Medical Insider Blog

Really? Fat is better?

  • Posted Jan 08, 2013
  • Alan Niederman, MD, FACC, FACP

It didn't take long for this year's first article to give me an example to show why I write this blog.  And to top it off, this one is a real beaut.

It was funded by The National Cancer Institute and by the Centers for Disease Control and Prevention.  This article was published in JAMA 2013: 309:71-82 and is titled "Association of all cause mortality with overweight and obesity using standard body mass index categories:  A systematic review and meta-analysis."  What the study said was that if you are overweight, you live longer.WHAT!  I kid you not.  This is why people and patients are all confused.  Coffee is good, coffee is bad.  Chocolate will save your life, chocolate will kill you.  Don't eat eggs, eat eggs.  Next week it will be smoking makes you live forever.  Seven out of 10 adults in this country are felt to be overweight.  In 2010, the CDC (the same people who paid for this foolishness) stated that 74% of men and 65% of women were overweight or obese.

How does this foolishness start?  It starts with using the BMI.  Now, close readers of my blog know that I dealt with the BMI foolishness back on 11/08/11 and 11/10/11 in blog posts titled "The tyranny of a number."  I explained how the BMI came into being and that, in general, it is a flawed number that yields silly results.

So why would anyone use it to do a study?  Further, why would we use tax dollars to pay for it?  Don't we have better things to do with our money?  Wait until the Republicans find out.

The study used a total of 97 studies and then discarded 44 of them because of methodical problems.  That left a total of 2.88 million subjects and 270,000 deaths.  The authors claim that severe obesity was associated with an increased risk of death from all causes.  At least they got that part correct.  "Normal" BMI is 18.5 -25 kg/m2.  It is known that a BMI of 18.5-22 has a higher mortality than a BMI of 22-25.  A BMI of 30-35 was associated with the same risk as the BMI of 22-25.  If you were overweight, you had a 6% decrease in mortality.  If you had Grade 1 obesity, it was a 5% decrease in the risk of death.  Kate Moss is doomed.

To have a better understanding of this true insanity, go to the BMI tables and check your number and see where you fall.  Are you happy now?

If you were really interested in this concept you would find 100,000 40 year olds and measure them.  You would then follow them for umpteen years and find out what their weight was when they died.  However, you really need to find out what their weight was when they became sick as patients are often quite emaciated after long illnesses.

This study was an "all cause mortality" study.  This means that it includes all death not just that from illness. The articles came pouring forth.  Weight Watchers stock took a nose dive.  Commentators went on to say that the likely reason for this finding was that if you were overweight, you were already in your doctor's office being treated for all the problems that might kill you. Realistically, as an article in the New York Times on January 3rd written by Paul Campos pointed out, "there is no reason to believe that the trivial variations in mortality risk observed across an enormous weight range actually have anything to do with weight or that intentional weight gain or loss would affect that risk in a predictable way."

Common sense and the fact that we can't fit into our clothes tell us that we are too heavy.  Just look around you and see for yourselves what we look like as a society.  For a real eye opener, go to any other country and look around.  Articles like this and the reporting that they receive don't do us any good.  We can all stand to lose a few pounds.  We all need to eat less and exercise more.  We all need to grow up and take some responsibility for ourselves.

Don't believe everything you read.

Can’t get enough of a good thing

  • Posted Jan 03, 2013
  • Alan Niederman, MD, FACC, FACP

More news about renal nerve denervation has been released.  I have blogged about this topic in the past beginning on 11/30/10 and 12/02/10.  Further blogs advancing the indications for the device can be found on 03/06/12 and 03/08/12.  We now have one year data that was released in print.

Published in Circulation 2012; 126:2976-2982 and entitled "Renal sympathetic denervation for the treatment of drug resistant hypertension: One year results from the Symplicity HTN-2 randomized control trial."  In a nutshell, at one year the patients who have uncontrollable hypertension in spite of being at maximally tolerated doses of three different medications who undergo this procedure have between a 10-20 mm drop in their blood pressure. This is truly astounding and seems to occur both quickly and/or over time.  Moreover, it still seems to be without consequences. The readers of my blogs know that I am a firm believer in "not fooling with Mother Nature." In general she always wins, and sometimes it is not pretty. This treatment is now well into its 5th year of follow-up, and there still doesn't seem to be a downside.  In general, medication doesn't achieve this type of control.  The side effects of taking three medications that still don't adequately work are significant.

