EU medical disciplinary hearings can be in public

Australian Medical Association opposes The Australian Medical Association has softened its hitherto firm policy regarding the right of members to individually set their own level of fees. In its national newsletter, Australian Medicine (Sept 18, 1995), the Association announced four resolutions made by the federal council at its August meeting: .the Association will publish a list of "fair and reasonable fees which shall not be exceeded unless the circumstances are exceptional and justified"; .the federal government allow, and the private health insurance industry cater for, cover at the level of the capped fees; . wherever possible, doctors give patients advance notice of proposed fees; and .the AMA’s fee-setting decisions be open to public input and criticism, consistent with patient confidentiality. Surgeon Don Sheldon, chair of the AMA’s council of procedural specialists, opposed the resolution on the grounds that "the ability to set fees was a fundamental sign of professionalism", according to Australian Medicine. The feecapping motion is said to have been prompted by a consensus between AMA pragmatists and the private health insurance industry, in response to the

enactment,

in

managed care

May, of managed-care

EU medical

disciplinary hearings can be in public

principles (Health Legislation [Private : A case in the Court of Human Rights in Health Insurance Reform] Amendment Strasbourg has raised the issue of whether : medical disciplinary hearings in the EuroAct). The political intent of the Act was said pean Union should be heard in private. to be to stop the continuing defection of In a judgment delivered on Sept 26, the people from private health insurance, Court opined that "while the need to prowhich would proportionately increase the tect professional confidentiality and the financial pressure on Medicare, already private lives of patients might justify hold: ing proceedings in camera, such an occurfinancially defunct for years. The federal AMA has the unanimous rence had to be strictly required by the : in the support of its State branches in opposing care. In August, AMA federal council resolved that "in view of overseas experience, doctors should refuse to enter all provider contracts with health insurance funds". In September, federal AMA v president David Weedon launched a national campaign against the concept. The campaign, which would focus on elderly consumers, "would warn the public about inherent problems with managed care, namely lack of choice [of : doctor and hospital], higher premiums for private health insurance, and compromised care". :

circumstances". However, case before the Court, the contested disciplinary proceedings were to deal only with a : "method of consultation by correspondence" on the part of the applicant, Dr Marcel Diennet, a general practitioner in Paris. The Court’s judgment commented that breaches of confidentiality were : unlikely, but "If it had become apparent : during the hearing that there was a risk of a breach of professional confidentiality or : an intrusion on private life, the tribunal : could have ordered that the hearing should continue in camera". In the event, : the public had been excluded because of : the provisions of a 1948 decree. The case dates back to March, 1984, when the Regional Council of the Ile-dePeter Harrigan France Ordre des Medecins ordered Diennet to be struck off the register for professional misconduct. On appeal, the Poland works towards rational use disciplinary section of the National Council of the Ordre decided in 1985 that he One of Poland’s efforts to encourage reimbursed by state funds, primarily should instead be disqualified from pracrational drug use, a consumer-education because of lack of evidence of tice for 3 years. He challenged this deciHowever, no specific rationale was pubproject, culminated in a seminar on Sept sion in the Conseil d’Etat (the court of 22-24 in Konstancin, near Warsaw. The lished for the drugs on this list and many final appeal on administrative law), which of the drugs were in common use. The project had been funded by the European in 1988 quashed the decision on the Commission and sponsored by the Ministry withdrew the initiative after ground that it had been reached after proPolish Consumer Federation and Health protests from doctors and the public. : ceedings that had been "irregular" and Action International. The Ministry has also had difficulties in : remitted the case to the disciplinary secMonika Skrzypiec of the PCF pointed enforcing controls of drug promotion. tion of the National Council of the Ordre. out that topping the list of the 20 mostAmong the examples given by That section-composed of seven memused drugs in Poland (based on Drug Kuzmierkiewicz, National Pharmaceutibers, three of whom, including the rapInstitute data on number of packages sold cal Inspector and Under-Secretary of porteur, had taken part in the 1985 in 1994), was "Tabletki od bolo glowy", State for Health and Social Welfare, was decision-heard the case in private in how a promotional clip presenting fluoxean over-the-counter analgesic containing April, 1989, and confirmed the 3-year distine as "an antidote to unhappiness" was acetylsalicylic acid, phenacetin, and cafqualification. A fresh appeal on points of feine. It was one of 14 (from the list of telecast as a news item rather than as law was dismissed by the Conseil d’Etat in commercial information. : October, 1990. 20) that were irrational, ineffective, or Several measures have been or are potentially harmful. "We would simply Diennet then took his case to Straslike to ensure that when it comes to being taken to encourage rational drug bourg, claiming contravention of Article 6 use. One is the booklet being produced . the most frequently sold drugs in Poland, of the European Convention on Human we will have the most dangerous drugs by the Institute of Psychiatry and NeurolRights. That Article covers rights to a fair removed", said Skrzypiec. : ogy for general practitioners on benzoand public hearing by an impartial tridiazepine treatment guidelines and bunal. In a preliminary examination, the Tightening of the registration procealternatives to drug therapy. The PCF has Commission of Human dure is needed. 334 new drugs were regisRights expressed, tered in 1994. According to Tadeusz just published an informational "pill box" . in 1994, the opinion that there had been a for consumers containing 12 leaflets, one violation of the right to a hearing in public Chrusciel, of the Polish Chamber of of which has a list of questions that (unanimously) but no violation of the Physicians, "Only 40 of these new drugs patients could put to doctors. And for right to an impartial tribunal (14 votes to represent progress in pharmacotherapy, doctors there will soon be the Polish ; 9). Unable to achieve a friendly settleand 18 are products such as soy lecithin National Formulary, modelled on the ment, the Commission referred the case or combined aminoacids that should not British National Formulary. have been registered as drugs". of the full Court. Earlier this year the Ministry of Health On the question of applicability, the Court judgment said that it was clear that published a negative list of 38 drugs, Barbara Mintzes recommending that they be no longer : disciplinary hearings in which the right to

