When People Fail

I am personally struggling with two pieces of information today.  The first is that Lance Armstrong has come clean with Oprah about his doping scandal.  I had hoped that it was all fabricated by those who were jealous, but alas he is guilty.  I cannot even understand why the leagues (baseball, biking etc...) don't realize that the cost of winning is at ALL costs.  Why not just make these substances all legal and do away with that aspect of what we are capable of doing on our own.  This is 2013.  I would say at this point most sports has seen their very best without enhancement.  What is left?  Enhancement. I know that seems bizarre for a pharmacist to say publicly that doping for sports should be made legal, but that is what I am saying.  As long as it stays illegal, the coaches and trainers and others involved in making the best of the best will go at all lengths to find substances that are not yet known or tested and continue to dope.  It is inevitable.

The other piece of information that I am struggling with today is that a former classmate in pharmacy school (who I will call Ed for his own privacy) has made a deal in pleading guilty in a case that I have had a hard time understanding.

You see, Ed was the type of student in our class who was a man of character.  He was one of the good guys.  I believe he was already married and was in the pharmacy fraternity that was more studious and less partying.  You can imagine that I was in the partying one and you would imagine right.  Ed has a large family now; he has small children and a wife that need him.

Ed has had some legal trouble in which there was some sort of federal charge brought against him for distributing controlled substance (Oxycontin) from his pharmacy.  I don't know how this whole thing began, but apparently it began fairly innocent enough with perhaps one bad decision or perhaps another part of the story that I do not know.  Maybe it was driven by needing money.  Perhaps it was driven by a bad decision further snowballing into extortion by some drug addicted criminals.

Either way, Ed is going to likely go to prison for around five years or so, and my heart breaks for him.

I know that it is easy for many to condemn a man like Lance Armstrong for doping but the bigger offense being the lies he told over the years and nastiness that ensued.  He threatened, sued and was a bully for the most part.  He "beat" cancer of the brain metastasized from testicular cancer, and he founded Livestrong.  There was good to the fame and notoriety even if he came by it by cheating.  Does the means justify the end?  Sometimes?

Fifteen years ago I would have looked at both men making bad decisions and would have spewed my opinion, and it would have been quite judgmental.  I tend to not do that as much because the situation is much more complicated the older I get.  You see, people fail.  People are human - even the most trusted professional, the pharmacist.  The moment that I believe that I am infallible of filling will be the moment where I am the most vulnerable.  We must always strive to do our best.  Do not compromise even for a moment the integrity and good name you have.  It is all you have in the way of public opinion, and in the case of Ed, I was a little saddened to read that he has struck a deal with the government about pleading guilty to one count and going to prison.  He will be sentenced right before this summer, and I dread it for him and his sweet wife and children.

I do hope for a silver lining for Lance Armstrong somehow.  I hope that he is able to look back at his life and see his own shortcomings and how they shaped him into something even better.  Yes, he made a mistake and turned that mistake into a snowball of lies and more denials that took years for him to admit, but there are good things that he has done.

My friend made a mistake and is going to pay the consequence for it by missing five years of his children's lives.  Both of them still are men I can admire for good things in the past and I hope even better things in the future.  Somehow.

5-Hour Energy Drink and Death

My heart raced when I saw this.  No pun intended.  I tend to down one prior to a run.  Maybe something I will reconsider, but I also drink a lot of coffee daily so maybe I have tolerance like an alcoholic to alcohol?

Thirteen deaths have been linked to the consumption of 5-Hour energy drinks according to a report by the Food and Drug Administration.  With the fatalities the energy 'shot' has been also linked to heart attacks, convulsions and in one case a spontaneous abortion according to 90 filings with the FDA released to the New York Times this week.  Question:  Um, yeah, avoid caffeine when you are pregnant, mmm kay?

Add also Monster Energy Drink, which I'm almost positive is the official drink of the retail and hospital pharmacist, to the list with the parents of Anais Fournier suing the company over her death.  Only 14-years-old, the parents allege she only drank two in a 24 hour period before becoming ill.

HAGERSTOWN, Md. -

The U.S. Food and Drug Administration is investigating reports of five deaths that may be associated with Monster Beverage Corp.'s energy drink.

The agency acknowledged the adverse reports Monday, but FDA spokeswoman Shelly Burgess says the reports don't prove that the drinks caused the deaths.

This follows news that the parents of Hagerstown, Md. teen Anais Fournier filed a lawsuit in California on Friday against Monster Beverage Corp. for failing to warn about the product's dangers.

