Search

It has been 3 years since the American Society for Clinical Pharmacology and Therapeutics (ASCPT) issued a position statement regarding dietary supplement safety and regulation. I was the Chair of the ASCPT task force charged with issuing the statement. At the time, after careful review of available data, the other members and I concluded that dietary supplement legislation in the United States was lacking and that enhanced oversight was essential to increase the safety of these products for the American consumer.

The relative added value of a drug is currently evaluated in France by the Transparency Commission (TC) of the National Health Authority (HAS), by assigning a level of Improvement in Actual Benefit (IAB). IAB is based on two parameters, efficacy and safety of the product, in a defined target population, either as compared to one or more other drugs with similar indications, or within therapeutic strategy. The items used for evaluation, including the level of clinical effect, the relevance of the comparator, the choice of comparison criteria and the methodology used (indirect comparison, non-inferiority studies, etc.), have been reviewed by the working group in Giens with regard to an analysis of the opinion on TC issued between 2004 and 2007 in several therapeutic areas First of all, this attempt at rationalisation based on the criteria used to assess the relative added value demonstrated the rareness of direct comparative data, and was followed by a discussion on the possible broadening of the evaluation criteria. The group discussed taking into account the Public Health Impact (PHI), which has now been incorporated into the assessment of Actual Benefit (AB). The group believes that PHI seems to be more related to the notion of IAB than to that of AB. Indeed, it is frequently the relative added value of a new drug that produces an impact in public health. Conversely, considering the comparative evaluation criteria of PHI, which are not systematically taken into account in IMSR (such as improvement in the health of the population, meeting a public health need or impact on the healthcare system), PHI could legitimately be included in the assessment of the relative added value of a drug. Other parameters such as compliance or impact on professional practice have been considered. Thus, the notion of relative added value, evaluated at initial registration, could be based on an expected improvement in medical service. The notion of expected medical service leads to the requirement of producing additional data in real life (post-registration studies), which would support the definitive notion of improvement in actual benefit at the time of renewed registration, while taking into account the place occupied by the drug in the therapeutic strategy.

A cosmetic is classically defined as any preparation that is applied to the skin, eyes, mouth, hair or nails for the purpose of cleansing, enhancing appearance, giving a pleasant smell or giving protection. Unlike drugs, which are used to treat or prevent a disease in the body, cosmetics are not thought to change or affect the body's structure or functions. However, the distinction between drugs and cosmetics is sometimes not clear. Regulations for cosmetic products primarily address the safety of products that may be used by large populations of healthy consumers. However, the efficacy and safety of cosmetic products are not reviewed or approved by national authorities before they are sold to the public. The identification and analysis of adverse effects related to cosmetic products is a process that is currently still, to a large extent, industry driven. It is the responsibility of manufacturers to determine that products and ingredients are safe before they are marketed, and then to collect reports of adverse reactions. However, although the manufacturers do their best to monitor the safety profile of their products, we should consider that there is always a potential inherent conflict of interest.

Harmonization of the market for herbal medicines is a fundamental requirement for European industries and health professionals and it will also be useful for consumers. Herbal medicines are generally sold as food supplements, but a common regulatory status in the various European countries does not exist. As a consequence, information on clinical indications for use, efficacy and safety are influenced by different opinions, according to the clinical or traditional experience of various folk medicines available in each European country. The European Directive 2004/24/EC released in 2004 by the European Parliament and by the Council of Europe provides the basis for the use of herbal medicines in Europe going forward. The Directive establishes that herbal medicines released in the market need authorization by the national regulatory authorities of each European country and that these products must have a recognized level of safety and efficacy. The safety of herbal medicinal products will be evaluated on the basis of existing scientific literature (data from clinical studies, case reports, pre-clinical studies). When data on safety are not sufficient, it will be communicated to consumers. According to the criteria of safety and efficacy, we will have two kinds of herbal medicinal products in the future: (i) 'well established use herbal medicinal products' (medicinal herbs with a recognized level of safety and efficacy); and (ii) 'traditional use herbal medicinal products'. The later category will include those medicinal herbs that do not have a recognized level of efficacy but are acceptably safe. Even though the fundamental objective of the new European herbal legislation is the harmonization of the market of herbal medicines, important regulations have been introduced, which will contribute to safer use of herbal substances if adopted by the whole of the European community.

