The People's Perspective on Medicine

FDA Silent On Generic Drug Fraud

The brand new report from ProPublica reads like a detective story. A whistleblower working for a drug testing firm alerts the FDA that some scientists in the company were fudging data. A team of FDA investigators arrives at Cetero Research in Houston on May 3, 2010 and confronts the president with the allegations. He admits, “You got us.”

If this scenario were in a spy novel, the revelation would be followed by full disclosure of who the bad guys were, what they did wrong, which drugs were involved and how the FDA planned to right the wrongs. Unfortunately, in real life this scandal was not publicized. Without ProPublica’s recent expose, we would never have heard about Cetero’s data falsification.

It turns out that between April 2005 and August 2009 the fraud at the firm was so “egregious” that the FDA could not trust the results of any of the studies done then. Roughly 100 drugs are affected, over 80% of them generics.

You might assume that the FDA would have immediately notified the American public which drugs were under a cloud. In fact, you might think that the FDA would have suspended sales of these products until other testing could confirm that they met the agency’s standards. But you would be wrong.

To our amazement, the FDA to this day has never released the names of the affected drugs. Their rationale is that this is “confidential commercial information.” What? Shouldn’t the health of the American public trump commercial interests, especially if questions about quality remain unanswered? As a consequence we have no idea which generic medications are really “identical” to their brand name counterparts and which ones might fall short.

This question has troubled us for some time. Over the last decade we have become increasingly concerned about the FDA’s approval process for generic drugs and the agency’s ability to monitor quality of such products. The reason for our uneasiness grew out of the thousands of complaints we received on our website (www.PeoplesPharmacy.com) about generic drug problems. Initially we did not know quite what to make of these grumbles. After all, we had been enthusiastic supporters of generic drugs for more than two decades. But eventually the chorus of complaints grew to such an extent that we could no longer ignore the stories.

The straw that broke the camel’s back occurred over six years ago when we started receiving reports of serious complications linked to the generic antidepressant formulation for Wellbutrin XL 300 called Budeprion XL 300 (bupropion). Readers of our syndicated newspaper column began sharing painful stories about distressing side effects that appeared when they were switched to the generic. J. in Dansville, New York, wrote to say: “I have been taking Budeprion XL 300 mg for three months instead of Wellbutrin XL 300 mg. I find that I am easily upset and cry very easily. Sometimes I feel aggressive. I also have short, stabbing pains in my head.” Others reported nausea, insomnia, tremors, anxiety and suicidal thoughts.

Eventually, so many problems were reported to the FDA that it asked the generic drug maker, Teva, to do another study. That was never completed, but the agency ultimately commissioned its own research that determined that Budeprion XL 300 was not bioequivalent to Wellbutrin XL 300. The Budeprion product was pulled from the market in October, 2012.

That wasn’t soon enough for one unfortunate patient. Andrew Richards was switched from Wellbutrin XL 300 to Budeprion XL 300 and soon after that, in March 2008, he had a seizure. Read the ProPublica story. It felt, he said, like a lightning bolt that brought him from his sofa to the floor. Although he is no longer taking the medication, he continues to be troubled by the aftermath of that event. He won a lawsuit against Teva.

A|though Budeprion does not seem to be one of the drugs tested by Cetero Research, it is so far the only generic medicine that has been taken off the market for not meeting bioequivalence requirements. How many other generic medications might be in the same situation? We have begged the FDA to look at the lower-dose Budeprion 150. Plotting the agency’s own data yields this graph comparing the generic to the brand-name compound:

Budeprion 150 versus Wellbutrin XL 150 bioequivalence curves

In this graph, the X axis (horizontal) is measured in hours, while the Y axis (vertical) is measured in ng/ml, a measure of how much medication is in the blood stream. Although the FDA considers these two lines to be “identical,” they don’t look identical to us. We think that FDA should take a second look at this medicine, but the agency may be so busy reviewing problems uncovered in the Cetero scandal that it doesn’t have time to scrutinize this. You may be surprised to learn that Budeprion XL 150 (the generic drug in the graph above) remains on the market to this day and the FDA maintains that it is fine and dandy, ie, bioequivalent to the brand name Wellbutrin XL 150. People would take this twice or three times a day according to the official prescribing information.

