Tainted Generic Drugs Recalled

By Jeralyn, Section Off Topic
Posted on Wed Jul 15, 2009 at 07:16:00 AM EST
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I've never fully trusted generic drugs. I know they are supposed to be the same as the real deal, but there are some that just don't seem the same to me.

In the wake of Michael Jackson's death, comes this news about diprivan, a generic form of propofol, one of the drugs he may have taken:

Two tainted lots of a generic version of a drug reportedly taken by Michael Jackson have been recalled by the drug maker.... The CDC issued a health advisory Monday, saying two lots of a generic version of the drug had tested positive for endotoxin, a contaminant. The drug maker, Teva Pharmaceuticals, voluntarily recalled the lots.

Srinivasan said the agency received 40 reports of patients around the country developing high fevers and muscle aches after being injected with the drug.

So if someone famous hadn't died while taking the drug, would we ever have found out and would there have been a recall? (Note, the article says no link has been established between Jackson's death and the tainted drug. But that's not my point.) Have there been other instances of generic drugs being tainted or recalled? [More...]

The discovery doesn't sound like a coincidence:

"I can say the DEA did contact us about a specific lot number, and that lot number is not from the two we are recalling," said spokeswoman Denise Bradley.She would not say whether the contact was related to the Jackson investigation.

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Tainted Generic Drugs Recalled | 35 comments (35 topical)

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The big problem in generics is with pills, (5.00 / 3) (#2)
by andgarden on Wed Jul 15, 2009 at 12:24:28 AM EST

and in particular, timed release pills. For various medications, patients often say that the generic just doesn't release in the same way.

But for contamination in an injected drug like this, I don't think there's any reason to trust the generic less than the name brand. However, I would feel better if we had a better FDA. (Maybe funding could be drawn away from the DEA. . .).

: Active ingredients (none / 0) (#20)
by gyrfalcon on Wed Jul 15, 2009 at 08:47:15 AM EST

Have to be identical. It's the inactive ingredients that sometimes cause a problem because they do vary. This is a particular problem with timed-release formulations, but it exists in other things, too. Every body reacts differently to different substances, and something that has no effect on one person can have a noticeable effect on the next.
I don't know how patent law works on this, but it seems that a company can keep the total formulation proprietary, even if the core active ingredient becomes public after a number of years. Coca-Cola, for instance, keeps its formula a tightly held secret after how many years?
I also think of the garden chemical Round-Up. Its active ingredient, glycophosphate, is now available from a number of other companies besides Monsanto, but if you've ever tried to use one of those, they simply are nowhere near as effective an herbicide as Round-Up, even with the same concentration of the active ingredient glycophosphate. Monsanto has worked out some sort of combination that delivers the herbicide far more effectively than anybody has been able to duplicate, and it's apparently allowed to keep that formula entirely to itself.
The trick with generics is to give them a try and see how they work. With the vast majority of drugs and the vast majority of people, they work just fine and there's no need to pay the outrageous price of the brand name. Caution and careful observation is definitely necessary with anything timed-release, and particularly with drugs that affect the neurological system or have a psychoactive component.

propofol is the generic (5.00 / 1) (#4)
by Fabian on Wed Jul 15, 2009 at 12:38:33 AM EST

Diprivan is the brand name.

Propofol is prone to microbial growth due to its formulation. The common formulation includes small amounts of lecithin and vegetable oil, so an open vial of the drug needs to be refrigerated and used promptly.

Quality control and testing to ensure sterility should be standard.

(There is a new formulation without the oil and lecithin, but it was only FDA approved in December of last year.)

: Uh Oh (5.00 / 1) (#37)
by squeaky on Wed Jul 15, 2009 at 11:40:55 AM EST

Looks like this is going to be the insurance cos angle in determining whether MJ's death was an OD or caused by contaminated drugs.
If he ODed, AEG collects, otherwise not so sure if tainted drug use is covered.

FDA web site (5.00 / 3) (#9)
by TeresaInSnow2 on Wed Jul 15, 2009 at 02:32:44 AM EST

The FDA web site tells you about drug recalls and you can sign up for alerts.

And FYI, Diprivan (the name brand from Astrazeneca of Propofol) was recalled in 2004, due to particulate matter.

Generics are often made in the same factory as their named brand counterparts. You are probably just as likely to have a defective name brand drug as you are to have a defective generic.

