Daniel R. Hoffman, Ph.D.
Editor’s Note: All this week Check Up will be sharing one new Pharma fact a day that was an important breakthrough in the world of pharmaceuticals in 2012. Today, Check Up delves into Pharma’s approach to cancer therapy.
For a decade or more pharma's researchers have believed that the most effective, least toxic way of treating cancer and, in all likelihood, most other diseases, lies in developing so-called targeted therapies that are based on the genotype of each patient. In many quarters this approach represents the basis of the so-called "personalized medicine."
The idea is that genotypes determine a disease's pathway in any given patient. Knowledge of the pathway in a individual will enable physicians to select the therapy to produce the best result and the smallest side effect for each patient.
The general idea is certainly captivating. Nowhere have scientists and physicians gone as far with it as in cancer. Now a study published this month in Science by researchers from the University of Toronto suggests that developing a targeted therapy based on a tumor's genome is not likely to be effective because tumors with identical genomes often behave very differently.
Daniel R. Hoffman, Ph.D.
Editor’s Note: As the year draws to a close, over the next four days, Check Up will be sharing one new Pharma fact a day that was an important breakthrough in the world of pharmaceuticals in 2012. Today, Check Up delves into health care premiums.
This month the CEO at Aetna, one of the US's largest health insurers, stated that premiums for individuals and small businesses are likely to rise by as much as 100% within the next year as a result of the Affordable Care Act.
That should come as no surprise. The very people who wrote the Affordable Care Act work in the revolving door that circulates people between lucrative jobs at major corporations and controlling positions in government where they craft laws and regulations to benefit their once-and-future employers.
On the specific matter of the Affordable Care Act, no one exemplifies this revolving door of plutocracy more than Elizabeth Fowler. This month it was revealed that she is leaving the White House for a senior position at Johnson & Johnson’s government affairs and policy group.
Will yogurt cure a yeast infection if I put it "inside"?
Matthew Fagan, MD, is an urogynecologist at Lankenau Medical Center, a part of Main Line Health.
Vaginal yeast infections are very common, and many women might be affected by them once or twice per year. Although there are different ways to treat a yeast infection, yogurt is not one of them. One of the myths surrounding yeast infections is that eating yogurt and the natural bacteria it contains can help to prevent an infection from occurring. While yogurt does contain natural healthy bacteria, it cannot prevent a yeast infection regardless of how it is used.
Yogurt isn¹t the answer to a yeast infection, but fortunately, the solutions are usually simple ones that don¹t necessarily require a doctor¹s visit. Effective self-care methods include nonprescription creams and over-the-counter medications, which can be purchased from pharmacies and most grocery stores. These treatments typically treat a yeast infection and the associated symptoms within a few days.
Could I be using hand sanitizer too frequently? For example, I'll use it after shaking someone's hand that appears to be sick, or in the car, after I've been grocery shopping.
Lisa Adams, CRNP, is a certified nurse practitioner at Paoli Hospital, a part of Main Line Health.
Avoiding germs and keeping your hands clean is never a bad thing. Many common illnesses can be contracted through germs picked up through person-to-person contact or from counter tops, doorknobs, and other shared surfaces. By using hand sanitizer regularly, you can not only decrease your risk for contracting other germs, but also decrease the risk of sharing your own.
It is important to note that while hand sanitizer can be an effective disinfectant, it shouldn¹t be the only method. Make sure to wash your hands regularly. Try to use sanitizer only when soap and water is unavailable. Some viruses or diseases can be immune to sanitizer. That is why traditional hand washing is so important. Don¹t think of hand sanitizers as a replacement, think of them as a supplement.
My Dad asked me the other day, in a somewhat contentious debate about the merits of a day trip to Disney World being the best idea, “You’re not giving up or anything, are you?” His question, and concern, was understandable – after recovering and taking it easy for the last several weeks, a slightly impulsive decision to join my family for a day at amusement parks can easily be seen as “getting it in now.”
That’s not why the Sharpe family was at The Most Magical Place on Earth, though. Our cousin had a dancing audition there, and Jen wanted to combine seeing extended family with a trip to the park. I felt up to tagging along for the ride to Disney and planned to join them in the evening at the Magic Kingdom. In the meantime, I would take care of some busy work in the room – paying bills, submitting insurance stuff, and generally getting us somewhat caught up with life.
