Category Archives: Drugs

Bacteria

Completely Resistant Superbug Strain Found in the US

It’s much more serious than Zika, Polio, or even Ebola. A drug resistant super-bug would send healthcare back to the days when the flu was lethal and infections led to amputation.

A genetic mutation that gives bacteria resistance to our strongest antibiotics has been found in the US for the first time ever.

Thankfully, the superbug isn’t ready just yet. The bacteria that was identified was vulnerable to a weaker subset of antibiotics, but that’s where the good news ends.

All it takes is for this gene to be transmitted to a bacteria that is already drug resistant, and healthcare might lose it’s upper hand over infections.

The drug resistance that has scientists worried comes from a gene called mcr-1. Unfortunately, this gene is easily transmitted to other bacteria. All it takes is for this gene to be transmitted to a bacteria that is already drug resistant and healthcare might lose it’s upper hand over infections.

The mcr-1 gene was found in Pennsylvania. Click here to learn more.

Pills

FDA Approves OxyContin For Extremely Sick Kids

(HuffPost) The U.S. Food and Drug Association approved the painkiller OxyContin for children ages 11 to 16 with pain “severe enough to require daily, around-the-clock, long-term opioid treatment,” according to a statement released on Aug. 14.

Some experts expressed concern that the approval might lead to drug misuse among children or their family members, who may have access to the drugs. But doctors who treat dying children and those in chronic pain say that the move will be a boon to many of their patients.

“Although thankfully uncommon, some children can experience prolonged periods of substantial chronic pain from conditions like cancer,” said Dr. Chris Feudtner, director of the Department of Medical Ethics at the Children’s Hospital of Philadelphia, who has no connection to the drug.

“For these patients, strong pain medications can offer tremendous relief,” he said.

OxyContin, the extended time-release version of the generic narcotic oxycodone, has been all over the news in recent years for its role in the public health crisis of opioid addiction. Experts blame the rise of prescription painkiller use in the United States for the nation’s current heroin epidemic. As it stands, four out of five new heroin users abused prescription painkillers first, according to the Center for Behavioral Health Statistics and Quality.

Although OxyContin, is just one of many painkillers on the market, it took particular criticism because representatives promised officials and doctors that the drug was safe and effective for patients with chronic pain. In actuality, its time-release formula made it more likely to result in abuse.

The company’s top executives pleaded guilty to misleading doctors, regulators and the public

OxyContin is made by Purdu Pharma, a drug company with a tarnished reputation after three of the company’s top executives pleaded guilty to misleading doctors, regulators and the public about OxyContin’s addiction risk in 2007. The company agreed to pay $600 million in fines. Following the trial, the FDA banned the original OxyContin formula and in 2010, the company developed an uncrushable tablet that was more difficult to snort or inject than the original.

But despite OxyContin’s rocky track record among adults, doctors who treat extremely sick children note that these powerful drugs aren’t as likely to result in abuse.

“Children rarely get ‘hooked’ on these medications the way that adults can,” Feudtner said, noting that all strong pain medications have the potential be misused by friends or family members of the patient.

It’s a question of “actively managing and monitoring the use of these medications,” Feudtner said. “So that children in need get what they need and everyone stays as safe as possible.”

“Children rarely get ‘hooked’ on these medications the way that adults can,” Feudtner said

“Everybody gets all excited about OxyContin, but we forget that there are a large number of children and adolescents who suffer from chronic pain,” said Dr. Lonnie Zeltzer, a professor of pediatrics and the director of the Mattel Children’s Hospital’s Pediatric Pain and Palliative Care Program at UCLA.

Zeltzer, an outside scientist who was a paid committee member of the data safety and monitoring board that oversaw the Purdu trials, said that she’s long been a proponent of encouraging companies to do studies of drugs like OxyContin on children.

“They are being used anyway, but without the data,” she said, noting that doctors and pediatricians will prescribe off-label drugs to chronically ill children, or children in palliative care, if they don’t have other options. “There was so little that was evaluated in children that physicians were using medication that wasn’t studied,” she said.