Illegal substance use is a serious problem all over the world. In order to effectively combat substance abuse it is important that both the particular features of drug users and the culture-specific risk factors that go along with drug abuse be identified. The present study was carried out in Bursa, Turkey, in order to document annual changes in the frequency of felons arrested of narcotics offenses and to establish the socio-demographics of these narcotics felons. Among the 2,230 narcotics felons reviewed, 24.3% had been charged with drug dealing but not consumption (profit-driven felons [PDFs]), 19.0% were narcotics felons charged with both dealing and consumption ([hard core drug users HCDUs]), and 56.7% were narcotics felons charged only with consumption and possession (not so hard core drug users [NHCDUs]). The NHCDUs were younger (< 30 years) than both the HCDUs and PDFs, while most of the PDFs and HCDUs were married. Despite the fact that the male/female ratio of the Bursa population was nearly 1:1 for the past 30 years, 93.0%, 95.0% and 96.0% of the PDFs, HCDUs, and NHCDUs, respectively, were male. It was also found that the most commonly used illicit substance in Bursa over this period of time was cannabis. Over the course of the 30-year period examined, the annual incidence rate of narcotics felons arrested increased from 0.4257 per 10,000 to 1.2389 per 10,000. Determining the socio-demographic characteristics of HCDUs and NHCDUs would be useful in preventing substance use before substance users become addicted.

In India, a million people with cancer and an unknown number of people with other incurable and disabling diseases, need opioids for pain relief. Only about 0.4% of the population in need have access to them. Major barriers to access to opioids are complicated regulations and problems related to attitude and knowledge regarding pain relief and opioids among professionals and the public. The Pain and Policy Studies Group at Madison Wisconsin has been collaborating with many Indian palliative care workers and government officials to improve availability of opioids to those who need them for pain relief. As a result of this collaborative effort, the Government of India asked all state governments to modify the narcotic regulations following a model given to them. To facilitate the process, the collaboration has conducted workshops in 13 states in association with local champions. Currently, 13 states in India and one union territory have simplified regulations, but opioid availability has improved only in a minority of these states. Establishment of simple standard operating procedures to implement the simplified regulations, advocacy, and improved education of professionals are essential for further improvement of the situation. The past decade has demonstrated that government policy can be changed if palliative care enthusiasts work in tandem with the government. The progress has been slow, but real and encouraging.

In a recent press release Joseph A. Califano, Jr., Chairman and President of the National Center on Addiction and Substance Abuse at Columbia University called for a major shift in American attitudes about substance abuse and addiction and a top to bottom overhaul in the nation's healthcare, criminal justice, social service, and eduction systems to curtail the rise in illegal drug use and other substance abuse. Califano, in 2005, also noted that while America has been congratulating itself on curbing increases in alcohol and illicit drug use and in the decline in teen smoking, abuse and addition of controlled prescription drugs-opioids, central nervous system depressants and stimulants-have been stealthily, but sharply rising. All the statistics continue to show that prescription drug abuse is escalating with increasing emergency department visits and unintentional deaths due to prescription controlled substances. While the problem of drug prescriptions for controlled substances continues to soar, so are the arguments of undertreatment of pain. The present state of affairs show that there were 6.4 million or 2.6% Americans using prescription-type psychotherapeutic drugs nonmedically in the past month. Of these, 4.7 million used pain relievers. Current nonmedical use of prescription-type drugs among young adults aged 18-25 increased from 5.4% in 2002 to 6.3% in 2005. The past year, nonmedical use of psychotherapeutic drugs has increased to 6.2% in the population of 12 years or older with 15.172 million persons, second only to marijuana use and three times the use of cocaine. Parallel to opioid supply and nonmedical prescription drug use, the epidemic of medical drug use is also escalating with Americans using 80% of world's supply of all opioids and 99% of hydrocodone. Opioids are used extensively despite a lack of evidence of their effectiveness in improving pain or functional status with potential side effects of hyperalgesia, negative hormonal and immune effects, addiction and abuse. The multiple reasons for continued escalation of prescription drug abuse and overuse are lack of education among all segments including physicians, pharmacists, and the public; ineffective and incoherent prescription monitoring programs with lack of funding for a national prescription monitoring program NASPER; and a reactive approach on behalf of numerous agencies. This review focuses on the problem of prescription drug abuse with a discussion of facts and fallacies, along with proposed solutions.

