The FDA discusses bad pharma in terms of warning letters and highly technical regulations. Companies are fined, promises are made and unfortunately, within a few months it is often back to business as usual.
There is another side of adulterated drugs, however, a story complete with names and faces. It is a story that we want to share.
Randy Hubley – Innocent Victim of Bad Pharma
Randy Hubley was a dialysis patient for the last 18 months of his life. Ironically, his wife Colleen Hubley is a dialysis nurse.
The drug Heparin is a lifeline for dialysis patients. It prevents blood from clotting and coagulating in the dialysis machine as it is being cleansed.
What should have been a routine dialysis treatment turned into a nightmare. Randy died shortly after receiving heparin on January 11th, 2008. The heparin was manufactured by Baxter International and is suspected of being part of the heparin API contaminated with oversulfated chondroitin sulfate.
Money Saving Substitute Finesses Protocols but No Medicinal Value and People Die
FDA scientists believe the chondroitin sulfate was deliberately substituted for the raw heparin because it is both cheaper and will pass most commonly used testing protocols. In other words, it has similar chemical properties but no medicinal value.
Randy Hubley received heparin on January 11th.
At 2:00 am on the morning of January 15th, Randy was pronounced dead.
Husband, father, grandfather, son, brother and uncle. Colleen and one of his sons were present to witness his painful death. Family members attempted to administer CPR in his last minutes of life.
Drug Company Accountants See Bad Pharma Victims as Line Items
Drug companies and insurance companies see these cases as a balance sheet liability but the human costs are real and tragic. They can’t be measured by accountants.
According to Colleen, her husband’s last days on earth were horrid and gruesome.
Baxter International claims that the adverse reactions to the contaminated heparin are “temporary”. Colleen tells a much different story. She says when Randy came home from dialysis he suffered from low blood pressure, severe diarrhea, abdominal pain, jaw pain, his throat was sore and felt ``tight'' to him. He needed an inhaler to breathe.
Randy suffered for several days, staying on a coach so he could be near the bathroom. On Monday, he missed his dialysis appointment. He was too weak and was still suffering from diarrhea. Randy didn’t want to soil himself while at the clinic.
Randy and Colleen decided that if things didn’t improve, Randy would have to go to the emergency room on Tuesday. He never made it. At 2:00 am that morning, Colleen awoke to Randy suffocating and clutching his chest. While one of their children called 911, Colleen began CPR.
Randy’s throat was so swollen that paramedics had difficulty inserting a breathing tube. Randy died approximately 2:00 am after five days of horrible suffering.
Contaminated Heparin – Lifesaving Medication, Actually Not – Congress Listens
In Colleen’s own words as told to Congress,
“There isn't enough time to make anyone understand what a loss this has been. There is a void that can never be filled. Randy wanted to spend his last years fishing with his family and spending time with his loved ones. He will not get that chance now, and his grandson will never know what a beautiful person he was.
As a nurse, I thought I would be there to save my husband from any errors, but I guess I was naive. I never thought that the lifesaving medication we were relying on might be contaminated.
Now, after learning that my husband was given contaminated heparin, I understand even more that everything in healthcare is vital, that there should be no ‘acceptable losses.' If citizens are truly going to ever feel safe in this country, going to a hospital, doctor or taking our daily medication, we all have a responsibility to make sure that everything that is given is free from contamination. I understand that the FDA is overworked and understaffed, it is something I deal with every day as a nurse, but if you take a deep breath and think for one moment, ``What if that was my mother, my husband--what would I want done?''
My husband was a fighter until the bitter end. He would have given anything for one more day, and I know he would want me to make sure this doesn't ever happen to anyone else. Please do not let his death be in vain. We, as a family, need to know that some good can come of this tragedy.
We at the Pharmaceutical Integrity Coalition agree. No human losses are acceptable. Courts can award monetary compensation but there is no way to truly value human life or its loss.
Shortcuts and Contamination Kill Real People – A Confidential Tip Can Save Lives
When greed and profit get in the way, some companies lose their way. Inevitably, the results are tragic. Anyone in the company can make a difference, however. Stopping contaminated drugs from leaving the factory and correcting cGMP violations is everyone’s responsibility, even if a few greedy managers disagree.
Everyone in the industry starts with a belief that his or her work can make a difference. It can.
Our mission is simple. End the greed, stop dirty pharma, restore integrity to the profession and empower individuals to come forward and report problems before more innocent people suffer or die.
People Who Report cGMP Violations Correctly Can Get Million Dollar Rewards
In 1863, the United States Congress passed the federal False Claims Act. That law allows workers or vendors with inside information about fraud involving federal program or funds to collect cash awards for their information. Because Medicaid and Medicare tax dollars subsidize so much of healthcare in the United States, the False Claims Act kicks in when adulterated or mislabeled pharmaceuticals are sold or dispensed in the U.S.
The awards to those who report violations in pharma cases are often in the tens of millions of dollars. Collecting an award requires very specific steps but there are several lawyers who handle these cases and they support us by offering confidential free advice and if you and they decide you are eligible for a reward, they won’t charge unless there is a recovery, i.e. they can simply be paid a percentage of what they get for you.
If you know about cGMP violations, adulterated drugs or other problems anywhere in the pharma supply chain, contact us. Every inquiry is kept completely confidential.