With the FDA advisory panel recommending approval of the home rapid HIV test using saliva on a mouth swab the U.S. is making a significant change in tactics in screening for HIV. I have been in clinical practice for all but the very earliest of the history of HIV. I was a resident from 1980-1983, and in practice in the Army from 1983-1987. I remember the first patient of mine diagnosed with HIV was a woman who was just a few years post a blood transfusion for a bleeding duodenal ulcer, and who died within months of her diagnosis of multiple opportunistic infections.
In practice in WA since 1987 I’ve tried to obey the letter and spirit of the law requiring pre and post testing counseling for patients receiving HIV testing, and have grumbled that this state law pushed into place by the gay-rights lobby at a time when little effective treatment was available and serious concerns about confidentiality and discrimination were major concerns. Now that highly effective treatment for HIV is available the advantages of early HIV diagnosis would seem to make any barriers to testing for HIV counterproductive. An easy to use, affordable, reasonably accurate HIV test is a big change to the current status-quo, where considerable emphasis is placed on protection of the patient via counseling regarding results, and places more value on more widespread testing, early diagnosis and opportunities for prevention of spread of HIV.
Tests have been available for years for use by individuals to obtain their own specimen and mail it away to a test facility for confidential testing without accessing a physician or medical care provider. These have not been widely used. If the home oral swab rapid test comes to market it is very likely to be much more widely used. I fully agree with the FDA advisory panel that the benefits of this test will outweigh its risks. Still we should not ignore the risks. I see the benefits and risks as outlined below:
Benefits Risks
More HIV positive patients identified Rare false positives may lead to poor decisions
Prevention of some cases of HIV Rare false negatives may lead to not getting blood test
Low financial barrier to HIV testing Some patients may not get appropriate test results counseling
I anticipate that in mass market use the false positive rate and the uninterpretable results rate will be higher than the extremely low rates in the test populations used in the initial studies, but even so I expect the use of a readily available home saliva HIV test will be one more step toward earlier diagnosis and slowing of the rate of spread of HIV in the U.S.
Lorcaserin hydrochororide (Lorqess®) yesterday received FDA advisory panel approval recommendation as the first new weight loss drug in the U.S. in 10 years.
I read a very interesting article today in the New York Times wellness blog by Danielle Ofri M.D. where she reminisced about an article in the annals of internal medicine entitled Lemons for Obesity. Obviously this was not to be taken at face value. I don’t think anyone would consider lemons as an alternative for the grapefruits promoted in the famous grapefruit that. No they are referring to the last several major weight loss drugs to going down in flames and comparing them to flawed products commonly referred to as lemons.
It was a surprise to me just hours later to see that today the FDA advisory panel 18-4 recommendation for the approval of a new medication for weight loss lorcaserin hydrochloride. Lorcaserin hydrochloride, to be marketed by Arena pharmaceuticals as Lorqess® is a drug with serotonergic properties reported to have anorectic benefits and lead to very modest weight loss. At first glance this sounds awfully like Meridia, a drug recently taken off US market because of cardiovascular side effects, in that the weight loss experienced by most patients taking it is quite modest. In the studies presented the FDA there was a 3.3% difference in the percentage of body weight decrease in patients taking locaserin hydrochloride when compared to placebo. The possibly good news that slightly more than 1/3 of patients taking lorcaserin hydrochloride lost 11% of their weight or approximately 25 pounds is somewhat promising.
The big controversy in the approval of lorcaserin hydrochloride appears to be that because it was initially presented the FDA for approval prior to their requirement that new weight loss drugs be thoroughly evaluated for valvular heart disease and other cardiovascular risks Arena pharmaceuticals was not required to present extensive cardiovascular safety data.
In 2010 the FDA rejected lorcaserin hydrochloride when first presented because of a variety of concerns over safety and the very modest claims to weight loss but apparently now with the presentation of additional safety data the FDA advisory committee has changed its position. It’s anticipated that in late June the FDA will present a final ruling on lorcaserin hydrochloride for approval or not.
There’s another drug that has a lot more buzz after 60 Minutes segment called Qnexa. Qnexa is a combination of currently FDA approved phentermine and the anticonvulsant topiramate. Phentermine is an amphetamine that is approved for short-term use but the FDA but is not infrequently prescribed for longer periods of time by some physicians and weight loss clinics. Phentermine gained fame as part of the infamous weight loss drug combination Fen/Phen. Fen/Phen led to huge class-action lawsuits when it became clear that it was associated with valvular heart disease and pulmonary hypertension. Since Fen/Phen many physicians have been much more cautious in jumping on the latest weight loss drugs.
