Glaxo Have Been Bullshitting The Public (Us, And The Regulators, And Doctors) About Side Effects Of Their Drugs For (At Least) 30 Years…


From the New York Times 1984:



http://www.nytimes.com/1984/12/14/us/drug-maker-pleads-guilty-over-lethal-side-effects.html

DRUG MAKER PLEADS GUILTY OVER LETHAL SIDE EFFECTS

ALLENTOWN, Pa., Dec. 13— The SmithKline Beckman Corporation has pleaded guilty and two of its medical officials have pleaded no contest to charges of failing to report to the Food and Drug Administration the lethal side effects of the blood-pressure drug Selacryn.

In June the Philadelphia-based pharmaceutical giant and the three officers were charged with 14 counts of failing to file reports with the drug agency of adverse reactions to Selacryn and 20 counts of falsely labeling the drug with a statement that there was no known cause-and-effect relationship between Selacryn and liver damage.

Doctors across the country have reported 36 deaths and at least 500 severe cases of liver and kidney damage linked to Selacryn.

Two top officials of SmithKline’s medical affairs department, Dr. Ralph M. Myerson of Merion, Pa., and Dr. Philip J. Tannenbaum of Broomall, and Dr. Theodore Selby of Haverford, a former official, pleaded no contest Wednesday in Federal District Court here to 14 counts of failing to file reports. The Government indicated it would drop charges against a fourth company official, Dr. Thomas G. Davis. Company’s Guilty Plea

The company pleaded guilty to all 34 charges filed this summer.

Judge Edward Cahn, who heard the pleas at a two-hour hearing, set no date for sentencing.

J. Peter Smith, an assistant United States attorney, said part of the plea- bargain agreement was that the Government would make no recommendation on sentences.

Donald J. Goldberg, Dr. Selby’s attorney, said the individual defendants would withdraw no-contest pleas and go to trial if Judge Cahn decided their sentences would include jail time.

SmithKline faces up to $34,000 in fines, and the individual doctors could receive up to 14 years in jail and $14,000 in fines. But Judge Cahn said community service could be part of whatever sentence he would impose.

The defendants were charged with failure to report to the drug agency within 15 days any unusual adverse effects of a drug.

Selacryn was developed 15 years ago by Anphar Laboratories, a subsidiary of Albert Rolland S. A., a French pharmaceutical company. In 1973, SmithKline obtained a license to develop and sell the drug in the United States.

Drug Won Quick ApprovalThe drug was introduced on May 2, 1979, after an unusually speedy review by the F.D.A. Typically the agency’s approval of new drugs follows clinical tests on up to 1,500 patients. But in April 1979, after Selacryn had been tested on 533 patients, officials of the agency concluded that no further tests were required.

That same month, SmithKline and the three physician-defendants received reports from Anphar Laboratories that Selacryn had damaged patients’ livers. The information was translated from French to English at SmithKline headquarters in Philadelphia in May 1979.

The information was never reported to the drug agency but ”dropped through the cracks,” Mr. Goldberg told Judge Cahn Wednesday. ”There was a very human error here, and there was damage that resulted from it.”

The company and the drug agency removed Selacryn, which was sold from May 1979 to January 1980, from the market after the Federal agency learned of deaths among its users.

Jeremy Heymsfeld, a SmithKline spokesman in Philadelphia, said the company was now involved in 13 outstanding lawsuits involving the drug and had settled numerous other legal cases.

Dr. Sidney Wolfe, executive director of the Public Citizen Health Research Group, founded by Ralph Nader, said SmithKline had already paid $100,000 to $500,000 in out-of-court settlements in numerous cases.


http://articles.chicagotribune.com/1985-01-06/news/8501010952_1_smithkline-fda-selacryn

Drug`s Deadly Side Effects Spark Whodunit

By Tim Weiner, Knight-ridder Newspapers. A

January 06, 1985

ALLENTOWN, PA. — In August, 1979, Dr. Mervyn Lakin of Phoenix, Ariz., fell ill with an inflamed liver, jaundice, chills, a high fever–the classic symptoms of hepatitis. The 45-year-old internist suspected that a prescription drug he was taking was harming him.

