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.
Mind You Reflections on mental illness, mental health and life 
I appreciate what you wrote and agree with most…the argument I hear most is about prescription drugs costing so much less in Canada…why is that?
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The price of drugs in Canada and in Europe are controlled by the governments to ensure that the prices are reasonable. See http://www.pmprb-cepmb.gc.ca/en/regulating-prices/price-review for Canada. Big Pharma in the US has no such controls so they charge what they can. Governments in Canada also negotiate with pharma companies when arranging large purchases for drugs that are paid for by the government (for seniors and the disabled) and they can therefore get volume discounts. I’m told that it this is not allowed in the US but I’m not positive on that. One pharma official told me that the US does all the research and thus need to charge a lot but are not allowed to do so in other countries so that Americans wind up subsidizing the world. However, many if not most of big pharma is not American but UK, French, Swiss, German. The official who told me that worked for a UK drug company in the US.
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Dear Marvin,
I greatly appreciate your blog: It’s a consistent voice for the value of treatment, especially medication as a first-line treatment for many mental illnesses. The premise of this entry–that pharmaceutical companies are amoral entities whose purpose is to earn their owners money by producing things that benefit people–is spot on, as are your comments about the opportunity the people have, through their elected officials, to regulate this commerce.
But I also think the post lacks nuance, which plays into the arguments of the anti-psychiatry camp. I’d like to challenge your notion that “only Big Pharmaceutical companies have the means and motive to invent, study, produce new and better treatments for our ailments.”
First, we can’t dismiss the possibility that clever researchers will be able to develop psychosocial therapies that have real treatment benefits for severe mental illnesses, perhaps even in conjunction with medications or some form of brain stimulation. Any psychological intervention that has some benefit is achieving that by changing the structure, connectivity and biochemistry of the brain.
But it does seem most likely that in the near term, more effective treatments for severe mental suffering or dysfunction — autism, psychosis, mania, depression, anxiety — is going to come in some form of molecular therapy. The second point I want to make is that most fundamental leads into new treatments, whether medicines or others, come not from “Big Pharma,” but from a combination of government-funded research at universities and small biotech companies, often started by academic scientists. The risky, exploratory science that underlies blockbuster drugs is paid for by taxpayers and conducted by smart, hard-working (underpaid) nonprofit scientists.
The big pharma companies have pretty much exited brain disorder research, laying off thousands and closing down entire CNS disorders departments—not just disorders like schizophrenia or bipolar disorder, but even Alzheimer’s and Parkinson’s. They’ll come back when they see some promising results from the academic researchers.
That adds another support to the argument for regulating drug prices: Because drug developers in industry stand on the shoulders of academic giants, the taxpayers that paid for the initial research are justified in demanding that prices be reasonable.
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Thanks for your comments. You are quite right but the problem is that governments will not and/or cannot get into lengthy clinical trials. I’m not sure what the solution is to improve the medications available for CNS illnesses. The same holds for the orphan illnesses where there is little incentive for big pharma to develop drugs with any condition where there are few sufferers. When they do, the prices charged are well beyond what most can pay and beyond what governments are willing to subsidize.
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It seems to me that an edict of lifetime medication for mental illness is a fallacy that needs deep research. Psychotropic drugs are extremely toxic and may not be necessary in most cases.
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Once again, Dr Ross, you have hit the nail on the head. whether the sector as a whole, including Big Pharma, are operating in a totally ethical manner is immaterial when one considers the benefits of their processes.
Perhaps ethically they are “dodgy” but this should be addresssed as an ethical issue and not from fantastic paranoid delusion. If govt had the courage, they could hold such corporations to acccount for their processes. But they don’t so Pharma does as it will.
In the mean time we still need effective treatments. We stil need to fund research into the neuropsychology of the organ in question and the govts of the world have shown that they are not prepared to fund research to the point of actually being effective.
well done sir! As consitent as ever.
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I’d like to point you to study 329 for Paxil as an example.
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I think that there is such a thing as excessive profitization that harms human quality of life. It is my understanding that drug research is usually funded by the government. Am I incorrect in thinking this?
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