Whitaker writes "In short, in the 1950s, what American physicians and the general public learned about new drugs was molded, in large part, by the pharmaceutical industry's marketing machine..[which] played a critical role in the recasting of neuroleptics as safe, antischizophrenic drugs for the mentally ill." (p.150, kindle edition). His contention here is that the pursuit of profit by pharmaceutical companies skews their ability to do unbiased research and clinical trials on their products.
In an article published in the New England Journal of
Medicine in 2008, researchers studied the clinical trials of 12 different
antidepressants that were approved by the FDA (involving 12,564 participants). Of all these studies conducted, 97% of the
studies showing positive results were published, whereas only 12% of the negative
studies were published.
Americans consume more prescription medications that all the world combined. Often we demand quick fixes of our "pathologies" -- a pill. It is easier to put a child on medications than to delve into deep family problems and issues and change them.
The social context here is twofold 1) Americans want medications to fix their problems, and 2) the pharmaceutical industry and it's marketing machine are driven by profit. It almost seems like the perfect storm, culminating in questionable clinical trials and findings that many feel are suspect.
Questions for consideration / posts / and replies:
1) How does social context impact research in general? what topics get researched and which ones do not?
(for example, there is very little research on sex and sexuality for people with developmental disabilities, because social mores frown upon people with DD having sex)
2) How much of an impact does the current social context (profit and demand) have on clinical trials of medications for mental illness? what might be the incentive for downplaying negative effects of these new classes of drugs?
3) The FDA is supposed to protect people from bad drugs coming to market. Is the organization successful in doing this? Why or why not?
Reference: Turner, E.,
Matthews, A., Linardatos, E., Tell, R., & Rosenthal, R. (2008). Selective
Publication of Antidepressant Trials and Its Influence on Apparent Efficacy New England Journal of Medicine, 358 (3) 252-260Cited
in Bojrab, 2014
In answer to question #3, I think that the FDA is not nearly as successful as it ought to be, given the resources at its disposal. Reports of the FDA being “fundamentally broken” are not new; in 2009 several FDA scientists sent an open letter to the Obama administration pleading for him to restructure the agency because “corrupt FDA managers” are putting the American people at risk (Mundy & Favole, 2009). In addition, the FDA itself has admitted to approving medications and medical devices that weren’t safe as a result of political pressure (with said politicians having received campaign contributions from the pharmaceutical companies) (Harris & Halbfiner, 2009). More recently, within the last year or two it’s come to light that the FDA is receiving huge amounts of money from Big Pharma (application fees of almost $2,000,000 for a single application don’t seem quite right) (Wapner, 2012; Kaplan, 2013).
ReplyDeleteThe FDA passed a law in 2007 that required all clinical trials to be published within a year of completion, with a fine of %10,000 per day for any study not in compliance. But when the first audit was conducted in 2012, it found that 80% of clinical trials covered by the law had ignored their requirement to report, and had never been fined even for a single day (Goldacre, 2013).
The pharmaceutical companies rarely voluntarily publish research that shows failure, so it’s not exactly hard to figure out what they’re trying to hide. But why would the FDA look the other way while they hide it? Well, those application fees line an awful lot of pockets, don’t they? Maybe I’m being pessimistic, but I’ve seen family members misdiagnosed and involuntarily drugged into zombies who lost entire years of their lives because of a corrupt and inept system. What you see depends on where you stand, I guess.
References:
Goldacre, B. (2013, Feb. 1). Health care’s trick coin. Retrieved from http://www.nytimes.com/2013/02/02/opinion/health-cares-trick-coin.html?_r=1&
Harris, G. & Halbfiner, D.M. (2009, Sept. 24). F.D.A. reveals it fell to a push by lawmakers. Retrieved from http://www.nytimes.com/2009/09/25/health/policy/25knee.html?_r=1&partner=rss&emc=rss
Kaplan, R. (2013, Oct. 7). Reports: Emails show alleged pay-to-play between drug companies, FDA. Retrieved from http://www.cbsnews.com/news/reports-emails-show-alleged-pay-to-play-between-drug-companies-fda/
Mundy, A., & Favole, J. (2009, Jan. 08). FDA scientists ask Obama to restructure drug agency. Retrieved from http://online.wsj.com/news/articles/SB123142562104564381?mg=reno64-wsj&url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB123142562104564381.html
Wapner, J. (2012, Jan. 25). How much money do drug companies pay the FDA? Retrieved from http://blogs.plos.org/workinprogress/2012/01/25/how-much-money-do-drug-companies-pay-the-fda/
Social context has a huge impact on research in that whatever ailments are “occurring” and being experienced most often. They are going to be the ones targeted for research. I feel like the topics that are being portrayed the most in media are the ones that research companies tend to lean towards. For instance when Viagra first came out there were multiple types of medications similar to it that were developed. During the winter months when there are more people experiencing depressed states due to lack of vitamin d there are more advertisements for medications to treat these conditions. I believe that the same goes for research. The hot topics lead the studies and the discussions that are avoided are the ones that are not delved into.
