I am a higher up project manager in a big pharmaceutical company. I know there is a lot of animosity towards big pharma as well as plenty of conspiracy theories. Always wanted to do an AMA to clear up the air regarding big pharma, but due to my desire to keep things anonymous (my employers are also on reddit, and they may not agree with or like everything I say), never had the opportunity...until this Causal Christmas event.
I am here to answer general questions and clear up misconceptions regarding the Big Pharma pipeline of drug development. So AMA!
Edit: Thanks for all the questions, hope I was able to help clarify and inform everyone. Happy new year!
Who is hiding the cure for cancer?
There is no "cure" for cancer. Cancer is particularly difficult to create treatments due to the difficulty of creating selective treatments (it's difficult to selectively target cancer cells without targeting your normal cells). Furthermore, there are actually a large number of different type of treatment options in clinical trials as we speak, and the past few years have seen a big boom in successful treatment options for a variety of different cancer types (e.g. car t-cells).
That being said, a large majority of the drugs fail because while they look promising in animal models, they aren't very effective when you apply them to patients (looks good on paper, but doesn't work as well as intended). To complicate matters, it is still unclear how many cancers form and operate, making developing treatment options for them difficult. You'd be surprised how little we truly know about the details of cancer.
What is your opinion on the opioid epidemic? Do you think big pharma is responsible in anyway? Disclaimer - it is obviously the users ultimate choice to use, just curious on a person's take
The opiod epidemic is a very complicated topic that many people like to make black and white.
1) For general pain symptoms, outside of anti-inflammatories, we don't really have anything to stop/prevent pain. Pain is suprisingly poorly understood, making it difficult to design anything to prevent pain in in of itself. The best approach would be to understand what's causing the pain, and resolve that (but that isn't always possible). It's for this reason often times, your best bet really is opiods (granted, you could have a whole debate regarding medical marijuana, but that's another topic).
2) Opiods are well understood. How they function, their side effects, the good and the bad. They also work. Doctors are in a tight spot. For one, patients that are in pain usually are looking and pressuring for any relief, regardless of the consequences, and they want immediate relief. The weaker drugs like tylenol and ibuprofein, might take the edge off, but most patients just want all the pain gone, not just a slight relief. And as stated in the first point, we don't really have better alternatives. You have a doctor who knows the opiod will work, knows the details and side effects of what they're prescribing, knows the dosage and dependency problems as well, and wants the best for their patient (who only cares about getting their pain resolved). So...they prescribe it, because if they don't, the patient will just go find another doctor who will.
3) That being said, the doctors are not off the hook. There are good doctors, and bad doctors. Many either didn't know, nor cared. It's FDA approved, it's gotta be good then. Again, it works, and shuts the patient up. Many either didn't know, or didn't care about the dependency issues.
4) Understand that when you want to point a finger at pharma, it's the execs you have to point to. I am one of the heads in R&D, but I don't have a say what happens to the drug once it's gone into clinical trials. If we discover a serious adverse side effect in our preliminary studies, all we can do is tell the higher ups and people conducting the clinical trails, that's it. As for the reps selling opiods to the doctors and convincing them to use them. Most of them don't have anything more than basic bachelors, and don't really understand the details of the product their selling. They know what they have been told, and they're job is to sell it following the script provided.
5) Finally, Opiod risks have been well known for years, and the epidemic is nothing new. It is the lack of regulations on any level in big pharma that has allowed it to flourish. The FDA approved the drugs with the full knowledge of the dependencies and side effects. There are very little to no regulations regarding the lobbying to doctors and medical students (yes, we have a huge budget and department meant to sell to upcoming residents and even medical students in their first years, gotta start young). It is a lack of oversight on big pharma, the doctors themselves, and a lack of information on the patients fault...all of which the FDA and government knew and chose to do nothing about for years that has caused this.
Do you agree with Medicare For All???
Definitely. I will say though the higher ups don't share the same values. If it were up to the higher execs, they would prefer to keep the system as is.
How long does it typically take to develop drugs? What are the main costs?
Are there lots of research that get shelved because it's not profitable even though it's actually better than current treatments?
Is it possible for tissue engineering/artificial organs to replace the need for clinical trials? How close is it to replace it?
