Archive: January, 2013
A common theme in the cancer world is that you are not in this alone. Many, many individuals are stakeholders in the battle. Some, like the medical professionals, have both a professional and personal interest in your treatment and recovery. Others, like the hospitals and pharmaceutical companies, have a more “client” relationship with you, but still hope for a positive outcome. Still others, especially volunteers, social workers, family, and friends, have a vested personal involvement. There are lots of interested parties, and all of them are pulling for yours to be a success story.
Former cancer patients and survivors often go above and beyond to offer their support to active cancer patients – well, everyone offers help – but those who walked this road before open up and relive their experiences in order to help prepare others for their battle. Many of those survivors reached out to share their personal cancer experience without prompting, or even introduction. People I don’t know – from as far away as Holland – have found me, shared their stories, gave encouragement, and offered “I am here if you need anything.”
It’s like being inducted into some sort of secret society – ‘Welcome Pledge Sharpe to the Kappa Rho Alpha Beta fraternity, here’s your pledge pin, start studying medical websites immediately and email us any questions.’
Michael R. Cohen, R.Ph.
The fungal meningitis outbreak that’s been gripping the country since last fall has now affected 678 patients and caused 44 deaths. Contaminated steroid injections tied to the outbreak have led to a wake-up call about a dangerous gap in regulatory oversight of compounding pharmacies that mix some injectable medications. In an earlier blog, I noted that such compounded preparations are not approved by the FDA and pharmacies also are generally not FDA-inspected. So there is inherent risk when a compounding pharmacy acts as a manufacturer using non-sterile drug powder. In most states, including Pennsylvania, compounding pharmacy sterile processes do not undergo intensive state inspection.
Should these conditions warrant disclosure to those prescribing and administering the medication and to patients who receive the compounded medications? Do healthcare providers even consider whether they have an ethical and legal obligation to inform end users when they dispense high risk sterile products (injectables made from non-sterile ingredients) prepared by a compounding pharmacy. To do that, doctors who inject these products need to be informed of the source. We decided to probe into pharmacy staff viewpoints about whether or not such transparency should be a part of the picture.
Results of a survey the Institute for Safe Medication Practices (ISMP) conducted in the fall were released this week and provide new insights into how hospitals have been managing the preparation and/or purchase of compounded high risk sterile products. Our survey was fielded in November and December and had 412 pharmacist and pharmacy technician respondents. Results were published in the January 24, 2013 issue of the ISMP Medication Safety Alert!®.
"One day they are gonna do a study that shows chicken causes cancer and pizza is good for you." -Slim, Spring 1999
"Chicken is poison." -Dr. Matt; ER at Broward General who made my initial cancer diagnosis, Summer 2012
Two quotes, taken 13+ years apart and in completely different contexts, and yet they seem eerily similar, no? The second was given to me by the admitting ER doctor at Broward General; he did a fellowship in age management and anti-aging medicine, and is a big believer in diet being the catalyst for our health. We have mutual friends, bring our kids to the same beach/pool club, and are roughly the same age. He and I have stayed in touch, and he is a big supporter and source of information as our family examined the effects of what we eat on our bodies.
The most difficult stretch of my treatment is officially in the rearview mirror. I was discharged Monday morning from Moffitt, almost a week to the hour after checking in. The recovery indicators shot up between Saturday morning and Sunday, so I just needed to remain off oxygen all Sunday and I was good to go Monday morning.
That the TIL + IL2 took only a week to go from infusion, through seven doses, and then get fully recovered is something that makes me proud. Originally, my goal had been to break records for the number of IL2 doses received; now, I am glad we halted them at seven before any markers got into the “red zone.” Sorry for any misconception at the end of the last post – both the doctors and I were thrilled to get seven doses in and remain fairly healthy. Stopping then was absolutely the right decision; there is no proof seven doses of IL2 is better than six or eight, when used as a TIL supplement. So, getting in a good number of doses, without triggering any cascading side effects and medicines, was very positive for my treatment and for my body in general – which has taken a beating the last few months and, frankly, could use a bit of good fortune.
