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My 23 yr. old daughter has had to take synthroid for 10 years now. She was got a generic brand (we have no health insurance) and it gave her diarrhea so bad that she had to go to the hospital to get fluids. Her doctor has put her back on the brand name. I thank all the prior respondents for your time on this topic.

GENERIC DRUGS AND BRAND DRUGS HAVE EQUAL CAPACITE TO TREAT ANY DISEASE.BUT DIFFRENT IN THE CONTENT OF ADITIVES. AND BRAND DRUGS ARE MENY IN NUMBER SO IT IS DIFFICULT TO SELECT ONE OF IT.ALL IN ALL "WE SHOULD TAKE A GENRIC DRUG"!!!

I am not sure if anyone else has experienced this. I went on generic drugs . I swtched from Klonopin to Clonzepam and also from the female hormone Estrace to Estradiol. Not right away but slowly I started to feel worse and worse. Exhaustion, dizziness, confusion are just a few things that happened. I was really feeling just loopy. I went to my GP DR.and explained what had happened to me. He does not give me these drugs but said get on the name brand again right away. I was on generics for 4 mo. and now back to name brand for 2 mo. I still have the days of dizziness. I think my hormones are way off. I am going to the gyne tomorrow. I warn all of you, as I have heard of ma ny cases now- DO NOT TAKE GENERICS! I don't care how much $$$$ you save , I am paying a price to get back to normal. Any comments or has anyone switched the hormones like I did and had similar oroblems? I would love to know. Thanks

6. The guest from the generics lobby did not mention the fact that generics are rated A and B and there are generics being marketed, e.g the generic of effexor XR, which are “B” rated, which the FDA defines as “inequivalent, not substitutable.” Ratings can be found in the “Orange Book” in which all FDA approved drug products are listed.
7. Pharmacists are incentivized to recommend generic medications. A letter from Cigna HealthCare Generic Solutions Pharmacy Management states “Please note that the plan sponsor (e.g., the subscriber’s employer) may compensate us based on our ability to help reduce the plan’s prescription drug costs through the increased use of generic drugs.” Doctors who write for brand medications are sent faxes from pharmacists (without the patient’s permission) asking would we be willing to switch to a generic. This is a waste of time, paper and holds up the patient’s receiving the treatment the doctor has ordered.
8. Similarly, insurance companies send faxes requesting a switch from a brand medication to a generic, which I must respond to before they will fill the prescription. I have been asked to switch patients from lexapro, for which there is no generic, to celexa, a structurally similar, but certainly not identical medication, which does come in generic. I believe this is either malpractice or practicing medicine without a license as whoever wrote the letter did not examine the patient. Again this is a waste of time, paper, but most importantly jeopardizes the uninterrupted care of the patient, all in the name of saving the patient money! I challenge the insurance companies and pharmacy chains to declare how much money they save by strong-arming doctors to write generic prescriptions.

Thank you for a very interesting discussion. I would like to add the following, #1, 2, 3, 6 can be found on FDA website under the Center for Drug Evaluation and Research:
1. The term bioequivalence is somewhat misleading as FDA guidelines require the generic to fall within 80-125% bioequivalence of the brand. Thus the generic can be the same or more or less potent.
2. As Dr. Klein mentioned for the most part bioequivalence is tested in single dose studies in NORMAL volunteers, not patients.
3. There are no differential requirements for drugs that have a narrow therapeutic index, i.e. drugs where a small difference in dose or blood level can make a big difference in toxicity.
4. The point that there has been no data presented to the FDA that there are differences between brand and generics is absurd. This is for the same reason there is no data presented by the generic manufacturers that they are the same clinically. No one wants to spend money on head to head comparisons. However, the American Academy of Neurology has published position statements in 1990 and 2007 warning of the risks of breakthrough seizures with a switch to generics, echoed by the Epilepsy Foundation’s statement, “There may be significant differences between the characteristics of brand-name and generic antiepileptic medications, as well as among generic antiepileptic drugs.”
5. As a physician, I have yet to come across an insurance company which does not charge a significantly higher co-pay, at times exorbitant and unaffordable to most patients, for a brand medication. This includes those medications as mentioned that may be in a different category where the switch could be lethal.