The 14-year-old's family says she went into cardiac arrest last December after drinking two 24-ounce cans of Monster Energy Drink in 24 hours.

An autopsy concluded she died of cardiac arrhythmia due to caffeine toxicity. She had an inherited disorder that can weaken blood vessels.

Monster says it doesn't believe its products caused any deaths.

Fungal Meningitis and the End of Lackadaisical FDA Involvement in Compound Pharmacies

New England Compounding Center (NECC) is at the center of this quite horrific tragedy that has affected the lives of many with fourteen already dead. I cannot personally fathom such a loss over something so seemingly accidental. As a pharmacist my thoughts immediately go to sterile technique and the FDA's regulation of our industry. You see, the states oversee the pharmacies compounding and normally that should be enough. However, something went terribly wrong here. But what is coming out lately is the role of compounding pharmacies and how in this case, there was a grey area they were working in. Basically compound pharmacies can make patient specific medications, what is not allowed is these compounding pharmacies acting as manufacturing and bulk shipping repackaged medications without FDA oversight.

It's all about the dollar, but in this case many priceless lives have been lost.

There are two fungi involved: aspergillus and Exserohilum rostratum.

In the past, these pharmacies have been the heroes making things like bioidentical hormones and other specialty concoctions.

Under the FDA's definition, compounding pharmacies are supposed to mix drugs to order only on a specific patient in response to a prescription from a doctor. Under this definition NECC was not operating as a compounding pharmacy but as a large-scale production of a drug. The FDa should have stepped in before these lives were lost.

Ambien and _______ Do Not Mix

Have you ever had the rare opportunity to have ambien (zolpidem) prescribed to you and experienced how quickly this medication takes effect? According to pharmacokinetic properties of this medication, zolpidem is rapidly absorbed after oral administration. Peak medication effects of the immediate-release tablet occur within 90 minutes of a single oral dosage. In single-dose studies in subjects administered 5 mg and 10 mg zolpidem, the mean peak concentrations (Cmax) were 59 (range: 29—113) and 121 (range: 58—272) ng/ml, respectively, occurring at a mean time (Tmax) of 1.6 hours for both strengths. The presence of food reduces the amount of absorption and increases the time taken to achieve maximum concentration, delaying sleep onset. Therefore all formulations of zolpidem should be taken on an empty stomach versus after a meal... unless of course you are out driving then by all means eat first, or do the right thing and don't take ambien and drive!

This medication has now been implicated in a car crash two weeks ago, when Kerry Kennedy, the daughter of Robert F. Kennedy, swerved into a tractor-trailer on New York's Route 684 and kept driving. Witnesses said she had been weaving in and out of lanes for miles before the accident.

Toxicology reports showed 14 nanograms per milliliter of zolpidem in Kennedy's blood, according to the Associated Press. Both her blood and urine samples were negative for alcohol or other drugs.

Police found Kennedy slumped in her white Lexus on the morning of July 13, according to Reuters. She was unsteady on her feet and slurring her words. Initially she told police she may have accidentally taken the sleeping aid earlier that day, mistaking it for her thyroid medication.

At a court appearance July 17, she pleaded not guilty to a charge of drunk driving and said the hospital where she was treated found no trace of drugs and doctors had suspected a brain seizure. She is due back in court Aug. 14.

In 2006, her cousin Patrick Kennedy, the former congressman from Rhode Island and the son of the late Sen. Edward Kennedy, was sent to alcohol and drug rehab, after crashing his car while on Ambien in Washington, D.C.

Ambien is a sedative-hypnotic that works by slowing activity in the brain, according to the National Institutes of Health. It is prescribed for those who have difficulty falling or staying asleep. It's meant to be taken immediately before bedtime and its effects last about seven to eight hours.

Sometimes patients can experience memory problems on awakening. Some have reportedly taken Ambien, left their bed and driven cars, prepared and eaten food, had sex or made phone calls while under the influence of the drug and not fully awake, according to the Food and Drug Administration.

The drug has a risk for anterior-grade amnesia, as well, according to Doering. "Memory never burns from RAM to ROM."

"The things that happen to a driver can be very scary," he said. "You are in a state where you are dreaming, but you are not quite sure whether you are awake or dreaming."

Health in the News

In short: The FDA approves Truvada to prevent HIV infection.  This is a first.  When taken daily, Truvada (emtricitabine/tenofovir disoproxil fumarate) reduced the risk of HIV infection by 42 percent compared with a placebo. That was in a clinical trial where HIV-negative people had unprotected sex with multiple partners, including some HIV carriers, according to the FDA. Another trial involving heterosexual couples where one partner was infected -- and condoms were used routinely -- found that Truvada reduced the risk of infections by 75 percent.

