Unearthing the Truth about the Drugs on the Market: A Medication’s Arduous Journey to Meet the Consumers

David Lipson

Pulmonary & Critical Care Physician/ Clinical Researcher at a Global Pharmaceutical Company

(Wynnewood, PA)

Dr. Lipson and I met at one of Saturday morning spin classes taught by Kevin Michael.  He had this gentle openness and friendliness about him that compelled me to approach him with lightning efficiency.  I think I said, “Hello. What do you do for a living?  Do you love what you do?” in one breath.  Thankfully, he didn’t seem taken aback by my directness.  When he said he loved his work and had dual posts as a physician in academia and a clinical researcher for a pharmaceutical company, I became truly intrigued and the phrase, “CONFLICT OF INTEREST” lit up like holiday lights in my middle-aged gray matter.  I was super excited when he agreed to be my subject.   We met up a couple of weeks later at our gym’s café one morning. 

Dr. David Lipson

Hazel:  Thanks so much for coming out to meet me, David! 

David:  No problem, Hazel.

Hazel:  What kind of physician are you, David?

David:  I’m a pulmonary and critical care doctor.

Hazel:  How did you decide on your specialty?

David:  While I was an intern in internal medicine residency training, there was this attending (fully-trained) pulmonologist who was super smart and had an excellent bed side manner.  He took a great care of the patients.  I really looked up to him and wanted to be like him. 

Thus, after finishing the 3-year internal medicine residency, I continued on and did 3.5 years of pulmonary and critical care fellowship.  I chose my sub-specialty because it is the broadest and one of the most general of the internal medicine specialties.  It compasses all lung diseases AND systemic diseases that could affect the lungs which means not limited to just looking at lungs.  I like that a lot. It keeps things interesting.  There are so many things I’ve had to learn and there is less repetition involved when seeing patients and cases. 

Hazel: I know you work as a clinician at University of Pennsylvania (Penn).  How often do you see patients?

David:  I now only see patients about 2 to 3 times a month because of my full-time job with the pharmaceutical company.   I primarily supervise and educate fellows at a pulmonary clinic. 

Hazel:  That makes sense.  I was thinking about this for the past two weeks… Does the medical school allow you to have joint appointment with a pharmaceutical company?  I thought that was a conflict of interest.

David:  I have not done research for Penn since taking the job in the pharmaceutical industry and only see patients and educate residents and fellows.  I do not see this as a conflict of interest.  My work in the clinic keeps my skills at a high level and allows me to know what is clinically relevant.  That helps me in industry in determining current unmet medical need.  I can also provide a different perspective for the fellows as they try to determine their career paths when they finish their training.

Hazel:  Thank you for your clarification. Makes perfect sense! What made you want to take the job with the pharmaceutical company?

David:  I was actually quite happy at my post with Penn and was on the full time faculty for about 8 years prior to moving to industry.  I thought I would stay forever.  Then, in 2006, a former coworker and faculty member at Penn who transitioned fully to the pharmaceutical industry (pharma) about 9 months prior contacted me.  She was a good friend and wanted me to have lunch with her at the pharmaceutical company’s campus.  She said I should meet some of her company’s people.  When I expressed that I was not looking for a job there, she said it would be worthwhile to at least meet them.  So I had a nice meet and greet lunch with them.  The lunch turned into an informal interview and one of the executives asked me, “Why do you want to leave Penn?”  And I said, “I don’t!  I’m happy where I am!”

Hazel:  But knowing the ending of the story, what changed your mind?

David:  One-on-one patient interaction was what I loved the most about being a physician.  But there was a limitation to how much I could help as there were only so many people I could see in a day, or a week, or a month.  In industry, I realized I could affect the lives of millions of people. My impact and contribution could be so much greater.  That scale was one that I had not considered before.  I didn’t sleep for two weeks contemplating what I should do.  In the end, the magnitude of impact I could have in helping people around the world was what made me want to join the pharmaceutical industry.

Hazel:  I could understand and respect your decision.  What do you exactly do for the pharmaceutical company?

