Friday, May 30, 2008
"The FDA is urging patients to talk with their health care professionals now about switching to HFA-propelled albuterol inhalers. These products are safe and effective replacements for CFC-propelled albuterol inhalers"
If you are a reader of this blog, then you were well prepared by a recent post on this issue. In any event, please read the previous post for more information.
Wednesday, May 28, 2008
One of our recent medical school graduates, Dr. Fred Weiss, pointed me toward one such website/blog at www.YourMisdiagnosis.com.
The premise does sound legitimate:
"This web site is designed as an aide in helping patients and their families address the concern of medical misdiagnosis. We built this as a place where people can share stories and learn from others’ experiences."
They even take efforts to state that they are not trying to blame doctors, but rather raise awareness, increase discussion, and hopefully solve the problem. Thus far there are two "posts" from "patients" who relate their stories of being misdiagnosed with cancer, and relieved to find out it was only an infection. You are similarly encouraged to post your own personal experience with misdiagnosis.
Here's the catch. There is one impressive looking advertisement on this "blog" for Premerus Diagnostic Excellence. Premerus is a diagnostics imaging site where physicians refer to local premerus imagining centers, and then the images are sent to a central site where the "Premerus Expert" interprets the study and communicates this back with the physician. Though it is not entirely clear why the Premerus radiologist is better than your local radiologist, the site touts that their product "increases diagnostic accuracy, improves patient outcomes, and decreases health care costs." The site also discusses the common problem of....(get ready)....misdiagnosis.
It took some very simple Internet snooping to easily discover that the owner of YourMisdiagnosis.com and Premerus Diagnostic Excellence is one in the same!!
I am sure that using a blog deceptively to promote some product is not new and will continue for as long as blogs exist. However, this is particularly disturbing since the Chief Medical Officer Gregg P. Allen, M.D and the medical director Norman Scarborough, M.D. of Premerus are both physicians. Though promoting health care services can be done in an ethical way, this deceptive way of using a medical blog is certainly an infraction of the ethical standards of the medical profession.
If you use the Internet, and medical blogs, in particular as a source for medical information, make sure to check on the source of information. Look at the "about" section to view the author's credentials. Look at who advertises on the site. Advertising is not inherently bad (I am up to $5 profit on my Google Ad for this blog), but look out for potential conflicts of interest. Finally, I believe the only way to solve this problem is to collectively police. If you find an unscrupulous medical blog, do more than just ignore it, call it out and warn others. This was my intent for this post.
Friday, May 23, 2008
This wave of "news" stems from recent reports that first the FAA banned pilots and air traffic controls from using Chantix, and subsequently The Federal Motor Carrier Safety Administration that oversees trucks and buses issued a warning that they would not qualify anyone currently using Chantix for commercial motor vehicle licenses. Both agencies based their decision from a report released from the non-profit Institute for Safe Medication Practices that examined adverse-event reports turned into the FDA and found 988 serious health problems reported in association with Chantix use, including seizures and heart trouble.
It is important to note that the ISMP is not a federal or regulatory agency, and it is not the FDA. The FDA reviewed these reports, and despite their eagerness to get out any bad news about medications, didn't seemed to concerned. This is because when millions of people start taking a drug, some people are going to have side effects. The side effects reported are rare and are consistent with side effects found in the studies that Pfizer submitted to the FDA.
However, looking at post-marketing side effects is very important. Chantix is a good example. As I blogged about previously, in the studies that the Pfizer submitted to the FDA, Chantix had few interactions and side effects (except nausea, which was usually mild and usually went away). However, because Chantix compared its drug to bupropion (the only other pill indicated for smoking cessation, but also used for depression), patients with mental illness were excluded from the study. What happened was that once the drug hit the market, and started to be taken by patients with mental illness, some patients and doctors observed worsening of their mental conditions, including suicide. This does not necessarily mean that this was caused be Chantix, because just stopping smoking can cause these effects. However, the FDA appropriately released an early warning back in November of 2007.