I'm not sure where you would find people to take part in a study such as this, but Truvada is a treatment for an individual is already infected.  A prevention besides the usual barrier methods (or abstenance) is novel.

Another - Watching TV Causes Larger Waistlines  - no brainer right?

And the unthinkable - Dr. Stephen Stein, Denver Oral Surgeon, May Have Exposed Over 8,000 to HIV, Hepatitis B and Hepatitis C.  The department sent out letters to 8,000 of Dr. Stein's patients Friday, urging them to seek tests for disease if they received intravenous (IV) medications, including sedation, under Stein’s care from September 1999 through June 2011.  Really?  What kind of healthcare professional would do this?  Of course now, he's skipped town.  Seems he may be guilty of prescription fraud and diverting medications.

Interestingly, in Germany, circumcision in the news.  German doctors are seeking an urgent clarification from the government over religious circumcision after a court ruling calling it a criminal act prompted an international outcry.  I know this is a hot button topic with many.

The College of Physicians called on the government to act to prevent clandestine circumcisions and to ensure that "children do not fall into the hands of any butcher or any old health worker".

The Cologne ruling concerned a case brought against a doctor who had circumcised a four-year-old Muslim boy in line with his parents' wishes.

When the boy later suffered heavy bleeding, prosecutors charged the doctor.

Although the doctor was acquitted, the court judged that "the right of a child to keep his physical integrity trumps the rights of parents" to observe their religion, potentially setting a legal precedent.

Want to lose weight?  Don't eat out at lunch, don't skip meals, and log everything you eat in a journal.  So, first thing I'm going to do since I've already started using Fitness Pal is to brown bag it from now on.

Related articles

• FDA approves first drug for reducing the risk of sexually acquired HIV infection (miamiherald.typepad.com)
• First HIV-prevention pill approved by FDA (cbsnews.com)
• Dentist behind HIV risk fears in Colorado: Dirty needles used? (examiner.com)
• Antiretroviral pre-exposure prophylaxis (PrEP) for preventing HIV in high-risk individuals. (zedie.wordpress.com)

LeapFrog vs Consumer Reports

What hospital is the best in your area? Which hospital is the safest? Many times the public uses word-of-mouth from their friends and families to choose. A lot of times our own insurance policies determine which hospital we choose. Consumer Reports just rolled out their own version of safety rankings comparable to another version LeapFrog Group that was released last year.

In June, Leapfrog Group, a Washington D.C.-based hospital safety advocacy group, created its own safety rankings, but unlike Consumer Reports’ numerical scores, Leapfrog used A, B and C letter grades, similar to New York City’s restaurant grading system that only has three grades.

The director of the Consumer Reports Health Ratings Center, John Santa M.D., explained the report as a type of advocacy. “We’re doing this in part because 12 years ago the Institute of Medicine made the same suggestions that we’re making. This kind of information needs to be publicly reported, these problems need to be solved, but the hospitals still haven’t done it,” he said. There are differences in reporting between the two groups. “We each looked at some different measures,” said Leah Binder, CEO of the Leapfrog Group. “Particularly, they [Consumer Reports] looked at patient satisfaction measures and rates of CT scans. We didn’t look at those things. We looked at injuries, errors and accidents only. It’s kind of like having two different book reviews. Different reviewers have different interests.”

This is a good thing in that it helps educate the public about hospital safety. This is a bad thing is that the guidelines for determining safety is different from study to study. Where does your hospital rank?

Physical Punishment and Mental Disorders

I do not care for statistics.  It's not in my DNA to ENJOY them but this is the perfect example why all pharmacists (and the lay public, for that matter) should understand and interpret study results.  Just the other night, I was watching the news and the anchor states, "Parents should think twice about spanking their children."  Most people would look at the anchor, hear the words, and then turn right around and pass it on as though it was spoken by God Himself. A study was cited:

BACKGROUND: The use of physical punishment is controversial. Few studies have examined the relationship between physical punishment and a wide range of mental disorders in a nationally representative sample. The current research investigated the possible link between harsh physical punishment (ie, pushing, grabbing, shoving, slapping, hitting) in the absence of more severe child maltreatment (ie, physical abuse, sexual abuse, emotional abuse, physical neglect, emotional neglect, exposure to intimate partner violence) and Axis I and II mental disorders.

METHODS: Data were from the National Epidemiologic Survey on Alcohol and Related Conditions collected between 2004 and 2005 (N = 34 653). The survey was conducted with a representative US adult population sample (aged ≥20 years). Statistical methods included logistic regression models and population-attributable fractions.

