Tough Pill to Swallow? Pfizer Trumped On Price Hike …

A day after President Trump lambasted Pfizer on a previously announced July 1 price hike on three dozen drugs, the pharmaceutical company backed down following what  the company CEO described as an “extensive discussion” with the president.

Trump said he spoke with Ian Read, the head of Pfizer, and the Health and Human Services Secretary Alex Azar and the drug company decided it was  “rolling back price hikes” that Pfizer already put in place.

Trump has been fairly consistent on admonishing the pharmaceutical drug-makers on their extravagant pricing. For the administration, its blueprint to reduce prescription drug costs is one of its hallmark efforts. Among other things, the administration  is seeking a “more competitive pharmaceutical marketplace” and “bring down out-of-pocket costs for Americans, Trump’s plan states.  For critics, the blueprint has been too loosely defined, and not tough enough.

In the meeting with the Pfizer chairman and CEO, the blueprint apparently took center stage.

“Just talked with Pfizer CEO and @SecAzar on our drug pricing blueprint,” Trump tweeted. “Pfizer is rolling back price hikes, so American patients don’t pay any more.”

“We applaud Pfizer for this decision and hope other companies do the same,” he added in the @realDonaldTrump tweet. “Great news for the American people.”

A day earlier, Trump scolded the company, saying it should be ashamed “that they have raised drug prices for no reason.”

“They are merely taking advantage of the poor & Others unable to defend themselves while at the same time giving bargain basement prices to other countries in Europe & elsewhere. We will respond!….” Trump tweeted.

After the meeting with Trump today,  Pfizer ‘s  Read said the company would “defer the company’s price increases that were effective on July 1.” That would give the president “an opportunity to work on his blueprint to strengthen the healthcare system and provide more access for patients,” Read said.

The company said it will maintain prices on three dozen drugs to their pre-July 1 levels as soon as technically possible. And, the prices will stay in place until the president’s blueprint goes into effect or the end of the year – whichever is sooner.

“Pfizer shares the President’s concern for patients and commitment to providing affordable access to the medicines they need,” said  Read.

— Joe Cantlupe

 

You Take Medications. You Take Herbs. Do They Mix?

One of the most important things you should consider when are taking medications, herbs or just about anything is how they interact with each other, and whether they can have complications that can harm you.

The danger is that with different types of medications even regular doses may become an overdose, depending on the interaction.

It’s important that everyone learns about their medications and become aware of the herbs they use, the supplements they take, and their response to them. It is best to check with responsible professionals and providers.

Herbs

Some of the herbs used in Chinese medicine may be safe, but others can interact with drugs and have serious side effects or be unsafe for people with certain medical conditions. Some of the most serious drug interactions involve prescription medications and supplements.

That is becoming increasingly important as the popularity of herbal medicine increases. The World Health Organization estimates that 80 percent of the world’s population uses herbal medicine.  Many Americans, not happy with Western medicine for their ailments, have turned to alternative and complementary medicine, studies show.

Regulations

Herbal medicines used in Traditional Chinese Medicine are sometimes marketed in the U.S. as dietary supplements. The U.S. Food and Drug Administration regulations for dietary supplements are not as stringent as for over the counter medications. The supplements are not as likely to have the same regulations as those for over the counter drugs. Supplements are also not as likely to be listed in a database of drug interactions.

Herbal Supplements and Drug Interactions

Nearly 25 percent of U.S. adults report also taking a prescription medication with a dietary supplement, according to an American Academy of Family Physicians study. 

Herbal interactions with prescription medications can interfere with how the drug may be broken down in the body, enhance side effects of prescription medications, or block the intended therapeutic effect of a drug.

Herb-drug interactions are complicated because many chemical components can be involved, and these compounds may possess diverse pharmacological activities, according to one study of the issue. 

The interactions potentially cause changes in drug levels and drug activities, which can sometimes have dire consequences.  Even though herbal supplements may be from plants, the ingredients can be chemical-related. As a result, herbal supplements may have drug interactions, not only with each other, but food or alcohol. And there may be no safety warnings so it may be difficult for someone to know if there is an interaction.

Different kinds of drug interactions

Some supplements, such as St. John’s Wort and Goldenseal, are known to cause drug interactions. As a result, they should be avoided with any pharmacological products.

Yet some supplements may cause interactions with some medications, but are safe with others, such as curcumin, Echinacea, garlic, Asian ginseng, green tea extract, and kava kava.

The kinds of interactions

Drug interactions can be in both pharmcokinetics and pharmacodynamics terms. Pharmacokinetics, sometimes described as what the body does to a drug, refers to the movement of drugs in, through and out of the body. Pharmacodynamics is the reverse: what a drug does to the body, such as the biochemical and molecular impacts.

