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Why We Have Lost Confidence in Generic Drugs: New Report Casts More Doubts on Imported Medicines

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Gardiner Harris has written a powerful front-page story for the New York Times titled "Medicines Made in India Set Off Safety Worries" (Feb. 15, 2014). If anything, the headline downplays the seriousness of the problem. Here is the first sentence of the article:

"India, the second-largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators for safety lapses, falsified drug test results and selling fake medicines."

We have been warning about drugs imported from abroad for more than a decade. That's because readers of our syndicated newspaper column and visitors to our website have been telling us for years that there were problems with the generic medicines they were taking. At first we were skeptical of these protests, thinking there might be a psychosomatic component to some people's bad experience. (We had long been big supporters of generic drug quality and the savings that can be gained by substituting generic for brand-name medications. It was hard to accept that we might have been overly enthusiastic.)

Eventually the sheer number of complaints and the compelling nature of the stories convinced us that there was something very wrong with the way the FDA approved and monitored generic drugs. The article by Mr. Harris confirms that there is indeed a scandal of immense proportions that has pretty much been ignored by physicians, pharmacists, patients, regulators and Congress. Here's the straight and skinny.

India now supplies roughly 40% of the active pharmaceutical ingredients found in our prescription and over-the-counter medications. Until recently, the FDA was incapable of inspecting most of India's manufacturing plants. It didn't have the resources or the manpower. New legislation has allowed the FDA to accept money from the generic drug industry to speed drug approvals. Some of those funds also go to inspections. Last year the FDA visited 160 Indian manufacturing facilities, triple the number from four years ago.

In the process the FDA has uncovered fudged data, shoddy plants and questionable quality control in a number of facilities, including India's largest drug maker, Ranbaxy. Just recently, the FDA banned all active pharmaceutical ingredients made at Ranbaxy's Indian facilities from the U.S. market. This was one of the first large foreign generic drug makers to make a splash in the U.S., starting its exports to this market in 1998. Perhaps coincidentally, that was the year we began to receive enough complaints to make us start to question our trust in the FDA's ability to guarantee generic quality. Here is just one example of the kind of story we were receiving from readers at that time:

"I have been treated for hypothyroidism for over thirty years, and have been on Synthroid 0.125 mg for the past ten. This year my doctor wrote the prescription for a generic at the same dose.

"By the fourth day on the generic, I felt as though I was on the end of a tightly coiled spring. I couldn't sleep; I had a slight case of diarrhea; I was sweating more than usual and my heart felt as though it would pound out of my chest. When I finally realized all this might be due to the change in medication, I had the pharmacist give me Synthroid instead. Almost immediately I calmed down, my heart stopped pounding so hard and I was back to my normal self." [published May 18, 1998]

We now know more about the flaws in the Indian drug regulatory system. The head of the Indian drug monitoring program is G. N. Singh. In response to a question about quality control he replied that, "If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those. We are not the US, the infrastructure and resources available there are much different from those in our country. Our priority is to make medicines available and affordable to all."

If the goals of Indian regulation are availability and affordability over quality, then it is little wonder that the FDA officials are finding problems. It was alarming to read in Mr. Harris's article that many generic drugs are under the supervision of state health departments in India rather than the national authority. He points out that:

"The making of medicines that have been on the market at least four years is overseen by state health departments, many of which are corrupt or lack the expertise to oversee a sophisticated industry."

The other large supplier of generic ingredients and products to the U.S. and the world is China. The former head of China's national drug regulatory authority was executed for corruption in 2007. He had taken office in 1998, the year we started hearing from our readers about increasing problems with generic medications. The FDA has historically had difficulty making unannounced inspections of drug manufacturing facilities in China. Here is what Gardiner Harris of The New York Times has to say about oversight there:

"Using its new revenues, the F.D.A. tried to bolster its staff in China in February 2012. But the Chinese government has so far failed to provide the necessary visas despite an announced agreement in December 2013 during a visit by Vice President Joseph R. Biden Jr., said Erica Jefferson, an F.D.A. spokeswoman.

"The United States has become so dependent on Chinese imports, however, that the F.D.A. may not be able to do much about the Chinese refusal. The crucial ingredients for nearly all antibiotics, steroids and many other lifesaving drugs are now made exclusively in China."

Despite all these concerns, the FDA still maintains that generic drugs are "identical" to brand names and that "FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs."

