Shares in Eli Lilly & Co fell on Friday after an article in a medical journal suggested that the drug maker had long concealed evidence that its well-known antidepressant, Prozac, could cause violent and suicidal behavior.
The accusations were made in yesterday's issue of the British Medical Journal, which said it had turned over documents related to the allegations to the US Food and Drug Administration (FDA).
The FDA was reviewing papers which had been missing for more than 10 years, according to the Journal article, which said they were originally gathered during a lawsuit against Lilly on behalf of victims of a gunman in Kentucky who had reportedly been taking Prozac for a month before going on a rampage.
FDA spokeswoman Kathleen Quinn could not confirm on Friday whether the agency had received the documents mentioned in the medical journal.
But at least one member of the US Congress said he had obtained copies of the documents reportedly given to the FDA.
In a written response, Eli Lilly said: "To our knowledge, there has never been any allegation of missing documents" from lawsuits involving Lilly.
The company also said it tried unsuccessfully to obtain copies of the documents from the British Medical Journal.
"Lilly has consistently provided regulatory agencies worldwide with results from both clinical trials and postmarketing surveillance," including data related to Prozac, the company's statement said.
Eli Lilly's stock fell US$0.75, or 1.3 percent, to US$56.75.
It is unclear what, if any, action might result from the matter. In October, the FDA ordered pharmaceutical companies to include "black box" warnings on the labels of their antidepressants, including Prozac.
The warnings are the strongest restriction the government can impose on pharmaceutical companies, short of banning a drug.
The warnings state that antidepressants increase the risk of "suicidal thinking and behavior in children and adolescents."
British medical regulators have recommended that many antidepressants not be prescribed for children and teenagers, but had not included Prozac in those advisories.
Even if the documents do not prompt legal or regulatory action, they could sully Eli Lilly's image. The company's fortunes have been closely tied to Prozac.
The company has long defended the drug in the face of legal and medical challenges and insisted that it has not suppressed relevant information about the drug.
The report comes at a time of renewed scrutiny of the pharmaceutical industry and the government's process for approving drugs.
US Representative Maurice Hinchey, a vocal opponent of the government's drug-approval process, said on Friday that he had some of the documents cited by the journal article. The congressman, who is a member of the Appropriations Committee, which oversees federal agencies including the FDA, said the documents date back to the 1980s and include memos between Eli Lilly employees.
They "clearly show a link between Prozac and actions of violence perpetrated by people taking the drug against themselves and against others," Hinchey said. "The documents we have show that the company was instructing its employees to hide this information. We're seeing evidence here that it was a conscious act on the part of the company."
‘SWASTICAR’: Tesla CEO Elon Musk’s close association with Donald Trump has prompted opponents to brand him a ‘Nazi’ and resulted in a dramatic drop in sales Demonstrators descended on Tesla Inc dealerships across the US, and in Europe and Canada on Saturday to protest company chief Elon Musk, who has amassed extraordinary power as a top adviser to US President Donald Trump. Waving signs with messages such as “Musk is stealing our money” and “Reclaim our country,” the protests largely took place peacefully following fiery episodes of vandalism on Tesla vehicles, dealerships and other facilities in recent weeks that US officials have denounced as terrorism. Hundreds rallied on Saturday outside the Tesla dealership in Manhattan. Some blasted Musk, the world’s richest man, while others demanded the shuttering of his
TIGHT-LIPPED: UMC said it had no merger plans at the moment, after Nikkei Asia reported that the firm and GlobalFoundries were considering restarting merger talks United Microelectronics Corp (UMC, 聯電), the world’s No. 4 contract chipmaker, yesterday launched a new US$5 billion 12-inch chip factory in Singapore as part of its latest effort to diversify its manufacturing footprint amid growing geopolitical risks. The new factory, adjacent to UMC’s existing Singapore fab in the Pasir Res Wafer Fab Park, is scheduled to enter volume production next year, utilizing mature 22-nanometer and 28-nanometer process technologies, UMC said in a statement. The company plans to invest US$5 billion during the first phase of the new fab, which would have an installed capacity of 30,000 12-inch wafers per month, it said. The
MULTIFACETED: A task force has analyzed possible scenarios and created responses to assist domestic industries in dealing with US tariffs, the economics minister said The Executive Yuan is tomorrow to announce countermeasures to US President Donald Trump’s planned reciprocal tariffs, although the details of the plan would not be made public until Monday next week, Minister of Economic Affairs J.W. Kuo (郭智輝) said yesterday. The Cabinet established an economic and trade task force in November last year to deal with US trade and tariff related issues, Kuo told reporters outside the legislature in Taipei. The task force has been analyzing and evaluating all kinds of scenarios to identify suitable responses and determine how best to assist domestic industries in managing the effects of Trump’s tariffs, he
Taiwan’s official purchasing managers’ index (PMI) last month rose 0.2 percentage points to 54.2, in a second consecutive month of expansion, thanks to front-loading demand intended to avoid potential US tariff hikes, the Chung-Hua Institution for Economic Research (CIER, 中華經濟研究院) said yesterday. While short-term demand appeared robust, uncertainties rose due to US President Donald Trump’s unpredictable trade policy, CIER president Lien Hsien-ming (連賢明) told a news conference in Taipei. Taiwan’s economy this year would be characterized by high-level fluctuations and the volatility would be wilder than most expect, Lien said Demand for electronics, particularly semiconductors, continues to benefit from US technology giants’ effort
RSS