This is a retrospective study which automatically introduces bias.  Correlation does not imply causation.  That's the biggest issue I see with this study.  For example, the media will pick up a press release about this type of study and report that spankings make children grow into adults with mental disorders, but correlation does not imply causation.  For example, children who were spanked may end up with a mental disorder, but there is no proof that it was the spanking itself that caused the mental illness but perhaps several other factors or combinations of factors.  Even schizophrenia and depression have had genetic components.  What happened to pure genetics?

The next big issue with this study is they looked at many types of mental illnesses since it is not very efficient to run a large study, gather data, and analyze it to look at only one type of mental illness.  Scientific studies, however, rely on statistical analysis to determine whether something is true.  Even if your estimated error is less than one percent, in a study examining thousands of items some will appear to have an effect even though they are just statistical aberrations.  These false positives are then reported, and when a new study fails to confirm them as true, the press reports a scientific “change of mind”.

Finally, when a cohort study is retrospective, the problem is compounded since retrospective studies often rely on memory.  If you developed a mental illness, you may have a different memory recall of punishment and its effect and your perception vs if you did not have a mental disorder.

Be careful with retrospective studies!   As in this case, there are many flaws and biased automatically introduced.

I definitely understand the rationale for wanting to run this study as many parents are probably over the top with physical punishment; however, I don't believe those parents that reserve a spanking for a type of punishment as abusive or that their child will end up with a mental illness due to that one decision.  Too bad the media doesn't know how to interpret studies!

Another critique:

While the new study rules out the most severe cases of physically lashing out at children, "it does nothing to move beyond correlations to figure out what is actually causing the mental health problems," says psychologist Robert Larzelere of Oklahoma State University,. He criticized the study's reliance on memories of events from years earlier, and says it's not clear when punishment occurred.

Afifi acknowledges that it's difficult to change people's mind on this topic, but says "we're confident of the reliability of our data, and the data strongly indicate that physical punishment should not be used on children — at any age. And it's important for parents to be aware of that."

Be the Match!

After years and years of wanting to join the bone marrow registry, I finally discovered that you don't even have to leave your house to join!  At Be the Match, the new name for the bone marrow registry, all you have to do is fill out a questionnaire and then wait for a kit to be delivered by mail within two weeks.  Then, taking a few swabs in your mouth, you send back and wait.  I hope to be able to help someone one day in this aspect. Take a look at the myths and facts of bone marrow donation before dismissing this opportunity to help save a life!

Pass the Ritalin Please

Methylphenidate.  Ritalin.  Concerta.  Etc...  THE MOST PRESCRIBED MEDICATION FOR KIDS AGES 12-17. What in the world?

I guess I'm kind of shocked and then again, maybe I'm not as shocked.  ADHD is on the rise.  There's no doubt about it.  I worry about it in my own children, and I also worry that I'll dismiss any possible behavior ADHD-like to just being a kid.  I waver between the parents that over react to those that don't.

I remember when I was in pharmacy school, we would joke around that Sesame Street caused ADHD.  If Sesame Street caused it, you know that crazy shows like Yo Gabba Gabba with seizure-like strobes and constant music in your face jumping from topic to topic will cause it!  There are links to video games and ADHD.  There are links to TV and ADHD.  Scary considering even my vehicle has a TV in it helping to ease the kids on the way to visit the grandparents.

But, then there's the argument of what ADHD even is.  I know in retail pharmacy, a pharmacist has GOT to be able to juggle several different things at once.  I remember having a telephone in my ear, writing something down, and answering someone at the register all simultaneously.  I am a multitasking extraordinary gal.  But even on webmd, look at these signs of adult ADHD:

1.  Adult ADHD Problem No. 1: Difficulty Getting Organized

For people with ADHD, the increased responsibilities of adulthood -- bills, jobs, and children, to name a few -- can make problems with organization more obvious and more harmful than in childhood. While some ADHD symptoms are more annoying to other people than to the person with the condition, disorganization is often identified by adults struggling with ADHD as a major detractor that affects their quality of life.

SERIOUSLY?  There are not enough hours in the day to be organized with two small children and a full-time job.  I bet that the majority of all parents fall into this category.

2.  Adult ADHD Problem No. 2: Reckless Driving and Traffic Accidents

Attention deficit hyperactivity disorder makes it hard to keep your attention on a task, so spending time behind the wheel of a car can be difficult. ADHD symptoms can make some people more likely to speed, have traffic accidents, and lose their driver’s licenses.