If you are having some doubts about the FDA's ability to guarantee quality in drugs from foreign manufacturing plants, you may want to get the rest of the story. Twelve years ago we interviewed key players at the Food and Drug Administration about these very issues. You can read what we discovered in our book, Best Choices from The People's Pharmacy. More recently, we uncovered another scandal at the FDA involving the process for approving generic drugs. We document those problems in our book Top Screwups and also provide guidelines on how to use generic drugs more safely in our Guide to Saving Monehy on Medicine.

Share your own story below. If generic drugs have worked well for you, please let us know. We're also interested in your experience with therapeutic failures or complications from generic medications.

 

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there is no question. we just need to stop being dependent on other countries. we need to make these things (and everything else for that matter) here in the US. create jobs as an added bonus.

Thank you for publishing this. It is very scary! I am forwarding to my pharmacist and my Doctor!

the generic drug for Ambien name of which I no longer remember, did not have any effect on me and I had to return to the very expensive Ambien.

I have first-hand experience of Ranbaxy products. I had taken atenolol, which is a generic, made by Sandoz for years. It worked without any undue side effects. Then the pharmacy switched to atenolol made by Ranbaxy. Worst case of insomnia ever! I talked to the pharmacist who promptly ordered me a bottle of the Sandoz version. Problem solved. All versions of a drug are not created equal.

The generic drug for Ambien, name of which I do not remember, did not work for me and after about 10 days of attempts with it I returned to the original Ambien and slept well ever since.

I have been on Metformin for 15 years for type II diabetes with very good
blood glucose control. My fasting reading ranges between 75 and 100 daily.
For 5 years my doctor was able to control my blood sugar with exercise and diet.

My eye doctor, however, would not allow the use of the generic version
of Xalantan for glaucoma treatment, saying that the generic was questionable!

At 85, I am in very good health, according to my doctors.
As an herbalist, I am also using herbals in addition to my 3 prescriptions.
I make a blend of gynema sylvestris, cinnamon, turmeric, and fenugreek in
capsules and take 1 daily with the knowledge of my doctor. I find it interesting that he isn't aware of the benefits of this combination of herbs
but his wife (a RN) who supervises his office is very aware of the benefits, and the history of their use in treating diabetes.

Refilled meloxicam 15 mg tabs lupi for mobic 15 mg. from name drug chain. Sticker said same med, may appear different. Same med, my foot! Oval tab, light yellow 15 on one side. Info is right but doesn't work like the previous rx's I've received.

Have rec no relief. Feel like this is a placebo. changed all rx to a different drug chain and when filled this first rx there, rec the same oval tabs. Guess I will have to check into paying for the brand med instead of the generic since I know that something is not right.

As an adult we know our meds, we know how they work for us. I dread it when I pick a rx and see that dreaded sticker "same med, just looks different" because now I wonder if there is any medication in the pills at all.

why don't we find another maker of generics; there's teva. I don't buy anything from china if I can avoid it

I have taken Lexapro for years. About a year ago the pharmacy started sending generic. I didn't think anything about it at the time, but as time went by I was returning to depression. I finally realized what might be the problem, got changed back to the real thing, and am back to what is "normal" for me.

I wonder if the generic you get from one pharmacy is a different generic from what you might get at another pharmacy. I would really like to know, because I have changed pharmacies and would like to try their generic if it is different and more reliable than what I was getting at the other place.

I like how my gabapentin looks like it is from Jersey, but it is just repackaged after being manufactured outside of the USA,

the only problem that I see here is that many people will "across the board" cast doubt on ALL generic drugs. Many US made generic drugs are made by the same manufacturer who makes the brand name and all are FDA approved. If People had to "across the board" switch to name brand ONLY. It would be exorbitantly expensive and many sick people would stop taking their needed medication.

The emphasis has to be made that the FOREIGN MANUFACTURES are the ones in question and of course this leaves open the question "why does the FDA check these manufacturing processes-BEFORE they enter the US market?"

I guess the worms are coming out of the can now. On the one hand the prescription medicines are very expensive even after patent expiration. The alternative was to produce generic drugs which are cheaper but identical in drug efficacy and quality.

There are two factors in the cost of generic drugs. First the high overhead and profit picture of the prescription drug is removed. Second, the generic drug is manufactured in third world countries where the cost of producing the drug is low (mainly due to low wages). Apparently due to pressure from drug distributors and insurance companies the generic drug manufacturers outbid each other in quoting the lowest price, thereby compromising their own operations in terms of oversight on quality.

Short of maintaining a constant presence by the regulators in such facilities it is difficult to have an effective supervision. The plant folks are under pressure from their own management to accelerate production and cut costs. Besides, the local regulators are not free from corruption and so the production may lack proper oversight.

