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FDA Issues June 2020 Statistical Guidance Report, Available For Download

The FDA advises that modifications to primary or key secondary endpoints would generally require a protocol amendment or an investigational device exemption (IDE) supplement.

The U.S. Food and Administration (FDA) issued its statistical guidance report for June 2020. This latest document is a series of FDA guidance reports that are created to keep medical experts, healthcare personnel, and others informed on the latest FDA research statistics and analysis for the COVID-19 public health emergency (PHE).

According to the FDA, the documents do not create or confer any rights for or on any person, and they do not operate in a way that would restrict or generally limit the Agency and its operation.  

The current FDA guidance report addresses the collection and the analysis of data during a clinical trial. Some previously planned critical tests were put on hold during the COVID-19 health emergency. While prioritizing the safety of trial participants, the sponsors planned to address the impact of COVID-19 on the program’s ability to meet the trial objectives.

The FDA advises that modifications to primary or key secondary endpoints would generally require a protocol amendment or an investigational device exemption (IDE) supplement. Similarly, changes to the analysis of primary or vital secondary parameters are reflected in an updated statistical analysis plan before locking the database and before any modifications to a non-blinded interim report.

When considering modifications to the trial to address the impact of COVID-19, sponsors should not propose any trial modifications based on data that may introduce bias into the interpretation of trial findings, the FDA advised. Generally, for a blinded trial, changes can be found on information that reveals the magnitude of the treatment. 

RELATED: FDA Pursues Action Against Companies Offering Misleading Antibody Tests

The FDA also indicated that information not specific to individual participants, such as information on site closures and the disruption of the supply of the investigational product, may also be appropriate to use when considering modifications to the trial. 

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As discussed in the Guidance summary, researchers need to capture specific information at the participant level, and must describe the context and/or reasons for post-baseline events as they relate to COVID-19. The reasons might include discontinuation of treatment, withdrawal from the trial, the use of alternative or rescue treatments, a missed endpoints, and the use of alternative endpoint ascertainment methods. This information may be useful for incorporating into analysis strategies to address potential biases or for the performance of sensitivity analyses related to the impact of COVID-19.

RELATED: What Healthcare Workers Need To Know About Newest FDA Drug Approvals

The FDA counsels that for sponsors considering stopping a trial and conducting a final analysis, a significant consideration is the loss of statistical power from a smaller sample size or less follow-up time than was anticipated.

The report gathers information from the following agencies: Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health, and the Center for Veterinary Medicine.

4 Ways Quarantine Has Affected Our Sex Lives

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Whether you’re alone or coupled (or thrupled, if that’s your thing), our sex lives have been impacted by the lockdown. Here’s how.

Ever since the pandemic appeared, people’s sex lives have taken a turn, whether they are single or in relationships. Social distancing guidelines have made it tough for established couples to meet up and singles to go on dates. Couples who’ve spent their quarantines together have also faced a lot of stress, constantly being on top of each other (and not in the fun way).

As the pandemic continues, single people have been adapting to this awkward new normal, keeping their distance while also trying to find a way to get back to having intimacy with others.

The future is uncertain in many regards, with rules and regulations evolving on a constant basis. Still, the coronavirus has already left an imprint on people’s sex lives. Here are four examples:

Some people are horny while others are not

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The pandemic and our current social climate is a big source of stress, prompting many different reactions from people, all understandable. While some people are hornier than usual and find sex and masturbation as a good form of relief, others are depressed causing their libidos to take a plunge.

Couples quarantined together have been experiencing different emotions altogether. While some have bonded over the shared stress, others have experienced some irritability and tension due to constant contact. Couples therapists recommend taking your time to process your emotions and creating a space for yourself, where you can process your feelings and have some time for self-care. (May we suggest getting high alone?)

More people are watching porn

People are spending large chunks of their time online and are understandably itching for human contact. Logically, people are watching tons of porn. Pornhub experienced a spike in traffic during March due to their free premium memberships. Now that the promotion has ended, traffic is still up when compared to pre-pandemic times.

