An Article About a Drug Recall

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Recently, I came across the following article (see below).  Since it contains any and all the elements I might point out had I written the article or even just quoted parts of this article, I am inserting the whole article, with an occasional comment of my own.

David Maris, author of the following article which first appeared in Forbes Magazine:

Pay attention, as I can’t say this seriously enough. Last week, the FDA took a drug off the market, and the reasons should send shivers of fear down the backs of consumers, investors, generic drug companies – and the FDA.

The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it.

The FDA apparently approved this drug – and others like it – without testing it. The FDA just assumed if one dosage strength the drug companies submitted for approval works, then the other higher dosages work fine also [my emphasis]. With this generic, American consumers became the FDA’s guinea pigs to see if the FDA’s assumption was right. It wasn’t.

Background

In December 2006, the first generic versions of the popular anti-depressant Wellbutrin XL were approved by the FDA.  The drug comes in two dosage strengths, 150 milligrams and 300mg. The 300mg dose is generally used for patients with more severe depression and anxiety and patients who don’t respond to the lower dose.  The FDA approved generic versions of both dosage strengths from a few generic drug companies: Teva Pharmaceuticals (manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals), Anchen, Actavis, Watson Pharmaceuticals and Mylan MYL -0.95% Pharmaceuticals.  Almost immediately, the FDA started receiving reports from patients that claimed the 300mg dose was being associated with side effects and reduced efficacy.

The People’s Pharmacy, a well-known syndicated radio and newspaper columnist husband and wife team, notified the FDA that hundreds of patients had logged their own complaints of side effects with the then-recently approved generic version of Wellbutrin XL. The FDA brushed off the People’s Pharmacy and others that raised the issue, stating that they had faith that the drugs were equivalent and that perhaps the patients, who had mental disease, were more prone to perceived problems with a change in the medication than others. This was seen by many as essentially telling patients “it’s all in their head.” [my emphasis added].   After several more years and public outcry, the FDA was forced to take action.

What Action Did The FDA Take?

Instead of doing its own study on the drug, the FDA asked the drug maker to conduct a study to determine whether the generic drug was equivalent to the brand. [my emphasis added and I will also add that asking the makers of a drug to conduct their own study might smack a little of conflict of interest. This also brings up a point that was made in the movie "Chow Down" that the FDA is not as independent a regulatory body as we are led to believe and their relationship with the food and drug industries are a lot closer than their relationship with the American people.] The FDA, in their recent press release, claims that Teva started the trial but later abandoned it because of slow patient enrollment. It was already 2010, several years after knowing there was a problem, the FDA was forced to do its own study.

Did The FDA Drag Its Heels?

The FDA study was completed in August 2012 – more than 5 years after the initial problems were reported. The FDA study showed that the 300mg dose from Teva is ineffective insomuch as it did not deliver enough of the drug.

Oddly, despite the result being available in August 2012, the public was only made aware of this in October 2012.

How Did This Happen?

When the FDA issued its press release on October 3rd, it said that the FDA made a mistake in that it had taken the data for the 150mg version.  Since that dosage had worked fine, the FDA just assumed that the 300mg dosage would work.  I am not joking – they indicated that this case caused them to change the way they do things.  They approved the drugs by extrapolating the data for the 150mg, assuming the 300mg works the same.

Clearly, the FDA has serious doubts on how they approved the 300mg dosages by just assuming if the 150mg works then the 300mg must work also. The FDA’s press release makes that clear:

FDA has approved five generic versions of Wellbutrin XL 300 mg. Each of these generics was approved based on bioequivalence studies comparing the 150 mg strength of the products to Wellbutrin XL 150 mg. Studies were not performed directly on the 300 mg strength of the products. Rather, the bioequivalence studies were performed using the 150 mg strength, and the results were extrapolated to establish bioequivalence of the 300 mg product.

FDA has determined that this approach is no longer appropriate to establish bioequivalence of 300 mg bupropion hydrochloride extended-release tablets to Wellbutrin XL 300 mg, and the Agency is revising its guidance to industry for how to conduct premarket bioequivalence studies in generic bupropion products.

