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Patients with Parkinson's disease if they had a problem with a runny nose. If they did I then asked if it developed before, with or after the PD. If the patient was accompanied by anyone over the age of 50 I asked that person too if they had a runny nose. To be "ethical" I prefaced my first question with the statement that I was doing a survey, which was a research study to determine if a runny nose was more common in PD than in people without PD. Of course I had a strong suspicion that this was the case but it's never been a published observation, although an ENT colleague told them that it's a well known observation in his field. This isn't the idiotic question you may think it is. For one thing it turns out that it may be very embarrassing. For another patients and families are generally very pleased to know when some oddball symptom is "part" of the disease and that they are not being hypochondriacal or "weird" in some way. In this case it turned out to be about ten times more common in PD patients than the controls. This probably has some clinical importance in that this is most likely the result of early sympathetic dysfunction that may, in fact, precede the motor signs of the disease. If true, this would provide another "pre-symptom" of the disease that will be helpful when we find a drug that slows the disease progression. The result was submitted as a letter to the editor of a prestigious journal. The journal was very interested, asked a number of questions, but refused to consider a revision when they learned that I had not obtained Institutional Review Board approval. I was not surprised, but had decided a priori to "test" whether common sense was a consideration in contemporary academic medicine. I then consulted the IRB about the study. The response was, "You don't need IRB approval for a study of this sort, unless you want to publish it. Many journals require IRB approval for any study." When I submitted the protocol the IRB stated that I needed to hand the patient a single page stating what I was studying and that they didn't need to participate. As Dave Barry says, I not making this up. There have been a lot of problems in the clinical trial arena. There is no question that doctors and pharmaceutical companies have, on occasion, abused their subjects. It is clear that clinical trials need to be policed. It is also clear that the FDA needs to monitor drug safety and that they need to be assidu.
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OffIce of HealTH care QualITY: The Maryland Department of Health and Mental Hygiene houses the Office for Health Care Quality OHCQ ; which exists to protect the health and safety of Maryland's citizens in health care settings. OHCQ is responsible for the licensure and certification of various health care programs and providers and they conduct surveys of settings and respond to community complaints. 1-877-402-8218 or 410-402-8000. dhmh ate. md ohcq.
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ADVANCIS PHARMACEUTICAL CORPORATION A Development Stage Enterprise ; NOTES TO FINANCIAL STATEMENTS -- Continued ; comprehensive income loss ; . At December 31, 2001, the unrealized gain on available-for-sale securities was de minimus. Investments available for current operations are classified in the balance sheet as current assets; investments held for long-term purposes are classified as noncurrent assets. Interest income and realized gains and losses on securities are included in ``Interest income'' in the statements of operations. Comprehensive Income SFAS No. 130, ``Reporting Comprehensive Income, '' requires a full set of general-purpose financial statements to be expanded to include the reporting of ``comprehensive income.'' Comprehensive income is comprised of two components, net income and other comprehensive income. For the years ended December 31, 2000, 2001 and 2002, there were no items of other comprehensive income. Property and Equipment Property and equipment are stated at cost and depreciated over their estimated useful lives using the straight-line method. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred. Intangible Assets Intangible assets consist of the cost of capitalized patent applications. Patents are carried at cost amounting to 0, 000, less accumulated amortization which is calculated on a straight-line basis over the legal, estimated useful lives of the patents, not to exceed 20 years. The Company periodically reviews the carrying value of patents to determine whether the carrying amount of the patent is recoverable. For the years ended December 31, 2001 and 2002, there were no adjustments to the carrying values of patents. The Company is amortizing the cost of the patent applications over a period of ten years. Ownership of all of its patents is retained by the Company in all its transactions. Amortization expense for each of the years ended December 31, 2000, 2001 and 2002 was , 000. Accumulated amortization as of December 31, 2001 and 2002 is , 000 and , 000, respectively. The estimated aggregate amortization expense for each of the five succeeding fiscal years is , 000. Revenue Recognition Corporate partner revenues include license fees and milestone payments associated with collaborations with third parties. Revenue from non-refundable, upfront license fees where the Company has continuing involvement is recognized ratably over the development or agreement period. Revenue associated with performance milestones is recognized based upon the achievement of the milestones, as defined in the respective agreements. Royalties from licensees are based on third-party sales of licensed products and will be recorded in accordance with contract terms when third-party results are reliably measurable and collectibility is reasonably assured. Research and Development The Company expenses research and development costs as incurred. Research and development costs primarily consist of salaries and related expenses for personnel and capital resources. Other research and development expenses include fees paid to consultants and outside service providers and the costs of materials used in clinical trials and research and development. F-8 and dicyclomine.
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Liquidity We expect that our existing cash resources and cash from operations will be sufficient to finance our foreseeable working capital requirements. 427 million of our cash and cash equivalents is held by our captive insurance and reinsurance companies in accordance with insurance regulations. As of year end 2006, we had no commitments for capital expenditures which we consider to be material to our consolidated financial situation. Available, undrawn lines of credit amounted to a total of 12.6 billion at December 31, 2006. For a discussion of our treasury policies, see "Item 11. Quantitative and Qualitative Disclosures about Market Risk." Off-Balance Sheet Arrangements Contractual Obligations and Other Commercial Commitments We have various contractual obligations and other commercial commitments arising from our operations. These obligations and commitments are more fully described at "Item 4. Information on the Company, " above. Our contractual obligations and our other commercial commitments at December 31, 2006 are shown in!
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Aged males had the highest stimulant prescription prevalence of more than 18% and the highest SSRI prevalence of nearly 3%. Stimulant and SSRI prevalence for white male patients were consistently higher than prevalence of other racial and sex groups for preschool and schoolaged children P .01 ; . Racial differences in prescription prevalence were even greater for SSRIs than stimulants, with a 2- to 3-fold higher annual SSRI prevalence for white Medicaid patients compared with black children of the same age groups P .001 ; . COMBINATION PRESCRIPTIONS In addition to increases in the individual medications, greater prescription of stimulants and SSRIs in combination occurred during the study period. The number of patients prescribed both types of psychotropic medications during the same year increased steadily. Since SSRIs had been recently introduced at the beginning of the study period, in 1992, only 32 children received both stimulants and SSRIs during this year, yet by 1998, 2102 pediatric patients were prescribed both types of medication. The combination of stimulants and SSRIs is still relatively rare among all Medicaid children, with an annual combination prescription prevalence among schoolaged children of 0.7%. However, among the 6984 children who received an SSRI in 1998, 30.1% also received a stimulant.
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