Judge Says “No” to Pharma Firms’ Request to Delay Opioid Trial

The first major trial of whether pharmaceutical companies bear responsibility for the opioid crisis is slated to start in Oklahoma on May 28.  Three major drug manufacturers and 10 of their subsidiaries tried to convince Cleveland County District Judge Thad Balkman to delay the jury trial for 100 days, but Balkman ruled that it will move forward as scheduled. [1]

Following a nearly 2-hour hearing in his Norman, Oklahoma, courtroom, Balkman said:

“The wheels of justice … will continue to grind toward a trial date of May 28, 2019.”

Lawyers for the companies say they will appeal the judge’s decision.

In a statement, Purdue Pharma, maker of the blockbuster drug OxyContin, said it was “disappointed the court has denied its motion for a continuance. The facts show clearly that the state of Oklahoma has repeatedly failed to meet its obligations to produce critical information and documents to Purdue and the other defendants in this case.”

Purdue accused the state’s privacy attorneys of “flagrantly” violating court orders to turn over the material, “which has unfairly prejudiced Purdue’s ability to adequately prepare our defenses.”

Read: This 1980 Letter from Researchers Helped Fuel the Opioid Epidemic

The judge further enraged the drug companies by saying he will permit cameras in the courtroom.

The trial stems from a lawsuit brought by Oklahoma Attorney General Mike Hunter against some of the largest opioid manufacturers in the nation that alleges the companies’ deceptive marketing practices over the past decade fueled the opioid epidemic in that state. Hunter claims that Purdue, Johnson & Johnson, Teva Pharmaceuticals, Allergan, and others deceived the public into believing that opioids were safe for extended use. [2]

In response to the defendants’ claims that state attorneys had been “stonewalling” discovery for the past year, the attorney general called the drug companies “desperate” and grasping “at whatever straws they can find.”

In a court filing, Hunter wrote:

“The State did not manufacture opioids. The State did not target veterans. The State did not target legislators. The State did not target doctors. The defendants did all that.”

Read: Study Shows How Doctors GET PAID to Fuel the Opioid Crisis

So far, 36 states have filed cases against pharmaceutical companies in state courts. The remaining 14 states are mulling bringing cases of their own. The Oklahoma case will be the first to reach trial.

In the past 3 years, 3,000 people have died of overdoses and more than 1,300 newborns have tested positive for the highly addictive painkillers in Oklahoma alone, the state attorney general’s office said.

In 2017, more than 47,000 Americans died of opioid overdoses, according to the U.S. Centers for Disease Control and Prevention (CDC).

Sources:

[1] Washington Post

[2] CNN

Researchers Develop Swallowable Device that Injects Insulin Painlessly

For many people with diabetes, living with the disease requires multiple needle sticks a day to inject insulin and control their blood sugar. But in the future, diabetics might be able to take their insulin in pill-form. Two groups of researchers are working to make this possible in the future.

The groups, from MIT’s Koch Institute for Integrative Cancer Research and Harvard’s Brigham and Women’s Hospital, have developed an insulin delivery system that still uses a needle, but it’s so small that it can be swallowed, pain-free.

The pea-sized device contains a spring that injects a tiny dart of solid insulin into the wall of the stomach, according to Carlo Giovanni Traverso, an associate physician at Brigham and Women’s Hospital.

Traverso said:

“We chose the stomach as the site of delivery because we recognized that the stomach is a thick and robust part of the GI tract.”

Once the device reaches the stomach, the humidity there allows the spring to launch the insulin dart. If the idea makes you cringe, you can relax; it doesn’t hurt, thanks to the lack of pain receptors in the stomach. Once the injection has occurred, the needle breaks down in the digestive tract. [1] [2]

The self-righting capsule orients itself inside the stomach and ejects a tiny dart of solid insulin that’s about a quarter of an inch long. Source: Ania Hupalowska, Alex Abramson, Muhammad Mahdi Karim/Science

That all sounded good, in theory, but the researchers had to overcome the issue of getting the device to orient itself in such a way that it injected the insulin directly into the stomach. If you swallow a pill, you don’t have much control over which direction it lands once it’s in the body. [1]

Fortunately, nature provided the solution.

Traverso explained:

“Leopard tortoises happened to have evolved a way of doing this.”

MIT wrote in the journal Science: [2]

“The researchers drew their inspiration for the self-orientation feature from a tortoise known as the leopard tortoise. This tortoise, which is found in Africa, has a shell with a high, steep dome, allowing it to right itself if it rolls onto its back. The researchers used computer modeling to come up with a variant of this shape for their capsule, which allows it to reorient itself even in the dynamic environment of the stomach.”

