Tag Archives: Big Pharma

DEA clamps down on hydrocodone

HydrocodoneHydrocodone, the nation’s most widely prescribed painkiller, will now be in the same category as other frequently abused medications such as OxyContin and fentanyl. The agency said Friday it had published a rule to reschedule hydrocodone combination products — which include Vicodin and Norco — from Schedule III to the more restrictive Schedule II of the Controlled Substances Act.

Americans consume 99% of the hydrocodone produced worldwide; because of the perception that such products are less risky than other narcotic painkillers, they are widely prescribed by general practitioners and dentists, according to this article.

Combination hydrocodone products are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.

Since 2007, more U.S. prescriptions were written for the combination of hydrocodone and acetaminophen than any other drug. In 2012, that was over 135 million prescriptions, or one prescription for every 2.3 men, women, and children in the U.S. that year, according to this article.

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Non-tamper-proof Oxy hitting U.S. from Canada

DRUG BANNEDAn older form of the powerful prescription painkiller OxyContin that has been banned in the United States is still showing up in some areas of the country, possibly making the journey from Canada, where it is still legal, according to this article. In 2013, the FDA banned generic versions of OxyContin, which could easily be crushed, in favor of a tamper-resistant version produced exclusively by Oxy maker Purdue Pharma under a new patent. The Canadian government has so far continued to approve generic, crushable forms of oxycodone that are highly prone to abuse — though it has recently indicated it may soon force all opioid manufacturers to render their products tamper-resistant.

The news came as a study into skyrocketing opioid deaths in Canada found that painkillers are responsible for one in eight deaths among young adults in Ontario, according to this article. Opioid overdoses killed nearly 6,000 people in Ontario between 1991 and 2010, half of them under the age of 42, the study found.

Canada is the world’s second largest per capita consumer of prescription opioids after the United States.

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Del. orders Zohydro prescribing restrictions

RXDelaware has put into place emergency prescribing regulations regarding Zohydro, a powerful new painkiller many critics fear may fuel the epidemic of painkiller abuse. Late last year, Zohydro gained FDA approval despite the fact that after its own advisory committee had voted 11-2 against allowing the drug on the market. Since then, 29 state attorneys general have urged the agency to reconsider its decision, and Massachusetts Gov. Deval Patrick even attempted to ban the drug (a federal judge later blocked that order). Delaware Secretary of State Jeffrey Bullock said the regulations were necessary “to address the imminent peril to the public health, safety and welfare of all Delawareans” caused by Zohydro. According to his statement:

The use of this new and dangerous narcotic painkiller known as Zohydro must be monitored closely because the abuse of it can be deadly. It carries even higher risks of abuse than other short-acting formulations.

Zogenix, the maker of Zohydro, recently reported that about 9,000 prescriptions were filled through June 13 since the drug hit the market in March. The company plans to target about 20,000 prescribers it describes as “high decile [extended-release/long-acting] opioid prescribers” who account for 60% of the market, and envisions Zohydro along the lines of the multibillion-dollar market for OxyContin, according to this article.

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Ca. counties sue Big Pharma over opioid marketing

pill money signTwo California counties have launched a lawsuit accusing five major pharmaceutical companies of obscuring the addictive effects of OxyContin, Percocet and other powerful opioid painkillers while reaping billions of dollars in profits from the drugs. The companies deceived tens of millions of doctors and patients about the “significant dangers and questionable benefits of prescription opioids” for the treatment of long-term non-cancer pain, according to a complaint filed today in California state court. The five opioid manufacturers — Purdue Pharma, Cephalon, Janssen Pharmaceuticals, Endo Health Solutions, and Actavis — concealed the dangerously addictive nature of the medicines while touting benefits that had no scientific support, in order to expand the market for the drugs and boost profits, the lawsuit alleges.

The complaint charges that the pharmaceutical companies marketed opioids as “rarely” addictive, misrepresented the evidence of their efficacy for treating chronic non-cancer pain, trivialized their serious side effects and falsely assured doctors and consumers that opioids were safer than over-the-counter drugs.

According to the suit:

These pharmaceutical companies have a long history of aggressively marketing these dangerous drugs through sophisticated campaigns. These campaigns employ industry-funded professional associations, patient advocacy groups, and physicians to deceive consumers and their doctors about the harms and purported benefits of opioids for treating chronic pain.

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Zohydro backlash intensifies despite FDA’s defense

No-pills-4-1-14Opposition to Zohydro, the powerful new opiate some critics are calling “heroin in a pill,” continues to build, but the U.S. Food and Drug Administration is strongly defending the agency’s approval of the drug, saying its benefits to pain patients outweigh the potential negative consequences.

Since its approval by the FDA last October, Zohydro has come under fire from members of Congress, state attorneys general, doctors and addiction specialists who have worked to block the pill from being sold in the U.S., according to this article. Critics want the agency to rescind its approval of Zohydro, citing the alleged danger of the drug as well as the growing abuse of prescription drugs nationwide, but the FDA says that instead of blocking the sale of Zohydro based on a fear of abuse and addiction, providers should screen patients before they prescribe the drug and while they are on it, the article says.