This cleverly worded press release hides the fact that this method of approving Wellbutrin XL or any drug is not only “no longer” appropriate, but was never an appropriate way of approving drugs.  Just extrapolating data is an erroneous assumption and ignores basic principles known by most high school science students. In addition, if you don’t test the larger dosages, what if drug companies simply submitted 300mg drugs that had no drug in them?  That seems like more than just a moronic mistake, but a dangerous approach to approving drugs.

But What About The Other Generics The FDA Approved?

Instead of immediately pulling the drugs that were approved with the same faulty approach and instead of the FDA doing their own bioequivalence studies, the FDA has asked the other generic drug companies to do these tests for the FDA and submit these results by March 2013.  The idea of a regulatory agency turning over the testing process of a drug to the drug companies when there is doubt about their safety and efficacy seems like it is giving up its role of independent oversight of the companies it has regulatory power over. [my emphasis]

It seems more appropriate that the FDA conduct these tests and, since the safe brand drug remains on the market, to immediately remove the other generics while we await the results of the testing. [I totally agree with the author's conclusion]

The FDA has long been a strong proponent of generic drugs, and generics have saved consumers and the federal government billions of dollars vs. brand-name drugs.  Many consumers incorrectly believe that a brand drug is identical to the generic drug, and even the FDA on its website calls generics “identical.”  Generic drug companies are subject to FDA inspections just like their name brand counterparts, but the drugs themselves do not need to be identical to the brands; they need to be “bioequivalent” and are given leeway on how close to the brand they need to be.   To me, it’s similar to how Cheerios are almost like the store brand of toasted oat cereal – “Cheery-O’s” – very similar, but not the same.  Roughly speaking, “bioequivalent” means they need to show that the drug releases an active ingredient in nearly the same, but not exact, concentration as the brand.

The whole system works if the generics are bioequivalent, and to ensure that they are, most consumers believe that the FDA would test to see if the generics being considered for approval work as promised.  It appears that many approved generic drug versions have not even been subject to independent FDA studies. [my emphasis]

But how could the FDA know if a drug is bioequivalent if it doesn’t even test it?  It can’t.

How This is A Safety Issue

The lack of efficacy for a high dose anti-depressant is really a safety issue, not a manufacturing issue.

How many patients who were not adequately treated on the 150mg dose were put on the 300mg only to see their symptoms get worse because the generic did not work as promised?  How many patients, doctors, and their families thought that this was simply a further deterioration of a patient’s condition and mental state? How many parents had to worry about their children when their anti-depressant seemed to stop working?  How many people committed suicide taking a generic antidepressant that did not work?

And the appalling part of all this is that the fact that this could have been prevented if the FDA had simply tested the drug before they approved it, or at the least heeded the hundreds of complaints.

8 Immediate Steps That Should Be Taken

Here are eight steps that should be taken immediately to address this crisis and the underlying issues that caused it:

  1. The FDA should immediately suspend approvals for generics Wellbutrin XL and advise doctors via a Dear Doctor Letter to switch to the brand. Pending confirmatory studies, suspend approvals of the other generics.  It is clear if the FDA is asking manufacturers to do new studies on these drugs, it does not 100% trust its effectiveness and safety.  The FDA should not keep drugs on the market where it cannot stand by the efficacy and safety of the drug when the brand is readily available
  2. The FDA should conduct their own study of the bioequivalence of the other generic Wellbutrin XL it approved and not rely on the drug makers.
  3. The FDA should immediately conduct a review of all generic drug approvals in this class and others to determine what other approvals were made with the same faulty approach of assuming that if one dose worked then the higher dose or lower dose must work the same.  Since the FDA has now abandoned this faulty procedure because it resulted in ineffective drugs being put on the market, then it should re-review all these previous approvals.
  4. The FDA should conduct a thorough study of how the vigilance system of early warnings and warnings from others such as the People’s Pharmacy went unheeded for more than 5 years.
  5. The FDA should undertake the difficult but important step of researching which patients took the 300mg generic, which ones may have attempted or committed suicide while on the 300mg or shortly after being switch from the ineffective. Research how many institutionalized patients are on the 300mg dose – advise they are switched to the brand immediately.  The families of these patients should know why the drugs they trusted to work didn’t.
  6. The FDA should tighten the regulations for bioequivalence for narrow therapeutic window drugs, especially those that pharmacists and patients have already complained about not working.
  7. The FDA should provide consumers with the timeline and all correspondence and phone records surrounding this case to show why a two month delay would take place from knowing the drug did not work to telling the public.
  8. Congress should convene an oversight committee on how this happened and what it means for drug safety. Was there anyone at the FDA during this or previously that had issue with the “if the 150mg works, then assume the 300mg works too” approach?