Then I looked in the mirror. Forget cancer, or even major surgery recovery. My kids were going to Disney, the youngest one for the first time. I am still recovering, but it wasn’t like I was or am incapacitated. Was I really going to sit and fill out forms and use my current medical state to justify a few hours of busy work? Was I really being given the chance to create a special memory and passing it up for AFLAC and Wells Fargo paperwork?
Off went the computer. Back into the to-do folder went the forms. On went the socks and sneakers and comfortable walking clothes. It’s not exactly carpe diem, but looking in that mirror, I remembered the first blog post – “I am not letting cancer define me” – and told a surprised and delighted Jen that we were taking the children to Disney World, right now, and that we had better hurry because the lines are already getting long.
Michael R. Cohen, R.Ph.
By Michael R. Cohen
In my entire career at the Institute for Safe Medication Practices, the meningitis outbreak was the worst safety disaster that I have ever seen, making 2012 a watershed year in drug safety stories. So without further adieu, the following are this year’s top 10 worst cases in drug safety:
Meningitis outbreak. In October, a deadly, multistate fungal meningitis outbreak began to unfold, exposing a lack of federal or state safety oversight of pharmacies that compound sterile drug products. Some pharmacy compounders have evolved into unregulated pharmaceutical manufacturers that distribute unapproved drugs in large quantities across state lines, often in response to drug shortages (see #2 below). The toll so far? Over 600 hospitalized and 39 deaths across 19 states, making this the worst drug-related public health disaster since a 1937 drug safety disaster that led to the Federal Food Drug and Cosmetic Act. FDA Commissioner Margaret Hamburg believes a new system is needed under which nontraditional pharmacies would have to register with the FDA and undergo regular inspections, similar to pharmaceutical manufacturers.
Drug shortages. Authorities are still grappling with an ongoing shortage of commonly used medications, including critically important drugs for cancer, emergency medications like sodium bicarbonate, nutritionals like calcium injection, pain medications including morphine, and even certain mainstay antibiotics and anesthetics for surgery patients. Importation of critical drugs from countries outside the US and new legislation signed by President Obama in July is helping FDA to address some of the causative factors. But the crisis still sometimes rivals what might be seen in developing nations! Even children with otherwise treatable cancer have sometimes been left without optimal treatment. One anesthesiologist, who usually uses IV drugs to put people under, told us he’s returned to inhalation anesthesia. Let’s hope we don’t need to bring back ether.
Daniel R. Hoffman, Ph.D.
The Christmas season is one of enchantment, myth, childhood wishes and the noble spirit of peace on earth and good will toward all men. It remains for pharma to bring us back to hard reality. During a year-end flourish, several companies have acknowledged their illegal kickbacks to physicians, off-label marketing and Medicare fraud. As a star atop this tree, Pfizer also announced it will eliminate 600 rep positions in the US, amounting to 20% of their primary care sales force here.
One cynical ex-Mercker privately wrote that this rush of pharma disclosures at least demands recognition of the drug industry's literary acumen. In his view they consistently emulate characters from Charles Dickens, either by recreating the thieves and pickpockets of Oliver Twist or by enacting Ebeneezer Scrooge from A Christmas Carol.
GlaxoSmithKline (GSK) led pharma's version of a holiday list. GSK has been a stalwart presence in the Delaware Valley ever since 1830, when John K. Smith opened its first Philadelphia pharmacy. This month they agreed to pay US drug wholesalers $150 million for abusing the consumer's "petition process," thereby, preventing generic versions of its allergy product, Flonase, from entering the market. GSK accompanied its agreement to pay this tidy sum with a statement that must have been as difficult to maneuver around their spokesman's tongue as a dowager aunt's fruitcake. "The settlement is not an admission...of any violation...or wrongdoing," according to a company communique. Instead GSK paid this sum to remove "protracted disruption, expense and uncertainty."
Such tortured language is the typical, illegitimate offspring of lawyers and PR specialists. Some skeptics might claim that the only uncertainty removed by paying $150 million concerns whether any hanky panky actually occurred..