David:  I’m a part of research and development (R&D) side of the company.  I design clinical trials to show a drug’s efficacy, safety, potential side effects and compliance with various medical governance.  I also share the clinical trial results with applicable regulatory agencies such as Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, etc.  My team and I try to bring excellent medicines to people around the world.

Hazel:  A potentially sensitive question… I must bring up the phrase “conflict of interest” again.  Do you ever feel pressured to show results to align them with what the pharmaceutical company wants to see?

David:  Absolutely no.  There are so many people involved in the whole process of gathering and analyzing the data from the trials.  Actually, a pharmaceutical company wants to identify potential problems with a drug as soon as possible, and not when a large trial is ongoing.  We absolutely want to ensure the safety of patients participating in our trials – that is of paramount importance. From a cost perspective, it is also much better to stop development of a drug that isn’t going to make it as a medicine as early as possible.

Hazel:  This makes me feel so relieved.  I’m sure whoever is reading this would feel the same.  I want to know more about the process of how a drug gets developed.  Can you walk me through it?

David:  Good to hear that.  I’d be happy to tell you the process.  Please note that at any given point, the drug development can cease and it often does.  (Note: I took the liberty of writing down the stages in the following format.)

  • Biologists look at different pathways identified as being linked to a disease to determine if there may be a way to alter the course of a disease.  For example, they explore the idea of blocking receptors, altering hormones, or isolating a gene product.
  • Medical chemists then develop specific chemicals, like small molecules or biologic therapies to try to impact that pathway identified by biologists. 
  • Preclinical scientists test the new molecules developed by medical chemists in animals.  The Safety department of the company would test pre-clinical safety and monitor how the chemicals are tolerated by the animals.

Hazel:  I have to interrupt you.  Do you ever feel conflicted about testing on animals?

David:  I do feel conflicted because I’m an animal lover but we may need to test these medicines with animals to advance science in search of a solution for a particular disease.  What’s important is to minimize the usage of animals as much as we can but it often cannot be avoided altogether. 

Hazel:  Thank you for addressing my question.  Please go on.

David:  After pre-clinical testing, we move onto:

  • Phase 1A – This is the first time in human study phase.  Healthy volunteers are tested.  Volunteers are usually compensated.  They are explained of potential risks associated with the study before we receive consent from them.
  • Phase 1B – This is the first patient study phase.  We are trying to figure out if the drug we are trying to develop has any impact on the disease with the targeted patients. 
  • Phase 2A – This phase is called “proof of concept”.  It’s a larger patient study.  We try to understand the safety and efficacy of the drug in patients being tested in a larger scale than 1B.  Note that an entirely different pool of patients is used at every phase.   
  • Phase 2B – This phase is called “dose ranging”.  We try to determine the optimal amount of drug to be given.  The key is to find the least amount to be administered that would be effective. 
  • Phase 3 – This phase is called “registration trial”. This is targeted really to prove safety and efficacy of the drug for regulatory agencies such as the FDA.  A trial would have a large number of patients proving that medicine is doing what we say it should be doing, and helping ensure the safety and tolerability of the drug.
  • We then file a new drug application (NDA) with the required regulatory agencies such as the FDA.  This phase is interactive in that we have to go meet with the agency in person.  We have to bring data, our interpretations and analyses of the results and answers to any questions they might have raised prior to meeting.  Usually, there are multiple rounds of questions addressed in person, via email and over conference calls.
  • We receive an official approval for use of the drug from the applicable regulatory agency. We also receive the drug label.  It’s the white folded sheet in every medicine you buy.  It explains all the testing and analyses ever done for the drug before being on the market.
  • Phase 4 – This is usually an optional but at times required by the regulatory agency.  We do a comparative study with other drugs that are on the market that treat the same condition/disease.  It’s helpful for a physician to determine order of use for different drugs for treatment.  It’s for the physicians to decide the best course of drug administration. 
  • The pharmaceutical company works with advertising and commercial agencies to commercialize the drug.  The advertising and commercials have to be in compliance with regulatory requirements in that the claims made are consistent with what’s on the label.  The regulatory agency would not allow anything that is not consistent with the label to be stated.  At the same time, it’s being commercialized and publicized, the drug gets manufactured.  Note that not all countries allow direct marketing to consumers.  The U.S. does but some countries don’t allow that.