I’m hopeful that both Qnexa and Lorqess are found to be safe and effective weight loss drugs. UBC academic in America is a gigantic concern and we’re a long ways from understanding obesity and from having effective nonsurgical approaches to weight loss and many patients. You may recall a previous post outlining obesity is the Leading Preventable Cause of Death in America as well as Just How Fat are Americans. It’s not that I’m obsessed with obesity but every day in the office I see several patients where their real underlying health problem is obesity. They usually see me for diabetes, hypertension, osteoarthritis, lymphedema, or any number of other presenting complaints that they and I both understand that the real solution to their health concerns is weight loss. Unfortunately I simply have little to offer as an effective solution. Bariatric surgery is gaining traction as an effective approach for the morbidly obese, but the financial barriers to actually getting the surgery are insurmountable in most cases. In addition the very long term risks and benefits of their after surgery are still somewhat uncertain.
Lorcaserin hydrochloride or Qnexa may turn out to be safe and useful tools in our battle to treat obesity but despite the seriousness of obesity and its associated medical complications I anticipate waiting for some aftermarket safety data prior to prescribing these new drugs if they receive FDA approval.
Somehow I was not in the least surprised when I came across a Huffington Post article showing which states in the US have the highest rates of medication use. Why am I not surprised? Intuitively I suspected that these are the states with the highest rates of obesity and smoking. Look back to a prior post on how obesity has surpassed smoking as the leading preventable cause of death in America. Every one of the top 9 most medicated states is in the highest tier of rates of obesity. What medical conditions lead inexorably to the use of multiple medications? Think diabetes, hypertension and chronic pain. All of these conditions are directly related to obesity in many cases. Also think heart and lung diseases like asthma, COPD and coronary artery disease, all well documented to be related to both smoking and obesity. Here are the 9 “most medicated states” from the Huffington Post article with the CDC 2011 rate of obesity in parentheses. For interest I’ve also put the state’s rank in terms of smoking incidence from the CDC data. State (Retail Rx per capita)Rate of obesity Smoking Rate (national rank)
West Virginia (18.4) >30% 25% (tie for 8th highest)
Tennessee (16.9) >30% 25% (tie for 8th highest)
Alabama (16.9) >30% 25% (tie for 8th highest)
Kentucky (16.5) 30% 29% (alone w/top rate)
Arkansas (16.4) >30% 26% (6 way for 2nd)
South Carolina (16.3) 25%-29% 24% (4-way tie for 12th)
Mississippi (15.9) >30% 26% (6-way tie for 2nd)
Iowa (15.3) 25%-29% 22% (3-way tie for 17th)
Missouri (15) >30% 26% (6-way tie for 2nd)
For reference there are nine states with 2009 rates of obesity > 30% of which 7 are here in the top 9 most medicated states. The national average rate of smoking is 21% and all 9 of the states with the highest rates of medication use are in the top 17 states for rates of smoking.
I cannot access the SDI data to see what the rates of obesity are in the states with the lowest incidence of obesity are but here are some other health related statistics and their relationship to a relative lower obesity rate.
1) Colorado is alone as the only state in the US with a 2009 rate of obesity at <20%. Why doesn’t Colorado rank at the very top for the lowest for death rates in adults? Possibly because of a smoking rate of 20% (tie for 28th highest leaving it pretty good but with a death rate of 709/100,00 (11th best).
