Xanax Worsens Anxiety and Panic

First posted 12/13/2012

Anxiety is one of the most common presenting complaints for people who come to my psychiatric practice. By the time people with anxiety visit a psychiatrist, they have usually discussed their symptoms with friends and family members, and some have been to their family care physician. And as a result of these initial ‘consultations’, they often have been recommended or prescribed valium-type medications like Xanax or Klonopin— a class of chemicals known as ‘benzodiazepines.’

There have also been several highly publicized deaths from combining pain pills with benzodiazepines. The medications are commonly prescribed, and there are a number of misconceptions among laypeople about their proper use. I’ve written about this class of medications in the past, but given the frequency that they are prescribed and mis-prescribed, the topic deserves another visit.

Most experienced doctors have learned to cringe every time a patient says the word “anxiety,” knowing that in all likelihood they are in a lose/lose position. Why lose/lose? Because the experienced doctor knows that the options are to do the right thing and disappoint their patient, or do the wrong thing and struggle with the consequences of their actions for months or years.

A primary reason for the lose/lose proposition is that the non-medical community associates SSRI’s like Prozac or Zoloft with antidepressants, and believes that the proper treatments for anxiety disorders are sedatives like Valium or Xanax. But in reality, sedatives are useful in some situations, for example acute or short-term anxiety. But for chronic anxiety, the proper treatment consists of SSRIs or closely-related SNRIs.

Today a new patient requested treatment of her addiction to pain medications. When I asked about other symptoms, she said that she takes alprazolam and clonazepam for anxiety and panic attacks. I explained that those medications are dangerous for opioid addicts, and are intended for short-term use. She assured me that the milligram of alprazolam she is taking doesn’t even do anything, intending to inform me that her medications are not potent enough to worry about. But I took her assurances the opposite way—that she has taken benzodiazepines to the point where even very large doses of the medications have little effect because of ‘tolerance.’

She then said she also has attention deficit disorder and takes amphetamine. I explained that she is doing herself a disservice by taking both amphetamines and benzodiazepines, since benzodiazepines CAUSE attention problems; in fact, that is how they work! Anxiety essentially consists of too much attention to a problem or a fear. Benzodiazepines treat anxiety by preventing the brain from attending, attaching and remembering.

Anesthesiologists and dentists use the short-acting benzodiazepine midazolam during uncomfortable procedures to block memory. Most adults have had the experience of watching an anesthetic medication injected into the IV tubing, and next waking up to people saying “you’re OK—it’s all done.” For minor procedures they experience a loss of memory, not a loss of consciousness. They transfer to the OR table when asked, but have no recall of doing so because of the benzodiazepine’s effects. I repeatedly tell students in my university practice to avoid benzodiazepines, if nervous about an important exam. Amnesia and studying don’t mix!

The patient described above said that she takes stimulants for attention deficit disorder. Beyond amnesia, it is simply a bad idea to take two polar-opposite medications as this patient is doing. Stimulants cause wakefulness, attention, tight muscles, and anxiety. Benzos cause drowsiness, amnesia, relaxation, and the inability to remember what you were supposed to worry about. Instead of taking both, take neither.

A related question came to me by e-mail yesterday:

Hello, I found your website and see that you do phone consultations. I have been having anxiety problems and attacks for over a year. It has gotten worse and worse. I’ve been to the doctors in my area but no one wants to treat me for it…they just want to keep giving me Paxil, Zoloft, Prozac, Cymbalta and all these things I’ve tried and nothing seems to be helping me. I have anxiety attacks all the time where my heart beats out of my chest and I can’t breathe and go almost into this blackout stage. I have a lot of things that trigger it; one is my anxiousness all the time. I can’t focus, and any little dilemma sets me off. Everything is a crisis to me. And on top of that, I have the responsibility to take care of a 3 year old all by myself. I’m so scattered and anxious and upset all the time it is affecting me being a good mother. I cannot take it anymore and I am at the end of my rope. I don’t know what to do; no one will treat me with anything to calm me down along with the Paxil because of all the other people in this county that have abused it. I DO NOT know what else to do. I have no one to talk to or turn to. It’s affecting my job, my personal life and my life in general. If you can’t help me maybe you know someone who will.

