March 20th, 2008 by Dr. Val Jones in News
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About a year ago I had the chance to speak with the founder of Micromedex Inc. about his views on the potential differences between brand name and generic drugs. He expressed some concern about the allergenic potential of filler substances in both brand name and generic drugs, and I was quite interested in the clinical impact of these differences.
Just recently, an article in the LA Times has shed more light on the debate about drug equivalency, and my fellow bloggers Abel Pharmboy and Joseph (at Corpus Callosum) have summarized the issues very well. As it turns out, the FDA allows for a fairly broad interpretation of equivalency when it comes to the rate at which the bioactive ingredients are released into the bloodstream.
To use an imperfect analogy – let’s pretend that water is the drug you’re taking. You can access water from a drinking fountain or a fire hydrant, and the amount you get in your mouth all at once may vary between the two sources, though the water itself is the same “drug.” This is the sort of difference that exists between some generic drugs and their brand name “equivalents.” The rate at which they get into your system can differ by as much as 36% and still be considered identical drugs by the FDA.
Now, imagine that someone offered you water in a paper cup or in a water balloon. The water’s container (analogous to the “inert filler” used to hold the medicine together in a pill or liquid form) is made of different substances (paper versus latex) and doesn’t make that much of a difference in quenching your thirst… unless you’re allergic to latex.
So there are true differences between generic and brand name drugs, though most of the time these differences are not clinically important. But in those special circumstances where people are allergic to fillers, or need a constant or regular concentration of their drug in the bloodstream, generic vs. brand name really does matter.
However, I think that in general generic drugs are terrific and have substantially reduced costs and increased access for millions of people. It is reasonable to save money by switching to generic drugs when possible. It is also important to resist the urge to believe that higher drug prices guarantee more effective products. In a recent JAMA article it was demonstrated that people believed that pain medication placebos were more effective if they were told that they were also more expensive.
But, if you’re one of those patients who tried switching to a generic drug and found it less effective – don’t let your doctor tell you you’re imagining things. There could be a real difference that you need to explore.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
March 13th, 2008 by Dr. Val Jones in Humor
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In case any of you aren’t familiar with The Onion, it’s a spoof newspaper whose articles range from hilarious to irreverent. Here are some recent health headlines that struck me as funny:
Depressed Cow Eats Entire Haystack
Nation’s Bachelors Demand Health Care Coverage For All Their Buddies
Pharmaceutical Company Says Its New Anti-Depressant Is ‘Worthless And Dumb’
Very Specific Food Pyramid Recommends Two To Three Shrimp Scampis Per Year
Disease-Free Water Tops List Of World’s Most Popular Beverages
Half Of 26-Year-Old’s Memories Nintendo-Related
Swanson Foods Launches Hungry Man Line Of Apparel
Area Man Thinks He Can Save Relationship With Pancakes
American Cancer Society Unveils 1.2-Megaton Anti-Cancer Missile
New Product Can Do All That, More
Barky Dog Just Going Bark, Bark, Bark
And for you scientists in the audience, here’s an Onion classic, mocking the medical peer review process. Enjoy!This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
March 10th, 2008 by Dr. Val Jones in News, Opinion
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When I eat out at a restaurant I’m inevitably asked whether or not I’d like bottled water with my meal. My answer usually depends upon the city I’m in – New York water tastes great, so I ask for tap water in Manhattan. The water in DC tastes like a swimming pool (at best), so I usually order bottled water at Washington restaurants.
But little did I realize that the water I’ve been drinking (whether from DC, NY or even from the bottle) has small traces of pharmaceutical chemicals in it. A new investigation conducted by the Associated Press suggests that most major urban water supplies are laced with tiny amounts of prescription drugs. How do the drugs get in the water supply?
Remember that water cycle you (or your kids) studied in grade school? Well, the “underground phase” is where the action happens. Drugs that we swallow pass through our bodies and some is released in our urine and stool. We flush that down the toilet and the fluid debris is treated in a sewage plant and then the water portion is released back into the water supply. Sewage plants and water filters are not designed to remove trace chemicals like heart medicines and anti-depressants, so they remain in the drinking water. Kind of disturbing, right?
Well, the good news (if there is any) is that the amounts of chemicals in the water are pretty small – we’re talking parts per trillion. Just to put that in perspective, that’s more than 1000 times smaller than the minimum amount needed for therapeutic effect from the fluoride added to the water system. And the concentration is far below the therapeutic threshold in the bloodstream for these drugs. But how do we know that tiny amounts of drug exposure isn’t harmful in some cumulative way?
Research into the potential long term effects of these chemicals in the water supply has focussed mostly upon the presence or absence of the drugs, and the concentrations at which they’re present. Animal studies (such as the “feminization” of fish exposed to environmental estrogens) and cell culture research suggest that exposure to larger concentrations of these drugs can cause negative outcomes, but to my knowledge there are no long term studies of the potential impact of very small concentrations on human health. But before we become outraged at this apparent lack of investigation, let’s think about why it’s so difficult to gather this kind of information.
First of all, concentration-wise, pharmaceuticals represent a small fraction of the thousands of man-made chemicals in the environment, including everything from pesticides to personal care products. So it’s very difficult to prove a cause and effect for any one drug’s influence – we are each exposed to a very dilute cocktail of chemicals in our daily lives, whether through the water we drink, the food we eat, or the air we breathe. How can we tease out the potential damage of one chemical over another?
