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Drug Abuse

Narcotic Subsys Draws Attention

Last week we blogged about controversy over Zohydro, an opioid approved last fall by the FDA. Another narcotic, Subsys, is generating attention, as is maker Insys Therapeutics. Subsys, a form of fentanyl which is sprayed under the tongue, is a narcotic used when painkillers such as morphine aren’t effective. Subsys was approved by the FDA in 2012 to treat a small number of cancer patients. In the past year, sales of Insys Therapeutics have soared and its share price has jumped nearly 270 percent. Over the last week, however, shares of Insys have lost roughly a third of their value after the arrest on federal fraud charges of a Michigan neurologist who was a top prescriber of Subsys.

Concern over Subsys are centered around aggressive marketing practices and off-label uses (uses the drug was not originally intended for), as the drug was approved to relieve cancer patients but fewer than 1% of prescribers are oncologists. Read more…

Serious Concerns with New Prescription Pain Killer

The prescription pain-killer Zohydro (pure hydrocodone in an extended-release formulation) was approved last fall by the FDA against the advice of its own advisory panel. Given the number of people in the U.S. who live with chronic pain (estimated to be around 100 million, though the figure is disputed), and that about half the drug overdose deaths in the U.S. are from prescription painkillers, Zohydro’s launch has drawn its share of attention.

In March, Gov. Deval Patrick of Massachusetts sought to ban Zohydro outright, calling it “a potentially lethal narcotic painkiller,” and 29 state Attorneys General have asked the FDA to reconsider approval. A number of patients had to leave the clinical study because they had serious adverse side effects or didn’t comply with the terms of the trial. Fewer than 300 subjects made it through a full year in the long-term safety trial, and there were five deaths.

Members of the F.D.A. committee who voted against approval acknowledged they were influenced by the drug overdoses claiming more and more lives each year. But they were also disturbed by red flags raised during the clinical trials of Zohydro.

“You still have a 1 percent, almost, death rate from this drug,” said Dr. Jeanmarie Perrone, a committee member from the University of Pennsylvania. What will happen in the doctor’s office, she wondered, where those receiving the drug will not be as carefully screened?

US Incarceration Policies: Public Shame, and Personal Tragedies

Going about one’s day becomes more challenging when one is confronted with articles such as this, describing a situation that is shameful for society and tragic for individuals and families. In our war on drugs, zealotry, government bullying, and perhaps no small component of self-interest and greed have combined to place the US as number one in incarceration rates among all nations.

Who is served by this situation and why is it tolerated at all? The manifest injustice of indeterminate sentencing for non-violent crimes that are clearly disproportionate to sentences for assaults, serious theft, and other matters where there is serious victimization and deprivation of the rights of others is compelling. Read the comments by readers for more insight.

These Deaths Are Not Statistics…

In medical school and residencies the teaching is that narcotics have no place in the treatment of most chronic pain, especially musculoskeletal pain. But these teachings have been ignored and people are dying as a result. This article cites findings on significant death rates among women due to opiate overdoses, including from Oxycontin. These are prescription drugs, either received directly or drugs diverted to the street. These deaths are disproportionately the poor, single mothers, and the defeated. Federal data shows a quintupling of deaths among women due to prescription pain killers since 1999, climbing at a rate higher than men, with the gender gap narrowing.

More women die from these drugs than from homicide or cervical cancer. These deaths are not statistics. They are men and women who did not need to die and most likely did not need the narcotics.

Physicians who prescribe them casually and the companies that create and promote them aggressively should rethink their motives and their practices. It is easy to say yes to drugs. It is harder to listen with one’s heart and mind to the real pain that underlies many of these lost lives. Collectively we must find a different path. Read more…

Risks and “Dangers” of Marijuana Legalization?

Overall evidence for dangers of marijuana do not support continued criminalization.

Steadily it appears that its use will be permitted, though there remains a disconnect between state laws liberalizing possession and growing, vs. federal standards that at least as written, continue to criminalize use and distribution.