The Bottom Line:

The Cetero scandal is unlikely to have been uncovered had it not been for an honest employee who blew the whistle. We don’t know about you, but we now worry if there aren’t other testing laboratories out there that may not be meeting rigorous scientific standards. And what about foreign manufacturing and testing? If the FDA can’t discover such problems here in the U.S., we have little hope that the agency can uncover fraud in countries where scientific integrity may not be as highly regarded.

The FDA inspector in Houston who unraveled the Cetero mess was Patrick Stone (since retired). Here is the conclusion from the ProPublica article:

“The FDA’s Stone draws little satisfaction from unraveling the problems at Cetero.

“There are thousands of bioequivalence studies done every year, he pointed out, with each study generating thousands of pages of paper records. ‘Do you really think we’re going to look at 100 percent of them? We’re going to look at maybe 5 percent if we’re lucky,’ he said. ‘Sometimes 1 percent.’

“Still, given how often he and other FDA teams had inspected the Houston lab, he thinks regulators should have spotted Cetero’s misconduct sooner.

“‘In hindsight I look back and I’m like, ‘Wow, should I be proud of this?'” he said. ‘It’s cool that I was part of it, but it’s crap that we didn’t catch it five years ago. How could we let this go so long?'”

If you are interested in problems with generic drugs, here are links to experiences other readers have shared.

If you are as outraged as we are, please contact the FDA and your Congressional representative. At the very least, demand that the FDA release the names of the drugs implicated in the Cetero scandal. Share your own story below.

 

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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I was prescribed a generic medicine(lisinopril) for my HBP. I have substained many severe & personal injuries. I’m interested to know All the” generic manafactuerers” & All generic medicine is involved !

I want to know side effects of Effexor XR (venlafaxine). Have been on it for decades, am 66 yrs. old.

I was put on Arimidex for one and a half years. Then for the last half of the year I was on the generic form called anastrozle.
On Arimidex I was paying $1,150.00 for a ninety day supply. The copay for the generic anastrozle was $5.00. Both medications are very dangerous and have a lot of side effects.
I look like a monster without hair or eye brows and half of the eye lashes are gone. Very hard for me to see. I have to wear dark glass even to bed.
Necrosis in the hips. Pain in my bones, feet, hands and fingers. Ulcers inside the body. I can not say enough about what I have been threw.
The doctors do not tell you of the possible effects of these medications. The
pharmacist gives you a list of side effects which also mentions death!

Thank you for what you do to keep us informed. Six yrs. ago I was started on Dyazide 37.5-25 for moderately high B/P. During that time, insurance switched me to Triamterene-Hctz 37.5-25. This generic form has caused me much joint pain, bloating and diarrhea. I went back to brand name Dyazide and symptoms mainly abated- I still experience joint pain.
Is it possible to stop this medication in a safe way? I have tried to wean myself off of it by focusing on natural ways to bring my blood pressure down – losing weight, healthy diet, increased exercise and I stopped smoking. Despite my success and lower B/P, if I do not take this medication daily, my urinary output is decreased both in frequency and in quantity and I become bloated, especially with some swelling in ankles. Are their more natural ways to provide my body the diuretic effect it seems to need? Thank you for your consideration.

Hi do you know when the FDA will publish results on the other 4 generic brands of wellbutrin?

This happens way to often. Many doctors do not care what your real problem might be, it takes to much time. Many just prescribe a drug that will give you more problems then you already had. Many become doctors, just to get the title, much like att’s at law who look for law suits to get income and have that title. I have experienced both good and bad in both cases and could write a book on some of the disasters they caused. Best to research your problem on your own and find, if you can a doctor who will listen, (GOOD LUCK) Also read what others have experienced on sites such as this one, and find natural ways to help with your problems. I do this and have helped my self and others with their problems. Good luck and even better, God bless your life.