So what's wrong with this picture? Well...let's start with the fact that this treatment is not yet available in the United States.  It is being done in this country under the auspices of the pivotal trial for approval for the FDA but only at investigational sites.  One of these sites is here locally at Baptist Hospital in Miami. This is another example of the delay that it takes for what is obviously important therapy to enter the American arena.  The earliest this procedure will be widely available here is in late 2014.  Everyone is trying to get into the initial rollout of this device and procedure much like the feeding frenzy that occurred with the rollout of TAVR.

It should be mentioned that the individuals in this study did not in general have their blood pressure problem solved.  Their blood pressure became easier to treat, and they were able to stop some medication and decrease their medication burden. However, and this is were it got interesting, the lay press went off and began to herald this procedure as a cure for mild blood pressure problems.  Why did they do this?  It seems that the American Heart Association had a press release that speculated that this technique might be able to be used in mild hypertension and that it might "cure it."

That concept is purely speculative and completely unsupported.  In time that study might be done.  A study might enroll patients who have mild hypertension and see whether it could be "solved" with this procedure.  The patients would then need to be followed for a considerable amount of time to see whether a "clinical benefit" occurred by having the procedure instead of taking medication.  This will be difficult to accomplish.  I can guarantee that when this procedure does hit the street, it will be paid for only when certain criteria are met.  It will not be "all comers."

All of us who treat hypertension have patients who need this procedure.  When it is available, it will be an important advance in the management of this illness, which when left untreated in this population, leads to kidney, heart, and brain damage. It is truly the next big thing.


This years last word on the use of the new anticoagulants

  • Posted Dec 31, 2012
  • Alan Niederman, MD, FACC, FACP

On July 27th I blogged about the 3rd musketeer apixaban, or as it will be known, Eliquis.  This is the last of the new oral anticoagulants to be approved (full disclosure: the Holy Cross Jim Moran Heart and Vascular Research Institute participated in this study, and I was a sub-investigator).  Why approval took so long is not clear.  It was the only drug of the three that had a mortality difference (i.e. if you took it versus taking warfarin, you had less chance of death).

Like the other two drugs, Xarelto and Pradaxa, this drug does not have a specific antidote in the case of active significant bleeding.  Eliquis will need to be taken twice a day like Pradaxa.  I personally believe that the once a day Xarelto is a better option for patients. Eliquis maybe a better option than Pradaxa.  It was superior to warfarin in preventing strokes 1.27% vs 1.60%.  It had significantly less bleeding episodes than warfarin  2.13% vs. 3.09%.  Any death 3.52% vs 3.94% and death from cardiovascular cause 1.80% vs. 2.02%.

To put these numbers in a more rational way, for every 1,000 patients treated with Eliquis instead of warfarin, six strokes would be avoided, major bleeding would be avoided in 15 patients, and death would be avoided in eight.  Small numbers but this is how we make changes.  The question of how much this costs society is not certain.  I am sure that analysis is being done to add up all the costs, but I have not yet seen it.

How your doctor will decide which one of the musketeers is for you, if any, is not clear.  None of these agents have been or will be subjected to the needed test of which agent is more effective "head to head." This is where the dreaded "drug detail" dance starts.  People will come to see me to convince me of the value of their drug versus the other drugs.  Lucky for me, none of them get to see me since I take no samples, and I will sign for nothing.  My choices are based on evidence.   The same that I present in my blogs.

One last piece of news: as I have blogged about before, there was an attempt to use these drugs in patients who have mechanical heart valves.  Nope.  The FDA has now formally declared to cease and desist, and the study (RE-ALIGN) has been permanently halted.  This is unfortunate as it would have been nice to use these drugs.  I do not believe that the dosing was correct.  We use higher doses of warfarin in this setting and so I believe we needed higher doses of the newer drugs.  It is unlikely that this will be accomplished.