The FDA Commissioner Peggy Hamburg needs to answer for this.  When you keep score by loved ones’ worry and by patient lives cut short by suicide, this is not just the tale of a simple recall, but of a failure of the system and sign of dangerous incompetence.

 

Note: An earlier version of this posting identified the recalled product as being from Teva Pharmaceuticals.  For greater clarification, we have noted that the generic drug subject to the FDA action is manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals

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No part of this article is intended to be investment advice nor should it be considered investment advice.  For disclosure purposes, at the time of this writing, I own shares of Teva Pharmaceuticals.

 

Nothing more need be added to this nicely presented article.

 

Moderation in All Things

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As I have stated in previous posts, our healthcare system is dominated by what I term the Big Three: Insurance Companies, Pharmaceuticals, Hospitals.  As with most communication, and by the fact that I am passionate about the need to re-vamp our healthcare approach, I may have sounded a little too strongly at how the system being dominated by the Big Three with focus on profits has a potentially adverse affect on the health of our country.

There is no question that the Three developed as the needs of our population arose.  Our Democracy is based on a capitalistic foundation.  Thus it would follow that pursuing profits would be an inherent part of any business.  We, as a country, also put great stock in the Scientific Community.  Thus it would follow that pursuing new means of coming up with cures would play a dominant factor in medicine.

However, as with any pursuit or endeavor in life, when the focus leans too much in one direction, it can have adverse affects on the opposite side and I do believe that at this stage, the focus of the Big Three has veered too much on the profits and finances, ultimately undermining the service side of their work.  If a doctor is required to bring X amount of $s into the “firm” and that can only happen by seeing X amount of patients in a given day and/or suggesting so many procedures or specialty visits, then the patient and his/her health is affected (not to mention the doctor’s, whose life has the added stress of having to bring in so much money).  Nowadays, often, young people go into the field of medicine because it assures a good living.  Even if a young person has gone into the field for idealistic reasons, ie, helping those in need, the demands of the system and the focus on the money side of things will quickly overwhelm the original intent of the young person going into the field.

When my grandfather practiced medicine, he was a General Practitioner.  He was the one that people went to if they had a tummy ache, or a toothache, or a wart, or were about to give birth.  If his patients didn’t have the money to pay, he might receive a side of ham instead.  If he did not have an answer, he would suggest a visit to someone who might have a more specialized background.  Litigation against doctors did not exist back then.  As far as I know, my grandfather never lost a patient on an operating table.  But people were much more accepting that death COULD be an outcome.

So the times they have changed.  But just as they have changed into this extreme scenario in which it is now considered natural to spend 15 minutes with a doctor and leave with a prescription and/or to try everything that is being offered to keep someone alive (regardless of statistics that may help families recognize that there is very little chance for survival),  maybe now is the time to re-focus our attention on the promotion of health, rather than playing catch up to ill-health and permit change to again occur.  (In fact, I believe the ability to change and see things in new ways is one of the elements that makes our country so great).

This, then, is the basis of my passionate writing on this subject.  Thus, just as I make the point that it is time for our system to moderate itself, I, too, plan to moderate my writings on the subject.

© Yvonne Behrens, M.Ed  2013

 

 

Anticholinergic Medication and Our Aging Population

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A friend sent me a study which was reviewing the side effects of anticholinergic medication in older Americans.  [for a list of medications that contain anticholinergic properties, please follow this link.  You may wish to review this list, particularly if you are taking any medications].

The study cites that

“patients older than 65 years are prescribed a mean of 6 medications [emphasis added].  Age related pharmacokinetic and pharmacodynamic changes increase the risk of adverse effects and interactions.”