Do you remember Weebles – those toys from your childhood that “wobble but they don’t fall down”? Those, too, provided inspiration for how to properly orient the device in the body. [1]

The researchers said in the journal Science that they’ve tested the insulin-delivery device on pigs, where it successfully injects a therapeutic dose of insulin provided the pig has an empty stomach.

Both teams of researchers have partnered with the global healthcare company Novo Nordisk to prepare the device for use in humans. It could be ready for human testing in a few years.

Sources:

[1] NPR

[2] TechCrunch

‘Big Pharma’ Spent Record Amounts on Lobbying in 2018, Report Shows

The pharmaceutical industry, as usual, is doing whatever it can to profit off the suffering of Americans. Recent filings show ‘Big Pharma’ spent a record amount of money on lobbying in 2018. While you and your family are struggling to figure out how to pay for prescriptions, pharmaceutical companies are trying to figure out how to dig an even deeper hole in your wallet to make theirs fatter.

In 2018, the industry’s leading trade group spent a record $27.5 million on lobbyingan increase of $1.4 million from 2009, when Congress and the White House created the Affordable Care Act (ACT), a.k.a., Obamacare. In fact, 2009 was the last time pharma companies spent record amounts on lobbying: just over $25 million. [1] [2]

Read: Pharma Companies Spend 19x More on Marketing than Research

The Pharmaceutical Research and Manufacturers of America (PhRMA) started pumping out larger sums of cash after lawmakers rejected a legislative fix that would have reduced the group’s share of disbursements in a popular Medicare program. [1]

Last year, PhRMA shelled out upwards of $6 million to lobby Congress and the Trump administration in the 4th quarter, disclosures filed with the Senate Office of Public Records show. But the first 3 months of 2018 were the costliest for the trade association, as it spent nearly $10 million during that period alone.

When looking at individual companies within the pharmaceutical and health sector, the price tag is even higher. As of October 24, 2018, individual companies spent $194.3 million on lobbying, far above the amount quoted by PhRMA. [2]

According to Open Secrets, the independent, non-partisan research group that tracks money in U.S. politics, Pfizer, Amgen, and Biotechnology Innovation Organization – a separate lobbying group for pharmaceutical companies and smaller biotechnology companies – spent the most money on lobbying. This was done with the knowledge – and fear – that the White House could limit Big Pharma’s price increases and profits on medicines.

Congress, the White House, and the American public want to see the creation of a comprehensive drug pricing plan. Lawmakers were emboldened to push for such a plan even more after a report published January 22 by the Health Care Cost Institute showed that the cost of insulin nearly doubled in the United States between 2012 and 2016.

Unaffordable insulin could easily make diabetes a public health crisis if it isn’t one already. A report published in 2016 revealed that the number of people living with diabetes has quadrupled since 1980. Obesity, too, is on the rise, and it is one of the leading causes of Type 2 diabetes. In the years between 2007-2008 and 2015-2016, rates of obesity among adults rose from 33.7% to 39.6%. Rates of severe obesity increased during this time from 5.7% to 7.7%. [3]

According to the recent report, people with Type 1 diabetes spent an average of $5,705 per person on insulin in 2016, an increase of $2,841 per person since 2012. [2]

Read: Did You Know? Most Clinical Trials are Funded by Pharma Companies

The institute wrote:

“The price of all types of insulin and insulin products increased, with point-of-sale prices roughly doubling on average between 2012 and 2016.”

There have been some “positive developments” in drug pricing behavior, US Health and Human Services Secretary Alex Azar said last week, but “drug companies have a lot further to go.”

That may be an understatement. Between May and the end of 2018, “drug companies took 57% fewer price increases on brand drugs compared with the same period in 2017,” according to Azar. But he praised Amgen, Merck, and Gilead for cutting the list prices on some of their drugs. He also pointed out that, so far, price increases in 2019 have been smaller and fewer than last year. Of course, we are only 1 month into the new year.

Even with these improvements, more needs to be done to make sure Americans can afford the medications they need, said Azar.

“We’ll continue taking action within the scope of the President’s blueprint. But if we need to go beyond its 4 corners to bring down list prices and out-of-pocket costs, we will.”

Sources:

[1] Bloomberg

[2] CNN

[3] American Cancer Society

Drugs In The Environment: The Importance of Properly Disposing Unused Medications

Scientists have found evidence that common methods of household prescription drug disposal can contaminate the environment and produce unwanted effects in wildlife.

