Clinical research: the influence of the pharmaceutical industry.

OBJECTIVE: The aim of the investigation is to throw light on the influence of the pharmaceutical industry on clinical research in Norway. The files of the five regional medical research ethics committees, which contain the application forms and the protocols of all the research projects on humans, were used as source for the statistics. The projects were first classified and registered in two groups: pharmacology/pharmacotherapy and others. Then the pharmacology/pharmacotherapy group was divided into projects sponsored or initiated by the industry and others. RESULTS: In the 3 years 1988-1990, the yearly average number of projects was 360. Sixty-two percent of the projects were pharmacology/pharmacotherapy; seventy-nine percent of these projects were conducted by the industry. The corresponding figures for the year 1997 were 747, 40% and 68%, respectively. We have not been able to find similar statistics from other countries. CONCLUSION: Our conclusion is that research in pharmacology/pharmacotherapy should be more independent of industry.

Survival of patients with squamous cell carcinoma of the supraglottic larynx--thirty-five-year experience with radiotherapy.

A retrospective comparison of treatment policies in two institutions revealed a change in the reliance on radiotherapy. Since 1978, high-energy, high-dosage radiotherapy has played a prominent role in the primary therapy of squamous cell carcinoma of the supraglottic larynx. Statistically, the overall determinate survival rate has improved compared with results during the preceding period, but the death rate from intercurrent disease and second primary cancers has remained unchanged. Improved cancer control and patient survival were restricted to clinical tumor stages III, T4N0, and T4N1. The choice of primary therapy and the radiation dose and fractionation pattern were important variables influencing the survival. A description of the data is followed by a critical analysis of the significance of the findings, in view of the fact that the treatments were performed in two different institutions at different time periods.

Static magnetic field and the inner ear. A functional study of hearing and vestibular function in man after exposure to a static magnetic field.

The sensory cells of the inner ear are vulnerable to several agents (aminoglycosides, cytostatics, ionizing irradiation). The effect of strong magnetic fields occurring in industries with production based on electrolytic processes and with medical magnetic resonance equipment is unknown. The aim of this study was to clarify the effect of strong static magnetic fields on the inner ear, by exposing 11 healthy men to a magnetic field with flux density of 2-7 mT for 9 h. No damage was found to the acoustic or vestibular system.

The nu6 + nnu9 Levels of Dicyanoacetylene.

In addition to the previously observed band system nu6 + (n + 1)nu9-nnu9 with n = 0 to 7, Deltal = 0, and l = n near 611 cm-1, we have identified the nu6 + (n + 1)nu9 - (n + 2)nu9 system with n = 0 to 6, Deltal = 0, and l = n + 2 near 397 cm-1. From these bands the rovibrational levels of the states (v6, nv9) with n < 4 have been determined and spectroscopic parameters have been obtained taking into account rotational and vibrational l-type resonances. Effective anharmonicity constants x69 and g69 have been calculated also for levels with n >/= 4. Copyright 1998 Academic Press.

Recurrence after different primary treatment for cancer of the supraglottic larynx.

Retrospective analysis of patient records at two hospitals was performed with the principal goal of clarifying the role of primary radiotherapy ill patients with squamous cell carcinoma of the supraglottic larynx. Primary surgery was frequently performed during the first period from 1958 to 1978. Primary radiotherapy with surgery in reserve was the prevailing therapy during the second period from 1978 to 1993. Fewer recurrences were observed during the second period. The improved results were apparent mainly in patients with the more advanced stages (III, T4N0 and T4N1). Analysis of many factors suggest that the more frequent choice of primary radiotherapy with surgery in reserve, or applied as preoperative treatment, with optimal dosage and technique, might have contributed to the improved results.

Scientific quality of clinical research. An analysis of 40 research projects in pharmacology/pharmacotherapy.