There’s a lot of self-pleasure

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RELATED: How To Take Care Of Your Libido When Quarantined With Others

Since a lot of people have been spending the last couple of months alone, there’s been an increasing interest in all sorts of sexual topics, with people purchasing sex books, discussing sex openly and buying tons of sex toys. While it’s normal for people to be bored and seek pleasure (i.e. masturbation and junk food), it’s also important to adapt to these circumstances and find healthy ways to cope, such as cooking and working out.

Virtual sex is a thing

As has been the case with most of the pandemic, virtual spaces have been stepping up and trying to fill the void of people’s needs. In this case, sexual connection. Sex parties and chats have been adapting to the digital, even if people should be careful about the websites they use and the necessary precautions in order to keep their data private and secure.

5 Questions To Ask Yourself Before Visiting A Marijuana Dispensary

A good dispensary should be a welcoming place for everyone. Here are some things to keep in mind before you patronize one.

One of the best aspects about legal marijuana is its dispensaries, which can inform newcomers and seasoned consumers on the types of cannabis that exist and the products that best suit their needs. But no matter a budtender’s level of expertise or way of communicating with costumers, it helps significantly if you know a few basics. Here are five questions to ask yourself before making visiting a marijuana dispensary.

Do you live in a legal state?

Basic stuff, sure, but the more states legalize marijuana the easier it is to lose track of them. As of this writing, recreational marijuana is legal in 11 states and D.C., allowing adults over 21 to enter their marijuana dispensaries and purchase products. Here’s a handy list that’s updated regularly to keep you in the loop on our nation’s state-by-state marijuana laws.

What kind of cannabis do you want to consume?

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Now that you know if your state is legal or not, it’s time to do some research and see which type of marijuana you’re interested in consuming. You can smoke flower, soak in some cannabis infused bath salts, dab, vape, eat an edible and more. Know the answer to this question or ask your budtender for more information on each method, learning which one suits your needs best. Depending on what method you chose, this is how long you’ll be high.

What effect are you looking for?

Most methods have specific strengths when it comes to how they affect your body. If you’re looking into medical marijuana, you might find better information by contacting a doctor who’s educated in the area versus a budtender who may or may not know your ailment and what you’re looking for. For starters, here’s a doctor’s general guide to help you find the best method of consuming medical marijuana.

How psychoactive do you want to get?

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RELATED: 4 Things You Need To Know Before Visiting A Marijuana Dispensary

Depending on your tolerance, strain and method of consumption, marijuana’s effects on mind and body can shift drastically. You should be clear with your budtender about your level of experience with the plant so that they can provide you with the proper product and dosage. It’s also important to be clear about the experience you’re seeking, whether you want some pain relief or are just looking for a fun experience with friends.

How discreet do you want to be?

Discretion varies from person to person. Some people are able to openly use dab rigs in their living room while others have to consume something less conspicuous. For those who don’t want to attract attention, edibles, vape pens, sublinguals and transdermal patches are great options.

Do The Dixie Chicks Smoke Weed?

The Chicks have never been ones to shy away from controversy, from criticizing the president to addressing spousal abuse. Do their liberal beliefs extend to weed?

We all know at least one song by The Dixie Chicks, no matter our age, gender, or tolerance for country music. But now, amid nationwide protests for racial justice, Natalie Maines, Emily Strayer and Martie Maguire are now just The Chicks. Like Lady Antebellum, who’ve recently changed their name to Lady A, The Chicks dropped the “Dixie” from their name, a word that romanticizes the pre-Civil War South.

The Chicks have updated their social media handles to reflect the name change, and released a video for their song “March, March,” which is a tribute to all of the past and present protests for equality and social justice.

