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PubMed2006

Development of antidotes: problems and strategies.

Antidotes against chemical warfare agents are "orphan drugs" given that these poisonings are rare. Therefore, they are of limited interest to the pharmaceutical industry. For this reason, and recognizing the increasing threat of terrorist or asymmetrical use of chemical warfare agents, the responsibility for research into medical countermeasures against these weapons is of primary interest to armies. Accordingly, the research activities of the Bundeswehr Institute of Pharmacology and Toxicology are dedicated to improving diagnosis, prophylaxis and therapy of individuals who are exposed to a chemical agent. Here, antidote development and testing are a high priority in the research program, particularly with respect to organophosphorus (OP) nerve agents and sulphur mustard. The Institute has been coordinating research activities undertaken in house and in collaboration with external researchers. The research program aims to develop primarily in vitro models to minimize the sacrifice of animals, using strategies, which involve human material early in antidote testing. An animal model using isolated mouse diaphragm demonstrated the correlation between AChE activity and neuromuscular function. A similar relationship was found between erythrocyte AChE and neuromuscular function in patients with acute OP pesticide poisoning. In vitro rate constants of the various reactions that are involved in enzyme inhibition and reactivation using human material were used for prediction of what would happen in vivo. This prediction could be confirmed in a patient with acute OP pesticide poisoning. Finally, computer models are being established to estimate the therapeutic effect of an antidote in various human poisoning scenarios. This approach is necessary to compensate for the lack of human clinical pharmacodynamic studies that are usually required for drug regulatory approval, given the obvious ethical issues preventing human volunteer studies with these agents.

Animals↗
PubMed1999

Chromatographic screening techniques in systematic toxicological analysis.

A review of techniques used to screen biological specimens for the presence of drugs was conducted with particular reference to systematic toxicological analysis. Extraction systems of both the liquid-liquid and solid-phase type show little apparent difference in their relative ability to extract a range of drugs according to their physio-chemical properties, although mixed-phase SPE extraction is a preferred technique for GC-based applications, and liquid-liquid were preferred for HPLC-based applications. No one chromatographic system has been shown to be capable of detecting a full range of common drugs of abuse, and common ethical drugs, hence two or more assays are required for laboratories wishing to cover a reasonably comprehensive range of drugs of toxicological significance. While immunoassays are invariably used to screen for drugs of abuse, chromatographic systems relying on derivatization and capable of extracting both acidic and basic drugs would be capable of screening a limited range of targeted drugs. Drugs most difficult to detect in systematic toxicological analysis include LSD, psilocin, THC and its metabolites, fentanyl and its designer derivatives, some potent opiates, potent benzodiazepines and some potent neuroleptics, many of the newer anti-convulsants, alkaloids colchicine, amantins, aflatoxins, antineoplastics, coumarin-based anti-coagulants, and a number of cardiovascular drugs. The widespread use of LC-MS and LC-MS-MS for specific drug detection and the emergence of capillary electrophoresis linked to MS and MS-MS provide an exciting possibility for the future to increase the range of drugs detected in any one chromatographic screening system.

Chromatography↗
PubMed2000

High-quality research and patient care: an overview of clinical trials.

BACKGROUND: One of the responsibilities of the dental profession is to protect and advance the well-being of the public through research of new pharmaceuticals and devices. The objective of this article is to present information about the scientific and regulatory process involved in the design and execution of randomized clinical trials. CONCLUSIONS: Dentists willing to serve as investigators in clinical trials--from Phase 1 to Phase 2 or Phase 3--need to be aware of the two main documents that contain the majority of guidelines and regulations governing clinical research: Title 21 of the U.S. Code of Federal Regulations and the guidelines for good clinical practice put forth by the International Conference on Harmonisation. CLINICAL IMPLICATIONS: Advancements in the frontiers of oral health science and the development of safe, innovative and effective treatment modalities are often the result of high-quality clinical research that is conducted by dental professionals. Knowledge of the research process, professionalism, scientific integrity and a detailed execution of the research plan are all required elements for a successful outcome.

American Dental Association↗
PubMed2004

Establishing pan-European clinical trials: regulatory compliance and other practical considerations.