Obesity is an epidemic with tremendous impact on both patients and health-care systems globally. This paper explores some of the questions related to the clinical development of new pharmacotherapies in the context of an evolving regulatory perspective. These include patient entry criteria, clinical database size, study designs, weight loss end points (including those for maintenance of weight loss and prevention of weight regain), clinically important patient-reported outcomes, comorbidity/risk factor end points, and challenges in establishing safety and efficacy in adolescent/pediatric patients, and approaches to the development of combination pharmacotherapies. Ultimately, patients, physicians, academia, industry, payers, and governments must continue to partner with regulators to help establish the appropriate balance between the known adverse consequences associated with inadequate treatment of the growing obesity epidemic and the concern for potential unknown risks that may be associated with the long-term use of new pharmacotherapies.

Access to the necessary medications for palliative care, especially opioids, is an essential part in the development of a national palliative care program. In November 2005, Romania's Parliament adopted new legislation concerning the medical use of opioids and psychotropic substances to replace the old and restrictive legislation of 1969. The new law and regulations are the result of a four-year project in which governmental authorities collaborated with health care professionals and international experts. The World Health Organization "Achieving Balance in National Opioids Control Policy--Guidelines for Assessment" was used to propose balanced legislation that would facilitate modern pain management and provide adequate control of these substances with the potential for abuse. A national education program to facilitate the implementation of the new legislation has been organized. The training started in November 2006 and will continue throughout 2007. It is anticipated that at least 3,000 doctors and 500 pharmacists will attend these courses.

Regulatory compliance in the development, production and sale of new drugs accounts for the largest single expense in bringing a drug product to market. To justify developmental and regulatory compliance costs, drug innovators turn to the intellectual property (IP) system to provide a means for securing returns on investment. Because the drug regulatory system in most countries operates in isolation of the IP system, one of the greatest challenges facing the pharmaceutical industry is the extent to which IP rights can be managed against an independent drug regulatory system. Many regulatory bodies in developed countries have sought to ensure a compromise between the rights of generic companies and IP owners by including safeguards in the regulatory framework, such as patent linking and data protection; however, these efforts are yet to be applied in some of the biggest potential drug markets in emerging economies.

The charter of medicines promotion recently adopted by France intends to constrain information given by sales representatives to the field of good prescription practices. Over a 11 year period (1994 to end 2004), 362 interdictions of promotional supports have been decided by the director of the French Medicines Agency. This accounts for 0.5% of the about 80 800 promotional supports controlled during this period. A date base shows the representation of the justifications of these interdictions and the predominance of documentation given or showed to the physicians. A challenge for health authorities would be to assess the actual impact of ethical and non ethical promotion.

Pharmaceutical patents are anachronistic holdovers from an era in which modern economic understanding and tax tools were unavailable. Superior mechanisms lie somewhere between a first best pricing solution for the entire economy at one extreme and the current arrangements at the other. We discuss the economics of suggested alternatives and suggest that the intertemporal bounty is the best way to meet the multiple objectives of immediate distribution at marginal cost pricing of newly innovated patented drugs and easily administered, efficient inducement to continued innovation. The intertemporal bounty prevents the expansion of monopoly power resulting from co-pay or -insurance provisions common to modern prescription drug plans.

Two papers, Legal and Ethical Issues in the Regulation and Development of Engineering Achievements in Medical Technology parts I and II were written in 1990 by three authors of diverse backgrounds and published in the IEEE Engineering in Medicine and Biology Magazine in March of the same year. Part I of the paper discusses the existing Food and Drug Administration (FDA) requirements that existed in 1990 to regulate the clinical trial process for medical devices, obtaining Marketing Approval and exceptions that may allow the use of unapproved devices. The paper discusses how the FDA has loosened some of the stringent regulations to further its goal of encouraging new development while protecting public health and maintaining ethical standards. Part H of the paper focuses on the ethical implications of the process of introducing a new technology to the market place, specifically in the usage of unapproved technologies for emergency use and feasibility studies. This paper discusses the topics covered in the two papers and the changes that have been made to the FDA guidelines since their publication in 1990.

The banned use of antimicrobial growth promoters resulted in a considerably decreased use of antimicrobials in food animal production in Sweden (65%), Denmark (47%), Norway (40%) and Finland (27%). The current prevalence of antimicrobial resistance in animal bacterial populations is also considerably lower than in some other countries in the EU. In the swine production, no or limited effect was found in the finisher production (>25 to 30 kg). Temporary negative effects occurred during the post weaning period (7-30 kg). In Denmark, the cost of production from birth to slaughter per pig produced increased by approximately 1.0 euro with a high variability between pig producers. In the broiler production the termination had no significant negative effect on animal health and welfare or on production economy.