There is one possible solution though. By mutual agreement between the manufacturers and distributors a certain amount of the price can be rebated to the manufacturers to hire independent regulatory staff to ensure quality.

By the way the situation with respect to quality control in the US is not something to gloat about either. All you have to do is to look at the number of 483s (failure to comply notices issued by the FDA to various pharma company facilities in the US) issued every year by the FDA. Yes, quality problem is a common occurrence everywhere. The only difference is the number and the remedial measures taken at various locations to rectify the problems .

Do you have any suggestion on holistic med for Rheumatoid Arthritis?

You have lost confidence in generic drugs? As a retired pharmacist, I have lost confidence in the pharmaceutical industry as a whole, and much of modern medicine. Pharma cash has polluted the scientific basis of modern medicine.

The medical system in the USA is a disgrace, based on profits rather than health and prevention. The critique may go even deeper than that. Some people equate the medical system in this country to a church. Accordingly, the Church of Modern Medicine is a faith-based enterprise, and resembles a religion more than a science.

There are certainly many safe and effective drugs on the market, but not as many as the public believes.

We need a single-payer (Medicare for all) system in which the profit motive is not the engine driving this abomination.

I am a recently retired family doctor of 35 years. This problem goes back at least 20 years. It was and still is most noticeable in psychiatric drugs which I used a lot in my clinic.

Patients often found that when the pharmacy would change generic manufacture they would loose control and as soon as they went back to the original brand (both generic) they felt better with in days. One person was on buproprion (Wellbutrin) and 3 different generics didn't work and within 3 days she could tell a MAJOR improvement back on the brand.

There is also a very control of prices presumably by US companies. In the last few years prices of very inexpensive generics that have been available for many years have suddenly gone up 3-10 times the previous price often over even months. Many prices are only slightly less than the brand name.

I have had good luck with generics and saved a lot of money using them. I always trusted that the "active" ingredients were exactly the same as the name brand drug based on the FDA's assurances until a few years ago when a trusted friend said her generic substitute for her reflux medication did not work at all for her, yet it was required by our health insurance plan at work. She had to pay for the very expensive name-brand drug herself.

I do wonder, in addition, whether a generic medication that did not help me, for example a depression medication, was due to the fact that it was a generic. How would I or my doctor ever know?

It seems to me that the FDA could target their investigations at plants in India and China by requiring a statement on the generic drugs' info sheets from the pharmacist that specifically asks patients to let them know if a particular generic doesn't work for them the way that the name-brand drug worked. Or to let them know even if it doesn't work the way it is supposed to work, for the cases in which a patient was never given the opportunity to use the name-brand version in the first place. This information (that something is not right with this generic version of a drug) is useless if we all just complain amongst ourselves, our pharmacists and our doctors.

Congress would be able to require this if the FDA is not able to do so independently (create or add to Federal regulations on generic drugs to protect the public). They could also require pharmacists and doctors to report to the FDA when a patient experiences these problems and reports it to them.

On a slightly different, related topic, I have been concerned about my partner's penchant to save a lot of money by buying OTC drugs at the "dollar" stores. I usually don't recognize the brands. Would the Graedons please comment on this concern? Give advice? I would like to save money without unduly risking our health!

PEOPLE'S PHARMACY RESPONSE:

One of the points that was made in the Gardiner Harris article in the New York Times is that many, if not most, of our OTC medications are now made abroad....many in India and China. If the FDA cannot manage to inspect plants where prescription drugs are being made, then we imagine the OTC situation is not any better.

One problem with trying to report generic drug failures is the following. The FDA requires the name of the manufacturer, the lot number, the expiration date and the NDC number. Few, if any, pharmacies put the lot number on the label of a generic drug container. The expiration date is also missing. Some pharmacies supply the manufacturer's name, but not the country of origin. The lack of uniformity in labeling (a state controlled situation) makes it hard for patients to fill out the official FDA forms to report a problem.

A few years ago when I got a refill on my prescription for Allegra, my pharmacy substituted a generic form of prescription Allegra allergy medication, made by Teva. I had very severe reactions to it, after taking only one pill. I threw the generic away, and waited until they ordered the brand name Allegra for me. This was before it went OTC. I make sure my meds for hypothyroid disease are the brand name, because the generics are not dependable.

Ok, so how do we avoid drugs from India and China, for example. Where can we find a list of drug manufacturers and their countries of origin? I take Zomig, and now get the generic, which is made by a division of the original manufacturer, and is the same pill, made in the same place, with a different package. I was dreading the switch to generic, but so far no problems.

However Tramadol is another story. What websites would have this information?