Do not get this warning confused with the recent news about the FAA and FMCSA. They are not related. The former is a warning from the FDA about newly discovered side effects and the later is an agency decision based on information from a non-profit regarding issues that the FDA knew about and didn't seemed too concerned.
Adverse event reporting is important, and it seems like the FDA is finally going to ramp of the process of reporting, which is currently voluntary and quite spotty.
However, in all the recent media storm about Chantix, very recent good news was lost. Hear are the headlines you didn't read.
New Smoking Cessation Guidelines find Chantix the Most Effective Pill to Help Smokers Quit
Earlier this month, the surgeon general released "Treating Tobacco Use and Dependence: 2008 Update" which is the latest smoking cessation guideline. The guideline builds on the previous document from 2000 showing that there are multiple therapies, including medications that are effective at helping smokers quit. In fact, medication (pills, patches, gum, etc. ) are so effective, the guidelines recommend these for EVERY smoker. Since Chantix was new, they looked at the data around Chantix. There is a table which shows the relative effectiveness of medications, and Chantix rose to the top. Tobacco smoke is the single leading preventable cause of death in the US. Guidelines clearly state that medications should be offered to all smokers who want to quit. Chantix is the most effective agent. That sounds like good news to me.
FDA Label Change to Chantix Reassuring
As mentioned above, the FDA looked into the issue of worsening of neuropsychiatric symptoms in patients taking Chantix. On May 19th, the FDA made the final update to the Chantix label, which was the following:
"Advise patients and caregivers that the patient should stop taking CHANTIX and contact their health care provider immediately if agitation, depressed mood, or changes in behavior that are not typical for them are observed, or if the patient develops suicidal ideation or suicidal behavior."
If you read between the lines, this is an appropriate warning, and not a serious precaution such as the dreaded "black box" warning. The label doesn't say that Chantix even causes these side effects (because they may not) but doctors and patients, especially those with mental health disorders should look out for these symptoms. This should be reassuring to patients and providers that they can use Chantix without concern, as long as they take this observation into account.
Why is it that we don't see these headlines in the media? The result is unnecessary worry and fear by doctors and patients.
Tuesday, May 20, 2008
The small grape like fruit (which is commonly pronounced a-sigh-ee) comes from a palm tree that grows in tropical Central and South America, such as the Amazon region of Brazil. This fruit has a large seed, with very little pulp. The juice and pulp from the berry is commonly used in juices and other beverages in these countries.
The potential health benefits from this berry (as well as other dark berries, like blueberries and raspberries) come from their pigment. Berry pigments contain Anthocyanin Antioxidants. A national symposium on the benefits of Anthocyanin Antioxidants held in 2005 presented data from laboratory studies showing potential benefit in:
- reducing the blood from clotting (potential stroke and heart attack prevention)
- increasing levels of “good” cholesterol, HDL
- decreasing the oxidation of “bad” cholesterol, LDL
- neutralizing oxygen radicals which can cause tissue damage (aging)
- down-regulating enzymes leading to inflammation
There is some data that the acai berry (particularly when freeze dried) has higher level of anti-oxidants than other dark berries. Some reports state it has 10 to 30 times the antixoidant ability of red wines (which have been studied in humans and have shown a beneficial effect). Specific studies on the acai berry have shown it to have potential anti-inflammatory benefits and in one University of Florida study some anti-cancer effects, but these have been done only in test tubes. The benefits are not yet proven in humans.
Other benefits from the Acai berry come from its amino acids and essential fatty acids. The fatty acid content in açaí is rich in monounsaturated oleic acid which has potential cardiovascular benefits. Amino acids help build muscles.
Bottom Line: There are certainly benefits from eating berries, some of which come from their anthocyanin antioxidants, and the Acai berry seems to be full of them, as well as other good things. There have been no studies that I can find that show human benefit. Since the berry is natural, its extract may help you and likely will not be harmful.