Several years ago I was taking Lexapro. My family practitioner suggested that I change to Celexa — “it is a mirror image of Lexapro.” He didn’t say why, but now I suspect that it was because Lexapro was “going generic” and the company’s drug rep was encouraging my doctor to put his patients on the new Celexa!
I had a manic reaction — not too severe — but bad enough for me to go back to the doctor and have a blood test to check my thyroid level (I take Levoxyl for Hypothyroidism and I thought that was the problem), My manic period lasted about three weeks; my doctor mailed me a note telling me my thyroid was fine! I changed primary care physicians and got over the mania in time. I really believe primary care or family practice physicians have no business prescribing anti-depressants unless they have special training. Psychiatrists should prescribe them. I had other experiences with family practice doctors abruptly switching anti-depressants with bad results until I finally learned that I should go to a psychiatrist!
Drug reps and doctors have a very cozy and profitable relationship, and unfortunately, it’s my feeling that the docs prescribe the new meds based strictly on what these drug reps tell them. Anybody can get a job as a drug rep — I think the only prerequisite is a college degree — in anything, and maybe that’s not even required. Basically, it’s a job as a salesperson, and being handsome or pretty really helps. They just have to pitch the new drugs from information given to them from the drug companies. There are lots of “perks” for doctors who work with the drug reps — nice trips, gifts, etc.

My own personal physician takes a statin (crestor) and has admitted he takes it every other day-still gets the same blood levels and no pains. I now do the same with my statin and by the way eat walnuts-take psyllium based fiber supplement daily-your lipid levels will come down (unless you have a genetic tendency for high lipids.)

Nearly two years ago now my pharmacy started to carry a generic version of Wellbutrin which I had never had before – having been on bupropion for years to good effect. I developed a seizure disorder and totaled two cars before my psychiatrist contacted the pharmacy and discovered what had happened. He found a non-controversial version of the drug, had it delivered to my house – really, I wasn’t in shape to drive, and tapered me off the meds to insure this never happened again.
In the meantime I was charged with a dwi – I let blood be taken after 2nd wreck because I knew I had not been drinking – which hung over my head from Sept to May, due to backlog at the State lab. And when the results came back, at last, charges were dropped, just as I thought they would be. In the meantime, however, I had undergone an ambulance ride to the ER, a ct scan, MRI, and the brain-wave test (can’t remember term for it just now) which you take after having stayed awake all night. In the end the neurologist agreed that my psychiatrist was most likely correct. However, I am still paying for some of these expensive tests. I am self-employed and lost a lot of work days while all this was going on. I am disgusted that inferior drugs are allowed to “sneak” onto the market and throw a potential monkey wrench into innocent consumers’ lives.

Hi although I’m not n US citizen I’m following this blog and its scary. Since we get our tablets from America. My dr put me on Simvastatin 2 months ago and immediately I experienced pain in my arms. After contacting him he said I should instead of the evenings drink it in the morning. The pain should go away! I did that because I trust him. No effect. I stopped taking it now and it has been 5 days and still have pain in my arms. Is this normal?

My grandson was on Keppra for seizures and was switched to a generic then within one month had a seizure. He immediately went back on Keppra and is doing well. The only bad side is it is so expensive his insurance pays 50% but his share is $600 a month. It is ludicrous that it should cost that much.

WOW. I read the Pro Publica’s article and hence ended up on this site. Thank you for your work! I looked at comments and first thing I saw was the drug I am on! Generic drug Gabapentin. I have Fibromyaglia and now severe Myofacial pain…. which is absolutely terrible. I have been suspecting the Neurontin recently, as the pain has INCREASED not DECREASED over the months. I thought it was a progression of the syndrome, but now I’m not so sure!The same as previous post, they have increased the med and not decreased it.

I am perplexed about this whole generic vs original med debate. At age 64 I had open heart surgery to replace an aortic valve and root. One year later I underwent a second open heart surgery to repair a “pseudoaneurysm”. Shortly thereafter, I had my first seizure. I had many tests and was thoroughly evaluated by several top medical specialists in major highly respected hospitals. I was prescribed Keppra, my wife insisted on me getting the original (which of course was more expensive). My symptoms grew, the dosage was increased to the max (1,500mg 2 x per day), and a second med (Depakote) 500mg 2 X per day was added.
I have major coordination/balance/walking problems and great difficulty speaking and swallowing. Although my neurologist previously recommended an increase in my dosage of depakote, I resisted and fortunately have had no seizures in 3 years. I still take the meds, changing to generic and thankfully, there’s no difference. I truly wonder sometimes just what is the right thing to do. Bottom line, I am just another “Joe the Plumber” and MD’s are just human.