Herbs may affect the behavior of a drug used at the same time by changing their absorption, distribution, metabolism and excretion.

Contamination of herbs

The National Center for Complementary and Integrative Health says there have been reports of Chinese herbal products being contaminated with drugs, toxins or heavy metals not containing the listed ingredients.

The Chinese herb ephedra (ma huang) has been linked to serious health complications, including heart attack and stroke. In 2004, the FDA banned the sale of ephedra-containing dietary supplements, but does not include Traditional Chinese Medicine remedies.

Interaction Examples

There are a host of interaction issues involving herbs and pharmaceuticals, with many related to bleeding, according to Drugs.com.

Among the herbs which could have potentially negative impacts in interactions with drugs:

Evening Primrose Oil

The flowering plant Evening primrose is known by other names such as Oenothera biennis, scabish, or King’s cure-all. Drugs or herbs that have the potential to thin blood may have a reaction with Evening Primrose Oil.

American Ginseng

Ginseng has been used for many purposes, ranging from stress to endurance.  There are many different kinds of ginseng, but American ginseng has a blood thinner impact and may decrease the effectiveness of blood-thinning medications, and also should not be used with anticoagulants.

Ginkgo Biloba

Ginkgo Biloba has been used for dementia, Alzheimer’s disease and related ailments, but it may impact patients who take blood thinners, diabetes drugs or seizure medications. Ginkgo has been known to have interactions with about 500 drugs.

Goldensea

Goldenseal, also a flowering herb, is used for a range of conditions, including cold, flu and skin ailments, but there are dozens of drug interactions linked with goldenseal.

Green Tea

Green tea has been used for many health related issues, such as being an antioxidant. But it should not be used in connection with some blood-thinning drugs.

Getting advice from healthcare providers

Healthcare providers can give the best advice for any serious health impacts from drug interactions.

Advice to providers

Clinicians have been told they should consult reliable dietary supplement resources, or clinical pharmacists or pharmacologists, to help assess the safety of specific herbal supplement – drug combinations.  Often, patients do not mention supplements they use to clinicians.

References

18 Herbal Supplements With Risky Drug Interactions, medically reviewed, L. Anderson, PharmD, Drugs.Com

Asher, G, Corbett, A, et al. Common Herbal Dietary Supplement-Drug Interactions. 

American Family Physician. 2017. July 15; 96 (2): 101-107.University of North Carolina, Chapel Hill, NC.

Singh, A, Zhao, K. Herb-Drug Interactions of Commonly Used Chinese Medical Herbs. 

International Review of Neurobiology. 2017. 2017;135:197-232. doi: 10.1016/bs.irn.2017.02.010. Epub 2017 Apr 14.

https://www.healthline.com/health/drug-interactions

https://nccih.nih.gov/health/whatiscam/chinesemed.htm

The Controversy Over Kratom and… Opioids

Editor’s Note: From my piece last month at  HCPnow

As the U.S. struggles with an opioid epidemic, government officials, doctors and patients are confronting drugs too heavily used and sometimes too often prescribed.

Everyone is searching for alternatives to opioids for patients, many of whom are coping with intense pain. An estimated 91 million people were prescribed opiate painkillers in this country, and 2 million people suffer from substance abuse disorders linked to the medications, according to the National Institutes of Health. 

There are many people seeking different treatments, including supplements, as options to opioids, or trying to treat their withdrawal symptoms from opioids. One of the most controversial is a plant-based supplement, Mitragyna speciosa, known as kratom, derived from a plant native that had been used for thousands of years in Southeast Asia for pain relief.

Kratom has a history of being sold as a dietary supplement and has been used to manage pain. Mitragyna speciosa grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea and has been used for many years in Southeast Asia as an opium substitute.

It’s from a plant, but it still can be an opioid, and produce morphine-like impacts, and that creates a dilemma.

Controversy Over FDA Warnings

Although it has been sometimes promoted as a natural alternative pain remedy, Kratom contains chemicals found in opioids, according to the federal Food and Drug Administration. While a few doctors have encouraged their patients to try kratom and their supporters enthusiastically support it, the FDA has been strongly against it.  Kratom has been usually taken as a powder, and the dosage has had stimulant and sedating properties. Kratom remains legal under federal law, but FDA officials want supplement companies to take kratom off the market. Inspectors also have been removing and destroying shipments of kratom from overseas.

The FDA has issued warnings about reports of injuries and deaths linked to kratom use. At least 44 deaths have been reported involving kratom since 2011, according to the FDA. Because of the reported health risks associated with its use, the FDA has banned the import of kratom.