2) The fifteen states with obesity rates from 20-25% (the best except for Colorado) are listed below in alphabetical order:
Death rate (rank) Smoking Rate (rank)
a) Alaska 742 (2oth) 24% (Tie for 12th highest)
b) California 660 (4th) 15% (50th highest, i.e. 2nd lowest)
c) Connecticut 691 (8TH) 18% (tie for 38th highest)
d) Hawaii 590 (1st) 16% (49th, i.e. 3rd lowest)
e) Idaho 723 (16th) 18% (tie for 38th highest)
f) Minnesota 675 (5th) 17% (tie for 44th highest)
g) Montana 786 (33rd ) 20% (tie for 29th highest)
h) New Jersey 717 (14th) 18% (tie for 38th highest)
i) New York 676 (6th) 19% (tie for 32nd highest)
j) Oregon 748 (22nd) 18% (tie for 38th highest)
k) Rhode Island 749 (23rd) 20% (tie for 28th highest)
l) Utah 659 (3rd) 11% (51st highest, i.e. lowest)
m) Vermont: 721 (15th) 18% (tie for 38th highest)
n) Virginia 762 (25th) 19% (tie for 32th highest)
o) Wyoming 773 (29th) 21% (tie for 21st highest)
Looking at this data you may note that 4 of the 5 states with the lowest death rates are in the 15 states with the lowest rates of obesity, and that none of them are worse than the 44th highest smoking rates. (only Arizona is missing, in the next 25%-29% obesity rate and at a tie for 21st in rate of smoking) You may also note that the only two states in the top 15 for lower obesity rates ranking in the bottom half for death rates have smoking rates ranking at 21st and 29th.
Contrast this with the five states with the highest death rates:
West Virginia with >30% obesity and 25% smoking rate (tie for 8th highest)
Mississippi with > 30% obesity and 26% smoking rate (tie for 2nd highest)
Oklahoma with >30% obesity and 26% smoking rate (tie for 2nd highest)
Alabama with > 30% obesity and 25% smoking rates (tie for 8th highest)
Louisiana with >30% obesity and 26% smoking rate (tie for 2nd highest)
In contrast the states with the lowest death rates have the opposite statistics for obesity and smoking rates:
Hawaii with 20-24% obesity and 16% smoking rate (3rd lowest).
Arizona is the exception in these states with 25-29% obesity and a smoking rate of 21% (right at the national average and ranking in a 6 way tie for 20th highest in the U.S.
Utah with in the 20-20% obesity and the lowest smoking rate in the U.S. at 11%.
California with 20-24% obesity and 16% smoking, second only to Utah.
Minnesota with 20-24% obesity and in a tie for 4th lowest smoking rates at 17%.
It appears that states where citizens choose not to smoke and trend to be less obese have both lower rates of medication use and lower death rates. My guess is that the observation of lower death rates and lower rates of medication use are the result of lower rates of diabetes, hypertension, COPD, cardiovascular disease in these same states. Yes these other health markers also trend directly with obesity and smoking rates.
So what can you as an individual learn from this? Get fit, avoid obesity and don’t smoke. No surprises here.
Overdiagnosis was not a term I ever heard in medical school, and I suspect it is one that few or you had heard of much more than a year or two ago. Overdiagnosis is when a condition is diagnosed that is not causing any symptoms for a patient now, nor will it cause symptoms at a later time in their life. I wrote about overdiagnosis earlier after reading the excellent book, “Overdiagnosed: Making People Sick in the Pursuit of Health” by H Gilbert Welch.
This book nicely discusses the issues of overdiagnosis in both chronic disease and in cancers. The long-held assumption that all malignancies left untreated progress, spread and lead to death is simply not true. We are learning that many types of cancer have unpredictable courses. Prostate cancer is the most notorious of these, with good evidence showing that most prostate cancers are ones patients live with asymptomatically whether they know about them or not and die of something else without ever having symptoms of the prostate cancer. This is the primary issue behind the recent USPSTF “D” recommendation against routine PSA screening in asymptomatic men. There is strong evidence that some percentage of renal cell cancers, some types of breast cancer and thyroid cancers not infrequently regress or remain indolent and never lead to symptoms.
The recent evidence suggesting frequent overdiagnosis in breast cancer is very disturbing. An April 3 article in the Annals of Internal Medicine in a large retrospective review in Norway infers a 15-25% incidence of overdiagnosis in women found to have breast cancer on mammographic screening. They used every other year screening, and suggest that for every 2500 women screened 6-10 cases of overdiagnosis occurred, 20 women were diagnosed with breast cancer that was not overdiagnosis, and 1 death related to breast cancer was prevented. We have strongly encouraged women to get annual mammograms for years. Personal anecdotal experience can make us even more confident that we are doing the right thing. I have had many patients diagnosed with early breast cancer by mammogram over the last 20+ years, and until recently had not had any women over age 40 that I can recall diagnosed with advanced stage breast cancer who had been getting their annual mammograms. It was very intuitive and tempting for me to believe that I was saving many lives and preventing much morbidity by aggressively pursuing early breast cancer diagnosis. I know that I have put many women through emotionally stressful and uncomfortable additional testing, biopsies, and breast cancer treatment. It is concerning to think that I may be subjecting some of these women to overdiagnosis and unnecessary treatment, but until we as a society actively address the issue of overdiagnosis and try to find ways to figure out which early cancers found on screening can be managed with active surveillance and which need curative treatment we are left with the inevitable overdiagnosis dilemma. This will involve asking a cohort of women with various very early cancers to be observed for progression prior to intervention. Whether this is going to be acceptable is not clear. We need to do the same thing for men with early prostate cancer. We are following lots of men with prostate cancer, but as far as I know not in a formal study that will give us help in knowing which cancers can be safely followed. For now I’m doing nothing different except keeping my eyes wide open to further research and recommendations.