Hazel:  Wow!  So many steps.  I should really read the label the next time I get a medicine.  I’ve never tried reading one before.  Thank you for explaining to me all the steps of developing a drug!  I’m curious to know, how long does it usually take, all the steps from the inception of an idea to getting a drug label?

David:  It can take 10-12 years or more for a drug to come to market from initial idea phase.  Each phase can take up to a few years.

Hazel:  That’s a really long time.  So here is another question.  What if there are conflicting results from studies conducted by different pharmaceutical companies trying to develop a solution to combat the same disease?  What happens then?

David:  We are very transparent and present the data to the medical research community. The medical community will evaluate the data and determine how it should be interpreted. 

Hazel:  When you said the drug development process can stop at any phase, how often does an idea of a drug actually make it all the way to production and distribution to consumers?

David:  I’m not sure about all the way to the end but certainly less than 10% of drugs in clinical trials will get approved. 

Hazel:  That’s a small number of success.  It must be tough at times to deal with it.

David:  Yes.  In order to be in drug development, you have to be Okay with failures especially for early stages.  You have to enjoy the journey of getting to a solution but not necessarily getting to the solution on your first try.

Hazel:  That sounds wise.  Which phases are you involved in developing a drug?  I’m assuming you wouldn’t be involved in every stage as there are too many. 

David:  My role has shifted a bit over the years.  I now come in later phase development around Phase 2 and 3 in the clinical research cycle.  I used to be involved in earlier stages of drug development.

Hazel:  What do you find to be the most exciting thing about your job at the pharmaceutical company? 

David:  I get excited by the prospect of bringing new medicine to patients.  I see the pharmaceutical industry as a vehicle to allow me to help improve the lives of patients with disease all over the world.

Hazel:  What has been the biggest achievement in your career with the pharmaceutical company?

David:  My team and I helped get a medicine called Trelegy for patients with smoking related lung disease approved by regulatory agencies in part by designing and executing a very large study. 

Hazel:  How large?

David:  It was 10,355 patient study conducted in 37 countries to better understand the efficacy and safety of the medicine.  It is regarded as one of the biggest clinical registration respiratory trials ever conducted.  I was the lead physician for the study and it took 3 years to complete.  This study was part of the Phase 3 of the drug development.  The entire Phase 3 for this medicine took 6 years. 

Hazel:  Wow!  I’m just astounded by all the numbers you’ve mentioned!!  That must have been one super expensive study!!

David:  Yes, it was.  And certainly a study of this magnitude could not have been possible without the funding from industry.  People need to understand how expensive clinical trials are, and understand that funding for research and development of the next set of drugs comes in part from medicine sales. 

Hazel:  I totally agree and realize that publicly funded (tax payer funded) research grant amounts from institutions such as the National Institute of Health (NIH) could not possibly allow such grand scale research.  Did you get your results published in any journals?

David:  Yes.  In fact, we were able to publish it with New England Journal of Medicine in 2018!  I was the first author. (Note:  New England Journal of Medicine is the crown jewel of the medical research journals.  Getting one’s research published even once in it is a major career achievement.  Being the first author indicates you took the lead on the research.)   

Hazel:  Oh my goodness!  My biggest congratulations to you!  What an achievement!  As a final thought.  What is the hottest topic in the pulmonary disease world right now?

David:  We are trying to better understand the role genetics play in pulmonary diseases.  We are trying to identify biological mechanisms behind the diseases and trying to figure out how the diseases start and find ways to impact different pathways. 

I’m so thankful that Dr. Lipson agreed to be part of my project.  Without having the above conversation with this accomplished physician and researcher, I could not have gotten much needed assurance about the drugs that we buy.  I also hope that this interview will help lessen the bias some may have against drug company funded clinical research.  Cheers to advancement in medical research! 

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