Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1994-10-31
2001-06-05
Geist, Gary (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S654000, C514S652000
Reexamination Certificate
active
06242463
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to improving the treatment of chronic illness in humans and animals. In particular, the invention relates to kits and methods that improve chronic treatments using data obtained from individual random crossover (n=1 or single patient) double-blind studies.
Inappropriate prescribing of potent and potentially dangerous drugs is a problem of staggering dimensions. Nonetheless, no commercial solution has been advanced to ensure appropriate treatment. Presently, doctors prescribe medications which have approved indications determined by large clinical trials. Drug manufacturers also demonstrate a product's safety and effectiveness using well controlled clinical studies in populations likely to require its use (e.g. hypertensive patients for antihypertensive drugs). Relatively small numbers of highly selected subjects are utilized. Too often, these studies do not accurately predict the safety and efficacy of a medication for individuals actually treated in practice.
Thus, prescribers are at a disadvantage because a highly selected, often homogeneous group of patients is actually studied for marketing approval. The prescribing physician often cannot distinguish which drugs are safe and effective for his/her heterogeneous collection of individual patients. Even in homogeneous groups of patients, individual variation is usually large when a pharmaceutical company measures a drug's disposition and activity. Therefore, average results may be poorly suited to the needs of any given individual. It is rarely clear to the prescribing physician how an individual patient might respond to a given medication. This is because all people respond differently, both positively and negatively, based upon individual genetic and environmental factors.
Furthermore, the physician rarely has objective information to help decide between alternative therapies for an individual patient. Although the physician wants unbiased data concerning how a patient responds to a given therapy, such data is almost never available unless the patient is in a drug trial. The physician is almost always required to use subjective “clinical judgment”.
Pharmaceutical manufacturers are also at a disadvantage since they have no means of providing unbiased data for individual patients. Manufacturers rarely receive feedback on how a drug is used in actual practice unless an adverse event is reported. Other organizations often need unbiased information for regulatory, patient care and business purposes. Currently, unreliable retrospective databases, such as government or health maintenance organizations' epidemiologic databases, are used.
In 1985, investigators proposed a single-patient drug trial as a possible solution. Using this study design, a patient is treated with a medication and a placebo in a double-blind randomized manner (n=1 or single patient drug trial). This approach permits assessment of whether a medication regimen is appropriate for an individual patient in terms of medical benefit and harm. This approach eliminates patient/physician bias by making the medication and placebo look and/or taste the same. Thus, a toxic or ineffective treatment can be avoided by using objective criteria and new treatment regimens can be pursued for well documented reasons and similarly tested, if needed. This alternative is purely subjective trial and error.
The single-patient method, however, has significant shortcomings. It has failed to provide validated results. There was no appreciation that the data obtained from the single trial should be compared against a database compiled from similarly affected and tested patients. Moreover, no guidance was provided concerning therapeutic alternatives based upon a database comprised of earlier patient experience during single-patient trials.
No commercial products are believed to be available which allow objective and definitive measurement of individual patient compatibility with drug treatment compared to placebo or a therapeutic alternative. The present invention addresses this need.
OBJECTS AND SUMMARY OF THE INVENTION
It is therefore an object of the present invention to develop methods and kits which can assess the appropriateness of specific drug treatment in individuals, particularly those suffering from chronic illnesses.
It is a further object to provide methods and kits for testing therapeutic alternatives for drug treatments in individuals.
Thus, in one aspect, the invention includes a method of treating human and veterinary illnesses. The method includes:
a) providing to a pool of humans or animals in need of such treatment a test kit containing:
i) a supply of a drug indicated or proposed for the treatment of an illness;
ii) a supply of a placebo substantially identical in appearance to the drug,
iii) a questionnaire designed to elicit from each pool member to be treated information concerning the actual usage, safety, efficacy and desirability of the selected treatment;
b) administering the drug and placebo to each member of the pool according to a random, double-blind schedule;
c) assembling a database from the pool based on the answers provided from the individual questionnaire;
d) revealing the random schedule and comparing the data obtained from known drug and placebo treatment periods;
e) providing a test kit containing the same materials as set forth in a) to a human or animal also in need of such treatment to obtain a separate or second set of data concerning the safety, efficacy and desirability of said treatment;
f) administering the drug and placebo to the human or animal according to a random, double-blind schedule;
g) assembling the second or separate database based on the answers provided to the questionnaire;
h) revealing the random schedule to uncover drug and placebo treatment periods;
i) comparing the data obtained from the pool with that obtained from the single human trial to determine an optimal treatment of the human or animal with the drug; and
j) administering to the human or animal a treatment consistent with the optimal treatment. The new dosing regimen for optimal therapeutic effect and quality of life can also be retested, if and when deemed appropriate, by the clinician and/or patient.
The method is suitable for evaluating and validating any prescription or non-prescription treatment regimen or medication for individuals as well as demographic groups. Using this method, one can periodically obtain further outcome information on tested individuals.
Other aspects of the invention include a method and kit for determining therapeutic alternatives and verifying generic equivalence of known medications. These methods include:
a) providing to a human or animal a test kit containing:
i) a supply of a drug indicated for the treatment of an illness;
ii) a supply of a therapeutic alternative or generic equivalent candidate substantially identical in appearance to the drug,
iii) a questionnaire designed to elicit from the human or animal information concerning the safety, efficacy and desirability of the treatment for the human or animal;
b) administering the drug and therapeutic alternative to the human or an animal according to a random, double-blind schedule;
c) assembling a database by eliciting from the human or animal caretaker answers to the questionnaire; and
d) revealing the random arrangement schedule to determine the relative effectiveness of the therapeutic alternatives in the human or animal by comparing the data obtained from knowing drug and alternative treatment periods.
There are several advantages associated with the present invention. For example, patients benefit by the assurance of treatment with appropriate drug and dosing regimen. The method is particularly useful before committing a patient to a long term drug treatment regimen. Documented evidence of the benefit is provided. Unnecessary side effects and expense can be avoided.
Government agencies could also benefit by the availability of a dynamic database on drug efficacy and safety in individuals. T
Chaudhry Mahreen
Davidson Davidson & Kappel LLC
Geist Gary
Opt-e-scrip, Inc.
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