Much of what we do in medicine today is aimed at early diagnosis of asymptomatic disease, and overdiagnosis is a very valid concern any time we are screening for asymptomatic disease. The recent changes in criterion for hypertension, diabetes and hypercholesterolemia are leading us to the preventative treatment of many diseases that are of themselves asymptomatic. The whole issue of overdiagnosis is going to be fascinating to follow over the next decade or two.
In order to help readers understand what causes heart disease here is another in my Monday series of selected Khan Academy Health related videos will focus on coronary artery disease and heart attacks. This video is quite helpful in laying out the basics of heart disease, and should answer most of the answers as to what causes heart disease. A few clarifying points may make it a bit more helpful. First when they talk about an atherosclerotic plaque rupturing and leading to a clot that causes a heart attack they don’t mention that the mechanism of the clot’s initial formation is the aggregation of platelets at the site of the ruptured plaque. That’s why we often recommend taking low dose aspirin to inhibit platelet aggregation, so that if a plaque ruptures platelets are less effective at aggregating at the site and causing complete coronary artery blockage. In addition medications like the statins and possibly the ACE inhibitors or ARB medications probably function at least in part by stabilizing the lining cells of arteries and reducing the chances of plaque rupture.
One other comment is that the video implies that only if a large heart attack occurs is cardiac arrest likely. Actually even small heart attacks, and likely even episodes of coronary ischemia not severe enough to cause actual death of cardiac tissue can lead to cardiac rhythm disturbances, a.k.a. cardiac arrhythmias that may cause cardiac arrest and sudden death.
The key to preventing coronary artery disease, heart attacks, heart failure and cardiac arrest is to lower your risk of developing atherosclerosis. The primary risk factors are tobacco use, high blood pressure, diabetes, lipid abnormalities like high LDL cholesterol and low HDL cholesterol, obesity and sedentary lifestyle. In some cases other familial factors play a role, but most often a strong family history of heart disease is because of a hereditary tendency to one or more of these risk factors.
So what do you do? In order of importance in my opinion:
Don’t smoke. If you do smoke quit now.
If you have high blood pressure be sure it is well controlled.
If you have diabetes do everything you can to control your blood sugars.
If you have high LDL cholesterol and other risk factors discuss use of a statin or other lipid lowering medications with your doctor.
Stay fit. Exercise regularly, reduce your dietary animal fat intake, and lose weight if you are overweight or obese.
If you already have atherosclerotic vascular disease, i.e. if you have had a heart attack, stroke, or peripheral artery disease even more aggressive treatment of risk factors like high cholesterol, high blood pressure, obesity, and diabetes is important. Ask your doctor about how to accomplish these things.
I like some Latin phrases that have become part of our language. See an earlier post Carpe Diem. ”Ad hoc” is a commonly used moniker meaning literally “for this”, but the term “post hoc,” or more properly “post hoc ergo propter hoc,” (Latin for after the fact, therefore because of the fact) is used to describe the tendency to infer a causal relationship to what happens after something to the preceding event or action. The whole debate about MMR and autism is because the MMR vaccine is given to 1-year-old children and the first signs of autism are usually noticed in the few months after the usual time to give MMR. This post hoc ergo propter hoc assumption is a big part of the reason that when you look at the list of side effects of any medication on the manufacturer’s prescribing guideline nearly every commonly encountered symptom is listed. When you look at the comparison of side effects of the drug being tested and compare this to the incidence of the side effects of placebo control, it is amazing how commonly “side effects” of placebo occur. I jokingly tell patients who come in for evaluation of a problem just as it seems to be resolving that I wish I had seen them yesterday. Then I could have taken credit for a cure. The tendency to assume that what happens in the period of time shortly after an intervention is the direct result of and caused by the intervention is natural although not always correct.