As women who aren’t afraid to stand up for their social or political beliefs (remember when Maines publicly criticized President Bush for invading Iraq? Or their 1999 song “Goodbye Earl” about the murder of an abusive husband?), what is their stance on marijuana?
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In a 2013 profile for Rolling Stone, Maines said she was stunned by the backlash she got from her controversial Bush remarks. “It shocked me and kind of grossed me out that people thought I would be a conservative right-winger, that I’d be a redneck,” she said. “But at that time, people didn’t ask us things like, ‘What do you think of gay marriage?’ If they had, they would have learned how liberal I was.”

RELATED: For The First Time, The Majority Of Republicans Favor Marijuana Legalization

She went on to say that, “Not only do I not like this president, I love gay people! And I’m pro-legalization of marijuana and all drugs! Yeah, let me blow your mind.”

So, while the answer to whether or not The Chicks (or at least some of them) smoke marijuana isn’t crystal clear, it sounds like they’re not opposed to it.

5 Ways To Keep Up With Your Quarantine Workout Once You Return To The Office

 Going back to the office doesn’t mean you have to stop the workout routine you nailed in lockdown. Here’s how.

The pandemic has proved to be the perfect opportunity to try out some new workouts, all with the intent of moving around and staving off boredom. Now that the weather is warming up, there’s ample opportunities for people to leave their homes, workout and return feeling refreshed and ready to take on some more isolation. Just kidding.

The world is slowly reopening, testing the waters and getting back to normal-ish. While this is exciting, it’s also important to be careful and to remember that we’re not out of the woods yet. It would also be great if we could all retain some of our fitness now that we have — or are gearing up — to jump back into office work.

Here’s 5 tips that can help you stay in shape:

Buy the right equipment

Going to work and then trying to find the time to go the gym or on a run during your day is difficult. If there’s one thing we learned from our months spent indoors is that you can work out a lot within your home. Purchase some weights, a yoga mat, a jump rope, or anything else that’s portable (and enjoyable). Make the time for workouts at home or somewhere else where you can just carry that stuff and burn some calories, no matter where you are.

Make time for the workouts you like

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There’s no need to pursue something you don’t enjoy. The important thing is that you have a workout routine. If you dread working out, try to transform your workout into something that you look forward to instead of it being something you dread. Hate running? Don’t do it then. Try going on long walks instead.

Use your calendar

Your calendar is a helpful tool whenever you’re too busy with appointments. Adding in the days and approximate times for your workouts will give you a reminder and also help you stick to them. Try getting up earlier, or sneaking in 10 or 15 minutes of jump roping before your morning shower or during your lunch break. No matter how busy you are, it’s entirely possible to fit in a workout.

Sneak in short workouts throughout the day

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A good strategy for days when you’re too busy and can’t block out an entire hour to exercise is to workout in chunks. Sneak in some push ups, bicep curls or a couple of runs up and down the stairs (assuming your office has a stairwell). While this method goes kind of against the norm, it will make you appreciate the movement of your muscles and how your body feels afterwards.

There’s no need to rejoin the gym

Gyms are still unsafe, which is why you don’t need to push yourself to rejoin them. Try new workouts that feel satisfying, no matter if they’re not as intense or grueling as what you’re used to. What matters is that you move around and stay motivated.

America’s Complicated Perception Of Weed And Booze

In addition to surveying public perception of alcohol and marijuana use, this research also aimed to find out why people turn to each substance.

America’s complicated perception of weed and booze is again evolving. Times are changing and as more states legalize both recreational and medical marijuana, it is obvious that public opinion about the two is changing, too. At face value, it appears that more people are accepting of marijuana, both as a recreational substance and plant-based medicinal product.

What if we take a closer look? A recent survey performed by the American Addiction Center aimed to do just that and shed some light on the public opinion on weed and booze. Their results confirm what we suspected from the start — the way Americans feel about weed and booze is pretty complicated.

More People Believe Marijuana Should Be Illegal

In the survey of 1,000 people, the American Addiction Center found that 17% of those surveyed believed marijuana should be an illegal substance. This is compared to only 10% of respondents stating that they would prefer alcohol be illegal.