The person doesn’t come right out and say it, but her comments about needing to be calmed down and about abuse of meds by others suggest that she is asking for a benzodiazepine.

Benzodiazepines include long-acting medications like clonazepam (Klonopin) and diazepam (Valium), intermediate-acting medications like lorazepam (Ativan) and alprazolam (Xanax), and the short-acting sleeping pills from my training years like triazolam (Halcion) and temazepam (Restoril). As an anesthesiologist, I gave patients midazolam (Versed) more than any other medication. All of these medications are appropriate in certain settings. Most have a street value. Some have active metabolites that accumulate in the body over time. All are sedating, all cause tolerance, and all have the potential to cause significant withdrawal symptoms. The longer-acting medications will self-taper to some extent, but the intermediate-acting agents in particular have the potential to cause withdrawal syndromes that are severe, and even fatal. The first patient I mentioned has been taking an anticonvulsant since presenting to the ER with a grand mal seizure while stopping Xanax “cold turkey.”

All of these medications have appropriate uses, almost always for short-term conditions. When given long-term, they cause problems. In fact, from the top of my head, I can think of 12 reasons to avoid prescribing benzos for “anxiety.” Let’s run through the list of 12 things, just in time for Christmas—and don’t forget to check it twice!

  1. Many anxious patients aren’t truly anxious. When a patient complains of anxiety, he or she is often complaining of something else. If I ask a patient to describe the symptoms without using the word anxiety, I often find that the patient is bored, restless, angry, depressed, overwhelmed, or appropriately frightened. Take a look at the second patient—the one who is “scattered,” “at the end of her rope,” and “caring for a 3-year-old boy all by herself.” Do you really think she will be a better mom if she is taking alprazolam or clonazepam? She is feeling overwhelmed, angry, tired, afraid, hopeless, depressed—feelings that when added together become ‘anxiety.’ Do we really want to give a person in this condition a medication that will make her sleepier, more forgetful, more scattered, and more disinhibited?
  2. Even if the medication is truly helpful, her relief will be short-lived due to tolerance. The human body quickly adjusts to benzodiazepines (and many other medications) so that a continued effect requires a higher and higher dose. Patients often escalate their dose at some point, no matter how many times they promise that they won’t. Dose escalation is not the patient’s fault; it is simply what these meds do. Dose escalation is difficult to control, once it has begun; patients will call two weeks into a month prescription to report that they are out of alprazolam, and the doctor feels pressured to issue a refill to prevent withdrawal.
  3. Benzodiazepines turn manageable anxiety into an anxiety disorder. Patients get a calming effect from the medication, but as the medication wears off, the anxiety returns, including extra anxiety from a rebound effect—a miniature form of withdrawal. Patients do not usually attribute that anxiety to rebound, but instead believe they have a horrible anxiety condition that appears as soon as the medication wears off. When I worked in a maximum security prison for women in Wisconsin, many inmates were taking benzodiazepines upon arrival. Several months later, the most amazing thing happened: the anxiety disorders went away!
  4. A problem specific to patients with addictions is that rather than take sedative medications to achieve the absence of anxiety, they take the medication until they feel relaxed. In other words, instead of seeking normalcy; they seek relaxation. There is a difference between the two states! The mistaken goal is simply a consequence of the conditioning process during addiction. People with addictions don’t often realize that they are seeking ‘fuzziness’— a feeling that people without addictive histories often find uncomfortable.
  5. Again specific to people with addictions, benzodiazepines (like other medications that have an immediate psychotropic effect) direct the person’s attention inward. People with addictions are overly aware of how they feel; a goal in treatment is to get the addict out of his or her own head to experience life on life’s terms. Benzodiazepines encourage the opposite effect, encouraging the addict to focus on internal feelings and sensations.
  6. People with addictions who favor one class of drugs, for example opiates, will often move to a different substance when the first drug of choice is removed. This phenomenon is called “cross addiction.”
  7. A final concern for people with addictions is that benzodiazepines help preserve the mistaken thought that the person cannot function without taking something.
  8. Benzodiazepines impair driving and working with dangerous machinery. And patients get anxious at work too—making the medications a poor choice. They also make a person appear intoxicated by causing slurred speech, forgetfulness, and sometimes loopy behavior, risking the person’s job and having other unforeseen consequences. Some people have completely different personalities when disinhibited by benzodiazepines.
  9. Benzodiazepines have been linked to fetal anomalies and early miscarriage.
  10. They destroy sleep in the long run through tolerance and through rebound effects. If the patient takes a benzodiazepine during the day, he or she will go to bed just as the sedation is wearing off. The alternative is to take the medication at bedtime, defeating the goal of finding relief for daytime anxiety. If the person takes benzodiazepines both day and night, tolerance increases even more quickly.
  11. I have already mentioned the need to taper off benzodiazepines and the risk of seizures (and worse) during withdrawal.
  12. Benzodiazepines may calm an anxious person, but they do not generally increase function. A person who can’t get out of bed becomes less likely to get out of bed. Bills that are unpaid become even less likely to be paid. Relationships do not generally improve when one partner is nodding off as the other talks about feelings!

