Do we need biological regulation?

Hello all,

Namaste! Today we are going to discuss an entirely new area that I came across a few years ago and which, became very close to my heart that I ended up taking a certification in the same. Regulatory affairs especially in the field of Biotechnology. Do we need it? If so why do we need it? Before getting into this question we need to go back a bit in history to know why the regulation started in the first place?

Nuremberg trials:  All of you must have heard about the second World War, which spanned from 1939 -1945, in which an estimated 50-80 million fatalities happened. Numerous war crimes were committed against innocent people and later the Allied forces decided to try the remaining military leaders of the Nazi party for crimes committed during the war. It was decided the Bavarian city of Nuremberg will be the venue for the trials as it was considered the birthplace of the Nazi party.


Nuremberg Trial
The war crimes included experiments conducted on Jewish concentration camp prisoners by Heinrich Himmler along with a physician Josef Mengele. The experiments reached atrocious levels and the victims were always kept in the dark about the tests being conducted on them. It included Malaria experiments, sulfonamide experiments, freezing experiments, head injury experiments and many of other sorts. The experiments were done at a heinous capacity it called for a war tribunal and resulted in the Nuremberg trials.

The judges for the trial came from USA, Great Britain, Soviet Union and France, and the trail lasted for almost one year from November of 1945 to October of 1946. This set the first precedent for the rules and regulations in many areas including the field of biological regulatory affairs.

Tuskegee Syphilis Experiment: This was an infamous study conducted on the rural African-American men in Alabama by U.S. Public health service between 1932- 1972. This was to observe the natural progression of untreated Syphilis under the pretense of free health care from the United States government. This was done in collaboration with Tuskegee University, a black college in Alabama. Among the 600 poor men enrolled in the study, around 400 already had the disease while 200 were infected with the bacteria. Even after losing funding for the study, the study continued without ever providing treatment for the subjects (people who were part of  the study). Later a whistleblower in 1972 exposed the details of the study and this led to a major overhaul in rules and regulations leading to protection of human subjects, informed consent and accurate reporting of diagnosis and test results.


Tuskegee syphilis experiment
The above two mentioned events along with several other organizational and policy changes led to the setting up of the Health and Human Services (HHS) department of the United States government, which oversees  FDA (Food and Drug Administration) and many other agencies likewise. There is also USDA (United States Department of Agriculture), which oversees food, food related products and dairy and dairy products. Likewise, European Union set up agencies for the overseeing of regulation of food, medicines and agricultural products across Europe, while similar agencies were created in individual countries for their effective regulation.

Now let us come to the question. Why do we need regulation? Do we need it? If we need it shouldn't as common man all of us should be a bit aware of it? This post is to just to give an opening into the area of regulation and how there is a lot of back end regulation happening, which at times as consumer many of us are not aware of. With one or two examples, we will try to draw a picture of how regulation is important and many times stringent regulation is the only protection we as consumers have in a global economic world. So it may be better to be aware and informed about regulation and be an active participant in our health and food.

Milk:  Most of us use milk for our tea, coffee or for our protein intake. The milk many times comes from a far off farm where the cows are grown in facilities where they are either kept enclosed or are allowed to graze freely. But as the cows are surrounded by soil, grass, and dirt, the chance of contamination of milk with bacteria is very high. The milk is stored in silos till it is transported to a processing facility. Here during the storage also it can get contaminated. Later it is pumped into storage tankers and transported to the particular processing facility. If proper transportation or a sanitized tanker is not used, again it can bring in bacterial contamination. In the processing facility, it is pasteurized, homogenized, separated and further processed. After that particular packaging is done, the milk is ready to be transferred to the consumer facility.


Milk
In between, each of this steps a few samples are taken, analyzed for their quality, the protein content, milk fat and bacterial count. Like this, the quality of the milk is preserved and the contamination possibilities are kept in check. At any stage of its processing milk can get degraded or contaminated. As there is an agency (USDA) overseeing this effort and the dairy farmers, facilities where milk is being processed and the shops were milk is being sold  submit an annual report and  maintain a USDA certification, all of the people involved in milk production and selling are diligent in maintaining the quality standards and certification. Also, USDA personnel  visit farms, facilities and  shops to do inspections many times to check on the quality and standard of the milk being produced and sold. This is how milk gets produced and processed.

Thus the USDA is the middle man who makes sure that we as consumers are getting the best milk and not becoming sick drinking contaminated milk or getting stomach upset due to degraded or decomposed milk. But above that we as consumers need to be informed, aware of how the milk is being produced, what are the steps in the process, how it is getting pasterurized and how it is coming to the shop to be distributed. As consumers we are using the milk and many times we are unaware of the process that is happening in the back end. Should we just take it for granted that the milk we use will reach our homes safely or should we be an advocate of our own milk needs and be sure that we get the best milk we possibly can get? Food for thought.

Drugs, Biologics and Vaccines: Any idea how the drugs like tablets, vaccines and biologics are produced, processed and checked for quality assurance? Many times the physician prescribes our medicines and we just get it from our pharmacy and take it for our aches and pains. Do we know that drugs are extensively regulated and in USA, FDA (Food and Drug Administration) and its affiliated agencies regulate the medicines and medical devices. There is a network of agencies that take upon themselves as the responsible parties to get us the best medicines and medical devices possible.