Here's what the FDA says about generic drugs:

Listen to your father the chemist rather than your gut. He knows better.

No question about it (5.00 / 2) (#10)
by NYShooter on Wed Jul 15, 2009 at 03:03:35 AM EST

Generics are not "exactly the same" as the Brands. That statement is not just my opinion, but confirmed by all the doctors and/or pharmacists I've questioned about this subject..

Now, the chemical formulas may be the same, but there's much more to a medication than the formula. Read the inserts and you'll find dozens of ingredients (besides the "formula") that are part of the pill. And dependant on which additives are included in your drug (no two generics use exactly the same fillers, additives, jells, colorings, etc.) the effect they have on you varies greatly.

I'm talking about the effect they have, not contamination, which is a completely different subject. Just for example, let's say you have a script for some headache remedy. The generic has the same formula as the Brand, but the pill has no effect on your headache, which is not the case with the Brand, which works just fine. Apparently, one or more of the additives neutralize, or negate, the effectiveness of the formula.

Unfortunately, I have medical issues which require my taking over a dozen prescription meds monthly, and each month it's a crapshoot as to whether the generic meds relieve the symptoms the Brands do. As to whether they medically have the same effect, I'm not sure. What I'm saying is that they may not feel like they do. An actual example: I take a prescribed antacid, a potent Pepcid. Some of the generics do nothing for the burning sensation, yet may actually reduce the acid creation. So I may have an actual reduction in acid generation, but my stomach still feels like there's an acetylene torch, on steroids, ablaze nonetheless. The Brand, Pepcid, relieves both the creation and the burning sensation. The generics may, or may not.

It is surprising that this fact is well known by medical professionals, yet it's not publicly discussed.

p.s..........Teresa (5.00 / 2) (#11)
by NYShooter on Wed Jul 15, 2009 at 03:44:02 AM EST

If you go to any web site where consumers of certain drugs meet, and discuss this very subject, you'll find that Mr. Gary J. Buehler's defense of generics is not 100% accurate. The impression he gives of generics being exactly the same as the Branded variety is, in my opinion, disingenuous. Of course, as the spokesman for the generic industry, his comments are not only somewhat skewed, but actually mis-leading. Most of what he claims is probably true, yet, as I stated in my post above, the physical effect these drugs may have on certain patients are not exactly the same.

Lately, the original manufacturers have taken a much more aggressive position in fighting off some of the generics. The heart drug, Plavixs, is one; the anti-pain med, Oxycontin, is another. They have sued, and won, forcing the generics to cease their manufacture. Again, the chemical formulae are the same, but the time-releasing features are not. The feature both these drugs have are that they release the chemical into the bloodstream in a precise, spanned time period, like a saline or morphine drip. The generics were able to duplicate the formula, but not the controlled releasing mechanism.

Hey, I'm not a spokesman for the big drug companies; most of the generics do what they claim, and work just fine. Some even get better results. I just object to the word, "exactly" the same, when in many cases they simply are not.

The power of suggestion (2.00 / 1) (#25)
by Dadler on Wed Jul 15, 2009 at 10:00:54 AM EST

Generics are fine, don't let yourself fall into this trap, which is just what drug manufacturers want. It is akin to research that shows, say, people without pain will suddenly be in pain if informed that the results of an MRI showed even a slight bit of damage to the physical structure of the body part in question (knee, back, etc.). Human beings are HIGHLY corruptable when it comes to suggestions. Remember when everyone had ulcers. Now, suddenly no one gets them, but instead we get back pain, carpal tunnel and others (ever wonder why no one had carpal tunnel when tons of folks were banging for hours on manual typewriter?). We are basically being led down a path that teaches us we are weak and frail and need all sorts of medical interventions or we'll just withter and die. And pills, pills, pills, we gotta have our pills. Now, SOME people need their pills, but most of us, the vast majority? We. Are. Fine.

Generics are not "fine" (5.00 / 1) (#28)
by Fabian on Wed Jul 15, 2009 at 10:10:39 AM EST

if you can't get the same results.

Especially WRT to anti-seizure meds. One seizure can cause you to lose your driver's license! There may be psychosomatic illnesses, but seizure disorders are not among them.