Still, without question there has been an increase in use of kratom in the U.S, while government agencies have stepped up their concerns. A July 2016 report by the Centers for Disease Control and Prevention (CDC) noted that calls to poison centers about kratom exposure increased ten-fold from 26 in 2010 to 263 in 2015

The FDA also has linked kratom-containing dietary supplements to 28 cases of salmonella poisoning.  While supporters of kratom say there should be recalls of any product that contains salmonella, they oppose using the food safety investigation as a government step toward a mandatory recall of kraton products in the marketplace.

Medical Uses?

The FDA claims kratom is an opioid based on the agency’s extensive computer reviews that show its receptors in the brain also respond to heroin, morphine, oxycodone and other opioids.

FDA Commissioner Scott Gottlieb said there was no FDA-approved medical uses for kratom. “Claiming that kratom is benign because it’s just a plant is shortsighted and dangerous,” Gottlieb said in a statement.  “It’s an opioid. And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated sold and used recreationally.”

However, a major supporter of kratom says it has a long history of acceptable safety consumer use as an alternative pain management therapy. In addition, it provides a “more favorable safety profile for consumers compared to more dangerously addictive and potentially deadly classical opioids,” says the American Kratom Association. 

The U.S. Drug Enforcement Administration had considered placing kratom in the same category of illegal drugs as heroin and LSD.  There were numerous protests about the proposal, however, including a letter signed by members of Congress, against it, forcing the agency to withdraw it. Some states, however, have taken steps to ban the supplement or classify it as a Schedule One drug, the same as heroin.

What’s Ahead

Gottlieb said the FDA is willing to evaluate further evidence involving kratom. He added: “The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom,” he said. “However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval.”

References:

FDA and NIH statements on kratom:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595622.htm

https://nccih.nih.gov/news/kratom.

American Kratom Association

https://www.americankratom.org/news

Investigating Marijuana-Linked Ingredients for ‘Important Therapies’? FDA says it’s OK with that.

There are more than 80 active chemicals in marijuana. Today, in an “important medical advance,” the FDA approved the first prescription drug made from marijuana, still illegal by federal government standards, based on one of those chemicals.

“This product approval demonstrates that advancing sound scientific research to investigate ingredients derived from marijuana can lead to important therapies,” FDA Commissioner Scott Gottlieb says.

The approved medication, named Epidiolex, is targeted to treat two rare, severe forms of epilepsy in patients 2 years and older, says Gottlieb. The medication is a purified form of a chemical ingredient found in the cannabis plant known as cannabidiol, or CBD. It reduces seizures in some people with epilepsy.

CBD is one of more than 80 chemicals found in marijuana. It doesn’t contain THC, the key psychoactive ingredient in  marijuana. The approval is for a purified form of CBD.

The decision showed a “milestone that  could spur more research” into marijuana, according to Associated Press.

“This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components,” the FDA chief says.

Docs: Head to the Mount Rushmore State! Oh, Jersey, No!

So who says Washington DC. is just for politicians? It’s got doctors, doctors, doctors.

The District of Columbia has the highest number of physicians per 1,000 residents in the country — 6.9 times higher than Nevada, the lowest at 1.20, according to WalletHub’s  just released 2018’s Best & Worst States for Doctors.

WalletHub compared the 50 states and DC on a range of issues including the  average annual wages of physicians to hospitals per capita to quality of public hospital system.

The best state for docs? — South Dakota.

The worst — New Jersey.

Speaking of wallets — docs have plenty of holes in them, WalletHub says.

“The average medical-school graduate left campus with more than $190,000 of debt in 2017. The medical profession has also been undergoing intense transformation in recent years,” wrote John S Kiernan, Senior Writer & Editor for WalletHub. 

“Health-care reform, the rise of branded hospital networks and the retirement of Baby Boomers are all complicating the lives of doctors,” he wrote. — Joe Cantlupe

 

 

Never Again! Enough is Enough! We Call BS! ‘Survivors of a Cruel and Silent Nation’

Parkland, Fla.

Parkland has well-manicured lawns, new developments, and huge parks, with trails and tennis courts and basketball courts and ballfields. At the intersection of Coral Springs and Parkland is a horse riding academy, Malachi Acres, with a boarding stable, amidst the palms.  Town hall is beautiful, and residents talk about the sense of community. A resident recalls how there was a mini-scandal when there were some car break-ins in a neighborhood.  The reason, he said with a near smile: “The owners left their doors unlocked.” It’s that kind of place. A month ago, my wife and I left Parkland, heading to the airport after visiting relatives there. The Lyft driver told us why he moved to Parkland, this proud man from Brazil. For the schools, he said. For the schools.