As 2012 comes to a close, I would like to thank you my readers for giving me some time in your busy lives to read my blogs.  I hope that they have provided you a better understanding of the issues that I have presented.  As we head over the fiscal cliff, Medicare providers face an almost 30% cut in fees across the board.  With or without the cliff, angioplasty procedural fees and electrophysiology procedural fees have been reduced by 20% for 2013.  I would like to think that when I perform angioplasty on a patient with an MI, that it is worth something.  I guess it is just 20% less than last year.  Is this any way to run medicine?

Happy New Year.  I wish all my readers and patients happiness and good health in the years ahead.

A hard way to learn an important fact

  • Posted Dec 27, 2012
  • Alan Niederman, MD, FACC, FACP

Our servicemen and women have been asked to provide a great deal over the past years.  Perhaps the last war fought that  truly needed to be fought was WWII.  Many people would agree that since then our battles have not accomplished all the goals that had been set out.  This lack of national focus, however, does not prevent the death and suffering that is the legacy of these events.  These events serve as a valuable insight into one aspect of our society.

Since WWII, autopsy results of some of the young men, and now women, who died during the war underwent analysis of their heart arteries during autopsy.  This data was found to be quite unsettling when it was first presented.  In 1953, 77% of the personnel killed during the Korean War that were analyzed had evidence of atherosclerotic changes in their heart arteries.  This atherosclerosis varied from advanced to minimal.  In most cases it was minimal, but the fact that it was present at all was a shock to medicine.

How can an illness like this take hold so early in life?  Are we all doomed to have it?  Can it be prevented? In our country's never-ending attempt to provide fresh data, the servicemen from Vietnam were subjected to the same analysis and were found to have a lower incidence of atherosclerotic changes.  45% of servicemen had evidence of disease.  How the prevalence diminished was not - and is not to this day - understood.

Once again we have had the opportunity to perform this analysis on the servicemen from Afghanistan and Iraq.  As reported in JAMA 2012;308(24):2577-2583, we now have the data from this cohort, and this data set is more complete as we have other information that allow some conclusions to be made. The average age of the group was 26 years old.  3,832 service members were included.  The coronary lesions were divided into minimal which is a fatty streak, moderate (10-49% of the lumen of the artery) and severe (>50% obstruction of the lumen of the artery).  Any atherosclerotic lesion was found in 12.1% - a significant decrease from the 45% of the Vietnam era.  Minimal disease was found in 1.5%, moderate disease was found in 4.7% and severe disease in 2.3%.  Not surprisingly age was the strongest predictor of disease.  Those individuals 4o years old or older had a prevalence of atherosclerosis of 45.9% compared to 24 year olds at 6.6%.

If the subject had high cholesterol, the prevalence was 50.0% vs 11.1%,  hypertension 43.6% vs. 11.1%, obesity 22.3% vs.11.1%.

It is not at all clear as to how the decrease in the amount of atherosclerosis has occurred over a short period of time.  We as a nation have certainly not changed our habits to account for this.  One difference in this group is that they were volunteers, and the other servicemen were predominantly drafted into the service.  How that affects the numbers is not clear.

No matter how you analyze the facts, the difference is striking.  Further, the risk factors of high cholesterol, hypertension and obesity hold up.  It is a clarion call for "prevention." We may have a chance to "prevent" some of this if we as a nation start early enough. I would like to think that this is the last time we will see data that was derived in this way but I'm not that naive.  I wish there was another way.

Throw away your niacin (Part II)

  • Posted Dec 25, 2012
  • Alan Niederman, MD, FACC, FACP

This part of the story surprises even me.  The HPS-2 THRIVE study was stopped by Merck this past week.  This was a huge study run by Oxford University in England.  It utilized 14,741 patients from the United Kingdom and Scandinavia and 10,932 patients from China.  Hold up!  What does this say about China?  Have they finally succumbed to the diseases of the West?  Does any research get done in the United States anymore? After four years of follow-up, this study showed no benefit in adding niacin to a statin in reducing cardiovascular events.  Further, there was a statistically significant increase in some types (not specified) of non-fatal serious side effects.  The story here is even more bizarre than AIM-HIGH.