As the matter evolves, we should not be naïve to the potential risk of users abusing and developing an addiction to marijuana and its potential impact on cognition, and youth, especially when not used in “moderation.”

A New York Times article, “Legalizing of Marijuana Raises Health Concerns,” states:

“While marijuana can be addictive, scientists generally agree that fewer than 10 percent of marijuana smokers become dependent on the drug, compared with 15 percent for alcohol, 23 percent for heroin and 32 percent for tobacco.

Marijuana does contain carcinogens, including tar and other toxins similar to those found in tobacco, but people generally do not smoke marijuana in the same amounts as cigarettes. Still, legalization takes health consumers into murky territory. Even though marijuana is the most commonly used illegal drug in the United States, questions about its health effects remain.”

Sounds like the same risks, more or less, of many other legal substances, consumed in excess or misused, including alcohol, prescription drugs, and/or firearms. Whether society should outlaw substances and products that can be used with little risk or high damage is a question that is increasingly being answered at the ballot box.

Deadly Meningitis Outbreak: Were Spinal Injections Necessary?

The tragedy of  deaths caused by the contaminated steroid vials is especially sad when one considers that in many cases, spinal injections may offer no benefit.

The New York Times article, “How Back Pain Turned Deadly,” addresses the October meningitis outbreak and the 25 victims who are now suing the New England Compounding Center for injury, illness, and deaths  caused by the spinal injections.

“Studies are at best inconclusive about exactly which groups of back-pain patients are likely to benefit from steroid shots. Though some patients clearly get much-needed relief, health researchers are nearly unanimous that the treatment is vastly overused in the United States.

But Dr. Laxmaiah Manchikanti, head of the American Society of Interventional Pain Physicians, said the increasing number of spine injections was just part of ‘an exponential increase in all interventional techniques’ and is a good thing, reflecting a better understanding of chronic pain and patients’ demands for improved pain relief.”

The statement by Dr. Manchikanti would appear to contradict academic researchers and such statements are commonly made by advocates of a particular point of view, citing a ‘better understanding of chronic pain and patients’ demands for improved pain relief. This sort of uncritical thinking or statement can be made by any of the many proponents for increased use of narcotics such as Oxycontin, which we have covered in our blog.

“Though doctors are still arguing, most academic researchers say there is no evidence that steroid injections are useful in easing straightforward chronic low back pain. Professional guidelines say such shots should generally not be used for back pain that is less than four to six weeks old, which studies show almost always gets better with noninvasive treatments. Although many Medicare patients get spinal injections to treat a condition called spinal stenosis, a narrowing of spaces between bones of the spine, Dr. Friedly said, shots are not used for that condition in many European countries.” Read More…

If one wants to do good, one must first ensure that one is doing no harm. Steroid injections to the spine and narcotics for chronic pain would not appear in many cases to meet this standard.

How many of the deaths and the sick stood to gain from the treatments they received? How many facilities and practitioners, as well as the pharmacy did just fine until people started dying?

Drug Distributors Pressured to Reduce Narcotic Painkiller Shipments

Over the past few months, the DEA has tried a variety of different tactics to battle our painkiller epidemic.

From arresting hundreds of doctors, cracking down on pill mills, and investigating pharmacies, it’s most recent attempt has large drug distributors rattled.

The New York Times reports that after honing in on Florida and Ohio, the DEA is now putting pressure on other pharmaceutical distributors nationwide.

Earlier this year, the agency charged drug distributor Cardinal Health for violating it license to sell controlled drugs. Since then, Cardinal no longer does business with a dozen pharmacies in Arizona, California, Nevada, and Oklahoma and the number is growing.

The article notes that the pressure has pushed distributors to create a nationwide shipment reduction to pharmacies and doctors who order a high volume of narcotic pain killers.

“We had a strong anti-diversion system in place, but no system is perfect,” Cardinal Chairman and Chief Executive told the Times.

