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PubMed2001

Direct-to-consumer drug marketing: public service or disservice?

Pharmaceutical industry spending on direct-to-consumer advertising has been increasing rapidly. While the primary goal of direct-to-consumer advertising is to sell drugs, supposed secondary goals include patient education and improved health. However, these benefits of direct-to-consumer advertising are unproved. Moreover, such advertising may create unnecessary tension between the patient and the patient's physician and insurer, and may divert physicians' efforts away from important patient concerns, and toward marketing-generated discussions. On the other hand, direct-to-consumer advertising may lead to patient-doctor encounters that would not have occurred otherwise. Direct-to-consumer advertising should be modified to unambiguously benefit the health-care interests of consumers and patients.

Advertising↗
PubMed2002

Buccoadhesive erodible disk for treatment of oro-dental infections: design and characterisation.

Buccoadhesive erodible disks of cetylpyridinium chloride were prepared using different bioadhesive polymers along with excipients like mannitol. The purpose of designing the erodible disk was to obviate the need for removal of exhausted device. The optimized disk containing 5.0 mg of cetylpyridinium chloride, 2.0 mg of magnesium stearate and 6.0 mg of mannitol along with sodium carboxy methyl cellulose DVP and hydroxypropylmethylcellulose K4M in the ratio of 1:3 was found to release the drug for a period of over 6.0 h without getting dislodged. Maximum in vitro drug release was found to be 94.78% in 6.0-h study. In situ release characteristics were evaluated using a 'flow-through assembly', which simulated the conditions of the human buccal cavity. The drug concentrations in the in situ samples were found to be above minimum inhibitory concentration (MIC) of the drug. The bioadhesive performance and the surface pH of the disks were satisfactory. Cetylpyridinium chloride disks were tested against microorganisms commonly found in oro-dental infections namely Candida albicans, Staphylococcus aureus, Escherichia coli and Streptococcus mutans. The disk as well as the in situ samples showed inhibition of growth of microorganisms. Approval was taken from Jamia Hamdard Review Board (Ethical Board) to perform in vivo studies in healthy human volunteers. In vivo evaluation of buccoadhesive disks revealed adequate comfort, taste, and non-irritation and none of the volunteers reported severe dry mouth/severe salivation or heaviness at the place of attachment. Salivary concentrations were maintained above MIC for 8.0 h. Correlation was found between the drug concentration in situ and concentration of drug in saliva collected in healthy human volunteers. The correlation was found to be positive with a correlation coefficient of 0.9596. It was found to be statistically significant at 5% confidence level (P<0.05).

Adhesives↗
PubMed2006

Residents' perceptions over time of pharmaceutical industry interactions and gifts and the effect of an educational intervention.

PURPOSE: To describe change in residents' attitudes toward gifts from and interactions with industry and to measure the effects of a formal educational workshop on changes in perceptions. METHOD: At the University of Chicago, 118 internal medicine residents completed an observational survey and took part in a controlled intervention across three years (2001-2004) of residency. Four cohorts of residents completing the program in 2004-2007 participated. The intervention was an interactive educational workshop, including reviews of literature and guidelines, and three videos demonstrating routine resident interactions with pharmaceutical representatives. Residents graduating in 2005 were the intervention group and residents graduating in 2004 the comparison group. Analysis of variance and linear regression models were used to determine the relationship between variables. RESULTS: Residents perceived "lunch sponsored at noon conference" and "pharmaceutical representative brief talk at noon conference" as increasingly appropriate over their training period (p < .02). Residents perceived "pens, notepads, pocket antibiotic guides" as increasingly appropriate and "tickets to sporting events," "round of golf," and "travel/registration for national conference" as increasingly inappropriate (p < .05). The intervention group was more likely to rate only one item, "lunch at noon conference," as less appropriate (p = .042). CONCLUSIONS: Residents' perceptions toward industry gifts and interactions changed modestly during their training to reflect institutional policy. "Appropriate" gifts of minimal value were generally perceived as increasingly appropriate, whereas "inappropriate" gifts were perceived as increasingly inappropriate over time. An educational workshop alone may not significantly alter residents' perceptions toward industry without the implementation of broad and consistent institutional policy.