First, the background: The compound being tested was a combination drug.  The two drugs in the pill were extended release niacin, known as Niaspan, and a new drug laropiprant. The drug laropiprant is a DP1 blocker and works on vascular cells to prevent flushing.  The concept was that the laropiprant would block the side effect of the flushing in the niacin so that people would take the medicine.  This drug has been tested before and was used for a period of time in the United States in 2008.  The FDA issued a "non-approvable" letter to Merck after their first United States study, and they were forced to do further work on the compound.  The  compound known as Tredaptive or Cordaptive is being sold and used in Europe, but now the European regulatory bodies will look into the compound based on this study.

Still not satisfied with the answer, the naysayers (like the NRA) blame everyone and everything except the obvious.  Maybe niacin just doesn't work?  Among the reasons that this study did not prove their point was because this study was all-comers.  This meant that the baseline HDL was 50 mg/dl.  Raising the HDL by 20% in that case would mean a HDL of 60 mg/dl.  I see two points here.  The first is that it says something when a group of patients who have cardiac disease have a mean HDL of 50 mg/dl.  That is felt to be rather high.  The risk is felt to be the greatest in low HDL like 30 mg/dl.   Maybe the whole idea of HDL and raising it to prevent cardiovascular outcomes is not correct.  Maybe Earth is not the  center of the universe.  Why didn't Merck only enroll those that had the lowest numbers?  The second - and perhaps more profound - reason that this study failed is because no one really knows what laropiprant does or what deleterious effects it might have. What if it counters the effect of Niaspan on the artery?  The study should have included more tiers, one of which would have been laropiprant alone.  Why did it not?  As I have mentioned before, the cost of all this is astronomical and getting higher all the time.  We are approaching a point where drug development may come to a grinding halt because the cost of development does not allow a company to obtain a profit.

Where do we go from here?  Eat sensibly, lose weight, stop smoking and take as much statin as you can.  The rest seems to be a waste of time and money.  We as a society will have to wait for the next big idea.  We are out of them for the time being.  I only hope that when the idea comes, we will have the ability and will to test it and bring it to market. I wish all of you a Happy Holiday season.

Throw your niacin away (Part I)

  • Posted Dec 20, 2012
  • Alan Niederman, MD, FACC, FACP

I have blogged about the uselessness of niacin in the past in a long blog piece about the AIM-HIGH study that began on May 31,2011 and ended on June 7, 2011.  The point of those blogs were that niacin, when added to statin, did not provide clinical benefit.  As always in medicine, and lately in every other walk of life, the naysayers come out and say that these facts don't matter.

Let's stop for a minute and consider why you as a patient and we as doctors give you a drug.  The simplest reason is that there is a clinical benefit.   When you take an antibiotic, your infection goes away.  When you take an antacid, like Zantac, the burning in your stomach stops.  When you take a statin, the clinical benefit is not that your LDL goes down.  The LDL number is a marker for the effect of the statin.  The reason you take the statin is that your clinical benefit is statistically less heart attacks, episodes of unstable angina and death.  This aggregate number is significant when compared to placebo.  The lower your LDL number goes, the less likely you are to have a clinical event.  In spite of what your doctor likely tells you, there is no LDL number too low.  35 seems to be optimal as I have explained in other blogs.

So how did we get to this point?  In the early days of trying to find a "cure" for atherosclerosis, niacin was found to  increase HDL levels by up to 20%.  This however was with doses of niacin that are generally intolerable: one to three grams a day.  Most people have trouble taking 500 mg a day.  These studies were performed before statins.  They utilized relatively small numbers of subjects given the numbers of patients needed today.  One reason is that in today's work, statins are so effective that very large numbers of subjects are needed to prove the point and so the clinical benefit.

In a recent meta-analysis published in Atherosclerosis (2010 Jun;210(2):353-61) entitled "Meta analysis of the effect of nicotinic acid alone or in combination on cardiovascular events and atherosclerosis," the authors reviewed 11 randomized trials.  In those trials combined, 2,682 active patients and 3,934 control patients were used.  Nowadays, each trial would be this big.  In the AIM-HIGH trial alone 3,500 patients were studied.  As discussed in the blogs mentioned above, AIM-HIGH was sponsored by NIH and stopped early as it was futile.  It found "That high dose, extended-release niacin offered no benefits beyond statin therapy alone in reducing cardiovascular-related complications."  Once again I must stress that the average LDL in this trial was 71 mg/dl.  That means that some patients had LDL's in the low 50's.  This remains the gold standard.