It sure seems like a no-brainer, doesn’t it? Trusopt worked but you had to BEG THE DOCTOR to change you back. I am glad you were successful.

I took Stalevo for Parkinson’s until my insurance company required that I switch to the new generic. I did, but the drug was obviously not the same as Stalevo. I went back to Stalevo, but am paying hundreds of dollars myself and hit the infamous donut hole in April last year.
We MUST clean up our county: it is not just the FDA, but the bankers and the insurance companies and all of the other amoral, greedy people who are ruining it for the vast majority of us who are good citizens.

I have glaucoma. I was switched from Trusopt eyedrops to a generic. The side effects were terrible. So I was switched to another, and another for about 6 drugs. Each, the same bad side effects. Also, the pressure in my eyes was higher than ever. My doctor was considering putting me on two drugs. I begged my doctor to change me back to Trusopt. I was willing to pay the full price which was over $100. The side effects disappeared and the pressure went down. My doctor was convinced and now helps me get the Trusopt at a slightly lower cost.

Scary! Horrifically scary!!

DS,
Trying to get off a thyroid med like sinthroid or its generics is at least as hard as trying to get ‘off” insulin. In both cases the drug is replacing something your body isn’t making enough of. Granted someone who makes tremendous life style changes, (major weigh loss, dietary and exercise changes) MAY wean themselves of the need for insulin, but those examples are far from common, approaching rare.
To wean yourself off of a thyroid replacement, you would have to find either 1) what’s causing your thyroid to be hypoactive and correct that (never heard of that happening;) or 2)Find some compound that will increase your thryoid levels that isn’t a drug.
Stopping thyroid medication will have some pretty unpopular side effects: itchy skin, dry brittle hair and nails; uncontrollable weight gain; and for a number of us, acute onset of allergies. [I don’t know why no one has studied the connection between allergies(incl. asthma!) and thyroid function but I’ve never seen one done but know many ppl who got allergies when their thyroid was low and they resolved when ithe levels were balanced again.]
Given that thyroid meds are not terribly expensive even without insurance, and prevent some pretty unpleasant if not down-right uncomfortable side effects, I can’t imagine why one would stop taking them. I never will voluntarily!

I have bad reactions to all drugs, generic or not. I am totally convinced that the human body can not handle any chemicals in it.

FINALLY, corroboration for what I have known for several years.
My new insurance company switched my Flonase to generic version. I began experiencing repeated ear and sinus infections.
with Flonase- 1 sinus infection per year
with generic fluticasone – 4 ear/sinus infections in 3 months
back to brand name Flonase- 1 sinus infection per year
My insurance will not pay for Flonase, only the generic, so I must pay the $80+ myself. It is cheaper than being sick and missing work and quality family time. Luckily, my ENT doctor admitted that some patients do not respond to generics and he insists that I only receive brand name Flonase.
Likewise, generic ibuprofen does not work for me. Generic ibuprofen is on the list of products tested by Cetero that the FDA has no comment on its effectiveness.
Thanks for providing this information and data to back it up.

I was prescribed Neurontin for fibromyalgia. My insurance company would only cover the generic Gabapentin, so that is what I have been taking. After taking it for about six weeks, I began to feel worse than I did before, most particularly, I’ve been exhausted, had headaches and felt nearly incapacitated. Can this generic drug cause these side effects?
PEOPLE’S PHARMACY RESPONSE: It can, although the brand name can cause them also.

I don’t think the 300 generic I’m on is working. The 150 that I started on worked. I did my own little test. I quit taking it (300mg) all together back in July 2012. I weaned by taking one every other day. I had no w/d of any kind. After 6 months off of it. I started to take it again. I got the Dr. to give me 150 (generic) I took one at 8 am and one at 4 pm. After 2 weeks I was feeling a lot better. When I ran out the Dr. insisted on the 300 again, not the 150 2 times per day. It is 4 weeks into it I don’t think the 300mg works. I had the worst case of PMS that I have ever had. I want the 150 2x per day. I will find a new doctor. I do not trust the 300 from any generic brand. Hope this made some sense.

remind any patient that receives a prescription with a different appearance than what they had been taking to question the pharmacist, M.D. or mail order company before taking the medication. If it is substituted, question why and ask for further info.
Yes, even competing BRANDS of the same med may react differently for some patients.

