Melody Peterson of the New York Times reports that in the first case brought against Bayer involving its anticholesterol drug, Baycol, a senior official of Bayer AG testified in court in Corpus Cristi, Texas. He acknowledged that company officials in Germany proceeded with the marketing of Baycol despite the reluctance of US company officials to do so.
More than 30 people who took the drug died in the US of rhabdomyolysis (rhabdo) before it was withdrawn from the market in 2001.
Internal Bayer company documents reveal a corporate culture among its executives that puts sales above patient safety. The documents reveal that the company was overwhelmed by the avalanche of spontaneous adverse drug reports from doctors: The steadily increasing numbers of spontaneous reports of rhabdomyolysis associated with Baycol, along with the additional telephone activity, has overwhelmed the available safety assurance resources.
Bayers vice president of scientific affairs wrote in an e-mail: Many of the cases are ugly, including reports of dialysis, long hospitalization, disability and two potentially related deaths.
However, the Times reports, even after numerous reports of rhabdo were mounting there is not a real push to find out about statins and rhabdo.
Of greater interest to Bayer officials were its sales. The Times reports that the minutes of a Bayer meeting indicate that Dr. Wolfgang Plischke, president of Bayers North American pharmaceutical division, reiterated the need to drive future sales and his belief that we can achieve blockbuster status.
Inexplicably The FDA obliged Bayer with its marketing strategy that increased fatalities by approving a higher dose formula of Baycol in July 2000: The Times reports that Bayer executives said their goal with the higher dose was to capture 15 percent of the market. At that time, the minutes said, Baycol had 5 percent.
FDA did nothing to protect the public from a lethal drug until Bayer pulled Baycol off the market in 2001 after more than 30 deaths were linked to the drug.
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) http://www.ahrp.org Contact: Vera Hassner Sharav 212-595-8974 e-mail: email@example.com
A senior executive at Bayer testified in court yesterday that company officials in the United States recommended against selling the anticholesterol drug Baycol several years before it was introduced in 1997 because they thought its sales potential was limited.
But Baycol was introduced because officials in Germany, where Bayer is based, decided to push ahead when market conditions improved and the potential for profit looked promising for many years.
Sales of Baycol increased rapidly until Bayer pulled Baycol off the market in 2001 after more than 30 deaths were linked to the drug. The company has been dealing with the aftermath since.
The Bayer executive, Dr. Lawrence Posner, senior vice president for pharmaceutical development, was testifying in county court in Corpus Christi, Tex., in a case brought by a patient who contracted a muscle disorder called rhabdomyolysis after taking Baycol.
It is the first case involving Baycol to go to trial. More than 10,000 patients or the families of those who died after taking Baycol have filed lawsuits against Bayer.
Dr. Posner defended the company for several hours yesterday as lawyers for the plaintiff, Hollis Haltom, 82, introduced dozens of internal company documents into evidence.
He said Bayer had monitored reports of rhabdomyolysis, known as rhabdo, in patients taking Baycol and had properly informed doctors about the risks of the medicine as it learned of them.
But several memos from Bayers safety officials in 1999, made public earlier in the trial, describe how its staff was struggling to respond to an increasing number of reports of patients who had become ill with rhabdo while taking Baycol.
In a memo written on Dec. 30, 1999, and addressed to Dr. Posner, safety officials said they had received reports of 60 cases of rhabdo in the United States in the previous two months. Doctors and others observing people becoming ill or dying while taking a medicine voluntarily file the reports in question, known as adverse event reports, with regulators and the drugs manufacturer.
The steadily increasing numbers of spontaneous reports of rhabdomyolysis associated with Baycol, along with the additional telephone activity, has overwhelmed the available safety assurance resources, the officials, who were not individually identified, wrote.
Philip S. Beck, an outside lawyer for Bayer, said in an interview yesterday that he disagreed that safety officials were ever overwhelmed. The company provided all the manpower that was needed, he said.
One document that lawyers for the plaintiff have mentioned at least twice is an agenda for a meeting of Bayers scientific relations department staff in January 2000. It is covered with handwritten notes, some describing Bayers willingness to study reports of rhabdo before introducing a new higher dose of the drug, which is an anticholesterol medicine known as a statin.
