U.S. courts have ruled in favor of a family that suspects the child’s symptoms were caused by a vaccine the child received.  All of this is true.  However, what the press wants you to think is that this is a concession by the United States that there is a link between autism and vaccines.  This is false.

First of all, the child was found to have autism-like symptoms, she was never diagnosed with autism.  She also had a rare genetic, mitochondrial deficiency.  Her symptoms were linked to the vaccine because, according to a time-line of symptoms, the vaccine may have exacerbated or exemplified her already underlying disease.  This led to her to have autism-like symptoms.  However, more than 5,000 people are now about to sue the government, claiming that vaccines caused their child’s autism.

The funny thing is, this “test case” was settled.  If the lawyers of this case thought they had a class-action lawsuit in the wake with this case, they never would have settled.  They would have forced a court ruling, in hopes to make a case for the other thousands of people. 

The government has set up this fund to reward people who actually get injured by vaccines.  They have done this to protect you, because for all those people who hate for their children to get vaccines, they know that if the vaccine causes harm to their child, they will be compensated.  However, rarely does the vaccine cause harm, in this case, it was not proved to be the cause, it just was possible, and therefore the case was settled.  In no way has there been a link to vaccines and autism.  Sorry. 

A recent study from the Journal of the American Medical Association has confirmed that the use of Epogen, Procrit, and Arenesp to treat anemia in cancer patients has been linked to a 57% increased risk of blood clots and a 10% increased risk of death.  The report shows that when hemoglobin, a blood marker used to measure anemia, reaches above 12 g/dl, the risk is high for both death and clots. 

Anemia is common in cancer patients undergoing chemotherapy or radiation therapy.  Chemo and radiation can destroy bone marrow, the quickly growing cells in your bone that make blood cells.  A lack of these blood cells can cause you to feel very weak and tired, a common sign of anemia.  Without blood cells, oxygen cannot be transported efficiently though your blood.  This level can be measure by the amount of hemoglobin in your blood.

Should you be worried?  Yes, if your hemoglobin is above 12 g/dl, otherwise, the bone marrow stimulating drugs should be used.  If you have any questions, contact your doctor and let him know of the new data.  If you are feeling weak and on chemotherapy or radiation therapy, these drugs could still help and be safe, just make sure your doctor is monitoring you correctly.

The company behind Airborne, the oh-so-popular anti-cold tablet developed by a school teacher, has settled litigation for $23.3 million.  Admitting no wrong-doing, the company has decided that it will have to pay for advertisements to give back customers their money.  Apparently, Airborne made claims of shortening the length of the common cold and preventing you from catching it.  It did have studies to back it up, only they were found out to be done by laypeople.  This was back in 2006.  Since then, Airborne has redone all print materials to say on its packaging that it only “boosts the immune system,” whatever that means…  This overrated multivitamin has been condemned for what it is worth, nothing more than a bunch of hoopty herbal medicines (none proven to work) and half an orange.  Oh, and eating half an orange is much cheaper than taking an Airborne tablet…and works better, too.

More details about the litigation are due out June 6th, so if you were suckered to buy the product, maybe then you can learn how to get your money back. 

Ketamine (known as Special K to you and me, I mean on the streets…) has been basically banned for human use as an anesthetic due to its hallucinogenic properties.  Not only do you sleep through the major surgery, but you have a great time during it as well.  It has been known for about 2 years that ketamine works as a great antidepressant, and almost instantly, compared with current antidepressant therapy, which can take 4-6 weeks to work.  (Imagine how long it takes for you to order something on TV and not being happy until it arrived.)

Now, scientists have a better understanding of how ketamine works.  It has been known that ketamine works against NMDA receptors in the brain, but now it has been discovered that they also work on a new kind of receptor, the AMPA receptor.  If we could some how develop a drug that works against both the NMDA and more importantly the AMPA receptors without giving you such a great hallucinogenic trip, we may come up with a better antidepressant. 

Of course, maybe it is the hallucinogenic effect itself that is causing the antidepressant effect…

Ever wondered why each day as you took your next diltiazem (Cardizem) pill that “hey, I’m not craving cocaine today!”?  Well, wonder no more.  Scientists at Boston University have recently found that diltiazem, a calcium channel blocker used to control blood pressure, can actually reduce cocaine cravings, at least in mice (they get all the good drugs!).