Recent studies have shown that chemicals associated with the breakdown of prescription drugs have been found in surface water and groundwater. According to this article published on the PBS website, scientists currently believe that this contamination does not pose a threat to people, but that it does have detrimental effects on wildlife.

Even though all releases of pharmaceuticals cannot be controlled, individuals can take precautions to dispose of unused or outdated prescription drugs properly in order to reduce their overall impact on the environment.

Pharmaceuticals Enter the Environment Through Household Waste

Homeowners have been told for years that toilet flushing was the safest way to dispose of unused or outdated prescription drugs; however, this is no longer the case. When medicine is flushed down the toilet, the waste enters the sewage system and is transported by pipeline to the local public wastewater treatment facility. These facilities are not designed to treat or remove pharmaceutical chemicals.

There are two waste streams generated at public sewage treatment plants. The first is treatment plant sludge. This material is composed of dewatered solids removed from the sewage entering the plant.

Sampling studies have confirmed that pharmaceutical chemicals are common in sewage treatment plant sludge. Usually this sludge is disposed of in local landfills, but in some cases, the sludge may be reused as fertilizer on local farms.

When sludge is deposited in landfills, the movement of rainwater through the landfill can pick up chemical contaminants and transport them to underground aquifers. When used as fertilizer, the sludge is exposed to storm water runoff that can move contaminants into local streams and rivers. Either way, pharmaceuticals end up contaminating the environment.

Currently, sludge used as fertilizer is required to meet specifications for nutrient content, metals content, and bacterial content. There are no specifications for pharmaceutical contaminants.

The second waste stream from public sewage treatment plants is the release of treated water into streams or rivers. In this case, since treatment plants are not designed to remove pharmaceutical chemicals, those chemicals end up being released directly into the environment.

Treatment plants are required to meet specific requirements for the release of treated water; however, testing for pharmaceuticals is not one of those requirements.

Adverse Effects of Pharmaceutical Contamination

The effects of pharmaceuticals on wildlife were first documented by researchers in the United Kingdom in the 1990s. Since then, researchers all over the world have been studying this problem.

So far, the greatest effect has been seen in fish, primarily related to contamination by estrogenic compounds associated with birth control pills and female hormones. Male fish found downstream of wastewater treatment plants have failed to develop sperm and instead develop eggs.

Other studies have shown detrimental effects on fish and frogs by chemicals associated with antidepressant medications and on aquatic insects by anticonvulsant medications.

In addition, scientists are particularly concerned about the increase of antibiotics in the environment and the creation of resistant bacterial strains. This is already a huge issue within factory farming, as these animals are commonly fed antibiotics, which in turn are consumed by those who eat meat.

Environmentally-Friendly Disposal of Household Prescription Drugs

The National Office of Drug Control Policy has published guidelines on proper disposal of pharmaceuticals. These guidelines state that medicine should not be flushed down toilets or drains unless the label contains that specific instruction. The preferred method of disposal is through community drug take-back programs or household hazardous waste collection events.

Through these programs, medicine is collected from the public and taken to regulated hazardous waste incinerators. If one of these programs is not available, medicine should be placed in the garbage, mixed with coffee grounds or kitty litter, and then placed in sealed containers or plastic bags.

Household Hazardous Waste Collection and Prescription Drug Take-Back Programs

Consumers should contact their local public recycling program office to find out about household hazardous waste collection. In some areas, collection sites are open on a regular basis, either every business day or for a couple days each week. In other areas, special collection events are held once or twice a year on weekends. The local recycling program office should be listed in the telephone book.

To locate availability of take-back programs, consumers can consult the Product Stewardship Institute. Another source for information is the National P2D2 Network Prescription Drug and Drug Disposal Program Network.

Sponsorship and development of local collection programs makes a great activist project for communities or school groups. Such groups can partner with large retail outlets or pharmacies. The Northeast Recycling Council Inc. of Vermont has published a guide for local communities called “Holding an Unwanted Medication Collection for Community Pharmacies.” This booklet is available in PDF format on the Product Stewardship Institute’s website. A community-sponsored event could even make a great Earth Day project!

It’s also important to question why so many people are disposing of drugs without having taken them. Are we as a society too reliant on pharmaceuticals? Are we being given more than we need to help us, or to help grow profits for Big Pharma?

