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Generic drugs--pros and cons. Archive in monopoly.

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Generic drugs--pros and cons. Archive in monopoly.

Posted by Walt Stoll [9.8] on October 07, 2004 at 07:03:54:

Thanks, Ernie.

Excellent treatment of the problem. Peresonally, I will continue my generics when possible and let my own physiology determine their effectiveness--------the only true way to do it.


For convenience and an apparent small price advantage, I recently switched
my prescriptions from CVS to Walgreens. I take a generic medication
(Metformin) for diabetes and a generic ace inhibitor and a generic beta
blocker for a high heart rate and high blood pressure. I've bought generics
from Canada and Mexico without noting any problems. What could go wrong?

As an aside, I recently subscribed to a low cost HMO for seniors called Blue
Care 65 which reduced my medical costs although I have Medicare Parts A & B.
Blue Care provides the cost of prescriptions with a small $8 co pay. There
are many other advantages to Blue Care 65 including free diabetic supplies
from my local pharmacy rather than mail order from Medicare. Mail order
required a lot of paperwork. This does not require any.

I received a $40 discount on purchases by switching to Walgreen and it
seemed more convenient, is larger, well-stocked and has a drive in
prescription window. After taking my Metformin from Walgreens, I noticed
immediately than my blood glucose was higher. No other changes or
differences. When I ran out of my CVS beta blocker and ace inhibitor, I took
the prescription meds I received from Walgreen. The next day my blood
pressure and pulse rate numbers were up higher. I have two different blood
pressure machines and 3 blood glucose monitors (free supplies). I
recalibrated the glucose monitors, they check OK.

After several days of frequent checking, I called the pharmacy and they
assured me there could be no difference in the generics. The pharmacist
claimed theirs was better. How could that be if they are the same? I called
CVS. Same answer. Call your doctor. Doctor says there should be no
difference. Test more. Wait a few days.

I've worked as a chemical engineer and laboratory quality control analyst
and quality manager. I know there are differences in manufacturing standards
and processes and that the FDA does allow for certain manufacturing
differences. Generic drug manufacturers do not have to prove drug safety or
efficacy because that was already done by the original manufacturer. I did
some research and found the following within minutes:

(BTW: there was a slight increase in price above what I should be charged.
I'm going back to CVS.

Are Generic Medications the Same?

Generic medications can usually be purchased for a fraction of the cost of
their branded counterparts. But even generics differ in price and the
differences can be costly. Many people, especially the elderly shop around
for better deals, lower prices and convenience. Generics are assumed to be
the same. Are they?

. What is a Generic Drug?

. Are There Any Differences Between Different Generics?

. The Bottom Line on Generic Drugs


The active ingredient of a 'generic' medication is chemically identical to
the active ingredient of the corresponding branded medication. Because
generic medications are often much cheaper than their branded counterparts,
very many people choose generics (whether buying discount medications online
or in traditional retail outlets), and many insurance companies actually
require that they be used.

According to the FDA's Office of Generic Drugs:

A generic drug is identical, or bioequivalent to a brand name drug in dosage
form, safety, strength, route of administration, quality, performance
characteristics and intended use. Although generic drugs are chemically
identical to their branded counterparts, they are typically sold at
substantial discounts from the branded price.

According to the Congressional Budget Office, generic drugs save consumers
an estimated $8 to $10 billion a year at retail pharmacies. Even more
billions are saved when hospitals use generics.


However, it should be noted that current regulations permit a variation of
up to 20% either way in the bioavailability of the active ingredient. (See
the Food and Drug Law Institute overview of the Hatch-Waxman Act of 1999.)
In one study (Borgheini 2003), a 31% variation was found in the blood plasma
levels of a particular medication after a patient switched from a branded to
a generic product. (Why does this happen? It may be accounted for by
differences in the manufacturing process yielding different particle sizes
that are absorbed at different rates, as well as other factors.)


This does NOT necessarily mean that switching generic medications or sources
due to cost is a bad idea -- in fact, in most cases it is probably still a
very good idea! -- but this does mean that the issue is not quite as clear
cut as it might otherwise seem.

In my view, provided that medications are taken under the supervision of a
qualified medical professional, and any changes are monitored, there is very
little advantage to buying branded medications if cheap generic drugs are
available. If cheaper generic exist from other sources, they should not be
overlooked. The only difficulty, of course, is that it sometimes takes many
decades before generic differences are ever noted or studied.

