How Science Commercialisation Affected AIDS History: Gertrude Elion and Shuping Sunshine Wang
What is the value of science? Do you find science factual, unbiased, and trustworthy? The biggest challenge science is currently facing is distrust, and one of the main reasons for this is the commercialisation of science. While commercialisation was originally intended to achieve wider distribution and fair development, it can also create problems such as exorbitant prices or unethical uses. In various countries, the lack of public healthcare system can also worsen these problems.
Today we look at two different women in the history of AIDS (Acquired Immune Deficiency Syndrome) whose works and lives were greatly impacted by science commercialisation.
Risky Business
Gertrude Elion had a difficult decision to make. It was the 1940s and she was undertaking her PhD while working full-time. However, after several years of long days, evening classes and long commutes she grew tired and realised she needed to give something up. She had always wanted to be a scientist, and her day job as a research assistant in the pharmaceutical company Burroughs-Wellcome was fulfilling and . She knew that obtaining a PhD would advance her career in the long run, but she immensely enjoyed her work at the time. With a heavy heart, she decided to leave her PhD programme. Her decision to stay was also motivated by her gratitude. Gender discrimination prevented her from getting many studentships and training programmes and it was when she joined the American branch of Burroughs-Wellcome in 1944 that she was treated with respect for her talent and dedication.
In Burroughs-Wellcome, her supervisor George Hitchings recognised her potential and assigned her to investigate purines, the organic compounds that form the basic building blocks of DNA. She observed that in bacteria, purines are required for DNA production. They confirmed that purines have similar roles in humans – they are involved in the metabolic pathways for DNA production and, subsequently, cell production and survival. In the case of cancers, targeting purines might stop abnormal cells from growing and spreading. Using this knowledge, they went on to develop synthetic purine compounds that compete with the naturally-occurring purines, thereby preventing them from entering the metabolic pathways. One compound, 6-MP, efficient and the least poisonous, is now regularly used for combination therapy in leukaemia.
Using the same principle they dubbed the “rational drug” approach, they went on to target various parts of the DNA in disease-causing viruses and bacteria. They successfully developed drugs against malaria, gout, meningitis, septicaemia, herpes and bacterial infections. Hitchings went on to become the vice president of research in 1967, leaving the day to day operations in the capable hands of Elion who went on to become the head of the department of experimental therapy. Their work brought in a lot of money, which was partly invested back into research.
In the 1980s, as the AIDS cases increased to an epidemic level, Elion and her colleagues used their expertise to confirm the mechanism-of-action of a drug called AZT. AZT, or azidothymidine, was an antiviral drug that was originally developed to combat retrovirus in mice. AZT didn’t gain much attention initially as no human disease was known to be caused by a retrovirus. That was true until in 1984, AIDS was confirmed to be caused by the retrovirus HIV-1. That confirmation prompted the USA National Cancer Institute (NCI) to work with various pharmaceutical companies to find a cure. Chemist Janet Rideout who worked with Elion in Burroughs-Wellcome found that AZT was able to inhibit the enzyme that HIV-1 needs to self-replicate. Their findings were brought to the NCI who then took it into clinical trials. In 1987 it was approved by the United States Food and Drugs Association (FDA) as an HIV therapy.
The high price of AZT was a huge problem worldwide, but particularly in the USA where it was developed. Burroughs-Wellcome owned the patent covering the use of AZT for HIV-1 therapy having taken a large risk in getting involved in the NCI project - AIDS was believed to be untreatable and the potential financial reward was unknown. The involvement of pharmaceutical companies expedited the drug discovery and testing process. AZT was approved by the FDA in record time of 20 months, instead of the usual 8-10 years. Countless lives were saved by these decisions.
Their gamble paid off — they were the first to find an effective therapy and the financial gain reflected this success. Later, NCI scientists took them to court in an attempt to produce AZT as a generic medicine to lower costs. However, Burroughs-Wellcome won the trial and retained the rights to AZT. For years they were criticised by activists until the patent eventually ran out in 2005 and multiple generic forms of AZT were then produced by the USA government agency Food and Drugs Association. Thirty years on, AZT is still regularly used in combination with other therapy.
For their innovative research and great contributions towards drug designs, Getrude Elion, George Hitchings and another researcher James Black were awarded the Nobel Prize in Physiology or Medicine in 1988. Elion never completed her PhD, but were awarded honorary degrees from Polytechnic University of New York, and an honorary Doctor of Science degree from Harvard University.