ReplyDeleteThe margin of profit and demand has a huge impact on clinical trials of medications for mental illness. As long as there is a demand for medications there will be new ones developed and the need for more trials. It is a never ending cycle. The incentive for downplaying the negative effects would be that it makes the medication look better. The more appealing it appears to be the better the chance individuals will be willing to take it.
I think that social context impacts research in many regards. Depending on where the demand is, is going to determine what research is focused on. I would have to agree with Sabrina’s post about what topics will be researched the most will depend on the ailments at the time. I also think that popular and easier topics get researched and focused on more so than difficult ones. Profit and depend is detrimental in regards to what topics get researched. If there is no profit coming in and the demand is low, research in turn will not keep going. Pretty much all the drugs companies have to do is prove to the FDA that the benefits of the drug outweigh the risks and they can be used. Although with that being said, drugs do have to be tested in labs, on animals and on humans to be able to make it to the market. Personally, I think it is very simple for drugs to be placed on the market. I think the FDA needs to have a better regimen that should be followed.
ReplyDelete1) How does social context impact research in general? what topics get researched and which ones do not? (for example, there is very little research on sex and sexuality for people with developmental disabilities, because social mores frown upon people with DD having sex)
ReplyDeleteI believe that research might get done on more topics/issues than we realize, but due to social norms, not all of the results become publicly known. Also, research that interests people with money tend to get funded, whereas research on things that people aren't interested in tend to get put on the back burner or stopped completely. Social context plays a role in everything. Researchers have to learn how to work the system, in order to get their projects funded, usually by working into the research something that society deems interesting while also researching their own idea.
2) How much of an impact does the current social context (profit and demand) have on clinical trials of medications for mental illness? what might be the incentive for downplaying negative effects of these new classes of drugs?
People that perform clinical trials will lessen the intensity of negative side effects by stating that every drug has side effects. They are also driven by the pharmaceutical company achieving a patent on a new drug, enabling them to gain all of the revenue for that drug for 8 years. This is why brand name drugs cost so much money, because they are still in their initial patent years, before a generic can be made. This drives pharmaceutical companies to create and test new drugs for anything and everything you can think of. With todays ideation of taking medication rather than changing lifestyle to improve health, pharmaceutical companies are only encouraged more to create and test their new drugs.
3) The FDA is supposed to protect people from bad drugs coming to market. Is the organization successful in doing this? Why or why not?
For the FDA to approve a drug, there has to be clear evidence that the good effects outweigh the bad. This can't always be done, whether that's because there wasn't enough research done or the bad effects are so blatantly obvious that they can't get past them. I think there are a lot of medications that pharmaceutical companies test and try to get approved through the FDA that never make it to the shelf, we just don't know about them. I think the FDA is successful in keeping the bad drugs from ever reaching the public. I also think that there are always going to be side effects, which is kind of the point of taking a medication. Some side effects help people, some cause other problems that force people to take more medication to counteract them, and so on. It's just the nature of the beast.
1)
ReplyDeleteSocial context impacts just about everything in life. The main component of social context is the fact that if one person does something and it gets positive feedback, we all want to do it. (Hence how things become "trendy" or "popular") With that being said, if one researcher does an experiment on one particular medication and raves about the results, more scientists will conduct experiments on the same medication.