My doctor said I should stick with Synthroid. It cost me a lot more because my insurance pays only for generic. When my doctor was away another doctor prescribed the generic and I found I did BETTER on it. I would like to get off of it altogether. Anyone had luck with that?

I too had a severe reaction to a generic, an antidepressant. My late hubby had had a very rough last 4 months and seen the effects those issues were having on me, my MD started me on an antidepressant. It worked fine, until the most recent refill. That refill was made with the generic, but from a different company – usually not a problem. Not so this time. Within 20 minutes of taking it, I was hugging the commode, vomiting up all my AM meds and the juice I’d taken with them.
There followed another 3-4 hours of mostly dry heaves. The second day was nearly as bad. I called the pharmacy and they agreed to swap the new formulation for the previous one: No problems since.
The new formulation was TEVA’s. I swear it had high doses of zinc in it, as my reaction to taking Zinc on an empty stomach is identical – vomiting, dry heaves and serious intestinal discomfort that rivals Labor lasting 6-8 hours. Those side effects are certainly NOT listed for the original Rx.

My son used Wellbutrin XL 300 mg in 2008 – 2009 with good results. He stopped using it in the summer of 2009. During 2011 he began using the Budeprion XL 300 mg product and it did not work as well as the brand name. When I learned that the product had been pulled of the market I went with him to his pharmacy to pickup a refill. I was surprised to find that he still got a generic brand. I asked the pharmacist about it because I thought it had been withdrawn. He said that the Teva product was withdrawn because that was the only one that was tested. Other generics remained on the market!
I used to work with the FDA in the food industry. 15 years ago they were focused on consumer safety. The agency definitely has changed from protecting the public to protecting the manufacturer. Between the FDA, the drug companies and the doctors professional societies the phrase “Let the buyer beware” has become the rule for consumers. I am grateful for organizations like The People’s Pharmacy that tell the ‘other side of the story.’ Unfortunately too many Americans have a blind trust in these organizations that is completely unfounded. Keep up the good work!

OLANZAPINE (generic of brand Zyprexa): We are merely consumers so we can’t scientifically verify if the generic was off, but my relative with schizophrenia decompensated severely to the point of needing hospitalization after he was switched from the brand (Zyprexa Zydis) to the generic version (unexpectedly by the health care insurance company, not by doctor’s orders). He was on the brand (Zyprexa Zydis, melts in mouth without water) for many years without any problems, but as soon as he got switched to the generic, he decompensated. Can’t verify if this had anything to do with the psychological issue of switching drugs (surprises can set off a psychotic break) or if it was the actual generic drug (OLANZAPINE) itself.
I ALWAYS get problems (racing heart/high pulse) with ANY generic. A pharmacist once mentioned I’m probably sensitive to the other ingredients of the generic (dyes, preservatives, stabilizers, etc.) My sister NEVER gets problems with the generic brands she’s taken and has always been fine…

Hi
The FDA website is more than huge. Do you know which person or office would be most effective to contact?
Thanks

CJ, Cetero filed for bankruptcy and was sold to an investor group which formed a company called PRACS, which is now out of business. So there is no company there to sue. As to suing the FDA, it would be difficult because of Sovereign Immunity, which means you can’t sue a government agency unless you get its permission to sue it (!). The consumer loses again!

Same experience, about two years ago. My pharmacist pushed and pushed me about trying the generic “to save money.” I was happy with Synthroid — for 25 years — but decided to try generic at her recommendation and with my doctor’s OK. In a short time I was beset with every symptom of hypothyroidism. I used the generic about six months or so, then got thyroid hormone tests which, sure enough, showed deficiencies. I went back to Synthroid (and its expense) and have felt, and tested, normal since then.

This is depressing. My husband has had some pretty sad experiences the past couple of years. Each problem only gets another prescription. Fortunately I read your newsletter. He is “experimenting” with not taking statins per reluctance from his cardiologist. My endocrinologist insists on synthroid. His dr only gives him the generic. Sad.

FDA steers clear of drug issues of ALL kinds but let any kind of natural remedy (supplement or otherwise) have a slight hiccup and they, as well as the media, are all over it with blatant threats to our health and well being.

