A sample of vaccine and injectable medication tragedies in the US during my lifetime

All have been due to failures of testing or failures in manufacturing processes.  Most of these tragedies occurred even before vaccine manufacturers were given virtually complete protection from liability in 1987. With the duration of patent exclusivity determining how much new products earn, products are rushed to market as quickly as possible, most using a shortened path for FDA review.  Recalls and market removals of approved products are much more common than they used to be.  We can only expect more of these disasters in the future, especially if the products are mandated for everyone.

This is what happens when you demand speedy production in an era of politicized regulation.

1.  1955: (Improperly inactivated) live polio vaccine caused polio in 40,000 children

The Cutter (now part of Bayer) Incident of 1955:  This early US Salk polio vaccine contained live polio virus, which had not been inactivated. It caused 40,000 cases of polio; 200 of these recipients became paralyzed; and ten died. Other companies also had problems with viral inactivation. The NIH director lost his job in the aftermath, since NIH scientist Bernice Eddy had earlier warned this lot of vaccine paralyzed monkeys, but her findings were suppressed in the rush to vaccinate.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1383764/

https://books.google.com/books?isbn=0199726590

2.  1950s-1960s: SV-40 (Simian Virus 40, a potentially cancer-causing virus) contaminated polio vaccines given to millions of Americans.

SV-40 can cause cancer in animals and has been found in human cancers, though its relationship to human cancers remains uncertain.

http://www.sv40foundation.org/cpv-link.html

3.  1970s-1985:  Factor 8 Concentrate. a pooled blood product used to prevent bleeding in hemophiliacs, was contaminated with HIV and Hepatitis C, but was sold worldwide even after manufacturers became aware of the contamination. 

Its manufacturers knew it was contaminated with HIV (and Hepatitis C), which spread through the injectable blood products used by hemophiliacs. About 8,000 US hemophiliacs at the time developed HIV infections this way, and an estimated 150,000 developed Hepatitis C, which frequently results in chronic liver disease, cirrhosis or death. The practice of distributing contaminated blood was widespread internationally, with many companies involved, and continued even after the problem was identified. It led to suits against pharmaceutical companies in a number of countries.  It led to thousands of deaths. Doctors went to jail.

Cutter/ Bayer knowingly sold HIV-contaminated products in the US and overseas, seemingly having learned nothing from its polio-contaminated vaccine disaster 25 years earlier.

http://en.wikipedia.org/wiki/Contaminated_haemophilia_blood_products

http://www.thelancet.com/pdfs/journals/lanhiv/PIIS2352-3018%2815%2900007-7.pdf

http://www.nytimes.com/2003/05/22/business/2-paths-of-bayer-drug-in-80-s-riskier-one-steered-overseas.html?pagewanted=print

4.  1976-1977:  Swine flu vaccine given to 45 million Americans for a non-existent disease, causing hundreds of cases of paralysis

A new flu virus was discovered in a soldier who died at Fort Dix, NJ. Concern that the virus might cause a 1918-like influenza pandemic led to a huge federally-instigated program to develop a vaccine and vaccinate every American against the virus. But the epidemic never occurred. And the affected soldier, despite having an acute infection, had been on a rigorous march before he died.  No one knew if the flu had killed him. US vaccine manufacturers agreed to produce vaccine on a short timeline, but only if they received a waiver of liability for possible vaccine injuries.  The decision to use the vaccine was strongly influenced by political considerations, according to a National Academy of Sciences investigation of the program, commissioned by HEW Secretary Joe Califano.  The report gives a bird’s eye view of how personal and political agendas came together to supercede considerations of the public health.

45 million  Americans received the new vaccine, of whom 400 people developed autoimmune paralysis (Guillain-Barre syndrome) at a rate 6-8 times expected during the six weeks post-inoculation, and about 30 died.

http://iom.edu/~/media/Files/About%20the%20IOM/SwineFluAffair.pdf

http://jama.jamanetwork.com/article.aspx?articleid=394635 (unfortunately now behind a paywall)

5.  1999:  Rhesus rotavirus vaccine (Rotashield) caused intestinal damage.

This oral Rotashield vaccine was designed to prevent a mild form of gastroenteritis.  However, it caused 1-2 cases per 10,000 recipients of intussusception of the bowel, and many affected babies required surgery to repair “telescoping” of the gut.  Several died.  Months after being licensed, the vaccine was taken off the market.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4843a5.htm

6.   1998-2001:  Lymerix vaccine likely caused autoimmune symptoms, taken off market

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2870557/pdf/S0950268806007096a.pdf

7.  2009-10 Pandemrix swine flu vaccine caused over 1300 cases of narcolepsy in Europe.

Children aged 5-19 were about 15 times more likely to develop narcolepsy if they received the GSK Pandemrix brand of swine flu vaccine, which was not sold in the US.  Other age groups were also at an increased risk of narcolepsy, but to a lesser degree. Narcolepsy is caused by autoimmune destruction of cells in the brain's Locus Ceruleus, and is newly recognized as a vaccine adverse reaction. The narcolepsy cases were severe, often preventing children from attending school.

https://www.sciencemag.org/news/2015/07/why-pandemic-flu-shot-caused-narcolepsy

http://ecdc.europa.eu/en/publications/publications/vaesco%20report%20final%20with%20cover.pdf

http://www.cdc.gov/vaccinesafety/Concerns/h1n1_narcolepsy_pandemrix.html

** The adverse effect profile of drugs and vaccines is generally not well known until millions of people have received the drug or vaccine.   New federal legislation (21st Century Cures Act of 2016 etc.) that speeds up licensing of vaccines, and removes liability from the manufacturers for all vaccines placed on the childhood schedule, all vaccines recommended by CDC for pregnant women, and new, potentially unlicensed products used during declared emergency situations -- increases the potential risk of vaccines.  http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm#categories

http://en.wikipedia.org/wiki/Public_Readiness_and_Emergency_Preparedness_Act