Do you also use simulation in drug development similar to that of in engineering?
1) Development can take years. My division in particular focuses on what you call "rational design". We use computational programs to screen millions of compounds for a specific target. Once we have a hit (i.e. a drug that does work on our target), then we spend a few years fine tuning and designing it to be more specific, more potent, etc. This is all done in conjunction with animal testing as well. Then the compound is set out to clinical trails, which takes a whole number of years to conduct and millions of dollars....only for the compound to usually fail. Despite how long we work on making, fine tuning, and testing these compounds prior to clinical trails, the bulk of the cost is from the clinical trail themselves. They cost millions and take years to conduct.
2) Hard to say what's "better", if you talk to the people who developed it they might argue it is, but without clinical trails its impossible to say if its "better" or if it even works. There definitely are a lot (and I mean a lot) of projects shelved (even those close to being finished), due to simply being deemed "not profitable enough". As said above, clinical trails are the big cost, if there is even a doubt that the drug might fail, then its tossed for a more viable option.
3) No, and not even close. The human body is too complex to be represented by a single organ or system. We already do animal testing, which is leagues closer to how the human body would react than artificial organs.
4) Don't exactly know what you mean by simulation. If you are discussing in silico simulations, yes, as per my first point. There are a number of different departments, some take compounds from universities that show promise and go straight to animal testing and efficacy. Others take promising compounds and do in vitro work. My department in particular uses computational methods to try and discover promising compounds to target a variety of promising targets.
how did you get to work in R&D? how did you start? and did you ever doubt you took the right path for your career?
Well in short, it really wasn't planned until I got my undergrad degree. I majored originally in chemistry, and was a synthetic organic chemist in the industry for a while. I didn't enjoy the attitude around many of those in the field, and wanted to focus more on the medicinal side, so I got my PhD in biophysics with a focus on biochemistry. During my PhD program, I also fell in love with programming, so also taught myself a number of languages and developed a variety of coding programs. So when I got my PhD, it only made sense to go rational drug design in R&D (you'd need a decent understanding of coding to understand how the libraries are made, a good understanding of biophysics to understand the analytical tools used, and a good understanding of chemistry and biochemistry to understand how the compounds work and are modified/used, all skill sets I had at this point).
People jump all over the costs of meds in the US... I've heard we end up paying the lion's share of the R&D costs... Can you break down the distribution of cost by country?
I'm afraid not. I have little to no knowledge regarding pricing nor the income the company makes via their products in other countries. That being said, the 2nd statement isn't entirely true. A lot of the higher costs in the US go to the insurance companies and higher execs in the pharma company. That said, they do have an impact on the stock of the company, which can strongly influence how much money they are willing to pour into R&D. That being said, from my experience, I have seen little correlation in terms of stock fluctuations and R&D funding (usually, they just allocate resources to another project).
Do you think Bernie Sanders will change the Big Pharma Industry?
One thing to understand is, Big Pharma is global. If the US did change its policies (which just changing how medical insurance works doesn't mean it changes how much Big Pharma can charge), then it would simply change how Big Pharma targets the customer basis in the US. As stated prior, the lengthiest and costliest thing in Big Pharma is the FDA approval process. Changing that will impact Big Pharma far more than changing the medical industry. I have also not heard anything regarding how Bernie plans to effect Big Pharma (more how they plan to effect medical insurance companies).
Two questions, I guess
1) How close are we, really, to an HIV vaccine?
2) There's been alot of talk about rising costs and bankruptcies at many hospitals, especially in rural areas. Tons of mergers are happening and costs are rising for patients. Is Big Pharma worried about the overall health of the medical industry?
1) This is actually difficult to answer, because we are close, but we also aren't. Vaccines against highly mutable viruses (like HIV) are difficult to design because while they may work for that current variant, it might not work for other variants (think flu shot you have to get every year). Granted, the vaccines currently being worked are designed to target multiple strains, there does lie the risk that you may need to get revaccinated. All that being said, I forsee an HIV vaccine by 2030, there are already plenty of promising vaccines in phase III trails, and our knowledge of how HIV works has vastly improved in the past couple years (meaning it will be easier for us to design vaccines and get them approved).