Advertising↗
PubMed1997

Quality assessment of economic evaluations published in PharmacoEconomics. The first four years (1992 to 1995).

Our objective was to assess the quality of reporting of original economic research articles in PharmacoEconomics from inception to the end of 1995, in order to identify areas of strength and weakness, and analyse trends over time. Each regular issue of the journal was examined for original economic evaluations. Accepted articles were categorised by study type and by year of publication. A previously developed 13-item quality-scoring checklist was applied. The maximum possible score that an article could be assigned was 4.0. Quality scores were analysed over time and by study type. 54 articles were identified for analysis. Mean overall score (OS) ranged from a minimum of 1.80 to a maximum of 3.75, with a mean OS of 3.01 [standard deviation (SD) = 0.47]. The item with the highest mean score was the 'definition of study aim' (mean OS = 3.46, SD = 0.69). The item with the lowest score was 'ethical problems discussed and identified' (mean OS = 1.44, SD = 0.92). Only 4 items on the checklist had mean scores lower than 3.0. No significant time trend was apparent for OS (R2 = 0.002). Cost-benefit (mean OS = 3.25, SD = 0.85, n = 5), cost-effectiveness (mean OS = 3.11, SD = 0.97, n = 27), and cost-utility (mean OS = 3.29, SD = 0.93, n = 6) analyses had mean scores significantly higher than cost-analysis/cost-of-illness studies (mean OS = 2.51, SD = 1.14, n = 8). The mean OS for cost-minimisation studies was 2.74 (SD = 0.49, n = 8). Despite some weaknesses in particular aspects of economic evaluations published in PharmacoEconomics, we conclude that the journal has offered publications with acceptable overall quality and adequate methodology.

Economics, Pharmaceutical↗
PubMed1984

Experiences in the application of NONMEM to pharmacokinetic data analysis.

Ethical issues arising from the use of patients in medical research have stimulated pharmacokinetic research in population kinetics, which requires only a few concentration samples of each individual. Using historical maprotiline data, the new approach of population kinetics was investigated and compared to individually estimated kinetics. Two different population kinetic methods were applied. The naive approach, a quick and dirty method, was compared to the nonlinear mixed-effects method, which was applied by the NONMEM package. Based on the results we obtained from actual maprotiline data as well as from simulated data, NONMEM is a reasonable tool for the estimation of population pharmacokinetic parameters. The main advantage of NONMEM over the naive approach lies in the possibility of obtaining standard deviations of random effects related to the variability between subjects.

Computers↗
PubMedDate not supplied

Cytochromes P450 and experimental models of drug metabolism.

For the development of new drugs, evaluation of drug-drug interactions with already known compounds, as well as for better understanding of metabolism pathways of various toxicants and pollutants, we studied the drug metabolism mediated by cytochromes P450. The experimental approach is based on animal drug-metabolising systems. From the ethical as well as rational reasons, the selection of an appropriate system is crucial. Here, it is necessary to decide on the basis of expected CYP system involved. For CYP1A-mediated pathways, all the commonly used experimental models are appropriate except probably the dog. On the contrary, the dog seems to be suitable for modelling of processes depending on the CYP2D. With CYP2C, which is possibly the most large and complicated subfamily, the systems based on monkey (Maccacus rhesus) may be a good representative. The CYP3A seems to be well modelled by pig or minipig CYP3A29. Detailed studies on activities with individual isolated CYP forms are needed to understand in full all aspects of inter-species differences and variations.

Animals↗
PubMed2004

Vaccines against biologic agents: uses and developments.