RELATED: Study: Alcohol More Harmful To The Brain Than Marijuana

Interestingly enough, when the results of the survey were adjusted based on the respondents’ own use of these two substances, the overall opinion was different. Among those who don’t drink alcohol at all, 38% want it to be illegal. When the same questioned was asked about marijuana among those who don’t use it, only 30% said they would like it to be illegal.

Is marijuana or alcohol more dangerous?

We know that alcohol use is significantly more dangerous than marijuana use, with an estimated 88,000 alcohol-related deaths occurring in the United States each year. How does public perception line up with the facts? When asked questions about the dangers of each substance, the researchers found that most people seemed to understand that alcohol is more dangerous but still many felt that marijuana was dangerous, as well. 

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The average response to the survey was that alcohol is somewhat dangerous or very dangerous. For marijuana, the average response was that it was not very dangerous or somewhat dangerous.

how to make drinking alcohol easier on your body
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When looking asked for more specific concerns about using marijuana or drinking alcohol, the biggest concern for both substances was how they behave in public. However, respondents were significantly more concerned about their public behavior when drinking alcohol than when using marijuana.

Why do people use marijuana and alcohol?

In addition to surveying public perception of alcohol and marijuana use, this research also aimed to find out why people turn to each substance. According to the results, a much higher number of people use alcohol to celebrate than they do marijuana.

A surveyed 14% of alcohol users admitted they felt they are addicted, while only 8.2% felt that was the reason behind their marijuana use. Interestingly, when asked if they use alcohol or marijuana to cope with stress, the results were nearly identical — 42% said they turn to alcohol while 41% turn to marijuana as a way of dealing with the stress in their life.

Remembering Dr. Lester Grinspoon, Intellectual Leader Of The Marijuana Movement

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Grinspoon’s book reads as prophetic today, at a time when cannabis reform intersects with the racial injustice and policing issues that currently plague society.

The notion that cannabis holds medical benefits worthy of scientific exploration isn’t such a radical idea today. Give credit to Dr. Lester Grinspoon for that, as he emerged as an invaluable scholarly voice promoting cannabis reform amid the Nixon Administration’s War on Drugs. Grinspoon, who was instrumental in early legalization efforts, died June 25 — one day after his 92nd birthday.

He attended Tufts University and Harvard Medical School, later becoming a longtime fixture in Harvard’s psychiatry department. When Grinspoon first entered Harvard, he viewed cannabis with the same criticism typical, believing it was a harmful drug. Then he met Dr. Carl Sagan, the famed astrophysicist and cannabis advocate. Sagan, a Harvard colleague and good friend to Grinspoon, offered to split a joint one day in the 60s.

“When I saw him smoking for the first time, I said, ‘Carl, you musn’t do that! That’s a very dangerous drug,’ ” Grinspoon told the Boston Globe in 2018. “He took another puff and said, ‘Here, Lester, have some, you’ll love it and it’s harmless.’ I was absolutely astonished.”

Grinspoon became determined to prove Sagan wrong, and reviewed the available research vigorously. In the process, he quickly changed his mind and became a cannabis advocate instead. He wrote his landmark book Marihuana Reconsidered in 1971, where he first argued legalizing a plant that had been prohibited for 34 years until then. At the time it was published, nine out of 10 Americans believed cannabis should remain illegal.

RELATED: How Marijuana Reform Intersects With Policing And Racial Justice

Grinspoon’s book reads as prophetic today, at a time when cannabis reform intersects with the racial injustice and policing issues that currently plague society.

“Indeed the greatest potential for social harm lies in the scarring of so many young people and the reactive, institutional damages that are direct products of present marijuana laws,” Grinspoon wrote.  “If we are to avoid having this harm reach the proportion of a national disaster within the next decade, we must move to make the social use of marijuana legal.”

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“And we must consider the damage inflicted on legal and other institutions when young people react to what they see as a confirmation of their view that those institutions are hypocritical and inequitable,” he added.

