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The Story Of One Of The Most Horrifying Scandals In The History Of Big Pharma

Discussion in 'Pharmacy' started by Nada El Garhy, Oct 5, 2018.

  1. Nada El Garhy

    Nada El Garhy Golden Member

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    Fossil fuel companies hid research into human-caused climate change. The tobacco industry was complicit in the smuggling of its own product. Then there was Ford’s “Pinto Memo” scandal – history is riddled with cases of big business making shady deals to boost profit margins at the expense of the consumer. A case in point: One of the world’s leading pharmaceutical companies knowingly sold HIV-contaminated blood products to people with hemophilia. Many later died of AIDS.

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    Experts believe the human immunodeficiency virus (HIV) emerged from the Cameroon jungle, where it passed from SIV-infected apes to humans by way of bushmeat – not interspecies sex, as rumor has it – at some point in the early-20th century. For decades, it lingered here, spreading to neighboring countries and infecting a handful of foreign visitors but attracting little global attention.

    Things began to change in the early seventies when cases of a strange and mysterious disease that caused victims to waste away before dying of a secondary infection appeared in big cities across the United States. By 1981, there was a full-blown AIDS epidemic.

    Little was known about the virus – only that it was strongly associated with clubs, drugs, and gay sex. However, by the summer of 1982, it was clear that it was being spread through infected blood. That July, the Centers for Disease Control and Prevention (CDC) released a report confirming that three hemophiliacs had contracted the virus.

    Hemophilia is a disorder where the blood lacks the proteins necessary to clot properly and, without proper treatment, it can be deadly. So to manage the disorder, hemophiliacs require regular transfusions of blood products like Factor VIII concentrate – which is where Bayer, or rather a unit of Bayer called Cutter Biological, comes in.

    Cutter was a producer and distributor of Factor VIII. To make the product, they used giant batches of blood plasma that had been donated from upwards of 10,000 or so people. This meant that only a small number of HIV-positive donors were needed to contaminate the batch. What's more, by ignoring federal legislation introduced in the wake of the AIDS crisis and recruiting prisoners, high-risk gay men, and intravenous drug users to donate their blood, the company increased that risk.

    As a result, thousands of hemophiliacs were affected in what the New York Times refers to as "one of the worst drug-related medical disasters in history."

    In 1983, the CDC warned that blood products "appear responsible for AIDS among hemophilia patients". Competitor companies began to create heat-treated products that rendered the HIV virus "undetectable", effectively killing the virus and making it safe for hemophiliacs to inject. So in response, Cutter released their own version and began distributing the treatment in February 1984.

    Of course, this was a major inconvenience for the pharmaceutical company, who were left with stores of unheated blood to dispose of. The market in Europe and the US had shrunk dramatically – so, they looked further afield. While they sold safer products in the West, Cutter was shipping the old, unheated stock to countries like Hong Kong, Taiwan, Argentina, and Malaysia in Asia and Latin America. The practice continued for more than a year, even as the evidence against it continued to mount up.

    It wasn't that there wasn't interest in the new product. In fact, a Hong Kong distributor inquired about the heated product in 1984. However, they were asked by Cutter to "use up stocks" of the unheated product before they could move on to the "safer, better" alternative. When, in 1985, the Hong Kong distributor made an urgent call to the Cutter HQ asking for the heated product amid an AIDs panic, they were told that there was a very small amount available for only the most vocal patients.

    But Cutter was only able to push the unheated product for so long. In May 1985, an official said there was no longer a market in the Far East "where we can expect to sell substantial quantities of nonheat-treated." According to Bayer, Cutter halted all shipping of unheated product by July 1985.

    Years later, a spokesperson from Bayer told the Times Cutter had ''behaved responsibly, ethically and humanely'' in distributing the unheated product abroad. Instead, they blamed plasma shortages and countries being slow to approve the new product (a claim foreign officials have since denied).

    AIDS tests weren't available at the time, so it is almost impossible to determine how many foreign hemophiliacs contracted HIV as a result, but records show at least 100 hemophiliacs became HIV positive as a result of Cutter's untreated product in just Hong Kong and Taiwan. Meanwhile, in the US, roughly half of patients who had hemophilia at that time contracted HIV from plasma-based pharmaceuticals, The Atlantic reports.

    Today, there are safety analyses and tests to effectively screen for viruses like HIV and Hepatitis C, so contamination from blood transfusions is extremely, extremely rare. What's more, advances in medicine means that HIV is not the death sentence it once was.

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