If medicine's inactive ingredients have some effect that was not detected, it is equally possible that generics would work BETTER than brand name drugs.

which works much better except that now I don't use capitals commas or periods

All generics are not the same,
I was switched to generic Wellbutrin XL 300 first time I got the Teva Pharmaceutical made generic within 2 weeks I drifted down, I went to my pharmacy and spoke with them they had a generic made by Watson I have used it for almost a year it seems to work as the original Wellbutrin

After a heart attack I had been taking Zocor for many years with no known adverse reactions. For insurance reasons I had to switch to Simvastatin when it came on the market as the generic. I experienced many adverse reactions that I had not had with Zocor. When I phoned Teva, the generic manufacturer, they did not attempt to claim that the brand and the generic are the same but rather stated that the generic uses fillers, or binders, not contained in the brand drug. In the U.S. unlike many European countries, post-marketing reporting by doctors of patients' adverse reactions is not required. With no clinical trials and with no required post-marketing reporting of adverse reactions, how can generic manufacturers claim that there are no differences?

mas,maslkwe

I don't understand the implied disrespect for patients in this conversation. Psychiatrists cannot flash a FMRI to determine what in fact is happening to a patient's brain. There is a good body of research on psychiatric illneses but the day to day administration of medicines to manage symptoms comes from what the patient is experiencing. I feel like there was a lot of qualifying apologetics for those "rare cases" that is, patients and people who did not respond to generics positively. For many, generics are not the same and medicine, in all of its research, surveys, and experiments has not yet caught up with the fact that individuals are different and respond differently. (What advantage to the patient is there to insist on a drug that is more expensive if not because of adverse symptoms?)

Slightly off-topic, but I think interesting: the characterization of the interaction between doctors (and most of the time, the nurses who work with them) and the insurance company representatives as a "fight" to get brand name drugs covered for their patients. Sometimes insurance companies want a "prior authorization" before the med is dispensed. Sometimes the co-pay will just be higher (possibly 90% of the cost of the med). Most of the time, it's just a matter of knowing what the patient is entitled to under his insurance plan, usually a group plan the choice of which that the patient has no power. You can't argue based on therapeutic need what a patient's co-pay is, just as you can't negotiate what his premiums are.

Most of the time enormous amounts of time are wasted by clinicians because the patient gives the clinician no information or wrong information about his policy and to which medications he's entitled.

Anecdotally, I am aware that many cardiologists and other internists have not been as comfortable with the generic formulations of the heart medication digoxin as with the brand formulation Lanoxin. Some internists have not been satisfied that generic formulations of the thyroid hormone levothyroxine are therapeutically equivalent to the brand Synthroid.

And some dermatologists point to published studies showing that generic versions of certain topical corticosteroids may not be equivalent to brand name versions of the same drugs.

Some drugs can be monitored by blood levels, such as thyroid meds, Coumadin, and seizure meds. As a doctor, I have definitely seen differences in levels after switching. But then you just redose to get the desired effects. The problem would be if the generics get switched all the time.

Please also host a programe on the safety of ALL drugs and supplements. So many ingredients are imported from Asia and we really don't know the quality of the drugs that we are ingesting. I was caught up in the Heprin scare last year and it was very revealing-the lack of safety checks in our system. We should know the source of all ingredients in all drugs and all vitamins and supplements.

Wow, pardon my typos.

About a month ago while ordering online from my insurer one of my meds a emergency notification came up advising me to discontinue another med which is the generic of Toprol XL because the generic I have may be defective. Seems the company that produced this particular med was not consistent in chemical content and could be dangerous. I was advised to have my Dr issue new Rx requesting the brand name.

I have been on Wellbutrin XL 300 for a couple of years. I finally gave in and told my doctor to go ahead and allow the generic to save money. After about a month, I could not figure out what was wrong with me as I was depressed, listless, and fatigued all the time. It finally hit me, I had changed drugs. When my doctor sent in an updated prescription for the brand, the insurance company would not fill it because I still had generic left! I finally filled it at a local pharmacy and paid for it myself. I plan to file a claim and fight it; the insurance companies should NOT be dictating prescriptions particularly if the generic was tried and did not work. This was NOT a placebo effect as I didn't even think about what was going on until after the face. I resent any doctor or insurance company who says it is 'all in our heads'.

