on chronic pain.

As the press release says, those who suffer with intractable pain in North America now outnumber a series of other disease states.

 

The film by Petrova and Eugene Weis examines the “forgotten ones”-pain patients who have been denied life-giving medications by government policies and examines how some are being driven to suicide. They also feature some physicians who fight on despite concerns about their license.

“Would we take away someone’s insulin or beta blocker because a small percentage found a way to monetize these drugs and get high off them?”, she asks.

Chronic pain patients build their lives around managing pain and often struggle to perform simple task each. The chronic pain demographic, which includes millions, is often invisible, shunned and disbelieved.

Gravitas is a Red Arrow Studios Company one of the world’s leading creators and distributors of entertainment content.

So, what can you do between now and late May? Promote this on your social media. Many chronic pain patients and providers complain—rightfully—that not enough people know about chronic pain. Here’s an opportunity to help let not only people who are already sympathetic to the plight of the chronic pain patient but also to people in your networks—family friends and co-workers—who you believe may not understand what chronic pain patients go through.

Put a link to this story in your Facebook, Twitter, Instagram accounts and send it via email. Also tag the social media sites of the film:

FB: Painwarriorsmovie

TWITTER @painwarriorsdoc

Instagram: painwarriorsmovie

It’s an important educational opportunity.

And as always, if you want to follow National Pain Report you can do so at:

TWITTER: @NatPainReport & @edcoghlan

FACEBOOK: @nationalpainreport

Arthritis Foundation Survey

After a prolonged discussions with the Arthritis Foundation I asked them to step up to the CDC and their defunct guidelines.
Anyone suffering from severe Arthritis here is another door that has been opened where your voice can be heard. 
They have finally decided to help us.
Please complete the survey if you are able.,
The Arthritis Foundation’s Live Yes! INSIGHTS℠ Assessment. Learn More Now!

when pts’ health & well being is behind a company’s stock price and bottom line profits ?

Okay, we all heard the rumor that CVS was going to cut R.Ph. hours. Appears it is no longer a rumor. Got a text from a CVS pharmacist that in her area all overlap hours were cut and hours were redistributed so each pharmacist got the same amount of hours. She said they are so busy that the pharmacist still stay after their shifts to try to help out and not get paid! Her store does 6,000 plus scripts per week now with only one pharmacist and at the most 3 techs. Granted they are a 24 hour store. And, she further elaborated, even with this pandemic it is still all about metrics. But, as she further texted me, “wait it gets even better. She was told be glad you have a job because R.Ph. are standing in line waiting for a job and they are starting at $48 an hour.” Also, her health insurance premium is going up for the year because now it is based on your salary

If one does the math on these numbers…. this CVS store is filling – on average – one Rx every 100 SECONDS.. and on their busier days… they would be filling one Rx every 60 SECONDS.  Those numbers presume one pharmacist and 3 techs… and no time allotted for meal breaks and restroom breaks…. and back log of Rxs are so great that Pharmacists tend to hang over at shift break to help the team to try and catch up.

It was recently reported that CVS Health’s 1st quarter gross revenue was up 8.3% and NET PROFIT was up 43%. It is VERY DIFFICULT for a MATURE COMPANY to have net profit to increase – as a percent – more than the gross revenue increases.

Here is a recent article that suggests how they could be accomplishing this

Aetna whistleblower accuses CVS Health’s Caremark of fraud in Medicare Part D drug prices

Having your prescriptions filled by a company that seems to put more emphasis on stock prices and net profits than the health & well being of their employees … are they putting the pts’ health and well being at risk because of the staffing levels they are forcing on their Rx dept staff ?  All those Rx staff are humans and humans make mistakes and at that volume..  mistakes will happen.. when will it be your turn to have a prescription mis-filled ? Do you really want to support/patronize a company that coerce their employees to work “off the clock” so that pts get their medications ?

What They Don’t Want You To Know About Covid-19. Dropping Bombs (Ep 264) | Dr. Rashid Buttar

https://youtu.be/S2Nt5L8-MqI

Coronavirus Conundrum: Part 2

Coronavirus Conundrum: Part 2

https://pharmacistactivist.com/2020/May15_2020.shtml

WHO, HCQ, FDA, Remdesivir, Moving Forward!
I appreciate the many responses I received to my editorial in the May 1 issue of The Pharmacist Activist. Most were very supportive of the perspectives I voiced, some called my attention to information of which I was not aware, and two were critical of my statement that I would use hydroxychloroquine (HCQ) without evidence of effectiveness and safety if I experienced the misfortune of having moderate to severe COVID-19.
World Health Organization
One of the responses I received noted the following:

“Regarding your opinion that using the names Wuhan or Chinese virus is not racist, I encourage you to read the 2015 World Health Organization (WHO) best practices for naming new infectious diseases (if you haven’t already).”

