You are too old/too young to participate. Sorry.
In my last post a about Santa and Dollars, I wrote about many of the "isms" and the hope that they are fading away. Friend UL wrote about an often overlooked type of discrimination - ageism. It made me think upon a recent example of ageism I learned about that is part of science and clinical trials of medications.
As I've mentioned before, I work for a large pharmaceutical company in the pharmacovigilance (PV) department (Drug Safety). We are the group that makes the list of all those nasty side effects that you hear listed in prescription drug commercials (e.g., dizziness, nausea, oily discharge, liver damage, etc.). Most of these lists come from what is discovered as side effects during the three phases of clinical trials for the product. When conducting these clinical trails, especially phase 3, you have to have very tight controls on subject selections so that the product is being tested against the disease and eliminating outside variables, as much as possible. To determine who gets the treatments (and depending on the target population of the medicine), you have to create a list of the Special Populations of those that will be excluded from the study. For most studies, the first two groups most often listed as special populations are pediatric and older patients.
Scientifically, it can make sense to exclude these two groups. For too long, children were thought of as little adults when it came to medicine. You just adjust the dose for the body weight. This was a big mistake since the metabolism, brains, and organ systems of children are developing and are much different than adults. In the past few decades, the FDA and other health regulatory agencies (MHRA, EMEA, SFDA, Health Canada, etc.) have increasingly emphasized the need for special clinical trials for children.
The older excluded group is a different issue. Older humans tend to have multiple issues that can affect/draw questions to the clinical trials. At 44, I am starting to age out of some studies. That can be attributed to my needing two different asthma medications along with being on the verge of high blood pressure and cholesterol. If I start taking meds for those, it would further complicate any clinical trials because of the potential issues of drug interactions and other pre-existing conditions becoming exacerbated. As we age, we become more medically complex. All of this can make medical testing very tough and is understandable for filtering out during clinical trials, but on the other hand...
The other hand is that by excluding these special populations, we don't learn what health issues the new product can introduce to the populations. It may greatly help them, hurt them, or do nothing at all. The danger can come though when the drug is approved and it gets out to the general population, which includes these special populations. We often learn more about the side effects of drugs for these groups from reports of adverse events from marketed drugs than those in clinical trials, especially for special populations. Sadly though, that meant a sick patient had to live (hopefully) through the adverse drug reaction. Because we didn't test on these subjects, we may not know the issues caused by more-complex health profiles of children and our older communities.
When practicing PV, we don't only list the side effects, we build up a benefit/risk profile for the product. We want to help the prescribing physicians, patients, and other healthcare providers by giving them the best and most current information on the drug. This enables them to weigh the benefits and the risks of the product. Many risks can be reduced or mitigated by taking special actions, so this knowledge is crucial for making the correct treatment plans. To truly understand this, we must include special populations in the clinical trials and determine how the medicines work within them. Sadly though, this isn't done, mostly due to the cost and time.
Currently it costs north of a billion dollars, not including production/manufacturing costs, to get a drug approved by regulatory authorities. With the short trademark life on the product and that it takes 8+years to get approval, doing further clinical trials aren't deemed cost effective or time efficient. For many products, warnings go out stating that data for special populations is incomplete or missing and that doctors should be very careful prescribing to them or should avoid prescribing them at all.
We (industry, regulatory authorities, insurance companies, advocacy groups, patients, etc.) need to determine a way to require further clinical trials that include special populations to ensure better data across all patient populations and yet makes it financially feasible for the drug companies to do so. I think all sides need to be flexible and working toward a solution rather than trying to protect only their own interests.
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| Unique Forms of Continuity in Space - Umberto Boccioni - MoMA - 122813 |
In my last post a about Santa and Dollars, I wrote about many of the "isms" and the hope that they are fading away. Friend UL wrote about an often overlooked type of discrimination - ageism. It made me think upon a recent example of ageism I learned about that is part of science and clinical trials of medications.