Although the Geneva protocol that prohibits the use of chemical and biologic weapons was ratified in 1925, many countries failed to accept this protocol: others stipulated retaliation, and some, like the United States, did not ratify the protocol for decades. This delay allowed the continued development of chemical and biologic agents. Members of the health care community are responsible for determining the best way to protect society from the potentially devastating effects of these biologic agents. Ideally,these diseases would be prevented from ever developing into systemic illnesses. In the past, vaccination has been a successful means of eradicating disease. Vaccines remain a hopeful therapy for the future, but time is short,and there are many obstacles.Information regarding bioterrorism agents and their treatments comes mainly from dated data or from in vitro or animal studies that may not apply to human treatment and disease. Additionally, the current threat of bioterrorism does not allow enough time for accurate, well-designed,controlled studies in humans before the release of investigational vaccines. Furthermore, some human studies would not be safe or ethical. Finally,many members of society suffer from illnesses that would put them at high risk to receive prophylactic vaccination. It is therefore naive to believe that vaccines would be the ultimate protection from these agents. In addition to vaccine development, there must be concurrent investigations into disease management and treatment. Even in instances in which vaccination is known to be an effective means of disease protection. biologic agents may be presented in a manner that renders vaccines ineffective. Virulent strains of organisms may be used, more than one organism may be used in tandem to increase virulence, and strains may be selected for antibiotic and vaccine resistance. Genetically engineered strains may use virulence factors other than those targeted in vaccines, and high concentrations of organisms may overcome vaccine protection. Finally,exposure may not be immediately noted until it is too late to vaccinate, as was the case with anthrax. Even in a case, such as smallpox, in which postexposure vaccination is possible, patients will still develop disease, and the health care system may be overwhelmed. The United States government has been defensively planning and researching the use of vaccines and chemoprophylaxis against any potential biologic agents since at least 1953, and resources are still lacking. There are inadequate stockpiles of vaccine to protect the entire population. The pharmaceutical industry also lacks a means of mass producing vaccines ina short timeframe. There is no policy in place for the use of vaccines that are yet unlicensed and experimental but may be the only therapy in the event ofa terrorist attack. Investigations into these solutions have been instituted only after the September 11, 2001, attacks heightened the awareness of terrorism. Although vaccination is an effective means of prophylaxis and a means of terminating epidemics or treating active disease, there is also resistance from the general public. In some instances there is a lack of acceptance of vaccines, or the risk of side effects is too great. In other cases, a questionable benefit does not justify the expense of mass vaccination. Because of this uncertainty, mass vaccination is deemed an impractical solution to the threat of bioterrorism. Extending vaccination with most vaccines to include all members of society who may be first responders in the event of an attack should be considered. In all instances, the benefit-to-risk must be weighed ratio when deciding how and when to offer preemptive prophylaxis to protect society from a real but unknown threat.

Anthrax Vaccines↗
PubMed2005

If 'atypical' neuroleptics did not exist, it wouldn't be necessary to invent them: perverse incentives in drug development, research, marketing and clinical practice.

Perverse incentives in drug development, research, marketing and clinical usage can be illustrated by considering the example of the so-called 'atypical' neuroleptics which have grown to become a standard - indeed expanding - part of psychiatric practice despite their probable inferiority to older sedative agents. There is now ample evidence to suggest that neuroleptics (aka. anti-psychotics and major tranquillizers) are dangerous drugs, and patients' exposure to them should be minimized wherever possible. This clinical imperative applies whether neuroleptics are of the traditional type or atypical variety, albeit for different reasons since the traditional agents are neurotoxic, while atypicals are mainly metabolic poisons. Usage of traditional neuroleptics seems indeed to be declining progressively, but the opposite seems to be happening for 'atypicals', and new indications for these drugs are being promoted. Yet the atypical neuroleptics are a category of pharmaceuticals which are close to being un-necessary since there are safer, cheaper and pleasanter substitutes, such as benzodiazepines and the sedative antihistamines (e.g. promethazine). If 'atypical' neuroleptics did not exist, it would not be necessary to invent them. Analysis of how such expensive, dangerous and inferior drugs as the 'atypicals' have nevertheless come to dominate clinical practice casts light on the perverse incentives which now motivate the pharmaceutical industry in an era of massive state regulation. The lack of positive incentives to deploy off-patent drugs is longstanding, but there is a new disincentive in the widespread but erroneous belief that only randomized controlled trials (RCTs) can provide valid 'evidence' of effectiveness. Consequently, those who control RCTs now control clinical practice. It sometimes makes commercial sense to develop and market new drugs that are inferior to existing agents, since new drugs are patent-protected and can be promoted on the back of a mass of new RCTs funded and 'owned' by the pharmaceutical corporations. The current regulatory and patenting situation, therefore, requires major reform if drug efficacy and patient safety are to become higher priorities. Given that psychiatric practice is apparently 'locked-in' to prescribing atypicals, and if (as seems likely) most informed individuals would wish to avoid neuroleptics for themselves and their loved-ones except as a last resort; then in the short-term it may be wise for patients and their families to explore the possibilities of increased self-management of psychiatric problems using over-the-counter drugs, such as the sedative antihistamines. In the long-term, there need to be legal reforms to change the regulatory and commercial framework of incentives relating to drug development. These might include new forms of short-term re-patenting of old drugs.