I do prescribe benzodiazepines, usually for short-term or intermittent use. Some patients do fine with them, but for others, benzodiazepines are a Pandora’s Box that is best not opened. As a psychiatrist, I often see treatment plans that lead to a mess that I must try to clean up—such as the case with the first patient I mentioned. I think most doctors who read this will understand what I am saying, and many will have similar thoughts about benzodiazepines. Perhaps others will find the use of benzodiazepine much more beneficial than harmful; comments are welcome!

Addendum:  Since the original post, a large British study showed a higher death rate in patients who have been on chronic benzodiazepine therapy, and a more recent study showed a link between benzodiazepine treatment and the later development of Alzheimer’s disease.

The End of Combusted Tobacco?

With E-cigarettes, a mixed bag of possible outcomes.

E-cigarettes represent a controversial and uncertain future for nicotine addiction, and for this reason they have attracted acolytes and naysayers in what feels like equal measure.

It has been almost 8 years since e-cigarette imports first reached our shores, and the FDA’s determination that they are subject to regulation as tobacco products brings the industry to a crucial crossroads.

On the one hand: “Marked interdevice and intermanufacturer variability of e-cigarettes… makes it hard to draw conclusions about the safety or efficacy of the whole device class.”

On the other hand: “Published evaluation of some products suggest that e-cigarettes can be manufactured with levels of both efficacy and safety similar to those of NRT [nicotine replacement therapy] products… they could play the same role as NRT but at a truly national, population scale.”

So which will it be? Is there an outside chance that the decision by the FDA’s Center for Tobacco Products will represent the first step in dealing with nicotine products currently “designed, marketed, and sold” outside the regulatory framework established for NRT?  A stalemate presently prevails. Writing in the New England Journal of Medicine, Drs. David Abrams and Nathan K. Cobb, Johns Hopkins professors affiliated with the American Legacy Foundation, a tobacco research and prevention organization funded with lawsuit money from the major tobacco companies, highlight the irony: In order to market e-cigarettes as smoking cessations devices, manufacturers must seek approval from the FDA to market pharmaceutical products, “an expensive and time-consuming process than no manufacturer has yet attempted.”

Thus, questions about nicotine content, additives of various kinds, and assorted carrier chemicals go unanswered. Yet these are precisely the questions that need answers before e-cigarettes can be viewed as tools in the harm reduction armamentarium. Cobb and Abrams note that current e-cigarettes “represent a single instance of a nicotine product on a shifting spectrum of toxicity, addiction liability, and consumer satisfaction.” But the market dictates that “to compete with and displace combusted tobacco products, e-cigarettes will need to remain relatively convenient, satisfying, and inexpensive,” regulation notwithstanding.

Still, the harm reductionists’ dreams for the product remain seductive, because “surely any world where refined nicotine displaces lethal cigarettes will experience less harm, disease, and deaths? That scenario is one endgame model for tobacco control: smokers flee cigarettes en masse for refined nicotine and ultimately quit all use entirely.”

