Timothy Rothwell, president and chief executive officer of Sandoz, says the decision was intended to end unwarranted criticism over the indication. "Parlodel is widely used to treat Parkinson's Disease and endocrine disorders," Rothwell says. "It would be unfortunate if the medical benefits that this product provides in those areas are overshadowed by attacks on Parlodel's use in the post-partum indication that have no scientific foundation."
Public Citizen argued that a ban was needed because of "an ever-increasing number of serious injuries such as strokes and heart attacks including many deaths in otherwise healthy young women associated with the use of Parlodel." Public Citizen said that from Parlodel's approval as a lactation suppressing drug in 1980 to June 1994, there have been 531 adverse reaction reports in women aged 15 through 45 who have used the drug, including 32 deaths.
"Although Sandoz, the manufacturer of Parlodel, must bear primary responsibility for this tragedy," wrote Public Citizen Heath Research Group Director Dr. Sidney Wolfe, "the FDA has clearly been complicit in allowing these deaths and injuries to continue."
But Rothwell said that the safety of Parlodel as a lactation suppression product has been demonstrated by independent studies and a review of data from millions of patients. "The post-partum lactation indication has never generated significant revenues for Sandoz, but we felt that women who needed this product should, in consultation with their doctors, have the choice available," Rothwell said.
Each year at least 300,000 women take Parlodel for treatment of post-partum breast engorgement, at a return to Sandoz of approximately $12.5 million a year.
Under the Federal Election Campaign Act, foreign nationals, including foreign companies, are prohibited from making contributions or expenditures in connection with any U.S. federal, state or local election. U.S. candidates are also prohibited from accepting contributions from foreign nationals.
The FEC investigated campaign contributions to Hawaiian gubernatorial candidates, Honolulu mayoral candidates and various Hawaiian State House and Senate campaign committees. The prohibited contributions came primarily from domestic subsidiaries and partnerships of Japanese businesses.
"The Commission's interest in this issue is not limited to Hawaii, and is not focused on any one nationality or ethnic group," FEC Chairman Trevor Potter says. "This case is important for any state with large levels of foreign residents or business activity."
The FEC probed more than $300,000 illegally flowing into more than 140 campaigns over four election cycles. The FEC reached a total of 18 conciliation agreements with 26 respondents, with penalties ranging from $125 to $38,000. Candidates who received the contributions were admonished by the FEC for accepting them, and were instructed to refund all such contributions, but the FEC fell short of fining the candidates.
The top foreign companies that contributed were: West Beach Estates, a domestic subsidiary of a Japanese corporation, which contributed $80,295; Haseko (Hawaii), Inc., a domestic subsidiary of a Japanese corporation, which contributed $60,830; and Y.Y. Valley Corp, a Hawaiian corporation owned by several Japanese companies, which contributed $60,390.
Perc affects the central nervous system and is linked to liver and kidney damage, bladder and liver cancer and leukemia. State health officials estimate that about 99,000 people may be exposed to indoor perc pollution from dry cleaners, 92 percent of whom live or work in the same building as a cleaner.
"Dry cleaners in New York City release about five million pounds of this toxic chemical into the air every year," Public Advocate Mark Green says. "They illegally dump an estimated 3,000 gallons into City sewers. We should go beyond the pending state regulations to adopt new cleaning procedures, such as æwet cleaning,' which do not require perc and can mimic hand washing. We should also prohibit new perc-based dry cleaning in residential buildings."
Green recommends further restrictions on perc, and has called for state and city agencies to assist small dry cleaners who will be faced with significant expenses in complying with the new regulations, which will require modernizing equipment and air testing. "Without appropriate assistance, many dry cleaners will either be forced to close or will continue to operate in a way that compromises public health," Green says. "The State and the City should immediately develop a plan that will address the very real health and economic issues that affect the industry. The manufacturers of perc, including Dow Chemical Company, should contribute to help these firms."
New York City is unique because nearly 40 percent of dry cleaners are in residential buildings, compared to 6 percent in the rest of New York State, where fumes, due to poor ventilation, antiquated equipment or careless storage, pose a risk for apartment dwellers.
- Russell Mokhiber