Sources :

Epa.gov : How to Dispose of Medicines Properly

Fda.gov : Disposal of Unused Medicines: What You Should Know

 

Survey: 40% of Medical Pot Users Able to Stop Using Pharmaceuticals

Medical marijuana is a touchy subject and many people are still on the fence about whether it’s a legitimate medicine and should be legalized. If you’re one of those people who remain unconvinced, perhaps this new study will change your mind.

In a survey of 450 adults who identified as current cannabis users, 78% said they used cannabis to treat a medical or health condition. Nearly half of those users – 42% – said they were able to give up pharmaceutical drugs because cannabis did the trick.

Another 38% of current cannabis users reported they were able to cut back on their use of pharmaceuticals because of cannabis.

Highly addictive opioids were among the pharmaceuticals that cannabis users were able to quit or reduce. Some 26% of users said they were able to wean themselves off opioids with the help of cannabis. [2]

Read: In States that Legalize Medical Marijuana, Opioid Use Decreases

In the study, people reported using cannabis for a variety of medical or health conditions, including chronic pain, depression, anxiety, post-traumatic stress disorder (PTSD), menstrual cramps, and headaches. Some even used cannabis to alleviate side effects from chemotherapy and to ease HIV/AIDS-related nausea. [1]

Respondents said they trusted medical marijuana more than pharmaceuticals and said cannabis was more effective and had fewer side effects. They also said that, in many cases, pot was more available and cost-effective than pharmaceuticals.

Daniel Kruger, a study co-author, said: [2]

“People are not only self-medicating, but they’re self un-medicating.”

Read: Survey: 42% of People Replaced Pharmaceuticals with Marijuana Compounds

Nearly 30% of current pot users said their doctor didn’t know they were using medical cannabis. [1]

The survey shed some light on the mindset of medical marijuana users, which the authors said needed to be explored to help shape future marijuana policy.

The authors of the study wrote:

“Given the state of the science of medical cannabis, even basic information about users’ attitudes and behaviors would be helpful.”

Current cannabis policy consists of a patchwork of laws across the U.S. There are already so many questions surrounding medical cannabis, and those questions will only increase in number and complexity as more states legalize marijuana. Every year, lawmakers try to legalize cannabis at the federal level. So far, no luck. It’s a shame because federal legalization would eliminate the need for patients to navigate often confusing state laws.

One thing is obvious to the authors: the federal government is not handling the issue of marijuana properly. Times have changed, but many lawmakers are stuck in the 1980’s, pleading alongside Nancy Reagan for people to “just say no.”

Kruger said in a statement:

“Given the growing use of cannabis for medicinal purposes and the widespread use for recreational purposes despite criminalization, the current public health framework focusing primarily on cannabis abstinence appears obsolete.”

You might not be in support of legalization, but chances are you will have to get used to it, sooner or later. A Pew Research Center survey published in October 2018 showed that 6 in 10 Americans – about 62% – approve of marijuana legalization. [3]

Kruger said that the federal government still treats cannabis use like “an abstinence-based program, like sex, and we know that doesn’t work.”

It’s not good that so many cannabis users are unwilling to inform their doctor that they use cannabis, but it’s easy to understand why they don’t. There is still a stigma attached to cannabis use. Perhaps if more people were open about their cannabis use and how much it has helped them, their honesty would slowly whittle away that stigma.

He added:

“It’s not wild to say, ‘here’s this plant that people have used medicinally for 5,000 years’ … why are we not taking it seriously?”

The study is published in the Journal of Psychoactive Drugs.

Sources:

[1] Men’s Health

[2] Daily Mail

[3] Pew Research Center

Drugmakers Could be Forced to Disclose Drug Prices in TV Ads

Fun fact: Drugmakers may legally advertise pharmaceuticals on television in only 2 countries, New Zealand and the United States. Now under new proposed rules, drugmakers may be forced to disclose in their TV ads how much their drugs cost. [1] [2]

A new federal rule has been drafted by Health and Human Services Secretary Alex Azar that would require drug manufacturers to disclose in television ads the list price for a 30-day supply of any drug that is covered through Medicare or Medicaid and costs more than $35 a month. [2]

In an October 15 speech before the National Academy of Medicine, Azar said:

“Sometimes it takes government to make the first move, to disrupt a broken system, and to lay down new rules of the road.”

Read: Merck Exec Explains Why Drug Prices are Out of Control

The draft rule will be debated throughout the fall. How much the pharmaceutical industry resists the proposed rule will likely dictate whether or not it will become a requirement.