First it was Fosamax, now Wellbutrin. Explains a lot about how I’ve been feeling, physically and mentally. Glaxo also makes “Elontril” (bupropion chlorhydrate). Is this their own generic for Wellbutrin? In Italy you wait weeks for W. It was the only reason our doctor switched me to E. I thought the mood changes were caused by reduced effectiveness due to longtime use. Oh, and my good ol’ Synthroid was replaced by Levothyroxin, with resulting TSH numbers at both extremes. The FDA needs to be split up, a division for profit-driven companies, and a division for the rest of us, NOW.

This is most disconcerting-as a health professional we see this as a created distrust to the patients who trust our advice. Let’s hope this is
not the “way of the land” with all manufactures of drugs.

I am totally outraged by the FDA’s refusal to do the things they should to help the public! Who (and why) are they trying to protect drug companies? I was put on the generic of Wellbutrin and experienced severe anxiety and panic attacks. At the present, I am off work and trying to get my life to the point where I can actually take an antidepressant. I am on drugs for nausea and anxiety and feel I will never be the same.
Is there going to be a class-action lawsuit against the FDA or Cetero? Or are the biggest companies the ones that cannot actually be held accountable when they very definitely should be?

Thank you for the article, it verifies what problems I have and had with generic drugs, namely synthroid and the infamous statins. I’ve been on both for years, I refused to take statins and got the medical personnel furious at me, even to the point of asking “where did you get your medical degree”, which I promptly said I googled it, that made no brownie points.
I get all of my medical treatment and my meds from the military hospital. They do not give anything but generics any longer. If you want the “real” med you have to go downtown and purchase, which makes it difficult when you are on Medicare and Tricare for Life. Having been a military spouse for over 50 years, I have always trusted our facilities, here at home and the countries we lived in abroad, but not anymore.
Not only do we not get the care we used to (we’re not seen by a true medical doctor) but our meds are not the same. Sadly I’m stuck with them due to the fact if I go to a civilian doc on my own I was told I could not go to the military clinics anymore. I’m grateful for finding your site and receiving your emails…

I agree.

I took the generic Citalopram, I had used Celexa the Brand name in the
passed with no bad effects. With the Citalopram I had bloody noses to the
point of dehydration from blood lose. I stopped the medication on my own. The doctor didn’t think it was the medication but it was the only thing in my life that had changed, and the only drug I was taking. These bloody noses were a factor in my being laid off from my job. I have been unemployed for 6 months, have no health insurance, and other finandcial
problems thanks to this drug.
Thank you for your artile, it is an eye opener. Health care seems to
be more about money and someones porfolio than about helping someone
heal and feel better.

A few years ago, my pharmacy substituted a generic drug for Allegra, when my prescription was refilled. I didn’t know it at the time. I ran out of my brand name Allegra, so I took the generic drug. I had a serious reaction to the very first dose, that really frightened me, because I was home alone. I never took another one of them, and reported the problem to my pharmacy. They replaced the generic with the brand name Allegra that I should have been given in the first place. The maker of the generic version was a company mentioned in this article.

I have had a problem with my Dialantin which I take because I had a severe stroke at age 27 & was not expected to live (I am now 82). The mfg of my med allowed another co to mfg for them. I had a stroke & it was discovered the strength was only 50 instead of 100. They stopped that co to stop & began mfg them selves again. The BCBS has allowed another co to mfg my prescription drugs. I take 2 other med because of other problems which have occurred. This co is in Tex. so I am very disturbed by what is happening. I am calling my insurance provider to be sure that that the place in Texas is providing me with the correct med quality. As a result of my earlier comment it always bothers me when they allow another co to provide my medicine.

My son was having problems with pain over a long period of time while working manual labor for a refrigeration company…..the doctors prescribed gabapentin. He got worse and his pain multiplied. He went back the doctor several times and they simply upped the dose. They claimed it kept people from having seizures. He did not have a history of seizures but he did have a history of heart disease having had two open heart surgeries. In the end after months of doctors giving him gabapentin he became very disoriented so they prescribed another drug to be given simultaneously.
Things went from bad to worse. He died in hospice care in 2011. I wonder what the outcome would have been if he had real doctors who wanted to actually look at his records vis a vis heart problems and his complaints about the pain and disorientation gabapentin caused him. I often think the drug companies and certain unscrupulous doctors use the public as Guinea pigs. A mean thing to say, I know but I do wonder.

