What is/was Selacryn?
Selacryn - a drug to combat high blood pressure.
Marketed an manufactured by SmithKline Beckman. **(SKB)
Selacryn was introduced in May 1979 and withdrawn by SmithKline the following January. It lasted just 8 months on the American market.
Why was it withdrawn from the market?
In the United States it was reported that there were 36 deaths and at least 500 severe cases of liver and kidney damage linked to Selacryn.
Should we praise GlaxoSmithKline for withdrawing the drug?
One would think, reading the above, that GlaxoSmithKline (then SKB) acted promptly and swiftly.
Think again.
In June 1984, some 4 years after SKB withdrew Selacryn from the market, they were charged with failing to warn consumers and the Federal Government about the dangerous side effects of Selacryn.
In December 1984 SKB pleaded guilty and three of its medical officials pleaded no contest to charges of failing to report to the Food and Drug Administration the lethal side effects of the blood-pressure drug.
In total there were 34 Federal misdemeanor charges against SKB. They pleaded guilty to all of them.
Three 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 to 14 counts of failing to file reports.
FDA Fast Tracking
Selacryn was developed 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.
Selacryn 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, bizarrely, in April 1979, after Selacryn had been tested on 533 patients, officials of the agency concluded that no further tests were required.
Also, in April 1979, SmithKline and the three company physicians 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.
SKB never reported this. Instead they continued to market the drug for a further 8 months, reaping in the rewards of sales to an estimated 200,000 patients.
The Punishment
In February 1985 Federal District Judge Edward Cahn placed Glaxo on two years' probation and ordered them to give $100,000 to a child abuse program for failing to promptly report the side effects of a Selacryn. He also ordered them to provide 500 hours of community service.
The three company doctors were sentenced to five years' probation and ordered to perform 200 hours of community service.
The company and doctors were charged with failing to promptly file reports of the drug's harmful effects on kidneys and livers with the Food and Drug Administration. They also were charged with falsely labeling the drug with a statement saying no cause-and- effect relationship existed between the drug and liver damage.
Here's what surfaced during the trial.
In August, 1979, 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 so he contacted SKB by placing an urgent call on Aug. 9, 1979, to Dr. Ralph M. Myerson, a group director for medical affairs at SmithKline.
Instead of informing the FDA, SmithKline sent a form letter to Lakin in Phoenix requesting additional information. On Sept. 7, 1979, after receiving a brief report from Lakin describing his original symptoms, Selby classified Lakin`s hepatitis as ``unrelated`` to Selacryn .
On receiving this assessment from SKB, Lakin carried out a 'positive rechallenge' on himself: He stopped taking the drug, and the symptoms of hepatitis disappeared; he resumed taking Selacryn, and they reappeared.
With this finding he, once again, contacted SKB. One day later, according to court records, Selby classified the side-effect as "indeterminate," recommended that no unusual or unexpected reaction be reported to the FDA, and sent his report to Myerson and Tannenbaum.
Lakin's adverse reaction report, along with 11 other cases of Selacryn-related liver damage was buried deep in the third volume of a routine, seven-volume, 2,500-page report.
By late December, 1979, or early January, 1980, FDA regulators read the report and realized that a dozen Selacryn users had developed hepatitis symptoms. They called an emergency meeting for Jan. 15, 1980, convening 17 SmithKline corporate officers and medical personnel and 15 FDA officials.
On that day, SmithKline officials revealed to the federal regulators that 40 more Selacryn users had suffered hepatitis reactions. Five of them were dead.
SmithKline's Drug Application, filed with the FDA in 1977 and 1978, showed that the company never tested the clinical trial data by performing positive rechallenges.
On June 22, 1979, seven weeks after the drug went on the U.S. market, representatives of the French company, Anphar Laboratories, met with SmithKline officials in Philadelphia and told them that they had six cases of positive rechallenges that linked Selacryn to liver damage. SmithKline did nothing.
It's unknown whatever happened to Messrs. Myerson, Tannenbaum and Selby. Did SmithKline keep them on their books or did they take a nice little early retirement package? It wouldn't surprise me, in the least, if they went on to higher paid jobs within the company.