This same issue occurs with everything from surgeries to chiropractic care. I remember in medical school that one student in our class was traumatized by the sudden death of his patient right in the middle of his first time alone with a patient for a physical exam. Did he do something to cause her death? Almost certainly not, but still he was likely pretty anxious the next few times he did a physical exam.
The natural course of many self-limited illnesses makes post hoc ergo propter hoc relationships very common. If you have a sinus infection that is going to last 10 days, but you see the doctor on day 8 and get an antibiotic, are told the medication should help within 2-3 days, when you recover in 2 days it is natural to credit the recovery to the antibiotic. If you get a headache the day after you start a new medicine, or a rash when you have been on the medication for a few days then post hoc. The relationship is assumed.
This issue is discussed very nicely in a recent article in Forbes by Henry Miller:
The Data on Drugs’ Side Effects Must be Reliable
As a medical resident at a major cancer center some years ago, I was responsible for administering a 4 a.m. intravenous dose of a drug that was part of the patient’s treatment protocol. I stood by the patient’s bedside, groggily flicking and tapping the syringe to get the last tiny air bubble out of the drug before injecting it.
Just as I was about to push the plunger to administer the drug, the patient died — just stopped breathing and expired. There was a “do not resuscitate” order, so sadly, that was that. The time was 4:01 a.m.
Had I more quickly removed the air bubbles and administered the drug at exactly 4 a.m., the patient would have died within seconds of receiving it. As a result, the investigators on the treatment protocol, the maker of the drug, federal regulators and I would all have suspected that the drug was the proximate cause of death. Read more
This post hoc issue plays havoc with everything from medication side effects reporting to patient’s expectations for treatment. I think it is an import concept to keep in mind when we try make sense of what we observe in live and medicine.
I was reading my American Family Physician at the YMCA this weekend, and found an article “Implementing Advance Directives” that prompted me to come home and write this post. I have to admit that I should need to more often and earlier with many of my patients. I need to have a better plan for helping patients successfully and confidently choose to complete both a living will and a durable power of attorney. A living will outlines you preferences for decisions you want made on your behalf in various circumstances if you are unable to verbalize you own preferences. A durable power of attorney legally authorizes someone to make health care decisions for you in the circumstances where you are unable to make them for yourself. These two documents complement each other. I’ve too often tried to maneuver the minefield of coming to decisions for a patient’s care when they have failed to make their preferences clear and implement a durable power of attorney giving one individual the power to execute those choices. Then an out of town relative shows up to save the day, or a sibling dispute over how to deal with Dad’s terminal illness care happens. This type of thing is all too common, and makes a stressful time for everyone. Making your preferences known, putting it in writing, and designating a legal power of attorney helps your loved ones avoid this unnecessary messy and at times ugly scenerio. Both of these documents are crucial to both you and your family to assure that your wishes for decision making about your health are carried out according to your wishes.
Why don’t I do a better job? I suspect it is a combination of factors. I think the first is that this is rarely high on a patients list of topics they want to discuss at an office visit. It is easy to put off this discussion when seemingly more pressing issues are the patient’s expressed reason for the office visit. Even at physical exam visits, or in the medical coding lingo “preventative care” or “health maintenance” visits, it is alluring to focus on topics that lead to a longer or healthier life rather than a better death experience. Here is the list of the physician-related barriers to completion of an advance directive listed in the AFP article:
Discomfort with the topic.
Lack of institutional support.
Lack of reimbursement.
Lack of time.
Waiting for the patient to initiate the discussion.
In my case it is certainly not discomfort with the subject, and I am not intentionally waiting for the patient to bring up the subject, but lack of time and reimbursement undoubtedly play a role.
In addition most patients really don’t need my help in working through this decision process if they address the issue before there is a crisis. Although there are cultural, personal and ethnic variables that shape our decision making, most of my patients can really quite quickly and easily work through the process of completion of both a very functional living will and a durable power of attorney without my assistance. So why doesn’t everyone just do it themselves? Here are the barriers listed in the AFP article that are patient related:
Fear of burdening others, i.e. family or friends.
Health Literacy
Lack of interest or knowledge of the subject.
Spiritual, cultural or racial traditions.
