Abstract
This research proposal discusses the issues with transparency in the pharmaceutical industry. The drug approval process is lengthy and expensive. This is reflected in the price of the drug once it is approved. If companies were to share their data and aid each other in the process, the drug development would be faster and cheaper. Additionally, companies often don’t publish their clinical trial data to the public. I propose that we create a database that compiles clinical trial data and a way that companies can share information with each other. This will allow there to be more transparency with the public and lower the final costs of drugs.
Introduction
Background
An enormous problem with the pharmaceutical industry is the lack of transparency and information sharing between companies. In 1997, the United States Food and Drug Administration (FDA) created a law known as the FDA Modernization Act of 1997. This law required that companies publish their clinical trial data. At the start, this rule only applied towards drugs which were life saving. However, in 2007, the FDA changed its Amendments Act so that all clinical trials had the same registration requirements (Millar n.d.). To try and motivate companies that were not sharing information, the nonprofit organization Bioethics International created the Good Pharma Scorecard (GPS) where they ranked different biotech companies based on how well they shared their data. The results showed that the median score was fairly low at 63%, but as companies received the data they began to implement new policies that improved the median score to 80% (Miller et al., 2019).
Before a drug can enter the US market, it has to be approved by the FDA. Drugs that have been previously labeled as over the counter (OTC) medicine do not have to receive any approval from the FDA once their monograph (information about the drug ingredients, side effects, uses, etc.) is finalized. For a new drug to receive FDA authorization, the drug manufacturers have to conduct lab, animal, and human clinical testing. The data they generate from the trials then has to be submitted to the FDA for review (registrar corp). A particular section of the FDA known as the Oncology Center of Excellence (OCE) is in charge of working with other researchers from Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research to determine what cancer treatments or biologics can be approved (Cancer.Net, 2018). Drugs that have been noted to have severe side effects can still be approved if the benefits outweigh the risks. This is quite common for patients who suffer from cancer and for whom previous approved treatments have failed to work. These patients have access to drugs that are still in the development process through partaking in clinical trials (Cancer.Net, 2018).
When a company has developed a formula or a drug, they apply for a patent. If they were the first to create this idea, the company would be awarded a patent for 20 years which can not be renewed after this time period. When two companies are developing the same type of drug, the first company to succeed will be the one that is awarded the patent (FDA, 2020). Oftentimes, the other company that was unable to finish first, loses money as they are unable to market their product. Once the patent expires, any other company has access to the formula and is able to develop their own drug based on it, otherwise known as a generic drug (PharmExec, 1998). When this happens, the original company that developed the drug starts losing their profit because the generic drugs will cost less.
While the drug approval rate is commonly criticized for being slow, there have been cases in which some drugs may be able to pass through the FDA surveillance and adversely harm the population. In 1999 the FDA approved the drug Paxil, an antidepressant, which was developed by the company SmithKline Beecham (GSK). Although this drug was only approved for adult use because of the severe side effects, GSK faked the results and marketed it for adolescents as well as pediatric patients (Kitwood, 2017). They did not publish data from two clinical trial studies that showed that Paxil had many unintended negative side effects in the younger population. Because of this, doctors prescribed the drug to teenagers. In the end, GSK had to pay 3 billion dollars to the US government because of the lawsuits they were served (Kitwood, 2017).
As a result of a history of misinformation, it is essential that the FDA or pharmaceutical community develops a way for drugs to be thoroughly assessed, tested, and held accountable. In particular, biotechnology companies have such information and data, in what they call libraries. A biotechnology library is where a company stores their DNA fragments that they have created through molecular cloning and is stored in microorganisms. A company uses their libraries in their first steps of developing a drug to identify the optimal formula. Each company views their library as something to be protected and does not share their compounds with other companies. If companies shared their databases, something that AstraZeneca recently did with Sanofi in 2015, they would have access to more compounds which would speed up the drug development process (Mullin, 2015).