Yesterday, it was about all of this, a sense of place,  the schools, and something much more profound:  passion, determination, unyielding force. Angry teen-agers with a grudge, clutching a sadness no one should have, fighting to curb gun violence, restrict the access to guns — assault weapons – and vowing, vowing, vowing to make politicians know they will be ousted from office if they don’t comply. So there is no more  terrible nonsense of gun violence that is taking lives, the “17 angels” — the 17 people –  students,  a football coach and athletic director, who were killed at Marjory Stoneman Douglas High School on Valentine’s Day. There were 14 wounded. The gunman was mentioned only in passing yesterday during the March For Our Lives rally, only in a word like horrible, but also as a pathetic reason why, why, why laws must be changed, gun laws, mental health laws, funding, you name it. All our hearts are broken, and we’ve had enough was the refrain, constant and true.

Parkland was center stage as a place, but its students were also taking the center stage  in  a rally in Washington D.C. Parkland is one piece of the gun-control puzzle. So is Chicago. So is New York. So is Miami. So is Los Angeles and everywhere where marches were held.  One bullet that fells any kid in a school, on a street. That’s what they fought against yesterday, mostly these kids, but there was plenty of support, no doubt about it, from parents, teachers, friends, the elderly.  Stop the gun violence. Stop people from having assault weapons.  Down with NRA. Thump the Trump. (ok, my term). Placard after placard. Sign after sign. The message was clear: Lawmakers and the President, if you don’t do enough you will be voted out by their supporters, damn it, when they are old enough to vote.  One student from Parkland told how she thought the privilege of the town helped draw it attention, but the fight  represents all races, all genders, all lifestyles. Those  voices at rallies across the country related personal experiences of friends, relatives, loved-ones cut down in senseless violence, in emotional, drive you to tears speeches. Eyes welling up all over.  Let’s hold those thoughts.

“We are survivors of a cruel and silent nation,” said D’Angelo McDade, 18, of Chicago at the Washington D.C. rally.  “I too, am a victim, a survivor and a victor of gun violence,” McDade said. “We are survivors not only of gun violence but of silence. I come from a place where minorities are controlled by both violence and poverty, leading us to be deterred by success. But today we say, ‘No More.’

No more, he said: violence, no more poverty, no more unjust policies and lack of resources. “You must be the change,” he told the crowd.

In 1970, after National Guard troops shot students at Kent State, we were young and demonstrated with passion and fury. We were convinced the wrongs of America would turn to rights.

We didn’t have social media. We had bull horns.

There’s something magical going  on now amidst the sadness.

These kids are articulate and their speeches are raw and practical. Blunt.  No more BS!

There are still huge bureaucratic mountains to climb, but as the protestors insisted yesterday, this is just the beginning. We’ll be hearing more of the words Ballet Box. — Joe Cantlupe

 

 

 

Did FBI drop the ball? Yes. Florida Gov. Wants FBI Director to Resign

The FBI conceded today that the agency did not follow proper protocols to pursue information on a tipline Jan. 5 about Nikolas Cruz, the self-confessed gunman in the Parkland high school massacre on Valentine’s Day and his “desire to kill people.”

Stunned by the admission, Republican Florida Gov. Rick Scott called for the FBI director to resign, saying: “The FBI’s failure to take action against this killer is unacceptable.

In an extraordinary  statement, the FBI said they did not followup on a call to the FBI’s Public AccessLine (PAL) tipline that reported concerns about Cruz, and his  “gun ownership, desire to kill people, erratic behavior and disturbing social media posts, as well as the potential of him conducting a school shooting.”

“Under established protocols, the information provided by the caller should have been assessed as a potential threat to life. The information then should have been forwarded to the FBI Miami Field Office, where appropriate investigative steps would have been taken,” the FBI said. “We have determined that these protocols were not followed for the information received by the PAL on Jan. 5. The information was not provide to the Miami Field Office an no further investigation was conducted at that time.”

The apparent mishandling of the information only adds to the tragedy in which 17 people were killed by the former student at Marjory Stoneman Douglas High in Florida. The defendant’s lawyer and President Donald Trump has said the 19-year-old Cruz, who had been expelled from the high school, had mental health problems.

News reports today said earlier that a tipster had alerted the FBI in September about a comment Cruz , who allegedly said he was going to be a “professional school shooter.” At the time the bureau checked databases but could not identify it as Cruz, or anyone else, according to the reports.

As a city and a country reels, the FBI is doing some soul-searching.

“We are still investigating the facts. I am committed to getting to the bottom of what happened in this particular matter, as well as reviewing our processes for responding to information that we receive from the public,” FBI Director Christopher Wray said. “It’s up to all Americans to be vigilant, and when members of the public contact us with concerns, we must act properly and quickly.

“We have spoken with victims and families, and deeply regret the additional pain this causes all those affected by this horrific tragedy,” Wray said. “All of the men and women of the FBI are dedicated to keeping the American people safe, and are relentlessly committed to improving all that we do and how we do it.” – Joe Cantlupe

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