Dopamine and glutamate are two chemicals in your brain that are blamed for the highly addictive properties of cocaine.  Both of these chemicals are basically pleasure compounds, and your brain has a lot to learn from pleasure compounds.  The happier your brain gets, the happier it likes to stay, so therefore you become addictive to certain drugs, like cocaine, that release these compounds.  Where diltiazem comes in is that, as a calcium channel blocker, it disrupts the communication between these compounds, in which calcium is needed.  No calcium means no communication, which leads to less happy feelings from the cocaine, and less cravings.  No wonder you haven’t had any of those cocaine cravings while on diltiazem all those years.

This research will be published in the March issue of Nature Neuroscience.  There are currently no drug therapies for cocaine addiction.  Do not, however, start taking diltiazem if you are addicted to cocaine, unless you are a rat, in which case if you are a cocaine addict rat, please e-mail me…

Are you a woman?  Are you on birth control pills?  Are you urinating?  If you answered yes to all three questions, then you might be to blame for the recent surge in females in fisheries.  Small species of fish have been found to be changing sex in rivers and streams that you pee into.  Now, I know you urinate into a toilet (at least I hope so…) but where do you think that urine ends up?  It’s cleaned and dumped into a lake, and the estrogens in your birth control are pee’d out and affect the fish population.  Think Jurassic Park.  So, how can this happen?

Well, when you take a drug, some (if not most) of the time you simply eliminate it by peeing it out, unchanged.  Sometimes your liver does most of the work, changing the drug around so you can pee it out easier, but for estrogens, you simply pee it out.  This is why you have to take drugs every day, because your body is very good at getting rid of them.  This goes for chemotherapy and radiation chemotherapy as well, as your urine could actually be radioactive, but I digress…

So, the medicines you take are leaking into the streams, the fish swim around it and change sexes.  So?  Well, too many females are a problem (in more ways then one…).  You cannot reproduce without males and females, so you can’t make babies.  No small fish babies equals no big fish food.  No big fish food equals no big fish.  No big fish equals no food for us.    This effect has also been seen in antibiotics as well, causing fish to succumb to superbugs too. 

Well, at least there will be more breast meat…Oh wait, that’s chicken.  Oh, and the fish’s acne has cleared up, and the sex is much safer…

Ok, so by now, you probably have heard that Vytorin is a horrible drug and everyone should stop taking it.  Relax, while some parts of this study have shown to be harmful, we need to look deeper to see if Zetia (one of two drugs in Vytorin) actually has a harmful effect.

So, what was the study?  Well, take 720 people with familial hypercholesterolemia (they all had high cholesterol from their families) and randomize them to either receive high dose Zocor (80 mg a day) or Vytorin (80 mg of Zocor and 10 mg of Zetia a day).  Then, measure the carotid artery (the one in your neck) for diameter and see how much plaque has grown in the artery.  Less plaque leads to less cardiovascular events, right?  Well…

Ok, so the Vytorin (Zetia and Zocor together) group had an increase in plaque diameter of 0.0111 mm and the Zocor alone group their plaque grew by 0.0058 mm.  This may seem like a huge difference, but statistically it was not.  There was no statistical significance between these two numbers.  (p=0.29)  (WTF is that p number?  Basically if the numbers were actually different, and didn’t happen by chance, then the p value should be < 0.05  0.29 is not less than 0.05, and therefore not statistically significant difference.  Don’t worry about it.)  So basically yes, Vytorin did cause the plaque to grow faster than with just Zocor alone, but this could have happened by chance.