Speeding?  Ok, yes I may find myself rushing to work because there was an epic meltdown at the daycare and I am late for work.  Especially since I clock in to work.  Seriously?  Let's not even mention most of the moms out there or a lot of them that text and drive.  Ok, so maybe I haven't had a traffic accident or lost my license, but maybe I was just lucky.

3.  Adult ADHD Problem No. 3: Marital Difficulties

Many people without ADHD have marital problems, of course, so a troubled marriage shouldn’t be seen as a red flag for adult ADHD. But there are some marriage problems that are particularly likely to affect the relationships of those with ADHD. Often, the partners of people with undiagnosed ADHD take poor listening skills and an inability to honor commitments as a sign that their partner doesn’t care. If you’re the person suffering from ADHD, you may not understand why you’re partner is upset, and you may feel you’re being nagged or blamed for something that’s not your fault.

Marital problems?  This again is vague.  You are going to have marital problems trying to juggle all that is life.

4.  Adult ADHD Problem No. 4: Extreme Distractibility

Attention deficit hyperactivity disorder is a problem with attention regulation, so adult ADHD can make it difficult to succeed in today’s fast-paced, hustle-bustle world. Many people find that distractibility can lead to a history of career underperformance, especially in noisy or busy offices. If you have adult ADHD, you might find that phone calls or email derail your attention, making it hard for you to finish tasks.

Uh... yeah.  This is me.  But isn't this everyone????

5.  Adult ADHD Problem No. 5: Poor Listening Skills

Do you zone out during long business meetings? Did your husband forget to pick up little Jimmy at baseball practice, even though you called to remind him on his way home? Problems with attention result in poor listening skills in many adults with ADHD, leading to a lot of missed appointments and misunderstandings.

Ok, so maybe hubby forgot because he was up all night with a teething toddler?  Maybe I zone out during meetings because I'm just TIRED.  Ever think of that one?

6.  Adult ADHD Problem No. 6: Restlessness, Difficulty Relaxing

While many children with ADHD are “hyperactive,” this ADHD symptom often appears differently in adults. Rather than bouncing off the walls, adults with ADHD are more likely to show restlessness or find they can’t relax. If you have adult ADHD, others might describe you as edgy or tense.

Who has time to relax?  I'm still trying to organize as in #1!!!

7.  Adult ADHD Problem No. 7: Difficulty Starting a Task

Just as children with ADHD often put off doing homework, people with adult ADHD often drag their feet when starting tasks that need a lot of attention. This procrastination often adds to existing problems, including marital disagreements, workplace issues, and problems with friends.

I can start a task... it's finishing!!!

THE LIST GOES ON.

So basically I'm just trying to point out that life with small children and working is going to make any adult seem to be suffering from these symptoms.  Children?  I believe that so much more is expected of them at school and they are fighting within themselves to listen and be still during school.

We are RUSHING to use medications as a quick fix.  How about find out WHY little Johnny is having trouble at school?  How about some behavioral therapy?  How about having a good school?  How about not just turning to medications that have some pretty bad side effects?  You don't want to stunt your kids' growth right?  Methylphenidate may slow children's growth or weight gain. Your child's doctor will watch his or her growth carefully.  Along with other side effects listed on the link above.

We need to take this study seriously.

Bath Salts Turn Man Into Cannibal?

Seems like a lot of news agencies are jumping the gun on the "zombie attack" in Miami, FL's toxicology results. I have read at least five different news blurbs blaming "bath salts.". The way the articles are written one could assume its a definite assumption considering he removed his clothes and was attacking some innocent guy so heinously. It couldn't be anything else right? Actually dextromethorphan can cause this (at toxic levels), ecstasy or MDMA, and cocaine. Bath Salts are similar, so thus the comparison, plus a headline claiming bath salts did this makes for good publicity over just talking about bath salts.

One website even falsely claimed bathing in those salts produced the effect. Incorrect. It is the usual snorting, smoking, injecting, or ingesting that causes the effect.

Mephedrone, MDPV (3,4-methylenedioxypyrovalerone), methylone (3,4-methylenedioxymethcathinone), 4-fluromethcathinone, or 3-fluromethcathinone. These chemicals are so dangerous when ingested that the DEA used an emergency measure to list bath salts as a Schedule I narcotic that expires this September.

The bigger question is why would a person want to take something that could cause extreme paranoia, psychotic symptoms, hallucinations, delusions, teeth grinding, headaches, erratic behavior, visual impairment, and erratic behavior.

But let's wait until the toxicology results are back before we jump the gun. I'm putting my money on a mixture of substances.