Still, I’m not out of the woods yet, though. Chemo and IL2 both have delayed side effects that can kick in over the coming weeks. Plus, two doses of Yervoy still remain, and no one is sure what the cumulative toxic effects are of two Yervoy doses, followed by TIL, followed by IL2, followed by two more Yervoy doses. Oh yea – throw two surgeries in there too. This sounds like the lineup of shots from my 21st birthday, not a cancer treatment plan. So, the next couple of months will be rest, recovery, and lots of praying that these t-cells do their thing. A preliminary scan is scheduled for the end of February, but we won’t know for sure until early April how well this worked.
Daniel R. Hoffman, Ph.D.
Developing new products through clinical trials represents the lifeblood of branded pharmaceuticals. Unless companies can develop new products to replace the existing ones that lose patent protection, their revenues will erode as payers and patients fill prescriptions with less expensive generics. Yet despite the vital importance of managing clinical development, pharma is content to outsource its central components in the hope that costs and timing can remain within budget.
Contract research organizations (CROs) are the most important of the agencies on which pharmas rely for managing clinical trials. CROs function similarly to general contractors on a building construction project in that they hire and manage the subcontractors. Trial service suppliers represent one type of subcontractor that works on clinical trials. Their tasks include such diverse matters as analyzing blood samples in the lab.
The other category of subs consists of the clinics, medical practices, hospital departments and academics that recruit patients into the various trials. CROs claim that their experience on previous trials makes them aware of which clinical sites are most likely to rapidly and reliably recruit the required number of patients for a sponsoring pharma's particular study.
“Do or do not. There is no try.” - Yoda
Since I received my diagnosis in August, Interluken-2 (IL2) has been something that was tossed around in a serious voice by every oncologist we spoke with. The initial view was that it was a long shot we didn’t want to try – something like 10-15% of patients using IL2 as a treatment had a complete response, but up to 5% getting treated die. We have since learned IL2 is targeted towards younger individuals without other medical issues, as their death rate is nearly non-existent. It also ended up being the final component in my Yervoy and TIL + IL2 treatment. It was something I would just have to do.
First-hand accounts of the IL2 treatment from several people who underwent it made it sound fairly awful. “I wouldn’t wish it on my worst enemy” said one, who happens to be an Army Major and has battled actual enemies on actual battlefields. Another cancer colleague relayed an IL2 experience where he began behaving oddly and quoting Star Wars (“Strong in the Force are these IL2 doses, mmm”) until his wife called in nurses, prompting him to label her a NARC.
Point is, we heard some pretty nasty stories about IL2 treatments– and that word continually came up, “nasty.” The most prevalent side effect is termed rigors (pronounced RYE-gors, but spelled way too close to describing a deceased body for my taste). Take a cold winter day and go outside in jeans and a t-shirt – that sudden, uncontrollable shaking you’ll eventually feel is pretty much the same as rigors. Luckily, two things combat this – warmed blankets and a drug called Dilaudid, which reduces the shakes in one or two doses.
Today is the big day. Navy SEAL-like t-cells are “storming the beach” sometime in the afternoon. We don't have the exact time; apparently, I am on a need to know basis, and, well, I don’t need to know yet. Chemotherapy has knocked out my immune system, and I am physically ready to tackle the part of the trial that determines my treatment outcome and, basically, the remainder of my life. As Eddie Vedder said at the start of the Spectrum’s last concert, “This is it.”
The week of chemo was relatively event-free. Fatigue and a bit of appetite loss were the only real side effects. I completed inpatient chemo with only bloating as the worst effect– bathroom use was frequent, as 10 pounds of saline solution and Meznax IV water weight has to go somewhere.
For the rest of the week, daily trips to the infusion center at Moffitt supplied me with Fludarabine, a leukemia chemotherapy that will finish off the existing white blood cells. From there, it is TIL infusion Monday, and IL2 beginning Tuesday at 6am. By the weekend, I should be recovering while watching the Flyers and Pens drop the puck – thanks NHL for giving me hockey back and putting the Flyers on national TV Saturday and Sunday! Until then, I will be in and out of coherency, but am hoping to have updates during the IL2 and immediately afterwards.
As of Monday afternoon, I had a 0.16 k/uLWBC count, meaning I have near-zero white blood cells left. Keep your sick kids away from me for the next few days.
Can I get a STD from a toilet seat or a hot tub?
