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The Pharmaceutical Industry

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The Pharmaceutical Industry

The pharmaceutical industry is huge and touches the lives of people every day. Chances are that you, your friends, your family members and most people you know use pharmaceuticals, but it wasn't always this way. How did the pharmaceutical industry become so important and influential?

History of the pharmaceutical industry

Until the nineteenth century, medical knowledge confined the pharmaceutical industry to apothecaries - a precursor to the pharmacies of today, where "wise women" sold various concoctions. Various plants, animal parts and minerals were popular as remedies.

Remedies that we still use today have roots as far back as Ancient Egypt - such as the use of peppermint for indigestion.

Greek doctor Galen also had a pioneering influence as one of the first people to realise that purity was vital and plants needed to be at the correct stage of maturity to be effective as medicines. During the Renaissance, the advent of the printing press in the 1400s was instrumental in spreading new ideas, including those of Galen; however, illiteracy was high among the general population and the scientific base of knowledge was scarce, meaning there was little progress.

The pharmaceutical industry had to wait until the nineteenth century before it really had an AIM:

Administer

One of the problems with the medicines from apothecaries was that they were sometimes impossible to swallow. In 1853, Charles Gabriel Pravaz created the hypodermic syringe with a hollow needle to inject medicine directly into the bloodstream as a new method of delivering medicine. In the same year, Scotsman Alexander Wood made some subtle alterations to the design, replacing Pravaz's metal with glass and using it to treat disease.

The Pharmaceutical Industry Alexander Wood's hypodermic needle StudySmarter

Alexander Wood's hypodermic needle, 1853, John Dixon Comrie, Wikimedia Commons

Isolate

With an increased understanding of the necessity for purity, the isolation of specific ingredients found in plants was far more common and in 1804 scientists extracted morphine from opiates. This reduced toxicity and allowed for accurate doses to be devised.

It also allowed scientists to begin studying chemical structures, giving scope for creating artificial compounds that mimicked the effects of a certain ingredient and could be produced on a large scale, without harmful side effects.

Medicine as a science

Some key breakthroughs in the second half of the nineteenth century moved medicine into its now recognised position as a science.

  • In 1802, Edward Jenner helped eliminate smallpox using cowpox as a vaccine in a campaign that started in 1802.
  • Louis Pasteur's 1861 Germ Theory and subsequent creation of vaccines for specific diseases, like rabies in 1885 highlighted the evidence of microbes and the effectiveness of a measured, isolated approach when combatting them.

With the continuous progress made in chemistry and biology, universities were soon given funding to help develop the pharmaceutical industry. The integration of science into medical departments was key to its progress.

Role of the pharmaceutical industry

As medical knowledge grew, there was a clear role for the pharmaceutical industry alongside scientists.

BiologistsChemistsPharmaceutical industry
  • Biologists studied the body and the natural world, gaining a better knowledge of what created and sustained living things.
  • As well as diseases, biologists studied hormones which helped homeostasis (the process by which the body regulates itself).

Understanding insulin, for instance, is vital in maintaining blood sugar levels for people with diabetes.

  • The role of chemists was to find solutions to these biological issues.
  • They would work on isolating an ingredient from a plant, mineral or animal and create synthetic compounds to imitate these.
  • It was then the pharmaceutical industry's job to produce and distribute these compounds on a large scale.

Let's examine a couple of important breakthroughs that demonstrate this process.

Salvarsan 606 or the "Magic Bullet"

Paul Ehrlich and his team managed to find the first synthetic chemical compound for fighting a specific disease - sexually-transmitted syphilis which had plagued mankind for hundreds of years. This differed from the vaccines created by Jenner and Pasteur, which were weakened versions of bacteria.

After isolating the bacteria that caused syphilis in 1905, Ehrlich tried over 600 different compounds to see if any could cure the disease without affecting other areas of the body. Finally, in 1909, Sahachiro Hata discovered that compound number 606 was effective.

Under the trade name Salvarsan 606, it went on to treat syphilis until the 1940s.

Penicillin

By chance, Alexander Fleming discovered penicillin in 1928. He was searching for a substance that killed staphylococci bacteria as it had resulted in the deaths of many soldiers from bacterial infections during World War I.

He noticed a fungal spore on an old culture plate that effectively killed this bacteria and published his findings. However, as penicillin had been growing organically there was no guarantee that it would be pure enough to have a pharmaceutical application.

Oxford scientists Howard Florey and Ernst Chain played an important role in purifying penicillin. Their implementation of the freeze-drying technique was an effective way to do this. Eventually, in 1941 the United States and later the British government saw the necessity for penicillin in World War II.

They gave economic incentives to manufacturers who mass-produced the first antibiotic that could be used for various infections.