2) I'm afraid I'm not too knowledgeable about the business side of things. I haven't heard anything regarding this from the higher ups.
Do you have any immediate family or anyone close to you that has suffered from opioid addiction and has anyone close to you died because of opioids? I feel, at this point, opioid deaths are like cancer - everyone has been affected by it.
No actually. I've had a friend very briefly get hooked on vicodin, but it was more than a craving at that point than an addiction and he shortly got over it. I myself have taken opiods a handful of times in my life, but usually prefer taking something like Ibuprofein. My family has been fortunous in not having any injuries and procedures that required opiods.
So follow up question to you... and this is meant in no way to be demeaning... Where do you get your motivation/pride to keep going?
I love what I do. I love the science, and I love being able to develop drugs to help people. Granted its take years for us to even get a drug to clinical trails, and granted almost none of them do make it past clinical trails. That being said, if it was easy, everyone would be doing it and all the worlds problems would be cured. Its my job to keep going. Everytime I see a sick child, or suffering person at the ER or hospital, it motivates me to keep going. Everytime I hear how our drugs (those in clinical trails), have helped suffering patients, it keeps me going. To be in R&D means to accept failure, but to never give up.
Its great we have learned a lot about technology with regards to Medical equipment but with regards to Type 1 diabetes all I have seen from the big companies is more devices yet no cure. Is anything being done about this? I have also seen insulin prices just being outrageous. Find it mind boggling to see the outrageous amount we pay here in the US for insulin a dire need for diabetics. I read an article that insulin to create is about $8 a vial how can they charge so much for a vial insulin?
This is because as you might see in all my other answers, we can only target what we know/understand. We know very little about what exactly is causing Type 1 diabetes, and why insulin is either not created, or destroyed before it can do anything by the body (the exact mechanism is unknown). Thus, the only real medicinal alternative is to better methods of delivering insulin. We know that a large part of type 1 is due to genetics, but what genes are being upregulated, down regulated, we don't know (it seems its quite a number of them, making it even difficult to design a drug target for the disease itself).
As for pricing, as you'll also see in my other answers, this is primarily due to how the insurance agency is setup with big pharma. They charge what you'll/insurance will pay (which with no regulations and oversight, is whatever the insurance company/pharma company chooses to charge).
I'm not sure if you're experienced and knowledgeable in this but what are your thoughts on IP laws surrounding pharmaceuticals? Do you think certain IP laws are too strict for consumers and aren't actually necessary to ensure R&D. Do you think with stricter IP laws there would be even more R&D? What do you think the right balance is? What if there was no IP at all? Do you feel because of IP there's too much focus on drugs that can patented rather than procedures that can cure?
I have had some interactions with IP laws with some of the universities we collaborate with. It's a very tricky subject. While IP laws can hinder and restrict translational science, it is a necessary evil. Without IP laws it would be very easy for competing pharma companies to simply design/create analogs of your drugs (biosimilars are all the craze now a days) and to sell them as your own (the same goes for various techniques that may be used to formulate your drug). On the other hand, I have seen promising therapeutics take years to come to the industry and into clinical trials because of all the legal paperwork and documentation for IP laws. I don't know what the right balance is, but as it stands, I definitely think it needs to be restructured.
Every medicine's have a load of side effect listed. Does whoever write those actually test and experiment to be sure that the side effect really occurs? Or do those people just write anything that might occur just to be safe?
Also, could you provide a bit more proof. I know the part about wanting to be anonymous, but could maybe take a photo from within the building.
The side effects come from the clinical trails conducted. There are hundreds to thousands of patients throughout these trails, and feedback is obtained from all of them. That being said, the reason so many medication have so many side effects is because they aren't very specific. A lot of drugs take a shotgun approach to the problem, and target a class of receptors or proteins, rather than targeting one individual receptor. The entire goal is designing drugs that are more selective, but that's easier said than done, and we are slowly getting there (e.g. benadryl versus Claritin)
When will Big Pharma get into Cannabis derivative medicine programs?