I was not familiar with this statement and the reader was kind enough to include the link to the document that includes these statements: “The best practices state that a disease name should consist of generic descriptive terms, based on the symptoms that the disease causes (e.g., respiratory disease, neurologic syndrome, watery diarrhoea) and more specific descriptive terms when robust information is available on how the disease manifests, who it affects, its severity or seasonality (e.g., progressive, juvenile, severe, winter). If the pathogen that causes the disease is known, it should be part of the disease name (e.g., coronavirus, influenza virus, salmonella).

Terms that should be avoided in disease names include geographic locations (e.g., Middle East Respiratory Syndrome, Spanish Flu, Rift Valley fever), people’s names (e.g., Creutzfeldt-Jakob disease, Chagas disease), species of animal or food (e.g., swine flu, bird flu, monkey pox), cultural, population, industry or occupational references (e.g., legionnaires), and terms that incite undue fear (unknown, fatal, epidemic).”

This is helpful guidance that I appreciate, but I consider it overly restrictive. It is also unfortunate that the WHO seems to ignore one of its best practices in characterizing COVID-19 as a pandemic, a designation that can incite fear. The WHO best practices apply to new diseases and not those that are already identified with commonly used names. However, it is interesting to speculate what Lyme disease should be called if it was identified now. The designation could not include Lyme, Connecticut, tick, deer or mice (the common animal hosts for the ticks), or even the name of the microorganism (although the latter escapes identification in the best practices, Borrelia burgdorferi includes the name of Dr. Burgdorfer). Perhaps Multi-system Spirochetal Disease would be an appropriate name for which the abbreviation MSSD would be adopted and the meaning of the specific letters soon forgotten. I recently asked several individuals who knew about SARS if they could identify the words represented by those letters, and no one identified all four.

And, in the news as I write this, is the Asian giant hornet, also known as the murder hornet! We must come up with a better designation.
Hydroxychloroquine
In my previous editorial I noted that the son-in-law of a friend of mine was in the ICU with serious COVID-19 and that hydroxychloroquine (HCQ) had been used for treatment. One reader inquired about this individual’s outcome, and I am pleased to report that he recovered and has been discharged from the hospital. It is not known whether, or to what extent, HCQ contributed to his recovery, but it certainly did no harm.

Most of the responses I received voiced strong agreement with the circumstances that I described in which I would insist on being treated with HCQ if I was the patient afflicted with COVID-19. These can best be summarized in the following response:

“My elderly mother is immunocompromised as a result of cancer chemotherapy. Using the ‘what would I do’ criteria, and if she was diagnosed with COVID-19, under the care of her physician and pharmacist, and might benefit from short-term treatment with HCQ, I would move heaven and earth to get her 20 tablets of HCQ if she chose to try it (which I would encourage).”

One of the critical responses I received concluded with the following statement:

“So sure, if someone is at death’s doorstep, let him/her try hydroxychloroquine. Let them try a witch doctor doing incantations. There is nothing to lose either way.”

He included a link to a story in Vanity Fair that was published that day (April 24) that was critical of statements made by President Trump about HCQ, and also included statistics from a report of patients with COVID-19 at some Veterans Administration (VA) hospitals that identified a higher death rate among individuals who had been treated with HCQ compared with those who didn’t receive it. I responded to him with the following:

“I had not seen the Vanity Fair article and read it on the link you sent. I consider it flawed reporting motivated by a political bias. I acknowledge that HCQ may not be effective for COVID-19. However, there have been numerous experiences (not studies) that have suggested it to be of benefit. When the VA ‘study’ that is cited in the Vanity Fair article is examined, the two groups of patients for whom the results have been publicized are not comparable. However, this is ignored or not recognized by those who have viewed this report as evidence that HCQ is not effective and dangerous to the point of causing deaths.”