FDA approval is typically based on small studies (20 to 30 people) of
bioequivalence. Applications to the FDA for approval of any therapeutic
equivalent must include evidence that, compared with the brand-name drug, it
is pharmaceutically equivalent and bioequivalent. Pharmaceutical equivalence
means that it contains the same active ingredient, requires the same dosage
and route of administration, and is of the same strength and concentration.
Bioequivalence means that it shows no significant difference from the rate
and extent of absorption of the reference drug.

[Tests of bioequivalence has been done primarily with male subjects. It is
now known that there are greater difference between men and women than among
men. This not acknowledged but just now being tested. There is no routine
testing to compare generics. It is not required by the FDA, only between a
generic and data on brand drugs.]

According to bioequivalence data used to acquire FDA approval, one recently
approved generic levothyroxine preparation (Sandoz Levothyroxine Sodium) is
significantly more potent than the most widely used brand of levothyroxine
(SynthroidR). Information from bioequivalence studies submitted to the FDA
show that the new generic may be as much as one-eighth more potent (+12.5%)
than the widely prescribed branded product.

Furthermore, levothyroxine is a drug known to have a narrow
toxic-to-therapeutic ratio with significant clinical consequences of even
minor excessive or inadequate dosing. Potential adverse events include
symptoms, osteoporosis, atrial fibrillation, worsening of heart disease,
preterm delivery in pregnancy, impaired fetal brain development, and high

"Unfortunately, this information confirms our concern that current FDA
standards defining the equivalence of levothyroxine products are too lax,"
said Carlos Hamilton, MD, AACE President. "Switching between two products
could compromise the effectiveness of treatment and even result in serious
side effects."

Generic off-brands have the same active ingredients, strength and dosage as
their brand-name counterparts. "The only difference between the drugs is
that the manufacturer of the generic product does not have to prove to the
FDA that it is safe and effective, because that already has been done," says
Dr. Pearson. "The approval process of a generic drug takes much less time,
usually within about two years from the time the company decides to
manufacture it."

So should you always go generic? Not necessarily, says Dr. Pearson. Patients
often wonder whether it is dangerous to switch from a generic product if
they have been taking a name-brand product. Switching is usually safe - but
there are exceptions.

Some drugs, both brand-name and generic, have what is known as a "Narrow
Therapeutic Index (NTI)." That means the drug can produce toxic side effects
or loss of disease control if it is absorbed or released at even the
slightest changes in doses - whether too high or too low. Remember, there
are "parameters" for bioavailability that must be met, not an exact number.

This is why many pharmacists, including Dr. Pearson, are unwilling to
substitute generic products for drugs with an NTI. "Even the slightest
change can result in upsetting the patient's disease control," he says.
"That's why I would recommend against switching for such drugs. There's a
real possibility that it might upset a patient's stability. It could be
absorbed differently; it could have fillers or dyes that change the
absorption or release of the dosage. While there may be side effects to
switching, I have no knowledge of it ever being fatal. If there is a switch,
it is essential to continually monitor the drug levels in the blood to make
sure there is a minimal risk of toxicity."

Among the drugs known to have an NTI:

* Conjugated estrogen (Premarin), prescribed as hormone replacement
therapy for prevention of osteoporosis or heart disease risk.

* Phenytoin (Dilantin) and carbamazepine (Tegretol), anticonvulsants.

* Theophylline (Theo-dur), for asthma and lung diseases.

* Cyclosporine (Sandimmune or Neoral), used as an organ transplant
antirejection drug.

Aside from the NTI drugs, it's usually safe to go with a generic drug, which
is why some insurance companies will only pay for generic drugs or require
an explanation if a doctor or pharmacist insists on a name-brand product. "A
patient can say they do not want generic products," says Dr. Pearson. "But
that means the insurance company will make them pay the difference in price,
and in many cases that can be a substantial amount. Insurance companies may
want the patient to pay the whole price. Then you will have to look for an
insurance company with a more reasonable co-payment plan. Patients should
keep a tight rein on what their insurance company is doing. Read the
material they send you in the mail to look for any changes in the policy."

[Non-text portions of this message have been removed]

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