So we have the failure of niacin, fibric acids like Lopid and unfortunately the new class of drugs know as CETP inhibitors like torcetrapib.  Hope in medicine springs eternal, and at the end of all the articles about the failure of AIM-HIGH was a plea to await the results of the final trial called Heart Protection Study 2 Treatment of HDL to Reduce the Incidence of Vascular Events.

Be careful what you wait for...

Bits and pieces

  • Posted Dec 18, 2012
  • Alan Niederman, MD, FACC, FACP


I always attempt to keep you my readers ahead of the curve.  On July 7, 2011 I published a blog post about a device and iPhone App that I believed would help many patients with their heart rhythm issues.  Many patients have episodic rhythms which trouble them but are very hard to capture.  The blog detailed what could change all that.

I urge you to go back to it: Something to do with your iPhone4.  In brief, Dr. David Albert is a physician and inventor who developed a back case for the iPhone 4 and 5.  This case allows you to touch your skin and record your heart rhythm.  You can then store the information or cut and paste it.  This information can then be sent to your healthcare provider.

Well, eventually the worm turns, and the FDA has finally allowed it on the market.  I cannot adequately explain why it takes a year and a half,  but it obviously does.  Known as the AliveCor monitor, it is already available for animals, although I'm not quite sure why you would want to know what Fido's or Fluffy's  heart rate is.  The information obtained can also be stored in the ubiquitous cloud and then downloaded by your doctor.

As I said in my blog post, this is going to be a game changer for everyone. But wait, there's more.  Now comes the second idea on how to use your phone for more than Angry Birds.  Who makes phone calls these days anyway?   This new App uses the camera and flash.  You place your finger on the flash and the camera records the changes in color.  A program in your phone then determines the "chaos" and can determine whether you are in normal rhythm or atrial fibrillation.  The study was done using two minutes, but it seems that one minute is sufficient.  These results were actually published in the journal Heart Rhythm (HeartRhythm 2012;DOI:10.1016/j.hrthm.2012.12.001).

It looks like soon I will not have to get out of bed to practice cardiology.  I will see you on Sykpe, and you can send me all the info on the iPhone apps.  Now, if I can only find a way to have you open up your own heart artery during a heart attack at 3am.

And Pieces

An interesting set of facts was published by David Leonhardt of the New York Times on December 15, 2012.  The facts relate to Medicare and its funding, and they are very important.  As an example, he uses a married couple, 66 years old.  They had "average earnings"; this is not defined.  The total amount of Medicare taxes paid in over their lifetime was $122,000.  They will use an average of $387,000 in Medicare funds.  Oops.  Who pays the rest?

In 25 years the Medicare percentage of Gross Domestic Product will rise from 3.7% this year to 6.7%.  This is an estimate and could very well be higher.  At that level we will not be able to afford to live.  As I have mentioned in other blog posts, when Medicare started in 1964, the average life expectancy was 75 years.  Now it is 20 years up from 16 years in 1980.  The longer we live, the more it costs.

We have to face the facts.  We as workers need to pay in more in taxes to Medicare.  We need to "means test" monthly premiums when we reach Medicare age.  We need to fix the payment system to pay for "quality," whatever that is, and not quantity.  We need to gore everyone's Ox equally.

We need to get to work.


  • Posted Dec 13, 2012
  • Alan Niederman, MD, FACC, FACP

I have blogged about aspirin many times dating back to September 19, 2009.  Yes I have been doing this for a long time.  What is old is new again in an article published in Circulation online last week.  Entitled "Drug Resistance and Pseudoresistance: An Unintended Consequence of Enteric Coating Aspirin" (DOI: 10.1161/CIRCULATIONAHA.112.117283), this article helps to dispel yet another Urban Legend, that of the concept that certain people do not respond to aspirin appropriately.

This is actually a big deal if it was true.  Taking aspirin after a myocardial event decreases your risk of death by 20%.  Like the discussion of "more taste, less filling" or the tooth fairy, you either believe in aspirin resistance or you don't.  A great deal of money is spent on testing for something that most people feel doesn't exist.  This article is just one in a long line of articles.  This article also helps disspell another myth, that of enteric coating.