Critics say fat chance: “As Big Tobacco’s scientists shift from blending leaves and additives to manipulating circuit boards, chemicals, and dosing schedules, they’re unlikely to relinquish their tolerance for risk and toxicity that prematurely kills half their users in their efforts to ensure high levels of customer ‘satisfaction,’ addiction, and retention.”

Once again, it is the dictates of the market that may end up shaping the future of tobacco, and making the plans of harm reductionists look naïve indeed. “Tobacco companies and their investors,” write Cobb and Abrams, “need millions of heavily addicted smokers to remain customers for decades, including a replenishing stream of young people. No publicly traded company could tolerate the downsizing implicit in shifting from long-term addiction to harm reduction and cessation.”

The marketing innovations most likely to stem from tobacco companies entering the market for e-cigarettes are those most likely to “sustain high levels of addiction and synergistic ‘polyuse’ of their existing combusted products,” while simultaneously crimping competition from NRT manufacturers and independent e-cigarette manufacturers. Tobacco companies are past masters at manipulating things like nicotine content, vaporization methodologies, flavorings, and unknown additives. They will surely bring this expertise to bear in seeking a major bite out of the e-cigarette market while maintaining acceptable profit margins on traditional cigarettes.

The authors suggest that the FDA could weight the matter in harm reduction’s favor by using its product-standard authority “to cripple the addictive potential of lethal combusted products by mandating a reduction in nicotine levels to below those of e-cigarettes and NRT products and eliminating flavorings such as menthol that make cigarettes more palatable.” Tax breaks for e-cigarettes would further load the dice.

But not today. The FDA’s proposal calls for warning labels or product safety and quality standards for e-cigarettes—but not for at least two years. Two years is a long time in a fast-emerging market already valued in excess of $2 billion. The authors call the delay disturbing, “given the variability in product quality and a documented spike in cases of accidental nicotine poisoning.”

In conclusion, the authors believe that for smokers hoping to quit, “NRT products still represent safer, more predictable choices, even if they are more expensive and less appealing.”

Photo credit:  http://www.rstreet.org/


The popularity of E-cigarettes could lead to the “demise” of cigarette smoking and save thousands of lives, but not until they are proven safe and are regulated by the U.S. Food and Drug Administration (FDA). That’s the message from two Georgetown University Medical Center researchers in a perspective piece published Oct. 16 in the New […]

Progress, Not Perfection on the Co-Dependents Journey

It seems that as the time goes on I am making progress on with my recovery as a co-dependent.  But, yet, I get frustrated that I can’t ‘get it’ right all the time. It’s an interesting paradox to immerse yourself into learning about co-dependency, what it is, how it is negative to yourself and others, how to change these behaviors. Then you have ‘book smarts’ about it, just like any other topic or subject you decide to become proficient about. So, why can’t I turn this information from intellectual understanding to daily behavior? It occurred to me that if I thought about a sports analogy then maybe I could make a parallel that would help me be a little easier on myself.
For instance, if I bought a book on water skiing and read it and studied it and even bought videos on instruction and technique, should I expect to go out on the water and be proficient at water skiing the first, second, third and so on tries at it? Of course we would never expect this. So, why do I think I can read about a behavior and think that I can take this intellectual understanding and instantly turn it into practice in my day to day life? What I’ve found is that with every opportunity to practice, I become a little more proficient. I’ve even found when those opportunities do not come for a bit, that I also become a bit rusty. It is progress, not perfection that I strive for.  As long as I am making progress I am heading in the right direction on this journey.

Persistent Insomnia and Alcoholism

Sleep problems complicate the treatment and recovery in alcoholism. 

Heavy alcohol consumption modifies the nature of sleep architecture.

A high blood alcohol concentration at bedtime may promote sleep early in the sleep cycle.

However, as alcohol levels decline, sleep is often interrupted with limiting rapid eye movement (REM) sleep duration.

Shortened total sleep time with alcohol can produce a lack of feeling well rested on awakening.

