By Marvin Ross
The world is full of conspiracy theories from President Obama was not born in the US and is a Muslim to vaccines cause autism, cancer could be cured but Big Pharma prevents the cure to make money and Big Pharma drugs people with mental illnesses to also make money.
The only truth in any of that is that Big Pharma’s goal is to make money. And that goal to make money is why they exist as they are private for profit companies in our capitalist society. TV networks, publishers, banks, retail outlets are all designed to make money by providing something that people either want or need.
What’s the big deal?
And if you are opposed to that concept, then join a political movement that advocates for socialism. However, bear in mind that only Big Pharmaceutical companies have the means and motive to invent, study, produce new and better treatments for our ailments. But they need to be monitored, regulated, and whatever research they sponsor that “proves” the safety and value of a new agent needs to be replicated by independent studies.
Profit companies provide a service or a product that is needed in order to make money for their shareholders or owners. In the case of Big Pharma, it is medications that will help to ameliorate illness – probably not cure but reduce symptoms. They are the ones who do this because governments either can’t or won’t. History has shown that their products have dramatically improved our lives, or at least the levels of health and wealth and comfort that many of us maintain.
The role of governments is to provide a regulatory framework to ensure that these capitalist outfits do not ignore ethics in their pursuit of profits. Restaurants need to abide by rules of cleanliness for example so that their customers do not get ill and there are government inspectors to ensure that. In order to drive a car, you need a license as proof that you are capable.
The banking system requires very stringent regulations to ensure they do not run amok which is what happened to cause the recession in 2008. Many of the banking controls in the US had been removed and we saw what happened. Canada, which has always had a very tightly regulated banking system, was only mildly impacted by the 2008 crash.
And so too Big Pharma. In the US, Teddy Roosevelt brought in legislation creating the FDA in 1906 to regulate food and drug purity. At that time, many medicinal elixers contained opium, heroin and cocaine so regulation was implemented to make these products safer. Today, the FDA regulates drug development via a very stringent process to ensure that when a drug is made available to the public, it has proven to be efficacious for its intended purpose with side effects that do not outweigh its benefits. Absolutely we should not trust them or the doctors who shill their products for big paychecks. But without them there would be no pharmaceutical progress.
In Canada, that role is carried out by Health Canada and in the European Union, it is the European Medicines Agency. Each agency must approve any drug sold in that jurisdiction so that Big Pharma must gain the approval of the FDA, Health Canada and the European Agency to sell their product in those jurisdictions.
And drug development is expensive. It is estimated that for every 5-10,000 agents that begin preclinical testing, only one ends up approved for dispensing. The cost of developing that one prescription item is about $500 million and takes 8-12 years. That is a lot of money and time to get to market. Now I’m not justifying the price of drugs but the company does have to get its money back and show a profit.
The resources required to accomplish all of this are far greater than governments can afford. For those who think that drugs are mostly poisonous and are foisted upon unwitting patients by evil people to make money, this is the process to ensure that the drugs are as safe as possible.
Promising therapeutic agents are identified based on the latest understanding of a particular disease. That agent is then tested in lab animals to determine safety before an application is made to the regulatory body for an investigational new drug license. At this point, the testing involves 3 phases of study. The first involves giving a small amount of the agent to a small group of healthy volunteers to see if there are any adverse effects.
In the second phase, a small group of subjects with that disease are studied to see how effective the agent is. The third phase, if they get that far, can last for years and involve thousands of patients in various locations to test for efficacy compared to a placebo or an already approved drug and side effect profile.
Only then, years later, is the drug submitted for approval to the regulatory agency who then have their own scientists evaluate all the data. A drug approved by one regulatory agency for a particular country as I said earlier will also have to be approved the same way by the regulatory agency in those other countries.
This is a very long and costly process to ensure that the drugs doctors use for their patients are effective and have a side effect profile that is not greater than the benefit they have. And everything has a side effect including something as seemingly benign as water
Of course, it isn’t always possible to predict what will happen when patients begin taking medications in the real world and so regulatory agencies do have adverse event reporting systems in place to track and investigate these occurrences. In many cases, drugs are removed from the market for various reasons that became clear with widespread use over time. Wikipedia has a very long list of these agents, the countries where they were pulled and the reasons.
The system is not perfect but it works for the most part and people are able to have prescription products to help ameliorate their symptoms. To attack Big Pharma for developing these drugs and the doctors who prescribe them for their patients, is absurd. I am not defending Big Pharma or suggesting that they do not sometimes go to excess but simply describing what is and why.