bashes generic drugs.
independence ends with the purse. The below article is a good example, for it
regurgitates out every industry used argument as to why a consumer should be
over three times as much for the same active ingredient. Though this article
has a LA Times staff-writers name, the structure, thoroughness, and style suggest the pen of Big PhARMA. The lack of balance is a key reason, the very failure for example to acknowledge that certain arguments
could be turned 180 degrees, is strong evidence—given the journalistic norm of including a statement from the other
side—that Big PhARMA was involved. AT the bottom I supply a rebuttal.
FDA standards for generics are
By Melissa Healy, Los Angeles Times Staff Writer
March 17, 2008
out its mission to ensure that generic drugs are "the same medicine" with "the same results" as the pioneer drugs they follow,
the Food and Drug Administration rigidly applies a standard of what is called "bioequivalence." Measured in laboratories and
in simple, small-scale human trials, a generic must deliver the same active ingredient to the bloodstream of patients in virtually
the same amount at virtually the same rate as the pioneer drug.
The FDA considers "bioequivalence" a good surrogate
for "therapeutic equivalence" -- the equal ability of two drug formulations to ease symptoms or cure disease. Physicians and
pharmacologists say that for some copycat drugs, showing bioequivalence to the original is not proof enough that the "same
medicine" will yield "the same results."
several potential flaws in the FDA's standards of comparison, drug experts say.
First, the agency's tolerance for variance in the content and release of a drug's active ingredient -- the healing
compound -- may be too broad.
2) Second, the FDA does not demand realistic
trials of different formulations in large patient populations.
third, by measuring a generic medication's ability to deliver a drug compound to the bloodstream, the FDA may be looking in
the wrong place. Most drugs work their magic not in the blood but in organs, cells or tissue elsewhere.
In fact, a
brand-name drug's generic counterpart is rarely an exact replica. Though the two share equal amounts of the same active ingredient,
they generally look different. And those differences, say some pharmacologists, can result in small variations in how they
work in patients.
A brand-name drug and its generic in most cases are formulated with different colorants, fillers
and binding materials. Though all of those must come from an FDA-approved list of pharmaceutical ingredients, they are, in
most cases, assembled differently in each manufacturer's product. One version of a drug might use lactose or sugar as an inactive
ingredient; another might not. But incidental ingredients like these can affect the way patients dissolve and metabolize a
drug's active ingredient -- faster or slower. And that, in turn, can result in variations in the two formulations' effects.
4) In almost all cases, the FDA permits a generic drug to release 80% to 125% of an active
ingredient into the bloodstream, compared to that released in a single dose of the original medication. That range would make
little practical difference in the effect that most drugs have. And the FDA and generics manufacturers defend the allowable
range of variance as the same that is permitted among "batches" of brand-name drugs.
But medical and pharmacology specialists warn that the FDA's range may be too broad for some drugs, especially in cases
where a drug has a "narrow therapeutic index" -- the fine line between an ineffective dose and a dangerous one.
6) Variations in the rate at which a brand-name and its generic (or two generics) release
their active ingredient could court disaster with some drugs, as well. On this front, experts said "extended release formulas"
-- doses usually taken no more than once a day -- can pose particular problems. If
one formulation releases its therapeutic agent evenly over 20 hours and another releases a large percentage in the first five
hours and very little in the final five, a patient might get a toxic concentration of drug in the morning and limp along with
a dangerously ineffective dose late in the day. In lab tests and in small samples of human subjects, FDA measures release
rates at periodic intervals. But pharmacologists warn that those intervals may not always be fine enough.
7) "Bioequivalence and therapeutic effectiveness are not necessarily the same," wrote neuropsychiatrist Dr. Giuseppe Borgheini in a 2004 article published in the journal Clinical Therapy
[Clinical Therapeutics, Volume 26, Issue 6, June 2003, Pages 1578-1592]. Borgheini reviewed medical literature documenting
differences in the effects of generic psychoactive drugs and their brand-name counterparts. In the case of three anti-seizure
drugs -- phenytoin, carabamazepine and valproic acid (marketed under the commercial names Cerebyx, Tegretol and Felbatol,
respectively), studies found that generic formulations either failed to release the correct dose to patients' bloodstreams
or eventuated in higher rates of "breakthrough seizures."
