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FDA Fails to Regulate - The Story of Joseph Randone and Trasylol

Posted by Jane Akre
Sunday, February 17, 2008 6:16 PM EST
Category: Major Medical, Protecting Your Family
Tags: FDA and Prescription Drugs, Drug Products, Trasylol, Wrongful Death, Product Liability, Fraud

52-year-old Joseph Randone was going in for a repair on his heart valve, he ended up dead over a controversial drug,Trasylol, whose maker withheld research it caused kidney failure.

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Joseph Randone, 52 and his wife Josephine joked about the January day he checked into Stony Brook University Hospital for some pre-surgery tests, Friday the 13th.  

"We laughed, we're not superstitious," Josephine tells IB News.

Randone was healthy but his doctor told him he'd "better take care" of a heart valve repair. You'll just be in the hospital a week, he was told. There is a five percent complication rate, he was assured.

So the Long Island businessman, who owned a travel agency, and his wife of 28 years did what most good consumers do, they checked out the surgeon and anesthesiologist. Dr. Todd Rosengart, Stony Brook's chief of cardiothoracic surgery had "top notch" credentials so they felt comfortable.

They never thought to ask what medication Joseph would be given during surgery. "Who would?" asks Josephine whose story was profiled on the Sunday, February 17th, 60 Minutes.

Randone was given Bayer Pharmaceutical's Trasylol to reduce blood loss during surgery. There are other reliable drugs that do the same thing at about $50 per unit but for some reason the $1,000 Trasylol was given. 

Trasylol was taken off the market last November in what Mrs. Randone's attorney, Marc Bern believes may be the next case of Vioxx. 

The FDA allowed the drug to stay on the market even after researcher Dr. Dennis Mangano warned an advisory committee that Trasylol doubled the risk of kidney and heart failure and had a 181 percent risk in the increase for stroke.  Dr. Mangano says between the time of his published study in January, 2006 and November, 2007 when Trasylol was finally taken off the market, 22,000 lives had been lost.   

His study, published in the New England Journal of Medicine in January 2006, concludes “The association between aprotinin (marketed as Trasylol) and serious end-organ damage indicates that continued use is not prudent. In contrast, the less expensive generic medications aminocaproic acid and tranexamic acid are safe alternatives."

In the case of Trasylol, Bayer hired a Harvard researcher, Dr. Alexander Walker to look at 70,000 patients. He too found elevated deaths from kidney failure. But Bayer never told the FDA about this study at the same advisory panel meeting where Dr. Mangano's conclusions were discussed.   

60 Minutes interviews Dr. William Hiatt, who chaired that advisory panel. He says he would have voted to remove Trasylol from the market if he had information about the Bayer study. As to the withholding of evidence of a drug's danger, Dr Hiatt says "I thought it was truly inappropriate."

Joseph Randone had a Trasylol drip for four hours during his surgery. His family was told there were complications. His kidneys had failed, Randone developed embolisms and blood clots in his lower extremities. His health spiraled downward. The blood clots led to both legs being amputated below the knee. His kidneys shut down so he was on dialysis.  Fluids backed up to the point where his body was overloaded and his cornea fractured. Doctors had to sew his eyes shut. He had a tracheotomy and a feeding tube and lived like this in Stony Brook Hospital for eight months.  

"He lived like he was in a glass casket" Marc Bern tells IB News adding that Randone was conscious and constantly aware of his surroundings.

Finally he died of infections August 8, 2006,  "He fought valiantly but my husband didn't give up, his body gave out" his wife says.

Josephine says her husband's doctor took her aside and said he had filed an adverse reaction report to the FDA about Trasylol. "That was the medication I used on Joe's surgery," he told her. 

Josephine Randone has filed an $80 million product liability case against Bayer, one of at least 20 nationwide.

Josephine Randone says about Bayer, "I was naive. I thought drug companies helped people and they make a profit too. After what I've learned and read, their bottom line is profit not people. They made billions and even if they have to pay $50 million, so what. My husband was worth more than any money and he 's not replacable."