The green light for Zohydro, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin, came after an FDA advisory panel last year voted against approving the drug, citing concerns about the danger of addiction posed by the opioid drug class.

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Judge nixes Zohydro ban in Mass.

gavelA federal judge has struck down Massachusetts Gov. Deval Patrick’s ban on the controversial new form of hydrocodone, Zohydro, saying the state lacked the authority to override the FDA’s approval of the painkiller. U.S. District Court Judge Rya W. Zobel noted that the FDA approved Zohydro after a screening process, and said the federal regulatory agency has more power than the state in this case, according to this article. She also said Massachusetts lacked the authority to force Zohydro’s maker, Zogenix, to make an abuse-resistant form of the drug because that formulation has not been approved by the FDA, the article says.

Gov. Patrick issued the Zohydro ban last month, declaring a public health emergency in response to the state’s growing opioid addiction epidemic and taking a number of other steps to curb overdoses and help the addicted. In a press release, the governor said the use of oxycodone and other narcotic painkillers, often as a route to heroin addiction, has been on the rise for the last few years in Massachusetts; at least 140 people have died from suspected heroin overdoses in communities across the state in the last several months, levels previously unseen. From 2000 to 2012, the number of unintentional opiate overdoses increased by 90 percent, he added.

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Mass. Gov. bans Zohydro amid opioid epidemic

pills and pill bottlesMassachusetts Governor Deval Patrick has declared a public health emergency in response to the state’s growing opioid addiction epidemic, issuing an order banning the controversial new form of hydrocodone, Zohydro, and taking a number of other steps to curb overdoses and help the addicted. In a press release, the governor said the use of oxycodone and other narcotic painkillers, often as a route to heroin addiction, has been on the rise for the last few years in Massachusetts; at least 140 people have died from suspected heroin overdoses in communities across the state in the last several months, levels previously unseen. From 2000 to 2012, the number of unintentional opiate overdoses increased by 90 percent, he added. The prescribing and dispensing of Zohydro, which was recently approved for sale by the FDA despite widespread protests, will be prohibited “until it is determined that adequate measures are in place to safeguard against the potential for diversion, overdose and misuse,” he said. The governor added:

The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large.

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Generation Rx

41mx4k+hrxL._SY344_BO1,204,203,200_As you may know, I am a journalist. When my 20-year-old brother Pat died of a heroin overdose in 2009, I had heard about powerful painkillers like OxyContin and knew he was addicted to them, but I didn’t understand the connection to heroin. I started digging deeper, trying to learn more about both Pat’s personal downfall and the painkiller and heroin abuse epidemic. I have spent the past five years traveling the country and talking to people who have been affected by this issue. My book on the subject, Generation Rx: A Story of Dope, Death, and America’s Opiate Crisis, will be published August 12 by Counterpoint Press and is available for pre-order on Amazon. I wanted to share my brother’s story and the stories of other families in the hopes of breaking down the stigma associated with drug addiction.

In 2010, 75% of the 38,000 yearly deaths by drug overdose in the U.S. were related to opioids; in 2011, almost 80% of people who had used heroin in the previous year also had a history of abusing prescription painkillers. This problem is getting worse, not better, and we need to start talking about it. If you’ve been touched by opiate addiction, I hope you’ll read my book and share it with others.

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Zohydro critics fear new wave of addiction

Vicodin-half-life-how-long-does-Vicodin-remain-in-your-body2The U.S. Food and Drug Administration’s approval of Zogenix Inc.’s Zohydro painkiller has come under fire from critics who say the agency should not be approving any additional opioids given the current prescription drug epidemic. Forty-two public health groups are urging the FDA to withdraw its support of the painkiller, according to National Public Radio. Zogenix says it will introduce a non-crushable version of Zohydro in three years and plans to closely monitor prescription abuse, and claims that millions legitimately need the drug, NPR reports. But addiction experts say another high-potent, high-dose, long-acting opioid drug will simply add more fuel to the painkiller addiction epidemic, NPR says.

The green light for Zohydro, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin, came after an FDA advisory panel last year voted against approving the drug, citing concerns about the danger of addiction posed by the opioid drug class.

Unlike other hydrocodone-containing drugs like Vicodin, Lortab and Norco, Zohydro is not buffered with acetaminophen or some other over-the-counter medication. The drug also lacks an abuse-deterrent feature such as the ones used in new formulations of drugs like OxyContin.

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Heroin addicts facing treatment barriers

drug moneyThe rise in heroin addiction across the nation, fueled by the prescription drug addiction epidemic, has caused an uptick in the number of people in need of inpatient treatment services — but many who need help are contending with a shortage of services and constraints placed on care by insurance companies. The increase in demand for treatment has left many addicts to wait weeks in some cases for care because of denial from their insurance companies, according to this article. Before insurance companies agree to cover inpatient services they want evidence that an addict has tried one or more outpatient programs, has little or no outside support network, and has a health condition that makes treatment a medical necessity, the article says.

Previously, a typical inpatient program lasted a month and the average detox program ran seven to 10 days; these days, as a result of insurance companies scaling back their coverage and increasing their deductibles, inpatient services generally run 10 days and detoxes three to five days — and most insurers will only pay for up to 10 days, the article says.

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