Just because it should work doesn't mean it does work.  Enteric coating was promulgated to reduce the risk of GI bleeding.  This "proof" was, however, incorrectly done.  What enteric coating does is reduce the risk of visible stomach lining lesions.  The proper study, never done, would have been to assess for all bleeding not only for those visibly seen.  This is because the bleeding is based on the prostaglandin function of aspirin and not the irritative function of aspirin.  You can get GI bleeding from aspirin by giving it rectally. Similarly, Plavix causes GI bleeding and it is not based on an irritative basis.

What is the science?  We believe that approximately 50 mg of aspirin is needed to inhibit the platelet receptor in question.  This, however, requires the aspirin to be perfectly absorbed from the stomach.  This definitely does not happen all the time.  Therein lies the problem with the enteric coating.  When the 400 healthy subjects in this study were given enteric coated aspirin, none were found to be aspirin resistant by common tests.  49% did not have proper activation at 4 hours, and this dropped to 17% at 8 hours.  Of the 17%, after one week of aspirin therapy, none were found to be resistant.

What have we learned?  Enteric coating does little to protect you from GI bleeding in aspirin use.  It does however interfere with the acute use of aspirin such that in emergency situations, regular aspirin should be used and preferably chewed.   It does not seem to help if you chew enteric coated aspirin. Good luck with finding regular aspirin in a hospital, however, since most - if not all - of the aspirin has been replaced with the enteric coated aspirin.  Long term administration of any form of aspirin eradicates the apparent resistance.

The naysayers have already appeared.  This study utilized healthy people, and their conjecture is that "sick" patients are different.  This may or may not be true.  It has yet to be determined but probably never will be because it takes time and money to do this work, and it is unlikely to get funding.

I can guarantee we have not seen the last on this topic.  Over 150 years and we still do not understand the "simple drugs."

Angels do walk the earth

  • Posted Dec 11, 2012
  • Alan Niederman, MD, FACC, FACP

This is a true story. It is a story about a patient, but it reflects the best that health care can do, and it brings several important issues into focus. The first issue is, "what is a hospital?" This simple question is not really defined in the American public's mind. People seem to think that hospitals are like banks and that they are all the same. They are not the same, and the differences in hospitals are real and may cost you your life if you go or are taken to the wrong one at the wrong time. This is becoming more acute a problem as techniques and advances become more sophisticated and require increasing expertise, which is often not available in every hospital.

A hospital is more than just a building. It is made up of doctors, nurses, allied personnel and equipment. That equipment is very expensive, and the doctors require more and more training and expertise. Like heart attacks that have to be treated in a timely fashion, strokes are a devastating and often fatal occurrence. Also, like heart attacks, the treatment for strokes has advanced since the time not long ago when doctors just pursed our lips and offered condolences and comfort to the patient and their family.

Much of the advance in stroke therapy is borrowed from Interventional Cardiology and are techniques which we pioneered in the coronary arteries. Much has been devised by the pioneers in the field of neuro-interventional radiology. The first hurdle was the belief that you could not work in the brain. Gruentzig faced the same prejudice when he started working in the heart arteries. No one believed it could be done until he proved it. Not being a Cardiologist, he was never subjected to the false understanding of what could and couldn't be done.

At Holy Cross Hospital, we are blessed by an Administration who has spent the money to buy the equipment to allow those of us with the expertise to better serve our patients and our community. Our hybrid operating room is an example. The Administration has also obtained the services of doctors with unique skill sets to serve unmet needs in our community. One such physician is Dr. Laslo Miskolczi.

Dr. Miskolczi and his team of angels apply their skills to save patients brains after they have a neuro event. They serve as our Code SERT or brain attack team. One of my patients is a 69 year-old female who developed cardiac symptoms and underwent coronary CT angiography, another advanced test that Holy Cross offers, with great expertise because of the radiologists that read our tests. They are among the best in the world, led by Dr. Claudio Smuclovisky - an innovator in this field.

My patient then underwent cardiac cath and was found to need coronary bypass surgery. Given that she was fit and otherwise without medical problems, it was predicted to go very easily for her, and it did until day four when she had a brief episode of atrial fibrillation that can occur in over 70% of patients with coronary artery bypass surgery. This was ended in about four hours. Two hours later while with a nurse in the bathroom, she suddenly collapsed and could not move the entire right side of her body or speak. A Code SERT was called, and she was immediately taken to CT scanning which showed a severe lack of blood flow to her left brain.