I suffer from Obsessive Compulsive Disorder and had taken Zoloft for 5 years with excellent symptom relief. Within a week of switching to the generic Sertraline, my symptoms returned full force.

At first I had no idea what was happening, but then I started thinking that maybe it was the switch to the generic. I returned to brand name Zoloft and my symptoms stopped within a few days.

My insurance company refused to pay for the brand name Zoloft even after my doctor told them it was medically necessary. I tried the generic several more times with the same results each time.

I now must pay over $200 a month for my brand name Zoloft because insurance won't cover it. If I want a normal life, I have no choice.

Is there a way for the consumer to tell by the bottle where the generic drug has come from. I have never wanted to use medicine from a foreign country.

Those articles are very scary Why are we getting so many imported drugs? My son has to have his meds or his brain tumor will grow. How do I know if his meds are working?

Is there any way to KNOW where your medication was manufactured (by country and maybe facility?) before buying it? Can that info be reliably found on some watchdog site on line? Or would this involve extensive research and calls to the US offices of the company -- and hopes that they were willing to tell you?

Was using CardizemHCI 300mg. The presription for name brand is no longer payed for. After trying a generic from a major discount store, it failed to control blood pressure, and I ended up in the hospital with a-fib.

After checking around I found the generic version was in fact made in India. I did research and found a generic called Cartia XT by Watson produced in California; it actually works better than Cardizem. Do you homework when looking for generics.

For those of use who have been ordering generics from India, it would be helpful to know the names of the manufacturers with substandard conditions. For two years I have been buying budesonide from India at $1/pill; if purchased in the USA, the same generic is $4+/pill. When you are retired and a widow, what other choices are there? So far I have been fortunate and the drug works for me.

So we have the choice of foreign generics of poor quality but low prices or domestic or European name brand drugs of good quality but exorbitant pricing.

Insurance companies usually force us to buy the generics. Perhaps health insurance plans can provide an option (for a small additional fee) to allow our acquisition of the domestic name brands? I know I would gladly buy in. Also, the FDA should step up its inspections of foreign generics. US markets should be closed to those that don't pass.

I wrote to you once before concerning the generic equivalent of Imitrex made by Ranbaxy. At the end of two hours my migraine is still there and I end up taking another pill or two.

I also have a problem with generic Synthroid. I think part of the problem with generic medications are the fillers they use.

Several years ago my husband was prescribed Norvasc for slightly elevated systolic blood pressure. The pharmacy filled the prescription with a generic form. Nothing happened. It did not work.

One month later I had the doctor sent a new prescription calling for the original Norvasc. It works. It is quite expensive, though. Normally, Caremark credits the pharmacy immediately and we only have to pay a small portion of the prescription cost. With Norvasc, they pay nothing up front. We have to bear the total cost and get a reimbursement check from Caremark about 2 weeks later. Luckily, we can afford to pay. Others may not be so lucky.

As a citizen of the USA I have the right to expect that our regulatory agencies are going to protect my health, safety and welfare. Time and time again we see substandard quality control and ingredients in products from abroad, especially China. Automobile parts that fail, clothing that is shoddily sewn, consumer goods that break whan they should last for years and food products that sicken. Now generic drugs.

Our government (and that includes ordinary citizens) as well as the agencies and the Congress is not doing its job to protect us. Instead billions of dollars and years or time are wasted on nonsensical theatrics in the Congress. Is the fox guarding the chicken coop? I avoid Made in China whenever possible. Only exception so far seems to be Apple products which have a great build and staying power...but who knows their real mean time between failure rate is?

I agree that as a nation we need to stop buying generics and other drugs from third world mentality countries and return their manufacture to the USA and first world countries we can trust.

You painted bad imported meds with a broad brush. India and China don't respect US drug patients, thus ineffective copies.

However, I've been more than satisfied with Canada, New Zealand and Great Britain generics. Plus I can choose between Generic and Branded. The savings is too great to brush them aside because of the "bad guys". Plus many of our drugs are formulated and mixed in other countries and imported to the USA in bulk containers for capsulizing or pressing into tablets.

I had the same experience with Atenolol. I have been taking it for 10 years, for high blood pressure. Before I bought a pill-box with the days on it, I would sometimes forget to take my pill. If I wasn't sure whether or not I had taken it, I would check blood pressure and could tell immediately whether I had.

Then about six months ago the pills stopped working and, even though I knew I had taken the pill, my blood pressure went up, sometimes dramatically. I told my doctor that I thought they were fake pills, but I know she didn't think that could be possible. She started me on different pills but none of them worked as well as the old atenolol used to do. Now I can send her a copy of your report.