And as for the risk of opioid abuse by friends of family members, Zeltzer doesn’t think kids should suffer for adults’ mistakes. “Diverted use in adults doesn’t mean that children should be deprived of the proper studies and safety parameters.”

By: Erin Schumaker

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Why Did Prescription Drug Spending Hit $374B in the US Last Year? Read This

(WSJ) Prescription drug spending in the U.S. ballooned last year to nearly $374 billion, which was not only a hefty 13.1% increase in growth, but also represented the highest level of spending since 2001, according to a new report from IMS Institute for Healthcare Informatics.

Two key factors were cited.

The first was the emergence of pricey and widely used hepatitis C treatments, including the Sovaldi and Harvoni medicines sold by Gilead Sciences. Sovaldi, in fact, was the biggest-selling drug last year at $7.9 billion, according to IMS calculation. Meanwhile, more than 161,000 patients started hep treatments in 2014, nearly 10 times more than in the previous year. A Gilead spokeswoman declined to comment.

The other reason cited for the jump in spending was that fewer brand-name medicines lost patent protection than in previous years. This meant there were fewer low-cost generic alternatives that became available to consumers. Last year, the loss of patent protection on brand-name drugs resulted in nearly $12 billion in reduced spending, which was well below the $19.6 billion in lower spending in 2013.

“It was truly a remarkable year,” says Murray Aitken, executive director of the IMS Institute. “We had an unusual confluence of events.”

Indeed, spending on new brand-name drugs – which IMS defined as medicines that were approved during the previous 24 months – amounted to $20.2 billion last year, much higher than the $6.5 billion seen in 2013. And spending on older brand-name drugs reached $26.3 billion, up from $20.3 billion during 2013. Price increases for brand-name drugs were helped by price increases that averaged 13.5%.

Hepatitis C treatments were not the only new medications contributing to rising spending. Aitken also points to drugs for treating cancer and multiple sclerosis, which contributed $1.6 billion and $2 billion, respectively, to spending growth. And spending on diabetes drugs jumped 30.5% to $32.2 billion last year, which was the second-highest therapeutic category in terms of spending growth after hepatitis C.

We should note that IMS based its data on invoice prices, not the standard average wholesale prices or wholesale acquisition costs that are generally used when describing drug prices. In addition, the research firm does not include rebates and discounts on invoices, which Aitken notes can be significant. For instance, discounts and rebates would have lowered diabetes spending growth to 22%.

Going forward, Aitken suggests such huge increases in spending are less likely. More patents on brand-name drugs are expected to expire over the next two years, which means more lower-cost generics arriving in pharmacies. And he believes that usage for the new hepatitis C treatments is expected to eventually moderate, at least compared with the sudden surge seen in 2014.

But what impact may new, pricey cancer meds have? Aitken readily acknowledges that big price tags will play a role in increased spending, but notes that “most of the new drugs still have relatively small patient populations. So they will be used on thousands of patients, rather than millions. Therefore, the impact on spending growth is expected to be relatively modest.”

A few other nuggets from the report: Spending on specialty medicines increased by $54 billion in the last five years, and contributed 73% of overall medicine spending growth during that period, according to IMS. Meanwhile, spending on cancer and autoimmune drugs rose 16.8% and 24%, respectively, and spending on multiple sclerosis medicines increased 24.4%.

Medicaid was the leading driver of retail prescription growth in the first year of expanded coverage under the Affordable Care Act. Retail prescriptions rose 2.4% in 2014, the first year of major coverage expansion. Overall, Medicaid prescriptions increased 16.8% in 2014, accounting for 70% of the growth in retail prescription demand.

Lower adherence is seen at every out-of-pocket level for patients with a deductible, which worsened after costs exceed $30, and most when costs exceed $125. The overall number of prescriptions where patients used a co-pay card has now reached 8% of all branded prescriptions.