Grinspoon advocated alongside The National Organization for the Reformation of Marijuana Laws (NORML) throughout the 80s. “For the last five decades, Dr. Grinspoon was the intellectual leader of the marijuana legalization movement,” NORML founder Keith Stroup wrote following news of Grinspoon’s passing.

Unlike Sagan, Grinspoon openly admitted to smoking cannabis in an interview with Barbara Walters on The Today Show. When the public saw a Harvard professor admit such a thing, he hoped it would reshape the image around marijuana users and stoner stereotypes. Decades would pass before that happened and Grinspoon suffered professionally for his public marijuana stance. He was denied full professorship by Harvard multiple times, with rumors circulating the university’s hiring committee disapproved of his cannabis relationship.

RELATED: Study Finds Medical Marijuana Patients Are Happier And Healthier Than Non-Users

Grinspoon’s advocacy continued into the last stages of his life. He memorably wrote an open letter to NFL commissioner Roger Goodell imploring the league to explore cannabis as effective treatment for football players, especially in diminishing concussion and CTE damage.

“In the end, Dr. Lester Grinspoon led the way to insist that our marijuana policies be based on legitimate science,” Stroup wrote. “He made it possible for us to have an informed public policy debate leading to the growing list of states legalizing the responsible use of marijuana.”

Can CBD Protect Your Dog Against Fireworks Anxiety

Fireworks can trigger a dog’s nervous system, quickly overwhelming their senses. Here’s what we know about CBD and your furry BFF.

People have been noticing a lot of fireworks lately. Maybe it’s due to the fact that we spend most of our time bored indoors, that cities are quieter than usual, or that people just don’t care anymore.

According to the New York Times, there are lots of conspiracy theories floating around regarding the origins of these nightly airshows: “The flood of illegal fireworks, heard in nightly booms, bangs and fizzles across the city and the country, has intensified to such a degree that some people are desperately seeking explanations for the chaos, with many suggesting government complicity.”

One thing is certain: Dogs don’t care about your junk theories.

Fourth of July is fast approaching, so we have to be prepared. Here’s where CBD might come in handy.

A lot of pets go missing or start acting out of character when there’s an increase in fireworks. These loud sounds cause dogs’ adrenaline to spike. Fireworks, unlike thunder and other loud sounds, come from the ground, triggering dogs senses and leaving them overstimulated. While a lot of people protect their dogs by giving them medication or keeping them indoors with the TV on, sometimes these options aren’t enough to keep your dog relaxed.

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Is there any science to support these claims of CBD treating canine anxiety?

The Huffington Post spoke with Dr. Adam Christman, an award winning veterinarian from New Jersey, who claims that most of the evidence out there on CBD is anecdotal. He mentions the first scientific study on CBD oil conducted on dogs, which found that those who suffered from osteoarthritis lived more comfortably if they were given two doses of the compound a day.

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“However, we are truly unsure of its true safety and potential drug interactions with traditional medications. Therefore, there’s a very gray zone on this,” he said.

RELATED: 5 Things to Know About Hemp-CBD In Pet Products

While most experts agree that more research needs to be conducted on the topic of CBD, there appears to be no risks in dogs consuming it, especially if you’re buying products from a trusted source and following their dosage instructions.

If your dog is very nervous and has a complicated history with fireworks, it might be best to avoid experimentation, at least for now. Stick with medicines that have provided scientifically sound results, like tranquilizers. When the stakes are lower and your dog is experiencing some anxiety, give CBD a try. Just make sure to purchase your product from a reputable source.

Why Bars Are So Dangerous During The Coronavirus

After months in isolation, people are exhausted and feeling lonely, which makes them more reckless when entering bars and restaurants.

Bars are hotspots for the coronavirus. A few weeks ago there was a report that detailed how 15 people contracted the virus in Jacksonville, Florida. Despite the fact that they had been diligent throughout the first couple of months of the pandemic, they went out to a pub to celebrate a birthday and were showing symptoms of COVID-19 a couple of days later. The one thing these victims had in common? Spending an evening together at a bar.