A few caveats:
1. Make sure you are doing other beneficial things for health and aging, such as diet, exercise, sun protection, stopping smoking, and controlling chronic diseases like diabetes and high blood pressure.
2. If you are going to use Acai berry as a supplement, make sure are already taking the supplements that are proven to have benefit, such as vitamin D and Calcium.
3. Acai berry appears to be sold comerically in juices. To make juices taste good and feel like they are working, sugar and caffeine are respectively added. Thus, the benefit of the acai berry may be outweighed by what you are getting with it, so be careful.
Sunday, May 18, 2008
As the articles point out, the fact that more and more children are obese is more than just a sign of the times, but rather has major implications on the fate of our entire country. A third of the children in the U.S> are overweight or obese. Currently, my colleagues in pediatrics are seeing diseases that I learned in medical school were only suppoed to be seen in adults: type 2 diabetes, arthritis, gallstones, etc. Unlike adults where the rate of obesity has doubled, it has trippled in children. There is also evidence that the effects of being overweight in childhood are much worse than adding the pounds later in life, likely due to cummulative effects over time. According to the article:
"The cumulative effect could be the country's first generation destined to have a shorter life span than its predecessor."
Friday, May 16, 2008
Shingles is caused by the same virus that causes chicken pox. When you get chicken pox as a child, the virus stays around dormant for years in the nerve roots in your spinor cord. Years later, when your immune system is weakened, the virus can reactivate and cause a very painful rash. (The wikipedia entry is actually quite qood for more information). Though the rash and pain usually resolve in a few weeks, about 20% of patients will develop post-herpetic neuralgia, which means that the pain keeps coming back. This can be quite debilitating.
This shingles vaccine is called Zostavax (made by Merk). It is now recommeded for adults 60 years of age and older even if they have had a prior episode of shingles. It only prevents half the cases (slightly more in the 60-69 group). However, given the likelihood of getting shingles (about 1/3 will get this at some point) and the potential severity of the disease, the recommendation seems warranted.
What you should do:
1. Get the shingles vaccine (Zostavax) if you are 60 or older. Even if you have had shingles, even if you are sure you haven't ever had chicken pox.
2. Check with your insurance company to see if it is covered. More and more insurances are covering this, and most should fall in line after this recent recommendation. However, you may need to get this pre-approved. It's about $200 out of pocket. It is covered under Medicare Part D.
3. Find out if your doctor give the vaccine and how. The vaccine has to be stored in a special freezer and needs to be given soon after it has been mixed for injection. Thus, not all offices are giving this yet. There may be a pharmacy in your area that is giving this out.
Tuesday, May 13, 2008
The New York Times has an excellent piece today on the phasing out of old asthma inhalers, which has already begun. However, the old asthma inhalers will completely unavailable by the end of the year. Many asthma inhalers are pressurized metered dose inhalers (pMDI's) which means that when you push down on them, the medication sprays out like an aersol spray. Not all inhalers are pMDI's. Some of the newer inhalers are dry powder inhalers (DPI's) where the medicine is not sprayed out, but simply inhaled (Advair and Pulmicort are both DPI's). However, all the rescue medication products available in the US (which is almost always albuterol) are only available in pMDI's. The problem is that the propellant in these sprays was a CFC, which is bad for the enviornment. CFC's have been banned by the government, and the asthma inhalers are the last remaining consumer products to have them. The new pMDI's are made with another propellant, that is more environmentally friendly, HFA. However, there are several differences between the CFC pMDI's and the HFA pMDI's.
There is no generic albuterol HFA
The FDA considers the HFA inhalers new drugs, even though the active ingredient is off patent.
Issue #1- if the physician just writes albuterol, the pharmacist will likely dispense the CFC pMDI which will not be available in January 2009, and more importantly may not be available now because supplies are limited
Issue #2- if the physician writes albuterol HFA, since this product does not exist, the pharmacist will likely substitute one of the 3 branded products (ProAir, Ventolin HFA, and Proventil HFA). However, it may matter to you which one of these you get because.........