Nonsense (5.00 / 2) (#29)
by gyrfalcon on Wed Jul 15, 2009 at 10:49:48 AM EST

People still get plenty of ulcers, but now we know what causes them and the right antibiotics makes them go away quickly, and in chronic cases, proton-pump inhibitors and the like keep them from forming. People complained about them -- and had terrible problems with them -- when there wasn't anything you could do about them.

My dad suffered with an ulcer for years, and suffered almost as much with the "bland diet" that made little difference. My mother in her last years got a perforated ulcer, but by that time they knew how to treat it and it was dealt with swiftly.

As for carpal tunnel, people got it all the time with manual typewriters but there was no name for it and plenty of women secretaries and clerks crippled themselves trying to keep their jobs.

Suggestion: Don't sneer unless you actually know what you're talking about.


With all due respect (none / 0) (#30)
by Dadler on Wed Jul 15, 2009 at 11:08:13 AM EST

People do not get ulcers at anywhere NEAR the rate they use to, and not because they happened to discorver a bacteria present in people with them. Also, explain why there was no epidemic of lower back pain until fairly recently, or capral tunnel, or plantar fascitis, or fibromyalgia. Sorry, they didn't exist like they do today, despite the fact peope did INFINITELY more laborious work physically years ago.

Buddy, I suffered from every kind of severe pain imaginable from the time i was 9 year-old kid living in abuse and torment. Ulcers, back pain, knee pain, headaches, panic attacks. Nothing ANY doctor did cured me or even helped me, in fact the doctors were ENTIRELY clueless, they only masked symptoms of the real malady if they did anything. The real malady was psychosomatic. MEANING, a lot of this pain, a lot of these conditions, are very real, but the origin of them is completely different.

I recommend you read up on research done with, say, WWI veterans, before the pharmaceutical industry took over medicine with the pill cure for everything paradigm.

Let me give you my most personal and recent example. I started suffering from platar fasciitis, shortly after I got all my back trouble to go away. And you know how I treated it? When the pain got terrible, I stretched that foot so hard it felt like it was going to explode. And you know what happened? The pain went away.

It is amazing to me how many people seem to think the human brain plays such a minor role in illness, disease, pain syndromes. It is the organ that controls EVERYthing in our bodies. So I would suggest you not sneer until you actually study up on psychosomatic medicine and related topics.

The Divided Mind by Dr. John Sarno, who's been working miracles at NYU medical center for decades. But he's just a kook, I suppose.

And if you think human beings are just machines, like cars, and that all our ills are because of defective parts, then so be it. I don't believe that, because I was cured of chronic pain you couldn't imagine, and all by understanding the origin of that pain.

Peace.


: Another Link (none / 0) (#32)
by Dadler on Wed Jul 15, 2009 at 11:21:40 AM EST

The Rise and Fall of American Psychosomatic Medicine.

See someone you love have a seizure (none / 0) (#31)
by Cream City on Wed Jul 15, 2009 at 11:09:31 AM EST

and then come on back with more education for this conversation. Have you even read the comments here?


Of course,... (none / 0) (#33)
by Dadler on Wed Jul 15, 2009 at 11:26:42 AM EST

...I must be talking about every case of every patient.

Hold Jaysus, my point was that MANY pain syndromes, many conditions, in which people are medicated to hell, do nothing to actually address the actual cause of the ailment.

OBVIOUSLY, there are real physical injuries, conditions, but there are many that are simply treated neglegently.

Again, I am amazed at the reaction you get when you even SUGGEST that we are a society brainwashed into thinking there is a pill for everything. That we are a society that completely neglects, rejects vehemently for some bizarre reason, to factor the human brain into our medical thinking and treatment.

To repeat, I suffered from various pain, for so many years, that was so severe it debilitated me. And I cured myself by understand the origin of that pain.

Remember, there is no money for the medical industry if people learn to cure themselves of many things we are now slaves to pills and desperation over.