As I've mentioned before, I work for a large pharmaceutical company in the pharmacovigilance (PV) department (Drug Safety). We are the group that makes the list of all those nasty side effects that you hear listed in prescription drug commercials (e.g., dizziness, nausea, oily discharge, liver damage, etc.). Most of these lists come from what is discovered as side effects during the three phases of clinical trials for the product. When conducting these clinical trails, especially phase 3, you have to have very tight controls on subject selections so that the product is being tested against the disease and eliminating outside variables, as much as possible. To determine who gets the treatments (and depending on the target population of the medicine), you have to create a list of the Special Populations of those that will be excluded from the study. For most studies, the first two groups most often listed as special populations are pediatric and older patients.
Scientifically, it can make sense to exclude these two groups. For too long, children were thought of as little adults when it came to medicine. You just adjust the dose for the body weight. This was a big mistake since the metabolism, brains, and organ systems of children are developing and are much different than adults. In the past few decades, the FDA and other health regulatory agencies (MHRA, EMEA, SFDA, Health Canada, etc.) have increasingly emphasized the need for special clinical trials for children.
The older excluded group is a different issue. Older humans tend to have multiple issues that can affect/draw questions to the clinical trials. At 44, I am starting to age out of some studies. That can be attributed to my needing two different asthma medications along with being on the verge of high blood pressure and cholesterol. If I start taking meds for those, it would further complicate any clinical trials because of the potential issues of drug interactions and other pre-existing conditions becoming exacerbated. As we age, we become more medically complex. All of this can make medical testing very tough and is understandable for filtering out during clinical trials, but on the other hand...
The other hand is that by excluding these special populations, we don't learn what health issues the new product can introduce to the populations. It may greatly help them, hurt them, or do nothing at all. The danger can come though when the drug is approved and it gets out to the general population, which includes these special populations. We often learn more about the side effects of drugs for these groups from reports of adverse events from marketed drugs than those in clinical trials, especially for special populations. Sadly though, that meant a sick patient had to live (hopefully) through the adverse drug reaction. Because we didn't test on these subjects, we may not know the issues caused by more-complex health profiles of children and our older communities.
When practicing PV, we don't only list the side effects, we build up a benefit/risk profile for the product. We want to help the prescribing physicians, patients, and other healthcare providers by giving them the best and most current information on the drug. This enables them to weigh the benefits and the risks of the product. Many risks can be reduced or mitigated by taking special actions, so this knowledge is crucial for making the correct treatment plans. To truly understand this, we must include special populations in the clinical trials and determine how the medicines work within them. Sadly though, this isn't done, mostly due to the cost and time.
Currently it costs north of a billion dollars, not including production/manufacturing costs, to get a drug approved by regulatory authorities. With the short trademark life on the product and that it takes 8+years to get approval, doing further clinical trials aren't deemed cost effective or time efficient. For many products, warnings go out stating that data for special populations is incomplete or missing and that doctors should be very careful prescribing to them or should avoid prescribing them at all.
We (industry, regulatory authorities, insurance companies, advocacy groups, patients, etc.) need to determine a way to require further clinical trials that include special populations to ensure better data across all patient populations and yet makes it financially feasible for the drug companies to do so. I think all sides need to be flexible and working toward a solution rather than trying to protect only their own interests.
Thank you for this rich post, Karl. Can you share what you know about the Shingles vaccine? That became a concern of mine over the holidays as my granddaughter's other grandmother got Shingles in mid-December, and she describes pain so severe she has become unconscious at times. The vaccine is only 50% effective and is a live virus that I've heard can actually cause Shingles. I would value your learned opinion.
ReplyDeleteUL - I am biased and am pro-vaccine. With that said, I went to webmd to research the shingles vaccine and it says that it is a very safe vaccine. Here is a link. http://www.webmd.com/skin-problems-and-treatments/shingles/shingles-vaccine
ReplyDeleteI recommend talking to your physician to get her/his opinion. For me, I will get it when I hit 50.
DISCLAIMER - I am not a health care professional, so please always check with your physicians/pharmacist before starting any treatment or receiving any medical care.