The individual who made this comment is a friend who is very knowledgeable about healthcare issues and pharmaceutical companies, and with whom I can have cordial and respectful discussions regarding matters on which we have differing opinions. I called him (April 24) to discuss the HCQ issues, and reiterated that I would insist on being treated with it if I was diagnosed with moderate or severe COVID-19. I asked if I was correct in understanding that he would decline to be treated with it if he was in that situation. He responded that he would not use it and I inquired as to whether that meant that he would expect no treatment except supportive care that might include use of a ventilator. He noted that he would request to be treated with remdesivir on a compassionate use basis, even though he recognized that it was an investigational drug for which effectiveness, safety, and dosage for treating COVID-19 had not been determined. I agreed that I would also want to be treated with remdesivir but, even with his connections, I noted that I considered it very unlikely that either of us would be among those selected on a timely basis from among the tens of thousands of individuals who would want to be included in a clinical trial or compassionate use program for the drug. (On May 1, the FDA issued an emergency use authorization for remdesivir that is discussed later in this commentary).

This response, as well as the other one that I received that challenged my decision to use HCQ for myself, were made in the context of comments that were highly critical of President Trump. A substantial amount of media coverage begins discussions of HCQ with the observation that it has been identified/recommended by the President as a medication that may be of benefit in treating COVID-19. It is very unfortunate that much of the consideration of the potential benefits, limitations, and risks of HCQ for COVID-19 has deteriorated to politically-charged discussions in which information, data, and commentary appear to be selected to fit a particular political point of view. In sharp contrast, it is experienced-informed clinical reasoning and judgment that are necessary while we wait for the results of studies that can provide evidence.
Some HCQ experience
HCQ has been approved and marketed in the U.S. for approximately 70 years, and is most commonly identified as an antimalarial drug. A short course of treatment is indicated for patients with active malaria infection, and it is used on a weekly basis before, during, and following travel for prophylaxis in individuals visiting areas in which chloroquine/HCQ-susceptible malaria infections are endemic. In the U.S., lupus is the condition for which HCQ is most commonly prescribed, for which it is administered on a daily basis and thousands of patients have taken it for many decades. The vast majority of these patients have tolerated it well, and ocular/retinal toxicity has been the greatest concern with its use for which patients should be monitored.

There are many medications marketed in the U.S. that are known to cause prolongation of the QT interval of the electrocardiogram that is associated with an increased risk of arrhythmias for which there are prominent warnings in the product labeling. To my knowledge, confirmed by my review of drug therapy and medical references, these complications have not been identified as risks with the use of HCQ for more than 60 years of the period of time in which it has been available. However, during the last several weeks there has been extensive publicity about the alleged danger of using HCQ in treating COVID-19 because of this risk.

I am very familiar with, and have great concern about the risks of using drugs that are known to prolong the QT interval. I have participated as an expert witness in a lawsuit pertaining to the death of a patient that was attributed to the additive QT-prolonging actions resulting from the concurrent use of ziprasidone (e.g., Geodon) and moxifloxacin (e.g., Avelox), two drugs that are well documented as having this risk (another story for a future issue). Indeed, this action of moxifloxacin is so consistent and well known that it has been used as an active comparator drug in studies in healthy volunteers in which the cardiovascular safety of investigational drugs is assessed to determine if a drug has a QT-prolonging action.

It would appear that a QT-prolonging risk of HCQ has only been identified within the last several years. A warning appears in the current product labeling but, to date, I have not been able to determine when the warning was added and whether the concern was communicated to health professionals. Plaquenil is the original trade name for HCQ and I have tried to track, without success, the revisions in the package insert that have been made for this product, that is made even more difficult by the fact that the product has been sold multiple times to another company just within the last seven years. I have not yet received a response from the FDA to my request to learn when the product labeling was last revised. From what I have been able to learn from online searching, it could be that a warning regarding the risk of QT interval prolongation has only been added to the labeling sometime within the last four years. How could a risk that is this serious escape attention for more than 60 years when so many patients are using it on a daily basis in multiple-drug regimens, unless the action is relatively weak and/or occurs rarely?

I am not minimizing the potentially fatal risk of a drug prolonging the QT interval or the need to observe important precautions when it is used. However, it is also very important to learn the degree of the risk that was only recently identified after so many decades of use.
The FDA
The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to permit the emergency unapproved use of hydroxychloroquine sulfate supplied from the strategic national stockpile (SNS) to treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible. The suggested dosage is 800 mg orally on the first day of treatment and then 400 mg daily for 4 to 7 days of total treatment based on clinical evaluation. The issuance of this EUA followed numerous observations/suggestions (not to be interpreted as studies or evidence) that HCQ might be of benefit in patients with COVID-19. The EUA provided very helpful guidance and helped assure the availability of the drug by making it available from the SNS.