managed

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drug

efficacy.

Wojciech

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practise was at stake came within the

area

of disputes over civil rights covered by Article 6. The Court reiterated that the holding of court hearings in public constituted a "fundamental principle" of Article 6, although it also provided that the press and public might be excluded from all or part of the trial under special circumstances. The fact that appeals on points of law to the Conseil d’Etat were held in public was not sufficient to

remedy the defect found to exist at the : discerned in the fact that three of the stage of the disciplinary hearings. The : seven members of the disciplinary section Conseil could not be regarded as a judi- : had taken part in the first decision." The Court did not make any order for cial body with full jurisdiction, in particular because it did not have the power to : damages, opining that "the finding of a assess whether the penalty was propor: breach of Article 6 constituted in itself tionate to the misconduct. : just satisfaction." However, costs and

impartiality of the disciplinary : proceedings the Court agreed with the Commission’s preliminary view that "no . ground for legitimate suspicion could be On the

expenses of FFr20 000

Arthur

were

awarded.

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viability is is delivery a related proprietary technology in which the elecwas used (linked to polyethylene glycol) trodes do not come into direct contact Although 600 people have received gene to target liver cells that overexpress the with the cells or their medium (Xi Zhao, therapy, with evidence of considerable benefit in some cases, the technology is folate receptor. The LPD vesicles bind to Incell Inc, Santa Clara, CA). Transducstill primitive. Two dozen researchers folate receptors on the cells, and are tion efficiency and cell viability are from the avant-garde convened at the US internalised, enclosed in endosomes. As extremely high. The device can be operatNational Institute of Health to compare the endosomes undergo their natural ed in a flow-through mode, as for treatnotes on Sept 21-22 with special emphaacidification, the LPD membrane fuses ment of blood that is immediately sis on therapy for the liver and gut. with the endosome membrane, dumping returned to the patient. the contents into the cytoplasm. : LPD resembles artificial virus particles, v In-vivo work on liver and colon Technological refinements : To repair aberrant genes, the mechanism but most gene-transfer experiments use In-vivo gene therapy will require vectors of choice would be homologous recombimodified forms of natural viruses. The targeted to specific cells or tissues, but nation, in which an exogenously supplied complement-dependent destruction, in sometimes anatomy provides the required normal gene finds its mutant homologue human blood, of a commonly used retroselectivity. Colonic epithelium can be in the cellular genome, and, by crossing viral vector (murine leukaemia virus) has transduced by using DNA in liposomes, been found to be due to the presence of delivered by enema, as has been done in over, replaces the defective chromosomal natural antibodies to the a 1-3 galactose laboratory animals (Carol A Westbrook, sequence with the normal sequence. antigen (Stephen Squinto, Alexion PharUnfortunately, the rate of homologous University of Chicago, IL). Uptake of the recombination in human cell experiments maceuticals, New Haven, CT). This antiliposomes efficiently inserts marker genes is only 0-1-1%. To stimulate higher rates gen is not found on the cells of humans or into whatever section of the bowel is irriof homologous recombination with old-world primates, but it is found in virgated. tually all other animals and actively transcribed genes, the desired Expression with Westbrook’s method on viruses packaged in their