What is it about bars that makes them so dangerous when it comes to the spread of the virus?

On the most basic level, bars are places where people tend to get careless. Most who enter the establishment are looking to be social and have drinks with their friends. Unless people are extremely diligent, they’ll likely drink alcohol, stand close to each other and raise their voices in order to be heard over the music, thus spreading more of their droplets.

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Four months into the pandemic and people have been lulled into a false sense of security. After spending months in isolation, people are exhausted and feeling lonely, which makes them more reckless when entering bars and restaurants — establishments that are trying their best to adapt to these unprecedented social distancing measures, with varying degrees of success.

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“There are certain counties where a majority of the people who are tested positive in that county are under the age of 30, and this typically results from people going to bars,” said Texas governor Greg Abbot.

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While the demographic that’s been getting more exposure to the virus is the same one that’s likely to face severe symptoms, few of these people are completely isolated, especially now that social distancing guidelines are lifting. This means they might be asymptomatic and will likely be in contact with others who are more vulnerable.

Public protocol can be confusing right now, but there are some common sense measures that limit the amount of risk people are exposing themselves and others to. It’s important to wear face masks and to comply with social distancing guidelines when immersed in crowded settings. While it may not work for an old fashioned party, it’s the reality that we’re living in.

FDA Pursues Action Against Companies Offering Misleading Antibody Tests

Violations include offering test kits for sale in the U.S. directly to consumers for at-home use without first receiving the necessary marketing approval, clearance, or authorization.

The U.S. Food and Drug Administration (FDA) issued advisory letters to three companies that have allegedly been promoting faux antibody tests for the treatment of COVID-19. The products and related marketing content reviewed by the FDA, and were singled out for marketing directly to customers at home, without the involvement of a health care professional, and evaluated as adulterated and misbranded. 

“Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “When tests are marketed inappropriately, with inaccurate or misleading claims — such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not — the (violators) put the health of Americans at risks.” 

The FDA issued warning letters to Medakit Ltd. of Sheung Wan, Hong Kong; Antibodiescheck.com and Yama Group; and Dr. Jason Korkus, DDS and Sonrisa Family Dental (My COVID19 Club) of Chicago, Illinois. Violations include offering test kits for sale in the U.S. directly to consumers for at-home use without first receiving the necessary marketing approval, clearance, or authorization from the FDA.

RELATED: FDA Has Approved A New At-Home Test For COVID-19

The FDA maintains an ongoing effort of vigilance to prevent companies from operating outside set policy guidelines. The letters, to the three companies, were announced on June 17th. The first of their kind to be sent out, the warning letters are an initial step in preventing the sale or marketing of these products. If there is no measurable response or action taken from the companies named, the FDA has the option to pursue additional steps, including taking legal action and seizure of the products that are violating the FDA policies. 

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Antibody tests (also known as serological tests) detect antibodies to SARS-CoV-2, which can help identify people who might have developed an adaptive immune response to the virus. The immune response can be part of either an active infection or a prior one. These tests may be necessary in the fight against this pandemic. They could potentially provide updated information on potential disease prevalence and help assess the current level of asymptomatic infection. 

RELATED: And Update To The FDA’s COVID-19 Home Testing FAQ

According to the Mayo Clinic, antibody tests are essential in determining who has the virus and to assess how it might be spreading. A medical professional uses finger prick or by drawing blood from a vein in the arm. The sample is tested to ascertain whether you have developed antibodies against the virus. The immune system produces these antibodies — proteins that are potentially critical for fighting and clearing out the infection. 

The FDA also advised medical professionals and health care providers, that it regularly posts updates (at https://www.fda.gov/) about products, medical information, and corrective actions it takes during the COVID-19 public health emergency.  Similarly, the FDA requests that healthcare professionals report questionable products or medically risky situations to the Agency. Reports can be submitted online at MedWatch located here. Medical professionals can also register for FDA information updates at the link.

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