When my asthma was considerably worse (thanks, Advair!) and needed to carry an inhaler around with my constantly, the generic albuterol (sp?) was vastly inferior to the brand-name Proventil, so much so that my doctor had to specifically write "no generic" on the prescription. The generic was harsh and acidic like primatine mist, which is horrible for asthmatics ... does that still exist?

I am a physician and have worked as a researcher testing new medications for FDA approval (both new brand-name drugs and generic drugs).

Dr. Klein is absolutely correct in that the manufacturers of generic drugs are not required to test the generics for therapeutic (as opposed to bioavailability) equivalence.

Further, the bioavailability studies usually enroll only a handful of study subjects, far fewer than are studied for the original approval of the brand-name drugs. The number of subjects studied is important because studies with small numbers of subjects may not have the statistical power to identify subtle differences in drugs that may have very important effects on individual patients.

I have recently been through this with my son. He was on a name brand drug that became available as a generic after about a year. Initially he had no problem with the generic, supplied through our mail order pharmacy program. Then one month the generic was a different shape and a different color and he did not react as well to it. His dr was happy to prescribe the trade version & he was fine after that. And then she mistakenly wrote a non-DAW rx and he got a generic again, but it was the same shape and color as the trade and he was fine. And then we had to switch drs and our insurance co switched pharmaceutical services and we got the odd-shaped pills again and he experienced the same side effects. I asked the new dr to write an rx for trade and she was perfectly willing. SHe did have to fax a letter and talk on the phone with the pharmaceutical co (Medco in the case) and they did take a bit longer to fill the rx, but as soon as we got the new meds I saw an immediate improvement in my son (and so did his teachers)> I appreciate what the dr said about anxiety and a placebo effect, but at them same time, I am willing to spend extra money in order to ensure that my son has a smooth time in school (the side effects, gastric disturbance and sleep disturbance were playing havoc with his ability to function in class).

I had a thyroidectomy 4 years ago, and it took me more than a year to stabilized my hormone levels. I found that the brand name of Synthroid made a huge difference in how I felt. I pay the difference because it makes such a difference in how I feel. I am dependent on this drug to replace a hormone that my body can no longer make. I have heard that this is a common situation with thyroid hormones.

the truth is that the drug distributors and pharmacies determine what generics version is available in the pharmacy and the consumer can't even request a particular version--a real problem when trying to dose generic ritalin to your little kid

I'm a clinical social worker and psychotherapist practicing in Manhattan. My understanding of the Wellbutrin XL debacle is that it involves patent lifespan of the time-release portion of the molecule. The patent for bupropion (Wellbutrin) has already expired, making way for generic manufacturers. The patent for the time release portion, however, has NOT yet expired. Hence, generic manufacturers are devising their own time release mechanisms - sometimes with fairly dreadful impact on the patient. 'Dumping' the medication into the bloodstream too quickly means a plethora of highly unpleasant side effects. Most of my patients on generic bupropion - non-time release - do quite well.

-- Andrea. LCSW

I'm writing to comment on the question of generics. I have epilepsy and generic neurological drugs effect me differently than the name brand ones. I'll find that pharmacists will switch me to the generic without asking and I'll feel it after I take the drug. Now, my neurologist writes that I need to receive the name-brand drug on the prescription. I appreciate the value of generics, but I do not think they are 100% the same as their branded counterparts. Patients should consult with doctors before switching.

My psychiatrist often gives me samples which she receives from pharmaceutical salespersons.

There are TV adverts for prescription drugs. Which patients will question doctors about.

Are doctors inadvertently pushing name drugs over generics?

My own insurance plan only covers generics (after the deductible). If generics really are as ineffective as described, what are we supposed to do?

I have taken Wellbutrin SR (150mg)for at least 15 years, long before a generic was available for that amount. I switched to the generic once it became available and never thought about it again as taking medication was part of my morning routine and therefore had no expecxtation or apprehension at taking it. Two months later I realized that all my symptoms had come back, neccessitating a return to the brand-name and the increased expense. Wellbutrin XL was not effective.