In a shocking move, health insurers’ main trade group said it was pleased with the proposed rule, citing the need to combat “out-of-control” drug prices.

The American Medical Association (AMA) is dead-set against direct consumer advertising, but said in a statement that “as long as the practice is allowed, the ads should come with at least a small dose of transparency.”

Currently, other wealthy countries spend about half as much per person on healthcare than the U.S. spends. In fact, the U.S. ranks highest in healthcare spending among the world’s developed nations. Those in favor of the proposed rule believe it will make Americans more aware of healthcare costs and, in turn, slow the ever-rising drug prices that have contributed to the U.S.’s unfortunate top ranking. [2] [3]

Hours before Azar’s speech, the Pharmaceutical Research and Manufacturers of America (PhRMA), the major pharmaceutical lobbying group, announced a new voluntary action that would send consumers to company websites with pricing information. Beginning April 15, 2019, the websites would provide the public with a variety of pricing information, including the list price of a drug, the expected out-of-pocket costs of a drug, and any available patient assistant programs. [2]

Read: Pharma Companies Spend 19x More on Marketing than Research

Azar dismissed the action, saying it was nothing but an attempt to thwart stricter federal intervention.

The secretary compared the proposed rule to a 1950’s-era rule requiring automobile companies to disclose their cars’ sticker prices.

“Despite the ample precedent for this common-sense measure, the pharmaceutical industry has resisted it fiercely.”

Azar further said PhRMA’s announcement was “no coincidence,” and that “placing information on a website is not the same as putting it right in an ad.”

Michael Rea, founder and CEO of software company RX Savings Solutions, agreed, saying that “the impact” of PhRMA’s announcement “is zero.”[4]

He added:

“It’s not going to do anything.”

Steve Ubl, president of PhRMA, said that disclosing drug prices in TV ads would be “very confusing, misleading, lacks appropriate context, and isn’t what patients want or need.” He also signaled that if the rule becomes a requirement, it would lead to a protracted legal battle, citing First Amendment concerns.

Read: Pharma Industry Ads Seek to Draw Attention Away from Drug Costs

But Azar said: [4]

“Patients deserve to know what a given drug could cost when they’re being told about the benefits and risks it may have. They deserve to know if the drug company has pushed their prices to abusive levels. And they deserve to know this every time they see a drug advertised to them on TV.”

Sources:

[1] Health System Tracker

[2] The Washington Post

[3] Investopedia

[4] USA Today

FDA Analysis: Hundreds of Dietary Supplements Tainted with Rogue Pharmaceuticals

When you buy supplements, you expect them to contain the advertised ingredients, right? And I’m sure you certainly don’t expect them to contain any pharmaceuticals, such as Viagra. But a U.S. Food and Drug Administration (FDA) analysis published in JAMA Network Open reveals that hundreds of dietary supplements actually contain pharmaceutical drugs. And yes, that includes Viagra, a drug that treats erectile dysfunction (ED). [1]

(Click for larger version.) Summary of Products Reported in the US Food and Drug Administration’s Tainted Supplements Database, 2007 through 2016a.

Researchers found unapproved and potentially dangerous drugs in 746 dietary supplements. The majority contained sexual enhancement drugs, but some contained weight-loss or muscle-growth drugs.

Read: Harvard Finds Amphetamine-Like Compound in Supplements

The team reviewed an FDA database of contaminated supplements from 2007 to 2016, and most of them tested positive for sildenafil, a.k.a., Viagra, as well as other ED drugs in sexual enhancement products. Additionally, the analysis found sibutramine and the laxative phenolphthalein, both banned by the FDA, in weight-loss supplements; and steroids or their analogues in muscle-building products.

Some of the Shocking Findings

Of the 746 supplements:

  • 80% were contaminated by 1 pharmaceutical.
  • 20% contained at least 2 pharmaceuticals.
  • 2 of the supplements contained 6 unapproved pharmaceuticals.
  • One supplement contained a drug that increases blood pressure and another drug that lowers it.

