By Leisa Zigman I-Team Reporter
St. Louis (KSDK) - How much would you pay for a medicine that would save your life?
How much to save your child's life?
The I-Team's Leisa Zigman obtained confidential records showing how vendors are preying on desperate patients and hospitals by offering hard to get, life saving medicine at astronomical prices.
These are critical drugs used in everything from surgery to chemotherapy. They are drugs people like 66-year-old Pat Stamps can't live without.
Stamps is a grandmother of 16. For the past four years, she has been fighting to survive ovarian cancer. A chemotherapy drug called Doxil was working to treat her cancer, but this summer doctors told her the drug was suddenly unavailable.
"It was devastating because that was mine and every other woman in there that is fighting for our life, that is our lifeline to being here," said Stamps.
Across the country thousands of Americans like Stamps are being confronted with shortages of more than 200 lifesaving medications forcing them into less effective treatment or no treatment at all.
"How can you do this to people who depend on you to make this drug...because we are looking at a death sentence," said Stamps.
While there have been no reported deaths due to drug shortages in St. Louis, across the nation, the Associated Press reports there's been 15 deaths in the past 15 months. The worst case occurred in Alabama were nine people on feeding tubes died this spring because the sterile premixed nutritional solution they would normally have received was unavailable. Instead, they received their nutrition from a hand-mixed batch that became contaminated by bacteria.
Rick Sumpter is the pharmacy operation manager for St. Anthony's Medical Center in south St. Louis County.
"Drug shortages have almost become an epidemic," said Sumpter.
Every day he and pharmacists at most every St. Louis area hospital are targeted by grey market vendors accused of buying up scarce drugs and offering them at exorbitant markups.
The I-Team received confidential documents showing how some of these companies were targeting St. Louis.
NewsChannel 5 has several e-mail drug pitches from Allied Medical Supply, out of Miami, Florida. The company is under congressional investigation for offering Cytarabine, used to treat and cure leukemia in children, at more than $990 per vial. The typical price is $12 a vial.
Documents obtained by the I-Team also show Gulf Coast pharmaceuticals from Ocean Springs, Mississippi, offering Labetalol, a critical high blood pressure medication at a 3500 percent markup.
In some states it might be illegal to scalp a concert ticket, but there are no laws against inflating the price of life saving medicine.
John LaKamp is in charge of pharmacy operations for 30 Mercy Hospitals. He oversees a pharmaceutical central distribution center for all of his hospitals, in Springfield, Missouri. So far, he says the drug shortage has only delayed patient treatments and he has been able to avoid buying from any of these secondary companies.
He cautioned about potentially serious consequences buying from a grey market vendor.
"The bigger question is how have they been stored? How have they been obtained? Are they even safe to use? Are they going to work," he said.
The I-Team contacted most hospitals in our bi-state region and they all deny buying from these types of distributors.
Ali McBride with Barnes-Jewish Hospital questions the ethics of those charging astronomical prices for life saving drugs in short supply.
"I think it is unconscionable. The issue is, they are in business to make money and there's no one regulating the grey market," he said.
Industry experts say the shortages of lifesaving drugs are due to manufacturing problems, a lack of raw materials, fewer companies making the drugs, and the fact that many of these drugs are generic and just not profitable.
Stamps says it just shows that profits are more important than human life.
"They're looking at people and saying you know, I just can't make enough money making this, and I'm sorry, but you're dead," said Stamps.
She is now on a drug that is more toxic, and doctors say less effective, than Doxil. She talks about a lack of humanity in those profiting on the grey market.
"They are monsters. Why would you gouge people that are dying," she said.
The makers of Doxil say the shortage is due to a manufacturing issue and has nothing to do with profits.
"Production constraints related to capacity have caused the current shortage of DOXIL® (doxorubicin HCl liposome injection). These capacity constraints are due in part to unplanned downtime created by equipment failures at this specialty manufacturer. We are working closely with this supplier to restore uninterrupted access to DOXIL® as quickly as possible. Until that time, we expect product supply to remain intermittent over the next several months as this manufacturer works to return production capacity to the levels necessary to supply all patients in need." "Suggestions that the DOXIL® shortage is driven by profit motive is without merit. As a commercial organization focused on improving the lives of patients with cancer, we are deeply committed to restoring the availability of DOXIL® for patients who await treatment and will not be satisfied until we can announce full supply is available for patients on a reliable, consistent basis," said Monica Neufang, a spokesperson for Janssen Products, which manufactures Doxil.
"We have not learned of any instances in which anyone has been able to purchase DOXIL® via web sites or other channels. In fact, we closed the distribution network in early August by implementing the DOXIL® Creating Awareness & Reinforcing Education Support (C.A.R.E.S.) Physician Allocation Program, which provides an allocation process for physicians to secure new, limited supply of DOXIL® for their patients who are currently receiving DOXIL® therapy.
"Controls are in place to ensure only patients enrolled by their physicians in the DOXIL® C.A.R.E.S. Physician Access Program receive DOXIL® via these authorized distribution channels. In addition, measures were instituted to prevent hoarding and price gouging which reports such as yours have noted can occur during drug supply shortages.
"Since its launch, approximately 2,000 patients have been able to receive DOXIL® through the DOXIL® C.A.R.E.S. Physician Access Program. Importantly, we have provided and will continue to provide regular updates to the FDA on the progress of the allocation program and the DOXIL® supply situation. Program information and regular updates to the healthcare community are available at www.DOXIL.com"
Allied Medical Supply, was the only reported grey market company that responded to phone calls from the I-Team.
In a statement, CEO Anthony Minnuto states:
"Recent media attention on prescription drug shortages highlights the vital role that Allied Medical Supply and other companies play to ensure that hospitals and patients have the medicines they need when they need them. Published surveys, highlighted in the media, grossly misrepresent Allied's business model and practices.
"Allied Medical Supply responds to daily requests from our hospital customers for medicines they need immediately for their patients. Our company purchases and delivers these medicines in real time. The critical drugs, utilized in surgery and treatment of life threatening conditions, are not always being provided by in a timely manner to our customers by suppliers because of a variety of network distribution issues.
"The amount of the Leukemia drug Cytarabine that we sourced and delivered to our hospital customers is less than one percent of the total need for the drug. But it is medicine that they needed immediately for their patients.
"Allied Medical Supply welcomes a review of the secondary wholesale distribution industry and will cooperate fully with the inquiry initiated by the Congressional Committee on Oversight and Government Reform."
There are no quick fixes to resolve the crisis and physicians and pharmacists say the shortages are getting worse.
"Why would a company produce a drug that loses money? There are things congress could do with the reimbursement structure," said one pharmacist who didn't want to be identified.
In Congress, some legislation has been introduced that might offer short term fixes. One bill would require companies to notify the FDA in advance about anything that might cause a shortage and give the agency new enforcement powers. Legislation pending would also increase penalties for drug thefts from warehouses and tractor-trailers.
Some industry representatives blame part of the problem on increased oversight by the FDA. It's a claim the FDA strongly denies. In fact, the FDA blames most of the shortages on production shutdowns due to manufacturing problems.
KSDK