(10o) Pharmaceutical companies need to earn money to improve their products
The anti-science and anti-companies or, more general anti-establishment movements continue to grow and not only in the USA when you see on social media the growing numbers of conspiracy theories that question e.g. pharmaceutical companies but even doctors and nurses. Yes, it is correct that some (people working in) pharmaceutical companies think more about profits than about helping people, or at least that impression we have. But the majority in those companies are people who want to help people to reach an old age in good health.
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| Pharmaceutical companies as friends |
People claim that pharmaceutical companies should be more open and even question whether patents should exist while patents earn companies money that they invested in past research but also will invest in future research while they have to pay their legal obligations and their employees and investors (this article projects what pharmaceutical companies may earn from the Covid-19 vaccines while I am not naive as big pharma exists but even universities act in the same way as that funds wages and research. Thus, changes are needed so medicines and vaccines remain affordable but profitable or society will enforce such changes when people no longer trust pharmaceutical companies but think it is only about big money).
Still, when you look into it you notice that pharmaceutical companies and at large the scientific community belong to one of the most open sectors that include the publication of peer-reviewed specialist publications but also more popular articles in journals, newspapers and the internet while people can share those publications so they reach a large audience. Also documentaries and series, including about medical issues, on TV and internet are very popular, even when they are not always easy subjects although some are wrong or even misleading to influence people and thus need correction. Of course, companies can't disclose everything they do, certainly not at the start of research
- to avoid other companies may steal their ideas as some try to do with the Covid-19 vaccines but also
- because what may look promising at the start may at the end be worthless when it may hurt or even kill as happened in the past and thus it is important scientists develop independently different solutions to health problems. But, when something is wrong than this too should be published to avoid others repeat the same.
And ones a new technique is developed, soon after other companies will start to commercialise their version. But, even when all information was freely available and patents didn't exist, even than it is still impossible that everyone can make medicines and vaccines as they must produce products under very strict conditions or people will be rightly scared to take medicines or vaccines.
To maintain high standards, pharmaceutical companies are also continuously checked via national and international inspections (including production), (peer-reviewed) scientific publications by these companies but also by independent doctors and scientists who use pharmaceutical products on patients to cure and in research to check whether safety and efficacy claims by companies are right and to discover the science behind the mechanisms how drugs act in our body. This may result in more specific drugs, thus with fewer side-effects but, as a likely result they may benefit fewer patients so these medicines generate less money unless they are more expensive, something that society find increasingly less acceptable - see also below. Yes, even doctors and patients can report any possible side-effects that they notice after a patient takes a medicine - see sections 4.8 of scientific and section 4 of public leaflets for the address where to report side-effects.
The publications of new data can result in changes in the product information, not only with the medicine for which a side-effect was identified, but with all relevant medicines from all companies that commercialise similar products, thus changes in the well-known public leaflet in the packaging of a medicine but also in the scientific leaflet that contains additional information for healthcare professionals; still, both public and scientific leaflet are public and can be found on the websites of medicine agencies.
Companies need approval to authorise medicines and vaccines before they can sell them but also for the approval of these changes by medicine agencies, both multinational agencies such as the European Medicine Agency (EMA) and national agencies such as Belgium's Federal Agency for Medicines and Health Products (and in Dutch and French). Further, these agencies can also force companies to introduce changes as the agencies follow up publications and collect data from doctors and patients when they report possible side-effects. These websites keep companies but also citizens informed about what is happening in the medical world and publish the latest leaflets for anyone interested (although I admit, it can be difficult to find information on these websites and well-designed apps could make it easier for patients but also professionals to find information).
Companies need to pay the medicine agencies for the assessment of the proposed changes while they risk a change in the benefit/risk so a product may no longer be used for certain illnesses so fewer patients can use it; or the authorisation can be stopped and the product removed from the market. Thus, although governments may co-finance research into drugs and thus spend money, during the approval of a drug and later after commercialisation to keep the information up-to-date, companies pay back some of the money that governments co-invested during the development while companies earn money from the sale. Indeed, the development of medicines and health products is no black-white story but an interaction between governments, universities and private companies. The problem is when the balance is broken and medicines become too expensive to be affordable, even for wealthy countries as they pay higher prices to partly pay for the sales in poorer countries.
Further, companies need to spend money to print new documents such as the updated leaflet and packaging and sometimes agencies demand that companies send letters to doctors to inform them of major changes compared with the previous information (yes, some doctors still refuse to use emails and thus may also refuse to use "advanced" technologies - can you trust doctors who don't move with their time?). In future, this will become less expensive for companies when digital leaflets and letters will become accepted as standard while as compensation, society will demand a reduction in the price of medicines - remember the balance.
Finally, today richer countries pay more for their medicines and vaccines to compensate for the losses pharmaceutical companies have when they sell products such as vaccines in developing countries - a kind of charity although often funds aid to pay; as those poor countries become wealthier while rich countries start to complain about the high prices, the price throughout the world may become more equal.
Covid-19, vaccines and being open
For anyone who thinks the pharmaceutical industry is one of the most corrupt industries in the world, working in secrecy as they want to protect their patents whereby some people go as far as claiming the industry develops illnesses so they can sell their cures such as vaccines, read this article for the general public and this more detailed article and thus primarily but not exclusively for specialists that discuss with remarkable openness the different vaccines under development, even before any vaccine received approval. Also results of clinical studies are discussed in scientific journals and in newspapers for the public, not to mention scientific meetings to show colleagues and journalists promising preliminary results. In addition, when side-effects occur such as an allergic reaction, then these are made public and the public is informed about actions taken (people with a history of severe allergic reactions should be careful with the Pfizer/BioNTech vaccin) to reduce the possibility that something similar will happen again. Quite astonishing for such a secretive cult. Still, people remain suspicious and spread disinformation that needs to be corrected (no, aborted children are not used to produce and test the vaccine but cell lines of long ago aborted children are) while a rumor spreads faster than the correction, certainly when society distrust governments and companies. Thus, many people are suspicious about the vaccine and even its origins and that is a normal response as we were always told that the development of medicines and vaccines takes years, so even some scientists find the development of the Covid-19 vaccine unbelievable fast while there is still no vaccine against HIV after 40 years of research. And thus the most suspicious individuals think the pharma industry developed a virus and its vaccine in order to make money - if correct those scientists deserve the death penalty.