For those with alcoholism or alcohol dependence, successful treatment and alcohol abstinence can restore a normal sleep pattern. However, the clinical picture appears more complicated.

Kirk Brower and colleagues at the University of Michigan published an important summary of the effects of alcoholism treatment on sleep.

In their study, 267 subject with alcoholism in treatment were assessed for sleep problems at baseline and again six months later.

The key findings from their study included:

  • 47% of subjects had insomnia at baseline
  • 60% of all subjects with insomnia at baseline had persistent insomnia six months later
  • Women and those with greater psychiatric severity had higher rates of insomnia persistence
  • Subjects who reduced drinking quantities had improvement in sleep
  • However, a quarter of subjects who maintained abstinence reported persistent insomnia

The authors noted their findings have significant implications for treatment and monitoring of alcohol dependence patient populations.

A significant high level of insomnia persistence despite abstinence is important. This group of persistent insomniacs need formal sleep assessment and many might benefit from an overnight sleep lab study known as polysomnography.

The current study did not assess specifically for sleep apnea but they note sleep apnea may contribute to sleep problems in many recovered alcoholics.

Successful restoration of normal sleep in abstinence may promote higher rates of alcoholism recovery

Readers with more interest in this study can access the free full-text manuscript by clicking on the PMID link in the citation below.

Photo of street scene from Galway, Ireland is from the author's files.

Follow the author on Twitter WRY999

Brower KJ, Krentzman A, & Robinson EA (2011). Persistent insomnia, abstinence, and moderate drinking in alcohol-dependent individuals. The American journal on addictions / American Academy of Psychiatrists in Alcoholism and Addictions, 20 (5), 435-40 PMID: 21838842

Beyond Drinking the Worm

By Ricardo Carvajal

That’s the clever title of a symposium on entomophagy being delivered at the next annual meeting of the Entomological Society of America (ESA), scheduled for the week of November 16 in Portland, Oregon.  As we noted in a prior posting, the market for insect-derived foods is stirring, and with that awakening comes greater interest in understanding the governing regulatory framework.  Hyman, Phelps & McNamara, P.C. will cover that topic at the symposium, which will also feature presentations on consumer perception, market research, bringing products to market, and other issues of interest to producers, consumers, and researchers.  For those planning to attend, no word yet on whether there will be samples on hand, but at least one local eatery aims to please.  Sushi Mazi offers a grasshopper roll that has its devotees. 

Marijuana Laws: Progressive Change or Society’s Downfall?

Originally posted 12/8/2012

I’ve been hearing more calls these days to change US marijuana laws (note- Colorado and Washington legalized recreational use of marijuana shortly after this article was originally posted).  Legalizing marijuana has been a cause for some citizens for decades, and efforts to change marijuana laws have waxed and waned since I was a teenager in the 1970’s.  Some people believe that this time around, attitudes are truly changing.  A recentQuinnipiac University poll  showed that as of November 2012, a majority of US voters favor legalization of the drug for recreational use.

The current status of marijuana laws are confusing, to say the least. Marijuana is regulated at multiple jurisdictional levels, so a person in any one location is subject to state, federal, and sometimes local laws.  These laws are often at odds with each other, so the legality of marijuana depends largely on the employer of the agent or officer making the arrest.

There are also multiple forms of legality. In November, Colorado and Washington State legalized possessing up to one ounce of marijuana.  Another dozen-or-so states decriminalized marijuana over the past 20 years, so that possession of the drug is punishable by citation, not prison time.  Another 20 or so states have laws allowing for the medical use of marijuana, including in some cases provisions to grow marijuana for personal use or for a small number of patients.

By Federal law, marijuana use remains illegal in virtually all settings.  The DEA classifies marijuana as ‘Schedule I’, the same status as heavy-hitters like LSD or Heroin.  Smoking marijuana can be reason enough for most employers to terminate employment.  And violation of marijuana laws, even possessing small amounts of marijuana, can result in permanent banishment from federal financial aid programs for higher education.