John Missanelli, DO, is a gynecologist at Lourdes Health System.
Sitting on a toilet seat or being in a hot tub cannot give you a sexually transmitted disease. As the name says, sex is needed to pass on these diseases. There are other ways some diseases can be passed other than sex, but this is rare.
Michael R. Cohen, R.Ph.
Is your medicine cabinet a source for a teen’s legal “high?” Because a doctor’s prescription is not needed, many mistakenly believe that over-the-counter (OTC) medicines are safer than prescription medicines and illegal street drugs. They are in fact safe and effective when taken as directed, but even OTC medicines—including herbals—can cause serious and potentially fatal side effects when abused.
Abuse of OTC medicines is most common among teens between the ages of 13 and 16. They know they might find a cheap high right in their family’s medicine cabinet, often without being caught. But young adults have also abused OTC medicines, particularly in combination with other medicines, alcohol, and illegal drugs, which increases the risks. The list that follows includes the top 10 medicines currently abused by teens and adults.
- Dextromethorphan: This is the active ingredient in more than 100 OTC cough and cold medicines such as Robitussin and NyQuil. One teen in every 10 has reported abuse of cough medicine to get high. Large doses can cause euphoria, distortions of color and sound, and “out of body” hallucinations that last up to 6 hours. Other dangerous side effects including impaired judgment, vomiting, loss of muscle movement, seizures, blurred vision, drowsiness, shallow breathing, and a fast heart rate. When combined with alcohol or other drugs, a large dose can lead to death. For example, Coricidin HBP Cough and Cold includes both dextromethorphan to treat a cough and chlorpheniramine to treat a runny nose. But chlorpheniramine alone abuse by itself has led to numerous deaths and hospitalizations. Dextromethorphan is also addictive and can cause withdrawal symptoms, including depression and difficulty processing thoughts, when the abuse stops. Not much is known about long-term abuse, but cases of bone marrow and nerve cell damage, high blood pressure, heart damage, and permanent brain damage have been reported.
- Pain relievers: Adults and teens have taken pain relievers like acetaminophen and ibuprofen in doses higher then recommended because they want the medicine to work faster. They don’t think of the side effects. They don’t know that liver failure can happen with large doses of acetaminophen, and that stomach bleeding, kidney failure, and cardiac risks are heightened when taking large doses of ibuprofen.
- Caffeine medicines and energy drinks: OTC caffeine pills like NoDoz or energy drinks like “5 Hour Energy,” or pain relievers with caffeine have all been abused for the buzz or “jolt of energy” they seem to impart. Large doses of caffeine can cause serious dehydration, gastric reflux, panic attacks, and heart irregularities that have occasionally been linked to accidental deaths, particularly in those with an underlying heart condition. Taking too much of a pain reliever can also cause serious side effects as noted above.
- Diet pills: In large doses, diet pills can create a mild buzz. But misuse of diet pills can also signal a serious eating disorder. Abuse of diet pills often starts with trying just a few in order to lose weight. But these OTC medicines can be highly addictive. Although the US Food and Drug Administration (FDA) has banned several of the most dangerous stimulants commonly found in OTC diet pills—phenylpropanolamine, ephedrine, and ephedra—other ingredients in these OTC products can be dangerous. To cite an example, bitter orange is a common ingredient that acts much like ephedrine in the body. It can cause nervousness and tremor, rapid and irregular heartbeat, high blood pressure, stroke, heart failure, and death. Many other diet pill ingredients cause digestive problems, hair loss, insomnia, anxiety, irritability, extreme paranoia, blurred vision, kidney problems, and dehydration. Furthermore, even the most “natural” diet preparations can have serious side effects when misused, particularly those containing ma huang (ephedra). An earlier FDA ban on ephedra pertained only to diet pills considered dietary supplements, not herbal remedies such as teas and Chinese preparations.
- Laxatives and herbal diuretics: Like diet pills, some teens and young adults also abuse OTC laxatives and herbal diuretics (water pills), including uva-ursa, golden seal, dandelion root, rose hips, and others, to lose weight. Laxatives and herbal diuretics can cause serious dehydration and life-threatening loss of important minerals and salts that regulate the amount of water in the body, acidity of the blood, and muscle function.