Minutes later, Dr. Miskolczi and his angels had her in the neuro interventional lab, and the following picture was obtained.

Soon after, Dr. Miskolczi worked his magic, and he and his team had the artery opened.

She was recovered from anesthesia, could speak a few words and began to move all of her extremities. By the next day she was speaking better and moving better. She is now on the Rehab floor at Holy Cross Hospital and working her way to what will hopefully be a full recovery. The ability to resolve what would have been a devastating or fatal stroke is a gift, and we at Holy Cross and our community are lucky to have this physician and his skill. We the medical staff, the nurses and allied personnel of Holy Cross Hospital are here for you, our community. Learn more about Dr. Miskolczi by visiting his online physician profile: Laszlo Miskolczi, MD


A stake through the heart (Part II): The rise of Gdufa

  • Posted Dec 06, 2012
  • Alan Niederman, MD, FACC, FACP

Who or what is Gdufa?

Is Gdufa the answer to the problem of generic drug manufacturing and the lack of transparency and accountability in the entire process?  Can we return to a time of naivety when we never thought or worried about this subject?  Should we return to that time?

Gdufa stands for Generic Drug User Fee Amendments of 2012.  It actually goes by Gdufa, and if you type that into Google, the information about the act is what shows up.  I will summarize its purpose and what it hopefully means for everyone.  First, some surprising numbers.

Since 1984 over 8,000 generic drugs have been approved by the FDA.  In 2011, 78% of all drug prescriptions were for generic drugs, and the estimated cost savings was $931 billion.  Almost a trillion dollars in one year alone.  I, and others like me, would have thought that somehow this savings should be protected as well as the public's safety.  Isn't that what the FDA does?

It seems that isn't the case.  Why?  The same reason things usually don't get done: money.  In the era of deficits and "small government," the protection of the American public took a backseat to expediency.  The system got a trillion dollars in savings and you got...who knows.  Somehow Afghanistan can be billed to us the taxpayers but drug protection...not so much.

Well our problem is solved.  The money to do what is needed is coming from the foxes guarding the hen house.  The generic drug manufactures are going to provide $299 million a year in inflation adjusted dollars. This represents one half of 1% of generic drug sales.  What did the drug manufacturers get?  Currently it takes 31 months on average to approve a new generic drug.  Seriously, I'm not making this up.  2,500 applications were awaiting approval at the time of the bill passage.  This time will be significantly shortened, and the FDA will have to be accountable to Congress.  The FDA promises to review 90% of the new applications within 10 months of the submission date by the 5th year of the agreement.

What did we, the people, get?  Currently the FDA inspects foreign drug manufacturers once every seven to 13 years.  I'll bet that scares them.  Now they will be inspected every two years with the riskiest sites being inspected more frequently.  Further, all facilities that manufacture drugs and their components will now be identified.

Certainly this is a good start.  Execution will be the problem as always.  It is hard for me, and I'm sure for you, to understand how this was not always the way it was.  Is glass in generic Lipitor the only problem?

One final note: the bill strives to create an improvement in, as they call it, "regulatory science."  Basically this refers to testing and maintaining the generic drugs to ensure they meet the potency and same activity that the formal product has.  When there were just a few drugs and manufacturers, this was not such a problem.  If 15 companies make the same generic Lipitor, are they all the same?  Can we choose or does the pharmacy just give us the pills and tell us, as my mother used to say, "take your medicine"?

I can guarantee you that this event, the finding of glass in generic Lipitor, is just the first in what will be a long line of problems.  We must as a country solve this problem and devise ways to protect patients from drugs that do not work or are harmful.


About Holy Cross Hospital

Holy Cross Hospital is a nonprofit, Catholic hospital in Fort Lauderdale, Florida, dedicated to innovative, high quality and compassionate care. For nearly six decades, Holy Cross has continuously expanded its services to provide leading-edge care for their patients in Florida and for those from elsewhere in the United States. Holy Cross also offers an International Services program to ensure that patients from outside the U.S. receive the care they need.

Blog Categories

Blog Archive