Why on earth do we allow important medications to be made in such unsafe facilities? Do you remember how the government tried to stop people from buying drugs from Canada because they were not examined by the FDA and therefore were unsafe?! Disgraceful!

Arthritis pain is "inflammation" pain. While yours is a more severe kind of arthritis the inflammation can be subject to your diet. I eat lots of 'organic' fruits and green vegs and eat drunken raisins for the arthritis in my hands and it works for me.

I get 'Brand' Zoloft from Great Britain - 30tab 100 MG - $106 or 112tab 100 MG - $233

I have used brand name Valium for about 60 yrs--1/2-1 5mg tablet as needed. No problems.

Last year I was sent a generic, and decided to try it. Within 20 minutes a friend looked at me over the card table and asked if I was all right. I felt totally "out of it" and could hardly focus. I have destroyed the bottle, and don't know the manufacturer. I got it from an Aetna pharmacy and , of course, told them my reaction.

6 or 8 years ago I was on Toprol XL for A-fib. I could use 25mg of a generic if I went into A-fib, which I did once or twice every 2 weeks, and that seemed to work fine. But when I was sent the generic for Toprol XL I went into A-fib 7 or 8 times in a 2 week period. That was the end of that!

I seem to be fine on the generic for Synthroid put out by Mylan .

Obviously there is a difference in generics.

I agree with the person who stated we should not be dependent so much on other countries, especially for medications, of all things!!!

I take levothyroxine, which I am guessing is a cheaper generic version of synthroid, as I think my insurance requires... and that's not fair!

It seems to me, if I can go to my local grocery store and they source where their fish comes from, Pharmacies should be able to source where their drugs come from.

I had considered myself lucky that I was taking Levoxyl rather than Synthroid for a hypothyroid condition, until the company which manufactures Levoxyl discovered a problem with it and stopped manufacture.

First it was just an odd smell, but then, apparently the company investigated further and found some other problem. I had to switch to generic levothyroxine, manufactured by Mylan, a company about which, so far, I have not read any negative reports.

Also, my doctor and pharmacist seem okay with it. In any event, I'm not having any problems---but if there is a resumption of manufacture of Levoxyl, I'm not sure what I will do.

This is SCARY. I wonder how I've been lucky enough to have taken Only Generic Drugs for 40 years primarily to control pain resulting from a severe disabling stroke-like injury with no problems. Maybe it's because I have (to my knowledge anyway) never (or only briefly) used the brand-name drugs so don't have that experience to compare the generics to.

I read here about people not finding generic Ambien (zolpidem) effective in helping them sleep. I have never used anything except zolpidem and always found it effective and I know I've used zolpidem from several different sources as the pharmacy I patronized for 35 years is an independent and continually searches for the cheapest supplier of drugs available.

Now I'm buying generics from a chain pharmacy and still have never had one problem with the drugs I've gotten. The problem I have had (particularly with the independent pharmacy) has been getting fewer pills than my prescription called for and even the wrong med altogether!

If the clonazepam (sometimes TEVA) I take to control the painful cramps and spasms I have (particularly when I walk) didn't work I would know it! The same for the gabapentin And the zolpidem. You'd better believe I would raise hell if the generics I've been getting didn't work! It's bad enough getting fewer than I pay for! That's why I left the independent. I think by threatening to stand at the register and count each pill into the organizers I use the next time they shorted me, I've got the chain pharmacy making its pharmacy techs count more carefully as last month I got the correct amount.

I have taken TEVA drugs with no problem, but believe the generic drug industry should be an American one so it can be overseen by the FDA as the drugs Americans consume are even more important than the food. I've either been incredibly lucky or am so bad off I'm incapable of noticing deficiencies in drugs as long as they help at least marginally.
Yours,
JB

Most Canadian drug suppliers will supply the country of origin for the drugs before you buy.
Don't know why the US cannot do this for its citizens, maybe the answer is spelled MONEY.

Wouldn't it also make sense to check the generics on a statistical sampling basis when they arrive in the United States? If the FDA randomly selected a decent sized sample on a regular basis, it should become clear quickly which foreign manufacturers are routinely failing to meet the specifications required for the generic.

One of my physicians recounted a story told to him by a patient who, as a pharmacist, works for a big drugstore chain. He and others must sell a very high percentage of generic drugs to 'make their quotas', read 'make their salaries'. How do they do that? They stay late (on their own time) to call doctors' offices to ask them to rewrite their prescriptions to generic.

The drugstore company makes WAY more $ on the generics than the expensive brand drugs. And so it goes.