- Motion sickness pills: Motion sickness pills that contain dimenhydrinate (Dramamine) or diphenhydramine (Benadryl) taken in large doses can cause one to feel high and have hallucinations similar to street drugs. The dose needed to cause these symptoms varies widely according to body weight and tolerance. Some teens and adults may take as many as 40 pills of Dramamine, for example, to experience the desired high. Extremely high doses of Dramamine have caused dangerous irregular heartbeats, coma, heart attacks, and death. Long-term abuse can cause depression, liver and kidney damage, memory loss, eye pain, itchy skin, urine retention, and abdominal pain.
- Sexual performance medicines: OTC sexual performance medicines, often purchased via the Internet, are sometimes abused by teens and adults who are drinking to counteract the negative effects of alcohol on sexual performance. These medicines can cause heart problems, especially when combined with alcohol or when taken in large doses.
- Pseudoephedrine: This nasal decongestant and stimulant is found in many cold medicines. Its similarity to amphetamines has made it sought out to make the illegal drug methamphetamine. The medicine has also been taken as a stimulant to cause an excitable, hyperactive feeling. Abuse may be less common with pseudoephedrine than with other OTC medicines due to a federal law requiring it to be kept behind the pharmacy counter, limiting the purchase quantity, and requiring photo identification prior to purchase. However, people have taken pseudoephedrine to lose weight, and athletes have misused the medicine to increase their state of awareness and to get them “pumped up” before a competition. Dangerous side effects include heart palpitations, irregular heartbeats, and heart attacks. When combined with other drugs, such as narcotics, pseudoephedrine may trigger episodes of paranoid psychosis.
- Herbal ecstasy: This is a combination of inexpensive herbs that are legally sold in pill form and swallowed, snorted, or smoked to produce euphoria, increased awareness, and enhanced sexual sensations. Marketed as a “natural” high, the main ingredient is ma huang (ephedra), an herb banned in the US but only in dietary supplements. The product can be purchased in gas stations, health food stores, drug stores, music stores, nightclubs, and online. It is easy to overdose on the product because the dose needed for desirable effects varies widely. The adverse effects can be severe, including muscle spasms, increased blood pressure, seizures, heart attacks, strokes, and death.
- Other herbals: Other herbal products are increasingly being abused for their stimulant, hallucinogenic, and euphoric effects. Besides being legal, another draw is that many herbals are not detected during routine urine drug screens. One example is salvia, which is ingested or smoked to experience a short-lived distortion of reality and profound hallucinations. Users can experience severe anxiety, loss of body control, extreme psychosis, and violent behavior. They are also at risk for accidents and injuries that may result from an altered mental state. Some states have regulated the sale of salvia. Another example is nutmeg, which is eaten as a paste to experience giddiness, euphoria, and hallucinations. Nausea and vomiting set in within an hour and hallucinations begin within 3 hours and can last for 24 hours or more. Effects such as blurred vision, dizziness, numbness, palpitations, low blood pressure, and rapid heartbeat may occur.
One of the greatest difficulties with preventing OTC drug use is that few teens and adults realize the danger. Unlike the risks associated with illegal street drugs like cocaine and heroin, the risks associated with OTC drug abuse are given little thought and attention. Teens and young adults who learn about the risks of drugs at home are up to 50% less likely to abuse drugs.
- By Michael R. Cohen, R.Ph.
Yea cancer pretty much sucks, but there are small benefits here and there if you know how to find them:
10. Facial hair freedom – First it was the playoff beard, now we’re rocking the Fu Man Chu (poorly I may add), who knows what is next.
9. Mid-day naps – I average two. Per day. And they are fantastic. Somehow, this will continue after all is said and done. Siestas are way better than trying to plow through the afternoon on 5 Hour Energy. Josie and Tommy are the perfect cuddle buddies for one of the aforementioned naps, as long as they don’t kick too much.
8. Baby weight loss – Granted, this wasn’t the ideal way to drop the sympathy pounds I put on while Jen was pregnant, but I do not have to worry about counting calories anytime soon.
7. Fashion – Elmo pajama pants, CMU Football t-shirts, gym shorts, and anything else comfortable makes the cut, funny looks from others be damned.