Every year they bring new rules and regulations, which make sure the Americans are protected from cheap, low quality or contaminated medicines.There are extensive steps to get a drug approved by FDA and other regulatory agencies of the world. First it goes through the discovery and development stage, where a drug is developed in the laboratory, then next comes the pre-clinical stage where the drug is tested on animals to answer questions of safety. The clinical research stage happens next where the drug is tested on humans to answer the question of safety, efficacy and effectiveness. Once this stage is finished then the manufacturer (the company that makes the drug) has to submit extensive data and results to the regulatory agency for review. The drug can get rejected at this stage if the data and results don't show safety and efficacy. Once the drug gets approved, it gets marketed. Later the manufacturing company has to keep a record on post-market surveillance (record on safety and efficacy after bringing it to market) and whether  the drug or medical devices are safe and effective once it has been brought to public use.

Same way each country has its own regulatory agencies and in each country the drugs and medical devices go through rigorous regulatory process. In Europe many times there are individual regulations for the country and there is another layer of regulation with European Union. Like this each country has its own set of rules and regulation for drugs and medical devices.And because many times the countries have very disparate rules and regulations they have made a consortium called ICH (International Conference on Harmonisation) to harmonize regulations of USA, Europe and Japan. Hopefully soon other countries also may be part of this consortium.

Now there is another set of products called Biologics, vaccines and blood products. Biologics are products derived from sugars, proteins, cells and tissues. If it is not properly regulated and controlled biologics can cause extensive allergic reactions as they are thought to work with the immune system. Vaccines consist of weakened virus particles, which bring about an immune response to the human body developing antibodies.
Small Pox vaccine

Remember how Smallpox, the debilitating disease was eradicated from the World by extensive vaccination? Then there are blood and blood products, which have high chances of contamination and are needed for every kind of surgery.

 Food: Now let us come to the last section, the food we eat. Don't you think we need to get the best food and food products for ourselves? As this is an extensive group, why don't we take a specific food like Spinach and see how it goes through regulatory process? Here the USDA website shows that the Spinach is graded into Grade 1 and Grade 2 standards. Grade 1 is the spinach free from mold, mildew and other contaminating particles and free from discoloration, insects, spray residue and dirt. Grade 2 is all the criteria mentioned in Grade 1 and some tolerance towards variation in handling. Same way in other countries also food is regulated as per the rules and regulations given by the particular agencies of that country.


Spinach salad
Is regulation needed?  So see how regulation is very important for us to get the best milk, medicine or food possible? The regulatory agencies do a great job of regulating the companies that produce Milk, Medicine and Food so that the residents of that particular country get the best possible products they can get. Many times these agencies are short staffed and have a humongous job of regulating the different kinds of products, facilities that produces them and regulate the companies to maintain their certification and quality standards current. Even with huge burdens and less resources they try to do a great job of keeping us, the common man safe and healthy.

Think of a world where there is no biological regulation. Companies may be able to push their products with low quality assurance, less ethical capabilities and a mentality of just making profits. The regulatory agencies try to keep the drug prices in check so that common man is able to afford it. For example in 2015, an American company called Turing Pharmaceuticals increased the price of  a drug Daraprim, which is used to treat Toxoplasmosis (a deadly bacterial infection) from $13.50 to $750, overnight. The CEO of Turing, Martin Shkreli got into trouble for increasing the drug price of that essential drug to exorbitant price, so that infectious specialists (doctors treating diseases that can spread) came out voicing their dissent against it. Later Mr.Shkreli was indicted on another unrelated charge. Here being a previous hedge fund manager, he just gave importance to profits and didn't realize that people may not be able to afford the price and the ethical and legal implications of raising the Daraprim price overnight.

Remember, anybody can become a patient and can have a health issue, which we may need to go to the hospital or need to take drugs to cure the disease. At that time shouldn't we be unperturbed with the knowledge that we will get good treatment, we are not given infected blood products and the drugs we take are safe for human consumption. This is the dedicated work the regulatory agencies are doing. Ofcourse the agencies are run by humans and human error do happen many times. But they do a fantastic job of keeping us the common man safe.

Now what can we as common man do about our health and wellness? The main thing we can do is to become aware of our body, what kind of food and milk we are having, how do they get processed, is there any chance we can have a food or milk poisoning, what and which type of regulation is there, what kind of disease we have, what are the drugs we are taking, are there any side effects, if there are side effects-what can we do about it, is there any alternate drugs we can take, how is the competition among drug companies for a particular drug, what is the long term effect of taking a drug or biologic- the list goes on.

No one will more interested in our health compared to us. Also we have been given only a body per life. Even if someone wants to lend their body, we cannot take it from them. Only a healthy body can have a healthy mind.So why not take care of ourselves? All of us have to be an informed person or patient and keep a close watch on our own health. Wishing all of us happy, healthy and informed days ahead.

I wish you a good weekend and I'll see you next Friday! 😉

Next week: Ascendant - A snap shot!

Note: All images were taken from Wikimedia Commons.

Ralph Waldo Emerson writes, "There is a time in every man's education when he arrives at the conviction that envy is ignorance ; that imitation is suicide; that he must take himself for better for worse as his portion that though the wide universe is full of good, no kernel of nourishing corn can come to him but through his toil bestowed on that plot of ground which is given to him to till. The power which resides in him is new in nature, and none but he knows what that is which he can do, nor does he know until he has tried". 
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SwaroopaBlog.


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