By: Ed Silverman
Photo by Chris Potter

spice_drug

‘It’s literally poison:’ Spice, today’s bathtub gin

(AL.com) Bathtub gin used to make you go blind, because you just couldn’t know where it came from or where it was distilled.

The bathtub gin of today – Spice – is every bit as bootleg and every bit as dangerous.

Spice is whipped up in Chinese kitchens, shipped across the world in random dosages, sprayed on plants to make “synthetic marijuana” by people who don’t know what they are doing, and marketed to 12-year-olds (some packaging features references to the ‘Scooby Doo’ cartoon, for example).

According to police, hundreds of people in recent months have called emergency services with physical and psychological reactions to the drug.

“It’s literally poison,” said Clay Morris, the Assistant Special Agent in Charge for the Drug Enforcement Administration in Alabama.

State officials say 462 patients were seen from March 15 through April 20 at hospital emergency rooms throughout Alabama. Of those, 96 patients were hospitalized and two of them died.

The alarming numbers have prompted an intense federal and state investigation into why there has been such a dramatic increase and whether it’s linked to similar problems in neighboring states. “We’ve got to identify the source of the supply and remove that source,” Morris said. “That’s literally what we’re working on daily. It is very much a priority with DEA as we speak.”

In particular, investigators are working closely with authorities in Mississippi where more than 30 people were hospitalized in just one weekend. “We have several bad batches of spice in circulation in our state,” Morris said. “It’s just too potent. We’re conducting an investigation in both states to see if there are commonalities.”

Public health experts and law enforcement officials both statewide and nationwide have issued warnings in recent weeks about spice. Dr. Jim McVay, director of Health Promotion and Chronic Disease at the Alabama Department of Public Health, said the agency started active surveillance on spice-related illnesses on April 15. They have requested that all 90 hospitals across Alabama now try to track spice overdoses and report the numbers to ADPH once a week. The newest numbers should come in Thursday or Friday, he said.

Officials from several state agencies are planning to meet today at the U.S. Attorney’s Office in Montgomery to discuss concerns over heroin, prescription drug abuse and use of synthetic marijuana. Organizers say the group will include Alabama Attorney General Luther Strange, Secretary of Law Enforcement Spencer Collier and officials from the FBI, DEA and more.

Spice is a synthetic cannabinoid. The designer drug substances consist of dried plant material sprayed with synthetic cannabinoids and a mixture of other unknown chemicals including pesticides and rat poison

Spice is a synthetic cannabinoid. The designer drug substances consist of dried plant material sprayed with synthetic cannabinoids and a mixture of other unknown chemicals including pesticides and rat poison, McVay said. The chemicals stimulate brain areas affected by marijuana, and users sometimes opt for the marijuana alternative because they believe they are safe.

That couldn’t be farther from the truth. Users of the synthetic drug typically experience rapid heart rate, nausea, vomiting, agitation, confusion, lethargy, hallucinations, seizures, and kidney and respiratory problems.  The reason, McVay said, is simple. “Drug dealers are selling a tainted product,” he said.

Morris explained how easily that happens. The synthetic drug is manufactured in clandestine labs in China. Dealers buy the chemicals, dried leaves and packaging separately, and assemble it themselves. “You literally mix your powdered synthetic drug with acetone and then put it in a spray bottle, like the kind you get at Walmart,” he said. “They put the leaves out on a six-foot table and spray the chemical on them. So if they’re texting on their cell phone and spraying at the same time, they’re not paying attention at all. They could hold it over one part longer and put 10 to 20 times more of it in some places.

“The dosing isn’t uniform,” he said. “You never know what you’re going to get.”

Spice, also known as K2, is primarily marketed toward youth. “That’s what people don’t understand. They’re literally targeting 12- to 17-year-olds,” Morris said. “Just look at the packaging alone – Scooby, iPhones – all those things are marketed to children.”

Over the past six months in Alabama, the victims have ranged in age from 13 to 60, and most are males in their 20s and 30s.