Brian,

1) Generic manufacturers are drug companies, too. Policies that favor generics favor some drug companies. Policies that go against generics favor other drug companies. But they are all drug companies.

2) I really wonder about this if most issues are with psychoactive drugs. Is it just apprehension? Why wouldn't there be good examples of other non-psychoactive drugs?

I took a brand name birth control pill and then b/c of insurance had to switch to a generic. These pills are not equivalent and I could have gotten pregnant.

why doesh't the generic representative just say the generics do not have to do clinical trials to establish therapeutic efficacy--they just ride on all the studies done by the brand ocmpany

I took a brand name birth control pill and then b/c of insurance had to switch to a generic. These pills were not equivalent and I could have gotten pregnant.

Ask about synthroid v. levothroxin. I believe there was considerable reporting on the difference some years back.

I'm a physician who is a strong advocate of prescribing generic drugs. I'd been taking Wellbutrin for years and didn't miss a beat when generic was introduced. Except my symptoms reappeared and I spent several weeks looking for stressors in my life. Then my psychiatrist suggested I return to the brad name - and presto I was back to baseline. Not a study, but to this physician as patient it mattered.

I was using Welbutrin XL 300 (generic) until recently, it just wasn't doing anything to me anymore, maybe now I know why. Last year I ordered a refill right before a trip and noticed a different pill. I had ot call the pharmacy the day of my flight just to make sure they hadn't made a mistake. I don't think this is a safe practice.

I have experienced the difference between a generic and brand name drug with Wellbutrin. These were not "anxiety" related nor because the medicine was a different color. The delivery systems between the generic and brand are just different and, for me, damaging. I fight each time to obtain the brand name and, for me, it is worth it. The pharmacist will ALWAYS say these drugs are the same. They are not. I am noticing, while listening, that no patient is represented. Please consider me a representation of a person who must take this medication and have found the generic NOT equivalent to the name brand. Sincerely yours, Suzanne Norwalk, CT

Since switching from Accupril to the generic, my blood pressure has spiked and become unstable. Even when I was given an increased dose and another drug to work to reduce my blood pressure. I insisted on begin placed back on the name brand at an additional cost to me of $50 a month. My blood pressure never really stabilized after that and I am now on another drug which seems to be helping. It is a name brand and I will never, if I can afford it, switch to a generic ever again. My cariologist agreed.

they are not bioequivalent--they are within 80 to 120 percdent of the brand

The argument against National Health Care is always "the government shouldn't tell us what physcians we can go to", but under our current system, our insurance company is telling us what medication we can or cannot take. We were just notified by Empire that they will no longer pay for Nexium, a medication that my husband needs because he has acute acid reflux and, according to our doctor, Nexium is the only medication that not only helps the sympotoms but helps heal the esophagus. I don't want the insurance companies writing my prescriptions.
Katie

My husband was on Lamictal for seizures, and when a generic was finally approvedlast summer, Medicare automatically switchd him over to the new dug. It cost $5 versus more than $300 for Lamictal, but within a few months he was in the hospital with a seizure, where he remained for almost a week. The neurologist said they are finding such reactions more common. Medicare did approve going back on Lamictal, but it still costs us $200 for a 90 day supply...it must have cst Medicare more than $20,000 for his hospital stay.

How much of their own money do pharmaceutical companies put into the research and development of drugs? How much money is government money.

And, is the FDA blocking any drugs that could be used to save lives right now?

there is a real problem if you've carefully titrated your drug and it is a generic and the next time you go to the pharmacy it is a different generic

Could there be an issue with chirality?

I've have bad experiences with over the counter generic drugs. I don't bother looking at generics anymore because I don't want to waste my time and money. The devil is in the details, i.e. inactive ingredients.

no--the range has to be 80 to 120 percent and the inactive ingredients can be different--there are also differences among generic versions

Can your experts explain what a "narrow therapeutic window" is? And does it make a difference in drugs like Synthroid and Premarin?

Too bad I can't even afford my refill of generic Welbutrin (copay deductible). American health care for the win!