Selacryn went on sale across the country on May 2, 1979, after winning approval of the U.S. Food and Drug Administration in near-record time. The drug`s manufacturer, SmithKline Beckman Corp., had high hopes for its new anti-hypertension drug. The company predicted that Selacryn would benefit millions of people suffering from high blood pressure and would produce annual sales of up to $80 million.

But in the eight months it was on the market, Selacryn was linked to at least 36 deaths and more than 500 serious injuries. It created one of the worst pharmaceutical disasters in recent American history.

It was to become the smoking gun in a medical detective story, reconstructed through court documents, testimony and interviews. On Dec. 12, after a 4 1/2-year federal investigation, the story`s penultimate chapter was written in the criminal convictions of SmithKline and three physicians it employed. No sentencing date has been set.

TO SMITHKLINE spokesman Jeremy Heymsfeld, there was a kind of vindication in the case. “After an exhaustive investigation of more than four years, there was no finding that the company acted intentionally, recklessly or for any commercial motive,“ he said.

To Dr. Sidney Wolfe, executive director of the Public Citizen Health Research Group, a public-interest advocacy organization in Washington, it was a corporate crime with a meaningless penalty.

“For a company with 1983 profits of $490 million, a $34,000 penalty is a cruel joke,“ he said. That is the maximum fine that can be levied against SmithKline under the law.

Lawrence McDade, an attorney with the U.S. Justice Department`s office of consumer litigation, said the investigation took place in “an extremely sensitive area–the monitoring of prescription pharmaceuticals. There is a very real risk to the public,“ he said.

“We attempted to establish that individuals would be held personally liable for personal negligence in this area. It is obviously not sufficient for the corporation to plead guilty. Bringing an action versus an individual has a deterrent effect.“

FOR McDADE AND the other federal regulators and lawyers who pursued the case, a tortuous route led to the federal courtroom in Allentown, Pa., where SmithKline pleaded guilty.

In June, 1981, 18 months after the drug was taken off the market, the FDA recommended criminal prosecution of SmithKline. Half a million documents were subpoenaed from the company in the course of the FDA probe and a subsequent two-year federal grand jury investigation.

Earlier this year, Justice Department officials and FDA attorneys agreed that they would not attempt to press felony charges alleging criminal intent on the part of the company and its doctors. Instead, last June, federal prosecutors filed 34 criminal misdemeanor charges against them. Each count is punishable by up to one year in prison and a $1,000 fine.

Under the misdemeanor statutes, the government was required to show only that SmithKline and its doctors had the power to prevent the illegal acts from occurring and failed to do so.

The decision followed heated debate about the proper course to follow, according to persons close to the investigation. If the prosecutors believed there had been criminal intent on the part of the company and the doctors, that could have resulted in felony charges with more stringent penalties, up to three years in prison and $10,000 fines on each count.

BUT THE PATH chosen by the Justice Department led the company to end the lengthy process with a guilty plea, “to get the thing over with and not have it drag on for a couple more years,“ according to an attorney close to the case.

The case ended with the company pleading guilty and the physicians pleading no contest to 14 counts of violating FDA regulations by failing to file timely reports of the information SmithKline had on liver damage and deaths caused by Selacryn.

The company also pleaded guilty to 20 counts of falsely labeling Selacryn with an inaccurate and misleading statement that there was no cause-and-effect relationship between the drug and liver damage.

More than five years ago, Lakin, the Phoenix internist, felt sure that there was such a relationship. In an interview, he said he had placed an urgent call on Aug. 9, 1979, to Dr. Ralph M. Myerson, a group director for medical affairs at SmithKline, which is base

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