She says Joseph Randone was loved by his community, where he took a leadership role in local politics, sports and school.  He will never walk his daughter down the aisle she says. "I tell my son he had the best father anyone could ever have in his 13 years." 

Randone is amazed at how insensitive some people have been questioning the family's motives. Reading blogs has sent her daughter into hysterics.  "Bayer killed my husband, we are suing Bayer. How can they personally attack a victim and a victim's family?" she asks adding that a $100,000 lawsuit is "like a mosquito" to Bayer.

60 Minutes Pelley asks Dr. Mangano - isn't the FDA charged with assuring a drug is safe?

Dr. Mangano says the FDA has to determine that a drug is "effective" and "in a relatively small number of studies it doesn't appear to be unsafe." That is the standard. 

"We don't have any enemies, but what happened to my husband shouldn't happen to anyone else, even Osama bin Laden," Josephine Randone says adding she will fight Bayer if it tries to reintroduce the drug back into the marketplace as it's indicated it might do.

Trasylol made Bayer about $291 million in 2005, $193 in 2006 and $135 million through the first three quarters of 2007 before it was discontinued after 14 years on the market.  And Trasylol was not one of the company’s top ten best-selling drugs.  #


4 Comments

Anonymous User
Posted by carol
Sunday, February 17, 2008 10:32 PM EST

This death could have been avoided if big pharma would put patients first instead of money. This indeed will be the next Vioxx!! Big pharma kept the vioxx studies secret and caused many deaths and lots of walking wounded. It changed many lives forever, and just think they never admit they caused this to happen. If the CEO's of these companies were heal accountable there would be less of this type of hiden information.

Anonymous User
Posted by jjb
Monday, February 18, 2008 9:44 AM EST

Based on my 30 years in the healthcare industry, I know that you must always "dig" for the truth when a lawsuit comes against "big pharma." The media is so slanted towards convicting "big pharma" that the truth is hardly revealed. At the same time, the media will immediately release a story on a new cancer therapy that showed efficacy and SAFETY in RATS and never tested in humans. Beware of what you read and hear.

By the by, to those of you who love to use the phrase “big pharma", let me pose a question; what is your solution? "Small pharma?" "Medium pharma?" "Tiny pharma" on every street corner across from walgreens? "No pharma?" All of your solutions mean "No Research", "No new drugs", and "No treatment for your cancer."

Anonymous User
Posted by Tonya
Monday, February 18, 2008 1:30 PM EST

My daddy was given trasylol during his heart bypass surgery and now has kidney failure requiring dialysis 3 days a week. He NEVER had kidney problems before being given this drug. He was in great health aside from needing bypass surgery. Now, he also has arterial fibrillation and congestive heart failure.

He has been in and out of the hospital for over a year now and just had to stay 2 weeks for testing at the Mayo Clinic in hopes of being eligible for a kidney transplant.

My parents cannot even take a 50th anniversary cruise as they had always wanted because he is on dialysis. They are retired and can''t travel anywhere because he has to stay close to home. Trasylol has completely robbed him of his quality of life.

I cannot believe that this was allowed to stay on the market for so long, even after studies had shown ill effects. Where is the CARE in health care? What is the FDA for?!

I believe there are many who don''t even know their problems are due to Trasylol. I know that we didn''t until someone told us to look it up. I am so glad 60 Minutes has done a story on this, so that more people can be made aware. Something has to be done about the "medicines" that are allowed on the market.

After what happened to my father, I no longer trust the health care system to have my best interest at heart. It is so sad that in this country money means everything, even at the expense of lives!!!!!!!!!!!

Anonymous User
Posted by Jane Akre
Tuesday, February 19, 2008 11:30 AM EST

Hi JJB-

After 30 years in the healthcare business you should know that people want Honest Pharma, that puts people at least on a par with profits. That's all.

Comments for this article are closed.

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