OBJECTIVE: The scientific quality of research is an important ethical issue. To clarify the quality of research projects in pharmacotherapy/pharmacology, 40 randomly selected research projects in pharmacotherapy/pharmacology submitted to a research ethics committee were reviewed. RESULTS: Eight of the projects would not have contributed new knowledge nor were they necessary as controls for the results of previous research. Fifteen of the research protocols were of good quality, 15 could be used after revisions, and 10 were unfit for use. Eleven of the research projects were not finished 5 years after they were started. A written report was produced from 26 of the projects. Nine were of good quality and could be accepted for publication in a medical journal, 10 of the reports were in need of revision before publication, and 7 should not be accepted for publication. CONCLUSION: Research in this field ought to be improved, and ways to improve the standard of clinical trials in pharmacotherapy are discussed.

The Fundamental Vibrations of NC-CC-CN (Dicyanoacetylene)

In the infrared spectrum of dicyanoacetylene the rotation vibration bands nu1 - nu9/2nu5 - nu9, nu1 + nu9/2nu5 + nu9 (Fermi resonance), nu2 - nu9, nu2 + nu8, nu4, nu6 - nu9, nu6 + nu8 - nu6, nu4 - nu7, nu4 + nu7, nu4 + nu7 - nu7, nu7 + nu8 - nu7, and 2nu7 + nu8 - nu7 (I and II) have been recorded with high resolution. From these bands the vibrational levels v1 = 1, v2 = 1, v4 = 1, v6 = 1, and v7 = 1 including the corresponding effective rotational constants have been calculated. Different methods for calculating the unperturbed position of the v1 = 1 level have been compared and the unperturbed B1 has been calculated. Additional information on the rotational constants of v8 = 1 and v9 = 1 is also given. Copyright 1997 Academic Press. Copyright 1997Academic Press

Squamous cell carcinoma of the respiratory tract following laryngeal papillomatosis.

With the object to disclose an association between laryngeal papillomatosis and laryngeal carcinoma, we reviewed 102 patients with laryngeal papillomatosis treated between 1950 and 1979. Seven cases of laryngeal carcinomas were recorded and 1 patient with spread of papilloma to the bronchial tree developed a bronchial carcinoma. The time between onset of papilloma and diagnosis of carcinoma was 4-55 years (mean 24 years). For laryngeal carcinoma the ratio of observed to expected cases was 88. Of the 8 patients developing respiratory tract carcinoma, 2 had received treatment with radiation and 2 had been treated with Bleomycin. Four of these 8 patients were known smokers. This study shows that papillomatosis is more often associated with laryngeal carcinoma than previously reported. It appears, however, that laryngeal papillomas alone seldom induce carcinomas. Apart from irradiation and smoking, Bleomycin could be an important co-factor.

The value of follow-up in patients treated for squamous cell carcinoma of the head and neck.

Clinical findings, treatment and results have been recorded prospectively in 661 patients with carcinoma of the head and neck. With an average follow-up of 3 years 7813 follow-up consultations revealed 220 recurrences. The overall "recurrence pick-up rate" and subsequent "cure rate" was 1:36 and 1:113 consultations, respectively. Laryngeal carcinomas treated with radiotherapy and oral carcinomas receiving radiotherapy and limited resections showed recurrence "cure-rates" of 1:89 and 1:110, respectively. For other tumour sites the average "cure-rate" was 1:238. Only 39% of the recurrences were detected through physical examination. Follow-up consultations revealed 9.1% of second primaries. More time should be spent on training patients to recognise symptoms and signs of recurrence. Routine follow-up is rarely indicated beyond the third year after completion of treatment, or in patients for whom we have little to offer in terms of curative treatment.

[Laser surgery in otorhinolaryngologic diseases]. / Laserkirurgi ved sykdommer i øre-nese-halsregionen.

This survey is based on our own experiences and a study of the literature. The CO2 laser has certain advantages in the surgical treatment of otosclerosis, both in the primary operation and in reoperation. In rhinal surgery the argon laser has been used with good results in Osler's disease. Laser surgery is not recommended for vasomotoric rhinitis and polyposis. The CO2 laser has improved the quality of treatment of laryngeal papilloma. With high precision and minimal bleeding the postoperative voice is better than with conventional surgery. The CO2 laser can also be used to exstirpate small malignant tumours of the tongue and leukoplasia of the oral mucosa. Healing is rapid and involves relatively little pain. The postoperative functional result is usually good, due to moderate formation of scars.