Yes, but the FDA doesn’t know that IDENTICAL doens’t mean = equal? (in drugs)

Yes, but the FDA doesn’t know that IDENTICAL doens’t mean = equal? (in drugs)

I too can’t take generic drugs, they do nothing on me… diabetic meds etc.. ZERO NADA NOTHING. I had to request my dr. to write a prescription with a note to the Insurance Co.

In looking at the published graph, I would say that the Budeprion 150 performs better than the Wellbutrin XL 150. If I assume that the desired level in the bloodstream is 40 ng/mL, then the Budeprion reaches the therapeutic dose at 1 1/4 hours and maintains this level for 5 hours while the Wellbutrin does not reach the therapeutic dose until about 4 1/4 hours (three hours later) and only maintains this level for 4 hours. I am not a doctor or a pharmacist, but I am used to analyzing data and this data doesn’t seem to support the thesis of the article – poor choice or the graph is mislabeled.
I am quite concerned about the lack of care by the FDA to look after the wellbeing of the citizens who are paying their salaries. What is it that drives the FDA to this behavior? Is it a lack of caring, laziness by the scientists, graft by the pharmaceutical companies, lack of funds to achieve their mission? And sequestration won’t help, though with the history, perhaps sequestration won’t hurt either (that said, since the FDA is not protecting us, perhaps we should just eliminate the FDA and save the taxpayer’s money). It seems the FDA needs to be dismantled and replaced by a new organization which places the wellbeing of the citizen first.
PEOPLE’S PHARMACY RESPONSE:
The goal is not necessarily to achieve rapid high blood levels but to increase blood levels gradually and sustain them over a period of time. Keep in mind that the brand name product has to demonstrate clinical effectiveness whereas the generic need only demonstrate that it is “identical” to the brand name in its bioequivalence curves.

I am stunned to tears – truly. According to its own website, “FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs…” REALLY? The rest of the statement should read, “…unless it involves confidential commercial information.”
In my opinion, the last honest FDA commissioner we had was David Kessler, who went up against food, drug, and tobacco giants as well as makers of silicone breast implants. When advised that with his “attitude,” he wouldn’t last long at FDA, he responded, “That’s why, in Washington, we rent.”

Thanks! Telling the truth just sank lower in virtue-power. Glad you guys are still around.

While this is tragic, do not think for 1 second that our “trusted” drug companies are innocent…as most of their so called clinical trials, involve manipulating the data, or massaging the numbers to make their drug more effective and less risky than it really is…look at statin drugs for example…relying on relative risk reduction in clinical trials…why not just pull a number out of a hat..

When I was switched to the generic for Synthroid it was as if I was not taking any thyroid meds. I gained weight rather quickly, my skin was dry and itchy, I just felt “blah”. Before the switch, I had maintained the same weight for many years. Back on Synthoid, my weight stays the same, and I feel much better physically.

When a generic med for Arimidex breast cancer drug came on the market, I jumped on it as I had fallen into the Part D gap twice and was tired of having to ask my Drs for samples since affording it was impossible. The pharmacy filled the generic prescription, using two different suppliers during the time I used it.
I had a feeling, for whatever reason I can no longer remember, that the generic from Teva wasn’t the same as the generic from the Dr. Reddy company. When Astra Zeneca came out with their offer to supply the brand for $40 a month when purchased directly from them, I jumped on it. When I started having to have repeated ultrasounds and MRIs because of “suspected” new cancers, I decided to have bilateral mastectomy to end the cycle. Sure enough, the biopsy of one of the removed breasts showed a cancerous node. I’ll never know if the generic simply didn’t prevent what Arimidex brand might have.

As I have written before: I had a very bad reaction to Gabapentin (the
generic for Neurontin?). It changed my life from being active to having
trouble walking. This was an anti-seizure medicine given for “off-use”
purposes.
All I had was stabbing pain in my feet and I wish I had that
back! I won’t go into all the details of what happened to my body but
it’s never been the same.
Not one of the doctors who saw me told me to
stop this medication! They said to take more. Very discouraging when
they don’t listen to you.

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