Issue #3- each insurance company has a different policy regarding the CFC to HFA transition. The HFA inhalers are much more expensive. On the other hand, insurers worry that increasing the cost of the co-pay may decrease the use by patients and land them in the Emergency Room. Some insurers have picked one of the 3 products and assigned it a generic co-pay while others have no preference and assign all products the same higher co-pay.
There are some differences between the old CFC inhalers and the new HFA inhalers
The spray from the HFA inhalers is weaker. Inhalers require more priming (wasting the first few pumps) before the first use. Patients may feel a difference in the force and taste of the spray ( and confuse this for the medication not working). The HFA inhalers also require a slower and deeper inhalation.
There are some differences between the new inhalers
ProAir, Ventolin HFA, and Proventil HFA are all albuterol products. Ventolin HFA (made by GSK) has one advantage in that it has a dose counter. Research has shown that many asthmatic patients incorrectly estimate how much medication is left in their inhaler. Most inhalers will continue to spray propellant even when the active ingredient has been used up.
Finally, there is a 4th product called Xopenex, which is levalbuterol. The medication is very similar, but because of its structure may have fewer side effects such as shaking or rapid heart beat. Though the branded Xopenex HFA is currently more expensive than the generic albuterol CFC, when compared to the other three albuterol HFA's, Xopenex may be the same or even less of a co-pay then the others, depending on your insurance.
What you should do
1. If you have asthma, disccus the CFC to HFA conversion with your doctor to make sure you are getting the right medication.
2. Know the co-pay level that your insurance will charge you for ProAir, Ventolin HFA, Proventil HFA and Xopenex HFA. If any of these are a generic co-pay, switch now. All things being equal, Ventolin (dose counter) and Xopenex (fewer side effects) may be preferred.
3. Use these medications for rescue only. The medications are really only for bad symptoms and emergencies. Current guidelines state that if you are using these medications more that two times a week, your asthma is not well controlled, and you need a better maintenance inhaler, which is an inhaler you take every day to control your asthma.
4. Recognize the differences between the HFA and CFC inhalers. As above, the spray will feel different, and will require some adjustments (priming, slower inhalations) than your previous albuterol pMDI.
5. Do not use Primatene Mist to save a few bucks. This is an over the counter asthma inhaler. It is dangerous and would never be approved by the FDA today. Older medications that are currently over the counter need to have been proven to kill or severely injure people before they will be pulled from the market. This is hard for Primatene Mist, because hard to say whether or not it was the inhaler or the asthma. The active ingredient is epinephrine which has a lot of side effects.
Thursday, May 8, 2008
I have blogged previously about the recent Chantix warnings and media hype surrounding this. The drug was not initially studied in patient with mental health disorders. These patients were excluded from initial studies, especially since Chantix was compared in these studies to bupropion, which is also used to treat depression. After the drug came to maker, there were reports of changes in behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior. These things also happen when you stop smoking, so the link between Chantix and neuropsychiatric symptoms is not clear. The warning is appropriate, but mostly for people who have mental health disorders or who may be at risk. The benefit of Chanitx seems to outweigh any of these concerns.
With regards to the author's finacial ties to the industry, it should be noted that Dr. Fiore is one of the leading experts on smoking cessation, and wrote the previous 2000 guideline, well before Chantix was even being developed (he cut ties with Pfizer several years ago).
The real news is not Chantix side effects or conflict of interest, but there is more and more evidence that treatments for smoking cessation work!
Things you should know if you smoke:
1. Chantix has been shown to be the most effective agent for smoking cessation.
2. Quit lines have been proven to be beneficial. They are completely free!!! Call 1-800-QUITNOW
3. The guideline offers more treatment options then before, especially in regards to combination of medications. There were two things shown to be better than the patch alone: Chantix and patch plus as needed gum or spray.