Secondly, it’s pretty likely that any potential harm (from chemicals at such small doses) would take many years of exposure before a clinically measurable threshold is reached. It’s very difficult and expensive to study large groups of people over time – and it’s hard to know what their lifestyle choices may contribute to their overall chemical exposure. Over time people change jobs, change what they eat or drink, change where they live… the complex interplay of environmental factors make it hard to interpret exposures and effects.
And finally, how do we know what outcomes to look at? It’s possible that these small doses of pharmaceutical products could affect our bodies in fairly subtle ways – which again makes it difficult to measure. It’s hard enough to study cancer rates in populations, but how would we study differences in physical or mental performance? Or slight changes in mood or heart function?
Since there’s no easy way to prove a connection between drugs in our water system and our general health and wellbeing, we are likely to be left with far more questions than answers. I think we all agree that we’d rather not be exposed to trace amounts of any chemicals in our water supply, but unfortunately the cost of filtering all potential contaminants from the water is exceedingly high. Reverse osmosis (a process currently used to reclaim fresh water from the sea) can cost as much as $1-18/gallon depending on the system in place and the country using it. While reverse osmosis could guarantee a chemical-free drinking water supply, we couldn’t afford to supply it to all Americans. And in the end, it’s still unclear if solving that part of the puzzle would improve our overall health.
I hope that we’ll find ways to reduce the chemical load on our environment, and that advanced water purification technology will become more affordable in the future. Unfortunately, trace amounts of chemicals, drugs, and pesticides are more ubiquitous than we’d like to believe. The impact they may have on our health is difficult to measure, and largely unknown at this point. Perhaps the bottom line is that we’re all connected to one another through our environment – so that granny’s heart medicines may yet live on (albeit in trace amounts) in your bottled water. All the more reason for Americans to pull together to live healthy lifestyles, control our weight, and try to prevent the diseases that are requiring all these drugs in the first place.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
February 5th, 2008 by Dr. Val Jones in Quackery Exposed
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So my last post stimulated some interesting discussion amongst friends and colleagues. Some applauded the late night supplement “smack down,” and others felt it was too harsh. Still others who don’t read my blog regularly complained that it was unfair to pick on the supplement industry without also pointing out the flaws of Big Pharma. Well, here’s to equal opportunity smack downs – where things “applied directly to the forehead” are as fair game as anti-psychotics, IT mishaps, healthcare professional SNAFUs, and misguided policies resulting in unanticipated harm to patients.
But let’s not forget the happy stories, the unlikely triumphs, and the snatching of victory from the jaws of defeat. We can laugh at ourselves, cry with our friends, and mourn the loss of the lonely. Medicine is full of a broad array of emotions and perspectives, captured here for you in this blog.
And now, back to bunnies and puppies…This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
January 23rd, 2008 by Dr. Val Jones in News
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I was shocked and saddened to hear of the sudden and unexpected death of actor Heath Ledger. As fate would have it, I had watched his movie, “Candy” on the weekend prior to his death. Candy is the sad story of a young Australian couple who get involved in the drug culture, begin shooting heroin, and end up as junkies, prostituting themselves to afford their habits.
While the cause of Heath’s death is not yet known, a drug overdose is suspected and autopsy results will not be available for up to two weeks. A coworker asked me why the results would take so long, and what’s involved in an autopsy. I found a good article on the subject and will excerpt it here:
- Before the actual autopsy, as much information as possible is gathered about the person who died and the events that led to the death. Other information may be gathered by investigating the area where the person died, and studying the circumstances surrounding the death.
- Procedures done during the autopsy may vary depending on the circumstances surrounding the death, whether the medical examiner or coroner is involved, and what specific issues are being evaluated during the autopsy.
- The autopsy begins with a careful examination of the external part of the body. Photographs may be taken of the entire body and of specific body parts. X-rays may be taken to evaluate skeletal or other abnormalities, confirm injuries, locate bullets or other objects, or to help establish identity. The body is weighed and measured. Clothing and valuables are identified and recorded. The location and description of identifying marks, such as scars, tattoos, birthmarks, and other significant findings (injuries, wounds, bruises, cuts), are recorded on a body diagram.
- A complete internal examination includes removal of and dissection of the chest, abdominal, and pelvic organs and the brain. The examination of the trunk requires an incision from the chest to the abdomen. The removal of the brain requires an incision over the top of the head. The body organs are examined before removal, then removed and examined in detail.
- In some cases, organs may be placed in a preservative called formalin for days to weeks prior to dissection. This is particularly important in the examination of the brain for certain types of diseases or injuries. Tissue samples are taken from some or all of the organs for examination under a microscope.
- Completion of the autopsy may require examination of tissues under a microscope, further investigation of the circumstances of death, or specialized tests (such as genetic or toxicology tests). The tests performed may vary based on the findings at the autopsy dissection, the circumstances of death, the questions asked about the death, and the condition of the tissues and body fluids obtained at autopsy. A written report describes the autopsy findings. This report may address the cause of death and may help answer any questions from the deceased person’s doctor and family.
So it makes sense that autopsy results take as long as they do. A thorough investigation requires everything from documenting items from the scene of the death, to a careful analysis of blood toxins, to preserving tissues in formalin before viewing them under a microscope. All of the clues must be carefully weighed (Is there any evidence of a heart attack? Was there a blot clot in the lungs? Was there a brain hemorrhage?) to get the full picture and to be sure of the exact cause of death. All things considered, it’s amazing that the pathologists can render an opinion so quickly.
My heart goes out to Heath’s family as they await closure on the cause of his death.
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See also:
Mira Kirshenbaum discusses depression, suicide, and a healthy way to handle stressful life circumstances
.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