On April 24 the FDA issued a statement that “cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems.” The statement includes the following comments:

“Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19.

The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT prolonging medicines.

Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia. These risks may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition. Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines.”

This information provided by the FDA is important and of value. However, I take strong exception to the FDA cautioning against use of HCQ outside of the hospital setting or a clinical trial. I recognize that the FDA is stating a “caution” and not a restriction or mandate. However, I consider this caution to be excessive, unnecessary, and alarming to the point that some are concluding that the use of HCQ outside of the hospital setting is inappropriate and/or dangerous. In our litigious society, can allegations of negligence or malpractice be far behind if a “caution” stated by the FDA is not observed and a patient is alleged to have experienced negative consequences whether or not it is known if they resulted from COVID-19, a particular medication, or other factor? Observing the FDA “caution” would preclude physicians from prescribing it “off-label” for patients with COVID-19 who are not hospitalized but for whom they consider it to be of potential benefit in avoiding more serious complications, or prescribing it for themselves or other healthcare providers as prophylaxis to reduce the risk of contracting COVID-19.

The FDA does not have the authority to regulate the practice of medicine or pharmacy; it is the state boards of medicine and pharmacy that have this authority. Off-label prescribing, dispensing, and pertinent counseling is common with many medications and, indeed, has been of value in identifying potential additional benefits and uses of approved medications and that have provided the impetus for subsequent clinical trials and evidence. It is important, and to be expected, that the FDA should communicate concerns about reports of potentially serious adverse events of available medications. However, to “caution against the use of HCQ outside of the hospital setting or a clinical trial” is an unacceptable intrusion by the FDA into the professional roles and judgment of physicians and pharmacists with respect to the off-label use of approved medications. In addition, the FDA “caution” could be alarming to the many patients with lupus who have been treated with HCQ effectively and safely for years, with the result that they stop using the medication and be at risk of exacerbation of the disease. The national medical and pharmacy organizations should be challenging the FDA regarding such statements/actions, but they have been silent regarding this.

The FDA statement notes that it “is aware of reports of serious heart rhythm problems,” and that HCQ “can cause abnormal heart rhythms such as QT interval prolongation.” However, “reports” must not be interpreted as “studies” or “evidence.” In addition to communicating a concern, the FDA should also accept the responsibility for sharing the pertinent information that is the basis for the concern. For example:

How many reports of serious heart rhythm problems are known to the FDA?

Did the patients who experienced heart rhythm problems have other risk factors for heart rhythm problems?

What consequences did the patients experience? (e.g., Were deaths attributable, at least in part, to the use of HCQ? If so, how many?).

What is the approximate number of patients who were treated with HCQ for COVID-19, or other conditions (e.g.,, lupus), during the relevant time period (i.e., to provide the denominator as part of the basis for determining the level of risk)?

What is the estimated degree of risk? (e.g., every patient treated with HCQ? 1 in 10? 1 in 100?, 1 in 1000?, 1 in 100,000?).

How does the prolongation of the QT interval with HCQ compare with that experienced with moxifloxacin and placebo? This is a study that could be conducted quickly in healthy volunteers if there was sufficient interest in doing so for the purpose of providing clarifying and useful information for assessing the level of risk.

It is noteworthy that many of those who demand science and/or evidence for every decision or opinion are not asking questions such as the above, but rather appear to accept the statement of a risk that is not accompanied with any data.

It is also of interest that the FDA statement identifies azithromycin as a medication that can prolong the QT interval. For a number of years, the labeling for this agent has included a warning regarding this possibility. However, it is probably impossible to estimate the number of millions of Z-Paks that have been prescribed, in large part as a result of its high level of effectiveness, safety, and convenience of use. Although appropriate precautions should be observed, I consider the risk of serious complications from prolongation of the QT interval with azithromycin to be extremely low.
Remdesivir
On May 1 the FDA issued an EUA for the investigational antiviral drug remdesivir (Gilead Sciences) for intravenous treatment of suspected or confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. In a preliminary analysis of 468 recovered patients, remdesivir was shown to shorten the time to recovery (to a median time of 11 days compared with 15 days for those receiving placebo), and it is the first drug to be demonstrated to provide benefit in patients with COVID-19 in an adequate and controlled clinical trial. More than 1,000 patients were enrolled in the study but the outcome for many of the patients was not yet known as of May 1. There was also a numerical reduction in the death rate in the patients treated with remdesivir (8.0%), compared with 11.6% in those receiving placebo; however, this difference was not determined to be statistically significant.