There is honestly not much known about the specific derivatives of cannabis (which receptors do they activate, how do they interact with them specifically). Furthermore, cannabis is really unselective, including its compounds. One of the issues is the difficulty in researching cannabis, it's actually on some level harder to research cannabis than it is opiods and amphetamines, due to it's schedule I status. Until some serious research is put into these derivatives, and the government laxes its stance on cannabis in general, I doubt any big pharma company would invest into even looking into cannabis.
Have you ever had any run-in with the antivax loons?
Personally, no. I will say this, as a scientist, I find the entire antivax craze incredibly upsetting. A lot of time, research, and money goes into creating vaccines, all in the name of the betterment of the world (they really aren't that profitable). To see all this hard work and effort going to waste because of misinformation and pseudoscience is definitely upsetting. In terms of business, the higher up business men don't care at all for it.
How often are the new treatments for schizophrenia that make it past the trials actually new versus a slight reformulation the way insulin is treated? I have heard that almost all treatments are based on similar principles but I did not respond positively to over 10 different medications. The 11th or 12th one was life-changing although without aid I would be completely unable to afford it because a month's supply is well over a thousand dollars without insurance.
Im afraid I'm not super knowledgeable when it comes to schiznophrenia medication (we don't have any in our pipeline nor in clinical trails right now. The issue with schizophrenia is how poorly it's understood. A lot of the drugs are actually targeting the exact receptors they're supposed too, the exact cause of schiznophrenia is variable amongst patients (i.e. there is no one schiznophrenia). Most of the medication do act more or less on the same dopamine receptors, but there are a handful out there that also effect other dopamine and seritonin receptors. The issue here is what is causing your schiznophrenia (which we don't know yet and can't determine yet), and then you can use the appropriate drug to target it. Currently, it's a shotgun approach, try to target all the ones we know about and cycle patients through various medication until you find one that works.
do you get to hear any success or failure stories about the drugs?
Lots and lots of failure stories, with a few success stories. I can put it to you this way, we've had over 50+ drugs go into clinical trails in the past 20 years, only 3 have been approved. From my department alone we've had 2 drugs in the past 10 years reach clinical, and they both failed in phase II.
Are there companies that want to permanently cure a disease but are held back because some CEO's want to maximise profits?
Also, and I know you probably answered questions on this, what are your opinions on the pandemic of Anti - Vaxers?
I don't know what you mean by companies? We definitely have scientists within our own company (singular) that want to focus on a particular disease, or a particular drug, but at the end of the day it all falls on whether A) there is any profit in it and B) whether there is enough information on it. We have a team whose job it is to scour the literature and determine suitable drug targets. Based off this literature, and what diseases are effected by the target, we determine whether its suitable for us to pursue efforts in trying to create drugs to target it. The CEOs themselves know very little about any given project at any given time, they leave it up to the project managers to find suitable leads and pursue them. So there is no CEO coming down telling us what to look into or how (although the higher ups do tell me sometimes how to do my job, which considering they don't even know half of what goes on, is quite frustrating/annoying).
Yes, I have already answered the anti-vax craze in another answer.
How many deaths do you personally take responsibility for?
Zero. As stated in the other answers, I have zero control regarding clinical trials and distribution. For various of our compouds I have discussed and addressed the various dangers and side effects to the companies running the clinical trails, but outside of that I don't have any power.
Are you able to get any drugs you Want? :)
No. While we do have a manufacturing department, that is located in another city. Our building only focuses on R&D, and while we have a lot of chemicals and even medicinal compounds here (a large variety of antibiotics for example), I would not recommend consuming any of them (they are all lab grade). I go to the pharmacy for my medicine.
Are you using a lot of single use now or still stainless? I work somewhere that supplies you. :)
I don't exactly know what this question is asking. If you are discussing lab materials, it's a mix. Most of our items used (syringes, tips, eppendorfs, etc.) are single use, but we do have some stainless steel items we use frequently.
Just curious, what is considered the success /failure ratio for a drug in clinical trials? For instance, say 100 people take the drug x while its in clinical trials, if it works flawless for 50% is it good enough or does it need to be 80+%.
I don't know the exact details since we don't conduct the trails themselves. That said, the FDA does have specific guidelines and regulations for the side effects and efficacy of a drug, unfortunately I don't know those off the top of my head. What I do know is, very high failure rate, low success rate for most drugs that are developed.