Waiting for their physician to initiate the discussion.
So how can you just “Do it yourself?” It’s really easy. Obvoiusly since you are reading this article you have access to the internet, and everything you need is just a few clicks away. I encourage you, if you have not already completed these documents, to DO IT NOW:
Down load your state’s Advance Directives at the caringinfo.org site. This is really easy and you can get everything you need by selecting your state from the list here.
Many states have a form called a POLST form. This stands for physician orders for live sustaining treatment. If you use a search engine like Google, and you type in your state + POLST form you will easily find a form to download if your state has a POLST form. You can get the Washington State form to download easily at WA POLST download. Many physician offices have these available, just ask your doctor.
For some people a form to help you ascertain your values on this subject and to make your values clear to the individual you choose to have your medical power of attorney is helpful. The University of New Mexico Institute for Ethics has published online a non-copyright protected form for you to download. Some patients will find it helpful to attach this to their advance directive as guidance to their proxy in making decisions in line with their values.
There you have it. You have no more valid excuses to keep you from completing your own advance directive and living will. Once you complete it be sure to not keep it a secret. Give a copy to your physician, to the person you choose as your DPA, and keep a copy handy at your home. Don’t be a victim of your own procrastination or discomfort with this topic. If you find it helpful ask questions on the subject up with your personal physician. Be sure to let them know you have these documents completed.
In my best cheer-leading mantra: You can do it! Go – Go – Go!
Is suicide the epitome of selfishness? I was initially taken aback when a person I completely respect told me how angry he was about a colleague who had committed suicide, telling me how selfish he though the person had been. I had not thought of suicide as a selfish act previously, but have thought a good deal about it since.
I see patients, parents, grandparents, siblings, friends and lovers concerned about suicide in the office from time to time. Other times I am the one concerned about suicide in patients I think may be at risk. Suicide is I a big and growing concern in the U.S. these days and I thought this would be a good time to write about this topic to share some statistical information and some thoughts. I hope to stimulate a forum for comments and sharing of thoughts in the comments below.
First some thoughts:
I think of suicide as the ultimate in selfish behavior most of the time. The purported victim leaves behind many other victims of their act. Family, loved ones, friends, associates and their whole community are left to grieve, often filled with guilt over the lost soul. Don’t ever think of suicide as leaving the world better off without out your presence, you will leave far more sadness and grief behind that if you live.
Never be afraid to ask anyone if suicide is a concern. They may lie and say no, but often people with suicidal intent will admit their concern if directly and empathetically asked.
If you have concerns about suicide for yourself or someone else ask for help. There are 24-hour crisis lines available, your physician, pastor, or other professional is obliged and usually happy to try to help.
Never think of a half-hearted suicide attempt as a way to find help. Miscalculations or other mishaps can make a suicidal gesture (not really meaning to kill yourself, but really asking for help) into a successful suicide all too often.
Is suicide the epitome of selfishness? I was initially taken aback when a person I completely respect told me how angry he was about a colleague who had committed suicide, telling me how selfish he though the person had been. I had not thought of suicide as a selfish act previously, but have thought a good deal about it since.
I see patients, parents, grandparents, siblings, friends and lovers concerned about suicide in the office from time to time. Other times I am the one concerned about suicide in patients I think may be at risk. Suicide is I a big and growing concern in the U.S. these days and I thought this would be a good time to write about this topic to share some statistical information and some thoughts. I hope to stimulate a forum for comments and sharing of thoughts in the comments below.
First some thoughts:
I think of suicide as the ultimate in selfish behavior most of the time. The purported victim leaves behind many other victims of their act. Family, loved ones, friends, associates and their whole community are left to grieve, often filled with guilt over the lost soul. Don’t ever think of suicide as leaving the world better off without out your presence, you will leave far more sadness and grief behind that if you live.
Never be afraid to ask anyone if suicide is a concern. They may lie and say no, but often people with suicidal intent will admit their concern if directly and empathetically asked.
If you have concerns about suicide for yourself or someone else ask for help. There are 24-hour crisis lines available, your physician, pastor, or other professional is obliged and usually happy to try to help.
Never think of a half-hearted suicide attempt as a way to find help. Miscalculations or other mishaps can make a suicidal gesture (not really meaning to kill yourself, but really asking for help) into a successful suicide all too often.
Next some statistics that I find interesting and informative:
N 2007 suicide was the 10th leading cause of death in the U.S.
