A few weeks after witnessing the final moments of my husband, a question from my 4-year-old son, Ryan, shook me to my core. He asked, ‘Why did Daddy receive the harmful medicine?’ Ryan, it seemed, had inadvertently heard my conversations about the unexpected death of his father, Dave, a much-loved special needs teacher, in the summer of 1997. Newly discovered revelations about how the pharmaceutical industry had pushed FDA-approved, HIV and hepatitis infected blood-clotting drugs towards patients suffering from hemophilia and other bleed-related conditions across the 1970s to the early 1990s, were still fresh in my mind.
Tightly held in Ryan’s grasp, I grappled with how to frame a reply about the ‘harmful medicine’. Internalizing the appalling decisions that resulted in infections among masses both within the U.S. and internationally was challenging. Products derived from infected plasma also inadvertently exposed sexual partners like me to HIV, a risk that translated to our unborn children as well. In the present day, it’s alarming to see the potential for similar dangers under the Trump administration.
My understanding of the truth strengthened two weeks post Dave’s passing, thanks to insights provided by the Committee of Ten Thousand (COTT). Established in 1989, this non-profit organization aids the infected and investigates the primary contributors to the near devastation of a rare-disease community. While there were various factors, the reduced FDA inspections and enforcement actions against imperfect product manufacturers during the Reagan era, largely due to deregulation and budget cuts, played a significant role.
With the Trump administration’s drastic reduction of roles within the FDA and the Centers for Disease Control and Prevention, I fear our preparedness for a new virus or pathogen penetrating our blood supply could be in jeopardy. Immediate concerns about food and drug safety were raised when HHS Secretary Robert F. Kennedy removed 3,500 FDA job positions. Although protests resulted in some positions being reinstated, blood supply safety continues to be overlooked.
News reports on staff reinstatements steer clear from mentioning this division. The Health and Human Services department has remained unresponsive to requests for additional information. Disturbingly, there is little clarity from the administration about the continuity of the services previously suspended, which is deeply concerning.
While it may seem that these issues are predominantly affecting those with blood clotting disorders, the reality is broader. Notably, the large group includes 3.2 million people living with von Willebrand disease. Usage of blood or its components is also prevalent for conditions like sickle cell disease, thalassemia, anemia, and immune system disorders. Periodically, there are new threats like the Ebola and Zika viruses, although the risk is currently quite low. Everyone’s life is dependent on a safe blood supply.
Any unfortunate event, a diagnosis of cancer, or significant surgery could need a blood transfusion. During the early phases of the AIDS crisis, transfusions caused twelve thousand HIV infections. How are we expected to evaluate the existing risk, particularly when there is a dearth of dedicated experts?
Hemophiliacs have often been referred to as canaries in the coal mine, the first victims when blood becomes lethal. Suffering hemophiliacs and mourning family members spent years advocating for accountability and justice on Capitol Hill. In a 2017 interview I had with Donald P. Francis, a former CDC epidemiologist, he detailed his frustration at a January 1983 emergency meeting called by his organization.
The CDC had proposed protocols to filter out high-risk donors after suspecting that blood was the transmission route for the cause of AIDS. Surprisingly, this even included inmates from state prisons. The deficiencies in FDA oversight resulted in a multitude of unnecessary fatalities due to the absence of a solid recall policy for known or suspected infected products.
In a devastating twist, Dave, my then-boyfriend and still uninfected by HIV, asked me to administer a vial of clotting factor that was made up of plasma proteins from thousands of paid donors in December 1985. Believing the assurances from the press that the blood supply was safe, I unwittingly introduced poison into his system.
Explaining the ‘harmful medicine’ to a four-year-old was profoundly challenging. I said, ‘Certain individuals made harmful choices that negatively impacted Daddy and numerous others.’ To which, he replied, ‘So, they’re killers. They kill people.’
We must remember that blood is inherently risky and, distressingly, also a high-value product. The plasma industry runs into several billion dollars, legitimizing the existence of blood shield laws that protect stakeholders from being held accountable for injury caused by their products. The need for ‘data, surveillance, and a blood governance system that prioritizes public interest’ is strongly felt.
Presently, we’re uncertain about plans to restructure the eliminated federal programs. After a brief pause in agency communications, there has been an inadequate response even after two months. According to Kennedy’s restructuring plan factsheet, the reductions ‘will not affect the drug, medical device, or food reviewers, nor will it impact inspectors.’ Still, even before the recent upheaval, the FDA wrestled with severe inspector shortages and staff retention. Reduced staffing will consequently allow companies to self-regulate as happened in the 1980s. A clear message from Kennedy on how the CDC and FDA will secure a safe national blood supply is sorely needed. As we ignore this precarious situation in our nation’s history, we’re putting ourselves in grave danger.
The post Unexpected Aftermath of Pharmaceutical Industry Mistakes: A Personal Narrative appeared first on Real News Now.
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