A history of the pharmaceutical industry
The oldest records of medicinal preparations made from plants, animals, or minerals are those of the early Chinese, Hindu, and Mediterranean civilizations. In 1546 the first collected list of drugs and medicinal chemicals, appeared in Nürnberg, Germany. In the 1800’s many important compounds were isolated from plants for the first time.
Originating as a pharmacy founded in Darmstadt, Germany in 1668, it was in 1827 that Heinrich Emanuel Merck began the transition towards an industrial and scientific concern, by manufacturing and selling alkaloids.
GlaxoSmithKline’s origins can be traced back to Beecham of London, producing patented medicine from 1842, and the world’s first factory for producing only medicines in 1859.
Meanwhile in the USA, Pfizer was founded in 1849 by two German immigrants, initially as a fine chemicals business. Their business expanded rapidly during the American civil war as demand for painkillers and antiseptics rocketed.
Bayer, founded in 1863 in Germany, commercialized aspirin around the turn of the 20th century, one of the most successful pharmaceuticals ever at that point.
These companies focused as much on cod liver oil, toothpaste, citric acid for soft drinks, and hair gel as on prescription medicines, as well as selling products like heroin on the over-the-counter market.
The period between 1918 and 1939 was marked by two breakthroughs, insulin and penicillin, that saw the arrival of the modern pharma industry. The US pharmaceutical industry was booming, thanks to the economy and generous funding from the government, with the National Institutes of Health seeing its federal funding rise to nearly $100 million by 1956. This investment fueled the development of drugs to come over the coming decades.
Since the passage in 1902 of the U.S. Biologics Control Act, which initiated the regulation of vaccines, problems with negligence in manufacture have declined greatly.
In 1955, about 200 people were paralyzed and ten died after contracting polio from the Salk polio vaccine, despite manufacturers’ adherence to federal government standards. The event was known as the Cutter Incident, after the manufacturer of one of the implicated vaccines. Many injured people and their families filed lawsuits against vaccine manufacturers, and most cases were settled out of court with monetary awards by the manufacturers.
Through the 1970s and 1980s, the number of lawsuits brought against vaccine manufacturers increased dramatically. Manufacturers made large payouts to individuals and families claiming vaccine injury, particularly from the combined diphtheria-pertussis-tetanus (DPT) immunization. In this environment of increasing litigation, mounting legal fees, and large jury rewards, many pharmaceutical companies left the vaccine business. By the end of 1984, only one U.S. company still manufactured the DPT vaccine, and other vaccines were also losing manufacturers.
We can’t let them fail …
In October 1986, the U.S. Congress responded to this precarious situation by passing the National Childhood Vaccine Injury Act (NCVIA). The act included many regulations related to informed consent and adverse event reporting. The Vaccine Information Statement (VIS) lists the risks and benefits of a particular vaccine. The Vaccine Adverse Event Reporting System (VAERS) was created to report suspected vaccine-related adverse events. Additionally, the act contained provisions for a program that would fairly and efficiently compensate individuals harmed by certain vaccines properly manufactured. Such a system, it was hoped, would stabilize the legal environment for manufacturers, allowing them to limit their liability, better anticipate their legal costs, and reduce potential barriers to research into new vaccines.
The U.S. Department of Health and Human Services (DHHS) established this system, the National Vaccine Injury Compensation Program (NVICP), in 1988. The NVICP does not cover all vaccines. However, vaccines routinely given to children as part of the recommended immunization schedule are included, and some adult vaccines are also covered.
Omnibus Autism Proceeding
Beginning around 2001, hundreds and then thousands of families began to petition NVICP, claiming their children’s autism resulted from vaccination.
To deal with the volume of these petitions, and to address the assertion that a causal relationship existed between vaccination and autism, the NVICP established a special program in 2002 called the Omnibus Autism Proceeding, housed within the U.S. Court of Federal Claims Office of Special Masters.
The first test case addressed whether measles-mumps-rubella (MMR) vaccine alone, or along with thimerosal-containing vaccines (TCVs), is a causal factor in autism. Three test cases was selected to represent this theory (Cedillo, Hazlehurst & Snyder).
A special master issued the first opinion in the OAP on theory one in 2009. The ruling found, in three test cases consolidated into theory one, that the MMR vaccine given alone or with TCVs is not a causal factor in autism.
The second test case examined TCVs alone. Theory two was decided in 2010, with a finding of no causal relationship between TCVs and autism.
As of March 2010, 13,330 cases had been filed under the VICP, of which 5,617 are autism cases. To date, the Court has held that there is no correlation between vaccinations and autism.
It’s all about the money
The NY Times – 12/16/2013
How can companies that need to maximize profits for shareholders be expected to evaluate their drugs objectively?
Drug companies sponsor the clinical trials that must be submitted to the F.D.A. to get approval to sell prescription drugs. The problem is that they can design those trials to make a favorable outcome much more likely. For example, they can test a drug in young people, even though it will be used in older people, because young people are less likely to have side-effects that indicate safety problems.
The three largest shareholders of Pfizer, J&J and Merck are Vanguard, SSGA and BlackRock, the multi-trillion dollar funds which make investments on behalf of their clients and keep a cut for their service.
Drug development is risky and expensive, thanks to the long testing and approval process. That’s why in 1984, the U.S. Congress struck a bargain with pharmaceutical companies. If they brought a new therapy to market, they won exclusive rights to sell that product in the U.S. for a limited amount of time.
After that, generic drugs could be made by competitors — at competitive prices. But increasingly, makers of branded drugs are using a variety of tactics to extend their exclusive rights. They’re using “pay-for-delay” agreements, citizen petitions, restricted distribution schemes, and legal challenges to delay the introduction of cheaper generic drugs. (Generic drug makers aren’t helping themselves by having issues with manufacturing quality.)
These delay tactics are costing consumers billions of dollars a year. The federal government should clamp down on these loopholes.
I think it’s time we get back to our roots. There is not a pill to cure every ailment and most pharmaceuticals cause more problems than they help. Let’s look first to our ancestors and the roots of holistic health and natural remedies.