[Care of hearing in the elderly in Akershus. Use of hearing aids]. / Hørselomsorg blant eldre i Akershus. Bruksfrekvens av høreapparat.

The daily use of hearing aids was investigated in two groups of persons over 70 years of age. One group received only initial instruction in the use of the hearing aid. In this group only six of the 35 patients used their hearing aid every day or on most days. In the other group, which received a further audiopedagogical follow-up, the corresponding figure was 48 out of 61. Better cooperation between the primary health care and ear-nose-and throat-departments/specialists may lead to a better audiopedagogical follow-up of these patients.

[Care of hearing in the elderly in Akershus. Needs and provisions]. / Hørselomsorg for eldre i Akershus. Behov og behovsdekning.

543 persons over 70 years of age and living in Akershus county near Oslo were offered a hearing test at the local health centre. 495 (91%) were tested. The test revealed that 111 (22.4%) needed a hearing aid. 52 (10.5%) of these already had a hearing aid. Most of those who required a hearing aid (97.3%) belonged to the group with subjective hearing problems. It is concluded that good health care for the elderly also includes a hearing test for persons with a hearing problem, and provision of a hearing aid if necessary. It is important that also this part of the health care is provided locally.

[Thyroid carcinoma and the recurrent nerve. Recurrence fall-out, incidence and causal circumstances in a large case-load of patients with thyroid carcinoma]. / Thyreoideakarsinomer og nervus recurrens. Recurrensutfall, forekomst og åraksforhold i et stort materiale av pasienter med thyreoideakarsinomer.

Impairment of vocal cord function is a threat to patients with thyroid carcinoma; either due to the tumor having infiltrated the larynx or the recurrent nerve, or to accidental damage to the laryngeal nerves during thyroid surgery. We have reviewed 1,245 patients' records which were filed under the diagnosis of thyroid carcinoma at Det Norske Radiumhospital from 1956 to 1978. Pareses of vocal cords were noted in 465 patients (37.3%) during the course of their illness. In 135 patients (10.8%) the pareses were due to infiltration by the tumor, most commonly seen in anaplastic carcinoma. In 267 patients (21.4%) the pareses followed surgery; planned resections of the recurrent nerves were performed in 48 patients (3.9%). Transient pareses with normal vocal cord movements within months were experienced in 137 cases (11%). Permanent paralysis caused accidentally during surgery was seen in 82 patients, representing 6.6% of all patients and 4.7% of the surgically exposed nerves. We stress the need for pre- and postoperative evaluation of vocal cord movement as an aid to future diagnosis and optimal surgical planning.

Primary irradiation, surgery or combined therapy in squamous cell carcinoma of the larynx. A comparison of treatment results from two centers.

We compared two groups of patients with squamous cell carcinoma of the larynx. Group 1 consisted of 483 patients treated from 1958 through 1978. Primary surgery was selected in 41% pre- or postoperative radiation therapy in 16% and primary radiation therapy in 43%. Group 2 consisted of 247 patients treated from 1978 through 1983. Primary surgery was selected in only 1.6%, pre- or postoperative radiation therapy in 23%, and primary radiation therapy, with surgery in reserve for residual or recurrent carcinoma, in 76%. Although the results were comparable for patients with early stage tumors in the two groups, significantly higher local-regional tumor control rates and corrected survival rates were recorded for patients with advanced tumors in group 2. More patients survived with a cancer-free functional larynx, the surgical salvage rates were higher, the complication rates and the death rates lower in group 2 compared to group 1.

Treatment of T3 laryngeal carcinoma. Clinical evaluation after 50 Gy, is it of any value?

29 patients with T3 carcinoma of the larynx were evaluated after irradiation with 50 Gy with special emphasis on the mobility of the vocal cord. 10 of the patients with fixation of the vocal cord were assumed to have unsatisfactory response to treatment and were therefore advised laryngectomy. In 4 of the patients the fixation was due to fibrosis. One patient also had a fixed vocal cord, but was discarded from the investigation because of inoperable regional metastases. 18 patients with improved mobility of the vocal cord continued the irradiation to 70 Gy. 6 of these patients later developed local recurrences. It is concluded that the mobility of the vocal cord after 50 Gy is of dubious prognostic value.