Literature Review
As much as the pharmaceutical industry has seen its own blunders, there has also been research on how we can prevent further problems in the future. The research article “Drug Development Challenges” written by the National Academic Press in 2014, discusses how drug development is a process that is expensive and takes a long time. They believe that the current drug development process should be changed so that there is more emphasis on human data, better diagnostic/therapeutic biomarkers, and better predictors of drug effects. There have been many examples of animal models not properly representing a human’s system response to a drug (Soek et al., 2013). Additionally, they found that there is not proper clinical pathotyping. Other papers can not be trusted when developing their own research. Bunnage (2011) noted that failures could be prevented by sharing results. This team conducted a literature review/meta analysis where they gathered information for a wide variety of sources and used it to create a paper. They also used information from the past 10 years about the drug development process. A limitation of this paper is that there was not much information about how exactly we could go about changing the policies to implement these ideas. The high costs of drug development cause many biotech companies to go bankrupt when their drug fails. The patients who need the drug have to pay more for the product. This paper discusses how the high costs of drug development can be prevented by certain measures that should be taken.
Moreover, by taking measures to assess drugs before they are manufactured, companies may be able to also reduce the prices of their drugs, make them more accessible to the population, and as a result, gain a more sustainable profit than selling them for exorbitant prices. One option to better control the drugs is giving more power to the government on which drugs are sold. The paper “How to Reduce Prescription Drug Prices: First, Do No Harm” by Scott Atlas discusses what can be done to decrease the cost of drugs for consumers (2020). Atlas believes that if the middlemen were not involved in the process, and the drug products were directly bought by the people, it would be more affordable. Atlas talks about how the government can give direct rebates to the buyers rather than to the PBM (middle men). The current research shows that in countries where drug prices are controlled, fewer drugs were created or attempted to be created. But for a country that bases its economy off of capitalism, it is hard to predict how exactly changing the structure of America’s pharmaceutical model to one that is similar would impact the economy and industry. Atlas believes that government negotiation would increase the wait type for drugs. Atlas gathered their data from studies and surveys that were done. He used what they learned to create a new possible solution. Measures taken by governments are discussed as well as the future plans for drug pricing. This topic mostly affects patients who have a disease that needs a specific type of drug. This paper discusses a solution the government can take to decrease the cost of drugs for consumers.
Another option to improve how the pharmaceutical industry develops its drugs is through databases, where information is readily available to all companies, motivating companies who are concerned that they might develop a faulty drug through misinformation. The article “Patent Protection Struggles'' by Himanshu Gupta et al. (2010) discusses how many companies lose money as their patents fail. It then goes on to include data and possible solutions a biotech industry can take to prevent a great loss of money. Current research shows that combining two drugs that are close to patent expiration can increase revenue. The team also found that drugs patents can be renewed if they drugs are found to be used in other cases. The research team gathered their information by using published data on drugs and their prices and profits. They also included information from other research articles. A limitation of this paper was that it only had access to public data, and was unable to include information from all types of drugs. This shows that by more openly sharing findings and making them accessible to the public, biotechnology companies can develop drugs that are cheaper and more robust, taking information from past failures and successes, which we will be discussing more in this paper.
Rationale
The reason why it is so important that clinical data is shared across companies, is that it could help save time. If companies had access to previous data, they would have a better understanding of not only the successes but the failures as well. This would allow companies to change their procedure to one that was more successful, allowing them to save money. Additionally, the data that is shared can be used as a control which would allow clinical trials to progress at a quicker pace since fewer people would need to be enrolled. By sharing data, pharmaceutical companies will be able to decrease their spending which would in turn lower the costs of drugs for consumers.
Objectives
My goal is to lay out a design of a database, similar to the National Institute of Health’s Drug Information Portal, where all companies can access data from clinical trials and share their components of their databases. This proposal will discuss possible components of the website.
Methodology
This database will be used for sharing data between biotech and pharmaceutical companies, and the website would contain information about clinical trial results/processes as well as information about the various formulas that companies have created to try and treat certain diseases. The estimated time of completion would be 6 months to one year. It is important that companies share both data on successes as well as failures. The information about the clinical trials should include the efficacy rate, patient/participant information, and how the trials were conducted. This information would have to be checked by researchers or other experts in the field for credibility before it could be posted on the database.