Here is the background on Patient #1's treatment - some of how I got here, supplemented with explanations of medical terms below. Understanding this stuff takes either a medical degree or a complete vested interest in it, so I will do my best to relate things in layman's terms. Plus, there’s a LOT here. Keep in mind I am not a doctor and couldn’t even play one on TV (even if I did stay at a Holiday Inn last night)…
The initial diagnosis in August 2012 was Stage 4 Malignant Melanoma - there were tumors in each lung, and one each on my spleen, liver, and small bowel. The stages of cancer aren't always understood easily and differ somewhat by type of cancers, but here is the generalization:
- Stage 1 is local to one specific area of the body, i.e. lung
- Stage 2 and Stage 3 are advanced cancers in one area of the body; the difference varies by cancer and degree of spread locally. Even I am confused about what is what sometimes (ok, all the time - "luckily" I skipped these two and went right to Stage 4).
- Stage 4 indicates the cancer has metastasized, or spread, to other organs or areas in the body. This is, uh, not good, as it severely limits the treatment options.
Selecting a treatment is a long and tiring process. I have been overwhelmingly lucky to have contacts at some of the country’s best hospitals. The initial suggestion from the Broward General oncologist was a combination of chemotherapy drugs, based on a genetic testing of the first removed tumor. Often, patients won't get a choice in the treatment suggested by the attending oncologist, and the "he-will-be-lucky-to-still-be-alive-in-two-years" prognosis that comes with it (yes, the actual words from the first consultation).
This hit my wife Jen hard - a life expectancy measured in months was not the future we were looking for. If you have had or know someone with cancer (sadly, a reality for all but the luckiest among us) two of the first things to comprehend and process are "life expectancy" and "survival rate":
- Life expectancy is the age where half the people with that stage of that specific cancer have passed away, and half are still alive, after diagnosis - i.e. the life expectancy for stage 4 melanoma is somewhere between 6-22 months after diagnosis, depending on several different factors (age, health, metastasized or not, etc...)
- Survival rate is the percentage of people alive X number of years after the diagnosis; the 1-year survival rate for Stage 4 melanoma with normal LDH levels is 61%; the 2-year rate is 33%, and the 5-year rate drops to a discouraging 18%. A number of factors affect this calculation, so it is never clear what a specific person's "odds" are - this just gives a benchmark.
My name is T.J. Sharpe. I’m a father, husband, brother, friend and fighter– of Stage 4 Melanoma.
You will be reading about a battle with cancer, but that is just the backdrop for this story - one that really focuses on life, health, family, and the challenges we all face every day to win our little battles. Ultimately the war on "Father Time" can never be won, but this is one man's tale on how I am fighting to keep that battle going for years.
I’m a South Jersey native and a 1993 graduate of Bishop Eustace. I parlayed an education and some success on the football field to gain admission to Carnegie Mellon, a Top 25 university in Pittsburgh – one that probably wouldn't accept me now, and likely would not have in 1993 either – without a little help from the athletic department. Regardless, a door was opened to another fantastic school, and four more years of football at the Division III level, where our biggest perks were the occasional travel meal money and some free grey t-shirts that I still wear today. At both schools, I was able to get a great education, play the sport I loved, and establish lasting relationships with more good people than I can easily count.
After college, I became an IT consultant, first based out of Hoboken, NJ, then Haverford, Pa., before relocating in 2004 to Fort Lauderdale, Florida, where I currently reside. There, I met a native Floridian (they do exist!) lawyer, married Jen in April of 2008, and now have two wonderful kids – 2-year-old Josie and 5-month-old Tommy. I love living in the Sunshine State, have met many great friends, and even have raised a little girl who is a Phillies and Flyers fan (Jen and I drafted teams for our children's allegiance; the Dolphins went first, followed by the two Philly teams, then the Heat. The top 3 picks have vastly underachieved). However, my roots are still in the Delaware Valley, and I will always call Philadelphia, South Jersey, and The Shore “home.”
Why does eating beets turn my pee and poop red? Are there any health concerns with this?
Mervyn D. Danilewitz, MD, FACG, AGAF, Chief of Gastroenterology, Mercy Philadelphia Hospital
The beetroot pigment called betanin is responsible for the red coloring in urine and feces and this should not cause any health concerns.
Some people cannot break the pigment down and this results in excretion of the pigment in urine and feces.The rest of the beetroot is digested and no nutrients should be lost. This usually lasts 48 hours, but it can vary in people who have a slow or faster rate of passing feces. It also depends on amount of fluids one drinks.