U.K. distributor pulls Norplant; U.S. holds firm
While sales of the Norplant implant will be discontinued in October by its United King dom pharmaceutical distributor, the Philadelphia-based company charged with sales in the United States affirms its continued support of the contraceptive method.
"The Norplant System is an important part of Wyeth-Ayerst’s contraceptive franchise," says company spokeswoman Audrey Ashby. "A safe and effective product, it is an attractive option for many women seeking a safe and effective long-term contraceptive."
U.K. distributor Hoechst Marion Roussel AG of Frankfurt, Germany, says its decision resulted from the "ongoing dispute between doctors and the government over funding of new contraceptive technologies, and a four-year trial by media’ associated with failed litigation against the company." The result of these two actions affected U.K. sales to a point where the product is no longer commercially viable, according to the company.
Hoechst Marion Roussel stresses that its decision is purely commercial, and its confidence in the safety and efficacy of the method remains unchanged.
"I think this action reduces choices, particularly for older women," says Pramilla Senanayake, MD, PhD, assistant director general of the International Planned Parenthood Federation in London. "Norplant is a good method and has been endorsed by our international medical committee as a safe and effective form of birth control."
Research on the progestin-only implant system spans more than 30 years, according to a chronology prepared by its developer, the Population Council in New York City. Leiras Oy of Turku, Fin land, holds the worldwide license for the implant’s manufacture and distribution. The method is now available in more than 60 countries, with more than 6 million users worldwide. Nor plant received U.S. market clearance from the U.S. Food and Drug Administration (FDA) in 1990.
"This is a safe and effective method, reaffirmed by the FDA in a 1995 Talk Paper,"1 says Sandra Waldman, Population Council spokeswoman. "We regret that women in the United Kingdom will not have this contraceptive choice after October."
Use of the Norplant System, which was launched in the United Kingdom in 1993, leveled off at 55,000 in 1995 after a dispute arose between the British Medical Association and the National Health Service Executive. The two London-based organizations clashed over adequate fees for counseling and insertion of the implant system, and to date they have not settled their differences, according to Hoechst Marion Roussel.
A compensation claim by 275 British women over alleged side effects of the implant system also was filed in 1995, touching off a flurry of media stories. According to Hoechst Marion Roussel, the claims represented less than half of 1% of U.K. users yet generated more than 400 adverse media reports.
The lawsuit was abandoned earlier this year after the Legal Aid Board in London withdrew funding.2 The claim would have been the first attempt under the Consumer Protection Act of 1987 to put a prescription-only medicine on trial as a defective product.2
Unholy alliance’ blamed
"This is a very unfortunate additional attack on Norplant, comparable to what occurred in the U.S.," observes Allan Rosenfield, MD, dean of the school of public health at Columbia University in New York City. "In the end, here, none of the cases went anywhere." (The only U.S. jury trial of the Norplant system ended in September 1998, with the jury finding for Wyeth-Ayerst. For details, see Contraceptive Technology Update, November 1998, p. 151. Several other claims have been dismissed. See CTU, July 1997, pp. 87-88.)
Hoechst’s public announcement of its U.K. sales decision lays blame at the feet of what the company terms an "unholy alliance’ of bureaucrats, lawyers, and the media.
"It raises serious questions as to who in the end decides which products survive on the UK prescription market — hitherto the province of doctors and patients," states the company’s prepared media release. "One has to ask whether the UK healthcare environment, with its reluctance to invest and its mushrooming U.S.-style litigation culture, really wants new technologies — despite clear benefits to the user and the NHS [National Health Service]."
Although the decision by Hoechst Marion Roussel to discontinue Norplant sales was termed "disappointing" by Toni Benefield, director of information for the London-based Family Planning Association, U.K., she points out that women will be able to use Implanon, a new single-rod implant system from Netherlands-based N.V. Organon, when it becomes available later this year.
The single-rod subdermal implant, which contains the progestin etonogestrel (3-keto- desogestrel), is inserted under the skin using a nonsurgical approach.3 Results from a nine- center clinical trial of the method indicate that Implanon has excellent contraceptive action during its three-year lifetime.4 The most frequently reported complaints with Implanon include acne, breast pain, headache, and weight gain, with weight gain and acne cited most often as reasons for discontinuation.5
Will media hysteria’ affect availability?
While the advent of a new contraceptive does represent an additional choice, family planners wonder about the impact of the discontinuation of an already-established method.
"I have been inserting more Norplants lately, and patients who are well-counseled about the method do very well," notes Sharon Schnare, RN, FNP, CNM, MSN, a Seattle-based family planning clinician and consultant who provides family planning education on an international basis. "I see very few side effects, especially when compared to DMPA [depot medroxyprogesterone acetate], and I am very concerned that media hysteria without factual information about Norplant will again ruin the availability of the most effective birth control method on the planet."
References
1. McLearn D. Norplant update. FDA Talk Paper. Rockville, MD: Food and Drug Administration; T95-42. Aug. 17, 1995.
2. Dyer C. Legal suit over Norplant collapses. BMJ 1999; 318:485.
3. Blaney CL. New approaches seek greater safety, appeal. Network 1995; 15:26-29.
4. Croxatto HB, Urbancsek J, Massai R, et al. A multicentre efficacy and safety study of the single contraceptive implant Implanon. Implanon Study Group. Hum Reprod 1999; 14:976-981.
5. Urbancsek J. An integrated analysis of nonmenstrual adverse events with Implanon. Contraception 1998; 58(6 Suppl):109S-115S.
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