But, the fast development can be explained, i.e. years ago other coronaviruses emerged so scientists could prepare for the bigger one that is SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus-2). In addition, pharmaceutical companies and universities were doing research to develop better vaccines and this knowledge and equipment to produce them is now used. Finally, this SARS-CoV-2 is more stable so a specific region can be selected to use in a vaccine than HIV that mutates at high speed while the flu virus mutates relatively fast, the reason why we need each year a new injection of a vaccine against a new flu virus.
And yes, these companies also need to earn money to invest in more research and production; therefore, they must sell while others hack the EMA in the hope to steal data and earn without having spend money in research. But, do you know many other companies that would inform about their new product long before it will be commercialised? I doubt it unless they are close to release their product on the markets. On the other hand, pharmaceutical companies also need to be careful that their enthusiasm doesn't end in disappointment as I mentioned higher under point (2) although data suggest the vaccines are very efficient.
Indeed, a difficult balance between being open and being too open so people become suspicious that it is only about money and companies don't invest enough time in the safety. Still, as our knowledge about how to develop vaccines grew and production halls were built over the past years, it is normal that vaccines are much faster developed; the Ebola vaccine is another example. But, the distrust is also partly to explain because people don't know the sector and the major efforts and costs to keep medicines, vaccines and health products safe. And yes, more openness in the way how the price of medicines is determined may also help to restore trust (or not).
Some people claim a microchip will be injected together with the vaccine. I doubt it. Still, already an app is used to trace whether we came in contact with someone with the virus and a QR code is used during testing. A microchip may be very convenient in case certain people received the vaccine or tested negative e.g. to move faster when boarding a plane compared with the use of a QR code that needs to be scanned. Thus, we shouldn't simply say that is rubbish as today it can be done.
Expensive drugs and health products - a rethink of the financing needed?
It is correct that the price of certain medicines is too high. I think this is partly the result of the "Kiwi model", invented by New Zealand whereby doctors are encouraged to prescribe the cheapest drugs, often by genetic companies who had the least costs as they almost "copy and past" from the originator who invested lots of money over many years to develop the product and keep its information up-to-date.
In addition, in the past more general drugs were developed such as acetylsalicylic acid (better known as Aspirin), paracetamol and ibuprofen whose sale resulted in huge income for companies. But now, even these drugs face more restrictions that may be the result of interactions with other drugs, or better knowledge why certain side-effects occur by some people, and this may restrict their widespread use.
Further, today scientists start to understand the mechanisms of certain (very) rare diseases and because of better techniques, treatment for people with rare and very rare diseases are developed that the developer can only sell for a limited time before the parent expires, and thus developers need to charge high prices to receive a return within a short period to reduce any debts they may have made during the development after which other companies can produce the treatment so income for the originators decrease, even when they need to continue their research into the safety of their products.
In the meanwhile, other cheaper or more effective products may replace the first one altogether. It is also possible that a one-off treatment is sufficient to heal someone (such as for gene or stem cell therapy) so the company earns money only ones for each patient with a rare disease. Indeed, smaller companies may go bankrupt as they built-up huge debts during the development while larger companies may buy those smaller companies and still decide rarer diseases are not worth further investigation - unless drugs such as paracetamol and ibuprofen generate sufficient money to invest in rare diseases. Finally, specialist equipment to produce medicines and vaccines become more expensive so companies need to earn more to buy them although in the longer term, companies will safe on salaries when they need to employ fewer people. Still, this equipment and how they make products need to be approved by medicine agencies before products can be made that can be considered safe for human consumption.
And thus, even when patents for e.g. the coronavirus vaccines are open source, it is unlikely other companies can help in the early production as they may not have the equipment to produce them large-scale. Further, an ever more expensive society is an illusion as I wrote before. And thus I think pharmaceutical companies are now at their biggest and soon may start to become smaller again as they can't finance the ever growing numbers of medicines and other products while richer societies no longer accept to pay ever higher prices because they can no longer afford this, even when these higher prices compensate for the losses companies have when they sell products such as vaccines in developing countries. Therefore, I think collaborations between universities and their spin-offs, small pharmaceutical companies and what is known as "big pharma" but also governments will increase but, on condition that a system exists that allows that inventors and researchers earn sufficient when their product is on the markets.
And thus I, and many others, think that how the development but also monitoring of the efficacy and safety of medicines, vaccines and health products is financed need to change,
- so companies make money to repay earlier development costs but also to invest in more research and better production and
- products remain affordable for patients, governments and insurance companies.
In a next publication, I will illustrate with an example how the product information, i.e. scientific and public leaflets are kept up-to-date.
Later, another publication will explain how medicines are developed and their safety checked before and after authorisation when they are sold on the markets, illustrating the huge costs and time to advance and benefit society.
This understanding is important to develop a new way to finance this research and production. Otherwise it is only blaming. And yes, control agencies and laws but also competition are needed to prevent abuse of power by these companies on which we all depend for our health.
Note: In case errors are seen, please leave a comment so the text can improve further. Comments on the content are also welcome.
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