HIV and AIDS
AIDS (acquired immune deficiency syndrome) is a term that describes a variety of illnesses and infections that can affect an individual that has contracted the HIV-1 virus. In the 1980s, AIDS was thought to be a condition that can only affect specific parts of the population — gay individuals or drug users. This was a huge misconception. The fear of the unknown meant many people living with HIV were discriminated against, isolated, and/or refused proper care and treatment. This discriminatory belief impended the research and therapy to treat AIDS. The virus can affect anyone as it is transmitted through body fluids such as blood, semen, vaginal and anal fluids, and breast milk. Anyone who has unprotected sex or shares needles/syringes is at risk of HIV infection.
Individuals with HIV might not be aware that they have the virus. The only symptom for most people is a flu-like illness 2 to 6 weeks after HIV infection, lasting about a week or two. HIV attacks the immune system, weakening the body and lowering its defence against infections. People with a higher risk of HIV infection due to lifestyle or regular use of needles are recommended to get regular blood testing. Upon diagnosis, they can receive treatment that will control the replication rate of the virus. Nowadays, individuals can continue living a normal life while receiving treatment. HIV treatments (pre- and/or post-exposure) aim to reduce the virus load (the level of virus in the body) and the ultimate goal is to reduce the load to an undetectable level. If the virus is undetectable for 6 months, the individual can no longer pass the virus on through sexual activities.
The Whistleblower
In the 1980s, despite the high number of AIDS cases and increasing awareness that the virus can be transmitted via blood, various US pharmaceutical companies such as Cutter Laboratories (part of Bayer Corporation) and Baxter International knowingly sold HIV-contaminated blood products to Hong Kong, Taiwan, Indonesia, Malaysia, Japan and Argentina. Discovery of AIDS-tainted products didn’t immediately stop production to save cost and the companies convinced distributors to continue using old stocks and that they contained “minimal risk”. Thousands of haemophilic patients in China became ill with AIDS, and the Chinese government immediately imposed an import ban on blood products. With the first AIDS death in China being a foreign national, there was an increasing paranoia that a “foreign disease” was going to ruin the country.
In an attempt to regain control, in the 1990s the government created the Plasma Economy which was a scheme to pay willing locals for their blood plasma. The intentions were multifold — to cater to local blood needs, to supplement the income of the locals, and eventually, to create blood products that the Chinese government can export for profit.
While some areas of China were building factories to make clothing, other provinces were building blood stations. One of the researchers and medical doctors working in these stations was Shuping Sunshine Wang, who graduated with a degree in infectious diseases. In 1991 while working in a blood station she became concerned that donated blood was not tested for Hepatitis C. Hepatitis C is another viral disease that can be transmitted through blood and was a disease Wang researched extensively. Her research and clinical background meant that she noticed some patients were exhibiting symptoms and that the blood collections and processing procedures are not regulated sufficiently. She started testing the collected samples, finding up to 34% of them were, in fact, positive for Hepatitis C. The absence of testing and the poor laboratory techniques were contributing factors to this high incidence.
She reported this to her superiors and recommended testing all samples and improving the procedures in these stations. Her suggestions were met with negativity as they would increase cost and slow the process. The plasma industry was booming and she was perceived as trying to throw a spanner in the works. While testing was eventually adopted by all stations, she was dismissed from her local station by her superiors. She then worked in a district-level Health Bureau, where she learned about the outbreak of HIV-1 virus amongst drug users in a province in China. She again became concerned that the blood samples may contain these viruses. She asked the Health Bureau to establish a monitoring unit and even funded it herself. In 1995 she found that a donor was HIV-positive and he had donated blood in three different blood stations. To confirm her suspicion, she purchased kits to test thousands of samples from these stations. Her fear was confirmed —13% of the samples contained the virus.
Wang again reported this dreadful reality to her superiors, who escalated the situation to the province leaders and eventually the ministry. This finding was met with hostility as it revealed the flaws in government policies and regulations, and Wang was cautioned about making this finding public. She pushed for an investigation and spent months arguing with officials from various departments about the validity of her findings. She gained a reputation as a whistleblower, and even though HIV-testing eventually became official protocol she was shunned by the scientific and medical communities which were controlled by the government.
The hostility towards Wang and her work eventually motivated her to move to the USA in 2001. She became a naturalised US citizen, working as a scientist until she died in 2019 at the age of 59. Internationally, she was hailed by media for her bravery. The scandal also inspired a theatrical production called the King of Hell’s Palace in London in 2019. The Chinese government made an official statement in 2001 that half a million people in China contracted HIV from the plasma program. They never welcomed Wang back.
In 1993, the US pharmaceutical companies Baxter International, Rhône-Poulenc and Alpha Therapeutic agreed to pay a $660 million settlement to more than 6,000 haemophiliacs infected in the United States. Bayer Corporation (on behalf of its US division Cutter Laboratory) settled for $600 million in 2003. There has been no concrete reporting on whether these companies ever compensated infected individuals outside the USA.
References:
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