Since then, they have strengthened their criteria and  have also  created a committee that evaluates pharmacies that order large amounts of narcotic drugs.

Another major distributor, AmerisourceBergen, recently disclosed that it also faces a federal criminal inquiry into its oversight of painkiller sales.

The DEA’s crackdown on pharmacies and big distributors like Cardinal and AmericsourceBergen have shown that the agency is taking a much more aggressive approach to ending our nations painkiller issue.

However, doctors and pharmacies are critical of the way distributors have abruptly cut them off from their supply. One California pharmacist argued that his pharmacy specializes in pain patients which would explain his high volume orders.

“The drug distribution system is a sprawling one that involves about 800 companies, which range in size from a few giants like Cardinal to hundreds of small firms. For wholesalers, the markup on medications can be small, sometimes a few pennies a pill. But with billions of pills sold annually, the profits can be big. Narcotic painkillers are now the most widely prescribed drugs in the United States, with sales last year of $8.5 billion.”

There is also added incentive to sell Oxycontin and other narcotic painkiller because of their addictive properties and because street value on the black market is as much as $80 per 80-milligram dose.

However, while the DEA is implementing new tactics against distributors for failing to notify the agency of a “suspicious order” from a pharmacy or other customer, it does not share those reports with officials in the state where the pharmacy is based.

After the New York Times had asked for the agency to disclose the number of such reports it received annually, they declined saying, the agency considered such statistics “law enforcement sensitive” information.

In response, the Times has filed a Freedom of Information Act request seeking that data. Read More…

 

DEA Crackdown Makes Prescription Drugs Harder to Find

Florida officials displayed prescription drugs that were surrendered to the state by pain clinics on Aug. 15. Photo credit Tim Chapman/Miami Herald, via Associated Press

In an effort to curb Florida’s painkiller epidemic, the Drug Enforcement Agency (DEA) cracked down on Florida pharmacies last month, making prescription opioids increasingly difficult to find for patients.

The Wall Street Journal article, “Making the Pharmacy Crawl,” explains the pressure that pharmacists and doctors have been under to regulate opioid prescriptions and how it has caused more tension for patients.

While the DEA had hoped these efforts would force pharmacists and physicians to exercise more caution, the issue conflicts with doctors and patients who legitimately need the painkillers. The author, Timothy Martin stated:

“Several states now make doctors criminally liable and revoke their licenses for writing prescriptions for painkillers that lead to overdoses, prompting many to stop prescribing them at all. Other states have tightened regulation of pain clinics, forcing so-called pill mills to close but leaving people in need of pain medications with fewer doctors.”

The term “pharmacy crawl”  has recently been used by chronic pain patients in Florida who must now travel around town to get their prescriptions filled. Many pain patients believe there is a precription shortage, but the DEA says the decrease in opioid prescription availability could be a number of factors, including pharmacists simply being more cautious.

The president of Physicians for Responsible Opioid Prescribing, Dr. Andrew Kolodny believes the regulation is necessary to help mitigate the diversion of controlled substance and make wholesalers and pharmacies more responsible. He stated:

“The efforts to crack down on pills mills and irresponsible pharmacies and wholesalers are really appropriate and necessary… These groups pointing at the DEA and others should look in the mirror. They only have themselves to blame for the prescription-drug epidemic.”

Until recently, the state of Florida had played the role of our nations “Pill Mill” capital and was known for having the worst Drug Monitoring Systems in the country. Frequented by drug addicts, corrupt physicians and pharmacists, and drug traffickers, it’s no wonder why the DEA honed in on Florida’s top drug wholesalers.

While it is unfair that legitimate chronic pain patients must suffer on behalf of those who abuse opioids, the fact is our nations prescription narcotic problem is killing millions each year, with a death toll now exceeding those of heroin and cocaine combined.