Which does not, in any way, take away from the legitimate physical treatment of legitimate physical defects and ills.


in fact... (none / 0) (#34)
by Dadler on Wed Jul 15, 2009 at 11:31:27 AM EST

...just last year, a good friend of mine was debilitated with back and leg pain, she couldn't walk for more than five minutes without being struck by severe pain. Her doctors were usless treating it conventionally, no pills worked. I simply told her what worked for me, I sent her Dr. Sarno's books, some other info I had, she read it, integrated it, and in a matter of weeks she was pain free entirely. And there are thousands of stories out there like that. Unfortunately, the medical industry has marginalized psychosomatic medicine terribly. There is no money in teaching people how to cure themselves of many conditions now epidemic in our pill-happy, paradigm addicted society.


lastly (none / 0) (#36)
by Dadler on Wed Jul 15, 2009 at 11:34:32 AM EST

regarding seizures, and not to blanket comment on all people with seizures obviously, but do you remember the story of the nurse who worked in the basement of Johns Hopkins keeping alive a special diet that was used to treat kids with epilepsy? It is very effective for many children, but was marginalized when pills for everything took over medicine. It wasn't, however, lost for good, only because this ONE nurse kept practicing it. And now it is once again being used, not enough, but more widely than it ever would have.

Very similar to the way psychosomatic medicine has been marginalized.


: Of course, I'm well aware of it (5.00 / 1) (#40)
by Cream City on Wed Jul 15, 2009 at 12:04:27 PM EST

and believe me, you cannot tell me anything that I haven't read about chronic seizure condition.
But you wrote initially in blanket terms about generics, so you got the logical response that you deserved. If you didn't mean to write about all generics, then back off and reread before you click.

: real last link (none / 0) (#38)
by Dadler on Wed Jul 15, 2009 at 11:42:15 AM EST

20/20 segment on Dr. Sarno. I'm no John Stossel fan usually, but he got this right. And it's interesting to note the reflexive hostility of the medical professionals who respond.

Is heparin, the blood thinner, generic? (none / 0) (#1)
by oculus on Wed Jul 15, 2009 at 12:22:35 AM EST

Small "h." link

warfarin is the generic (none / 0) (#3)
by Fabian on Wed Jul 15, 2009 at 12:29:00 AM EST

Heparin is...a bit complicated. It's not a single chemical compound - which is why there is such a thing as LMW heparin, low molecular weight heparin.


I thought warfarin was the generic (none / 0) (#21)
by Inspector Gadget on Wed Jul 15, 2009 at 08:48:53 AM EST

for cumadin.

Just took my mother through a huge blood clot. The heparin was used in the hospital in the form of an IV drip. (I believe it's stronger than cumadin and warfarin.) She couldn't go home until they had her on cumadin pills for a few days, but they sent her home with the generic pill, warfarin.


I think you are right. (none / 0) (#26)
by Fabian on Wed Jul 15, 2009 at 10:05:29 AM EST

Got them confused. I don't take meds, so I rely too much on my memory.

You'll find heparin used as an anticoagulant in medical devices too.

(Coumadin therapy is tricky and monitoring and testing are essential to set the right dosage.)


It's all so (5.00 / 1) (#35)
by Inspector Gadget on Wed Jul 15, 2009 at 11:33:56 AM EST

tricky to me....I am very lucky that I've not needed to be on a regular medication.

Coumadin/warfarin is tricky. Every aspect of it was intimidating to me. My mom passed away, but not because of the warfarin.


: Not simple to administer. (none / 0) (#41)
by Fabian on Wed Jul 15, 2009 at 02:20:36 PM EST

You start on the coumadin, it takes at least a day to get consistent levels, then you need to do coagulation tests to see if the dose is correct. If not, adjust, wait another day, do another round of tests, and check again. (If you need to know why, just look up a graphic of the clotting cascade - it's a complex and variable process. Nice link here showing where warfarin and heparin fit in.)
Fortunately, most drugs are of the simple X milligrams per kg of body weight and don't require that kind of testing.

Well all I can say is that (none / 0) (#6)
by FoxholeAtheist on Wed Jul 15, 2009 at 12:53:54 AM EST

Diazepam doesn't work nearly as well as Valium - may be a placebo effect though. And the heart-shaped "V" is so pretty.

Is there any conclusive evidence that generics run a higher risk of being contaminated?

that's what I'd like to know (5.00 / 1) (#7)
by Jeralyn on Wed Jul 15, 2009 at 01:49:26 AM EST

My dad was a bio-chemist in drug research his entire career. After he retired from a major pharmaceutical company (he was in research and development, not sales) and moved to Denver, he was hired by a major European generic drug company. He always told me the generic were as good, and the same, but I never fully accepted that. Only in the past few years when drug prices have gotten so high, have I allowed my pharmacy to give me generic on some medicaitons. But I always wonder whether the original drug doesn't have a little more "oomph."


