Thursday, December 5, 2019

Shady Pharma At It Again?

Since 2004 gay men and women, as well as other at-risk groups, rejoiced over the release of a drug designed to nearly eliminate the risk of HIV transmission. Truvada, also called tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), is an antiretroviral medication that claims a 90% efficacy rate at preventing HIV infection as long as patients adhere to the daily regimen (Riddell, Amico, & Mayer, 2018). However, as with any medication, Truvada comes with some risks. A study released just this year by Drak et al. found that the miracle medication causes serious renal impairment, with an average eGFR reduction of 2.5mL/min/1.73m^2. Renal function was also found to continue to gradually decline over time at a rate of -0.38 mL/min/1.73m^2. Additionally, Gilead Sciences, Inc. also reports that lactic acidosis, severe liver problems, and severe bone thinning and fractures may occur with use.

Fear not! Gilead Sciences is now releasing a newer, safer drug called Descavoy. Here is where things get a little sketchy though. This new drug, which comes with fewer side effects, was developed in 2005, but its development and release were put on hold by the manufacturer, and was only resumed after generic medications could be released. Advocates are now claiming that this was a money-making scheme that exploited those that benefit from these kinds of life-saving medications. According to the Washington Post, this claim was also made in a class-action lawsuit currently under review in California.

This begs the question, was Gilead in the wrong? We give a lot of freedom to pharmaceutical companies for the sake of Capitalism and free enterprise, but should this be the case when it comes to our health? Do we not owe it to ourselves to require drug developers to always work with beneficence in mind and only release the safest and most effective drugs available? Or do we continue to allow them to only operate with profits in mind?

References:

Drak, D., Barratt, H., Templeton, D. J., O'Connor, C. C., & Gracey, D. M. (2019). Renal function and risk factors for renal disease for patients receiving HIV pre-exposure prophylaxis at an inner metropolitan health service. PloS one14(1), e0210106. doi:10.1371/journal.pone.0210106

Riddell J, Amico KR, Mayer KH. HIV Preexposure ProphylaxisReview. JAMA. 2018;319(12):1261–1268. doi:https://doi.org/10.1001/jama.2018.191
Rowland, C. (2019, December 5). Gilead delayed safer HIV drug to extend monopoly profits, advocates allege. Retrieved from https://www.washingtonpost.com/business/economy/gilead-delayed-safer-hiv-drug-to-extend-monopoly-profits-advocates-allege/2019/12/05/71d4d6ae-1538-11ea-8406-df3c54b3253e_story.html.

2 comments:

  1. The development of pharmaceuticals to treat diseases more effectively or to finally have a treatment for a rare disease is a great advantage in medicine, but at what cost. Pharmaceutical companies appear to be a great idea on the surface, but it is easy to forget that these companies are out to make a profit. The current pharmaceutical system in the United States is broken for many reasons. First off, access to prescription drugs is not equal. About 28 million in the United States do not have healthcare insurance (Berchick, Barnett, & Upton, 2018). Just cause a new drug is on the market, does not mean everyone can afford to take it. High out-of-pocket costs prevent many Americans from being able to fill prescriptions. Out of 11 developing countries, the United States had the highest percentage of adults, 55 and older, (12.8%) that could not adhere to their medical treatment plan due to cost (Morgan & Lee, 2017). Furthermore, cost related non-adherence was compounded by lower income and older age (>65 years old) (Morgan & Lee, 2017). Even if you have health insurance in the United States you still may not be able to afford the copays for medications.

    The price of common, brand name medications is higher in the United States as compared to Canada and Europe. For example, a daily 50 unit dosage of Lantus (insulin glargine) cost $186.38 a month in the US, $63.65 in England, $60.90 in Germany, and $46.60 in France (Kesselheim, Avorn, & Sarpatwari, 2016). The costs of these medications cannot be attributed to research and development as most pharmaceutical companies claim. Pharmaceutical companies spend, on average, $648.0 million on cancer drug research and development, and see an average return of $1658.4 million 4 years after releasing the drug (Prasad & Mailankody 2017). That was just one study looking at 10 cancer drugs! There are many other issues associated with pharmaceutical companies that individuals have written entire reviews on, but the main three were mentioned in this post. Of course, these problems with pharmaceutical companies have been noticed before. Attempts to make changes have been made, but have been turned down as solutions since pharmaceutical companies continue to hold power within our government due to the influence money provides them. Over the past few years, there have been some pushes for non-profit drug research and development, but these attempts are currently at a crossroads within the United States government.

    References

    Berchick, E. R., Barnett, J. C, & Upton, R. D. (2019). Health insurance coverage in the United States: 2018. Current Population Reports. US Government Printing Office, Washington, DC, 60-267 (RV).

    Kesselheim, A. S., Avorn, J., & Sarpatwari, A. (2016). The high cost of prescription drugs in the United States: origins and prospects for reform. Jama, 316(8), 858-871. doi: 10.1001/jama.2016.11237

    Morgan, S. G., & Lee, A. (2017). Cost-related non-adherence to prescribed medicines among older adults: a cross-sectional analysis of a survey in 11 developed countries. BMJ open, 7(1), e014287. doi: 10.1136/bmjopen-2016-014287

    Prasad, V., & Mailankody, S. (2017). Research and development spending to bring a single cancer drug to market and revenues after approval. JAMA internal medicine, 177(11), 1569-1575. doi: 10.1001/jamainternmed.2017.3601

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  2. The comment about waiting to release the medication until the generic was released to me is blatantly wrong and deceitful. Drug companies love exploiting its consumers (hello Insulin), so why would they hold off on making money on a drug that worked more effectively until the generic version was ready? It all seems very sketchy knowing that drug companies exploit populations of individuals who have no choice but to pay for medication if they want to survive (cancer, HIV, diabetes, etc.).


    Regarding beneficence, I think the initial creation of such drugs come from biomedical principles, and for the most part try to convey reactions in medications that can target most patients with such disorders. However, when it comes time for the drug to be released and supported by physicians who are sometimes paid by drug companies, the original beneficence is replaced by greed. To be fair (Nick, this is where you counter with your to be fair), the scientists and research analysts who make these drugs have the best intentions of patient health in their core values to begin with. However, anytime money can be made, especially off a population of people that has seen the devastating effects of death within their community via disease (AIDS epidemic), then why not? Fear has been instilled, and knowing drugs like PREP work to prevent disease, who wouldn’t want to be on it, especially when you know what the damage of HIV/AIDS is capable of? I believe it is one of those examples of great ideas with poor execution; the initial idea showed non malfeasance and beneficence, however once implemented and targeted towards a certain population, once traction is gained and the popularity of the medication increases, so can prices since it is more desirable.

    Knowing that all medications have a myriad of health-related issues, it is not surprising that Truvada also has these metabolic precautions. However, to withhold a medication that was shown to be more effective than the medication being offered is backhanded and goes to show how big pharma is taking advantage of its clientele. Savage Love’s Dan Savage often rallies for his listeners that PREP even exists in the first place and is an effective method in preventing HIV. Knowing how the AIDS epidemic impacted the world during the 80s and 90s, the creation of such a drug gave people who were at higher risk of developing HIV a chance of autonomy and justice. However, by withholding a better alternative compared to the currently available method removes justice out of the equation.

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