2)
There are many benefits to downplaying negative side effects for the drug industry. If a new drug comes out that seems to work great, many people will purchase the drug from the pharmacy, and then the company that manufactures the drug will make billions on it. All of the middlemen will also make tons of money off the product too. So, many drug companies hide the negative effects just because they're making a lot of money off of it. For example, there is the common birth control YAZ that was on the market for years. It was originally reported that YAZ was a great birth control, and it soon became popular. Millions of women were on the pill, and then there were commercials on TV saying how harmful it is. And yet, people still stayed on YAZ because the company and the doctors were reassuring them that it was alright to take. Come to find out, it caused many deaths and medical complications, and it's now being taken off the market years later.
3) Overall, the FDA is somewhat successful with keeping bad drugs off the market. There are many drugs on the shelf that can cause serious complications to a person's health, and I would eventually like to see those taken away. As for the side effects, I think most medications have them. It's important to list all of the side effects though, which I'm sure many companies do not. I think that is something that needs to be regulated more by the FDA.
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ReplyDeleteThe reason for the FDA is to protect the public health and ensure that bad drugs do not come on the market. There are SO many drugs waiting to be approved by the FDA that it's possible some become approved without being fully critiqued or having enough research done to show the negative health effects. Also, like mentioned above it Leanne's comment, it is very possible that not all information is given to the FDA from the companies.
ReplyDeleteTo reduce the likelihood of having bad drugs being put on the market it think it’s very important that A LOT of research studies takes place, especially longitudinal studies. My reason behind thinking more longitudinal studies should take place is because when this happens we’re able to see the long term effect that we don’t see when new drugs come on the market.
Is unfortunate that some drugs can fall through the cracks and become harmful drugs on sale for consumers
Delete1. Society dictates nearly everything we do and think nowadays, which is terrifying, as we are a part of society, but it collectively dictates our lives. It's really unfortunate. We all tend to "follow the leader," so to speak. When one trailblazer comes along to study something new, people either love it and pick up similar studies, or they shun the researcher for thinking too far outside of the box. It's unfortunate that this is the society we live in.
ReplyDelete2. I think that nowadays, pharmaceutical companies are driven by profit more than ever. There's always a rush to be the first to find the cure for something, or to come up with the newest, best treatment It's less about helping the patients and more about turning a profit.
3. I think that the FDA does do a good job keeping harmful drugs out of drugstores, however, it has gotten sloppy. Pushed by drug companies to let new drugs onto the market that may not have been properly tested, etc, the FDA has missed the mark on a few new drugs. It also loosens it's restrictions in times of crisis, such as when H1N1 was sweeping the nation. In order to deliver an effective drug to the people in need, the FDA loosens it's restrictions to allow a drug to pass more quickly.
I agree its scary that society can determine so much of how we live our day to day lives.
Delete1) How does social context impact research in general? what topics get researched and which ones do not?
ReplyDelete(for example, there is very little research on sex and sexuality for people with developmental disabilities, because social mores frown upon people with DD having sex)
Research is most certainly influenced by society. I believe that the research that is most widely published and accepted depends on two factors, 1. How much money and/or support from society, and the societal views on the subject. For example when Masters and Johnson conducted their research on the human sexual response it was found improper and inappropriate work, and created much controversy for the researchers. Because of the time period this kind of research was at first rejected. I feel that the topics that most often get researched fall within the bounds of what society deems appropriate and noteworthy, as well as how much interest and funds can be raised for the specific research. Topic that are more taboo or are considered high risk and rather obscure are most often not researched. I believe it boils down to society and especially the medical community to consider a research study appropriate and credible work.
2) How much of an impact does the current social context (profit and demand) have on clinical trials of medications for mental illness? What might be the incentive for downplaying negative effects of these new classes of drugs?
Profit of drugs is a huge problem in todays society. Consumers are spending tons on medications and the drug companies want people to choose their brand name drug over the competitors. The bigger the drug company, the bigger the money, the more clinical trials being conducted to develop the next “big” drug to market to the consumer. For this reason I feel the developers focus more on developing a drug that works and less on the side effects. Downplaying side effects makes the consumer feel safe about using the drug. Focusing on what the drug is capable of and down playing the negative effects suggest the drug is harmless and provides little negative effects.
3) The FDA is supposed to protect people from bad drugs coming to market. Is the organization successful in doing this? Why or why not?
I believe that the FDA prevents drugs that with cause death or severe complications from side effects. However I think their needs to be more awareness and information out their for consumers on exactly how to take the drug for the best potential outcome and the least side effects, and most importantly which drugs to not take together.