The second part of this database is one that is specifically created for biotech companies. This section would be where companies could post information about what is in their library and conduct exchanges with other biotech/pharmaceutical companies. This will allow companies to have more compounds that they can test on which allow for them to save time in having to create the products.
The biggest issue with this proposal is getting the companies to want to work together. The pharmaceutical industry is highly competitive, where only the top companies are able to survive. It is possible that these companies do not want to share their data with the smaller companies, because they might fear that they would lose profits. A way this is combatted could be through use of something similar to the GPS, where each pharmaceutical company that shares their data is awarded ‘points,’ which reflects on how open a pharmaceutical is to the public, which could help a company's public relations and image. In addition, the government could try and provide monetary incentives for companies that share their resources based on the number of points they receive.
Links with Other Projects
This project is similar to the one Bioethics International created when they made their GPS. Except this proposal expands on ranking the companies to creating a database where they can store their information. Right now there are many biotechnology tools such as cBioPortal, the database from the company Drugs, xena browser, depmap, genemania, etc. that have information stored about genes and cancers. The database cBioPortal even has a way that you could recall a specific study based on different variables. If we worked with these biotechnology websites, we could use these methods to develop a database that also includes information about all the clinical trials and their results.
Legal Considerations
Since this website will have private information about different companies, it is important that the data on this website is properly secured. The ideas of the companies should also be protected to make sure that one company does not steal another’s idea without giving credit. To prevent this from happening, companies should only post ideas that are patented.
Anticipated Problems
One possible issue that is important to note is that similar to other government organizations, it is essential that this website is closely monitored by the public in order to prevent lobbying and biased information from circulating. Companies can lobby against the government in order to ensure that their own drugs will be passed with a good reputation, which leaves room for further faulty drugs being developed. In order to combat this case, it is essential that the website provides all information on funding clearly for the public to see who funds the organizations as well as ensure that many competing companies may be able to fund the organization, to ensure that the competition is fair game and competing companies may be able to test other companies.
Additionally, as there are many clinical trials that have been conducted, it will be quite difficult to try and compile them all on a website. This is not a task that can be completed by one person, but is one that will require many people and time.
Discussion
While some pharmaceutical companies may be hesitant to see this as an opportunity for other companies to steal their information on their current clinical trials and drug development processes, this project has the potential to actually help develop a database that would make sure that the right company gets credit for providing the public with safe, effective, and accessible drugs to use. If data about clinical trials is made available to the public, it could help more people understand the safety of the drugs. Moreover, having a database where companies can exchange their resources would also allow drugs to be developed faster and save money in the development process, creating an industry founded by honesty and integrity.
Bibliography
Commissioner, O. of the. (n.d.). FDA backgrounder ON FDAMA. U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/food-and-drug-administration-modernization-act-fdama-1997/fda-backgrounder-fdama.
Drug approval and labeling. Cancer.Net. (2019, December 13). https://www.cancer.net/research-and-advocacy/introduction-cancer-research/drug-approval-and-labeling.
Miller J, Ross J S, Wilenzick M, Mello M M. Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices BMJ 2019; 366 :l4217 doi:10.1136/bmj.l4217 https://www.bmj.com/content/366/bmj.l4217
Mullin, R. (2015). No Strings Attached In Compound Library Deal. C&EN. https://cen.acs.org/articles/93/i47/Strings-Attached-Compound-Library-Deal.html .
PharmExec. (2020, November 15). What happens when a product loses its patent? PharmExec. https://www.pharmexec.com/view/what-happens-when-product-loses-its-patent.
Why is Pharma so bad at sharing clinical trial data? - Pharma TECHNOLOGY focus: ISSUE 87: October 2019. Pharma Technology Focus | Issue 87 | October 2019. (2019, September 27). https://pharma.nridigital.com/pharma_oct19/why_is_pharma_so_bad_at_sharing_clinical_trial_data#.