Morris said spice is shipped kilos at a time from China through any number of mail services. “We’ve had several cases where New York is a good supplier for Alabama, and Atlanta,” Morris said.

We’ve had several cases where New York is a good supplier for Alabama, and Atlanta

So far, McVay said, a minority of the state’s 90 hospitals have seen spice-related illnesses. “It first came to light in Tuscaloosa, then Mobile and then Montgomery,” he said.

Overdoses on spice in Tuscaloosa County in recent weeks left one victim dead and two dozen others hospitalized. The leaders of the area’s public safety and law enforcement agencies held a joint press conference earlier this month to make the public aware of the problem, which Tuscaloosa’s Chief of Police Steven Anderson called “a public health crisis and a public safety crisis.”

Since about March 15 at least 250 people have been treated in Mobile County emergency rooms for serious health complications related to spice

Since about March 15 at least 250 people have been treated in Mobile Countyemergency rooms for serious health complications related to spice, McVay said. Law enforcement officials there say the selling of spice has evolved from the storefronts to the streets. “The differences we are seeing are that it is distributed more street-level, person-to-person than in previous years,” Mobile Police Department spokeswoman Ashley Rains said in a previous interview with AL.com. “Because of this, there is also information that the spice on the streets now is not the commercial grade imported from overseas but instead a homemade variety, made with any amount of household chemicals.”

Authorities in Montgomery County say more than three dozen people were recently treated in local hospitals for medical issues linked to the synthetic drug known as spice. Montgomery police and fire officials along with the county’s district attorney said during a meeting on Monday that 41 young people had gotten sick after using a synthetic form of marijuana known as spice, the Associated Press reported. Director of Public Safety Chris Murphy says local authorities are concerned because so many of the cases were reported between Thursday and Monday.

It’s even finding its way to state inmates. Two weeks ago, six inmates at Elba Community Work Center were transported and treated at an unspecified hospital this week possibly due to using spice. Alabama Department of Corrections spokesperson Bob Horton told AL.com two inmates at the Coffee County facility who appeared to be under the influence of an unknown substance were transported to an offside medical facility. Four others exhibiting similar symptoms were transported to a medical facility.

We’ve got to stop the distribution network to save our kids.

A couple weeks ago, four people overdosed in Fairfield within six hours and authorities suspect the drug of choice was spice. The victims, all four adult males, survived and were taken to local hospitals. Police Chief Leon Davis said an investigation is underway, but said it’s hard to confirm spice was behind the illnesses without toxicology test results.

Aside from the Fairfield incident, the Birmingham area has largely escaped the alarming numbers seen in other parts of the state. Law enforcement officials in Birmingham and surrounding cities said they rarely run into the drug or related illnesses. “You would think it would be evenly distributed but it isn’t,” McVay said. “Drug dealers have a limited geographic area.”

Alabama isn’t alone with the spice issue. At least two deaths in Hancock County in Mississippi two weeks ago are possibly linked to spice, and the state has had at least seven deaths possibly associated with the drug. “It’s hard to know for sure at this point,” said State Epidemiologist Dr. Thomas Dobbs. “I can’t speak to the two most recent but we’re looking at possibly seven associated deaths.”

New York Gov. Andrew Cuomo said earlier this month that more than 160 patients in nine days have been rushed to hospitals across the state for adverse reactions to spice.  In Virginia, there were 43 reported overdoses in Hagerstown since April 11, and 14 reported overdoses in the Northwestern region of Virginia since April 13.

In Texas, an autopsy concluded that synthetic marijuana was to blame for the death of a Fort Hood soldier shortly after his return from deployment to an Ebola hot zone in West Africa. And in Arizona, agents from the United States Drug Enforcement Administration seized 500 pounds of Spice, hydroponic marijuana, nearly $500,000 in cash, and arrested three people.

“This is something we have to get on immediately,” Morris said. “We’ve got to stop the distribution network to save our kids.”

By Carol Robinson