There are currently many concerns in the pharmaceutical and scientific community working in or around clinical research on the EU Directive 2001/20/EC or Clinical Trials Directive. The Directive introduces regulatory requirements for all phases of study in human subjects, drawing no distinction between commercially funded drug trials and non-commercial/academic research. The Directive makes Good Clinical Practice (GCP) a legal requirement in Europe and all clinical research will be subjected to the same rigorous standards including GCP and Good Manufacturing Practice (GMP) application even at the early clinical phases as well as exhaustive pharmacovigilance and protection of trial subjects. Some of these requirements may be seen as additional burden and a brake to clinical research in Europe. However, the application of the directive should provide a single and highly regulated market of 25 European countries for investigational medicinal products. This article reviews the main aspects and areas of concern of the Directive and provide US sponsor with useful references.

Adverse Drug Reaction Reporting Systems↗
PubMed1992

[The analects of Hajime Hoshi (No. 3) - philosophy of Hoshi].

Hajime Hoshi was the founder of Hoshi Pharmaceutical Company and Hoshi University. He made one of the biggest pharmaceutical companies in Japan in the early 20th century, and furthermore was a journalist, member of the Diet, educator, and also a writer. With such a checkered career, he had an attractive and invincible philosophy. As well as his most import philosophy "kindness first" described in the previous paper, "cooperation first" also had weight in his thought. In the Creed of the Hoshi Pharmaceutical Company, he said "self-reliance should go hand-in-hand with cooperation. Cooperation is an essential requisite in all successful enterprises." "Cooperation is an order of the god, and leads directly to progress." "Cooperation is construction, but noncooperation is destruction." Besides the thought "cooperation first," a part of his profound aphorism is described below. "Patience produces everything and conquers everything." "Success is proportioned to the degree of patience." "Success or failure is determined not at the end, but at the start of an enterprise. A well-conceived plan is the mother of success." "Train your mind. Man's brains become the more fertile and keen, the more they are used." "The is no limit to improvement and invention. We should never relax our endeavor to improve and invent." "Smile! Smile! Do your work with a smile on your face. Conquer difficulty and discontent with smiles." "Yesterday's impossibility is today's possibility. Today's impossibility is tomorrow's possibility."

Commerce↗
PubMed2003

Paediatric medicines research in the UK: how to move forward?

There have been numerous studies to show that many of the medicines used in children are used off-label or are unlicensed for use in children. When children are prescribed unlicensed and off-label medications, some people may see them as unknowing participants in informal and uncontrolled experiments. However, the licensing status of a drug can be seen as a by-product of the real issues: the safety, efficacy and quality of these medicines in the current licensing system. It is important to conduct research in order to provide high quality data regarding safety and efficacy to support evidence-based paediatric prescribing. Clinical trials will always be an invaluable means of acquiring vital information about a drug; but when it comes to children, we may find that these trials are not always practical for technical, ethical and financial reasons; therefore, it is important to explore other methodologies in paediatric medicines research. Pharmacoepidemiological and prospective cohort studies could provide vital safety and efficacy data on paediatric medicines; however, resources need to be invested in the methodological research. Paediatric drug formulation research is under-resourced and under-valued, and, unfortunately, fatal and serious adverse reactions due to inappropriate formulations have been reported in many instances. Paediatric medication is a complex problem; we need to use all available tools for research on safety, efficacy and formulation. The reason for lack of progress in paediatric drug research is most likely due to lack of resources and research capacity. The industry and government should work together and invest more money in paediatric drug research. Finally, regulatory authorities, healthcare professionals and academics need to rethink the research strategy in order to provide better medicines for children.

Child↗
PubMed1984

Absorption properties of two theophylline sustained-release products in smokers.

The absorption of theophylline from two commercial products labelled as having sustained-release properties (Theo-dur; Rio-Ethicals; and Euphyllin Retard; Byk-Gulden) was compared with that of a solution of theophylline (Alcophyllin syrup; Propan-Lipworth) in a multiple-dose study in smokers. As regards bioavailability, results for Theo-dur and Euphyllin Retard tables were statistically indistinguishable from that for the standard, but both products showed significantly slower absorption as reflected by longer times to attain peak concentration and lower peak concentrations. Theo-dur exhibits better sustained-release properties than Euphyllin Retard as judged from the peak/trough ratio and the persistence of concentrations from 6 hours to 12 hours after administration. Assuming linear pharmacokinetics and projecting to therapeutic doses, Euphyllin Retard results in much wider fluctuations between peak and trough concentrations (18,9 and 9,8 micrograms/ml) than does Theo-dur (13,8 and 10,2 micrograms/ml), and this product might be more acceptable in smokers if given in an 8-hourly schedule.