Although persons of all ages may commit suicide young men and the elderly are by far at highest risk. The incidence of suicide in adolescents ages 15-19 is 6.9/100,000, in young adults 20-24 is 12.7/100,000 and in adults 65 and older 14.3/100,000. In the age range 15-19 males are 5x as likely as females, and in 20-24 males are 6x as likely as females to die of suicide.
Access to firearms is a major risk for successful suicide. Children in homes with firearms are 10x as likely to die of suicide as children in homes without firearms.
Both men and women die of firearms related suicide but males are especially at risk. 56% of male suicides involve firearms vs. 30% of females. Males are also more likely to die of suffocation than females at 24 vs.21%.
Females are far more likely to die of poisoning at 40% vs. 13% than males.
Gay young men are especially at risk for suicide. See comments below.
Risk factors for suicide include:
Prior suicide attempts
Mental health problems
Drug or alcohol abuse
Separation or divorce
Physical or sexual abuse
Being young and gay. Several studies show higher risks of suicide in gay male adolescents. Risk estimates range from 2-10x. (1,2)
Returning veterans of the recent Iraq and Afghanistan wars are at risk.
So what can we do to keep suicide from affecting those near us? I suggest a few things.
If you choose to have firearms in your home, take rigorous precautions to keep them away from adolescents. Recognize this as a major risk factor.
Even if you do not suspect any concern, make the topic a regular subject to bring up with your child. Be sure they understand that suicide is not acceptable, and that you are very willing to help them in any way if suicide becomes remotely a concern.
Take any suicidal hints or references very seriously.
Keep prescription and non-prescription medications well away from youth. Buy non-prescription drugs in small quantities or keep larger quantities locked away.
Never think of suicide as beneficial to others. It is strictly a selfish exit from life, and leave behind others to struggle with your loss as well as all of their own problems. It makes nothing better.
I’d love to hear comments from readers. Leave a comment below.
The possible increased incidence of pradaxa side effects of serious bleeding have become newsworthy since my post on Pradaxa in July, Pradaxa side effects especially bleeding complications have dominated the news on this new anticoagulant. I think it is hard to put these pradaxa bleeding side effects in perspective. The use of Pradaxa has been quite popular in the treatment of patients with atrial fibrillation for the treatment of stroke. In the initial study of approximately 18,000 patients that led to the FDA approval of Pradaxa the incidence of bleeding complications was fairly similar to the incidence of bleeding on warfarin therapy. Between the FDA approval of Pradaxa in October 2010 through August 2011 the FDA reports approximately 1.1 million Pradaxa prescriptions dispensed in the US and over 3 to 70,000 individual patients treated with Pradaxa from outpatient retail pharmacies. This is a lot of patients and with the known bleeding complication rates of both warfarin and Pradaxa significant number of major bleeding side effects would’ve been expected. This is been the case and the FDA is currently reviewing aftermarket use of Pradaxa using a process called The Mini-Sentinal surveillance program to see if the bleeding complication rate in newly started patients on Pradaxa is comparable to warfarin or maybe better or worse. Certainly the Pradaxa side effects of major bleeding are dramatic and can be life-threatening, just as the same as these complications with warfarin use can be. Still the benefit of stroke prevention in atrial fibrillation patients is generally felt to be enough higher than the risk of bleeding complications that anticoagulation therapy with either warfarin, Pradaxa, apixaban or one of the other anticoagulants on the market is felt to be indicated for many patients.
I’ve heard from patients and red in the news about the fact that Pradaxa cannot be reversed with vitamin K like warfarin can. I think this is a seriously flawed argument. The Pradaxa half-life is short enough that requires twice daily dosing (12-17 hours) and within about 36 hours after the last dose of Pradaxa it’s anticoagulation effect should be largely gone in patients with normal renal function. When using vitamin K as an antidote warfarin it takes a day or two for significant hepatic metabolism of the coagulation factors inhibited by warfarin and I seriously doubt if use of vitamin K leads to a reversal of the anti-coagulation in warfarin patients any faster than or even as fast as simply discontinuation of Pradaxa therapy. It’s true that in major emergencies either fresh frozen plasma or other coagulation factor products can be used as an infusion to reverse the quite neuropathy in warfarin use. Pradaxa works directly as an inhibitor of coagulation, so its anticoagulation effect should be less responsive to this type of therapy. Still I suspect that the argument that there’s no antidote for Pradaxa is less important clinically than it sounds in newsprint.