no, there isn't. (5.00 / 1) (#13)
by cpinva on Wed Jul 15, 2009 at 05:41:28 AM EST

generics must have the exact same operative formulation as the brand name, to receive FDA approval, though external casings may be slightly different.

what separates generics from their pricier brand cousins is the absence of initial R&D costs, as well as the lack of billions of dollars in marketing, neither of which have to be recovered by the generic producer.

i must add, a fair bit of the R&D costs supposedly factored into the price of brand names was actually shouldered by us, the taxpaying public, in the form of grants to various and sundry research colleges/universities/medical schools, hence the ginormous profits made by the pharmeceutical companies. go read their 10-k's, available through the SEC web site. ignore all the fancy dancy stuff, go straight to the required notes to the financials, that's where the required disclosure data is, and the goodies to be found.

but I never fully accepted that.

whether you fully accepted it or not is irrelevant, a matter to be taken up with competent medical counsel. absent corruption in high places (certainly possible), generics must be fully as effective as the brand names, for whatever use it is they've been approved for. as well, they must meet the minimum safety standards required for the brands.

any lack of perceived effectiveness, on the part of generics, is attributable mostly to psychological impact of years of advertizing done by the brands, not the drugs themselves.


DDS - drug delivery system. (none / 0) (#14)
by Fabian on Wed Jul 15, 2009 at 06:01:02 AM EST

Identical chemical formulation doesn't mean that the drug is delivered the same way.

This can be a real problem with anti-seizure drugs (among others) because it isn't how many milligrams you swallow, it's what your drug serum level is. For some drugs, it is essential that you have steady drug levels in your blood. Drug delivery systems that are less efficient or cause peaks and troughs can cause problems.


: Exactly -- anti-seizure generics (5.00 / 2) (#17)
by Cream City on Wed Jul 15, 2009 at 07:57:47 AM EST

simply cannot be trusted, as I know from experience with a family member. The insurance company made the pharmacist switch to generics -- and the result was seizures. (And keep in mind that seizures can cause further brain damage, so I wish that the family member had sued to stop this insurance company practice. Add in that family member had finally gone enough years without seizures to get a drivers license -- thank heavens that a seizure didn't occur while behind the wheel -- and lost the license for a year again, almost losing a job, etc.)
It may be the timed-release factor that you and other commenters note, finally explaining for me how the seizures happened again on generics. Fortunately, the pharmacist is a great one and took on the battle with the insurance company, forcing it to allow a switch back to the brand- name drugs. And the result? No more seizures.

: Allergic reactions (5.00 / 1) (#22)
by Inspector Gadget on Wed Jul 15, 2009 at 08:51:19 AM EST

I've also heard that the fillers can often cause an allergic reaction in people.

Actually, there was a huge (none / 0) (#39)
by Inspector Gadget on Wed Jul 15, 2009 at 11:52:17 AM EST

problem with drugs from China. Some were even made of cement and coated with paint, but to the eye looked just like the real thing.

One of the Dateline-type investigative shows did a big deal on it. Some of the people caught on film selling these fake drugs were arrested and are serving lengthy prison terms now.


I'd also say "oomph" is the right word (none / 0) (#8)
by FoxholeAtheist on Wed Jul 15, 2009 at 02:30:38 AM EST

I have reservations about generic drugs. However, it seems likely that once the original patent expires on a brand name drug, the original patent owners would be very vigilant in policing the quality of generic drugs that subsequently come to market. I mean, Eli Lily still wants us to buy the brand name "Prozac" (now "Sarafem") vs. a generic form of fluoxetine.

How interesting for you to have a dad who was a bio-chemist in drug research. I've always had a major soft spot for those brainiacs, meaning bio-chemists and biologists in general.

Here's a twist re generic of Ambien. (none / 0) (#23)
by oculus on Wed Jul 15, 2009 at 08:54:14 AM EST

Shape of the generic changed from oval to round.

Teva Pharma manufactures world-wide (none / 0) (#24)
by DFLer on Wed Jul 15, 2009 at 09:58:27 AM EST

I can't find out where this generic was made. Perhaps China?

The obvious bs re outlawing non-US drug companies: US companies manufacture abroad anyway.

: India is also (none / 0) (#27)
by Fabian on Wed Jul 15, 2009 at 10:08:42 AM EST

a big pharma exporter.
I remember an NPR bit on pharma factories in India dumping untreated waste into rivers.