Absorption↗
PubMed1993

Therapeutic uses of gastrointestinal peptides.

The GI tract is one of nature's great pharmacies. Most, if not all, biologically active peptides can be found there, and it is quite likely that others remain to be discovered. Our ability to exploit this resource has expanded considerably over the past two decades. Advances in analytical techniques have allowed investigators to rapidly isolate and purify new compounds from tissue extracts. Sequencing and de novo synthesis of newly discovered peptides are now routine, and the structural modifications required to alter activity and tailor a compound to a particular use are easily made. A number of gastrointestinal peptides or their analogues for use in clinical studies are available from commercial sources (see Table 7). Somatostatin is the first gut peptide to successfully complete development and yield a pharmaceutical compound with a broad range of action. Several of the peptides discussed in this article have similar potential. TRH stands out as a candidate because of its effectiveness in the treatment of experimental spinal cord injury and a variety of shock states. Such a broad range of action in critical fields may justify the intensive development required to yield potent, long-acting, and highly specific analogues. Similarly, the antimetastatic and immunostimulant properties of the enkephalins offer promise for new therapies in the treatment of AIDS, ARC, and cancer. Studies with amylin may lead to new and more precise regimens of blood sugar control in insulin-dependent diabetics and could in turn, prevent some of the worst long-term effects of the disease. The development of effective intranasal forms of GHRH could spare children with GH-GHRH deficiency the distress of repeated injections and help to prevent excessive GH blood levels. Secretin, glucagon, or CGRP might be used one day in cardiovascular emergencies, and VIP or its analogues could prove effective in the treatment of asthma. Although preliminary results with many of these peptides are encouraging, further progress will require the development of standardized experimental models and a more rigorous approach to experimental design. Many of the studies reported here suffered from small patient numbers, a narrow or nonexistent range of doses, or the use of only one or two dosing regimens. Lack of objective criteria for determining the level of response, e.g., in studies of mental illness or degenerative diseases, and the ethical problems of withholding treatment from some patients to establish proper controls further hamper research in this area. If the questions of efficacy and safety are to be resolved, thorough, well-planned trials will be required.

Amino Acid Sequence↗
PubMed2002

[Prosecution of Mélanie Hahnemann in 1847 at the court of Paris: illegal practise of pharmacy and medicine].

Recently married, the Hahnemanns came to Paris in 1835. The great man, 80, was authorised to practice in France. His wife Mélanie always assisted him in writing prescriptions, and in recruiting patients. When he died in 1843, she was continuing to practise assisted or not by a physician, Deleau or Croserio. A young pharmacist, Charles LeThiére, lived close to her as her adoptive son, grandson of the famous painter Guillaume Guillon-LeThière who was the director of the French Academy of Fine Arts of Rome at the Villa Medici, grandson as well of the Roman pharmacist Giuseppe Meli. Early Charles remained orphan and was educated by Mélanie. In 1844, he obtained his pharmaceutical graduation at the Ecole supérieure de Pharmacie de Paris. In 1847, she was accused of illegal practising of medicine and pharmacy. She claimed that she held the degree of doctor in homeopathy granted to her by the Academy of Pennsylvania. The court condemned her on the medical side considering that she earned money without legal certification in medicine. But as the drugs were prepared by a pharmacist, and delivered free of charge to the patients, no sentence was pronounced against her neither against LeThière. However, the court tempted to object that LeTière did not meet all the legal requirements for practising his pharmaceutical activity, especially aruging that he did not own an open shop of pharmacy, and that he did not declare his activity to the authorities in Paris. This point underline the fact that during the XIXth century the French law (21 germinal An XI- 1803), obliged the starting drug industry to be in dependence of the shops of pharmacy opened to the public, owned by a graduated pharmacist. As defender Mrs. Hahnemann chose the quite known solicitor Chaix d'Estange. Many testimonies came for justifying her capability of medical prescribing from artists, officers, writers and several aristocrats. From abroad came the supports of American doctors, Hempel, Hering and Hull. But the core question motivating her sentence came from the medical lobby acting in Paris led by the professor Orfila. Among the adepts of the homeopathy themselves, raised division and rivalry, but all considering that Mélanie Hahnemann's behavior was criticable. The court fined her for hundred francs that she paid. Then, she kept the circle of her friends and continued in medical counselling.