My husband and I use some of the same medications. For him, only Clarinex works which costs quite a bit more than the generic, desloratadin. Both are sinus decongestants. The generic version works fine for me. We both use fluticasone, a nasal decongestant spray and the generic form of Flonase, and we're both fine with the generic version. In both cases, I have no idea where the generic versions are made.

The New York Times article makes me wonder how safe the generic medications my husband and I use really are, even if they work. I'm appalled that the FDA can't make sure these medications are meeting the requirements for safety and usage in the United States. I'd rather see all generic medications made in the United States or imported from Canada. It would be easier to inspect the laboratories here and in Canada.

My Wellbutrin XL 300mg was changed to bupropin (spelling?) and within 3 mo my family was concerned as I was showing traits of when I first broke down. Called dr, went in, took bottle with me. She cancelled that immediately and put me back on Wellbutrin and told me to always make sure every dr put "DAW" dispense as written on further prescriptons.

Within a few weeks I was doing fine. Since then I question every generic as there is not enough info as to where it is made, what country made it, what was in it. Why should we depend on foreign countries to take care of our basic medical needs when they are not as developed as this country is. That is turning our lives over to questionable facilities.

This is an excellent short summary of what is wrong with the US health care system: profit!

For years our physician has attempted to prescribe Generic drugs to my wife and I. Both my wife and I have refused to accept the Generic drugs inasmuch as previous experience in taking them has proven that they do not seem to work and provide the relief that the brand name drugs provide. The Insurance Company continually sends us literature indicating that taking Generic drugs is a real money saver for us (and no doubt for them). However, if the drugs are not going to work for us, we absolutely refuse to take them.

No wonder this country is experiencing so many problems when we depend on 3rd world countries to provide us something as important as food and drugs and other important products. Its no wonder that so many people are dying after ingesting some of these food and drug products. If the FDA believes that these other countries abide by the strict standards that we have here, they are fooling themselves, the American public, et al.

I work in pharmacy. Request them to order Greenstone brand sertraline for you. Pfizer (makers of Zoloft), own Greenstone and the tablets come off the same line. Insurance sees Greenstone sertraline as a generic and you would pay your generic copay, but you're essentially getting brand Zoloft.

The U.S. banned pet foods coming from China when our pets started dying due to plastic particles in the pet foods.

Why can't we ban bad drugs from them, or at least have some control to inspect the facilities if the drugs are going to keep coming to our country?

Why aren't the pharmaceutical companies required to test their own imported drugs. I would think it would be in their best interest because if they get bad drugs, no one is going to trust them again.

How do I know where my drugs come from?

I, too, think there's an easy fix - sample the shipments at the port of entry into our country. The only needed change is a line in the purchase order agreement that sampling must be x% accurate or the shipment will be returned at the exporter's expense. The economic impact on the company will spur improvement and foreign companies who are doing well will not be cast in suspicion. Manufacturers do this all the time.

PEOPLE'S PHARMACY RESPONSE:

We could not agree more. The testing must be done by an objective, independent party supervised by the FDA. We can no longer rely upon companies to supply such documentation.

We would also like to see random testing from pharmacy shelves. This needs to be more than the token effort the FDA currently employs.

We think that with several standard monitoring practices we could once again have confidence in generic drugs.

those of us who follow the Graedons' People's Pharmacy have been aware of this !!! thank YOU, Terry & Joe !

Find a good naturopathic physician.

Today Katie Couric, on her TV show, talked about fake drugs that are obtained online. She and her guest implied that this was a problem just when buying drugs online. I wish you would send her the information from your column today about generic drugs that we get at our corner drugstore that are also a problem.

Diet does affect rheumatoid arthritis. A Mediterranean diet, the use of only olive and canola oil, no chicken or turkey, antioxidants, no processed snacks, olive oil bread, and salmon are helpful. I just recently started turmeric,
So I can't vouch for it yet.

Another perhaps more important issue isn't really generics or inferior, foreign pills; that's like arguing over who gets the "good" seats on the Titanic. It's over-use of drugs generally. There's so much money in disease that medicine has turned topsy-turvey!

Assuming it's inert, a fake pill from some far-flung place could very well be healthier, as it would not have the deadly "side" effects of the (probably unnecessary) real one!

The drug companies invent or re-define disease, and distort research results as marketing. Misinformed and pressed for time, MDs let drug-reps do the doctoring. Psychiatric meds contribute to suicides and massacres. Cholesterol pills artificially lower serum cholesterol but do nothing for the underlying cardiovascular inflammation, and they deplete needed hormones and CoQ10. Blood pressure and heart pills are responsible for deadly falls, loss of appetite etc in the elderly... Dizzy? Back or joint pain? Headache? diarrhea? Vision blurry? Can't sleep? Check the "side effects" of your pills! The doctor probably won't. She'll pile on another pill. As each drug makes us sicker it creates a market for more.