Further, according to this study,  there are

“medications  that are considered inappropriate in adults older than 65 years. “

Yet,

“12 to 21% of older patients in the United States use such agents.”

The study further expounds that

“medications with Anticholinergic properties have frequently been cited in the literature as causing an increase in adverse events.  Such conditions often lead to consequences such as falls, impulsive behavior and loss of independence.  Higher rates of cognitive dysfunction and delirium are found in patients experiencing a greater Anticholinergic load.

“The study created an Anticholinergic Risk Scale (ARS) specifically to review cognitive dysfunction and delirium. The objective of this study was to determine if the ARS score could be used to predict the risk of anticholinergic adverse effects in a geriatric evaluation and management (GEM) cohort and in a primary care cohort.”

In other words, would prospective older primary care population patients taking medication with anticholinergic properties who experienced similar side effects potentially experience the increased adverse effects of multiple use or cumulative amounts of anticholinergic remnants in their system that their older counterparts do, i.e. cogtnitive impairement, delirium.

They found a direct correlation between increased adverse effects and increase in age and, potentially, use of more agents containing Anticholinergic properties.

I have written about this before but I find that  the topic is so important because we have become a country of drug users.  Our doctors have become the pushers and the pharmaceuticals are the source.  The above study claims that the mean number of pharmaceuticals taken by the average 65 year old is six.  Most of these pills have side effects.  combine them and the side effects increase exponentially.

I write about this because these statistics are frightening to me.  I write about this because, knock on wood, God willing and the Creek don’t rise, I do not take any pharmaceuticals.  In fact, one day a couple of years ago, I was at the eye doctor.  The intake nurse asked me my age.  Her second question: “What medications are you taking?”  I replied, “None.”  Her head shot up and she looked at me.  She replied, “None?”  I said, “None. Is that unusual?”  She replied, “You are the first person who has ever given me that answer.”  !!! Wow! I guess it is unusual.

 

© Yvonne Behrens, M.Ed  2012

What is this Website All About?

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Recently, a friend who is a social media guru, told me that my site did not effectively communicate what my message was.

Being a person who is aging in a society wherein aging is looked at in negative terms,  I decided to begin a website that explored all those aspects of life/society that affect the aging person, positively and negatively.  I am interested in exploring a more positive outlook towards aging.  Baby Boomers make up a large percentage of the population.  We should be working together to pro-actively create twilight years more to our making and liking, not follow, like sheep, society’s definition of what aging is all about.

Where does the story begin?  In some societies, the elderly are venerated.  In other societies, they are taken care of.  In our society, unbelievable amounts of energy and money are expended to avoid the aging process and to avoid death.

The real problem with all of this is that gerontology is looked on as dealing with “old” people and our concept of “old” is decrepit , demented, incontinent. Until we reach “old” (at least in our society) no one wants to deal with “old” and so the image of “old” continues to be perpetuated in the above fashion.

People need to recognize that those of us who don’t age, die. In other words, unless something else takes us away, we are all going to age. Unless those of us who are aging now (but are denying that fact, other than to laugh about “senior moments” or complain about the “new aches and pains,”) take responsibility for this fact, buy into it and prepare for it, we will not have the infrastructure in place to deal with it properly (which is where we are today in our society). Time for a paradigm shift. Unless the baby boomers (46-66) create that paradigm shift, we will have quite a mess on our hands.

Why do I say that we will have a mess on our hands?  In sheer numbers, the baby boomers outnumber those following them.  Studies show that younger folk do not seem to be attracted to service oriented jobs.  The traditional definition of family has been expanded to several parents/siblings/grandparents by virtue of high number of divorces and re-marriages, which will also have an impact on care-giving.  Not only that, but we, beginning with our parents, are the highest users of pharmaceutical drugs, all of which have some side effect which causes some other problem which necessitates taking more pharmaceutical drugs.

Now all of this is glorious news for the health care industry (note the word industry — their term, not mine).  What better scenario for profits than having an individual with a chronic illness who is totally dependent on the health care system?  And better yet, particularly for the insurance companies [-- one part of the triage that makes up the health care industry, the other two being pharmaceuticals and hospitals/doctors --]  is a person who is on medicare and has all these chronic problems because then 80% of the cost for their care is covered by Medicare.