Ethics, Pharmacy↗
PubMed2004

Changing requirements for evaluation of pharmacologic agents.

Children sadly have been excluded from some of the therapeutic advances that have marked pharmaceutical drug development during the past 100 years. Most drugs in use today lack Food and Drug Administration approval for use in children or are restricted to certain pediatric age groups, predominantly older than 12 years. Only a few of the new drugs approved each year have pediatric indications and dosing guidelines described in the drug labeling information. However, many of these drugs are used in children. The lack of suitable information places children at risk for over- or underdosing, and there is a lack of suitable dosage forms, which can result in improper drug administration. This lack of information on the safe and effective use of drugs in the most vulnerable patients--infants and neonates--is of greatest concern. Recent changes in the regulations that govern drug development has dramatically increased the number of drugs that undergo testing in children. This article reviews new laws that govern drug testing in children and the use of children in therapeutic research.

Child↗
PubMed2004

Clinical holistic medicine: when biomedicine is inadequate.

The modern physician is using pharmaceuticals as his prime tool. Unfortunately, this tool is much less efficient than you might expect from the biochemical theory. The belief in drugs as the solution to the health problems of mankind, overlooking important existing knowledge on quality of life, personal development, and holistic healing seems to be one good reason why approximately every second citizen of our modern society is chronically ill. The biomedical paradigm and the drugs are certainly useful, because in many situations we could not do without the drugs (like antibiotics), but curing infections or diseases in young age is not without consequences, as the way we perceive health and medicine is influenced by such experiences. When we get a more severe disease in midlife, we also believe drugs will make us healthy again. But at this age, the drugs do not work efficiently anymore, because we have turned older and lost much of the biological coherence that made us heal easily when we were younger. Now we need to assume responsibility, take learning, and improve our quality of life. We need a more holistic medicine that can help us back to life by allowing us to access our hidden resources. The modern physician cannot rely solely on drugs, but must also have holistic tools in his medical toolbox. This is the only way we can improve the general health of our populations. Whenever NNT (Number Needed to Treat) is 2 or higher, the likelihood of the drug to cure the patient is less than 50%, which is not satisfying to any physician. In this case, he must ethically try something more in order to cure his patients, which is the crossroads where both traditional manual medicine and the tools of a scientific holistic medicine are helpful.

Clinical Medicine↗
PubMed2006

Advertising and disclosure of funding on patient organisation websites: a cross-sectional survey.

BACKGROUND: Patient organisations may be exposed to conflicts of interest and undue influence through pharmaceutical industry (Pharma) donations. We examined advertising and disclosure of financial support by pharmaceutical companies on the websites of major patient organisations. METHOD: Sixty-nine national and international patient organisations covering 10 disease states were identified using a defined Google search strategy. These were assessed for indicators of transparency, advertising, and disclosure of Pharma funding using an abstraction tool and inspection of annual reports. Data were analysed by simple tally, with medians calculated for financial data. RESULTS: Patient organisations websites were clear about their identity, target audience and intention but only a third were clear on how they derived their funds. Only 4/69 websites stated advertising and conflict of interest policies. Advertising was generally absent. 54% of sites included an annual report, but financial reporting and disclosure of donors varied substantially. Corporate donations were itemised in only 7/37 reports and none gave enough information to show the proportion of funding from Pharma. 45% of organisations declared Pharma funding on their website but the annual reports named more Pharma donors than did the websites (median 6 vs. 1). One third of websites showed one or more company logos and/or had links to Pharma websites. Pharma companies' introductions were present on 10% of websites, some of them mentioning specific products. Two patient organisations had obvious close ties to Pharma. CONCLUSION: Patient organisation websites do not provide enough information for visitors to assess whether a conflict of interest with Pharma exists. While advertising of products is generally absent, display of logos and corporate advertisements is relatively common. Display of clear editorial and advertising policies and disclosure of the nature and degree of corporate donations is needed on patient organisations' websites. An ethical code to guide patient organisations and their staff members on how to collaborate with Pharma is also necessary, if patient organisations are to remain independent and truly represent the interests and views of patients. As many organizations rely on Pharma donations, self-regulation may not suffice and independent oversight bodies should take the lead in requiring this.