Antipsychotic Agents↗
PubMed1994

Canadian marketing codes: how well are they controlling pharmaceutical promotion?

Pharmaceutical promotion in Canada is controlled by two codes: a voluntary one developed by the Pharmaceutical Advertising Advisory Board dealing mostly with printed promotional material, and one from the Pharmaceutical Manufacturers Association of Canada covering other forms of promotion. This article looks at enforcement of the provisions of these codes and at areas in which they are deficient. One of the major weaknesses in both codes is their lack of effective sanctions for companies that violate their provisions. Strong codes are necessary because many physicians rely heavily on promotional material for their source of prescribing information. However, voluntary codes or codes developed by the industry are inherently weak and lack effective enforcement mechanisms. Although the U.S. Food and Drug Administration is currently very active in curtailing promotional excesses, government control is not the solution since regulatory action will depend on the ideological position of the head of the regulatory body and/or the party in power. An independent body backed by legislative authority is preferable.

Advertising↗
PubMed1994

Clinical trials -- a brave new partnership: a response to Mrs. Thornton.

In this commentary on the previous paper it is explained that screen-detected Duct Carcinoma In Situ is effectively a new disease of unknown natural history. It is therefore impossible that 'the doctor knows best' and it is therefore both in the patient and the public's best interests that such cases are submitted to the rigours of the randomised controlled trial. Inevitably this brings the ethical dilemma of how to explain to patients the uncertainty and how to involve them in a rational decision to take part in the randomised controlled trial. It is argued that as well as there being a collective benefit for future generations of women, that we should resolve this problem now, the individual woman is likely to benefit from being treated according to a strict protocol. Nevertheless the time of diagnosis is paradoxically not the best time for a patient to become aware of these matters and it is about time that the lay public and the opinion formers recognized their responsibility to become acquainted with the benefits and the needs of the randomised controlled trial in anticipation of the day when they themselves will be patients.

Breast Neoplasms↗
PubMed2006

Quality assessment of published health economic analyses from South America.

BACKGROUND: Health economic analyses have become important to healthcare systems worldwide. No studies have previously examined South America's contribution in this area. OBJECTIVE: To survey the literature with the purpose of reviewing, quantifying, and assessing the quality of published South American health economic analyses. METHODS: A search of MEDLINE (1990-December 2004), EMBASE (1990-December 2004), International Pharmaceutical Abstracts (1990-December 2004), Literatura Latino-Americana e do Caribe em Ciências da Saúde (1982-December 2004), and Sistema de Informacion Esencial en Terapéutica y Salud (1980-December 2004) was completed using the key words cost-effectiveness analysis (CEA), cost-utility analysis (CUA), cost-minimization analysis (CMA), and cost-benefit analysis (CBA); abbreviations CEA, CUA, CMA, and CBA; and all South American country names. Papers were categorized by type and country by 2 independent reviewers. Quality was assessed using a 12 item checklist, characterizing scores as 4 (good), 3 (acceptable), 2 (poor), 1 (unable to judge), and 0 (unacceptable). To be included in our investigation, studies needed to have simultaneously examined costs and outcomes. RESULTS: We retrieved 25 articles; one duplicate article was rejected, leaving 24 (CEA = 15, CBA = 6, CMA = 3; Brazil = 9, Argentina = 5, Colombia = 3, Chile = 2, Ecuador = 2, 1 each from Peru, Uruguay, Venezuela). Variability between raters was less than 0.5 point on overall scores (OS) and less than 1 point on all individual items. Mean OS was 2.6 (SD 1.0, range 1.4-3.8). CBAs scored highest (OS 2.8, SD 0.8), CEAs next (OS 2.7, SD 0.7), and CMAs lowest (OS 2.0, SD 0.5). When scored by type of question, definition of study aim scored highest (OS 3.0, SD 0.8), while ethical issues scored lowest (OS 1.5, SD 0.9). By country, Peru scored highest (mean OS 3.8) and Uruguay had the lowest scores (mean OS 2.2). A nonsignificant time trend was noted for OS (R2 = 0.12; p = 0.104). CONCLUSIONS: Quality scores of health economic analyses articles published in South America were rated poor to acceptable and lower than previous research from other countries. Thus, efforts are needed to improve the reporting quality of these analyses in South America. Future research should examine the region's level of expertise and educational opportunities for those in the field of health economics.

