What drug companies can't tell you about your presciption

[Guest guest]

This is from an article in the January 2008 issue of " The

Fibromyalgia Network Newsletter " :

" Pharmaceutical compaines hands are tied when it comes to giving tips

on the best use of medications.

A recent flurry of print and television advertising for drugs that

treat fibromyalgia related symptoms tells viewers to 'Ask you doctor'

about the medication. The problem is that many doctors are not

familiar with new drugs and may be hesitant to prescribe them. Often

the only information they receive about the drug is from a packet

approve by the Food and drug Administration (FDA),. But this

information does not include advice on how to minimize side effects

or practical tips to help patients reap the most rom any given drug.

And don't expect your pahrmacists to have the insdie scoop on a new

drug because they only have access to the same material.

Perpetuating an already watered down loop of information,

pharmaceutical company representatives also are restricted by the FDA

on what they can say about their drugs.

So why is the FDA withholding information about new drugs and what

are they not telling you? In the lengthy and expensive process to

obtain FDA approval for a new drug, pharmaceutical companies and

researchers need to be practical and usually only evaluate two or

three dose-strengths of the medication using a predefined dosing

schedule. Perhaps after testing their drug on 150 people in Phase 1,

they decide that the drug works best when 200 mg to 300 mg is taken

twice a day....but this dose range and schedule is based on a small

number of patients. Oftentimes the testing of a drug enters its

final phase before researchers learn the most successful way to dose

a patient up on the medication or the details of the side effects and

how to manage them.

In the end the FDA approves the drug and prescritpion information

based on the results of these clinical trials including the dosing

regimen. Any practical advice discovered by physicians during the

course of the trials performed for the FDA over the three to seven

years is filtered out of the information loop, even though this is

the type of advice you and your doctor would benefit from.

'There are some things the drug companies aren't even allowed to talk

about,' says Clauw, M.D., of the University of Michigan in Ann

Arbor. Clauw is the lead investigator for a new drug , milnacipran,

which will soon be considered by the FDA for the treamtnet of FM.

Clauw also assisted with the many clinical trials for Lyrica and

Cmbalta so he was able to offer Fibromyalgia Network insightful

information about what the drug companies can and cannot say. Take

for example the recent approval of the drug Lyrica for FM pain. The

only prescription information you and your doctor will receive from

the manutfacturer Pfizer will adhere strictly to how the patients

were dosed up on the medication during the trials. Doctors will read

that the side effects of the drug include sleepiness and dizziness,

but the recommended dosing will be to take Lyrica during the day.

'Untill Pfizer does a study showing that the drug is better tolerated

when taken as a predominant or single nighttime dose, the FDA

restricts the company from disseminating the information,' syas

Clauw. In fact, I. Jon , M.D. Ph.D., of the University of

Texas at san , presented a nightly doseing strategy for Lyrica

in the October Journal that is considered 'off-label' because it is

not how Lyrica was studied in the trials.

The same holds true of Cymbalta. Patients may complain about nausea,

dry mouth, constipation , or heartburn because they are dosing as

prescribed based on clinical dtials and not an optimal lower dose

rate that could reduce the incidence of side effects. The

instructions also state the medication can be taken with or without

food because that is how it was done in the clnical trials. Yet,

doctors with experience prescribing Cymbalta tell patients to take it

with food to decrease nausea.

'In clinical trials, researchers want the patient to have as

immediate a positive effet as possible so they continue in the trial,

so dosing up on the drug may be faster than optimal,' says Clauw.

Eventually, after a drug has been out for several years, doctors

learn the best way to prescribe it through patient feedback, trial

and error, and other colleagues. Also, drug companies often give

grants to local hospitals or medical associations that offer

educational conferences for physicians. These events provide doctors

with unrestricted information and answers (i.e., not controlled by

the FDA). Finally, since FM Network is not bound by any government

agencies or pharmaceutical companies, it disseminates ll the nuances

of the latest research discussed at these confereces and reports,

them in the Journals and enews Alerts. Now that medications are

being approved for FM, you can count on the Network to give you the

practical information that keeps you and your doctor out of the

watered-down loop! "

It seems to me that the best route would be to have larger groups of

people in the trials and give each group different doses and some

with food, without, etc. But the drug companies are in a big hurry

to make the big money so they do the shortest trials allowed to get

the drugs on the market before the optimal dosing and the worst side

effects are available. Knowing that the drug companies spend much,

much more on advertising than on research and development, I still

feel the cost could be much lower than it is now. Most people with

FM cannot afford these new drugs due to cost as their insurance

companies will not pay the price. There has to be a way for our

country to control drug prices if we are ever to have affordable

health care and drug prices. Just my opinion.

sue in ohio