The notes on the agenda say that because Bayer had described the risk of rhabdo in Baycols label, there is not a real push to find out about statins and rhabdo.
The note - by a person not yet identified in court - also says that a safety database has been developed. Some are scared to uncover such data (bad data) because of the launch of 0.8 mg, it says about the higher dose. If F.D.A. asks for bad news, we have to give, but if we dont have it, then we cant give it to them.
Bayer did undertake an internal analysis of the reports of rhabdo cases around that time. In March 2000, Steve Niemcryk, an epidemiologist at Bayer, and Paul Cislo, a database analyst, reviewed the reports of rhabdo that regulators received through June 1999. They said Baycol substantially elevates the risk of rhabdo, compared with similar drugs on the market.
But the analysts also said the magnitude of the problem could not be determined with the available data. The report said the company was talking to health insurers and other organizations with large numbers of patients taking Baycol about doing a better analysis.
Mr. Beck said the study was not scientific. The adverse event reports, he said, say only that a drug may be associated with the side effect, not that it actually caused it.
About that time, Dr. Richard Goodstein, vice president for scientific relations at Bayer, wrote an e-mail message to two dozen Bayer executives working on Baycol in the United States. He said that alleged cases of rhabdo caused by Baycol were coming into his office at a rate of about one a day.
Many of the cases are ugly, he wrote, including reports of dialysis, long hospitalization, disability and two potentially related deaths.
Dr. Goodstein continued, To me, it has never been an issue of, should-if-will we need to respond, but rather to whom, how, what?
It will be too long a time until the potentially helpful results of new epidemiologic/scientific studies envisioned by Bayer World-Wide are completed, he wrote.
In videotaped testimony played for the Corpus Christi jury, Dr. Goodstein said he recalled being worried about the rising reports and said he had discussed with his boss and other Bayer executives whether the analysis by Mr. Niemcryk and Mr. Cislo should be disclosed to doctors. We decided that it was not substantive data, Dr. Goodstein said. We cant have anybody making decisions based on unreliable data.
The documents also indicate that Bayer executives decided to limit the spread of studies with unfavorable findings on Baycols effectiveness.
For example, at a July 1997 meeting of Bayers Baycol publications committee, executives discussed a study comparing cerivastatin, the chemical name for Baycol, to simvastatin, a competing drug. The U.S. did not want to publish this data, since simvastatin did better than cerivastatin and included doses that were lower than those in another study, the minutes said.
Bayer has been largely silent about how important the higher dose of Baycol was to the company. But company documents indicate that Bayer was counting on the stronger pill to increase sales.
According to minutes of a meeting of the U.S. Baycol Project team in July 2000, just before the Food and Drug Administration approved the higher dose of the drug, executives said their goal with the higher dose was to capture 15 percent of the market. At that time, the minutes said, Baycol had 5 percent.
The minutes also say that Dr. Wolfgang Plischke, president of Bayers North American pharmaceutical division, attended the meeting and reiterated the need to drive future sales and his belief that we can achieve blockbuster status.
Pharmaceutical companies often refer to a blockbuster drug as one that reaches sales of $1 billion a year.
When Bayer pulled the drug from the market in August 2001, the F.D.A. said some of the 31 deaths reported had been linked to the stronger pill. Mr. Beck has said that Bayer knew that side effects increased with the higher dose, but that the company began selling it to help people with severe heart problems who needed a stronger medicine.
Another document that lawyers for the plaintiffs have raised repeatedly was created after Baycol was pulled from the market in August 2001. The document is a slide that was presented to top Bayer executives at a global planning meeting in December 2001 that says, DIG; THROW (The Corpse); COVER (With sand).
Lawyers for the plaintiffs say the document is one of many supporting their allegation that Bayer covered up information about the serious risks of Baycol.
But Mr. Beck told the jury that the document - one slide in a set presented to top global Bayer executives - should be disregarded. It refers, he said, to a plan by people at the company who wanted Baycol put back on the market. The author of the slide wished to make the point that putting Baycol back on the market was a bad idea that should be buried, Mr. Beck told the jury.
Copyright 2002 The New York Times Company