Paxil/Seroxat - No Withdrawal
As far as I am aware GlaxoSmithKline or any of their previous names they were known by, never did any positive rechallenges during the Paxil clinical trials. Begs the question, why?
I find it remarkable that one phone call to SKB kicked off a lawsuit against them, particularly when over 9,000 consumers who had experienced Paxil withdrawal signed an online petition where reports of Paxil addiction were summarized by those who signed the petition (Links at bottom)
Here's just a handful of some of those 9,000+ concerns. (Paxil is the brand name of Seroxat in the US and Canada)
I have tried twice to stop taking Paxil. Each time I tried I got severely sick with shakes, vomiting, severe headache and flu like symptoms where I missed several days of work. I was completely incapacitated, I could not even get out of bed as everything seemed to be spinning around. My doctor finally put me back on Paxil but lowered the dosage. I have been taking Paxil now for three years with no hope of withdrawing any time soon. Before I was put on Paxil, I specifically asked my doctor if this medication is habit forming and I was assured that it is not, however, my experience has been one of desperation and extreme fear that I am now dependent on this medication. I need help. - HH - USA
I thought I was the only one feeling the zaps, extreme dizziness, lumps, and emotional detachments. I'm 28 and have been on 60 mg of Paxil for a year. I am terrified to come off of it - PP - Canada
I tried suicide on Paxil and my 17 year marriage ended. This drug is dangerous. I am not the same person anymore. I am trying to get off Paxil after four and a half years and the symptoms of withdrawal are so severe that I have chosen to stay on it at this time. - MC - USA
I called the company because my symptoms were so severe. The representative told me I was the exception and to go to my doctor. I specifically asked for instructions on what I could be doing to lessen the side effects and they refused to offer me any assistance. I even asked if I could have my doctor contact them directly so that he could assist me and they refused! - DC - USA
Remember, there were over 9,000 of these reports. Are we expected to believe that none of these 9,000 ever contacted GlaxoSmithKline?
We know, through various litigation in the US that GlaxoSmithKline monitor the internet and should act on what they see. Or are these 9,000 reports just anecdotal, ergo meaningless because they wasn't reported through the 'official channels'? Why would anyone want to report an adverse reaction to Glaxo anyway, given that adverse reactions to Selacryn were reported then subsequently ignored?
GlaxoSmithKline are due to defend their corner in the UK where consumers allege that they were not warned that Paxil (known as Seroxat in the UK and Europe) had a propensity to cause severe withdrawal reactions. Not warned that they would have to endure months, sometimes years, injecting a syringe of Seroxat liquid into their mouths because breaking the pill in half just wasn't an option due to the severity of cutting down the dosage by too much. Not warned either about those electric zaps jolting through the head due to the brain trying to readjust to the lack of Seroxat it had come accustomed to over the years. Hey, thanks for that Glaxo!
Despite settling over 3,000 similar Paxil withdrawal/addiction cases in America, GSK believes that there is no merit in the UK litigation. The reason for settling those American lawsuits, claim Glaxo, was to avoid costs for both parties. All 3,000 plaintiffs agreed to sign a confidentiality agreement that a, laid no blame on Paxil for their addiction and b, laid no blame on GlaxoSmithKline. It is unknown how much Glaxo paid to settle this case (All documents were sealed as part of the agreement.)
It takes just one phone call to SKB to spark a lawsuit and investigation into Selacryn.
It takes over 9,000 consumers to report severe withdrawal side effects regarding its best selling antidepressant for GlaxoSmithKline to do... well, um, nothing, at least not for its UK consumers.
How utterly perverse.
Plus ça change, plus c'est la même chose.
Bob Fiddaman.
**Smith, Kline, French, became the SmithKline Corporation in 1976, and then SmithKline Beckman in 1982, after merging with diagnostics company, Beckman Instruments. Glaxo later merged with Wellcome, a company established in the nineteenth century and built up since, to become Glaxo Wellcome. In 2000, the year of the millennium, Glaxo Wellcome and SmithKline Beecham merged to form the name we know today, GlaxoSmithKline.**
Online Seroxat/Paxil Petition.
Seroxat Withdrawal Reports Part I
Seroxat Withdrawal Reports Part II
Seroxat Withdrawal Reports Part III
Selacryn back story here.
Google Selacryn here.
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