Now, the end-point in this study was the plaque, however, they did follow up on deaths, non-fatal heart attacks and non-fatal strokes, and so on and so on.  These are the numbers you are worried about when it comes to cholesterol.  Yes the drugs do lower cholesterol, but if you do not lead to less deaths and heart attacks, what does it matter, right?  So, we should find, according to the hype, that the people on Vytorin had more deaths, heart attacks and strokes, because, by gosh, their carotid arteries grew plaque faster, right?  Wrong…  There were no statistical difference between the two groups in deaths (0.6 % Vytorin vs. 0.3% Zocor), non-fatal heart attacks (0.8% vs. 0.6%) and non-fatal strokes (0.3% vs. 0.3%).  p=NS for all (there’s that darn p guy again.  NS?  that means not signifcant, or basically not <0.05, the magic number).  So, was there a value that there was actually a difference between the two groups?  Yep.  LDL (the bad cholesterol) was lowered greater in the Vytorin (Zocor/Zetia) group (58%) vs. the Zocor alone group (41%).  p<0.01.  (Damn you p guy!  Ok, since p value here was <0.05, then there is a significant difference between the two groups.  The only value (LDL) that was found to be significantly different between the two groups in this study.)

So, what could be concluded from this study, according to the outcome?  Yes, Vytorin was found not to have slowed down the progression of plaque build-up in the carotid arteries vs. Zocor in the study, but not by a great enough margin that it couldn’t have just happened by chance.  There was no difference between deaths, heart attacks, or strokes in the study (what we actually care about as an outcome, who cares if the patient has a 0.0053 mm more growth of plaque if it doesn’t do anything), and the bad cholesterol was actually lower in the Vytorin patients.  My conclusion is that Vytorin is a good drug at lowering cholesterol, but it has not been shown to reduce the risk of death or heart attacks (unlike Zocor, which has been proven to do so).  It may just not keep you from dying…So, what should you do if you are currently taking Vytorin?  Just keep taking it as prescribed by your doctor, and if your doctor asks you to switch medications, ask him if he has actually read the study.  

However, there is one thing I didn’t like about this study, and was its timing in getting the results.  This was a two year study that ended in April 2006, and because the drug company thought the public were going to freak out when the results came out (which it did) that the company (Merck & Schering) did not release the results until Jan 2008, nearly two years later.  They say it was because it was hard to calculate the results.  B.S.  You just didn’t want the people to stop taking Zetia, because the press would interpret the results incorrectly (which it did) and physicians would stop prescribing the medicine (which they did).  I wonder if all those physicians actually read the study, or just the New York Times. 

P.S.  Look!  Just another study that proves lowering cholesterol does not affect death rates, number of heart attacks or the prevalence of stroke.  Looks like there may be some hype in all of these cholesterol-lowering medications, but I guess that’s a topic for another post.  Funny how no one drew that conclusion from this study. 

What is off-label use?  Basically, drug manufacturers have to submit approvals to the FDA for new drugs they wish to sell in the US.  Usually, most drugs go under the approval process for a specific indication, or what the drug is actually used to treat.  For example, Neurontin (gabapentin), is approved by the FDA (or indicated) to treat epilepsy.  However, most people I know use it for neuropathic pain (pain originating from the nerves themselves, usually without outside stimulus).  This is an off-label use, or a use differing from the original indication of a drug (the epilepsy).  So, is this dangerous?  Yes and no.  If the FDA approves a drug, it is lawful for a doctor to prescribe it for any reason s/he sees fit.  Some off-label use comes with research backing it up, others do not.  If it works and has few side effects, why not?

So, what’s the fuss now?  Originally, the FDA did not allow drug companies to promote drugs for off-label uses.  But, in 1997, the FDA granted a temporary exemption to pharmaceutical companies to allow them to promote proven research to physicians and representative agencies to promote off-label uses.  ”Proven research” meant that companies had to submit the research to the FDA prior to promoting the research themselves.  The problem?  It expired in 2006.  Now, the FDA is looking again at the issue.  Now the FDA wants to limit its ties to off-label uses of drugs and devices even more.  Under the new plan, drug companies would be able to promote off-label uses of their drugs as long as the research was done well and that the companies were not the ones funding the studies. 

So why doesn’t pharmaceutical manufacturers get additional indications for their drugs?  Money.  It costs millions or even billions for the drugs to get approval from the FDA, even if the drugs are on the market, since the approval process basically starts over again.  So, say you have a drug that is used to treat Blood Pressure in males ages 20-55.  Can doctors write it for a female, aged 65?  Sure, but it’s an off-label use.  Research may support it, but in reality, the FDA has not approved its use for this purpose.  Why should the company spend the money to get it approved when the doctor’s are writing prescriptions anyway?  This happens more often then you think.  More than 50% of stents (a procedure where a blood vessel is reopened in the heart via a “tube”) are done with off-label uses. 