I have no pressing opinion on this issue.  I don’t have a ‘marijuana problem’, and I never really had a problem with the drug.  I smoked it as a teen, and note that the year of my high school graduation, 1978, was the peak year for marijuana use in this country.  But I never enjoyed smoking pot as much as some people appear to.  I always had things that I wanted to do or accomplish, and smoking marijuana, as I grew older, got in the way of those things.

Marijuana was a much less potent drug in the 1970’s than it is today.  In my teens, people talked about ‘smoking a joint or two.’  Now that the THC content is much greater, people have ‘hits.’  I just realized, by the way, how ‘square’ I sound right now.

It is difficult to know whether perceptions surrounding marijuana are accurate or based in fantasy.   Last night I saw a Facebook post from one of my HS classmates that included a picture of my geography teacher in 1976, wearing extra-long, extra-wide, plaid bell-bottom slacks.  It is hard to remember 1970’s marijuana without remembering all the other silly things that we did in the 1970s, that seem so harmless in retrospect.  On the other hand, I remember the fallout shelters and nuke drills back then, which on paper seem every bit as serious as any ‘fiscal cliff.’   Clearly, dangerous things in the past seem less frightening than dangerous things now.

Is marijuana a ‘gateway drug’ that leads to use of more dangerous substances? Marijuana smokers are more likely to use heavier drugs than are non-marijuana-users, but correlation is not causation.  I’m reluctant to conclude that marijuana use ‘causes’ people to use pain pills or heroin. At the same time, I don’t buy the arguments by some pot smokers that marijuana keeps them sober from alcohol or illicit substances.

My Klout score isn’t so high as to impact the likelihood of legalization of marijuana, but I will share a few thoughts anyway about my clinical experiences and observations:

  • Many of my patients can smoke marijuana without apparent negative impact on their lives.
  • Many patients have shared with me their desire to stop smoking, but are unable to leave the drug behind.
  • The biggest downside of marijuana use from my perspective is the complacency that some users develop.  Some marijuana smokers seem to accept miserable circumstances that they would be more likely to change if forced to endure them without smoking pot.
  • Medical marijuana, at least in some cases, is a system rife for abuse.  I meet patients from neighboring Michigan who are prescribed marijuana to treat pain from cancer and side effects from chemotherapy.  I see other patients prescribed marijuana for headaches, fibromyalgia, anxiety, depression, irritable bowel, Crohn’s disease, and a host of other symptoms and disorders.  For all other medications, the FDA provides guidelines on the proper indications for the drug.  Medical marijuana, however, has been embraced as a panacea for so many symptoms and conditions that it is difficult to accept any specific treatment as ‘clinically indicated.’  The illegal status of marijuana, of course, prevents the FDA from considering the drug as medically indicated for any condition.  So we have the worst of both worlds;  a drug without proper vetting by the FDA, only-legal-enough to allow for use without good clinical study.
  • Proponents of marijuana legalization compare marijuana to alcohol from the perspective of fairness, but when doing so often neglect to consider the huge societal costs from use of alcohol.  Or as your grandma used to say, ‘two wrongs don’t make a right.’

Many young people have been led to believe that the Obama administration is on ‘their side’ in regard to legalizing marijuana.  I wonder, though, if legalization of marijuana will require the lead of a traditional antagonist—as Clinton participated in welfare reform, and Nixon opened relations with China.  In other words, I’m not expecting big changes on the federal level anytime soon.

(Addendum: We have a good experiment underway in two states— let’s follow the data….)

Avoid Common Employer Substance Abuse Prevention Program Mistakes

Mark de Berndardo

Today, 14.6 million employees in the United States are current drug users, meaning the employee has used an illicit drug at least once in the past month. Substance abuse in the workplace adversely impacts performance, attendance, safety and health care costs.

Our presenter, Mark A. de Bernardo, is a nationally recognized expert in workplace drug testing and substance abuse prevention. As a Senior Partner of Jackson Lewis LLP, he focuses on employment litigation and counseling, government relations and workplace drug testing issues. In addition, Mr. de Bernardo is the founder and Executive Director of the Institute for a Drug-Free Workplace, a national coalition dedicated to promoting and preserving the rights of employers and employees in effective substance abuse prevention programs.