8) Finally, the agency demands little clinical evidence that
a proposed generic drug will work the same as a pioneer drug in a broad cross section of real patients. The agency conducts
quality-control tests on generic samples periodically after marketing begins, and patients and physicians can report problems
with a generic drug to the FDA’s adverse-event monitoring system. But neither generic-drug manufacturers nor the FDA does post-marketing studies that might indicate patients are responding
differently to a generic than to its brand-name counterpart.
In the generics approval process, the FDA typically requires
a manufacturer to administer a single dose of its proposed product to a group of 24 to 48 healthy volunteers, then to sample
their blood levels periodically to gauge concentrations of the active ingredient. The generic's performance is then compared
with the pioneer drug in the same group.
But that may not be a good gauge of how large populations of sick patients
will tolerate or respond to a variant of the medication they've already been on, say critics of the approval process.
don't use these medicines in normal volunteers: our patients are old, their hearts, their livers, their kidneys don't work
so well," said Pennsylvania State medical center cardiologist Dr. Gerald Naccarelli. "They test these generics on a healthy
30-year-old and test his blood levels and say, 'OK, close enough.' And they translate that into an 80-year-old-guy who's on
nine different meds? I would suggest that someone who knew nothing about medicine would say that's problematic."
The above arguments assume that the pharmaceutical company has figured out the ideal amount and the ideal rate of absorption. However, there research is too limited to arrive out this conclusion. It is equally possible that the generic formulation could produce superior therapeutic results.
4) One reason for permitting such difference is that different
people have different rates of absorption and percentage of absorption. Moreover,
there is in most cases an even greater variance in absorption for the same person depending on what is in the stomach (drugs
and food) and the persons activities during the time of absorption. Digestion
for example is nearly shut down during strenguous activity. Variation is the
5) Narrow therapeutic index is rare, for the drug industry recommends
higher doses of their medication, and most doctors obligingly prescribe the higher dose.
Receiving less has little or no effect upon the therapeutic course.
6) Release rate is measured in so far if a generic is rapidly released,
it will show up as a greater amount upon the initial measurement. (Delayed release
assumes absorption throughout the small intestines.)
7) The smoking gun, supposed proof of a clinically confirmed negative
difference. That such a difference would be found is not surprising giving the
confluence of funding by the industry for such research, and that the literature had been scanned for negative findings. The experimenter’s bias calls the results in question.
8) The reason testing is not required comes from a well-proven
principle of medicine, that with identical molecular structure, drugs have the same therapeutic effects. Generic drugs are required to mimic in method of delivery the patented drug.
The only thing worse than
generic drugs (from big PhARMA viewpoint) are those which are both cheap and not patentable—such as barbiturates, aspirin,
From American Heart Association at http://www.americanheart.org/presenter.jhtml?identifier=163
Niacin (nicotinic acid)
This drug works in the liver by
affecting the production of blood fats. Niacin is prescribed to lower triglycerides and LDL cholesterol and raise HDL
Niacin side effects may
include flushing, itching, and stomach upset. Your liver functions may be closely monitored, as niacin can cause toxicity.
Non-prescription immediate release forms of niacin usually have the most side effects, especially at higher doses. Niacin
is used cautiously in diabetic patients as it can raise blood sugar levels.
NOTICE how in the following end comment of the above they caution against the non-prescription source.
Niacin comes in prescription
form and as “dietary supplements.” Dietary supplement niacin must not
be used as a substitute for prescription niacin. It should not be
used for lowering cholesterol because of potential very serious side effects. Dietary supplement niacin is not regulated by
the U.S. Food and Drug Administration (FDA) the same way that prescription niacin is. It may contain widely variable amounts
of niacin — from none to much more than the label states. The amount of niacin may even vary from lot
to lot of the same brand. Consult your doctor before starting any niacin therapy.
It should be noted that the American Heart Association receives funds from big PhARMA and also its directors
receive their funds.