However, fewer than half of the products were recalled. What’s more, 97.6% of the pharmaceuticals found in the products weren’t listed on the products’ labels. [1] [2]

The authors of the report state that the presence of unknown pharmaceuticals in supplements “poses a serious public health risk.” Take Viagra, for instance. The erectile dysfunction medication can cause severe side effects, such as priapism (a painful, long-lasting erection), sudden hearing loss, increased intraocular (eye) pressure, heart arrhythmias, and even heart attack. [2] [3]

Products in the US Food and Drug Administration’s Tainted Supplements Database by Marketing Category, 2007 through 2016

Watch: The Truth About Most Vitamins and Supplements

According to Medical News Today, sildenafil is particularly dangerous for men who:

  • Take nitric oxide donors, nitrates, and organic nitrites;
  • Are advised to avoid sexual intercourse because of cardiovascular risk factors;
  • Have severe liver impairment;
  • Have kidney disease;
  • Have hypotension (low blood pressure);
  • Have had a heart attack or stroke, and
  • Have hereditary degenerative retinal disorders.

More than 50% of the U.S. population takes dietary supplements, believing them to be carefully regulated and accurately labeled. In reality, the FDA has little to do with supplements, unless it comes to light that something is wrong with them.

(Click for larger version.) Undeclared Ingredients Identified in 353 Sexual Enhancement Products From the US Food and Drug Administration’s Tainted Supplements Database, 2007 through 2016

The Dietary Supplement Health and Education Act of 1994 dictates that dietary supplements are regulated as food. That means the products are not subjected to the same premarket safety and effectiveness testing as pharmaceutical drugs.

Dr. Pieter Cohen, a general internist at Cambridge Health Alliance in Somerville, Massachusetts, wrote in a commentary accompanying the study: [4]

“The agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk.”

Read: 4 Common Dangers Lurking in Your “Health” Supplements

Unlike Most Common Supplements

(Click for larger version.) Undeclared Ingredients Identified in 317 Weight Loss Products From the US Food and Drug Administration’s Tainted Supplements Database, 2007 through 2016

However, Daniel Fabricant, president of the Natural Products Association, a supplement industry trade group, says that sexual enhancement, weight-loss, and muscle-building products shouldn’t fall into the same category as vitamins and other traditional dietary supplements. The contaminated products found in the FDA database are “fringe products” made by unscrupulous manufacturers that are sold online or in convenience stores. [1]

As a general rule of thumb, if you wouldn’t eat gas station sushi, you shouldn’t take gas station supplements.

Fabricant said:

“We’re completely on the FDA’s side here. This is someone spiking the product. They’re saying it’s a supplement. It’s not a supplement in any way, shape, or form.”

He said he hopes the FDA will bring misdemeanor charges against companies that add pharmaceuticals to their so-called supplements.

We have to agree, especially considering previous research by Cohen and his colleagues shows that adulterated supplements continue to be sold in stores even after they’ve been recalled. They were left on the market possibly due to the FDA’s inability to reach manufacturers to get them to issue a recall. It is also possible that some of the companies simply denied the agency’s request to recall their products. [4]

(Click for larger version.) Warnings Associated With Products in the US Food and Drug Administration’s Tainted Supplements Database, 2007 through 2016

Asleep at the Wheel

Though the FDA does not regulate supplements, the agency is not powerless to stop shady companies that manufacture adulterated products. The health watchdog can send companies warning letters, visit factories, and issue mandatory recalls.

The study found, however, that the FDA rarely dips into its bag of tricks to stop the sale of potentially-dangerous products. Out of the 146 companies involved in the manufacturing of the tainted supplements, the FDA issued just 7 warning letters. No mandatory recalls were ordered.

Cohen said:

“There’s just no way to interpret this other than the FDA is simply not doing its job.”

A viable solution to the problem would be for Congress to change dietary-supplement regulations to force companies to register supplements with the FDA before they can sell them. That would require each supplement to have an identifying registration code that would allow the FDA to know exactly what supplements are being sold in the United States. If a supplement was found to be tainted, the agency could “deactivate” the code so customers couldn’t buy it, Cohen explained.

Sources:

[1] The Washington Post

[2] Forbes

[3] Medical News Today

[4] Scientific American

Study Shows How Doctors GET PAID to Fuel the Opioid Crisis

Most doctors are wonderful people and consummate professionals who truly want the best for their patients. But a recent study suggests much of the blame for the opioid crisis lies squarely on the shoulders of doctors who write prescriptions for hard-hitting opioids when other simpler pain-relieving methods would suffice.

The study shows that as recently as 2015, doctors were still prescribing the addictive and potentially deadly painkillers even for minor injuries in great numbers.

Researchers wrote in the Annals of Emergency Medicine that 1/4 of patients treated for ankle sprains between 2011 and 2015 were prescribed an opioid to deal with the pain.

For the study, researchers from the University of Pennsylvania analyzed private insurance claims filed by nearly 31,000 patients who had been treated in the emergency room for a sprained ankle. The patients were over the age of 18 and had not been prescribed an opioid in the 6 months prior to their injury.

