Unknown number of recipients tested positive for HIV, hepatitis and syphilis. A medical detective has confirmed that an unknown number of recipients tested positive for HIV, hepatitis and syphilis, after receiving potentially diseased tissue from the now-defunct Biomedical Tissue Services.
Dr. Arjun Scrinivasan, a medical epidemiologist at the Centers for Disease Control, said he could not tally the number of confirmed positive cases in the body-parts scandal, but may be able to do so in the next few weeks.
“Unfortunately, we may never be able to say whether those folks contracted the disease from the [BTS] tissue because of the forgeries in the case,” said CDC spokeswoman Nicole Coffin, referring to apparent faked records.
Separate probes of the scandal also proceed in Brooklyn, Philadelphia
As separate probes of the scandal proceed in Brooklyn, Philadelphia, at the CDC and at the Food and Drug Administration, U.S. Rep. Frank Pallone Jr., D-N.J., and U.S. Sen. Charles Schumer, D-N.Y., have introduced House and Senate versions of the “Safe Tissue Act” to stop the illegal trafficking in diseased body parts and create safeguards and oversight.
Their jurisdictions have been hardest hit by the revelations from the local and federal probe of BTS, based in Fort Lee, N.J., and a ring of more than 30 funeral homes that allegedly harvested body parts some of which were diseased without consent of the donors.
The tissue was then processed and implanted in unsuspecting recipients around the country.
Investigators from the Brooklyn district attorney’s office and the FDA found that donors’ medical records had been tampered with, citing changes to the donor’s age and cause of death, as well as failure to list other diseases.
“It’s very challenging to figure out,” said Scrinivasan, who has been tracking the medical side of the issue since last October.
Some of the blood samples did not come from the donors
“Some of the blood samples did not come from the donors,” he added. “How can we go back and determine a connection between a donor and an infection?”
“It’s very unfortunate,” the doctor said. “Our hearts go out to the people impacted by this. It’s such a difficult thing to struggle with.”Scrinivasan is reviewing medical records and tracking down reports of patients who tested positive.
“We know that tissues were treated with a variety of methods to inactivate the risk of microorganisms that could create infection in transmitted tissue,” he said. “So the risk of disease is low.”
Even if a recipient tests positive, he or she may not have the disease
But even if a recipient tests positive, he or she may not have the disease, he said.
With hepatitis C, for example, a positive screening test would show antibodies, indicating the recipient had been exposed to the disease.”But the body may have mounted a defense and fought it off,” he added, “and there may be no virus present.”
Doctors know how most diseases usually manifest in a patient the incubation, symptoms and recovery.
Syphilis symptoms are “quite delayed,” as much as 18 months, he added. But if a diseased tissue is implanted, “this is all new” to doctors, he said.
The Senate version also proposes civil penalties up to $5,000
The two bills propose a model donor form; an accreditation process for employees and businesses that recover, process, store, package or distribute tissue-based products; and inspecting or auditing tissue banks.
The Senate version also proposes civil penalties up to $5,000 and criminal penalties up to a $250,000 fine and 10 years in prison for a second offense.
Detectives from the Philadelphia D.A.’s office are investigating Louis Garzone Funeral Home in Kensington where two recovery technicians told the Daily News they extracted tissue from corpses and took it to BTS.