Although the issuance of the EUA is different than FDA approval of remdesivir, the preliminary results of this study are very encouraging, and additional experience is being acquired in this study as well as other clinical trials. As studies of other medications are also being conducted, it appears likely that remdesivir will be one component of a multi-drug regimen that will be determined to be most effective for the management of severe COVID-19.
Moving forward
We must continue to move forward in conducting clinical studies and acquiring experience with treatments that have the potential for effectiveness in treating COVID-19 in a manner that includes sound clinical reasoning and judgment. Components of a forward path also include, but are not limited to the following:

Sufficient protective equipment and workplace environments that are as safe as possible must be provided for pharmacists, physicians, nurses, and other essential workers who have the responsibility of providing care and services for patients afflicted with COVID-19.

Individuals who are at greater risk of contracting COVID-19 (e.g., the elderly, immunocompromised) must avoid/minimize to the extent possible activities and socialization that might increase their risk of infection, while concurrently assuring and protecting their personal rights and civil liberties

We must accelerate the pace at which restrictions are reduced and individuals, society, and our country return to life, work, and school. I recognize that the removal of current restrictions will result in an initial increase in the number of cases and deaths from COVID-19. Every COVID-19 death is a tragedy but the consequences of the restrictions imposed must not be underestimated, and include massive unemployment and delays in needed elective surgeries and treatments, as well as increased experiences of depression, domestic violence, suicide, and drug misuse/overdoses too numerous to count.

Partisan politics and criticisms pertaining to COVID-19 and related issues must stop! COVID-19 does not discriminate with respect to its victims and the scope and consequences of the current tragedies demand a collaborative and united fight against the viral enemy. Those who politicize these events should be called out and their comments should be rejected! There must be respectful dialogue among those with differing opinions.

Colleges of pharmacy and other health professional schools should provide leadership in restoring campus-based instruction and activities. Some universities are actively considering not resuming on-campus instruction and events until 2021. I want to think that colleges of pharmacy and other health professions can provide the creative thinking, strategies, and leadership that will enable the safe resumption of campus-based instruction and events this fall, and provide the educational experiences that will best assure the preparation of competent and dedicated health professionals who will soon have the responsibilities of responding to COVID-19 and future challenges.

No observations in this commentary should be misinterpreted to suggest that I am minimizing the level of risk and tragedy that exists from COVID-19 now or into the future. On the day that I write this (May 4), the number of COVID-19 deaths predicted to occur by August in the U.S. has been substantially increased to 134,000. We must continue to comply with appropriate precautions, but we also must not permit the crisis to cripple our lives, society, or economy. We must not live in fear!.

Daniel A. Hussar
danandsue3@verizon.net

CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 1

CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 2

CVS is Destroying the Profession of Pharmacy – PART 3*

CVS is Destroying the Profession of Pharmacy – Part 4

CVS is Destroying the Profession of Pharmacy: Part 5!

CVS is Destroying the Profession of Pharmacy: Part 6

 

RESPIRATORY THERAPIST BLOWS WHISTLE ON VIRUS PANDEMIC

https://www.youtube.com/watch?v=sAKNnJJerFc

UPDATED: Dr. Anthony Fauci’s ex-employee, was jailed, finally tells all – Fauci: “the Bernie Madoff of science”

What youtube.com takes away.. Pharmaciststeve RESTORES…  I have been exploring how one can download videos that show up on the web to my hard drive.  I OWN my own domain www.pharmaciststeve.com and after some experimentation… I found out how I could upload these videos to my domain and make them available on my blog.  Below is the hyperlink that will allow my readers to view the video that youtube.com made disappear 🙂

This video has been deemed to be full of false narratives …. per this link

https://www.whas11.com/article/news/verify/verify-the-plandemic-documentary-is-full-of-misinformation/417-95caed4e-7a95-4452-ba7f-98cd0442c9e9

https://www.pharmaciststeve.com/video/Dr. Anthony Fauci’s ex-employee, was jailed, finally tells all..mp4

Go behind the scenes with an experienced expert, virologist who worked under Anthony Fauci,director of the National Institute of Allergy and Infectious Diseases since 1984. She was jailed and now tells all. All is revealed and be prepared for a future you are NOT PREPARED FOR! “Plague of Corruption: Restoring Faith in the Promise of Science,” April 14, 2020 by Kent Heckenlively and Judy Mikovits OUT OF STOCK! Sign up for movie update http://plandemicmovie.com/