Researchers looked at prescriber habits shortly before 2016, when the U.S. Centers for Disease Control and Prevention (CDC) issued guidelines urging doctors to only prescribe opioids in dire situations and the federal government announced it would limit the length of first-time opioid prescriptions. [2]

Read: The DEA Will Slash Opioid Production 25% in 2017

Study leader Kit Delgado, an assistant professor of emergency medicine and epidemiology at the University of Pennsylvania’s Perelman School of Medicine, said:

“There was this leap to opioids, either in perception of patient expectations or to meet patient expectations.”

The team found that:

  • Overall, 25.1% of the patients studied received an opioid prescription.
  • Most of the opioid prescriptions were for short-term use – about 15 pills (enough for 3 days) and low-dose. However, a small number of patients received a prescription equivalent to more than 30 tablets of medium-strength oxycodone – a drug with “high potential for abuse,” according to the Drug Enforcement Agency (DEA).
  • Nearly 5% of patients who received a mid-strength opioid prescription progressed to prolonged opioid use, compared to about 1% of patients who were given a more moderate prescription, and 0.5% of patients who did not receive an opioid prescription.

Where a patient lived played a significant role in whether or not they would be prescribed one of the powerful analgesics. In Arkansas, 40% of patients left the ER with an opioid prescription, compared to just 3% of patients in North Dakota. All but 1 of the 9 states that recorded above-average opioid prescribing is in the South or Southwest. [1] [2]

Above-average prescribing was documented in North Carolina, Tennessee, Georgia, Alabama, Arkansas, Texas, Oklahoma, Kansas, and Arizona. [2]

Fortunately, during the study period, overall prescription rates fell from 28% of patients in 2011 to 20.4% in 2015. [1]

Read: Opioid Prescriptions Down for 1st Time in 20 Years

Most opioid prescriptions are written by primary care physicians; emergency room doctors are a blip on the entire map. Overall, there were about 215 million prescriptions for the painkillers in 2016, according to the CDC. [2]

In light of the opioid epidemic that wipes out thousands of lives a year in the U.S., why did doctors prescribe such addictive drugs in such large amounts and doses to so many people? There are 4 possible explanations.

Read: This NJ Hospital Will Do Anything to Avoid Prescribing Opioids

Freebies and Financial Perks

Click for larger version.

No one likes to think their doctor is prescribing them a drug because he or she stands to gain from it, but the disturbing reality is that it happens all the time.

In 2014 and 2015, opioid makers had no problem paying doctors 6-figure sums for speaking, consulting, and other services. The companies paid thousands of other dollars $25,000 sums during that time. [3]

Click for larger version.

Doctors who hocked the most pain pills to their patients were the most likely to bring in big bucks. It’s not hard to imagine how tempting a 6-figure sum could be to someone with a prescription pad. It’s also not hard to imagine how a doctor would feel beholden to a pharmaceutical company after being paid such exorbitant amounts.

You could almost say the drug companies were the drug kingpins, the doctors were the dealers, and in tragically too many cases, the patients became – unwittingly – the junkies. And if the dealers wanted to get paid, they had to keep moving the kingpins’ product.

Click for larger version.

Ignorance

It’s possible that some of those doctors during the study period offered more opioids because they lacked the medical training to know the full addictive nature of the drugs. [2]

It is a doctor’s job to ease suffering, after all, and physicians have been taught to aggressively treat pain.

In 1980, a 101-word letter written by Boston University Medical Center researchers published in the New England Journal of Medicine, served as the foundation for doctors’ opioid prescribing habits for decades.

In the letter, the scientists claimed that “despite widespread use of narcotic drugs in hospitals, the development of addiction is rare in medical patients with no history of addiction.”

Based on these promises of safety, opioid prescriptions exploded.

The scientists went on to say in the letter that in a review of 11,882 hospitalized patients treated with narcotics, they found “only four cases of reasonably well-documented addiction.”

That letter went on to be cited in hundreds of reputable medical journals.

Clueless Prescribing

 

Doctors don’t always know how many pills to prescribe in individual cases. [2]

A Yale University study found that hospitals were able to successfully decrease opioid prescriptions by going into electronic medical records and lowering default settings for pill limits.

Previous studies show that when surgeons have specific guidelines for how many pills they should prescribe after common procedures, opioid use decreased sharply.