Economics, Medical↗
PubMed1991

Commentary on "Sedation before ventilator withdrawal.

In any important article in the field of clinical ethics, the focus should not be on the specific case example, but rather on the issues it presents for thought and discussion. Barbara Springer Edwards and Winston M. Ueno achieve this end admirably. They present a terminally ill patient who requested termination of ventilator support, despite the overwhelming odds that he would die as a result. The authors ask whether or not the physician acted appropriately in accommodating the patient's wish and in sedating him to decrease suffering in his last moments. They present compelling arguments that sedation was warranted in this case. They also note correctly that competent patients have the right to refuse treatment. However, in addition to the question of sedation, this case raises other important issues, specifically those related to pain management and depression in the terminally ill....

Depressive Disorder↗
PubMed2006

Prediction of maximum exposure in poor metabolizers following inhibition of nonpolymorphic pathways.

Marked increases in exposure of some substrates have been noted in poor metabolizers given inhibitors of nonpolymorphic enzymes. Among the small number of clinical trials conducted to investigate this problem, a wide variation in the degree of maximum exposure ratios (area under the curve in poor metabolizers in the presence of inhibitor/area under the curve in extensive metabolizers) among the different substrates has been reported, with some trials reporting profound increases (> tenfold), and others demonstrating less remarkable changes (< twofold). The conduct of such trials raises safety concerns for the trial participants, in addition to other ethical and logistic concerns; therefore, the possibility was investigated that maximum exposure (area under the curve in poor metabolizers in the presence of an inhibitor) could be predicted, and that substrates susceptible to large increases in exposure could be identified. Existing clinical trials were identified by data mining the literature. A theoretical approach was developed to predict maximum exposure in poor metabolizers from studies in extensive metabolizers treated with an inhibitor of the nonpolymorphic pathway. Maximum exposure was predicted in eleven instances and the mean percentage difference between predicted and observed was 11.9%. Substrates with a fraction of substrate dose metabolized by the polymorphic enzyme (fm(POLY)) higher than 75% are at greater risk of exhibiting maximum exposure ratios of more than tenfold.

Algorithms↗
PubMed2007

What's next in translational medicine?

Translational medicine is the integrated application of innovative pharmacology tools, biomarkers, clinical methods, clinical technologies and study designs to improve disease understanding, confidence in human drug targets and increase confidence in drug candidates, understand the therapeutic index in humans, enhance cost-effective decision making in exploratory development and increase phase II success. Translational research is one of the most important activities of translational medicine as it supports predictions about probable drug activities across species and is especially important when compounds with unprecedented drug targets are brought to humans for the first time. Translational research has the potential to deliver many practical benefits for patients and justify the extensive investments placed by the private and public sector in biomedical research. Translational research encompasses a complexity of scientific, financial, ethical, regulatory, legislative and practical hurdles that need to be addressed at several levels to make the process efficient. Several have resisted the idea of supporting translational research because of its high costs and the fear that it may re-direct funds from other biomedical disciplines. Resistance also comes from those more familiar with traditional clinical research methods. In this review, we argue that translational research should be seen as enabled by ongoing efforts in basic and clinical research and not competing with them. Translational research provides the knowledge necessary to draw important conclusions from clinical testing regarding disease and the viability of novel drug mechanisms. Advancing translational research requires education and new sources of funding. This could be achieved through public and congressional education by a joint coalition of patients' advocacy groups, academia, drug regulatory agencies and industry.