Understanding the pharmaceutical industry

We can see that despite its effectiveness, penicillin took a while to be mass-produced. Consequently, to truly grasp the gradual process by which a new medicine arrives on pharmacy shelves we need a deeper understanding of the industry itself.

Large companies with greater financial aspirations such as Bayer, which perfected aspirin in 1897, replaced apothecaries. In the UK, after its establishment in 1948, the National Health Service (NHS) became a singular government-funded buyer for all manner of prescription and non-prescription drugs.

Facts of the pharmaceutical industry

The journey of a substance from laboratory to general sale is a long process. Let's examine the journey from discovery to market in the UK.

Research

Research begins with a new understanding of biological functions such as metabolism, hormones and enzymes. Only once this occurs can specific pharmaceutical products be considered. Analysis using existing knowledge of natural or chemical products allows researchers to narrow their line of enquiry. They can decide which group of medicines the required solution belongs to.

For example, beta-blockers are a group of drugs that block the adrenaline hormone to reduce stress.

Screening

Laboratory studies of chemical compounds before the clinical stages involve screening 5000 - 10,000 different compounds after the medical issue has been isolated and can take several years depending on the drug. Chemists will screen thousands of possible synthetic chemicals or plant-derived ingredients from their library selecting the most appropriate ones to decide if they are adequate.

Once screening is complete, preclinical trials of around 250 compounds take place. From these, around five compounds with the highest effectiveness are chosen. Paul Ehrlich, who discovered Salvarsan 606, tested his chemicals on mice but nowadays researchers often favour drug targets that focus on the interaction of specific chemicals. The clinical trials then test the medicine on healthy humans.

Clinical Trials

Clinical trials generally involve a small group of healthy volunteers.

  • Phase 1 determines the safety of the dose and allows researchers to have a good idea of exactly how the drug works.
  • Phase 2 is to analyse the drug's effectiveness and normally has up to 200 participants.
  • Phase 3 typically involves a meta-study in several locations or countries and with a far greater number of participants, during this stage, a drug is compared to existing treatments.
  • Phases 2 and 3 may last several months or years.
  • Phase 4 focuses on the length of time a drug should be used with the side effect it induces and therefore normally lasts around two years.
  • If there are no issues, the medicine will move to the licensing stage.

Regulation

Every government has a department tasked with analysing the effectiveness and safety of any new medicine before it hits the market. In the UK the Medicines and Healthcare products Regulatory Agency has performed this role since 2003.

As it is often difficult to weigh up the potential benefits of the medicine with the drawbacks, the gravity of the biological problem and current public opinion often play a significant part in dictating this. At this stage, the recommended dosages and delivery methods (oral or other) are also reconsidered. It often takes 10 - 15 years for a drug to go from discovery to market.

Threats to the pharmaceutical industry

Despite the huge scale of the pharmaceutical industry, employing around 80,000 people in the UK, it has faced and continues to face some significant issues.

Unforeseen reactions

All medications today come with a set of warnings about side effects. Patients also need to be careful about high dosages, as thresholds for toxicity may vary from person to person.

Consideration of interaction with other drugs or medication is also important. Drugs normally target specific receptors; if another substance blocks these, the drug is distributed to other areas of the body, which can be harmful.

Pregnant women need to be particularly careful about the potential side effects of medications, as damage can reach a foetus.

The use of thalidomide to treat medical issues including pneumonia and flu began in 1958 in the UK. During that time it was widespread, with no warnings of the adverse effects of the drug when passing through the placenta of a pregnant woman to her baby.

Thalidomide affected around 10,000 babies worldwide in such a variety of ways that doctors were slow to establish a link to the drug, despite half of them dying within months of being born. In 1968, the UK government responded with a Medicines Act which distinguished prescription and non-prescription drugs meaning that only a set of very specific circumstances would create the necessity for thalidomide.

Alternative medicines

One criticism of the pharmaceutical industry is that it has often thrived on its ability to alleviate symptoms but not tackle the cause of health problems.

For this reason, there has been a recent increase in Complementary and Alternative Medicine (CAM). These methods, for instance, yoga, meditation and chiropractics try and isolate the natural causes of illnesses, preventing them instead of creating an addiction to a drug after it is already too late.

A study published in 2018 by the University of Bristol found that whilst only 12% of the population used CAM in 2005, 15% used CAM in 2015. 38% explained their reasons for this as back pain, which fits in with the notion of our increasingly sedentary lifestyles.1

The Pharmaceutical Industry Woman doing yoga StudySmarterYoga has become increasingly popular as a form of CAM, image by Sourav Mukherjee via PixaHive

Keeping up with technology

As knowledge of our genetics increases, there is a growing desire for personalised pharmaceutical programs using 3D printed technology. Already approved in the United States in 2015, these aim to depart from the traditional one size fits all approach of the pharmaceutical industry and, crucially, enable quick delivery and no wastage.