This is a scenario that I find dismaying and will speak out against again and again.  We should never have allowed a service industry to become a profit making industry.  When we did, health no longer became the focus — profits did.  Making money did.  And when that happened, individuals’ health became compromised by the very system that claims to be proponents for health.

So in a nutshell, this website will (mostly) focus on our aging process and those steps we can take to better prepare ourselves (boomers corner) and it will focus on the health care industry by presenting articles that demonstrate the need for a major overhaul of that industry in the hopes of recapturing its original intent: health. (Health Blog).

At least for now…..

I would appreciate any thoughts you may wish to share with regard to this.

© Yvonne Behrens  2012

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Are Supplements Dangerous?

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Dietary supplements, such as the vitamin B sup...

Dietary supplements, such as the vitamin B supplement show above, are typically sold in pill form. (Photo credit: Wikipedia)

Being a person who gravitates to “alternatives” over conventional forms of medicine when it comes to keeping myself healthy, I found myself drawn to an article in the AARP Bulletin entitled, “When Supplements become Dangerous.”  The further I read, the more  apparent it became that the supplements themselves were not necessarily dangerous. What was potentially dangerous was their interactions with pharmaceuticals.

We are a country that relies on pharmaceuticals to a large extent for all sorts of symptoms.  It is inherent in our health care system.  A person goes in to see the doctor complaining of insomnia.  Typically, the doctor, instead of suggesting something nice and healthy like deep breathing  exercises, writes a prescription for a sleeping pill.

So it may not be so surprising that the AARP article was written from the perspective that it is the way supplements interact with the pharmaceuticals that might cause problems, rather than the other way around.

One myth that continues to dominate and was reflected in this same article is that mega amounts of vitamin C can interfere with chemo regimens.  Hm.  I have been told too many stories by individuals I know who knew individuals who successfully overcame their cancer with mega amounts of Vitamin C.  My husband, in his fight with pancreatic cancer, took mega amounts of vitamin C.  Not only did it not interfere with the chemo he was also taking, it boosted his immune system, something the chemo was destroying along with the cancer cells.  Although not scientifically proving this, I believe the Vitamin C did serve to enhance and extend my husband’s life.

Obviously, we all know that too much of anything can potentially be dangerous. The crucial words in that statement are “too much”

So bottom line, if you are taking pharmaceuticals and you are taking supplements, it would be wise to check with your doctor or pharmacist to see how they may interact.  But this need really only exists if you are on pharmaceuticals.

© Yvonne Behrens  2012

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Can Anti-Psychotic Abuses Be Stopped?

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Just as I think I have presented a fairly comprehensive picture about the abuses of anti-psychotic prescriptions and the elderly,  I come across another horror story. This time, the story appeared in the AARP Bulletin.

Apparently, in Florida, that golden state for retirees, a psychiatrist, Huberto Merayo,

“prescribed powerful drugs to thousands of patients at his Coral Gables, FLa., practice. In 2009 alone, he doled out more than 7,500 prescriptions to some 1,600 patients.  And that cost taxpayers big-time.  That year, Medicaid paid more than $1.9 million to fill scripts for antipsychotics written by Merayo.”

To add insult to injury, Merayo was earning $100,000 in consulting and speaking fees from the pharmaceuticals that manufactured these drugs.

Unfortunately, this story is not an isolated incident.  Lawmakers are apparently considering writing legislation that would address the misuse in administrations of these anti-psychotic drugs to the elderly.

Our elderly are frail and need protection.  The weakness inherent in creating laws by which to do this, of course, is the ability to manipulate the laws and/or the all too prevalent tendencies on the part of our lawmakers to be bought.

No.  The only way to protect the frail is to have a community, a village, if you will, or an extended family in which many people take responsibility for the care and protection of their nanas and grandpas.  Add to this picture doctors, general practitioners or geriatric, who know their patients and know what ailments may arise as one ages and, we might nip most of the abuses in prescribing anti-psychotic drugs that are prevalent today.  Oh, but then I guess I am talking about a society in which humans and not profits are the focus.  Hm.

[Next week: Why the dearth of geriatric practioners?]