Mr. de Bernardo says, “Employees should know that their choice to engage in illicit drug use jeopardizes their employment with the company.”

Below are some valuable tips from his presentation to help to create an effective workplace policy and substance abuse prevention program.

  • Ensure the three essentials – justification, prohibitions and penalties – are included in your company’s policy.
  • Be direct and to the point with your company policy. Do not dilute the language of the policy. If your message is clear and strong, it effectively defines the penalties for a violation.
  • Use the words safety and health in the first sentence of your policy. Emphasize that your company is committed to ensuring a drug-free work environment for all of its employees.
  • Include the misuse of illegal drugs, illicit drugs (such as synthetic drugs), legal drugs taken without a valid prescription or not in accordance with a prescription, and alcohol in your policy.
  • Follow federal law regardless of what’s happening at the state level. The Controlled Substances Act (CSA) outlines all illegal drugs.
  • Conduct a pre-employment drug test post-offer and pre-hire. A job candidate should not start working prior to passing their drug test.
  • Do not limit your prohibitions to “on-the-job.” Simply prohibit drug use – period.
  • Implement a “post-incident,” not a post-accident drug testing policy to cover all circumstances.
  • Communicate your policy repeatedly and on an ongoing basis. Conduct employee education and awareness programs to encourage cooperation.
  • Universally apply the policy to all employees across the company.

Visit our webinar page to listen to a recording of this webinar and other presentations by Quest Diagnostics.

For more information about drug testing and how to build an effective program, contact us online.

Invitation Accepted: PhRMA Sues HHS Over “Interpretive” 340B Orphan Drug Rule

By Jay W. Cormier & Alan M. Kirschenbaum

As we previously reported, in late August, the U.S. District Court for the District of Columbia denied PhRMA’s request that the Court vacate a recent HRSA interpretive rule on the orphan drug exception under the 340B drug discount program, ruling that the interpretive rule was not the subject of PhRMA’s lawsuit. The Court stated that PhRMA “is free to challenge that interpretive rule, but such a challenge is beyond the scope of the instant action.”   It should come as no surprise that PhRMA was not deterred by the procedural hiccup.

Briefly, in July 2013, HRSA issued a regulation providing that the orphan drug exclusion added to the 340B statute by the Affordable Care Act – which exempts orphan drugs from 340B pricing in cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals – applies only to orphan drugs that are used for the rare condition or disease for which that orphan drug was designated.  (For a more detailed description of the 340B program and the orphan drug rule specifically, please see our previous post.)  In October of 2013, PhRMA filed suit alleging that the final rule violated the Administrative Procedures Act (see our previous post here).  In May of this year, the Court agreed with PhRMA, finding that HRSA did not have statutory authority to promulgate the rule.  (See our previous post here.)  In July, HRSA issued what was styled an interpretive rule, which set forth the same use-based limitation contained in the final rule that had been invalidated by the Court.  PhRMA then asked the Court to strike down the interpretive rule, and, as mentioned at the opening of this post, the Court dismissed PhRMA’s motion on the ground that PhRMA needed to file a new suit (see our previous post here).

Last week, PhRMA did file a new lawsuit in the D.C. District Court, challenging HRSA’s use-based interpretation of the orphan drug exclusion as arbitrary, capricious, and not in accordance with law.  PhRMA’s complaint requests declaratory and injunctive relief, arguing that, although styled an interpretive rule, the rule requires PhRMA members to either change their conduct and comply with HRSA’s interpretation or risk substantial penalties, including a requirement to pay refunds to 340B covered entities. 

As if to substantiate PhRMA’s latter point, HRSA has recently sent letters to at least some manufacturers of orphan drugs, warning them that, if they do not offer 340B pricing on orphan drugs when used for non-orphan indications, they will be in violation of the 340B statute and their 340B agreements with HHS.  The letters request the manufacturer to submit to HRSA within 30 days a plan for providing refunds to covered entities that have overpaid for orphan drugs and for providing the 340B price in the future.

We will continue to keep our readers updated as events continue to unfold.