cells. To lasts only for the lifetime of normal sequence is introduced into the cell in the form of a hybrid oligomer containing the develop murine cell-lines that produce intestinal epithelial cells (a few days). virus lacking the al-3 galactose antigen, Retroviral vectors, delivered to ligated seccorrect DNA sequence linked to its comthe a 1-3 galactosyl transferase can be tion of the mouse small bowel, transduce plementary RNA (Eric Kmiec, Jefferson deleted from the virus-producing mice by epithelial stem cells with marker genes Cancer Center, Philadelphia, PA). Durknockout techniques, or the producer (SusanJ Henning, Baylor College of ing transcription, when the DNA double helix is opened up and RNA is being cells can be transfected with the &agr;1-2 Medicine, Houston, TX). Efficiency is synthesised on the coding strand, the fucosyl transferase, which generates the H low, because stem cells reside within the RNA/DNA constructs tend to find antigen (the type 0 blood antigen), and crypts, access to which is normally blocked by mucus. However, once these blocks the action of the offending galactohomologous human genes and cross over with them much more efficiently than do syl transferase. Unlike other retroviruses, cells are transduced, they continue (for which can be used to transduce human months, at least) to produce progeny cells double-stranded DNA constructs. of DNA Another way into cells only ex vivo in artificial medium, positive for the transduced gene. introducing Several types of selectivity have been made in these modified cells is to make retroviruses cells, lipid-entrapped, polycombined in a treatment for colorectal can be used to transduce human cells in cation-condensed DNA (LPD) (Leaf the presence of blood, and could be used metastases in the liver (Brian E Huber, Huang, University of Pittsburgh, PA). : Glaxo Wellcome, Research Triangle Park, The DNA is sonicated with polylysine (in in vivo. to form small other viral vectors the slight excess), positively Among under NC). The gene for cytosine deaminase, a that T other consideration is with its each SV-40, charged particles repel antigen non-mammalian enzyme, is coupled to therefore do not S When deleted (and aggregate). (David Strayer, Jefferson Med- the promoter for carcino-embryonic antisonicated with excess anionic phosphoical College, Philadelphia, PA). The T gen, which is expressed in colon cancer lipids, these cationic particles form negaantigen is responsible for the transform- but not in normal liver. When introduced into the portal vein, this gene construct is tively charged vesicles, most of which are ing ability of the wild-type, and is essentaken up entirely in the liver, but loaded with DNA. (When naked DNA is : tial for replication. SV-40 is a small sonicated with anionic phospholipids, expressed only in colorectal metastases. double-stranded DNA virus, which is most of the vesicles formed are empty.) Cytosine deaminase converts 5-fluoroeasy to work with, can be concentrated to These negatively charged vesicles are cytosine, which is relatively non-toxic, to very high titres, and can be used either 5-fluorouracil. The use of an enzyme to stable, do not form aggregates (which episomally or as a way of inserting genes a pro-drug in situ, allows high convert would be taken up poorly by cells), and into the host chromosome. It induces litlocal concentration of the active agent, do not contain unnatural cationic lipids tle or no immune response or inflammawhile its minimising systemic toxicity. tion in laboratory animals. (which can be immunogenic). To target vesicles one incorthese to specific cells, Electroporation may be used to deliver Paul M Rowe porates a ligand for some receptor. Folate DNA to cells, but the transduction effi-

Novel gene

ciency

therapies for liver and GI tract

is

typically low,

and cell

poor. Electronic pulse

-

consequently

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