With hopes of finding a balance between monitoring improper prescription and maintaining patient access to these drugs, the National Alliance for Model Drug Laws, are working with state officials to find a solution to the current “pharmacy crawl” issue. Read More…

DEA Investigates Walgreens for Oxycodone Distribution

In an effort to battle the prescription drug abuse epidemic, the U.S. Drug Enforcement Agency (DEA) is turning it’s focus to drug wholesalers and retail pharmacies. Last Friday, the DEA issued warrants to inspect six Walgreens Florida pharmacies on suspicion that Oxycodone is being diverted to the black market.
The Reuters article “Crackdown on Prescription Painkillers Widens to Walgreens,” provides a breakdown of the DEA’s investigation and why increased sales volume of highly addictive painkillers sparked some red flags. The article stated:

“The purchase of large amounts of Oxycodone by a retail pharmacy is indicative of a pharmacy that fills prescription issued by physicians at pain clinics and/or a pharmacy which services primarily drug seeking individuals that abuse the medication.” Read More…

The death toll from narcotic painkillers now exceeds those of heroin and cocaine combined and DEA agents are determined to stop the illegal distribution of Oxycodone. They have already suspended  CVS Caremark Corp and Cardinal Health Inc’s license to distribute because they believe they “failed to conduct due diligence to insure that all prescription drugs are sent only to legitimate channels.”

All DEA Registrants have an obligation to ensure that medications are getting into the hands of legitimate patients, and when they choose to look the other way, patients suffer and drug dealers prosper,” DEA Special Agent in Charge Mark Trouville said in the email. Read More…

What Ever Happened to the 7 Poster Children of Oxycontin?

When Oxycontin was introduced to the world, the public was led to believe that it was some kind of addiction-proof miracle drug. In 1998, Purdue Pharma featured a video of seven chronic pain patients who used Oxycontin and could advocate that the drug had helped them regain normal function and enjoyment of everyday life.

The marketing campaign marked the beginning of the industry’s’ hard push for narcotic painkillers and would convince physicians and the public that opioid use was safe, effective, and normal for people with chronic pain. Now, as addictions to painkillers have skyrocketed and fatal overdoses have more than tripled in the past decade, the U.S. has declared prescription drug abuse as a national epidemic.

So what ever happened to these seven poster children of Oxycontin? A very interesting article by the Milwaukee Journal Sentinel, “Where Are They Now?”, explains what happened to the seven patients who spoke glowingly of their experiences with Oxycontin 14 years ago.

In the 1998 video, one patient, Johnny Sullivan, advocated for Oxycontin saying, “Never a drowsy moment here.” Ten years later after severe addiction to Oxycontin and other opioids, he died in a car crash after falling asleep at the wheel.

“Two of the seven patients were active opioid abusers when they died. A third became addicted, suffered greatly, and quit after realizing she was headed for an overdose. Three patients still say the drug helped them cope with their pain and improved their quality of life. A seventh patient declined to answer questions.” Read More…

Purdue’s marketing campaign was so misleading that they plead guilty in 2007 to a federal criminal count of misbranding the drug “with intent to defraud and mislead the public,” paid $635 million in penalties and remains on probation.

Fortune’s article “Oxycontin: Pursue Pharma’s painful medicine”, provides insight into the $3 billion dollar drug and how new legislation has forced the pharmaceutical industry to take action. Read More…

“Oxycontin’s bad reputation, however, has obscured a significant step. Last year Purdue began selling a reformulated version that should help reduce the worst form of abuse. The original drug had a time-release mechanism that could be defeated by crushing the pill and snorting it, smoking it, or adding water to the powder and injecting it for a heroin-like high. (Purdue’s claims that the time-release process reduced the addiction risk were crucial in making doctors feel comfortable prescribing a powerful addictive drug.) By contrast, the new version breaks into chunks rather than a powder; if water is added, the result is a gelatinous goop.”

While some progress is being made to defeat the Prescription drug epidemic, the story of the seven Oxycontin poster children is a sad example of how a powerful marketing campaign and money out-shined the  harmful consequences  of opioid use throughout the country.