In the 60's they said "what if they gave a War and nobody came?" Well let's not give the doctors anything to treat. We'll stay off the drug-go-round by eating our veggies, taking a walk, avoiding toxic chemicals, exploring the causes of any symptoms, and staying healthy.

I am so very glad to see this article! It should be published in every paper and medical journal across American!

I don't know how many times various healthcare professionals have insinuated to me, "that it was all in my head", because I was complaining about the efficacy of Brand vs. Generic and even Generic vs. Generic. depending on manufacturer. Maybe now there will be some creedance given to our arguments.

American needs to be self sufficient and self regulating. We as Americans should never be subjected to having to rely on any foreign country for food, meds., fuel or anything else!

I am on a 10 mg dose of generic Lipitor--made by Ranbaxy, but the label says pills are made in US. I am 83, and not a particular risk for heart problems--but I wonder if it is doing anything for my health. It is being paid for at least in part by Medicare. Obviously the FDA has not communicated to Medicare the problems they have found.

In relation to another generic, I gave my dog, at my vet's suggestion, my last Benedryl to calm her separation anxiety. It worked wonders. I replaced my supply with generic, and it did nothing to help my anxious dog. Dogs don't know the difference between name brand and generic, but her system surely did!!

It seems a lot of folks here don't understand the PHARMA industry. Even products you buy from us and EU companies are many times made in India China elsewhere. And even if the finished dosage form is manufactured or packaged in the EU or USA the ingredients the API the excipients come from all over the world...

Safe efficacious good quality meds are not cheap... It cost an incredible amt if money to manufacture a drug with all the requirements for quality, good manufacturing practices, compliance with regulations and legislation etc...

Just knowing a manufacturer will not really help... And rather than focus on country of origin. Write your congressman and senators and tell them you expect safe and quality meds and that they should provide adequate funding to the FDA. That there should be stronger penalties for those who adulterate and counterfeit medicines, that you expect every company to have a focus on quality and quality systems incl all ingredients, that you expect that all manufacturers audit their suppliers to GMP and so on.

And folks it isn't just generics. If you looked at the OTC industry their failure to comply with basic GMPs is even worse evidenced by the number of warning letters and 483s. And these are mfr in the USA not even abroad.

Thank you so very much!! I will definitely try this.

Having a horrible time with the switch from Cymbalta to generic. I take it for arthritis and it has been very helpful (NO herbal stuff did not help anymore). I am having crying bouts, horrible headaches. This from Lupin. Cymbalta is time released with hundreds of tiny capsules. Lupin - 6 little pills in a capsule. Really. I have filed a complaint with the FDA.

This program is a joke. The FDA is a joke ..... bought and sold. Totally compromised. You won't hear the truth from somebody working for the FDA or the govt. Ask a pharmacist. I'm one and I don't think people can handle the truth or believe it.

Well, I agree manufacturing medicines should be done here, more jobs for people here and assured quality. We desperately need jobs here.

20+ years in the industry convinced me the FDA is powerless, having been sold lock, stock and barrel to the pharmaceutical industry. Our legislators are also well represented in the industry, as are many of their family members. The pharmaceutical industry is interested in one thing only, market share and the resulting obscene profits that generates. PATIENT BEWARE is an understatement.

I have absolutely no faith in the "integrity" of the FDA, with the exception of my respect for Dr. David Graham.

Things are only going to get worse.

I used to take 25 mg of Cozaar (losartan) for hypertension. Even though my bp was really high, this low dose worked. For insurance reasons I switched to generic. At 50 mg, not only did it not work, but seemed to make my bp higher. For 3 years, Dr. did not believe I was taking med. I had a small brain bleed last year attributed to bp spikes. Finally went to a different doctor and went back on brand (although a different ARB), lowest dose. Working very well. Stay away from losartan made by Lupin and/or Zygenetics. Both made in India. I reported to FDA Medwatch.

I started a new generic for Lipitor 5,5 months. Four months ago I came down with diarrhea. I switched brands ... manufactures, and we'll see what happens. Anybody else having this problem?

I have used the birth control Yasmin for nearly a decade, with no noticeable side effects at any point. The price increased slowly over time, until about 2010 when it skyrocketed, at which point my insurer had the pharmacy dispense the generic equivalent. However, within just a few months I began to notice weight gain, as well as mild depression. I demanded a switch back, explaining my plight to the pharmacist each time the generic was suggested, and within just a couple of months felt back to my old self.