Advertising↗
PubMed2006

Barriers to accepting e-prescribing in the U.S.A.

PURPOSE: With the number of prescriptions rising nationally each year, it is surprising that Web-based technology is not fully embraced in the pharmacy industry as an aid to quality-assuring prescribing processes. Traditional prescription handling is done in a manual fashion with physicians hand-writing prescriptions for the patients during an office visit, giving the patient the responsibility of taking the prescription to a pharmacy or mailing the prescription to a mail order company for fulfillment. Electronic prescribing (e-prescribing) has the ability not only to streamline the prescription writing process, but also to reduce the number of errors that may be incurred with hand-written prescriptions. The purpose of this paper is to investigate these phenomena in the U.S.A. DESIGN/METHODOLOGY/APPROACH: A number of hypotheses were tested using principal-components analysis (PCA) and factor analyses. As a result, a total of 55 fully employed, professional and semi-professional service management and internet users, representing a college-educated and knowledge-based sample derived from the metropolitan section of Pittsburgh, was selected. FINDINGS: The six major constructs generated from the factor loadings in descending order of importance were: profit and risk factors, shipping and handling, saving, customer relationship management (CRM) and ethics, age, and awareness. The dependent variable chosen to be regressed against these major independent factor-based constructs was willingness to purchase prescriptions online. The overall relationship was found to be statistically significant (F = 2.971, p = 0.015) in predicting willingness to use e-prescribing options based on the various independent constructs. However, when testing the various standardized beta coefficients in the linear model, only the factor score-based construct CRM and ethics was found to significantly contribute to predicting the willingness to purchase prescriptions online (t = -3.074, p = 0.003). RESEARCH LIMITATIONS/IMPLICATIONS: Although this study appears to represent the e-prescribing process in the U.S.A., the sample size and region studied are only one slice of the general population. Practical implications - Unfortunately, the adoption of e-prescribing has been difficult to attain owing to numerous barriers throughout the industry. Such acceptance barriers include lack of technology trust, associated system costs, and risk of un-securing patient health and medical information. ORIGINALITY/VALUE: This article documents that increasing numbers of pharmacies today are building their IT-infrastructures to accept electronic prescriptions and it may soon be the preferred method for physicians to write prescriptions. It is with great anticipation that this technology will also enhance the prescription-writing abilities of prescribing physicians globally, giving them electronic access to patient medical records and resources that will assist them in prescribing the correct drug for the patient.

Adolescent↗
PubMed1997

A random walk rule for phase I clinical trials.

We describe a family of random walk rules for the sequential allocation of dose levels to patients in a dose-response study, or phase I clinical trial. Patients are sequentially assigned the next higher, same, or next lower dose level according to some probability distribution, which may be determined by ethical considerations as well as the patient's response. It is shown that one can choose these probabilities in order to center dose level assignments unimodally around any target quantile of interest. Estimation of the quantile is discussed; the maximum likelihood estimator and its variance are derived under a two-parameter logistic distribution, and the maximum likelihood estimator is compared with other nonparametric estimators. Random walk rules have clear advantages: they are simple to implement, and finite and asymptotic distribution theory is completely worked out. For a specific random walk rule, we compute finite and asymptotic properties and give examples of its use in planning studies. Having the finite distribution theory available and tractable obviates the need for elaborate simulation studies to analyze the properties of the design. The small sample properties of our rule, as determined by exact theory, compare favorably to those of the continual reassessment method, determined by simulation.

Biometry↗
PubMed1982

The drugging of the Third World.

This article reports an investigation of the promotion of more than 500 products marketed by over 150 pharmaceutical companies in the United States, Great Britain, Latin America, Africa, and Asia. In contrast to the promotional material provided to physicians in the United States and Great Britain, material presented to physicians in Third World countries was found to be marked by gross exaggeration of product effectiveness and minimized or completely omitted potential hazards. No substantial differences could be found between multinational and domestic companies, brand-name and generic firms, or companies based in capitalist nations and those in socialist or communist-bloc countries in terms of the adequacy and accuracy of their promotion. Little evidence was found to support industry claims that the discrepancies in promotion reflect the different policies of various drug regulatory agencies. Much of the promotion concerned "luxury products," including costly tonics and appetite stimulants marketed in poor countries where the pressing need is for food. Bribery of influential physicians and key governmental officials may play an important role in irrational drug promotion and use in the Third World. Some of the proposed corrective approaches to this problem are examined.

