Drug Development Process: A Primer

“Americans only care when white people die,” was one of the reactions I heard last week when the news reported that two Americans recovered from Ebola after receiving a “secret serum.”  At first, I also didn’t believe it.  It suggested that the West was stockpiling a “cure” and was indifferent to deaths of poor Africans.

Constant Gardener

Once the validity of the report was confirmed, I thought faceless Americans or the drug companies were in a Catch-22.  By giving the drug to these white Americans, they were accused of favoritism; by not giving the drug out earlier, they could also be accused of experimenting on poor Africans if the serum didn’t work.  In fact, this is basically (SPOILER ALERT)  the plot of the John Le Carre’s The Constant Gardener.   It’s also reminiscent of how the US government did conduct experiments on poor blacks in the South from 1932 to 1972 who thought they were receiving free health care.

Weak Copyright Laws

I’ve learned that in Ghana and other countries with weak copyright laws that people do not appreciate the time and resources that go into the production of anything that relies on intellectual property.  The most egregious examples are software, music, film, and TV series that can be easily copied.  Good luck trying to sell an original copy of Microsoft Office Suite in China!  Many Ghanaians I encountered thought movies were only worth paying maybe $1 for.  I’m sure they would be surprised to learn that a typical episode of Game of Thrones costs $6 million.  All that money goes in for costumes, bringing a crew to fantastic locations in Iceland and Ireland, and paying for actors.  Thus, a season of Game of Thrones is $60 million.  Similarly, Tom Cruise’s Mission Impossible: Ghost Protocol cost $145 million.

Scientific Research Process

Center for Disease Control laboratory conditions

Center for Disease Control laboratory conditions

Now, imagine trying to do something important: saving human lives.  Creating a vaccine or ‘secret serum’ involves several steps including: figuring out how the pathogen — Ebola virus, in this case — infects its host, probably studying the pathogen’s life cycle, then determining if there are any ‘weaknesses’ that the pathogen may exhibit.  Scientists then make hypotheses on how they can attack these weaknesses and test them in a living organism. Typically, they start with organisms that no one cares about, e.g. yeast, then work their way up to mice, monkeys, chimps, and then finally humans.  (I believe scientific research in Europe follows a similar process.)

Each experiment is done more than once to determine if the results are reproducible.  If they get encouraging results, then they may expand the size of the population under study.  If results cannot be reproduced, then the scientists review what happened and determine if they should continue on that line of research or start over.

Once the researchers begin experimenting on humans, then they must adhere to federal guidelines on how to do them properly.  This process is called “clinical trials.”

Source: Cancer Information and Support Network

Source: Cancer Information and Support Network

Recall that for Ebola, the scientists have to do all of their experiments while wearing ‘space suits’ because they don’t want to get infected.

Cost of Research

I’ve muddled which of these experiments are paid for by the federal government and those paid for by pharmaceutical companies because for each drug, it depends.  Generally, the earlier in the process, the more the research is supported by the federal government.

For some long-standing diseases like cancer, I wouldn’t be surprised if the cost of research to date approached a trillion dollars.  The National Cancer Institute (USA)’s 2013 research budget was $4.9 billion.  That’s just public funding for cancer research in the USA for one year.   You need to also consider private funding (corporations) and the fact that cancer research has been going on for decades (> 50 years).

Eventually, the ‘research football’ is handed off to private corporations who then risk shareholder funds on prospective drugs.

According to Forbes, the cost of bringing a drug to market is $5 billion.  Given the high cost of bringing a drug to market, the pharmaceutical companies are looking to solve diseases that kill or impair large populations – cancer, arthritis, heart disease, HIV/AIDS.

Long ago, I worked in a research lab.  I recall someone saying that drug companies may actually shy away from some of the headline grabbing diseases because if you actually found a cure for AIDS, then the public would demand that the price be ‘reasonable.’  Of course, what is ‘reasonable’? In fact, that debate is going on over Gilead Sciences’ Hepatitis C drug, Sovaldi, which costs $84,000 for a 12-week treatment. It cures you but how many people have that type of money laying around?  Thank goodness for insurance companies.

Innovation Belongs To Those Who Respect Intellectual Property

Given the high cost of drug development, it’s not surprising that there are not any leading pharmaceutical companies in China, India, nor Africa.  The list is dominated by the USA, Japan, and Germany.  Why would any company in the first list even bother creating something new if other companies in the same country could just rip off their work? Wikipedia states that much of the Chinese drug companies focus on generic drugs — those drugs that have lost patent protection — because intellectual property is not respected.

No Cure Yet

Fortunately, Ebola and all its variants have ‘only’ killed less than 3,000 people over 40 years.  This could explain why there is no cure for Ebola yet.  Though it’s a horrible way to die, Ebola — prior to this outbreak — was not lethal enough to show up on drug companies’ radars.

2011 Leading Causes of Death in USA – Total Deaths: 2.5 million

  • Heart disease: 596,577
  • Cancer: 576,691
  • Chronic lower respiratory diseases: 142,943
  • Stroke (cerebrovascular diseases): 128,932
  • Accidents (unintentional injuries): 126,438
  • Alzheimer’s disease: 84,974
  • Diabetes: 73,831
  • Influenza and Pneumonia: 53,826
  • Nephritis, nephrotic syndrome, and nephrosis: 45,591
  • Intentional self-harm (suicide): 39,518

 Source: Centers for Disease Control (CDC)

 

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  1. Pingback: Regulatory Submissions – Risks and Challenges | Panacea

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