It may be impractical, but I would like to see a legal requirement that all generic-advocating lobbyists, legislators, insurance executives, etc. be legally required to take only foreign-manufactured generic drugs (that are sole in the U.S.). Country of manufacture and manufacture's name to be randomly selected, not their choice.

try natural sleep inducers such as valerian-melatonin-get the Tv out of your bedroom (too much excitement at bedtime) try some hops-chamomile-all these have no adverse effects and develop a routine for getting to bed-be repetitious!

A reputable Pharmacy will have the following on each and every prescription label-name of drug (manufacturer) color of drug if caps or tab-will tell what it is generic for if generic-also auxiliary labels
to advise how to be taken-with-without food-plenty of water etc-and if a mfg is changed upon refill (due to various reasons) the new color and the new mfg.

Also take the time to read the literature given with each med and don't be afraid to question the pharmacist-even if you have to wait a few minutes-most reputable pharmacies have private consultation areas-if you don't like the manufacturer ask for another brand that your ins will pay for.

Some years ago,I was prescribed Effexor XL 75 mg. daily for anxiety and mild depression, and took the brand name drug with good results. Two years ago, I again was prescribed Effexor and had good results, even though this prescription was for the generic drug. In March, I refilled my prescription and within two or three weeks, felt very depressed, anxious, and teary. I checked with the drugstore that had filled my prescription (as well as all my past prescriptions). I found out that their supplier had changed since the drugstore chain was bought by another well-known drugstore chain. Many of their generics were now made by different manufacturers. This had caused them to switch me from the generic Effexor made by Aurobindo to one made by Zydus.

I also found out that some drugs made by Zydus have been banned in the U.S. due to possible underdosing. I got a new prescription, fought with the insurance company for refilling my prescription too early, and switched pharmacies to one that could give me Aurobindo's generic. Now I am back on an even keel. My husband and I have since switched all our generic prescriptions from the original pharmacy, after finding more instances of their new supplier having generics from companies, some in India, with complaints about their quality.

Here's the solution. If a drug is found to be non bio-equivalent by the FDA, then for the remainder of the company's existence, they must submit a sample of each drug batch (weekly) to independent testing to a facility of the FDA's choosing, at the company's expense, to prove that the drug is bio-equivalent. If a second batch of that drug or another drug the company makes is found to be non bio-equivalent, then all drugs that the company and its subsidiaries/parent company manufactures that are sold in the United States must undergo this weekly testing at their expense.

If the company is bought, or sold or transferred out of bankruptcy, that requirement flows to the purchasing/new company.

That will fix the problem.

But of course, the government isn't really interested in cracking down on cheap generics, is it?

I wasn't aware of this mess until I got a bad script of my ADHD medicine from Actavis. I suffered muscle pain so severe, I was bed ridden and couldn't hold my son. I had headaches and nausea depression, and fell asleep on the medicine. It was awful and I was just furious.

I highly doubt the prescription had any active ingredients. I felt better as soon as I stopped taking the drug which is how I realized it was the meds and not something I caught. Got the script changed but the new medicine is bad too. I won't be taking this again unless I can count on quality. I'm so happy that I'm not sick like I was....terrible experience.

Yes- the generics from one pharmacy can absolutely differ!

The pharmacies I have dealt with have one or two different generics for a particular drug that are dictated by the parent company and stocked by that chain's warehouse. Another pharmacy may or may not have the same generic. That is the problem I ran into when my neighborhood chain pharmacy was bought by another chain. The warehouse that supplied them also changed, and I received a prescription for venlafaxine (Effexor) that plunged me back into depression. The new generic was manufactured by an Indian company that has had some of its generics banned by the FDA due to underdosing.

I inquired as to what generic I had received previously (and that had worked fine), and found it at another pharmacy, to which I transferred my prescription. had to fight the insurance company for three months, however, since I had a 90-day supply of the inferior drug on hand that I could not use. You need to find out the manufacturer of generics that work for you (usually the name of the company or an abbreviation will be on the bottle)and make sure you receive it next time. Good luck!

I have the exact same problems with my generic pills. Ambien, Meloxicin, Tizandine, Pantoprazole to name the most inconsistent ones. I thought it was just me being weird. I have wondered often if the problems were caused from the generic pills. Besides the irritation of my pills changing shapes and colors, I have often thought they were just not working. I will investigate the name of the company to see if there is a pattern. Thank you for sharing this information. I am so glad my husband found your Web site.

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