March 20th, 2008 by Dr. Val Jones in News
Tags: Pharmaceuticals, Research
1 Comment »
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 News
Tags: Finance, Hospitals, Medical Ethics, News
4 Comments »
There have been some recent news stories about a new type of identity theft – people (presumably without health insurance) are able to get coverage by stealing your insurance information and posing as you during hospital visits. Alternatively, hospital employees can steal your information and sell it on the black market. Some people estimate that medical identity theft may account for up to 3% of all identity theft in the US. Yikes! I even blogged about an infuriating previous encounter I had with a medical identity thief in the inner city.
I had my identity stolen once about 7 years ago – it was a very sobering experience. One day my credit card company called me to ask about some suspicious activity… which led to tracing events and purchases with eventual police involvement, further investigations, culminating in a Nigerian crime ring apprehended in upstate New York. Wild stuff. But I still use credit cards.
I would hate to think that medical identify theft could stall our good faith efforts at streamlining the healthcare experience. Sharing information securely and safely is a critical piece of the continuity of care and quality puzzle. Will there be hackers? Probably. Will some people be victimized? No doubt. But the vast majority of folks (if appropriate precautions are taken) will benefit from having all their providers on the same page, their medications, tests and procedures de-duped, and accurate records available for loved ones in emergencies.
The elephant in the room is whether or not people will be excluded from insurance coverage based on their electronic health records. To me, that’s scarier than potential medical identity theft, and probably the largest reason why patients are hesitant to digitize their health information (i.e. use PHRs).
What do you think about this elephant? Is there anything that can be done about him?This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
March 11th, 2008 by Dr. Val Jones in News
Tags: Cancer, Infectious Disease, News, Obstetrics And Gynecology, Pediatrics, Research, Urology, Vaccines, Women's Health
1 Comment »
I was surprised by recent recent findings from the CDC’s National Health and Nutrition Examination Survey– one in four teenage girls (ages 14-19, chosen at random in the US) tested positive for some sort of sexually transmitted disease, most commonly HPV (human papilloma virus) (18%), followed by chlamydia (4%), trichomonas (2.5 %), and herpes (2%).
I asked Revolution Health expert, Dr. Iffath Hoskins, (Senior Vice President, Chairman and Residency Director in the Department of Obstetrics and Gynecology at Lutheran Medical Center in Brooklyn, N.Y.) what she thought of this news.
“This relatively high infection rate is cause for concern. We need to increase our education efforts so that teenagers are more aware of the risks of sexually transmitted diseases, especially since women’s reproductive futures are at stake. Chlamydia infections can substantially decrease fertility rates, long after the infection has been fully treated with antibiotics.
As far as the high HPV rates are concerned, I’m not surprised since previous research has estimated that 80-90% of adults have been infected with at least one of 80 subtypes of this very common virus. Only 6 of these 80 are known to predispose women towards cervical cancer. But the HPV vaccine can substantially reduce the risk for contracting those 6, so it’s important to vaccinate young girls against this virus.
No teenage girl should be walking around with chlamydia or trichomonas. They are treatable with antibiotics.”
The study also found racial differences between STD infection rates in teenage girls, with blacks being infected at twice the rate of white or Hispanic girls. The CDC is calling for educational outreach to at-risk groups, and the American Academy of Pediatrics supports confidential teen screening.
I hope that these staggering statistics act as a wake up call to health care providers who may not have thought to screen their teen patients for STDs. Apparently, these infections are more common than we realized.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
March 10th, 2008 by Dr. Val Jones in News, Opinion
Tags: Cancer, Food and Nutrition, News, Pharmaceuticals, Research, Technology
2 Comments »
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.
March 5th, 2008 by Dr. Val Jones in News
Tags: Cancer, News, Oncology, Pancreatic Cancer
5 Comments »
Patrick Swayze, the popular actor perhaps known best for his role in the 1987 hit movie “Dirty Dancing,” reportedly has pancreas cancer (commonly called pancreatic cancer). Pancreas cancer is among the more deadly forms of cancer. I asked Revolution Health cancer expert Heinz-Josef Lenz, M.D., professor of medicine and professor of preventive medicine in the Division of Medical Oncology at the Keck School of Medicine at the University of Southern California, to explain pancreas cancer.
Dr. Val: Why is pancreas cancer so much more deadly (i.e. less treatable) than many other forms of cancer?
Dr. Lenz: Unfortunately we don’t have very effective drugs for pancreas cancer, which makes it one of the deadliest cancers of all. The median survival is about 8 months with metastatic disease. Even when the tumor is successfully removed there is a very high risk for tumor recurrence. We need more funding to better understand the risk for pancreas cancer and identify and develop more effective therapies.
Dr. Val: Can you describe the typical course of metastatic pancreas cancer?
Dr. Lenz: Unfortunately, the 5 year survival rate for pancreas cancer is only 15 to 20%. The average survival after diagnosis is 12 to 19 months. The best predictor of long term survival is if the tumor is found and removed before it reaches 3 cm in size. Patients with metastatic pancreas cancer are usually treated with a combination chemotherapy consisting of gemcitabine, tarceva, xeloda or oxaliplatin. However the response rates are (despite using aggressive combination therapies) low. Large clinical trials recently did not show any benefit from erbitux or avastin, again demonstrating that pancreas cancer therapy is a difficult clinical challenge.
Dr. Val: Are certain populations at higher risk than others for pancreas cancer?
Dr. Lenz: Age is the most important risk factor for this cancer. It is most common in individuals over age 50 and increases in frequency with age. Black men and women are slightly more likely to get pancreas cancer (though the reasons for this are unclear), and men are slightly more likely than women to get the cancer. Other risk factors are smoking, diabetes, and obesity.
Dr. Val: If you suspect that someone is “high risk” for pancreas cancer, what tests should he/she have?
Dr. Lenz: Patients with a genetic predisposition for breast cancer known as BRCA are also at higher risk for pancreas cancer. There is also a familial form of pancreas cancer. These high risk families are being followed up with specific screening plans. However there is not a reliable test for pancreas cancer. Imaging with CT or MRI can miss pancreas cancer and there is no reliable blood marker. The most common used is CA 19-9, which can be used for monitoring and diagnosis but is not elevated in all patients.
Dr. Val: What if the cancer is caught very early? Does that increase likelihood of survival?
Dr. Lenz: Absolutely. The best chance of survival is when the cancer is limited to the pancreas, and is surgically removed before it reaches a size of 3 centimeters. There are certainly people who have been cured this way, but unfortunately it’s very rare to catch the cancer at such an early stage since it usually has no symptoms until it’s quite advanced.
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There is a wonderful advocacy group for those whose lives are touched by pancreas cancer: PanCAN. One of PanCAN’s founders, Paula Kim, is a friend of mine and was inspired to create the organization after her dad was diagnosed with pancreas cancer in 1999. At that time there was very little advocacy for this deadly disease. PanCAN helps people with pancreas cancer find help and support.This post originally appeared on Dr. Val’s blog at RevolutionHealth.com.