Advertising↗
PubMed2005

Authors' reports about research integrity problems in clinical trials.

BACKGROUND: There is little information about the prevalence of research integrity problems in the scientific literature. We sought to determine how frequently authors of published pharmaceutical clinical trials reported fabrication of data or misrepresentation of research. METHODS: We conducted a mail survey of 549 authors who had published reports of pharmaceutical clinical trials from 1998 to 2001 that appeared in the Cochrane Database of Systematic Reviews. We asked authors about fabricated data or misrepresentations of research in three contexts: the target study (the report from which their name was obtained), another study they had participated in, or a study that they personally knew about. RESULTS: We received replies from 64% of authors with valid addresses. Two authors (1%) reported that the target article misrepresented the research. Almost 5% reported fabrication or misrepresentation in a study they had participated in the last 10 years, and 17% of authors personally know about a case of fabrication or misrepresentation in the last 10 years from a source other than published accounts of research misconduct. CONCLUSIONS: Fraud and misrepresentation in clinical trials appear to be rare on a per-published report basis. However, they occur sufficiently frequently that scientists have a significant chance of participating in a project affected by fraud or misrepresentation during their research careers. These rates of exposure justify vigorous efforts to prevent research misconduct.

Adult↗
PubMedDate not supplied

Kinetics of two different iron formulations and their effect on diurnal variation of serum iron levels.

Iron polymaltose complex (IPC) is a recently marketed preparation with questionable bioavailability. We compared the absorption kinetics of IPC with ferrous sulfate. We also studied the effect of oral iron on diurnal variation. The study was conducted in eight healthy, non-smoking, non-alcoholic volunteers after obtaining their written informed consent and after Institutional Ethical Committee approval. The study was conducted in three phases: during the first phase no drugs were given, whereas in the second and third phases, ferrous sulfate (66 mg elemental iron) and IPC (100 mg elemental iron) were given in a randomized, two-way, cross-over design, with a wash-out period of 1 week. The blood samples were collected, iron levels estimated and the pharmacokinetic parameters calculated. Circadian rhythm in iron levels was demonstrated by cosinor analysis with a mesor of 93.6 microg/dl, acrophase 10.40 h and amplitude of 26.4 microg/dl. Evening levels were higher as compared with morning levels. Drug treatment increased the mesor (115.7 microg/dl; p < 0.05), delayed the acrophase (11.30 h; p < 0.05) and increased the amplitude (38.5 microg/dl; p < 0.05). The bioavailability of ferrous sulfate was significantly greater as compared with IPC with greater Cmax and AUC (p < 0.05). A clear cut circadian rhythm in iron concentrations was demonstrated. Ferrous sulfate was shown to have significantly higher bioavailability as compared with IPC. Further studies having hemoglobin levels as an endpoint may be planned.

Adult↗
PubMed1997

Effects of an educational intervention on residents' knowledge and attitudes toward interactions with pharmaceutical representatives.

To assess primary care resident and faculty knowledge and attitudes concerning interactions between physicians and pharmaceutical representatives (PRs) and to measure changes in residents' knowledge and attitudes after an educational intervention, we conducted preintervention and postintervention surveys with a causal-comparative group in a university-based primary care residency program. All primary care internal medicine and internal medicine-pediatrics residents and faculty were given the voluntary survey. In general, residents and faculty demonstrated similar responses for the preintervention survey. Differences between faculty and resident opinions were seen in two areas. Faculty were more likely than residents to believe that PRs sometimes use unethical marketing practices (p < .05) and that the amount of contact with PRs in the outpatient clinic is excessive (p < .01). The postintervention survey of residents demonstrated significant differences between the control and intervention groups for three attitude scales. After the intervention, residents showed an increased belief that PRs may use unethical marketing practices (p < .01), that marketing gifts with no patient benefit may be inappropriate (p = .05), and that other physicians' prescribing patterns could be negatively influenced through the acceptance of gifts (p < .05). A brief educational intervention can change resident attitudes concerning physician interactions with PRs.

Data Collection↗