Animals↗
PubMed1984

Informed consent: a crucial step in cancer patient education.

Informed consent is an issue of major importance for cancer patients and for the practitioners who treat them. Recently, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research emphasized the educational goals of the consent process. Nevertheless, past research confirms that these goals are difficult to attain. In this paper, we present an overview of informed consent and describe a study of informed consent to cancer treatment conducted at the Fox Chase Cancer Center in which the consultation between the patient and physician (and/or other health professional) was observed and patients were interviewed. On the average, patients recalled less than 40% of what they were told. Patients who were told more items recalled more; however, they recalled a smaller proportion of what they were told. Several implications for health education are drawn from the study results.

Cognition↗
PubMed2000

Prodromal schizophrenia and atypical antipsychotic treatment.

Early recognition and intervention in psychosis is the focus of more intensive research. In this paper, we critically review the ideas that have emerged in this field. We also propose a model or hypothesis for testing in the prodromal phase of schizophrenia. Attention to practical and ethical issues, particularly with the use of atypical antipsychotics in one arm of the protocol, is addressed. Studies by Yung and Falloon describe prodromal intervention with psychosocial strategies and time-limited low potency neuroleptics, respectively, that suggest benefits of such a model. Although we have respect for the DSM system, this paper is written more from a Bleulerian than Kraepelinian perspective in that we emphasize affective, cognitive, and negative symptoms in addition to positive symptoms. The paper recognizes the strong conceptual disagreements implicit in this area stemming not only from Kraepelin and Bleuler but work from the 1930s by Cameron. The clinical research advocated is timely in that the atypicals are more congruent to the Bleulerian conception with a neurodevelopmental hypothesis of schizophrenia. We also have exciting new imaging and genetic technologies to refine our concepts of schizophrenia and its prodromal and premorbid phases.

Age of Onset↗
PubMed1991

The registration and control of medicines in South Africa: legal issues.

In the provision of health care medicines occupy a central position, both at primary and more advanced levels. Sound medicines have the capability to control and prevent common diseases, and to alleviate suffering. People's confidence in the health services that are provided by the state and by the private sector (as the case may be) is influenced by their knowledge that the medicines that they receive are of good quality and proven efficacy and safety, and that they are continuously available at reasonable cost. A sound national policy for the provision of safe and cost-effective medicines needs to be based on several elements. The most important are: A sound pharmaceutical industry that is able to function in an atmosphere of confidence, with the knowledge that its efforts in support of the public health are understood and respected; and a drug regulatory authority that is trusted for its expertise, independence and integrity. This is as true for a country such as South Africa as it is for a fully industrialised country such as the United States. The regulation and control of medicines in South Africa falls under the aegis of the Medicines Control Council, a statutory body established in accordance with the Medicines and Related Substances Act. In terms of the Act, the council has the mandate to ensure that the medicines available to the South African public are safe, effective, and of high quality, and that their availability is in the public interest. In considering this, the council may take into account only the scientific data available.(ABSTRACT TRUNCATED AT 250 WORDS)

Confidentiality↗
PubMed2002

[Physicians--victims or promoters of corruption?].

According to the media the recent physician bribery scandal in Germany draws ever further sets. The public prosecutor determines against hospital physicians and coworkers of a pharmaceutical firm. The suspicion: Physicians were recompensed for using up medicines particularly with pleasure trips. Which is qualified in Germany regularly as bribery and advantage grant as well as aid for tax evasion, is punishable in Austria as unfaithfulness, gift acceptance as well as bribery. The following contribution lights up--from Austrian view--the criminal page of the narrow burr between permitted sponsoring and undue corruption in the medicine. Bribery is globally punishable in Austria. Allowances to physicians can be for the payee in particular gift acceptance (section 153a StGB) or gift acceptance by leading employees of a public enterprise (section 305 StGB), for the giver in particular bribery (section 307 StGB). Occasional allowances, which are not located in connection to a concrete business, but only promoted the sympathetic consideration of the recipient, are not usually punishable. The punishing frameworks for offensces reach up to three years imprisonment. In addition still the absorption of enriching comes (section 20 StGB).

Conflict of Interest↗