It will be interesting to see how the aftermarket evaluation of Pradaxa and the other newer anticoagulants bears out. Patients taking Pradaxa seem to certainly appreciate not needing to have frequent coagulation clinic visits to monitor their quite elation status necessary with warfarin use, and so far thankfully I’m not aware of any of my patients who have had bleeding complications from Pradaxa. I seem to see the current local cardiologists still prescribing Pradaxa fairly frequently and my expectations are that as more data comes to bear on the situation Pradaxa will be found to have a bleeding complication rate fairly similar to warfarin. Stay tuned for more updates regarding Pradaxa side effects and efficacy as they become available.
I read with a personal interest the approval of Kalydeco (ivacaftor) this week for treatment of the 4% of cystic fibrosis patients carrying the G551D mutation. My first wife Lenore had cystic fibrosis and died at age 26. At that time in 1983 we knew a great deal less about CF than we know now. The introduction of Kalydeco this week brings several key issues in health care to the forefront. Development of drugs to treat disorders with a limited number of patients to use the drug can make the cost to each individual seem crazy expensive. The specific direct targeting of Kalydeco at a specific gene mutation is possibly an indicator of personalized treatments for more common disorders in the future. The whole fast-track process used by the FDA in approval of Kalydeco is an example of their faster approval of some drugs working as promised.
In the years since Lenore’s death CF has been found to be caused by a mutation in the cystic fibrosis trans-membrane conductance regulator (CFTR) gene that regulates ion transportation (ions like chloride hence the traditional sweat chloride test for CF) and therefore fluid flow within cells. One specific mutation is the G551D mutation (substitution of aspartic acid for glygine at position 551), and the new drug Kalydeco specifically targets the abnormal protein in these specific CF patients. Kalydeco helps the defective protein work more normally, and so reduces the abnormalities in CF patients with this specific mutation.
Unfortunately only about 1 in 25 CF patients have this specific mutation in the CFTR genetic code. The rest have some combination of the other at least 1000 known mutations. The most common CFTR mutation is called F508del (a 3 nucleotide deletion at location 508 leading to a missing phenylalanine amino acid “F”) and about 1 in 30 Caucasians have this specific mutation in the CFTR gene. Kalydeco is not effective in patients who are homozygous for the F508del mutation. This homozygous F508del mutation is the most common genetic code in CF patients. IN the 4% of CF patients with at least one copy of the G551D mutation Kalydeco has been shown to be effective in reducing CF symptoms, and is an exciting breakthrough.
Patients with the G155D mutation produce a protein that is able to make it to the cell membrane, where Kalydeco allows it to function much more normally. In patients with the F508del mutation the protein fails to fold in a way that allows it to move to the cell membrane, and so a drug like Kalydeco cannot function. Scientists are working on possible medications that could allow the migration of the other defective genes to the cell membrane where use in combination with Kalydeco could potentially be effective.
It is exciting not just for the 1200 U.S. patients with this specific type of CF, but also because it is an example of how genetic research, gene analysis in genetic disorders, and great basic science can lead to novel therapy for genetic disorders.
The rapid approval of Kalydeco is a great example of the new expedited FDA approval process for drugs that have the potential to be novel or breakthrough products where there is currently no effective therapy, or the drug is a major advance in therapy. It took only 3 months for Kalydeco to get FDA approval, even faster than the promised fast-track approval promised for special circumstance drugs.
The catch in this whole process is the incredible anticipated cost of Kalydeco. In a Wall Street Journal article the estimated annual cost of Kalydeco is reported to be $294,000. Since the anticipated number of patients eligible to receive this orphan drug is so small, and because of the novel and documented improvements demonstrated in patients using Kalydeco it is expected that insurers will pay for the cost of the medication. If all 1200 eligible patients take Kalydeco the annual cost at this price would be $353 million annually. Still this price is not Guinness world record. Two more expensive drugs are Soliris for a rare condition parosysmal nocturnal hemoglobinuria at $409K annually and Elaprase for the rare genetic disorder Hunter Syndrome , a polysaccharide storage disorder, at $375K annually. These are examples of orphan drugs with very limited markets where the cost of development is shared by very few patients.
I look forward to seeing more examples of genetic research leading to personalized medications for individuals.