Yet other studies show that long-time use may partly depend on whether an individual was treated by a “low-intensity” or a “high-intensity” prescriber in the ER.

Ego

Anyone can go online and give a doctor a positive or negative review. Delgado and his colleagues believe that in some cases, doctors prescribe more opioids in pursuit of glowing reviews.

Sources:

[1] Time

[2] The Washington Post

[3] CNN

OxyContin Maker Wins Patent for Addiction Treatment

A member of the family that owns Purdue Pharma – the same company that makes OxyContin – has been awarded a patent for a treatment for opioid use disorder. [1]

Purdue Pharma is currently being sued by more than 1,000 jurisdictions for allegedly fueling the opioid crisis with its OxyContin painkiller. But Dr. Richard Sackler, one of 6 inventors of the new patent, doesn’t seem to be bothered by that. He is more than willing to gain financially from the very problem he himself helped create, even if it means generating a great deal of criticism in the process.

Colorado is one of the states suing Purdue Pharma. In a statement, Colorado Attorney General Cynthia Coffman said: [2]

“Purdue’s habit-forming medications coupled with their reckless marketing have robbed children of their parents, families of their sons and daughters, and destroyed the lives of our friends, neighbors, and co-workers. While no amount of money can bring back loved ones, it can compensate for the enormous costs brought about by Purdue’s intentional misconduct.”

In the lawsuit, the state accuses Purdue of downplaying the risk of addiction associated with opioids and exaggerating the medicine’s benefits. The lawsuit further alleges that the drug maker “advised healthcare professionals that they were violating their Hippocratic Oath and failing their patients unless they treated pain symptoms with opioids.”

It’s enough to turn your stomach.

Related Read: The Opioid Crisis Deemed a National Emergency – So What Happens Now?

Profiting from People’s Pain

Source: Sun Herald

There were more than 63,000 drug overdoses in the United States in 2016, and more than 66% of them were attributed to opioids, according to the most recent data from the U.S. Centers for Disease Control and Prevention (CDC).

Source: Aiken Standard

The patent is for a new formulation of buprenorphine, a medication known to help people kick their opioid addiction. The U.S. Food and Drug Administration (FDA) has already approved it in tablet and film form, but the patent is for a wafter version of the drug that dissolves even faster than existing forms when placed under the tongue. [1]

The patent states that the faster buprenorphine dissolves, the less risk there is for diversion.

As mentioned, Purdue Pharma is facing more than 1,000 lawsuits from cities, states, counties, and tribes. But a case brought by Massachusetts recently named the Sackler family as defendants.

Read: Washington City Sues OxyContin Maker over Opioid Epidemic

Right now, Congress is seeking from Purdue a copy of a deposition from Sackler that was taken as part of a lawsuit brought by Kentucky against Purdue. Though the case was settled in 2015, it marked the only time a member of the Sackler family was questioned under oath about their role in the marketing of OxyContin and what Purdue knew about the addictive nature of the opioid painkiller.

In the patent, Dr. Sackler doesn’t even attempt to hide the fact that he’s trying to profit off of other people’s suffering. The description for the patent justifies the need for a new form of opioid addiction treatment by pointing out that people addicted to OxyContin are often willing to break the law in order to get their “fix.” Public safety and law enforcement costs associated with addiction are cited in some of the lawsuits against Purdue.

The description of the patent also states that buprenorphine could also be used to treat pain in people and animals.

Purdue Made Efforts on Paper…

Purdue is trying to show that it is taking steps to address the opioid crisis. The pharmaceutical giant has donated money to the National Sheriffs’ Association to purchase naloxone – a drug that can reverse an opioid overdose – and train law enforcement on its use. It has backed safer prescribing efforts, and in early September 2018, Purdue contributed $3.4 million to a company working on an inexpensive naloxone nasal spray.

…However

There is no question that Purdue Pharma is at fault for a pretty big chunk of the opioid crisis. In 2007, 3 top current and former company employees pleaded guilty to criminal charges, admitting that they falsely duped doctors and their patients into believing that OxyContin was less addictive than other opioid analgesics. It was reported earlier in 2018 that Purdue planned to stop promoting the drug. [2]

Luke Nasta, director of Camelot, a New York-based treatment center for drug and alcohol addiction, said:

“It’s reprehensible what Purdue Pharma has done to our public health.”

He added that the Sackler family “shouldn’t be allowed to peddle any more synthetic opioids – and that includes opioid substitutes.”

Sources:

[1] STAT (featured image source)

[2] The Washington Post

Sun Herald

Aiken Standard