I am on Synthroid and Cytomel for thyroid (I had Graves Disease and RAI). My doctor is really pushing for me to be on the name brand, but I would like to save money. Is there a difference with these meds? Thank you.

I am on Seasonale. I started on the name brand but then took the generic for a bout 6 months because my insurance greatly prefers it (much much cheaper). The only problem is that I was getting tons of side effects that I had not gotten on the name brand. I got back on the non-generic and am back to normal. Obviously they are not the same. However my pharmacist says they are made by the same company. Strange.

1 more point

For several years Big Pharma Brands have enjoyed their quickest growth in sales and valuations in marketing their own GENERIC drugs and partnering/buying generic firms.

B/c of R&D, regulation and pricing and simple attractiveness of growth. So not that simple as generic vs. brand

(Remember flu vaccination maker Chiron, and the "globalization" and related opacity in the drug-making industry? 2004)

http://www.commondreams.org/views04/1027-26.htm

Finally someone is focusing on generic drugs!

I don't trust generic drugs.
Last year my mom was having severe pains in her chest, she was eventually hospitalized. After a battery of tests she was discharged with nitroglycerine tablets to put under her tongue for heart problems.
She had also been taking generic drugs for acid reflux. She was getting weaker and afraid to eat because of the pain.
I finally convinced her to stop taking the generic drug and I gave her some of my Nexium. To our surprise, in a day or so she was back to her gardening, eating full meals and the chest pains were gone. She could not get a prescription for Nexium because her health insurance would not cover it.
Nexium is costly, I have a 50% drug coverage and I still pay $80.00 for a prescription, but it works. I believe generic drugs have only a fraction of the real medicine.

the generic Zyrtec for allergies, is almost in effective. I can tell the difference, since i was prescribed the Rx version many years ago for my persistent allergies.

I have recently been dispensed a generic form of zoloft - is there any resource to compare generic drugs to their name brand counterpart?

As third party factories in Eastern Europe and Asia make more and more brand name drugs (yes, it surprised Bush too back in 03 or so when he had to swallow his words after knocking dangerous "foreign made" pharmaceuticals), can't those same factories produce exactly the same products under different labels?

Assuming this is already taking place, is it FDA-legal, marketable, and can your guests name specific off-label products?

Also, which common pharmaceuticals are identical and which are measurably different? Presumably FDA or at least CDC has or will have such a database -- if so, is it public?

This has me scratching my head. Are the generics supposed to be the chemical twins of the brand names? Are the chemicals in equal amounts? I don't understand how there can be a difference unless, as was pointed out above there is an added ingredient that has nothing to do with the therapy itself. I wonder if in the case that Post #1 pointed out if the side effects were observed in so many more people because a much larger population was taking the drug. Can't that change the percentages of side effects? I thought that was why we needed long-term, large numbered studies.

As with most things, the answer is "It depends". My sig. other is on Tegretol for seizure disorder and always got the brand name. One time the Dr forgot to check no substitution on the scrip and she was given the generic. Given that the absorption equivalence of generic has to be 90% or 95% (don't remember exactly) cf. branded either over or under, she was over-medicated and had side effects because of that. Luckily she was over-medicated and not under- or the side effect could have been a seizure instead of headache & double vision.

Some years ago my wife was prescribed tylenol with codeine, following a surgical procedure, and was given the generic version for use at home. But her pain and discomfort grew worse, rather than better, until an astute pharmacist surmised that she was having an allergic reaction to the cheap binding materials in this generic. He replaced it with the name brand drug, and it worked as it should have. Even though active ingredients might be the same in a generic as in a name brand, non-active ingredients might not be, and can cause side effects.

in 2006 right after undergrad, I was a sales rep with novartis and the company was in an ugly patent figth with teva (generics giant) over the drug lotrel. Teva won the fight and lotrel immediatly went generic. The side effects of branded lotrel were dry cough and edema, each occuring in about 5% of the population treated. Once patients switched to generic, doctors told me side effects went up to 20% in some case 40% of the treatment population suffered the side effect (not a controlled observation).
Big pharma has done its fair share of harm but teva, sandoz and the others (walgreens, duane reade, walmart) are not angels either. If given a choice, people prefer branded drugs, we just have to figure out a way to make them cheaper