So, what does the ruling mean to you?  Not much, unless you take a drug for an  off-label use.   The U.S. Supreme Court has now ruled that you the patient cannot sue for a medical device (including stents) that is defective if you use it as an off-label use.  That’s right.  If you have a stent and it breaks, or it breaks off as you put it in, and you are one of the 50% of people that use it as an off-label use, you are out of luck.  For now, this only applies to medical devices, not drugs, but I bet that ruling is not far off.  Pair that with the fact that the FDA is trying to get more lenient with their ability to control the marketing of off-label use, and we have a problem on our hands.  Imagine if the drug companies could soon promote a drug with an off-label use without sending the research by the FDA (assuming they didn’t fund the study of course, well, at least not out-right…), and then couldn’t get sued if it harmed you for that use?  I hope it never gets that bad…

Here I am, a noble pharmacist giving out flu vaccines like candy back in October, when, what do I hear?  This year, only about 40% of the strains of the flu were covered by the flu shot.  That means that if you got the flu shot and some flu-invested snob sneezes in your face, you had a 60% chance of getting the flu.  Usually, the FDA (the governing body who decides which 3 strains, that’s right only 3 strains, of the flu are covered by the vaccine each year) has been doing pretty well the past 19 years.  However, this year, with major outbreaks coming in January, the FDA needs to take action.  And, well, it’s done their best…

For the first time in history, the FDA has changes all 3 of the strains for the following year’s flu vaccine.  See, the FDA meets now, in February, to plan for next year’s flu vaccine.  It picks 3 strains of the ever changing flu to stop dead in its tracts for next year.  Why decide so soon?  Well, the manufacturing process of vaccines is tedious, and requires millions of eggs.  Basically, one egg equals one dose of vaccine.  The egg is inoculated with the strains of flu, the flu is harvested from the eggs, killed off and injected into you.  Ok, it’s a little more complicated then that, but a tedious process no doubt.  (Hopefully your pharmacist asks you if you are allergic to eggs before giving you the shot.  This is why.  However, most if not all of the egg has been filtered out, since the egg is basically used only as a petri dish.  If you can eat cake, you can take a flu shot.)  And, of course, a very volatile process.  Remember, back in 2006, with the flu vaccine shortage?  One bad egg spoils the bunch…

What can we do now?  Not much.  Tamiflu only works if you can get treatment within 24-48 hours of symptoms.  Hopefully in the future we will have newer technology to be able to make vaccines quicker, and therefore get a better picture of the following flu season.  Better luck next time, FDA.

So, you have a stroke, and it took you longer than 3 hours to get treatment.  Maybe it was because you were alone and couldn’t get help, maybe you thought the vision change, weakness on one side of the body, the extreme headache, the slurred speech would just go away, maybe traffic was bad.  In any rate, now you still might be ok.  New studies in The Lancet this week have shown that alteplase, a clot busting agent used in ischemic (no blood getting to brain type stroke, different from a hemorrhagic stroke or a bleeding in the brain type stroke,  “don’t give clot busters to a hemorrhagic stroke” and vice versa…) stroke, can now be used between 3 and 6 hours after initial symptoms develop and still show improvement over placebo.  Before, clot busters were thought to be ineffective after 3 hours, but now some of that damage could be reversed.  Blood flow was reinstated even after 3 hours from time of attack, and showed marked improvement over neurological outcome and better functional outcome over placebo.  So, there’s still hope if you have to wait in the ER for over 3 hours if you think you have a stroke!  Just don’t worry!  (In all fairness, if you have any signs or symptoms of stroke such as quick onset extreme headache of unknown origin, weakness in one side of the face or body, slurred speech or trouble interpreting speech, or blindness or decreased vision in one eye, please go to the ER or get treatment as soon as possible.  This study shows late treatment is good, but is no where close to being ideal.  The sooner, the better.)