Some companies, including pharmaceutical giant Merck, are keen to break into this technology. One thing is for certain if it continues to develop - the pharmaceutical industry will undergo a huge change.

The Pharmaceutical Industry - Key takeaways

  • Medical developments in the nineteenth century allowed medicine to be viewed as a science. When combining biology and chemistry it would be able to create medication that targets specific medical issues.
  • Chemical progress meant that artificial chemicals with specific properties could mimic substances found in the natural world, often without the harmful side effects.
  • Pharmacies and large companies replaced apothecaries. Important breakthroughs by Ehrlich and Fleming, coupled with the Pharmaceutical Industry led to mass-produced drugs that attacked bacteria in isolation to great effect.
  • The road from discovery to market is a long one. It involves both biological and chemical processes and many trials before reaching the regulation stage and hitting the market. This can often take 10-15 years.
  • Several factors threaten to derail the Pharmaceutical Industry. These include the unforeseen effects of drugs such as thalidomide, an increase in CAM methods and 3D printed and personalised pharmaceuticals.

References

  1. Debbie Sharp, "CAM Survey in England" University of Bristol, (2018) https://www.bristol.ac.uk/primaryhealthcare/news/2018/national-cam-survey.html

Frequently Asked Questions about The Pharmaceutical Industry

The pharmaceutical industry is a huge industry that plays a part in our everyday lives and has changed healthcare forever.

When drugs or medicine prove effective, the role of the pharmaceutical industry is to mass-produce and distribute them for widespread consumption.

The pharmaceutical industry has many parts including clinics, factories, laboratories, hospitals and pharamacies.

The future of the pharmaceutical industry involves more CAM methods and 3D printed and personalised pharmaceuticals.

The pharmaceutical industry is huge, employing around 80,000 people in the UK alone.

Final The Pharmaceutical Industry Quiz

Question

Which Ancient Greek emphasised the need for purity in medicine?

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Answer

Galen

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Question

Which important invention occurred in 1853?

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Answer

A hypodermic syringe with a hollow needle for delivering medicine directly into the bloodstream.

Show question

Question

Who managed to find a vaccine for rabies in 1885?

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Answer

Louis Pasteur

Show question

Question

What was the synthetic chemical benzocaine used as?

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Answer

A local anaesthetic

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Question

Which of these words describes the self-regulating process of the body?

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Answer

Homeostasis

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Question

What did Salvarsan 606 treat?

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Answer

Syphilis

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Question

Who discovered penicillin?

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Answer

Alexander Fleming discovered penicillin in 1928 when he found it growing on an old culture plate.

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Question

How long does it normally take for a medicine to go from discovery to market?

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Answer

Around 10 to 15 years.

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Question

What is used nowadays to test chemicals in a preclinical testing laboratory?

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Answer

Drug targets

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Question

How did the UK government react to the thalidomide crisis?

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Answer

The UK government introduced the Medicines Act in 1968 which distinguished prescription and non-prescription drugs.

Show question

Question

Who was responsible for finding a way of mass-producing penicillin?

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Answer

Florey and Chain used a freeze-drying technique which allowed penicillin to be produced on a larger scale.

Show question

Question

What does CAM stand for?

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Answer

Complementary and Alternative Medicine

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Question

What is NOT a benefit of 3D printed pharmaceuticals?

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Answer

They are cheap to make

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Question

What kind of medicine is penicillin?

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Answer

Antibiotic

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Question

Which event caused Alexander Fleming to look for an antibiotic?

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Answer

World War I

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Question

Which was the original method of delivery for penicillin?

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Answer

Florey and Chain injected penicillin into an infected person, it was effective.

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Question

What are the four steps for mass-producing penicillin?

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Answer

Get a culture of the penicillin mould, ferment it in giant containers, purify and bottle it then dehydrate the drug using the freeze-drying method.

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Question

Who described penicillin mould as "as temperamental as an opera singer"?

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Answer

John L. Smith

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Question

Which of these penicillins is naturally occurring?

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Answer

Penicillin G

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Question

What does the NHS website say is the most common side effect of penicillin?

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Answer

Disruption to the digestive system such as nausea or vomiting.

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Question

What is the difference between an antiseptic and an antibiotic?

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Answer

Antiseptics work to prevent infections occurring, antibiotics kill bacteria.

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Question

What did Fleming warn about during his Nobel Prize acceptance speech?

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Answer

Antibiotic-resistant bacteria

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Question

Which bacteria did penicillin mould grow on in 1928?

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Answer

Staphylococcus bacteria

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